Last updated on September 3rd, 2024 at 11:47 pm
Title 42—Public Health–Volume 1
CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A—GENERAL PROVISIONS
PART 2—CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS
Subpart A—Introduction
Title 42, United States Code, section 290dd-2(g) authorizes the Secretary to prescribe regulations to carry out the purposes of section 290dd-2. Such regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection 290dd-2(b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the purposes of section 290dd-2, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.
§ 2.2 Purpose and effect.
(a) Purpose. Pursuant to 42 U.S.C. 290dd-2(g), the regulations in this part impose restrictions upon the use and disclosure of substance use disorder patient records (“records,” as defined in this part) which are maintained in connection with the performance of any part 2 program. The regulations in this part include the following subparts:
(1) Subpart B: General Provisions, including definitions, applicability, and general restrictions;
(2) Subpart C: Uses and Disclosures With Patient Consent, including uses and disclosures that require patient consent and the consent form requirements;
(3) Subpart D: Uses and Disclosures Without Patient Consent, including uses and disclosures which do not require patient consent or an authorizing court order; and
(4) Subpart E: Court Orders Authorizing Use and Disclosure, including uses and disclosures of records which may be made with an authorizing court order and the procedures and criteria for the entry and scope of those orders.
(b) Effect. (1) The regulations in this part prohibit the use and disclosure of records unless certain circumstances exist. If any circumstance exists under which use or disclosure is permitted, that circumstance acts to remove the prohibition on use and disclosure but it does not compel the use or disclosure. Thus, the regulations in this part do not require use or disclosure under any circumstance other than when disclosure is required by the Secretary to investigate or determine a person’s compliance with this part pursuant to § 2.3(c).
(2) The regulations in this part are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. They are intended to ensure that a patient receiving treatment for a substance use disorder in a part 2 program is not made more vulnerable by reason of the availability of their record than an individual with a substance use disorder who does not seek treatment.
(3) The regulations in this part shall not be construed to limit:
(i) A patient’s right, as described in 45 CFR 164.522, to request a restriction on the use or disclosure of a record for purposes of treatment, payment, or health care operations.
(ii) A covered entity’s choice, as described in 45 CFR 164.506, to obtain the consent of the patient to use or disclose a record to carry out treatment, payment, or health care operations.
§ 2.3 Civil and criminal penalties for violations.
(a) Penalties. Any person who violates any provision of 42 U.S.C. 290dd-2(a)-(d), shall be subject to the applicable penalties under sections 1176 and 1177 of the Social Security Act, 42 U.S.C. 1320d-5 and 1320d-6.
(b) Limitation on criminal or civil liability. A person who is acting on behalf of an investigative agency having jurisdiction over the activities of a part 2 program or other person holding records under this part (or employees or agents of that part 2 program or person holding the records) shall not incur civil or criminal liability under 42 U.S.C. 290dd-2(f) for use or disclosure of such records inconsistent with this part that occurs while acting within the scope of their employment in the course of investigating or prosecuting a part 2 program or person holding the record, if the person or investigative agency demonstrates that the following conditions are met:
(1) Before presenting a request, subpoena, or other demand for records, or placing an undercover agent or informant in a health care practice or provider, as applicable, such person acted with reasonable diligence to determine whether the regulations in this part apply to the records, part 2 program, or other person holding records under this part. Reasonable diligence means taking all of the following actions where it is reasonable to believe that the practice or provider provides substance use disorder diagnostic, treatment, or referral for treatment services:
(i) Searching for the practice or provider among the substance use disorder treatment facilities in the online treatment locator maintained by the Substance Abuse and Mental Health Services Administration.
(ii) Searching in a similar state database of treatment facilities where available.
(iii) Checking a provider’s publicly available website, where available, or its physical location to determine whether in fact such services are provided.
(iv) Viewing the provider’s Patient Notice or the Health Insurance Portability and Accountability Act (HIPAA) Notice of Privacy Practices (NPP) if it is available online or at the physical location.
(v) Taking all these actions within a reasonable period of time (no more than 60 days) before requesting records from, or placing an undercover agent or informant in, a health care practice or provider.
(2) The person followed all of the applicable provisions in this part for any use or disclosure of the received records under this part that occurred, or will occur, after the person or investigative agency knew, or by exercising reasonable diligence would have known, that it received records under this part.
(c) Enforcement. The provisions of 45 CFR part 160, subparts C, D, and E, shall apply to noncompliance with this part in the same manner as they apply to covered entities and business associates for noncompliance with 45 CFR parts 160 and 164.
§ 2.4 Complaints of noncompliance.
(a) Receipt of complaints. A part 2 program must provide a process to receive complaints concerning the program’s compliance with the requirements of this part.
(b) Right to file a complaint. A person may file a complaint to the Secretary for a violation of this part by a part 2 program, covered entity, business associate, qualified service organization, or lawful holder in the same manner as a person may file a complaint under 45 CFR 160.306 for a violation of the administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
(c) Refraining from intimidating or retaliatory acts. A part 2 program may not intimidate, threaten, coerce, discriminate against, or take other retaliatory action against any patient for the exercise by the patient of any right established, or for participation in any process provided for, by this part, including the filing of a complaint under this section or § 2.3(c).
(d) Waiver of rights. A part 2 program may not require patients to waive their right to file a complaint under this section or § 2.3 as a condition of the provision of treatment, payment, enrollment, or eligibility for any program subject to this part.
Subpart B—General Provisions
§ 2.11 Definitions.
For purposes of the regulations in this part:
Breach has the same meaning given that term in 45 CFR 164.402.
Business associate has the same meaning given that term in 45 CFR 160.103.
Central registry means an organization which obtains from two or more member programs patient identifying information about individuals applying for withdrawal management or maintenance treatment for the purpose of avoiding an individual’s concurrent enrollment in more than one treatment program.
Covered entity has the same meaning given that term in 45 CFR 160.103.
Diagnosis means any reference to an individual’s substance use disorder or to a condition which is identified as having been caused by that substance use disorder which is made for the purpose of treatment or referral for treatment.
Disclose means to communicate any information identifying a patient as being or having been diagnosed with a substance use disorder, having or having had a substance use disorder, or being or having been referred for treatment of a substance use disorder either directly, by reference to publicly available information, or through verification of such identification by another person.
Federally assisted—see § 2.12(b).
Health care operations has the same meaning given that term in 45 CFR 164.501.
HIPAA means the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the privacy and security provisions in subtitle D of title XIII of the Health Information Technology for Economic and Clinical Health Act, Public Law 111-5 (“HITECH Act”).
HIPAA regulations means the regulations at 45 CFR parts 160 and 164 (commonly known as the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules or “HIPAA Rules”).
Informant means a person:
Informant means a person:
(1) Who is a patient or employee of a part 2 program or who becomes a patient or employee of a part 2 program at the request of a law enforcement agency or official; and
(2) Who at the request of a law enforcement agency or official observes one or more patients or employees of the part 2 program for the purpose of reporting the information obtained to the law enforcement agency or official.
Intermediary means a person, other than a part 2 program, covered entity, or business associate, who has received records under a general designation in a written patient consent to be disclosed to one or more of its member participant(s) who has a treating provider relationship with the patient.
Investigative agency means a Federal, state, Tribal, territorial, or local administrative, regulatory, supervisory, investigative, law enforcement, or prosecutorial agency having jurisdiction over the activities of a part 2 program or other person
holding records under this part.
Lawful holder means a person who is bound by this part because they have received records as the result of one of the following:
(1) Written consent in accordance with § 2.31 with an accompanying notice of disclosure.
(2) One of the exceptions to the written consent requirements in 42 U.S.C. 290dd-2 or this part.
Maintenance treatment means long-term pharmacotherapy for individuals with substance use disorders that reduces the pathological pursuit of reward and/or relief and supports remission of substance use disorder-related symptoms.
Member program means a withdrawal management or maintenance treatment program which reports patient identifying information to a central registry and which is in the same state as that central registry or is in a state that participates in data sharing with the central registry of the program in question.
Minor, as used in the regulations in this part, means an individual who has not attained the age of majority specified in the applicable state law, or if no age of majority is specified in the applicable state law, the age of 18 years.
Part 2 program means a federally assisted program (federally assisted as defined in § 2.12(b) and program as defined in this section). See § 2.12(e)(1) for examples.
Part 2 program director means:
(1) In the case of a part 2 program that is a natural person, that person.
(2) In the case of a part 2 program that is an entity, the person designated as director or managing director, or person otherwise vested with authority to act as chief executive officer of the part 2 program.
Patient means any individual who has applied for or been given diagnosis, treatment, or referral for treatment for a substance use disorder at a part 2 program. Patient includes any individual who, after arrest on a criminal charge, is identified as an individual with a substance use disorder in order to determine that individual’s eligibility to participate in a part 2 program. This definition includes both current and former patients. In this part where the HIPAA regulations apply, patient means an individual as that term is defined in 45 CFR 160.103.
Patient identifying information means the name, address, Social Security number, fingerprints, photograph, or similar information by which the identity of a patient, as defined in this section, can be determined with reasonable accuracy either directly or by reference to other information.
Payment has the same meaning given that term in 45 CFR 164.501.
Person has the same meaning given that term in 45 CFR 160.103.
Personal representative means a person who has authority under applicable law to act on behalf of a patient who is an adult or an emancipated minor in making decisions related to health care. Within this part, a personal representative would have authority only with respect to patient records relevant to such personal representation.
Program means:
(1) A person (other than a general medical facility) that holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or
(2) An identified unit within a general medical facility that holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or
(3) Medical personnel or other staff in a general medical facility whose primary function is the provision of substance use disorder diagnosis, treatment, or referral for treatment and who are identified as such providers.
Public health authority has the same meaning given that term in 45 CFR 164.501.
Qualified service organization means a person who:
(1) Provides services to a part 2 program, such as data processing, bill collecting, dosage preparation, laboratory analyses, or legal, accounting, population health management, medical staffing, or other professional services, or services to prevent or treat child abuse or neglect, including training on nutrition and child care and individual and group therapy, and
(2) Has entered into a written agreement with a part 2 program under which that person:
(i) Acknowledges that in receiving, storing, processing, or otherwise dealing with any patient records from the part 2 program, it is fully bound by the regulations in this part; and
(ii) If necessary, will resist in judicial proceedings any efforts to obtain access to patient identifying information related to substance use disorder diagnosis, treatment, or referral for treatment except as permitted by the regulations in this part.
(3) Qualified service organization includes a person who meets the definition of business associate in 45 CFR 160.103, paragraphs (1), (2), and (3), for a part 2 program that is also a covered entity, with respect to the use and disclosure of protected health information that also constitutes a “record” as defined by this section.
Records means any information, whether recorded or not, created by, received, or acquired by a part 2 program relating to a patient (e.g., diagnosis, treatment and referral for treatment information, billing information, emails, voice mails, and texts), and including patient identifying information, provided, however, that information conveyed orally by a part 2 program to a provider who is not subject to this part for treatment purposes with the consent of the patient does not become a record subject to this part in the possession of the provider who is not subject to this part merely because that information is reduced to writing by that provider who is not subject to this part. Records otherwise transmitted by a part 2 program to a provider who is not subject to this part retain their characteristic as records in the hands of the provider who is not subject to this part, but may be segregated by that provider.
Substance use disorder (SUD) means a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues using the substance despite significant substance-related problems such as impaired control, social impairment, risky use, and pharmacological tolerance and withdrawal. For the purposes of the regulations in this part, this definition does not include tobacco or caffeine use.
Substance use disorder (SUD) counseling notes means notes recorded (in any medium) by a part 2 program provider who is a SUD or mental health professional documenting or analyzing the contents of conversation during a private SUD counseling session or a group, joint, or family SUD counseling session and that are separated from the rest of the patient’s SUD and medical record. SUD counseling notes excludes medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date.
Third-party payer means a person, other than a health plan as defined at 45 CFR 160.103, who pays or agrees to pay for diagnosis or treatment furnished to a patient on the basis of a contractual relationship with the patient or a member of the patient’s family or on the basis of the patient’s eligibility for Federal, state, or local governmental benefits.
Treating provider relationship means that, regardless of whether there has been an actual in-person encounter:
(1) A patient is, agrees to be, or is legally required to be diagnosed, evaluated, or treated, or agrees to accept consultation, for any condition by a person; and
(2) The person undertakes or agrees to undertake diagnosis, evaluation, or treatment of the patient, or consultation with the patient, for any condition.
Treatment has the same meaning given that term in 45 CFR 164.501.
Undercover agent means any federal, state, or local law enforcement agency or official who enrolls in or becomes an employee of a part 2 program for the purpose of investigating a suspected violation of law or who pursues that purpose after enrolling or becoming employed for other purposes.
Unsecured protected health information has the same meaning given that term in 45 CFR 164.402.
Unsecured record means any record, as defined in this part, that is not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary in the guidance issued under Public Law 111-5, section 13402(h)(2).
Use means, with respect to records, the sharing, employment, application, utilization, examination, or analysis of the information contained in such records that occurs either within an entity that maintains such information or in the course of civil, criminal, administrative, or legislative proceedings as described at 42 U.S.C. 290dd-2(c).
Withdrawal management means the use of pharmacotherapies to treat or attenuate the problematic signs and symptoms arising when heavy and/or prolonged substance use is reduced or discontinued.
§ 2.12 Applicability.
(a) General— (1) Restrictions on use and disclosure. The restrictions on use and disclosure in the regulations in this part apply to any records which:
(i) Would identify a patient as having or having had a substance use disorder either directly, by reference to publicly available information, or through verification of such identification by another person; and
(ii) Contain substance use disorder information obtained by a federally assisted substance use disorder program after March 20, 1972 (part 2 program), or contain alcohol use disorder information obtained by a federally assisted alcohol use disorder or substance use disorder program after May 13, 1974 (part 2 program); or if obtained before the pertinent date, is maintained by a part 2 program after that date as part of an ongoing treatment episode which extends past that date; for the purpose of treating a substance use disorder, making a diagnosis for that treatment, or making a referral for that treatment.
(2) Restriction on use or disclosure. The restriction on use or disclosure of information to initiate or substantiate any criminal charges against a patient or to conduct any criminal investigation of a patient (42 U.S.C. 290dd-2(c)) applies to any information, whether or not recorded, which is substance use disorder information obtained by a federally assisted substance use disorder program after March 20, 1972 (part 2 program), or is alcohol use disorder information obtained by a federally assisted alcohol use disorder or substance use disorder program after May 13, 1974 (part 2 program); or if obtained before the pertinent date, is maintained by a part 2 program after that date as part of an ongoing treatment episode which extends past that date; for the purpose of treating a substance use disorder, making a diagnosis for the treatment, or making a referral for the treatment.
(b) Federal assistance. A program is considered to be federally assisted if:
(1) It is conducted in whole or in part, whether directly or by contract or otherwise by any department or agency of the United States (but see paragraphs (c)(1) and (2) of this section relating to the Department of Veterans Affairs and the Uniformed Services);
(2) It is being carried out under a license, certification, registration, or other authorization granted by any department or agency of the United States including but not limited to:
(i) Participating provider in the Medicare program;
(ii) Authorization to conduct maintenance treatment or withdrawal management; or
(iii) Registration to dispense a substance under the Controlled Substances Act to the extent the controlled substance is used in the treatment of substance use disorders;
(3) It is supported by funds provided by any department or agency of the United States by being:
(i) A recipient of federal financial assistance in any form, including financial assistance which does not directly pay for the substance use disorder diagnosis, treatment, or referral for treatment; or
(ii) Conducted by a state or local government unit which, through general or special revenue sharing or other forms of assistance, receives federal funds which could be (but are not necessarily) spent for the substance use disorder program; or
(4) It is assisted by the Internal Revenue Service of the Department of the Treasury through the allowance of income tax deductions for contributions to the program or through the granting of tax exempt status to the program.
(c) Exceptions— (1) Department of Veterans Affairs. These regulations do not apply to information on substance use disorder patients maintained in connection with the Department of Veterans Affairs’ provision of hospital care, nursing home care, domiciliary care, and medical services under Title 38, U.S.C. Those records are governed by 38 U.S.C. 7332 and regulations issued under that authority by the Secretary of Veterans Affairs.
(2) Uniformed Services. The regulations in this part apply to any information described in paragraph (a) of this section which was obtained by any component of the Uniformed Services during a period when the patient was subject to the Uniform Code of Military Justice except:
(i) Any interchange of that information within the Uniformed Services and within those components of the Department of Veterans Affairs furnishing health care to veterans; and
(ii) Any interchange of that information between such components and the Uniformed Services.
(3) Communication within a part 2 program or between a part 2 program and an entity having direct administrative control over that part 2 program. The restrictions on use and disclosure in the regulations in this part do not apply to communications of information between or among personnel having a need for the information in connection with their duties that arise out of the provision of diagnosis, treatment, or referral for treatment of patients with substance use disorders if the communications are:
(i) Within a part 2 program; or
(ii) Between a part 2 program and an entity that has direct administrative control over the program.
(4) Qualified service organizations. The restrictions on use and disclosure in the regulations in this part do not apply to the communications between a part 2 program and a qualified service organization of information needed by the qualified service organization to provide services to or on behalf of the program.
(5) Crimes on part 2 program premises or against part 2 program personnel. The restrictions on use and disclosure in the regulations in this part do not apply to communications from part 2 program personnel to law enforcement agencies or officials which:
(i) Are directly related to a patient’s commission of a crime on the premises of the part 2 program or against part 2 program personnel or to a threat to commit such a crime; and
(ii) Are limited to the circumstances of the incident, including the patient status of the individual committing or threatening to commit the crime, that individual’s name and address, and that individual’s last known whereabouts.
(6) Reports of suspected child abuse and neglect. The restrictions on use and disclosure in the regulations in this part do not apply to the reporting under state law of incidents of suspected child abuse and neglect to the appropriate state or local authorities. However, the restrictions continue to apply to the original substance use disorder patient records maintained by the part 2 program including their use and disclosure for civil or criminal proceedings which may arise out of the report of suspected child abuse and neglect.
(d) Applicability to recipients of information—
(1) Restriction on use and disclosure of records. The restriction on the use and disclosure of any record subject to the regulations in this part to initiate or substantiate criminal charges against a patient or to conduct any criminal investigation of a patient, or to use in any civil, criminal, administrative, or legislative proceedings against a patient, applies to any person who obtains the record from a part 2 program, covered entity, business associate, intermediary, or other lawful holder, regardless of the status of the person obtaining the record or whether the record was obtained in accordance with subpart E of this part. This restriction on use and disclosure bars, among other things, the introduction into evidence of a record or testimony in any criminal prosecution or civil action before a Federal or state court, reliance on the record or testimony to inform any decision or otherwise be taken into account in any proceeding before a Federal, state, or local agency, the use of such record or testimony by any Federal, state, or local agency for a law enforcement purpose or to conduct any law enforcement investigation, and the use of such record or testimony in any application for a warrant, absent patient consent or a court order in accordance with subpart E of this part. Records obtained by undercover agents or informants, § 2.17, or through patient access, § 2.23, are subject to the restrictions on uses and disclosures.
(2) Restrictions on uses and disclosures—(i) Third-party payers, administrative entities, and others. The restrictions on use and disclosure in the regulations in this part apply to:
(A) Third-party payers, as defined in this part, with regard to records disclosed to them by part 2 programs or under § 2.31(a)(4)(i);
(B) Persons having direct administrative control over part 2 programs with regard to information that is subject to the regulations in this part communicated to them by the part 2 program under paragraph (c)(3) of this section; and
(C) Persons who receive records directly from a part 2 program, covered entity, business associate, intermediary, or other lawful holder of patient identifying information and who are notified of the prohibition on redisclosure in accordance with § 2.32. A part 2 program, covered entity, or business associate that receives records based on a single consent for all treatment, payment, and health care operations is not required to segregate or segment such records.
(ii) Documentation of SUD treatment by providers who are not part 2 programs. Notwithstanding paragraph (d)(2)(i)(C) of this section, a treating provider who is not subject to this part may record information about a SUD and its treatment that identifies a patient. This is permitted and does not constitute a record that has been redisclosed under this part. The act of recording information about a SUD and its treatment does not by itself render a medical record which is created by a treating provider who is not subject to this part, subject to the restrictions of this part.
(e) Explanation of applicability—(1) Coverage. These regulations cover any information (including information on referral and intake) about patients receiving diagnosis, treatment, or referral for treatment for a substance use disorder created by a part 2 program. Coverage includes, but is not limited to, those treatment or rehabilitation programs, employee assistance programs, programs within general hospitals, school-based programs, and private practitioners who hold themselves out as providing, and provide substance use disorder diagnosis, treatment, or referral for treatment. However, the regulations in this part would not apply, for example, to emergency room personnel who refer a patient to the intensive care unit for an apparent overdose, unless the primary function of such personnel is the provision of substance use disorder diagnosis, treatment, or referral for treatment and they are identified as providing such services or the emergency room has promoted itself to the community as a provider of such services.
(2) Federal assistance to program required. If a patient’s substance use disorder diagnosis, treatment, or referral for treatment is not provided by a part 2 program, that patient’s record is not covered by the regulations in this part. Thus, it is possible for an individual patient to benefit from federal support and not be covered by the confidentiality regulations because the program in which the patient is enrolled is not federally assisted as defined in paragraph (b) of this section. For example, if a federal court placed an individual in a private for-profit program and made a payment to the program on behalf of that individual, that patient’s record would not be covered by the regulations in this part unless the program itself received federal assistance as defined by paragraph (b) of this section.
(3) Information to which restrictions are applicable. Whether a restriction applies to the use or disclosure of a record affects the type of records which may be disclosed. The restrictions on use and disclosure apply to any records which would identify a specified patient as having or having had a substance use disorder. The restriction on use and disclosure of records to bring a civil action or criminal charges against a patient in any civil, criminal, administrative, or legislative proceedings applies to any records obtained by the part 2 program for the purpose of diagnosis, treatment, or referral for treatment of patients with substance use disorders. (Restrictions on use and disclosure apply to recipients of records as specified under paragraph (d) of this section.)
(4) How type of diagnosis affects coverage. These regulations cover any record reflecting a diagnosis identifying a patient as having or having had a substance use disorder which is initially prepared by a part 2 program in connection with the treatment or referral for treatment of a patient with a substance use disorder. A diagnosis prepared by a part 2 program for the purpose of treatment or referral for treatment, but which is not so used, is covered by the regulations in this part. The following are not covered by the regulations in this part:
(i) Diagnosis which is made on behalf of and at the request of a law enforcement agency or official or a court of competent jurisdiction solely for the purpose of providing evidence; or
(i) Diagnosis which is made on behalf of and at the request of a law enforcement agency or official or a court of competent jurisdiction solely for the purpose of providing evidence; or
(ii) A diagnosis of drug overdose or alcohol intoxication which clearly shows that the individual involved does not have a substance use disorder (e.g., involuntary ingestion of alcohol or drugs or reaction to a prescribed dosage of one or more drugs).
§ 2.13 Confidentiality restrictions and safeguards.
(a) General. The patient records subject to the regulations in this part may be used or disclosed only as permitted by the regulations in this part and may not otherwise be used or disclosed in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, state, or local authority. Any use or disclosure made under the regulations in this part must be limited to that information which is necessary to carry out the purpose of the use or disclosure.
(b) Unconditional compliance required. The restrictions on use and disclosure in the regulations in this part apply whether or not the part 2 program or other lawful holder of the patient identifying information believes that the person seeking the information already has it, has other means of obtaining it, is a law enforcement agency or official or other government official, has obtained a subpoena, or asserts any other justification for a use or disclosure which is not permitted by the regulations in this part.
(c) Acknowledging the presence of patients: Responding to requests.(1) The presence of an identified patient in a health care facility or component of a health care facility that is publicly identified as a place where only substance use disorder diagnosis, treatment, or referral for treatment is provided may be acknowledged only if the patient’s written consent is obtained in accordance with subpart C of this part or if an authorizing court order is entered in accordance with subpart E of this part. The regulations permit acknowledgment of the presence of an identified patient in a health care facility or part of a health care facility if the health care facility is not publicly identified as only a substance use disorder diagnosis, treatment, or referral for treatment facility, and if the acknowledgment does not reveal that the patient has a substance use disorder.
(2) Any answer to a request for a disclosure of patient records which is not permissible under the regulations in this part must be made in a way that will not affirmatively reveal that an identified individual has been, or is being, diagnosed or treated for a substance use disorder. An inquiring party may be provided a copy of the regulations in this part and advised that they restrict the disclosure of substance use disorder patient records, but may not be told affirmatively that the regulations restrict the disclosure of the records of an identified patient.
§ 2.14 Minor patients.
(a) State law not requiring parental consent to treatment. If a minor patient acting alone has the legal capacity under the applicable state law to apply for and obtain substance use disorder treatment, any written consent for use or disclosure authorized under subpart C of this part may be given only by the minor patient. This restriction includes, but is not limited to, any disclosure of patient identifying information to the parent or guardian of a minor patient for the purpose of obtaining financial reimbursement. The regulations in this paragraph (a) do not prohibit a part 2 program from refusing to provide treatment until the minor patient consents to a use or disclosure that is necessary to obtain reimbursement, but refusal to provide treatment may be prohibited under a state or local law requiring the program to furnish the service irrespective of ability to pay.
(b) State law requiring parental consent to treatment.
(1) Where state law requires consent of a parent, guardian, or other person for a minor to obtain treatment for a substance use disorder, any written consent for use or disclosure authorized under subpart C of this part must be given by both the minor and their parent, guardian, or other person authorized under state law to act on the minor’s behalf.
(2) Where state law requires parental consent to treatment, the fact of a minor’s application for treatment may be communicated to the minor’s parent, guardian, or other person authorized under state law to act on the minor’s behalf only if:
(i) The minor has given written consent to the disclosure in accordance with subpart C of this part; or
(ii) The minor lacks the capacity to make a rational choice regarding such consent as determined by the part 2 program director under paragraph (c) of this section.
(c) Minor applicant for services lacks capacity for rational choice. Facts relevant to reducing a substantial threat to the life or physical well-being of the minor applicant or any other person may be disclosed to the parent, guardian, or other person authorized under state law to act on the minor’s behalf if the part 2 program director determines that:
(1) A minor applicant for services lacks capacity because of extreme youth or mental or physical condition to make a rational decision on whether to consent to a disclosure under subpart C of this part to their parent, guardian, or other person authorized under state law to act on the minor’s behalf; and
(2) The minor applicant’s situation poses a substantial threat to the life or physical well-being of the minor applicant or any other person which may be reduced by communicating relevant facts to the minor’s parent, guardian, or other person authorized under state law to act on the minor’s behalf.
§ 2.15 Patients who lack capacity and deceased patients.
(a) Adult patients who lack capacity to make health care decisions—(1) Adjudication by a court. In the case of a patient who has been adjudicated as lacking the capacity, for any reason other than insufficient age, to make their own health care decisions, any consent which is required under the regulations in this part may be given by the personal representative.
(2) No adjudication by a court. In the case of a patient, other than a minor or one who has been adjudicated as lacking the capacity to make health care decisions, that for any period suffers from a medical condition that prevents knowing or effective action on their own behalf, the part 2 program director may exercise the right of the patient to consent to a use or disclosure under subpart C of this part for the sole purpose of obtaining payment for services from a third-party payer or health plan.
(b) Deceased patients—(1) Vital statistics. These regulations do not restrict the disclosure of patient identifying information relating to the cause of death of a patient under laws requiring the collection of death or other vital statistics or permitting inquiry into the cause of death.
(2) Consent by personal representative. Any other use or disclosure of information identifying a deceased patient as having a substance use disorder is subject to the regulations in this part. If a written consent to the use or disclosure is required, that consent may be given by the personal representative.
§ 2.16 Security for records and notification of breaches.
(a) The part 2 program or other lawful holder of patient identifying information must have in place formal policies and procedures to reasonably protect against unauthorized uses and disclosures of patient identifying information and to protect against reasonably anticipated threats or hazards to the security of patient identifying information.
(1) Requirements for formal policies and procedures. These policies and procedures must address all of the following:
(i) Paper records, including:
(A) Transferring and removing such records;
(B) Destroying such records, including sanitizing the hard copy media associated with the paper printouts, to render the patient identifying information non-retrievable;
(C) Maintaining such records in a secure room, locked file cabinet, safe, or other similar container, or storage facility when not in use;
(D) Using and accessing workstations, secure rooms, locked file cabinets, safes, or other similar containers, and storage facilities that use or store such information; and
(E) Rendering patient identifying information de-identified in accordance with the requirements of 45 CFR 164.514(b) such that there is no reasonable basis to believe that the information can be used to identify a particular patient.
(ii) Electronic records, including:
(A) Creating, receiving, maintaining, and transmitting such records;
(B) Destroying such records, including sanitizing the electronic media on which such records are stored, to render the patient identifying information non-retrievable;
(C) Using and accessing electronic records or other electronic media containing patient identifying information; and
(D) Rendering the patient identifying information de-identified in accordance with the requirements of 45 CFR 164.514(b) such that there is no reasonable basis to believe that the information can be used to identify a patient.
(2) Exception for certain lawful holders. Family, friends, and other informal caregivers who are lawful holders as defined in this part are not required to comply with paragraph (a) of this section.
(b) The provisions of 45 CFR part 160 and subpart D of 45 CFR part 164 shall apply to part 2 programs with respect to breaches of unsecured records in the same manner as those provisions apply to a covered entity with respect to breaches of unsecured protected health information.
§ 2.17 Undercover agents and informants.
(a) Restrictions on placement. Except as specifically authorized by a court order granted under § 2.67, no part 2 program may knowingly employ, or enroll as a patient, any undercover agent or informant.
(b) Restriction on use and disclosure of information. No information obtained by an undercover agent or informant, whether or not that undercover agent or informant is placed in a part 2 program pursuant to an authorizing court order, may be used or disclosed to criminally investigate or prosecute any patient.
§ 2.18 Restrictions on the use of identification cards.
No person may require any patient to carry in their immediate possession while away from the part 2 program premises any card or other object which would identify the patient as having a substance use disorder. This section does not prohibit a person from requiring patients to use or carry cards or other identification objects on the premises of a part 2 program.
§ 2.19 Disposition of records by discontinued programs.
(a) General. If a part 2 program discontinues operations or is taken over or acquired by another program, it must remove patient identifying information from its records or destroy its records, including sanitizing any associated hard copy or electronic media, to render the patient identifying information non-retrievable in a manner consistent with the policies and procedures established under § 2.16, unless:
(1) The patient who is the subject of the records gives written consent (meeting the requirements of § 2.31) to a transfer of the records to the acquiring program or to any other program designated in the consent (the manner of obtaining this consent must minimize the likelihood of a disclosure of patient identifying information to a third party);
(2) There is a legal requirement that the records be kept for a period specified by law which does not expire until after the discontinuation or acquisition of the part 2 program; or
(3) The part 2 program is transferred, retroceded, or reassumed pursuant to the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. 5301 et seq., and its implementing regulations in 25 CFR part 900.
(b) Special procedure where retention period required by law. If paragraph (a)(2) of this section applies:
(1) Records in non-electronic (e.g., paper) form must be:
(i) Sealed in envelopes or other containers labeled as follows: “Records of [insert name of program] required to be maintained under [insert citation to statute, regulation, court order or other legal authority requiring that records be kept] until a date not later than [insert appropriate date]”.
(A) All hard copy media from which the paper records were produced, such as printer and facsimile ribbons, drums, etc., must be sanitized to render the data non-retrievable.
(B) [Reserved]
(ii) Held under the restrictions of the regulations in this part by a responsible person who must, as soon as practicable after the end of the required retention period specified on the label, destroy the records and sanitize any associated hard copy media to render the patient identifying information non-retrievable in a manner consistent with the discontinued program’s or acquiring program’s policies and procedures established under § 2.16.
(2) All of the following requirements apply to records in electronic form:
(i) Records must be:
(A) Transferred to a portable electronic device with implemented encryption to encrypt the data at rest so that there is a low probability of assigning meaning without the use of a confidential process or key and implemented access controls for the confidential process or key; or
(B) Transferred, along with a backup copy, to separate electronic media, so that both the records and the backup copy have implemented encryption to encrypt the data at rest so that there is a low probability of assigning meaning without the use of a confidential process or key and implemented access controls for the confidential process or key.
(ii) Within one year of the discontinuation or acquisition of the program, all electronic media on which the patient records or patient identifying information resided prior to being transferred to the device specified in paragraph (b)(2)(i)(A) of this section or the original and backup electronic media specified in paragraph (b)(2)(i)(B) of this section, including email and other electronic communications, must be sanitized to render the patient identifying information non-retrievable in a manner consistent with the discontinued program’s or acquiring program’s policies and procedures established under § 2.16.
(iii) The portable electronic device or the original and backup electronic media must be:
(A) Sealed in a container along with any equipment needed to read or access the information, and labeled as follows: “Records of [insert name of program] required to be maintained under [insert citation to statute, regulation, court order or other legal authority requiring that records be kept] until a date not later than [insert appropriate date];” and
(B) Held under the restrictions of the regulations in this part by a responsible person who must store the container in a manner that will protect the information (e.g., climate-controlled environment).
(iv) The responsible person must be included on the access control list and be provided a means for decrypting the data. The responsible person must store the decryption tools on a device or at a location separate from the data they are used to encrypt or decrypt.
(v) As soon as practicable after the end of the required retention period specified on the label, the portable electronic device or the original and backup electronic media must be sanitized to render the patient identifying information non-retrievable consistent with the policies established under § 2.16.
§ 2.20 Relationship to state laws.
The statute authorizing the regulations in this part (42 U.S.C. 290dd-2) does not preempt the field of law which they cover to the exclusion of all state laws in that field. If a use or disclosure permitted under the regulations in this part is prohibited under state law, neither the regulations in this part nor the authorizing statute may be construed to authorize any violation of that state law. However, no state law may either authorize or compel any use or disclosure prohibited by the regulations in this part.
§ 2.21 Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity.
(a) Research privilege description. There may be concurrent coverage of patient identifying information by the regulations in this part and by administrative action taken under section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c) and the implementing regulations at 21 CFR part 1316); or section 301(d) of the Public Health Service Act (42 U.S.C. 241(d) and the implementing regulations at 42 CFR part 2a). These research privilege statutes confer on the Secretary of Health and Human Services and on the Attorney General, respectively, the power to authorize researchers conducting certain types of research to withhold from all persons not connected with the research the names and other identifying information concerning individuals who are the subjects of the research.
(b) Effect of concurrent coverage. The regulations in this part restrict the use and disclosure of information about patients, while administrative action taken under the research privilege statutes and implementing regulations in paragraph (a) of this section protects a person engaged in applicable research from being compelled to disclose any identifying characteristics of the individuals who are the subjects of that research. The issuance under subpart E of this part of a court order authorizing a disclosure of information about a patient does not affect an exercise of authority under these research privilege statutes.
§ 2.22 Notice to patients of Federal confidentiality requirements.
(a) Notice required. At the time of admission to a part 2 program or, in the case that a patient does not have capacity upon admission to understand their medical status, as soon thereafter as the patient attains such capacity, each part 2 program shall inform the patient that Federal law protects the confidentiality of substance use disorder patient records.
(b) Content of notice. In addition to the communication required in paragraph (a) of this section, a part 2 program shall provide notice, written in plain language, of the program’s legal duties and privacy practices, as specified in this paragraph (b).
(1) Required elements. The notice must include the following content:
(i) Header. The notice must contain the following statement as a header or otherwise prominently displayed.
This notice describes:
• HOW HEALTH INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED
• YOUR RIGHTS WITH RESPECT TO YOUR HEALTH INFORMATION
• HOW TO FILE A COMPLAINT CONCERNING A VIOLATION OF THE PRIVACY OR SECURITY OF YOUR HEALTH INFORMATION, OR OF YOUR RIGHTS CONCERNING YOUR INFORMATION
YOU HAVE A RIGHT TO A COPY OF THIS NOTICE (IN PAPER OR ELECTRONIC FORM) AND TO DISCUSS IT WITH [ENTER NAME OR TITLE] AT [PHONE AND EMAIL] IF YOU HAVE ANY QUESTIONS.
(ii) Uses and disclosures. The notice must contain:
(A) A description of each of the purposes for which the part 2 program is permitted or required by this part to use or disclose records without the patient’s written consent.
(B) If a use or disclosure for any purpose described in paragraph (b)(1)(ii)(A) of this section is prohibited or materially limited by other applicable law, the description of such use or disclosure must reflect the more stringent law.
(C) For each purpose described in accordance with paragraphs (b)(1)(ii)(A) and (B) of this section, the description must include sufficient detail to place the patient on notice of the uses and disclosures that are permitted or required by this part and other applicable law.
(D) A description, including at least one example, of the types of uses and disclosures that require written consent under this part.
(E) A statement that a patient may provide a single consent for all future uses or disclosures for treatment, payment, and health care operations purposes.
(F) A statement that the part 2 program will make uses and disclosures not described in the notice only with the patient’s written consent.
(G) A statement that the patient may revoke written consent as provided by §§ 2.31 and 2.35.
(H) A statement that includes the following information:
(1) Records, or testimony relaying the content of such records, shall not be used or disclosed in any civil, administrative, criminal, or legislative proceedings against the patient unless based on specific written consent or a court order;
(2) Records shall only be used or disclosed based on a court order after notice and an opportunity to be heard is provided to the patient or the holder of the record, where required by 42 U.S.C. 290dd-2 and this part; and
(3) A court order authorizing use or disclosure must be accompanied by a subpoena or other similar legal mandate compelling disclosure before the record is used or disclosed.
(iii) Separate statements for certain uses or disclosures. If the part 2 program intends to engage in any of the following activities, the description required by paragraph (b)(1)(ii)(D) of this section must include a separate statement as follows:
(A) Records that are disclosed to a part 2 program, covered entity, or business associate pursuant to the patient’s written consent for treatment, payment, and health care operations may be further disclosed by that part 2 program, covered entity, or business associate, without the patient’s written consent, to the extent the HIPAA regulations permit such disclosure.
(B) A part 2 program may use or disclose records to fundraise for the benefit of the part 2 program only if the patient is first provided with a clear and conspicuous opportunity to elect not to receive fundraising communications.
(iv) Patient rights. The notice must contain a statement of the patient’s rights with respect to their records and a brief description of how the patient may exercise these rights, as follows:
(A) Right to request restrictions of disclosures made with prior consent for purposes of treatment, payment, and health care operations, as provided in § 2.26.
(B) Right to request and obtain restrictions of disclosures of records under this part to the patient’s health plan for those services for which the patient has paid in full, in the same manner as 45 CFR 164.522 applies to disclosures of protected health information.
(C) Right to an accounting of disclosures of electronic records under this part for the past 3 years, as provided in § 2.25, and a right to an accounting of disclosures that meets the requirements of 45 CFR 164.528(a)(2) and (b) through (d) for all other disclosures made with consent.
(D) Right to a list of disclosures by an intermediary for the past 3 years as provided in § 2.24.
(E) Right to obtain a paper or electronic copy of the notice from the part 2 program upon request.
(F) Right to discuss the notice with a designated contact person or office identified by the part 2 program pursuant to paragraph (b)(1)(vii) of this section.
(G) Right to elect not to receive fundraising communications.
(v) Part 2 program’s duties. The notice must contain:
(A) A statement that the part 2 program is required by law to maintain the privacy of records, to provide patients with notice of its legal duties and privacy practices with respect to records, and to notify affected patients following a breach of unsecured records;
(B) A statement that the part 2 program is required to abide by the terms of the notice currently in effect; and
(C) For the part 2 program to apply a change in a privacy practice that is described in the notice to records that the part 2 program created or received prior to issuing a revised notice, a statement that it reserves the right to change the terms of its notice and to make the new notice provisions effective for records that it maintains. The statement must also describe how it will provide patients with a revised notice.
(vi) Complaints. The notice must contain a statement that patients may complain to the part 2 program and to the Secretary if they believe their privacy rights have been violated, a brief description of how the patient may file a complaint with the program, and a statement that the patient will not be retaliated against for filing a complaint.
(vii) Contact. The notice must contain the name, or title, telephone number, and email address of a person or office to contact for further information about the notice.
(viii) Effective date. The notice must contain the date on which the notice is first in effect, which may not be earlier than the date on which the notice is printed or otherwise published.
(2) Optional elements. (i) In addition to the content required by paragraph (b)(1) of this section, if a part 2 program elects to limit the uses or disclosures that it is permitted to make under this part, the part 2 program may describe its more limited uses or disclosures in its notice, provided that the part 2 program may not include in its notice a limitation affecting its right to make a use or disclosure that is required by law or permitted to be made for emergency treatment.
(ii) For the part 2 program to apply a change in its more limited uses and disclosures to records created or received prior to issuing a revised notice, the notice must include the statements required by paragraph (b)(1)(v)(C) of this section.
(3) Revisions to the notice. The part 2 program must promptly revise and distribute its notice whenever there is a material change to the uses or disclosures, the patient’s rights, the part 2 program’s legal duties, or other privacy practices stated in the notice. Except when required by law, a material change to any term of the notice may not be implemented prior to the effective date of the notice in which such material change is reflected.
(c) Implementation specifications: Provision of notice. A part 2 program must make the notice required by this section available upon request to any person and to any patient; and
(1) A part 2 program must provide the notice:
(i) No later than the date of the first service delivery, including service delivered electronically, to such patient after the compliance date for the part 2 program; or
(ii) In an emergency treatment situation, as soon as reasonably practicable after the emergency treatment situation.
(2) If the part 2 program maintains a physical service delivery site:
(i) Have the notice available at the service delivery site for patients to request to take with them; and
(ii) Post the notice in a clear and prominent location where it is reasonable to expect patients seeking service from the part 2 program to be able to read the notice in a manner that does not identify the patient as receiving treatment or services for substance use disorder; and
(iii) Whenever the notice is revised, make the notice available upon request on or after the effective date of the revision and promptly comply with the requirements of paragraph (c)(2)(ii) of this section, if applicable.
(3) Specific requirements for electronic notice include all the following:
(i) A part 2 program that maintains a website that provides information about the part 2 program’s customer services or benefits must prominently post its notice on the website and make the notice available electronically through the website.
(ii) A part 2 program may provide the notice required by this section to a patient by email, if the patient agrees to electronic notice and such agreement has not been withdrawn. If the part 2 program knows that the email transmission has failed, a paper copy of the notice must be provided to the patient. Provision of electronic notice by the part 2 program will satisfy the provision requirements of this paragraph (c) when timely made in accordance with paragraph (c)(1) or (2) of this section.
(iii) For purposes of paragraph (c)(2)(i) of this section, if the first service delivery to an individual is delivered electronically, the part 2 program must provide electronic notice automatically and contemporaneously in response to the individual’s first request for service. The requirements in paragraph (c)(2)(ii) of this section apply to electronic notice.
(iv) The patient who is the recipient of electronic notice retains the right to obtain a paper copy of the notice from a part 2 program upon request.
§ 2.23 xxx
§ 2.23 Patient access and restrictions on use and disclosure.
(a) Patient access not prohibited. These regulations do not prohibit a part 2 program from giving a patient access to their own records, including the opportunity to inspect and copy any records that the part 2 program maintains about the patient. The part 2 program is not required to obtain a patient’s written consent or other authorization under the regulations in this part in order to provide such access to the patient.
(b) Restriction on use and disclosure of information. Information obtained by patient access to their record is subject to the restriction on use and disclosure of records to initiate or substantiate any criminal charges against the patient or to conduct any criminal investigation of the patient as provided for under § 2.12(d)(1).
§ 2.24 Requirements for intermediaries.
Upon request, an intermediary must provide to patients who have consented to the disclosure of their records using a general designation, pursuant to § 2.31(a)(4)(ii)(B), a list of persons to which their records have been disclosed pursuant to the general designation.
(a) Under this section, patient requests:
(1) Must be made in writing; and
(2) Are limited to disclosures made within the past 3 years.
(b) Under this section, the entity named on the consent form that discloses information pursuant to a patient’s general designation (the entity that serves as an intermediary) must:
(1) Respond in 30 or fewer days of receipt of the written request; and
(2) Provide, for each disclosure, the name(s) of the entity(ies) to which the disclosure was made, the date of the disclosure, and a brief description of the patient identifying information disclosed.
§ 2.25 Accounting of disclosures.
(a) General rule. Subject to the limitations in paragraph (b) of this section, a part 2 program must provide to a patient, upon request, an accounting of all disclosures made with consent under § 2.31 in the 3 years prior to the date of the request (or a shorter time period chosen by the patient). The accounting of disclosures must meet the requirements of 45 CFR 164.528(a)(2) and (b) through (d).
(b) Accounting of disclosures for treatment, payment, and health care operations. (1) A part 2 program must provide a patient with an accounting of disclosures of records for treatment, payment, and health care operations only where such disclosures are made through an electronic health record.
(2) A patient has a right to receive an accounting of disclosures described in paragraph (b)(1) of this section during only the 3 years prior to the date on which the accounting is requested.
§ 2.26 Right to request privacy protection for records.
(a)(1) A part 2 program must permit a patient to request that the part 2 program restrict uses or disclosures of records about the patient to carry out treatment, payment, or health care operations, including when the patient has signed written consent for such disclosures.
(2) Except as provided in paragraph (a)(6) of this section, a part 2 program is not required to agree to a restriction.
(3) A part 2 program that agrees to a restriction under paragraph (a)(1) of this section may not use or disclose records in violation of such restriction, except that, if the patient who requested the restriction is in need of emergency treatment and the restricted record is needed to provide the emergency treatment, the part 2 program may use the restricted record, or may disclose information derived from the record to a health care provider, to provide such treatment to the patient.
(4) If information from a restricted record is disclosed to a health care provider for emergency treatment under paragraph (a)(3) of this section, the part 2 program must request that such health care provider not further use or disclose the information.
(5) A restriction agreed to by a part 2 program under paragraph (a) of this section is not effective under this subpart to prevent uses or disclosures required by law or permitted by this part for purposes other than treatment, payment, and health care operations.
(6) A part 2 program must agree to the request of a patient to restrict disclosure of records about the patient to a health plan if:
(i) The disclosure is for the purpose of carrying out payment or health care operations and is not otherwise required by law; and
(ii) The record pertains solely to a health care item or service for which the patient, or person other than the health plan on behalf of the patient, has paid the part 2 program in full.
(b) A part 2 program may terminate a restriction, if one of the following applies:
(1) The patient agrees to or requests the termination in writing.
(2) The patient orally agrees to the termination and the oral agreement is documented.
(3) The part 2 program informs the patient that it is terminating its agreement to a restriction, except that such termination is:
(i) Not effective for records restricted under paragraph (a)(6) of this section; and
(ii) Only effective with respect to records created or received after it has so informed the patient.
Subpart C—Uses and Disclosures With Patient Consent
§ 2.31 Consent requirements.
(a) Required elements for written consent. A written consent to a use or disclosure under the regulations in this part may be paper or electronic and must include:
(1) The name of the patient.
(2) The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure.
(3) A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion.
(4)(i) General requirement for designating recipients. The name(s) of the person(s), or class of persons, to which a disclosure is to be made (“recipient(s)”). For a single consent for all future uses and disclosures for treatment, payment, and health care operations, the recipient may be described as “my treating providers, health plans, third-party payers, and people helping to operate this program” or a similar statement.
(ii) Special instructions for intermediaries. Notwithstanding paragraph (a)(4)(i) of this section, if the recipient entity is an intermediary, a written consent must include the name(s) of the intermediary(ies) and:
(A) The name(s) of the member participants of the intermediary; or
(B) A general designation of a participant(s) or class of participants, which must be limited to a participant(s) who has a treating provider relationship with the patient whose information is being used or disclosed.
(iii) Special instructions when designating certain recipients. If the recipient is a covered entity or business associate to whom a record (or information contained in a record) is disclosed for purposes of treatment, payment, or health care operations, a written consent must include the statement that the patient’s record (or information contained in the record) may be redisclosed in accordance with the permissions contained in the HIPAA regulations, except for uses and disclosures for civil, criminal, administrative, and legislative proceedings against the patient.
(5) A description of each purpose of the requested use or disclosure.
(i) The statement “at the request of the patient” is a sufficient description of the purpose when a patient initiates the consent and does not, or elects not to, provide a statement of the purpose.
(ii) The statement, “for treatment, payment, and health care operations” is a sufficient description of the purpose when a patient provides consent once for all such future uses or disclosures for those purposes.
(iii) If a part 2 program intends to use or disclose records to fundraise on its own behalf, a statement about the patient’s right to elect not to receive any fundraising communications.
(6) The patient’s right to revoke the consent in writing, except to the extent that the part 2 program or other lawful holder of patient identifying information that is permitted to make the disclosure has already acted in reliance on it, and how the patient may revoke consent.
(7) An expiration date or an expiration event that relates to the individual patient or the purpose of the use or disclosure. The statement “end of the treatment,” “none,” or similar language is sufficient if the consent is for a use or disclosure for treatment, payment, or health care operations. The statement “end of the research study” or similar language is sufficient if the consent is for a use or disclosure for research, including for the creation and maintenance of a research database or research repository.
(8) The signature of the patient and, when required for a patient who is a minor, the signature of a person authorized to give consent under § 2.14; or, when required for a patient who has been adjudicated as lacking the capacity to make their own health care decisions or is deceased, the signature of a person authorized to sign under § 2.15. Electronic signatures are permitted to the extent that they are not prohibited by any applicable law.
(9) The date on which the consent is signed.
(10) A patient’s written consent to use or disclose records for treatment, payment, or health care operations must include all of the following statements:
(i) The potential for the records used or disclosed pursuant to the consent to be subject to redisclosure by the recipient and no longer protected by this part.
(ii) The consequences to the patient of a refusal to sign the consent.
(b) Consent required: SUD counseling notes. (1) Notwithstanding any provision of this subpart, a part 2 program must obtain consent for any use or disclosure of SUD counseling notes, except:
(i) To carry out the following treatment, payment, or health care operations:
(A) Use by the originator of the SUD counseling notes for treatment;
(B) Use or disclosure by the part 2 program for its own training programs in which students, trainees, or practitioners in SUD treatment or mental health learn under supervision to practice or improve their skills in group, joint, family, or individual SUD counseling; or
(C) Use or disclosure by the part 2 program to defend itself in a legal action or other proceeding brought by the patient;
(ii) A use or disclosure that is required by § 2.2(b) or permitted by § 2.15(b); § 2.53 with respect to the oversight of the originator of the SUD counseling notes; § 2.63(a); § 2.64.
(2) A written consent for a use or disclosure of SUD counseling notes may only be combined with another written consent for a use or disclosure of SUD counseling notes.
(3) A part 2 program may not condition the provision to a patient of treatment, payment, enrollment in a health plan, or eligibility for benefits on the provision of a written consent for a use or disclosure of SUD counseling notes.
(c) Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which:
(1) Has expired;
(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through reasonable diligence could be known, by the person holding the records to be materially false.
(d) Consent for use and disclosure of records in civil, criminal, administrative, or legislative proceedings. Patient consent for use and disclosure of records (or testimony relaying information contained in a record) in a civil, criminal, administrative, or legislative investigation or proceeding cannot be combined with a consent to use and disclose a record for any other purpose.
§ 2.32 Notice and copy of consent to accompany disclosure.
(a) Each disclosure made with the patient’s written consent must be accompanied by one of the following written statements (i.e., paragraph (a)(1) or (2) of this section):
(1) Statement 1.
This record which has been disclosed to you is protected by Federal confidentiality rules (42 CFR part 2). These rules prohibit you from using or disclosing this record, or testimony that describes the information contained in this record, in any civil, criminal, administrative, or legislative proceedings by any Federal, State, or local authority, against the patient, unless authorized by the consent of the patient, except as provided at 42 CFR 2.12(c)(5) or as authorized by a court in accordance with 42 CFR 2.64 or 2.65. In addition, the Federal rules prohibit you from making any other use or disclosure of this record unless at least one of the following applies:
(i) Further use or disclosure is expressly permitted by the written consent of the individual whose information is being disclosed in this record or as otherwise permitted by 42 CFR part 2.
(ii) You are a covered entity or business associate and have received the record for treatment, payment, or health care operations, or
(iii) You have received the record from a covered entity or business associate as permitted by 45 CFR part 164, subparts A and E.
A general authorization for the release of medical or other information is NOT sufficient to meet the required elements of written consent to further use or redisclose the record (see 42 CFR 2.31).
(2) Statement 2. “42 CFR part 2 prohibits unauthorized use or disclosure of these records.”
(b) Each disclosure made with the patient’s written consent must be accompanied by a copy of the consent or a clear explanation of the scope of the consent provided.
§ 2.33 Uses and disclosures permitted with written consent.
(a) If a patient consents to a use or disclosure of their records consistent with § 2.31, the following uses and disclosures are permitted, as applicable:
(1) A part 2 program may use and disclose those records in accordance with that consent to any person or category of persons identified or generally designated in the consent, except that disclosures to central registries and in connection with criminal justice referrals must meet the requirements of §§ 2.34 and 2.35, respectively.
(2) When the consent provided is a single consent for all future uses and disclosures for treatment, payment, and health care operations, a part 2 program, covered entity, or business associate may use and disclose those records for treatment, payment, and health care operations as permitted by the HIPAA regulations, until such time as the patient revokes such consent in writing.
(b) If a patient consents to a use or disclosure of their records consistent with § 2.31, the recipient may further disclose such records as provided in subpart E of this part, and as follows:
(1) When disclosed for treatment, payment, and health care operations activities to a covered entity or business associate, such recipient may further disclose those records in accordance with the HIPAA regulations, except for uses and disclosures for civil, criminal, administrative, and legislative proceedings against the patient.
(2) When disclosed with consent given once for all future treatment, payment, and health care operations activities to a part 2 program that is not a covered entity or business associate, the recipient may further disclose those records consistent with the consent.
(3) When disclosed for payment or health care operations activities to a lawful holder that is not a covered entity or business associate, the recipient may further disclose those records as may be necessary for its contractors, subcontractors, or legal representatives to carry out the payment or health care operations specified in the consent on behalf of such lawful holders.
(c) Lawful holders, other than covered entities and business associates, who wish to redisclose patient identifying information pursuant to paragraph (b)(3) of this section must have in place a written contract or comparable legal instrument with the contractor or voluntary legal representative, which provides that the contractor, subcontractor, or voluntary legal representative is fully bound by the provisions of this part upon receipt of the patient identifying information. In making any such redisclosures, the lawful holder must furnish such recipients with the notice required under § 2.32; require such recipients to implement appropriate safeguards to prevent unauthorized uses and disclosures; and require such recipients to report any unauthorized uses, disclosures, or breaches of patient identifying information to the lawful holder. The lawful holder may only redisclose information to the contractor or subcontractor or voluntary legal representative that is necessary for the contractor, subcontractor, or voluntary legal representative to perform its duties under the contract or comparable legal instrument. Contracts may not permit a contractor, subcontractor, or voluntary legal representative to redisclose information to a third party unless that third party is a contract agent of the contractor or subcontractor, helping them provide services described in the contract, and only as long as the agent only further discloses the information back to the contractor or lawful holder from which the information originated.
§ 2.34 Uses and Disclosures to prevent multiple enrollments.
(a) Restrictions on disclosure. A part 2 program, as defined in § 2.11, may disclose patient records to a central registry or to any withdrawal management or maintenance treatment program not more than 200 miles away for the purpose of preventing the multiple enrollment of a patient only if:
(1) The disclosure is made when:
(i) The patient is accepted for treatment;
(ii) The type or dosage of the drug is changed; or
(iii) The treatment is interrupted, resumed or terminated.
(2) The disclosure is limited to:
(i) Patient identifying information;
(ii) Type and dosage of the drug; and
(iii) Relevant dates.
(3) The disclosure is made with the patient’s written consent meeting the requirements of § 2.31, except that:
(i) The consent must list the name and address of each central registry and each known withdrawal management or maintenance treatment program to which a disclosure will be made; and
(ii) The consent may authorize a disclosure to any withdrawal management or maintenance treatment program established within 200 miles of the program, but does not need to individually name all programs.
(b) Use of information in records limited to prevention of multiple enrollments. A central registry and any withdrawal management or maintenance treatment program to which information is disclosed to prevent multiple enrollments may not use or redisclose patient identifying information for any purpose other than the prevention of multiple enrollments or to ensure appropriate coordinated care with a treating provider that is not a part 2 program unless authorized by a court order under subpart E of this part.
(c) Permitted disclosure by a central registry to prevent a multiple enrollment. When a member program asks a central registry if an identified patient is enrolled in another member program and the registry determines that the patient is so enrolled, the registry may disclose:
(1) The name, address, and telephone number of the member program(s) in which the patient is already enrolled to the inquiring member program; and
(2) The name, address, and telephone number of the inquiring member program to the member program(s) in which the patient is already enrolled. The member programs may communicate as necessary to verify that no error has been made and to prevent or eliminate any multiple enrollments.
(d) Permitted disclosure by a central registry to a non-member treating provider, to prevent a multiple enrollment. When, for the purpose of preventing multiple program enrollments or duplicative prescriptions, or to inform prescriber decision making regarding prescribing of opioid medication(s) or other prescribed substances, a provider with a treating provider relationship that is not a member program asks a central registry if an identified patient is enrolled in a member program, the registry may disclose:
(1) The name, address, and telephone number of the member program(s) in which the patient is enrolled;
(2) Type and dosage of any medication for substance use disorder being administered or prescribed to the patient by the member program(s); and
(3) Relevant dates of any such administration or prescription. The central registry and non-member program treating prescriber may communicate as necessary to verify that no error has been made and to prevent or eliminate any multiple enrollments or improper prescribing.
(e) Permitted disclosure by a withdrawal management or maintenance treatment program to prevent a multiple enrollment. A withdrawal management or maintenance treatment program which has received a disclosure under this section and has determined that the patient is already enrolled may communicate as necessary with the program making the disclosure to verify that no error has been made and to prevent or eliminate any multiple enrollments.
§ 2.35 Disclosures to elements of the criminal justice system which have referred patients.
(a) Consent for criminal justice referrals. A part 2 program may disclose information from a record about a patient to those persons within the criminal justice system who have made participation in the part 2 program a condition of the disposition of any criminal proceedings against the patient or of the patient’s parole or other release from custody if:
(1) The disclosure is made only to those persons within the criminal justice system who have a need for the information in connection with their duty to monitor the patient’s progress (e.g., a prosecuting attorney who is withholding charges against the patient, a court granting pretrial or post-trial release, probation or parole officers responsible for supervision of the patient); and
(2) The patient has signed a written consent meeting the requirements of § 2.31 (except paragraph (a)(6) of this section which is inconsistent with the revocation provisions of paragraph (c) of this section) and the requirements of paragraphs (b) and (c) of this section.
(b) Duration of consent. The written consent must state the period during which it remains in effect. This period must be reasonable, taking into account:
(1) The anticipated length of the treatment;
(2) The type of criminal proceeding involved, the need for the information in connection with the final disposition of that proceeding, and when the final disposition will occur; and
(3) Such other factors as the part 2 program, the patient, and the person(s) within the criminal justice system who will receive the disclosure consider pertinent.
(c) Revocation of consent. The written consent must state that it is revocable upon the passage of a specified amount of time or the occurrence of a specified, ascertainable event. The time or occurrence upon which consent becomes revocable may be no later than the final disposition of the conditional release or other action in connection with which consent was given.
(d) Restrictions on use and redisclosure. Any persons within the criminal justice system who receive patient information under this section may use and redisclose it only to carry out official duties with regard to the patient’s conditional release or other action in connection with which the consent was given.
§ 2.36 Disclosures to prescription drug monitoring programs.
A part 2 program or other lawful holder is permitted to report any SUD medication prescribed or dispensed by the part 2 program to the applicable state prescription drug monitoring program if required by applicable state law. A part 2 program or other lawful holder must obtain patient consent to a disclosure of records to a prescription drug monitoring program under § 2.31 prior to reporting of such information.
Subpart D—Uses and Disclosures Without Patient Consent
§ 2.51 Medical emergencies.
(a) General rule. Under the procedures required by paragraph (c) of this section, patient identifying information may be disclosed to medical personnel to the extent necessary to:
(1) Meet a bona fide medical emergency in which the patient’s prior written consent cannot be obtained; or
(2) Meet a bona fide medical emergency in which a part 2 program is closed and unable to provide services or obtain the prior written consent of the patient, during a temporary state of emergency declared by a state or federal authority as the result of a natural or major disaster, until such time that the part 2 program resumes operations.
(b) Special rule. Patient identifying information may be disclosed to medical personnel of the Food and Drug Administration (FDA) who assert a reason to believe that the health of any individual may be threatened by an error in the manufacture, labeling, or sale of a product under FDA jurisdiction, and that the information will be used for the exclusive purpose of notifying patients or their physicians of potential dangers.
(c) Procedures. Immediately following disclosure, the part 2 program shall document, in writing, the disclosure in the patient’s records, including:
(1) The name of the medical personnel to whom disclosure was made and their affiliation with any health care facility;
(2) The name of the person making the disclosure;
(3) The date and time of the disclosure; and
(4) The nature of the emergency (or error, if the report was to FDA).
§ 2.52 Scientific research.
(a) Use and disclosure of patient identifying information. Notwithstanding other provisions of this part, including paragraph (b)(2) of this section, patient identifying information may be used or disclosed for the purposes of the recipient conducting scientific research if:
(1) The person designated as director or managing director, or person otherwise vested with authority to act as chief executive officer or their designee, of a part 2 program or other lawful holder of data under this part, makes a determination that the recipient of the patient identifying information is:
(i) A HIPAA covered entity or business associate that has obtained and documented authorization from the patient, or a waiver or alteration of authorization, consistent with 45 CFR 164.508 or 164.512(i), as applicable;
(ii) Subject to the HHS regulations regarding the protection of human subjects (45 CFR part 46), and provides documentation either that the researcher is in compliance with the requirements of 45 CFR part 46, including the requirements related to informed consent or a waiver of consent (45 CFR 46.111 and 46.116) or that the research qualifies for exemption under the HHS regulations (45 CFR 46.104) or any successor regulations;
(iii) Subject to the FDA regulations regarding the protection of human subjects (21 CFR parts 50 and 56) and provides documentation that the research is in compliance with the requirements of the FDA regulations, including the requirements related to informed consent or an exception to, or waiver of, consent (21 CFR part 50) and any successor regulations; or
(iv) Any combination of a HIPAA covered entity or business associate, and/or subject to the HHS regulations regarding the protection of human subjects, and/or subject to the FDA regulations regarding the protection of human subjects; and has met the requirements of paragraph (a)(1)(i), (ii) (iii), and/or (iv) of this section, as applicable.
(2) The part 2 program or other lawful holder of data under this part is a HIPAA covered entity or business associate, and the use or disclosure is made in accordance with the requirements at 45 CFR 164.512(i).
(3) If neither paragraph (a)(1) or (2) of this section apply to the receiving or disclosing party, this section does not apply.
(b) Requirements for researchers. Any person conducting scientific research using patient identifying information obtained under paragraph (a) of this section:
(1) Is fully bound by the regulations in this part and, if necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by the regulations in this part.
(2) Must not redisclose patient identifying information except back to the person from whom that patient identifying information was obtained or as permitted under paragraph (c) of this section.
(3) May include data under this part in research reports only in aggregate form in which patient identifying information has been de-identified in accordance with the requirements of 45 CFR 164.514(b) such that there is no reasonable basis to believe that the information can be used to identify a patient.
(4) Must maintain and destroy patient identifying information in accordance with the security policies and procedures established under § 2.16.
(5) Must retain records in compliance with applicable federal, state, and local record retention laws.
(c) Data linkages—(1) Researchers. Any person conducting scientific research using patient identifying information obtained under paragraph (a) of this section that requests linkages to data sets from a data repository(ies) holding patient identifying information must:
(i) Have the request reviewed and approved by an Institutional Review Board (IRB) registered with the Department of Health and Human Services, Office for Human Research Protections in accordance with 45 CFR part 46 to ensure that patient privacy is considered and the need for identifiable data is justified. Upon request, the researcher may be required to provide evidence of the IRB approval of the research project that contains the data linkage component.
(ii) Ensure that patient identifying information obtained under paragraph (a) of this section is not provided to law enforcement agencies or officials.
(iii) Ensure that patient identifying information is not redisclosed for data linkage purposes other than as provided in this paragraph (c).
(2) Data repositories. For purposes of this section, a data repository is fully bound by the provisions of part 2 upon receipt of the patient identifying data and must:
(i) After providing the researcher with the linked data, destroy or delete the linked data from its records, including sanitizing any associated hard copy or electronic media, to render the patient identifying information non-retrievable in a manner consistent with the policies and procedures established under § 2.16 Security for records.
(ii) Ensure that patient identifying information obtained under paragraph (a) of this section is not provided to law enforcement agencies or officials.
§ 2.53 Management audits, financial audits, and program evaluation.
(a) Records not copied or removed. If patient records are not downloaded, copied or removed from the premises of a part 2 program or other lawful holder, or forwarded electronically to another electronic system or device, patient identifying information, as defined in § 2.11, may be disclosed in the course of a review of records on the premises of a part 2 program or other lawful holder to any person who agrees in writing to comply with the limitations on use and redisclosure in paragraph (f) of this section and who:
(1) Performs the audit or evaluation on behalf of:
(i) Any federal, state, or local governmental agency that provides financial assistance to a part 2 program or other lawful holder, or is authorized by law to regulate the activities of the part 2 program or other lawful holder;
(ii) Any person which provides financial assistance to the part 2 program or other lawful holder, which is a third-party payer or health plan covering patients in the part 2 program, or which is a quality improvement organization (QIO) performing a QIO review, or the contractors, subcontractors, or legal representatives of such person or quality improvement organization; or
(iii) An entity with direct administrative control over the part 2 program or lawful holder.
(2) Is determined by the part 2 program or other lawful holder to be qualified to conduct an audit or evaluation of the part 2 program or other lawful holder.
(b) Copying, removing, downloading, or forwarding patient records. Records containing patient identifying information, as defined in § 2.11, may be copied or removed from the premises of a part 2 program or other lawful holder or downloaded or forwarded to another electronic system or device from the part 2 program’s or other lawful holder’s electronic records by any person who:
(1) Agrees in writing to:
(i) Maintain and destroy the patient identifying information in a manner consistent with the policies and procedures established under § 2.16;
(ii) Retain records in compliance with applicable federal, state, and local record retention laws; and
(iii) Comply with the limitations on use and disclosure in paragraph (f) of this section; and
(2) Performs the audit or evaluation on behalf of:
(i) Any federal, state, or local governmental agency that provides financial assistance to the part 2 program or other lawful holder, or is authorized by law to regulate the activities of the part 2 program or other lawful holder; or
(ii) Any person which provides financial assistance to the part 2 program or other lawful holder, which is a third-party payer or health plan covering patients in the part 2 program, or which is a quality improvement organization performing a QIO review, or the contractors, subcontractors, or legal representatives of such person or quality improvement organization; or
(iii) An entity with direct administrative control over the part 2 program or lawful holder.
(c) Activities included. Audits and evaluations under this section may include, but are not limited to:
(1) Activities undertaken by a Federal, state, or local governmental agency, or a third-party payer or health plan, in order to:
(i) Identify actions the agency or third-party payer or health plan can make, such as changes to its policies or procedures, to improve care and outcomes for patients with substance use disorders who are treated by part 2 programs;
(ii) Ensure that resources are managed effectively to care for patients; or
(iii) Determine the need for adjustments to payment policies to enhance care or coverage for patients with SUD.
(2) Reviews of appropriateness of medical care, medical necessity, and utilization of services.
(d) Quality assurance entities included. Entities conducting audits or evaluations in accordance with paragraphs (a) and (b) of this section may include accreditation or similar types of organizations focused on quality assurance.
(e) Medicare, Medicaid, Children’s Health Insurance Program (CHIP), or related audit or evaluation. (1) Patient identifying information, as defined in § 2.11, may be disclosed under paragraph (e) of this section to any person for the purpose of conducting a Medicare, Medicaid, or CHIP audit or evaluation, including an audit or evaluation necessary to meet the requirements for a Centers for Medicare & Medicaid Services (CMS)-regulated accountable care organization (CMS-regulated ACO) or similar CMS-regulated organization (including a CMS-regulated Qualified Entity (QE)), if the person agrees in writing to comply with the following:
(i) Maintain and destroy the patient identifying information in a manner consistent with the policies and procedures established under § 2.16;
(ii) Retain records in compliance with applicable federal, state, and local record retention laws; and
(iii) Comply with the limitations on use and disclosure in paragraph (f) of this section.
(2) A Medicare, Medicaid, or CHIP audit or evaluation under this section includes a civil or administrative investigation of a part 2 program by any federal, state, or local government agency with oversight responsibilities for Medicare, Medicaid, or CHIP and includes administrative enforcement, against the part 2 program by the government agency, of any remedy authorized by law to be imposed as a result of the findings of the investigation.
(3) An audit or evaluation necessary to meet the requirements for a CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must be conducted in accordance with the following:
(i) A CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must:
(A) Have in place administrative and/or clinical systems; and
(B) Have in place a leadership and management structure, including a governing body and chief executive officer with responsibility for oversight of the organization’s management and for ensuring compliance with and adherence to the terms and conditions of the Participation Agreement or similar documentation with CMS; and
(ii) A CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must have a signed Participation Agreement or similar documentation with CMS, which provides that the CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE):
(A) Is subject to periodic evaluations by CMS or its agents, or is required by CMS to evaluate participants in the CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) relative to CMS-defined or approved quality and/or cost measures;
(B) Must designate an executive who has the authority to legally bind the organization to ensure compliance with 42 U.S.C. 290dd-2 and this part and the terms and conditions of the Participation Agreement in order to receive patient identifying information from CMS or its agents;
(C) Agrees to comply with all applicable provisions of 42 U.S.C. 290dd-2 and this part;
(D) Must ensure that any audit or evaluation involving patient identifying information occurs in a confidential and controlled setting approved by the designated executive;
(E) Must ensure that any communications or reports or other documents resulting from an audit or evaluation under this section do not allow for the direct or indirect identification (e.g., through the use of codes) of a patient as having or having had a substance use disorder; and
(F) Must establish policies and procedures to protect the confidentiality of the patient identifying information consistent with this part, the terms and conditions of the Participation Agreement, and the requirements set forth in paragraph (e)(1) of this section.
(4) Program, as defined in § 2.11, includes an employee of, or provider of medical services under the program when the employee or provider is the subject of a civil investigation or administrative remedy, as those terms are used in paragraph (e)(2) of this section.
(5) If a disclosure to a person is authorized under this section for a Medicare, Medicaid, or CHIP audit or evaluation, including a civil investigation or administrative remedy, as those terms are used in paragraph (e)(2) of this section, the person may further use or disclose the patient identifying information that is received for such purposes to its contractor(s), subcontractor(s), or legal representative(s), to carry out the audit or evaluation, and a quality improvement organization which obtains such information under paragraph (a) or (b) of this section may use or disclose the information to that person (or, to such person’s contractors, subcontractors, or legal representatives, but only for the purposes of this section).
(6) The provisions of this paragraph (e) do not authorize the part 2 program, the Federal, state, or local government agency, or any other person to use or disclose patient identifying information obtained during the audit or evaluation for any purposes other than those necessary to complete the audit or evaluation as specified in this paragraph (e).
(f) Limitations on use and disclosure. Except as provided in paragraph (e) of this section, patient identifying information disclosed under this section may be disclosed only back to the part 2 program or other lawful holder from which it was obtained and may be used only to carry out an audit or evaluation purpose or to investigate or prosecute criminal or other activities, as authorized by a court order entered under § 2.66.
(g) Audits and evaluations mandated by statute or regulation. Patient identifying information may be disclosed to federal, state, or local government agencies, and the contractors, subcontractors, and legal representatives of such agencies, in the course of conducting audits or evaluations mandated by statute or regulation, if those audits or evaluations cannot be carried out using deidentified information.
(h) Disclosures for health care operations. With respect to activities described in paragraphs (c) and (d) of this section, a part 2 program, covered entity, or business associate may disclose records in accordance with a consent that includes health care operations, and the recipient may redisclose such records as permitted under the HIPAA regulations if the recipient is a covered entity or business associate.
§ 2.54 Disclosures for public health.
A part 2 program may disclose records for public health purposes without patient consent so long as:
(a) The disclosure is made to a public health authority as defined in this part; and
(b) The content of the information from the record disclosed has been de-identified in accordance with the requirements of 45 CFR 164.514(b) such that there is no reasonable basis to believe that the information can be used to identify a patient.
Subpart E—Court Orders Authorizing Use and Disclosure
§ 2.61 Legal effect of order.
(a) Effect. An order of a court of competent jurisdiction entered under this subpart is a unique kind of court order. Its only purpose is to authorize a use or disclosure of patient information which would otherwise be prohibited by 42 U.S.C. 290dd-2 and the regulations in this part. Such an order does not compel use or disclosure. A subpoena or a similar legal mandate must be issued to compel use or disclosure. This mandate may be entered at the same time as and accompany an authorizing court order entered under the regulations in this part.
(b) Examples. (1) A person holding records subject to the regulations in this part receives a subpoena for those records. The person may not use or disclose the records in response to the subpoena unless a court of competent jurisdiction enters an authorizing order under the regulations in this part.
(2) An authorizing court order is entered under the regulations in this part, but the person holding the records does not want to make the use or disclosure. If there is no subpoena or other compulsory process or a subpoena for the records has expired or been quashed, that person may refuse to make the use or disclosure. Upon the entry of a valid subpoena or other compulsory process the person holding the records must use or disclose, unless there is a valid legal defense to the process other than the confidentiality restrictions of the regulations in this part.
§ 2.62 Order not applicable to records disclosed without consent to researchers, auditors, and evaluators.
A court order under the regulations in this part may not authorize persons who meet the criteria specified in §§ 2.52(a)(1)(i) through (iii) and 2.53, who have received patient identifying information without consent for the purpose of conducting research, audit, or evaluation, to disclose that information or use it to conduct any criminal investigation or prosecution of a patient. However, a court order under § 2.66 may authorize use and disclosure of records to investigate or prosecute such persons who are holding the records.
§ 2.63 Confidential communications.
(a) A court order under the regulations in this part may authorize disclosure of confidential communications made by a patient to a part 2 program in the course of diagnosis, treatment, or referral for treatment only if:
(1) The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, including circumstances which constitute suspected child abuse and neglect and verbal threats against third parties;
(2) The disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one which directly threatens loss of life or serious bodily injury, including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or
(3) The disclosure is in connection with a civil, criminal, administrative, or legislative proceeding in which the patient offers testimony or other evidence pertaining to the content of the confidential communications.
(b) [Reserved]
(a) Application. An order authorizing the use or disclosure of patient records or testimony relaying the information contained in the records for purposes other than criminal investigation or prosecution may be applied for by any person having a legally recognized interest in the use or disclosure which is sought in the course of a civil, administrative, or legislative proceeding. The application may be filed separately or as part of a pending civil action in which the applicant asserts that the patient records or testimony relaying the information contained in the records are needed to provide evidence. An application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the patient is the applicant or has given written consent (meeting the requirements of the regulations in this part) to disclosure or the court has ordered the record of the proceeding sealed from public scrutiny.
(b) Notice. A court order under this section is only valid when the patient and the person holding the records from whom disclosure is sought have received:
(1) Adequate notice in a manner which does not disclose patient identifying information to other persons; and
(2) An opportunity to file a written response to the application, or to appear in person, for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order as described in § 2.64(d).
(c) Review of evidence: Conduct of hearing. Any oral argument, review of evidence, or hearing on the application must be held in the judge’s chambers or in some manner which ensures that patient identifying information is not disclosed to anyone other than a party to the proceeding, the patient, or the person holding the record, unless the patient requests an open hearing in a manner which meets the written consent requirements of the regulations in this part. The proceeding may include an examination by the judge of the patient records referred to in the application.
(d) Criteria for entry of order. An order under this section may be entered only if the court determines that good cause exists. To make this determination the court must find that:
(1) Other ways of obtaining the information are not available or would not be effective; and
(2) The public interest and need for the use or disclosure outweigh the potential injury to the patient, the physician-patient relationship and the treatment services.
(e) Content of order. An order authorizing a use or disclosure must:
(1) Limit use or disclosure to only those parts of the patient’s record, or testimony relaying those parts of the patient’s record, which are essential to fulfill the objective of the order;
(2) Limit use or disclosure to those persons whose need for information is the basis for the order; and
(3) Include such other measures as are necessary to limit use or disclosure for the protection of the patient, the physician-patient relationship and the treatment services; for example, sealing from public scrutiny the record of any proceeding for which use or disclosure of a patient’s record, or testimony relaying the contents of the record, has been ordered.
(a) Application. An order authorizing the use or disclosure of patient records, or testimony relaying the information contained in those records, to investigate or prosecute a patient in connection with a criminal proceeding may be applied for by the person holding the records or by any law enforcement or prosecutorial official who is responsible for conducting investigative or prosecutorial activities with respect to the enforcement of criminal laws, including administrative and legislative criminal proceedings. The application may be filed separately, as part of an application for a subpoena or other compulsory process, or in a pending criminal action. An application must use a fictitious name such as John Doe, to refer to any patient and may not contain or otherwise use or disclose patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny.
(b) Notice and hearing. Unless an order under § 2.66 is sought in addition to an order under this section, an order under this section is valid only when the person holding the records has received:
(1) Adequate notice (in a manner which will not disclose patient identifying information to other persons) of an application by a law enforcement agency or official;
(2) An opportunity to appear and be heard for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order as described in § 2.65(d); and
(3) An opportunity to be represented by counsel independent of counsel for an applicant who is a law enforcement agency or official.
(c) Review of evidence: Conduct of hearings. Any oral argument, review of evidence, or hearing on the application shall be held in the judge’s chambers or in some other manner which ensures that patient identifying information is not disclosed to anyone other than a party to the proceedings, the patient, or the person holding the records. The proceeding may include an examination by the judge of the patient records referred to in the application.
(d) Criteria. A court may authorize the use and disclosure of patient records, or testimony relaying the information contained in those records, for the purpose of conducting a criminal investigation or prosecution of a patient only if the court finds that all of the following criteria are met:
(1) The crime involved is extremely serious, such as one which causes or directly threatens loss of life or serious bodily injury including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, and child abuse and neglect.
(2) There is a reasonable likelihood that the records or testimony will disclose information of substantial value in the investigation or prosecution.
(3) Other ways of obtaining the information are not available or would not be effective.
(4) The potential injury to the patient, to the physician-patient relationship and to the ability of the part 2 program to provide services to other patients is outweighed by the public interest and the need for the disclosure.
(5) If the applicant is a law enforcement agency or official, that:
(i) The person holding the records has been afforded the opportunity to be represented by independent counsel; and
(ii) Any person holding the records which is an entity within federal, state, or local government has in fact been represented by counsel independent of the applicant.
(e) Content of order. Any order authorizing a use or disclosure of patient records subject to this part, or testimony relaying the information contained in those records, under this section must:
(1) Limit use and disclosure to those parts of the patient’s record, or testimony relaying the information contained in those records, which are essential to fulfill the objective of the order;
(2) Limit disclosure to those law enforcement and prosecutorial officials who are responsible for, or are conducting, the investigation or prosecution, and limit their use of the records or testimony to investigation and prosecution of the extremely serious crime or suspected crime specified in the application; and
(3) Include such other measures as are necessary to limit use and disclosure to the fulfillment of only that public interest and need found by the court.
(a) Application. (1) An order authorizing the use or disclosure of patient records subject to this part to investigate or prosecute a part 2 program or the person holding the records (or employees or agents of that part 2 program or person holding the records) in connection with a criminal or administrative matter may be applied for by any investigative agency having jurisdiction over the program’s or person’s activities.
(2) The application may be filed separately or as part of a pending civil or criminal action against a part 2 program or the person holding the records (or agents or employees of the part 2 program or person holding the records) in which the applicant asserts that the patient records are needed to provide material evidence. The application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny or the patient has provided written consent (meeting the requirements of § 2.31) to that disclosure.
(3) Upon discovering in good faith that it received records under this part in the course of investigating or prosecuting a part 2 program or the person holding the records (or employees or agents of that part 2 program or person holding the records), an investigative agency must do the following:
(i) Secure the records in accordance with § 2.16; and
(ii) Immediately cease using and disclosing the records until the investigative agency obtains a court order consistent with paragraph (c) of this section authorizing the use and disclosure of the records and any records later obtained. The application for the court order must occur within a reasonable period of time, but not more than 120 days after discovering it received records under this part; or
(iii) If the agency does not seek a court order in accordance with paragraph (a)(3)(ii) of this section, the agency must either return the records to the part 2 program or person holding the records, if it is legally permissible to do so, within a reasonable period of time, but not more than 120 days after discovering it received records under this part; or
(iv) If the agency does not seek a court order or return the records, the agency must destroy the records in a manner that renders the patient identifying information non-retrievable, within a reasonable period of time, but not more than 120 days after discovering it received records under this part.
(v) If the agency’s application for a court order is rejected by the court and no longer subject to appeal, the agency must return the records to the part 2 program or person holding the records, if it is legally permissible to do so, or destroy the records immediately after notice from the court.
(b) Notice not required. An application under this section may, in the discretion of the court, be granted without notice. Although no express notice is required to the part 2 program, to the person holding the records, or to any patient whose records are to be disclosed, upon implementation of an order so granted any of those persons must be afforded an opportunity to seek revocation or amendment of that order, limited to the presentation of evidence on the statutory and regulatory criteria for the issuance of the court order in accordance with paragraph (c) of this section. If a court finds that individualized contact is impractical under the circumstances, patients may be informed of the opportunity through a substitute form of notice that the court determines is reasonably calculated to reach the patients, such as conspicuous notice in major print or broadcast media in geographic areas where the affected patients likely reside.
(c) Requirements for order. An order under this section must be entered in accordance with, and comply with the requirements of § 2.64(e). In addition, an order under this section may be entered only if the court determines that good cause exists. To make such good cause determination, the court must find that:
(1) Other ways of obtaining the information are not available, would not be effective, or would yield incomplete information;
(2) The public interest and need for the use or disclosure outweigh the potential injury to the patient, the physician-patient relationship, and the treatment services; and
(3) For an application being submitted pursuant to paragraph (a)(3)(ii) of this section, the investigative agency has satisfied the conditions at § 2.3(b). Information from records obtained in violation of this part, including § 2.12(d), cannot be used in an application for a court order to obtain such records.
(d) Limitations on use and disclosure of patient identifying information. (1) An order entered under this section must require the deletion or removal of patient identifying information from any documents or oral testimony made available to the public.
(2) No information obtained under this section may be used or disclosed to conduct any investigation or prosecution of a patient in connection with a criminal matter, or be used or disclosed as the basis for an application for an order under § 2.65.
(a) Application. A court order authorizing the placement of an undercover agent or informant in a part 2 program as an employee or patient may be applied for by any investigative agency which has reason to believe that employees or agents of the part 2 program are engaged in criminal misconduct.
(b) Notice. The part 2 program director must be given adequate notice of the application and an opportunity to appear and be heard (for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order in accordance with § 2.67(c)), unless the application asserts that:
(1) The part 2 program director is involved in the suspected criminal activities to be investigated by the undercover agent or informant; or
(2) The part 2 program director will intentionally or unintentionally disclose the proposed placement of an undercover agent or informant to the employees or agents of the program who are suspected of criminal activities.
(c) Criteria. An order under this section may be entered only if the court determines that good cause exists. To make such good cause determination, the court must find all of the following:
(1) There is reason to believe that an employee or agent of the part 2 program is engaged in criminal activity;
(2) Other ways of obtaining evidence of the suspected criminal activity are not available, would not be effective, or would yield incomplete evidence;
(3) The public interest and need for the placement of an undercover agent or informant in the part 2 program outweigh the potential injury to patients of the part 2 program, physician-patient relationships, and the treatment services; and
(4) For an application submitted after the placement of an undercover agent or informant has already occurred, that the investigative agency has satisfied the conditions at § 2.3(b) and only discovered that a court order was necessary after such placement occurred. Information from records obtained in violation of this part, including § 2.12(d), cannot be used in an application for a court order to obtain such records.
(d) Content of order. An order authorizing the placement of an undercover agent or informant in a part 2 program must:
(1) Specifically authorize the placement of an undercover agent or an informant;
(2) Limit the total period of the placement to twelve months, starting on the date that the undercover agent or informant is placed on site within the program. The placement of an undercover agent or informant must end after 12 months, unless a new court order is issued to extend the period of placement;
(3) Prohibit the undercover agent or informant from using or disclosing any patient identifying information obtained from the placement except as necessary to investigate or prosecute employees or agents of the part 2 program in connection with the suspected criminal activity; and
(4) Include any other measures which are appropriate to limit any potential disruption of the part 2 program by the placement and any potential for a real or apparent breach of patient confidentiality; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient’s record has been ordered.
(e) Limitation on use and disclosure of information. No information obtained by an undercover agent or informant placed in a part 2 program under this section may be used or disclosed to investigate or prosecute any patient in connection with a criminal matter or as the basis for an application for an order under § 2.65.
§ 2.68 Report to the Secretary.
(a) Any investigative agency covered by this part shall report to the Secretary, not later than 60 days after the end of each calendar year, to the extent applicable and practicable, on:
(1) The number of applications made under §§ 2.66(a)(3)(ii) and 2.67(c)(4) during the calendar year;
(2) The number of instances in which such applications were denied, due to findings by the court of violations of this part during the calendar year; and
(3) The number of instances in which records under this part were returned or destroyed following unknowing receipt without a court order, in compliance with § 2.66(a)(3)(iii), (iv), or (v), respectively during the calendar year.
(b) [Reserved]
PART 2a—PROTECTION OF IDENTITY—RESEARCH SUBJECTS
§ 2a.1 Applicability.
(a) Section 303(a) of the Public Health Service Act (42 U.S.C. 242a(a)) provides that “[t]he Secretary [of Health and Human Services] may authorize persons engaged in research on mental health, including research on the use and effect of alcohol and other psychoactive drugs, to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.” The regulations in this part establish procedures under which any person engaged in research on mental health including research on the use and effect of alcohol and other psychoactive drugs (whether or not the research is federally funded) may, subject to the exceptions set forth in paragraph (b) of this section, apply for such an authorization of confidentiality.
(b) These regulations do not apply to:
(1) Authorizations of confidentiality for research requiring an Investigational New Drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new drugs, such as methadone, requiring continuation of long-term studies, records, and reports. Attention is called to 21 CFR 291.505(g) relating to authorizations of confidentiality for patient records maintained by methadone treatment programs.
(2) Authorizations of confidentiality for research which are related to law enforcement activities or otherwise within the purview of the Attorney General’s authority to issue authorizations of confidentiality pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c)) and 21 CFR 1316.21.
(c) The Secretary’s regulations on confidentiality of alcohol and drug abuse patient records (42 CFR part 2) and the regulations of this part may, in some instances, concurrently cover the same transaction. As explained in 42 CFR 2.24 and 2.24-1, 42 CFR part 2 restricts voluntary disclosures of information from applicable patient records while a Confidentiality Certificate issued pursuant to the regulations of this part protects a person engaged in applicable research from being compelled to disclose identifying characteristics of individuals who are the subject of such research.
§ 2a.2 Definitions.
(a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.
(b) Person means any individual, corporation, government, or governmental subdivision or agency, business trust, partnership, association, or other legal entity.
(c) Research means systematic study directed toward new or fuller knowledge and understanding of the subject studied. The term includes, but is not limited to, behavioral science studies, surveys, evaluations, and clinical investigations.
(d) Drug has the meaning given that term by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
(e) Controlled drug means a drug which is included in schedule I, II, III, IV, or V of part B of the Controlled Substances Act (21 U.S.C. 811-812).
(f) Administer refers to the direct application of a drug to the body of a human research subject, whether such application be by injection, inhalation, ingestion, or any other means, by (1) a qualified person engaged in research (or, in his or her presence, by his or her authorized agent), or (2) a research subject in accordance with instructions of a qualified person engaged in research, whether or not in the presence of a qualified person engaged in research.
(g) Identifying characteristics refers to the name, address, any identifying number, fingerprints, voiceprints, photographs or any other item or combination of data about a research subject which could reasonably lead directly or indirectly by reference to other information to identification of that research subject.
(h) Psychoactive drug means, in addition to alcohol, any drug which has as its principal action an effect on thought, mood, or behavior.
§ 2a.3 Application; coordination.
(a) Any person engaged in (or who intends to engage in) the research to which this part applies, who desires authorization to withhold the names and other identifying characteristics of individuals who are the subject of such research from any person or authority not connected with the conduct of such research may apply to the Office of the Director, National Institute on Drug Abuse, the Office of the Director, National Institute of Mental Health, or the Office of the Director, National Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville, Maryland 20857 for an authorization of confidentiality.
(b) If there is uncertainty with regard to which Institute is appropriate or if the research project falls within the purview of more than one Institute, an application need be submitted only to one Institute. Persons who are uncertain with regard to the applicability of these regulations to a particular type of research may apply for an authorization of confidentiality under the regulations of this part to one of the Institutes. Requests which are within the scope of the authorities described in § 2a.1(b) will be forwarded to the appropriate agency for consideration and the person will be advised accordingly.
(c) An application may accompany, precede, or follow the sumission of a request for DHHS grant or contract assistance, though it is not necessary to request DHHS grant or contract assistance in order to apply for a Confidentiality Certificate. If a person has previously submitted any information required in this part in connection with a DHHS grant or contract, he or she may substitute a copy of information thus submitted, if the information is current and accurate. If a person requests a Confidentiality Certificate at the same time he or she submits an application for DHHS grant or contract assistance, the application for a Confidentiality Certificate may refer to the pertinent section(s) of the DHHS grant or contract application which provide(s) the information required to be submitted under this part. (See §§ 2a.4 and 2a.5.)
(d) A separate application is required for each research project for which an authorization of confidentiality is requested.
§ 2a.4 Contents of application; in general.
In addition to any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project shall contain:
(a) The name and address of the individual primarily responsible for the conduct of the research and the sponsor or institution with which he or she is affiliated, if any. Any application from a person affiliated with an institution will be considered only if it contains or is accompanied by documentation of institutional approval. This documentation may consist of a written statement signed by a responsible official of the institution or of a copy of or reference to a valid certification submitted in accordance with 45 CFR part 46.
(b) The location of the research project and a description of the facilities available for conducting the research, including the name and address of any hospital, institution, or clinical laboratory facility to be utilized in connection with the research.
(c) The names, addresses, and summaries of the scientific or other appropriate training and experience of all personnel having major responsibilities in the research project and the training and experience requirements for major positions not yet filled.
(d) An outline of the research protocol for the project including a clear and concise statement of the purpose and rationale of the research project and the general research methods to be used.
(e) The date on which research will begin or has begun and the estimated date for completion of the project.
(f) A specific request, signed by the individual primarily responsible for the conduct of the research, for authority to withhold the names and other identifying characteristics of the research subjects and the reasons supporting such request.
(g) An assurance (1) From persons making application for a Confidentiality Certificate for a research project for which DHHS grant or contract support is received or sought that they will comply with all the requirements of 45 CFR part 46, “Protection of Human Subjects,” or
(2) From all other persons making application that they will comply with the informed consent requirements of 45 CFR 46.103(c) and document legally effective informed consent in a manner consistent with the principles stated in 45 CFR 46.110, if it is determined by the Secretary, on the basis of information submitted by the person making application, that subjects will be placed at risk. If a modification of paragraphs (a) or (b) of 45 CFR 46.110 is to be used, as permitted under paragraph (c) of that section, the applicant will describe the proposed modification and submit it for approval by the Secretary.
(h) An assurance that if an authorization of confidentiality is given it will not be represented as an endorsement of the research project by the Secretary or used to coerce individuals to participate in the research project.
(i) An assurance that any person who is authorized by the Secretary to protect the privacy of research subjects will use that authority to refuse to disclose identifying characteristics of research subjects in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to compel disclosure of the identifying characteristics of research subjects.
(j) An assurance that all research subjects who participate in the project during the period the Confidentiality Certificate is in effect will be informed that:
(1) A Confidentiality Certificate has been issued;
(2) The persons authorized by the Confidentiality Certificate to protect the identity of research subjects may not be compelled to identify research subjects in any civil, criminal, administrative, legislative, or other proceedings whether Federal, State, or local;
(3) If any of the following conditions exist the Confidentiality Certificate does not authorize any person to which it applies to refuse to reveal identifying information concerning research subjects:
(i) The subject consents in writing to disclosure of identifying information,
(ii) Release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of Federal Regulations), or
(iii) Authorized personnel of DHHS request identifying information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See § 2a.7(b));
(4) The Confidentiality Certificate does not govern the voluntary disclosure of identifying characteristics of research subjects;
(5) The Confidentiality Certificate does not represent an endorsement of the research project by the Secretary.
(k) An assurance that all research subjects who enter the project after the termination of the Confidentiality Certificate will be informed that the authorization of confidentiality has ended and that the persons authorized to protect the identity of research subjects by the Confidentiality Certificate may not rely on the Certificate to refuse to disclose identifying characteristics of research subjects who were not participants in the project during the period the Certificate was in effect. (See § 2a.8(c)).
§ 2a.5 Contents of application; research projects in which drugs will be administered.
(a) In addition to the information required by § 2a.4 and any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project which involves the administering of a drug shall contain:
(1) Identification of the drugs to be administered in the research project and a description of the methods for such administration, which shall include a statement of the dosages to be administered to the research subjects;
(2) Evidence that individuals who administer drugs are authorized to do so under applicable Federal and State law; and
(3) In the case of a controlled drug, a copy of the Drug Enforcement Administration Certificate of Registration (BND Form 223) under which the research project will be conducted.
(b) An application for an authorization of confidentiality with respect to a research project which involves the administering of a controlled drug may include a request for exemption of persons engaged in the research from State or Federal prosecution for possession, distribution, and dispensing of controlled drugs as authorized under section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 21 CFR 1316.22. If the request is in such form, and is supported by such information, as is required by 21 CFR 1316.22, the Secretary will forward it, together with his or her recommendation that such request be approved or disapproved, for the consideration of the Administrator of the Drug Enforcement Administration.
§ 2a.6 Issuance of Confidentiality Certificates; single project limitation.
(a) In reviewing the information provided in the application for a Confidentiality Certificate, the Secretary will take into account:
(1) The scientific or other appropriate training and experience of all personnel having major responsibilities in the research project;
(2) Whether the project constitutes bona fide “research” which is within the scope of the regulations of this part; and
(3) Such other factors as he or she may consider necessary and appropriate. All applications for Confidentiality Certificates shall be evaluated by the Secretary through such officers and employees of the Department and such experts or consultants engaged for this purpose as he or she determines to be appropriate.
(b) After consideration and evaluation of an application for an authorization of confidentiality, the Secretary will either issue a Confidentiality Certificate or a letter denying a Confidentiality Certificate, which will set forth the reasons for such denial, or will request additional information from the person making application. The Confidentiality Certificate will include:
(1) The name and address of the person making application;
(2) The name and address of the individual primarily responsible for conducting the research, if such individual is not the person making application;
(3) The location of the research project;
(4) A brief description of the research project;
(5) A statement that the Certificate does not represent an endorsement of the research project by the Secretary;
(6) The Drug Enforcement Administration registration number for the project, if any; and
(7) The date or event upon which the Confidentiality Certificate becomes effective, which shall not be before the later of either the commencement of the research project or the date of issuance of the Certificate, and the date or event upon which the Certificate will expire.
(c) A Confidentiality Certificate is not transferable and is effective only with respect to the names and other identifying characteristics of those individuals who are the subjects of the single research project specified in the Confidentiality Certificate. The recipient of a Confidentiality Certificate shall, within 15 days of any completion or discontinuance of the research project which occurs prior to the expiration date set forth in the Certificate, provide written notification to the Director of the Institute to which application was made. If the recipient determines that the research project will not be completed by the expiration date set forth in the Confidentiality Certificate he or she may submit a written request for an extension of the expiration date which shall include a justification for such extension and a revised estimate of the date for completion of the project. Upon approval of such a request, the Secretary will issue an amended Confidentiality Certificate.
(d) The protection afforded by a Confidentiality Certificate does not extend to significant changes in the research project as it is described in the application for such Certificate (e.g., changes in the personnel having major responsibilities in the research project, major changes in the scope or direction of the research protocol, or changes in the drugs to be administered and the persons who will administer them). The recipient of a Confidentiality Certificate shall notify the Director of the Institute to which application was made of any proposal for such a significant change by submitting an amended application for a Confidentiality Certificate in the same form and manner as an original application. On the basis of such application and other pertinent information the Secretary will either:
(1) Approve the amended application and issue an amended Confidentiality Certificate together with a Notice of Cancellation terminating original the Confidentiality Certificate in accordance with § 2a.8; or
(2) Disapprove the amended application and notify the applicant in writing that adoption of the proposed significant changes will result in the issuance of a Notice of Cancellation terminating the original Confidentiality Certificate in accordance with § 2a.8.
§ 2a.7 Effect of Confidentiality Certificate.
(a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate while the Certificate is in effect. The authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of the research. Persons so authorized may not, at any time, be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify the research subjects encompassed by the Certificate, except in those circumstances specified in paragraph (b) of this section.
(b) A Confidentiality Certificate granted under this part does not authorize any person to refuse to reveal the name or other identifying characteristics of any research subject in the following circumstances:
(1) The subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information,
(2) Authorized personnel of DHHS request such information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See 45 CFR 5.71 for confidentiality standards imposed on such DHHS personnel), or
(3) Release of such information is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated thereunder (title 21, Code of Federal Regulations).
(c) Neither a Confidentiality Certificate nor the regulations of this part govern the voluntary disclosure of identifying characteristics of research subjects.
§ 2a.8 Termination.
(a) A Confidentiality Certificate is in effect from the date of its issuance until the effective date of its termination. The effective date of termination shall be the earlier of:
(1) The expiration date set forth in the Confidentiality Certificate; or
(2) Ten days from the date of mailing a Notice of Cancellation to the applicant, pursuant to a determination by the Secretary that the research project has been completed or discontinued or that retention of the Confidentiality Certificate is otherwise no longer necessary or desirable.
(b) A Notice of Cancellation shall include: an identification of the Confidentiality Certificate to which it applies; the effective date of its termination; and the grounds for cancellation. Upon receipt of a Notice of Cancellation the applicant shall return the Confidentiality Certificate to the Secretary.
(c) Any termination of a Confidentiality Certificate pursuant to this section is operative only with respect to the names and other identifying characteristics of individuals who begin their participation as research subjects after the effective date of such termination. (See § 2a.4(k) requiring researchers to notify subjects who enter the project after the termination of the Confidentiality Certificate of termination of the Certificate). The protection afforded by a Confidentiality Certificate is permanent with respect to subjects who participated in research during any time the authorization was in effect.
PART 3—PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
Subpart A—General Provisions
§ 3.10 Purpose.
The purpose of this part is to implement the Patient Safety and Quality Improvement Act of 2005 (Pub. L. 109-41), which amended Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) by adding sections 921 through 926, 42 U.S.C. 299b-21 through 299b-26.
§ 3.20 Definitions.
As used in this part, the terms listed alphabetically below have the meanings set forth as follows:
Affiliated provider means, with respect to a provider, a legally separate provider that is the parent organization of the provider, is under common ownership, management, or control with the provider, or is owned, managed, or controlled by the provider.
AHRQ stands for the Agency for Healthcare Research and Quality in HHS.
ALJ stands for an Administrative Law Judge of HHS.
Board means the members of the HHS Departmental Appeals Board, in the Office of the Secretary, which issues decisions in panels of three.
Bona fide contract means:
(1) A written contract between a provider and a PSO that is executed in good faith by officials authorized to execute such contract; or
(2) A written agreement (such as a memorandum of understanding or equivalent recording of mutual commitments) between a Federal, State, local, or Tribal provider and a Federal, State, local, or Tribal PSO that is executed in good faith by officials authorized to execute such agreement.
Complainant means a person who files a complaint with the Secretary pursuant to § 3.306.
Component organization means an entity that:
(1) Is a unit or division of a legal entity (including a corporation, partnership, or a Federal, State, local or Tribal agency or organization); or
(2) Is owned, managed, or controlled by one or more legally separate parent organizations.
Component PSO means a PSO listed by the Secretary that is a component organization.
Confidentiality provisions means for purposes of subparts C and D, any requirement or prohibition concerning confidentiality established by sections 921 and 922(b)-(d), (g) and (i) of the Public Health Service Act, 42 U.S.C. 299b-21, 299b-22(b)-(d), (g) and (i) and the provisions, at §§ 3.206 and 3.208, that implement the statutory prohibition on disclosure of identifiable patient safety work product.
Disclosure means the release, transfer, provision of access to, or divulging in any other manner of patient safety work product by:
(1) An entity or natural person holding the patient safety work product to another legally separate entity or natural person, other than a workforce member of, or a health care provider holding privileges with, the entity holding the patient safety work product; or
(2) A component PSO to another entity or natural person outside the component PSO and within the legal entity of which the component PSO is a part.
Entity means any organization or organizational unit, regardless of whether the organization is public, private, for-profit, or not-for-profit.
Group health plan means an employee welfare benefit plan (as defined in section 3(1) of the Employee Retirement Income Security Act of 1974 (ERISA)) to the extent that the plan provides medical care (as defined in paragraph (2) of section 2791(a) of the Public Health Service Act, including items and services paid for as medical care) to employees or their dependents (as defined under the terms of the plan) directly or through insurance, reimbursement, or otherwise.
Health insurance issuer means an insurance company, insurance service, or insurance organization (including a health maintenance organization, as defined in 42 U.S.C. 300gg-91(b)(3)) which is licensed to engage in the business of insurance in a State and which is subject to State law which regulates insurance (within the meaning of 29 U.S.C. 1144(b)(2)). This term does not include a group health plan.
Health maintenance organization means:
(1) A Federally qualified health maintenance organization (HMO) (as defined in 42 U.S.C. 300e(a));
(2) An organization recognized under State law as a health maintenance organization; or
(3) A similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.
HHS stands for the United States Department of Health and Human Services.
HIPAA Privacy Rule means the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), at 45 CFR part 160 and subparts A and E of part 164.
Identifiable patient safety work product means patient safety work product that:
(1) Is presented in a form and manner that allows the identification of any provider that is a subject of the work product, or any providers that participate in, or are responsible for, activities that are a subject of the work product;
(2) Constitutes individually identifiable health information as that term is defined in the HIPAA Privacy Rule at 45 CFR 160.103; or
(3) Is presented in a form and manner that allows the identification of an individual who in good faith reported information directly to a PSO or to a provider with the intention of having the information reported to a PSO (“reporter”).
Nonidentifiable patient safety work product means patient safety work product that is not identifiable patient safety work product in accordance with the nonidentification standards set forth at § 3.212.
OCR stands for the Office for Civil Rights in HHS.
Parent organization means an organization that: owns a controlling interest or a majority interest in a component organization; has the authority to control or manage agenda setting, project management, or day-to-day operations; or the authority to review and override decisions of a component organization. The component organization may be a provider.
Patient Safety Act means the Patient Safety and Quality Improvement Act of 2005 (Pub. L. 109-41), which amended Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) by inserting a new Part C, sections 921 through 926, which are codified at 42 U.S.C. 299b-21 through 299b-26.
Patient safety activities means the following activities carried out by or on behalf of a PSO or a provider:
(1) Efforts to improve patient safety and the quality of health care delivery;
(2) The collection and analysis of patient safety work product;
(3) The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;
(4) The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;
(5) The maintenance of procedures to preserve confidentiality with respect to patient safety work product;
(6) The provision of appropriate security measures with respect to patient safety work product;
(7) The utilization of qualified staff; and
(8) Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.
Patient safety evaluation system means the collection, management, or analysis of information for reporting to or by a PSO.
Patient safety organization (PSO) means a private or public entity or component thereof that is listed as a PSO by the Secretary in accordance with subpart B. A health insurance issuer or a component organization of a health insurance issuer may not be a PSO. See also the exclusions in § 3.102 of this part.
Patient safety work product:
(1) Except as provided in paragraph (2) of this definition, patient safety work product means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material)
(i) Which could improve patient safety, health care quality, or health care outcomes; and
(A) Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or
(B) Are developed by a PSO for the conduct of patient safety activities; or
(ii) Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
(2)(i) Patient safety work product does not include a patient’s medical record, billing and discharge information, or any other original patient or provider information; nor does it include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a PSO shall not by reason of its reporting be considered patient safety work product.
(ii) Patient safety work product assembled or developed by a provider for reporting to a PSO may be removed from a patient safety evaluation system and no longer considered patient safety work product if:
(A) The information has not yet been reported to a PSO; and
(B) The provider documents the act and date of removal of such information from the patient safety evaluation system.
(iii) Nothing in this part shall be construed to limit information that is not patient safety work product from being:
(A) Discovered or admitted in a criminal, civil or administrative proceeding;
(B) Reported to a Federal, State, local or Tribal governmental agency for public health or health oversight purposes; or
(C) Maintained as part of a provider’s recordkeeping obligation under Federal, State, local or Tribal law.
Person means a natural person, trust or estate, partnership, corporation, professional association or corporation, or other entity, public or private.
Provider means:
(1) An individual or entity licensed or otherwise authorized under State law to provide health care services, including—
(i) A hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioner’s office (includes a group practice), long term care facility, behavior health residential treatment facility, clinical laboratory, or health center; or
(ii) A physician, physician assistant, registered nurse, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner;
(2) Agencies, organizations, and individuals within Federal, State, local, or Tribal governments that deliver health care, organizations engaged as contractors by the Federal, State, local, or Tribal governments to deliver health care, and individual health care practitioners employed or engaged as contractors by the Federal State, local, or Tribal governments to deliver health care; or
(3) A parent organization of one or more entities described in paragraph (1)(i) of this definition or a Federal, State, local, or Tribal government unit that manages or controls one or more entities described in paragraphs (1)(i) or (2) of this definition.
Research has the same meaning as the term is defined in the HIPAA Privacy Rule at 45 CFR 164.501.
Respondent means a provider, PSO, or responsible person who is the subject of a complaint or a compliance review.
Responsible person means a person, other than a provider or a PSO, who has possession or custody of identifiable patient safety work product and is subject to the confidentiality provisions.
Workforce means employees, volunteers, trainees, contractors, or other persons whose conduct, in the performance of work for a provider, PSO or responsible person, is under the direct control of such provider, PSO or responsible person, whether or not they are paid by the provider, PSO or responsible person.
Subpart B—PSO Requirements and Agency Procedures
§ 3.102 Process and requirements for initial and continued listing of PSOs.
(a) Eligibility and process for initial and continued listing—(1) Submission of certification. Any entity, except as specified in paragraph (a)(2) of this section, may request from the Secretary an initial or continued listing as a PSO by submitting a completed certification form that meets the requirements of this section, in accordance with § 3.112. An individual with authority to make commitments on behalf of the entity seeking listing will be required to submit contact information for the entity and:
(i) Attest that the entity is not subject to any exclusion in paragraph (a)(2) of this section;
(ii) Provide certifications that the entity meets each requirement for PSOs in paragraph (b) of this section;
(iii) If the entity is a component of another organization, provide the additional certifications that the entity meets the requirements of paragraph (c)(1)(i) of this section;
(iv) If the entity is a component of an excluded entity described in paragraph (a)(2)(ii), provide the additional certifications and information required by paragraph (c)(1)(ii) of this section;
(v) Attest that the entity has disclosed if the Secretary has ever delisted this entity (under its current name or any other) or refused to list the entity or whether any of its officials or senior managers held comparable positions of responsibility in an entity that was denied listing or delisted and, if any of these circumstances apply, submit with its certifications and related disclosures, the name of the entity or entities that the Secretary declined to list or delisted;
(vi) Attest that the PSO will promptly notify the Secretary during its period of listing if it can no longer comply with any of its attestations and the applicable requirements in §§ 3.102(b) and 3.102(c) or if there have been any changes in the accuracy of the information submitted for listing, along with the pertinent changes; and
(vii) Provide other information that the Secretary determines to be necessary to make the requested listing determination.
(2) Exclusion of certain entities. The following types of entities may not seek listing as a PSO:
(i) A health insurance issuer; a unit or division of a health insurance issuer; or an entity that is owned, managed, or controlled by a health insurance issuer;
(ii)(A) An entity that accredits or licenses health care providers;
(B) An entity that oversees or enforces statutory or regulatory requirements governing the delivery of health care services;
(C) An agent of an entity that oversees or enforces statutory or regulatory requirements governing the delivery of health care services; or
(D) An entity that operates a Federal, state, local or Tribal patient safety reporting system to which health care providers (other than members of the entity’s workforce or health care providers holding privileges with the entity) are required to report information by law or regulation.
(iii) A component of an entity listed in paragraph (a)(2)(ii) may seek listing as a component PSO subject to the requirements and restrictions of paragraph (c)(1)(ii) of this section.
(3) Submission of certification for continued listing. To facilitate a timely Secretarial determination regarding acceptance of its certification for continued listing, a PSO must submit the required certification no later than 75 days before the expiration of a PSO’s three-year period of listing.
(b) Fifteen general PSO certification requirements. The certifications submitted to the Secretary in accordance with paragraph (a)(1)(ii) of this section must conform to the following 15 requirements:
(1) Required certification regarding eight patient safety activities—(i) Initial listing. An entity seeking initial listing as a PSO must certify that it has written policies and procedures in place to perform each of the eight patient safety activities, defined in § 3.20. With respect to paragraphs (5) and (6) in the definition of patient safety activities regarding confidentiality and security, the policies and procedures must include and provide for:
(A) Compliance with the confidentiality provisions of subpart C of this part and with appropriate security measures as required by § 3.106 of this subpart.
(B) Notification of each provider that submitted patient safety work product or data as described in § 3.108(b)(2) to the entity if the submitted work product or data was subject to an unauthorized disclosure or its security was breached.
(ii) Continued Listing. A PSO seeking continued listing must certify that it is performing, and will continue to perform, each of the patient safety activities defined in § 3.20, and is and will continue to comply with the requirements of paragraphs (b)(1)(i)(A) and (B) of this section.
(2) Required certification regarding seven PSO criteria—(i) Initial Listing. In its initial certification submission, an entity must also certify that, if listed as a PSO, it will comply with the seven requirements in paragraphs (b)(2)(i)(A) through (G) of this section.
(A) The mission and primary activity of the PSO must be to conduct activities that are to improve patient safety and the quality of health care delivery.
(B) The PSO must have appropriately qualified workforce members, including licensed or certified medical professionals.
(C) The PSO, within the 24-month period that begins on the date of its initial listing as a PSO, and within each sequential 24-month period thereafter, must have 2 bona fide contracts, each of a reasonable period of time, each with a different provider for the purpose of receiving and reviewing patient safety work product.
(D) The PSO is not a health insurance issuer, and is not a component of a health insurance issuer.
(E) The PSO must make disclosures to the Secretary as required under § 3.102(d), in accordance with § 3.112 of this subpart.
(F) To the extent practical and appropriate, the PSO must collect patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers.
(G) The PSO must utilize patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.
(ii) Continued Listing. A PSO seeking continued listing must certify that it is complying with, and will continue to comply with, the requirements of paragraphs (b)(2)(i)(A) through (G) of this section.
(iii) Compliance with the criterion for collecting patient safety work product in a standardized manner to the extent practical and appropriate. With respect to paragraph (b)(2)(i)(F) of this section, the Secretary will assess compliance by a PSO in the following manner.
(A) A PSO seeking continued listing must:
(1) Certify that the PSO is using the Secretary’s published guidance for common formats and definitions in its collection of patient safety work product (option (I));
(2) Certify that the PSO is using an alternative system of formats and definitions that permits valid comparisons of similar cases among similar providers (option (II)); or
(3) Provide a clear explanation for why it is not practical or appropriate for the PSO to comply with options (I) or (II) at this time.
(B) The Secretary will consider a PSO to be in compliance if the entity complies with option (I), satisfactorily demonstrates that option (II) permits valid comparisons of similar cases among similar providers, or satisfactorily demonstrates that it is not practical or appropriate for the PSO to comply with options (I) or (II) at this time.
(c) Additional certifications required of component organizations—(1) Requirements when seeking listing—(i) Requirements that all component organizations must meet. In addition to meeting the 15 general PSO certification requirements of paragraph (b) of this section, an entity seeking initial listing that is a component of another organization must certify that it will comply with the requirements of paragraph (c)(2) of this section. A component PSO seeking continued listing must certify that it is complying with, and will continue to comply with, the requirements of this same paragraph (c)(2). At initial and continued listing, a component entity must attach to its certifications for listing contact information for its parent organization(s).
(ii) Additional requirements and limitations applicable to components of entities that are excluded from listing. In addition to the requirements under paragraph (c)(1)(i) of this section, a component of an organization excluded from listing under paragraph (a)(2)(ii) of this section must submit the additional certifications and specified information for initial and continued listing and comply with paragraph (c)(4) of this section.
(2) Required component certifications—(i) Separation of patient safety work product. A component PSO must maintain patient safety work product separately from the rest of the parent organization(s) of which it is a part, and establish appropriate security measures to maintain the confidentiality of patient safety work product. The information system in which the component PSO maintains patient safety work product must not permit unauthorized access by one or more individuals in, or by units of, the rest of the parent organization(s) of which it is a part.
(ii) Nondisclosure of patient safety work product. A component PSO must require that members of its workforce and any other contractor staff not make unauthorized disclosures of patient safety work product to the rest of the parent organization(s) of which it is a part.
(iii) No conflict of interest. The pursuit of the mission of a component PSO must not create a conflict of interest with the rest of the parent organization(s) of which it is a part.
(3) Written agreements for assisting a component PSO in the conduct of patient safety activities. Notwithstanding the requirements of paragraph (c)(2) of this section, a component PSO may provide access to identifiable patient safety work product to one or more individuals in, or to one or more units of, the rest of the parent organization(s) of which it is a part, if the component PSO enters into a written agreement with such individuals or units which requires that:
(i) The component PSO will only provide access to identifiable patient safety work product to enable such individuals or units to assist the component PSO in its conduct of patient safety activities, and
(ii) Such individuals or units that receive access to identifiable patient safety work product pursuant to such written agreement will only use or disclose such information as specified by the component PSO to assist the component PSO in its conduct of patient safety activities, will take appropriate security measures to prevent unauthorized disclosures and will comply with the other certifications the component has made pursuant to paragraph (c)(2) of this section regarding unauthorized disclosures and conducting the mission of the PSO without creating conflicts of interest.
(4) Required attestations, information and operational limitations for components of entities excluded from listing. A component organization of an entity that is subject to the restrictions of paragraph (a)(2)(ii) of this section must:
(i) Submit the following information with its certifications for listing:
(A) A statement describing its parent organization’s role, and the scope of the parent organization’s authority, with respect to any of the following that apply: Accreditation or licensure of health care providers, oversight or enforcement of statutory or regulatory requirements governing the delivery of health care services, serving as an agent of such a regulatory oversight or enforcement authority, or administering a public mandatory patient safety reporting system;
(B) An attestation that the parent organization has no policies or procedures that would require or induce providers to report patient safety work product to their component organization once listed as a PSO and that the component PSO will notify the Secretary within 5 calendar days of the date on which the component organization has knowledge of the adoption by the parent organization of such policies or procedures, and an acknowledgment that the adoption of such policies or procedures by the parent organization during the component PSO’s period of listing will result in the Secretary initiating an expedited revocation process in accordance with § 3.108(e); and
(C) An attestation that the component organization will prominently post notification on its Web site and publish in any promotional materials for dissemination to providers, a summary of the information that is required by paragraph (c)(4)(i)(A) of this section.
(ii) Comply with the following requirements during its period of listing:
(A) The component organization may not share staff with its parent organization(s).
(B) The component organization may enter into a written agreement pursuant to paragraph (c)(3) but such agreements are limited to units or individuals of the parent organization(s) whose responsibilities do not involve the activities specified in the restrictions in paragraph (a)(2)(ii) of this section.
(d) Required notifications. Upon listing, PSOs must meet the following notification requirements:
(1) Notification regarding PSO compliance with the minimum contract requirement. No later than 45 calendar days prior to the last day of the pertinent 24-month assessment period, specified in paragraph (b)(2)(iii)(C) of this section, the Secretary must receive from a PSO a certification that states whether it has met the requirement of that paragraph regarding two bona fide contracts, submitted in accordance with § 3.112 of this subpart.
(2) Notification regarding a PSO’s relationships with its contracting providers—(i) Requirement. A PSO must file a disclosure statement regarding a provider with which it has a contract that provides the confidentiality and privilege protections of the Patient Safety Act (hereinafter referred to as a Patient Safety Act contract) if the PSO has any other relationships with this provider that are described in paragraphs (d)(2)(i)(A) through (D) of this section. The PSO must disclose all such relationships. A disclosure statement is not required if all of its other relationships with the provider are limited to Patient Safety Act contracts.
(A) The provider and PSO have current contractual relationships, other than those arising from any Patient Safety Act contracts, including formal contracts or agreements that impose obligations on the PSO.
(B) The provider and PSO have current financial relationships other than those arising from any Patient Safety Act contracts. A financial relationship may include any direct or indirect ownership or investment relationship between the PSO and the contracting provider, shared or common financial interests or direct or indirect compensation arrangements whether in cash or in-kind.
(C) The PSO and provider have current reporting relationships other than those arising from any Patient Safety Act contracts, by which the provider has access to information regarding the work and operation of the PSO that is not available to other contracting providers.
(D) Taking into account all relationships that the PSO has with the provider, the PSO is not independently managed or controlled, or the PSO does not operate independently from, the contracting provider.
(ii) Content. A PSO must submit to the Secretary the required attestation form for disclosures with the information specified below in accordance with § 3.112 and this section. The substantive information that must be included with each submission has two required parts:
(A) The Required Disclosures. The first part of the substantive information must provide a succinct list of obligations between the PSO and the contracting provider apart from their Patient Safety Act contract(s) that create, or contain, any of the types of relationships that must be disclosed based upon the requirements of paragraphs (d)(2)(i)(A) through (D) of this section. Each reportable obligation or discrete set of obligations that the PSO has with this contracting provider should be listed only once; noting the specific aspects of the obligation(s) that reflect contractual or financial relationships, involve access to information that is not available to other providers, or affect the independence of PSO operations, management, or control.
(B) An Explanatory Narrative. The second required part of the substantive information must provide a brief explanatory narrative succinctly describing: The policies and procedures that the PSO has in place to ensure adherence to objectivity and professionally recognized analytic standards in the assessments it undertakes; and any other policies or procedures, or agreements with this provider, that the PSO has in place to ensure that it can fairly and accurately perform patient safety activities.
(iii) Deadlines for submission. The Secretary must receive a disclosure statement within 45 days of the date on which a PSO enters a contract with a provider if the circumstances described in any of the paragraphs (d)(2)(i)(A) through (D) of this section are met on the date the contract is entered. During the contract period, if these circumstances subsequently arise, the Secretary must receive a disclosure statement from the PSO within 45 days of the date that any disclosure requirement in paragraph (d)(2)(i) of this section first applies.
§ 3.104 Secretarial actions.
(a) Actions in response to certification submissions for initial and continued listing as a PSO. (1) In response to an initial or continued certification submission by an entity, pursuant to the requirements of § 3.102 of this subpart, the Secretary may—
(i) Accept the certification submission and list the entity as a PSO, or maintain the listing of a PSO, if the Secretary determines that the entity meets the applicable requirements of the Patient Safety Act and this subpart;
(ii) Deny acceptance of a certification submission and, in the case of a currently listed PSO, remove the entity from the list if the entity does not meet the applicable requirements of the Patient Safety Act and this subpart; or
(iii) Condition the listing of an entity or the continued listing of a PSO, following a determination made pursuant to paragraph (c) of this section or a determination after review of the pertinent history of an entity that has been delisted or refused listing and its officials and senior managers.
(2) Basis for determination. In making a determination regarding listing, the Secretary will consider the certification submission; any prior actions by the Secretary regarding the entity or PSO including delisting; any history of or current non-compliance by the entity or the PSO or its officials or senior managers with statutory or regulatory requirements or requests from the Secretary; the relationships of the entity or PSO with providers; and any findings made by the Secretary in accordance with paragraph (c) of this section.
(3) Notification. The Secretary will notify in writing each entity of action taken on its certification submission for initial or continued listing. The Secretary will provide reasons when an entity’s certification is conditionally accepted and the entity is conditionally listed, when an entity’s certification is not accepted and the entity is not listed, or when acceptance of its certification is revoked and the entity is delisted.
(b) Actions regarding PSO compliance with the minimum contract requirement. After the date on which the Secretary, under § 3.102(d)(1) of this subpart, must receive notification regarding compliance of a PSO with the minimum contract requirement—
(1) If the PSO has met the minimum contract requirement, the Secretary will acknowledge in writing receipt of the notification and add information to the list established pursuant to paragraph (d) of this section stating that the PSO has certified that it has met the requirement.
(2) If the PSO states that it has not yet met the minimum contract requirement by the date specified in § 3.102(d)(1), or if notice is not received by that date, the Secretary will issue to the PSO a notice of a preliminary finding of deficiency as specified in § 3.108(a)(2) and establish a period for correction that extends until midnight of the last day of the PSO’s applicable 24-month period of assessment. Thereafter, if the requirement has not been met, the Secretary will provide the PSO a written notice of proposed revocation and delisting in accordance with § 3.108(a)(3).
(c) Actions regarding required disclosures by PSOs of relationships with contracting providers. The Secretary will review and make findings regarding each disclosure statement submitted by a PSO, pursuant to § 3.102(d)(2), regarding its relationships with contracting provider(s), determine whether such findings warrant action regarding the listing of the PSO in accordance with paragraph (c)(2) of this section, and make the findings public.
(1) Basis of findings regarding PSO disclosure statements. In reviewing disclosure statements, submitted pursuant to § 3.102(d)(2) of this subpart, the Secretary will consider the disclosed relationship(s) between the PSO and the contracting provider and the statements and material submitted by the PSO describing the policies and procedures that the PSO has in place to determine whether the PSO can fairly and accurately perform the required patient safety activities.
(2) Determination by the Secretary. Based on the Secretary’s review and findings, he may choose to take any of the following actions:
(i) For an entity seeking an initial or continued listing, the Secretary may list or continue the listing of an entity without conditions, list the entity subject to conditions, or deny the entity’s certification for initial or continued listing; or
(ii) For a listed PSO, the Secretary may determine that the entity will remain listed without conditions, continue the entity’s listing subject to conditions, or remove the entity from the list of PSOs.
(3) Release of disclosure statements and Secretarial findings. (i) Subject to paragraph (c)(3)(ii) of this section, the Secretary will make disclosure statements available to the public along with related findings that are made available in accordance with paragraph (c) of this section.
(ii) The Secretary may withhold information that is exempt from public disclosure under the Freedom of Information Act, e.g., trade secrets or confidential commercial information that are subject to the restrictions of 18 U.S.C. 1905.
(d) Maintaining a list of PSOs. The Secretary will compile and maintain a publicly available list of entities whose certifications as PSOs have been accepted. The list will include contact information for each entity, a copy of all certification forms and disclosure statements submitted by each entity in accordance with paragraph (c)(3)(ii) of this section, the effective date of the PSO’s listing, and information on whether a PSO has certified that it has met the two contract requirement. The list also will include a copy of the Secretary’s findings regarding each disclosure statement submitted by an entity, information describing any related conditions that have been placed by the Secretary on the listing of an entity as a PSO, and other information that this Subpart states may be made public. AHRQ may maintain a PSO website (or a comparable future form of public notice) and may post the list on this website.
(e) Three-year period of listing. (1) The three-year period of listing of a PSO will automatically expire at midnight of the last day of this period, unless the listing had been revoked or relinquished earlier in accordance with § 3.108 of this subpart, or if, prior to this automatic expiration, the PSO seeks a new three-year listing, in accordance with § 3.102, and the Secretary accepts the PSO’s certification for a new three-year listing, in accordance with § 3.104(a).
(2) The Secretary plans to send a written notice of imminent expiration to a PSO at least 60 calendar days prior to the date on which its three-year period of listing expires if the Secretary has not yet received a certification for continued listing. The Secretary plans to indicate, on the AHRQ PSO website, the PSOs from whom certifications for continued listing have not been timely received.
(f) Effective dates of Secretarial actions. Unless otherwise stated, the effective date of each action by the Secretary pursuant to this subpart will be specified in the written notice of such action that is sent to the entity. When the Secretary sends a notice that addresses acceptance or revocation of an entity’s certifications or voluntary relinquishment by an entity of its status as a PSO, the notice will specify the effective date and time of listing or delisting.
§ 3.106 Security requirements.
(a) Application. A PSO must secure patient safety work product in conformance with the security requirements of paragraph (b) of this section. These requirements must be met at all times and at any location at which the PSO, its workforce members, or its contractors receive, access, or handle patient safety work product. Handling patient safety work product includes its processing, development, use, maintenance, storage, removal, disclosure, transmission and destruction.
(b) Security framework. A PSO must have written policies and procedures that address each of the considerations specified in this subsection. In addressing the framework that follows, the PSO may develop appropriate and scalable security standards, policies, and procedures that are suitable for the size and complexity of its organization.
(1) Security management. A PSO must address:
(i) Maintenance and effective implementation of written policies and procedures that conform to the requirements of this section to protect the confidentiality, integrity, and availability of the patient safety work product that is received, accessed, or handled; and to monitor and improve the effectiveness of such policies and procedures, and
(ii) Training of the PSO workforce and PSO contractors who receive, access, or handle patient safety work product regarding the requirements of the Patient Safety Act, this Part, and the PSO’s policies and procedures regarding the confidentiality and security of patient safety work product.
(2) Distinguishing patient safety work product. A PSO must address:
(i) Maintenance of the security of patient safety work product, whether in electronic or other media, through either physical separation from non-patient safety work product, or if co-located with non-patient safety work product, by making patient safety work product distinguishable so that the appropriate form and level of security can be applied and maintained;
(ii) Protection of the media, whether in electronic, paper, or other media or format, that contain patient safety work product, limiting access to authorized users, and sanitizing and destroying such media before their disposal or release for reuse; and
(iii) Physical and environmental protection, to control and limit physical and virtual access to places and equipment where patient safety work product is received, accessed, or handled.
(3) Security control and monitoring. A PSO must address:
(i) Identification of those authorized to receive, access, or handle patient safety work product and an audit capacity to detect unlawful, unauthorized, or inappropriate receipt, access, or handling of patient safety work product, and
(ii) Methods to prevent unauthorized receipt, access, or handling of patient safety work product.
(4) Security assessment. A PSO must address:
(i) Periodic assessments of security risks and controls to establish if its controls are effective, to correct any deficiency identified, and to reduce or eliminate any vulnerabilities.
(ii) System and communications protection, to monitor, control, and protect PSO receipt, access, or handling of patient safety work product with particular attention to the transmission of patient safety work product to and from providers, other PSOs, contractors or any other responsible persons.
§ 3.108 Correction of deficiencies, revocation, and voluntary relinquishment.
(a) Process for correction of a deficiency and revocation—(1) Circumstances leading to revocation. The Secretary may revoke his acceptance of an entity’s certification (“revocation”) and delist the entity as a PSO if he determines—
(i) The PSO is not fulfilling the certifications made to the Secretary as required by § 3.102;
(ii) The PSO has not met the two contract requirement, as required by § 3.102(d)(1);
(iii) Based on a PSO’s disclosures made pursuant to § 3.102(d)(2) , that the entity cannot fairly and accurately perform the patient safety activities of a PSO with a public finding to that effect; or
(iv) The PSO is not in compliance with any other provision of the Patient Safety Act or this part.
(2) Notice of preliminary finding of deficiency and establishment of an opportunity for correction of a deficiency. (i) Except as provided by paragraph (e) of this section, if the Secretary determines that a PSO is not in compliance with its obligations under the Patient Safety Act or this subpart, the Secretary must send a PSO written notice of the preliminary finding of deficiency. The notice must state the actions or inactions that encompass the deficiency finding, outline the evidence that the deficiency exists, specify the possible and/or required corrective actions that must be taken, and establish a date by which the deficiency must be corrected. The Secretary may specify in the notice the form of documentation required to demonstrate that the deficiency has been corrected.
(ii) The notice of a preliminary finding of deficiency is presumed received five days after it is sent, absent evidence of the actual receipt date. If a PSO does not submit evidence to the Secretary within 14 calendar days of actual or constructive receipt of such notice, whichever is longer, which demonstrates that the preliminary finding is factually incorrect, the preliminary finding will be the basis for a finding of deficiency.
(3) Determination of correction of a deficiency. (i) Unless the Secretary specifies another date, the Secretary must receive documentation to demonstrate that the PSO has corrected any deficiency cited in the preliminary finding of deficiency no later than five calendar days following the last day of the correction period that is specified by the Secretary in such notice.
(ii) In making a determination regarding the correction of any deficiency, the Secretary will consider the documentation submitted by the PSO, any assessments under § 3.110, recommendations of program staff, and any other information available regarding the PSO that the Secretary deems appropriate and relevant to the PSO’s implementation of the terms of its certification.
(iii) After completing his review, the Secretary may make one of the following determinations:
(A) The action(s) taken by the PSO have corrected any deficiency, in which case the Secretary will withdraw the notice of deficiency and so notify the PSO;
(B) The PSO has acted in good faith to correct the deficiency, but the Secretary finds an additional period of time is necessary to achieve full compliance and/or the required corrective action specified in the notice of a preliminary finding of deficiency needs to be modified in light of the experience of the PSO in attempting to implement the corrective action, in which case the Secretary will extend the period for correction and/or modify the specific corrective action required; or
(C) The PSO has not completed the corrective action because it has not acted with reasonable diligence or speed to ensure that the corrective action was completed within the allotted time, in which case the Secretary will issue to the PSO a notice of proposed revocation and delisting.
(iv) When the Secretary issues a written notice of proposed revocation and delisting, the notice will specify the deficiencies that have not been timely corrected and will detail the manner in which the PSO may exercise its opportunity to be heard in writing to respond to the deficiencies specified in the notice.
(4) Opportunity to be heard in writing following a notice of proposed revocation and delisting. The Secretary will afford a PSO an opportunity to be heard in writing, as specified in paragraph (a)(4)(i) of this section, to provide a substantive response to the deficiency finding(s) set forth in the notice of proposed revocation and delisting.
(i) The notice of proposed revocation and delisting is presumed received five days after it is sent, absent evidence of actual receipt. The Secretary will provide a PSO with a period of time, beginning with the date of receipt of the notice of proposed revocation and delisting of which there is evidence, or the presumed date of receipt if there is no evidence of earlier receipt, and ending at midnight 30 calendar days thereafter, during which the PSO may submit a substantive response to the deficiency findings in writing.
(ii) The Secretary will provide to the PSO any rules of procedure governing the form or transmission of the written response to the notice of proposed revocation and delisting. Such rules may also be posted on the AHRQ PSO Web site or published in the
(iii) If a PSO does not submit a written response to the deficiency finding(s) within 30 calendar days of receipt of the notice of proposed revocation and delisting, the notice of proposed revocation becomes final as a matter of law and the basis for Secretarial action under paragraph (b)(1) of this section.
(5) The Secretary’s decision regarding revocation. The Secretary will review the entire administrative record pertaining to a notice of proposed revocation and delisting and any written materials submitted by the PSO under paragraph (a)(4) of this section. The Secretary may affirm, reverse, or modify the notice of proposed revocation and delisting and will make a determination with respect to the continued listing of the PSO.
(b) Revocation of the Secretary’s acceptance of a PSO’s certifications—(1) Establishing the date and time of revocation and delisting. When the Secretary concludes, in accordance with a decision made under paragraphs (a)(5), (e)(3)(iii) or (e)(3)(iv)(C) of this section, that revocation of the acceptance of a PSO’s certification is warranted for its failure to comply with requirements of the Patient Safety Act or of this Part, the Secretary will establish the effective time and date for such prompt revocation and removal of the entity from the list of PSOs, so notify the PSO in writing, and provide the relevant public notice required by § 3.108(d) of this subpart.
(2) Required notification of providers and status of data. (i) Upon being notified of the Secretary’s action pursuant to paragraph (b)(1) of this section, the former PSO will take all reasonable actions to notify each provider, whose patient safety work product it collected or analyzed, of the Secretary’s action(s) and the following statutory information: Confidentiality and privilege protections that applied to patient safety work product while the former PSO was listed continue to apply after the entity is removed from listing. Data submitted by providers to the former PSO for 30 calendar days following the date and time on which the entity was removed from the list of PSOs pursuant to paragraph (b)(1) of this section will have the same status as data submitted while the entity was still listed.
(ii) Within 15 days of being notified of the Secretary’s action pursuant to paragraph (b)(1) of this section, the former PSO shall submit to the Secretary confirmation that it has taken the actions in paragraph (b)(2)(i) of this section.
(3) Disposition of patient safety work product and data. Within 90 days following the effective date of revocation and delisting pursuant to paragraph (b)(1) of this section, the former PSO will take one or more of the following measures in regard to patient safety work product and data described in paragraph (b)(2)(i) of this section:
(i) Transfer such patient safety work product or data, with the approval of the source from which it was received, to a PSO that has agreed to receive such patient safety work product or data;
(ii) Return such work product or data to the source from which it was submitted; or
(iii) If returning such patient safety work product or data to its source is not practicable, destroy such patient safety work product or data.
(c) Voluntary relinquishment—(1) Circumstances constituting voluntary relinquishment. A PSO will be considered to have voluntarily relinquished its status as a PSO if the Secretary accepts a notification from a PSO that it wishes to relinquish voluntarily its listing as a PSO.
(2) Notification of voluntary relinquishment. A PSO’s notification of voluntary relinquishment to the Secretary must include the following:
(i) An attestation that all reasonable efforts have been made, or will have been made by a PSO within 15 calendar days of this statement, to notify the sources from which it received patient safety work product of the PSO’s intention to cease PSO operations and activities, to relinquish voluntarily its status as a PSO, to request that these other entities cease reporting or submitting any further information to the PSO as soon as possible, and inform them that any information reported after the effective date and time of delisting that the Secretary sets pursuant to paragraph (c)(3) of this section will not be protected as patient safety work product under the Patient Safety Act.
(ii) An attestation that the entity has established a plan, or within 15 calendar days of this statement, will have made all reasonable efforts to establish a plan, in consultation with the sources from which it received patient safety work product, that provides for the disposition of the patient safety work product held by the PSO consistent with, to the extent practicable, the statutory options for disposition of patient safety work product as set out in paragraph (b)(3) of this section; and
(iii) Appropriate contact information for further communications from the Secretary.
(3) Response to notification of voluntary relinquishment. (i) After a PSO provides the notification required by paragraph (c)(2) of this section, the Secretary will respond in writing to the entity indicating whether the proposed voluntary relinquishment of its PSO status is accepted. If the voluntary relinquishment is accepted, the Secretary’s response will indicate an effective date and time for the entity’s removal from the list of PSOs and will provide public notice of the voluntary relinquishment and the effective date and time of the delisting, in accordance with § 3.108(d) of this subpart.
(ii) If the Secretary receives a notification of voluntary relinquishment during or immediately after revocation proceedings for cause under paragraphs (a)(4) and (a)(5) of this section, the Secretary, as a matter of discretion, may accept voluntary relinquishment in accordance with the preceding paragraph or decide not to accept the entity’s proposed voluntary relinquishment and proceed with the revocation for cause and delisting pursuant to paragraph (b)(1) of this section.
(4) Non-applicability of certain procedures and requirements. (i) A decision by the Secretary to accept a request by a PSO to relinquish voluntarily its status as a PSO pursuant to paragraph (c)(2) of this section does not constitute a determination of a deficiency in PSO compliance with the Patient Safety Act or with this Subpart.
(ii) The procedures and requirements of § 3.108(a) of this subpart regarding deficiencies including the opportunity to correct deficiencies and to be heard in writing, and the procedures and requirements of § 3.108(b) are not applicable to determinations of the Secretary made pursuant to this subsection.
(d) Public notice of delisting regarding removal from listing. If the Secretary removes an entity from the list of PSOs following revocation of acceptance of the entity’s certification pursuant to § 3.108(b)(1), voluntary relinquishment pursuant to § 3.108(c)(3), or expiration of an entity’s period of listing pursuant to § 3.104(e)(1), the Secretary will promptly publish in the
(e) Expedited revocation and delisting—(1) Basis for expedited revocation. Notwithstanding any other provision of this section, the Secretary may use the expedited revocation process described in paragraph (e)(3) of this section if he determines—
(i) The PSO is not in compliance with this part because it is or is about to become an entity described in § 3.102(a)(2).
(ii) The parent organization of the PSO is an entity described in § 3.102(a)(2) and requires or induces health care providers to report patient safety work product to its component PSO; or
(iii) The circumstances for revocation in paragraph (a)(1) of this section exist, and the Secretary has determined that there would be serious adverse consequences if the PSO were to remain listed.
(2) Applicable provisions. If the Secretary uses the expedited revocation process described in paragraph (e)(3) of this section, the procedures in paragraphs (a)(2) through (5) of this section shall not apply and paragraph (a)(1) and paragraphs (b) and (d) of this section shall apply.
(3) Expedited revocation process. (i) The Secretary must send the PSO a written notice of deficiency that:
(A) Identifies the evidence that the circumstances for revocation and delisting under paragraph (a)(1) of this section exist, and any corrective action that the PSO must take if the Secretary determines that corrective action may resolve the matter so that the entity would not be delisted; and
(B) Provides an opportunity for the PSO to respond in writing to correct the facts or the legal bases for delisting found in the notice, and to offer any other grounds for its not being delisted.
(ii) The notice of deficiency will be presumed to be received five days after it is sent, absent evidence of the actual receipt date.
(iii) If the PSO does not submit a written response to the Secretary within 14 calendar days of actual or constructive receipt of such notice, whichever is longer, the Secretary may revoke his acceptance of the PSO’s certifications and remove the entity from the list of PSOs.
(iv) If the PSO responds in writing within the required 14-day time period, the Secretary may take any of the following actions:
(A) Withdraw the notice of deficiency;
(B) Provide the PSO with more time to resolve the matter to the Secretary’s satisfaction; or
(C) Revoke his acceptance of the PSO’s certifications and remove the entity from the list of PSOs.
§ 3.110 Assessment of PSO compliance.
The Secretary may request information or conduct announced or unannounced reviews of, or site visits to, PSOs, to assess or verify PSO compliance with the requirements of this subpart and for these purposes will be allowed to inspect the physical or virtual sites maintained or controlled by the PSO. The Secretary will be allowed to inspect and/or be given or sent copies of any PSO records deemed necessary and requested by the Secretary to implement the provisions of this subpart. Such PSO records may include patient safety work product in accordance with § 3.206(d) of this part.
§ 3.112 Submissions and forms.
(a) Forms referred to in this subpart may be obtained on the PSO Web site (http://www.pso.ahrq.gov) maintained for the Secretary by AHRQ or a successor agency or on successor publication technology or by requesting them in writing by e-mail at [email protected], or by mail from the Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville, MD 20850. A form (including any required attachments) must be submitted in accordance with the accompanying instructions.
(b) Information submitted to AHRQ in writing, but not required to be on or attached to a form, and requests for information from AHRQ, may be submitted by mail or other delivery to the Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville, MD 20850, by facsimile at (301) 427-1341, or by e-mail at [email protected].
(c) If a submission to the Secretary is incomplete or additional information is needed to allow a determination to be made under this subpart, the submitter will be notified if any additional information is required.
Subpart C—Confidentiality and Privilege Protections of Patient Safety Work Product
§ 3.204 Privilege of patient safety work product.
(a) Privilege. Notwithstanding any other provision of Federal, State, local, or Tribal law and subject to paragraph (b) of this section and § 3.208 of this subpart, patient safety work product shall be privileged and shall not be:
(1) Subject to a Federal, State, local, or Tribal civil, criminal, or administrative subpoena or order, including in a Federal, State, local, or Tribal civil or administrative disciplinary proceeding against a provider;
(2) Subject to discovery in connection with a Federal, State, local, or Tribal civil, criminal, or administrative proceeding, including in a Federal, State, local, or Tribal civil or administrative disciplinary proceeding against a provider;
(3) Subject to disclosure pursuant to section 552 of Title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal, State, local, or Tribal law;
(4) Admitted as evidence in any Federal, State, local, or Tribal governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
(5) Admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.
(b) Exceptions to privilege. Privilege shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
(1) Disclosure of relevant patient safety work product for use in a criminal proceeding, subject to the conditions at § 3.206(b)(1) of this subpart.
(2) Disclosure to the extent required to permit equitable relief subject to the conditions at § 3.206(b)(2) of this subpart.
(3) Disclosure pursuant to provider authorizations subject to the conditions at § 3.206(b)(3) of this subpart.
(4) Disclosure of non-identifiable patient safety work product subject to the conditions at § 3.206(b)(5) of this subpart.
(c) Implementation and enforcement by the Secretary. Privilege shall not apply to (and shall not be construed to prohibit) disclosures of relevant patient safety work product to or by the Secretary if such patient safety work product is needed to investigate or determine compliance, or to seek or impose civil money penalties, with respect to this part or the HIPAA Privacy Rule, or to make or support decisions with respect to listing of a PSO.
§ 3.206 Confidentiality of patient safety work product.
(a) Confidentiality. Subject to paragraphs (b) through (e) of this section, and §§ 3.208 and 3.210 of this subpart, patient safety work product shall be confidential and shall not be disclosed.
(b) Exceptions to confidentiality. The confidentiality provisions shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
(1) Disclosure in criminal proceedings. Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after a court makes an in-camera determination that:
(i) Such patient safety work product contains evidence of a criminal act;
(ii) Such patient safety work product is material to the proceeding; and
(iii) Such patient safety work product is not reasonably available from any other source.
(2) Disclosure to permit equitable relief for reporters. Disclosure of patient safety work product to the extent required to permit equitable relief under section 922 (f)(4)(A) of the Public Health Service Act, provided the court or administrative tribunal has issued a protective order to protect the confidentiality of the patient safety work product in the course of the proceeding.
(3) Disclosure authorized by identified providers. (i) Disclosure of identifiable patient safety work product consistent with a valid authorization if such authorization is obtained from each provider identified in such work product prior to disclosure. A valid authorization must:
(A) Be in writing and signed by the provider from whom authorization is sought; and
(B) Contain sufficient detail to fairly inform the provider of the nature and scope of the disclosures being authorized;
(ii) A valid authorization must be retained by the disclosing entity for six years from the date of the last disclosure made in reliance on the authorization and made available to the Secretary upon request.
(4) Disclosure for patient safety activities—(i) Disclosure between a provider and a PSO. Disclosure of patient safety work product for patient safety activities by a provider to a PSO or by a PSO to that disclosing provider.
(ii) Disclosure to a contractor of a provider or a PSO. A provider or a PSO may disclose patient safety work product for patient safety activities to an entity with which it has contracted to undertake patient safety activities on its behalf. A contractor receiving patient safety work product for patient safety activities may not further disclose patient safety work product, except to the provider or PSO with which it is contracted.
(iii) Disclosure among affiliated providers. Disclosure of patient safety work product for patient safety activities by a provider to an affiliated provider.
(iv) Disclosure to another PSO or provider. Disclosure of patient safety work product for patient safety activities by a PSO to another PSO or to another provider that has reported to the PSO, or, except as otherwise permitted in paragraph (b)(4)(iii) of this section, by a provider to another provider, provided:
(A) The following direct identifiers of any providers and of affiliated organizations, corporate parents, subsidiaries, practice partners, employers, members of the workforce, or household members of such providers are removed:
(1) Names;
(2) Postal address information, other than town or city, State and zip code;
(3) Telephone numbers;
(4) Fax numbers;
(5) Electronic mail addresses;
(6) Social security numbers or taxpayer identification numbers;
(7) Provider or practitioner credentialing or DEA numbers;
(8) National provider identification number;
(9) Certificate/license numbers;
(10) Web Universal Resource Locators (URLs);
(11) Internet Protocol (IP) address numbers;
(12) Biometric identifiers, including finger and voice prints; and
(13) Full face photographic images and any comparable images; and
(B) With respect to any individually identifiable health information in such patient safety work product, the direct identifiers listed at 45 CFR 164.514(e)(2) have been removed.
(5) Disclosure of nonidentifiable patient safety work product. Disclosure of nonidentifiable patient safety work product when patient safety work product meets the standard for nonidentification in accordance with § 3.212 of this subpart.
(6) Disclosure for research. (i) Disclosure of patient safety work product to persons carrying out research, evaluation or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by the Secretary, for the purpose of conducting research.
(ii) If the patient safety work product disclosed pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR 160.103 and contains protected health information as defined by the HIPAA Privacy Rule at 45 CFR 160.103, such patient safety work product may only be disclosed under this exception in the same manner as would be permitted under the HIPAA Privacy Rule.
(7) Disclosure to the Food and Drug Administration (FDA) and entities required to report to FDA. (i) Disclosure by a provider of patient safety work product concerning an FDA-regulated product or activity to the FDA, an entity required to report to the FDA concerning the quality, safety, or effectiveness of an FDA-regulated product or activity, or a contractor acting on behalf of FDA or such entity for these purposes.
(ii) Any person permitted to receive patient safety work product pursuant to paragraph (b)(7)(i) of this section may only further disclose such patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider.
(8) Voluntary disclosure to an accrediting body. (i) Voluntary disclosure by a provider of patient safety work product to an accrediting body that accredits that provider, provided, with respect to any identified provider other than the provider making the disclosure:
(A) The provider agrees to the disclosure; or
(B) The identifiers at § 3.206(b)(4)(iv)(A) are removed.
(ii) An accrediting body may not further disclose patient safety work product it receives pursuant to paragraph (b)(8)(i) of this section.
(iii) An accrediting body may not take an accrediting action against a provider based on a good faith participation of the provider in the collection, development, reporting, or maintenance of patient safety work product in accordance with this Part. An accrediting body may not require a provider to reveal its communications with any PSO.
(9) Disclosure for business operations. (i) Disclosure of patient safety work product by a provider or a PSO for business operations to attorneys, accountants, and other professionals. Such contractors may not further disclose patient safety work product, except to the entity from which they received the information.
(ii) Disclosure of patient safety work product for such other business operations that the Secretary may prescribe by regulation as consistent with the goals of this part.
(10) Disclosure to law enforcement. (i) Disclosure of patient safety work product to an appropriate law enforcement authority relating to an event that either constitutes the commission of a crime, or for which the disclosing person reasonably believes constitutes the commission of a crime, provided that the disclosing person believes, reasonably under the circumstances, that the patient safety work product that is disclosed is necessary for criminal law enforcement purposes.
(ii) Law enforcement personnel receiving patient safety work product pursuant to paragraph (b)(10)(i) of this section only may disclose that patient safety work product to other law enforcement authorities as needed for law enforcement activities related to the event that gave rise to the disclosure under paragraph (b)(10)(i) of this section.
(c) Safe harbor. A provider or responsible person, but not a PSO, is not considered to have violated the requirements of this subpart if a member of its workforce discloses patient safety work product, provided that the disclosure does not include materials, including oral statements, that:
(1) Assess the quality of care of an identifiable provider; or
(2) Describe or pertain to one or more actions or failures to act by an identifiable provider.
(d) Implementation and enforcement by the Secretary. The confidentiality provisions shall not apply to (and shall not be construed to prohibit) disclosures of relevant patient safety work product to or by the Secretary if such patient safety work product is needed to investigate or determine compliance or to seek or impose civil money penalties, with respect to this part or the HIPAA Privacy Rule, or to make or support decisions with respect to listing of a PSO.
(e) No limitation on authority to limit or delegate disclosure or use. Nothing in subpart C of this part shall be construed to limit the authority of any person to enter into a contract requiring greater confidentiality or delegating authority to make a disclosure or use in accordance with this subpart.
§ 3.208 Continued protection of patient safety work product.
(a) Except as provided in paragraph (b) of this section, patient safety work product disclosed in accordance with this subpart, or disclosed impermissibly, shall continue to be privileged and confidential.
(b)(1) Patient safety work product disclosed for use in a criminal proceeding pursuant to section 922(c)(1)(A) of the Public Health Service Act, 42 U.S.C. 299b-22(c)(1)(A), and/or pursuant to § 3.206(b)(1) of this subpart continues to be privileged, but is no longer confidential.
(2) Non-identifiable patient safety work product that is disclosed is no longer privileged or confidential and not subject to the regulations under this part.
(3) Paragraph (b) of this section applies only to the specific patient safety work product disclosed.
§ 3.210 Required disclosure of patient safety work product to the Secretary.
Notwithstanding any other provision in this part, providers, PSOs, and responsible persons must disclose patient safety work product upon request by the Secretary when the Secretary determines such patient safety work product is needed to investigate or determine compliance or to seek or impose civil money penalties, with respect to this part or the HIPAA Privacy Rule, or to make or support decisions with respect to listing of a PSO.
§ 3.212 Nonidentification of patient safety work product.
(a) Patient safety work product is nonidentifiable with respect to a particular identified provider or a particular identified reporter if:
(1) A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable:
(i) Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an identified provider or reporter; and
(ii) Documents the methods and results of the analysis that justify such determination; or
(2)(i) The following identifiers of such provider or reporter and of affiliated organizations, corporate parents, subsidiaries, practice partners, employers, members of the workforce, or household members of such providers or reporters are removed:
(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;
(B) Geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code and equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census, the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people;
(C) All elements of dates (except year) for dates directly related to a patient safety incident or event; and
(D) Any other unique identifying number, characteristic, or code except as permitted for re-identification; and
(ii) The provider, PSO or responsible person making the disclosure does not have actual knowledge that the information could be used, alone or in combination with other information that is reasonably available to the intended recipient, to identify the particular provider or reporter.
(3) Re-identification. A provider, PSO, or responsible person may assign a code or other means of record identification to allow information made nonidentifiable under this section to be re-identified by such provider, PSO, or responsible person, provided that:
(i) The code or other means of record identification is not derived from or related to information about the provider or reporter and is not otherwise capable of being translated so as to identify the provider or reporter; and
(ii) The provider, PSO, or responsible person does not use or disclose the code or other means of record identification for any other purpose, and does not disclose the mechanism for re-identification.
(b) Patient safety work product is non-identifiable with respect to a particular patient only if the individually identifiable health information regarding that patient is de-identified in accordance with the HIPAA Privacy Rule standard and implementation specifications for the de-identification at 45 CFR 164.514(a) through (c).
Subpart D—Enforcement Program
§ 3.304 Principles for achieving compliance.
(a) Cooperation. The Secretary will, to the extent practicable, seek the cooperation of providers, PSOs, and responsible persons in obtaining compliance with the applicable confidentiality provisions.
(b) Assistance. The Secretary may provide technical assistance to providers, PSOs, and responsible persons to help them comply voluntarily with the applicable confidentiality provisions.
§ 3.306 Complaints to the Secretary.
(a) Right to file a complaint. A person who believes that patient safety work product has been disclosed in violation of the confidentiality provisions may file a complaint with the Secretary.
(b) Requirements for filing complaints. Complaints under this section must meet the following requirements:
(1) A complaint must be filed in writing, either on paper or electronically.
(2) A complaint must name the person that is the subject of the complaint and describe the act(s) believed to be in violation of the applicable confidentiality provision(s).
(3) A complaint must be filed within 180 days of when the complainant knew or should have known that the act complained of occurred, unless this time limit is waived by the Secretary for good cause shown.
(4) The Secretary may prescribe additional procedures for the filing of complaints, as well as the place and manner of filing, by notice in the
(c) Investigation. The Secretary may investigate complaints filed under this section. Such investigation may include a review of the pertinent policies, procedures, or practices of the respondent and of the circumstances regarding any alleged violation. At the time of initial written communication with the respondent about the complaint, the Secretary will describe the act(s) that are the basis of the complaint.
§ 3.308 Compliance reviews.
The Secretary may conduct compliance reviews to determine whether a respondent is complying with the applicable confidentiality provisions.
§ 3.310 Responsibilities of respondents.
(a) Provide records and compliance reports. A respondent must keep such records and submit such compliance reports, in such time and manner and containing such information, as the Secretary may determine to be necessary to enable the Secretary to ascertain whether the respondent has complied or is complying with the applicable confidentiality provisions.
(b) Cooperate with complaint investigations and compliance reviews. A respondent must cooperate with the Secretary, if the Secretary undertakes an investigation or compliance review of the policies, procedures, or practices of the respondent to determine whether it is complying with the applicable confidentiality provisions.
(c) Permit access to information. (1) A respondent must permit access by the Secretary during normal business hours to its facilities, books, records, accounts, and other sources of information, including patient safety work product, that are pertinent to ascertaining compliance with the applicable confidentiality provisions. If the Secretary determines that exigent circumstances exist, such as when documents may be hidden or destroyed, a respondent must permit access by the Secretary at any time and without notice.
(2) If any information required of a respondent under this section is in the exclusive possession of any other agency, institution, or person, and the other agency, institution, or person fails or refuses to furnish the information, the respondent must so certify and set forth what efforts it has made to obtain the information.
§ 3.312 Secretarial action regarding complaints and compliance reviews.
(a) Resolution when noncompliance is indicated. (1) If an investigation of a complaint pursuant to § 3.306 of this subpart or a compliance review pursuant to § 3.308 of this subpart indicates noncompliance, the Secretary may attempt to reach a resolution of the matter satisfactory to the Secretary by informal means. Informal means may include demonstrated compliance or a completed corrective action plan or other agreement.
(2) If the matter is resolved by informal means, the Secretary will so inform the respondent and, if the matter arose from a complaint, the complainant, in writing.
(3) If the matter is not resolved by informal means, the Secretary will—
(i) So inform the respondent and provide the respondent an opportunity to submit written evidence of any mitigating factors. The respondent must submit any evidence to the Secretary within 30 days (computed in the same manner as prescribed under § 3.526 of this subpart) of receipt of such notification; and
(ii) If, following action pursuant to paragraph (a)(3)(i) of this section, the Secretary decides that a civil money penalty should be imposed, inform the respondent of such finding in a notice of proposed determination in accordance with § 3.420 of this subpart.
(b) Resolution when no violation is found. If, after an investigation pursuant to § 3.306 of this subpart or a compliance review pursuant to § 3.308 of this subpart, the Secretary determines that further action is not warranted, the Secretary will so inform the respondent and, if the matter arose from a complaint, the complainant, in writing.
(c) Uses and disclosures of information obtained. (1) Identifiable patient safety work product obtained by the Secretary in connection with an investigation or compliance review under this subpart will not be disclosed by the Secretary, except in accordance with § 3.206(d) of this subpart, or if otherwise permitted by this part or the Patient Safety Act.
(2) Except as provided for in paragraph (c)(1) of this section, information, including testimony and other evidence, obtained by the Secretary in connection with an investigation or compliance review under this subpart may be used by HHS in any of its activities and may be used or offered into evidence in any administrative or judicial proceeding.
§ 3.314 Investigational subpoenas and inquiries.
(a) The Secretary may issue subpoenas in accordance with 42 U.S.C. 405(d) and (e), and 1320a-7a(j), to require the attendance and testimony of witnesses and the production of any other evidence including patient safety work product during an investigation or compliance review pursuant to this part.
(1) A subpoena issued under this paragraph must—
(i) State the name of the person (including the entity, if applicable) to whom the subpoena is addressed;
(ii) State the statutory authority for the subpoena;
(iii) Indicate the date, time, and place that the testimony will take place;
(iv) Include a reasonably specific description of any documents or items required to be produced; and
(v) If the subpoena is addressed to an entity, describe with reasonable particularity the subject matter on which testimony is required. In that event, the entity must designate one or more natural persons who will testify on its behalf, and must state as to each such person that person’s name and address and the matters on which he or she will testify. The designated person must testify as to matters known or reasonably available to the entity.
(2) A subpoena under this section must be served by—
(i) Delivering a copy to the natural person named in the subpoena or to the entity named in the subpoena at its last principal place of business; or
(ii) Registered or certified mail addressed to the natural person at his or her last known dwelling place or to the entity at its last known principal place of business.
(3) A verified return by the natural person serving the subpoena setting forth the manner of service or, in the case of service by registered or certified mail, the signed return post office receipt, constitutes proof of service.
(4) Witnesses are entitled to the same fees and mileage as witnesses in the district courts of the United States (28 U.S.C. 1821 and 1825). Fees need not be paid at the time the subpoena is served.
(5) A subpoena under this section is enforceable through the district court of the United States for the district where the subpoenaed natural person resides or is found or where the entity transacts business.
(b) Investigational inquiries are non-public investigational proceedings conducted by the Secretary.
(1) Testimony at investigational inquiries will be taken under oath or affirmation.
(2) Attendance of non-witnesses is discretionary with the Secretary, except that a witness is entitled to be accompanied, represented, and advised by an attorney.
(3) Representatives of the Secretary are entitled to attend and ask questions.
(4) A witness will have the opportunity to clarify his or her answers on the record following questioning by the Secretary.
(5) Any claim of privilege must be asserted by the witness on the record.
(6) Objections must be asserted on the record. Errors of any kind that might be corrected if promptly presented will be deemed to be waived unless reasonable objection is made at the investigational inquiry. Except where the objection is on the grounds of privilege, the question will be answered on the record, subject to objection.
(7) If a witness refuses to answer any question not privileged or to produce requested documents or items, or engages in conduct likely to delay or obstruct the investigational inquiry, the Secretary may seek enforcement of the subpoena under paragraph (a)(5) of this section.
(8) The proceedings will be recorded and transcribed. The witness is entitled to a copy of the transcript, upon payment of prescribed costs, except that, for good cause, the witness may be limited to inspection of the official transcript of his or her testimony.
(9)(i) The transcript will be submitted to the witness for signature.
(A) Where the witness will be provided a copy of the transcript, the transcript will be submitted to the witness for signature. The witness may submit to the Secretary written proposed corrections to the transcript, with such corrections attached to the transcript. If the witness does not return a signed copy of the transcript or proposed corrections within 30 days (computed in the same manner as prescribed under § 3.526 of this part) of its being submitted to him or her for signature, the witness will be deemed to have agreed that the transcript is true and accurate.
(B) Where, as provided in paragraph (b)(8) of this section, the witness is limited to inspecting the transcript, the witness will have the opportunity at the time of inspection to propose corrections to the transcript, with corrections attached to the transcript. The witness will also have the opportunity to sign the transcript. If the witness does not sign the transcript or offer corrections within 30 days (computed in the same manner as prescribed under § 3.526 of this part) of receipt of notice of the opportunity to inspect the transcript, the witness will be deemed to have agreed that the transcript is true and accurate.
(ii) The Secretary’s proposed corrections to the record of transcript will be attached to the transcript.
§ 3.402 Basis for a civil money penalty.
(a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty for each act constituting such violation.
(b) Violation attributed to a principal. A principal is independently liable, in accordance with the federal common law of agency, for a civil money penalty based on the act of the principal’s agent, including a workforce member, acting within the scope of the agency if such act could give rise to a civil money penalty in accordance with § 3.402(a) of this subpart.
§ 3.404 Amount of a civil money penalty.
(a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section and § 3.408.
(b) The Secretary may impose a civil monetary penalty in the amount of not more than $11,000. This amount has been updated and will be updated annually, in accordance with the Federal Civil Monetary penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). The amount, as updated, is published at 45 CFR part 102.
§ 3.408 Factors considered in determining the amount of a civil money penalty.
In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:
(a) The nature of the violation.
(b) The circumstances, including the consequences, of the violation, including:
(1) The time period during which the violation(s) occurred; and
(2) Whether the violation caused physical or financial harm or reputational damage;
(c) The degree of culpability of the respondent, including:
(1) Whether the violation was intentional; and
(2) Whether the violation was beyond the direct control of the respondent.
(d) Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:
(1) Whether the current violation is the same or similar to prior violation(s);
(2) Whether and to what extent the respondent has attempted to correct previous violations;
(3) How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
(4) How the respondent has responded to prior complaints.
(e) The financial condition of the respondent, including:
(1) Whether the respondent had financial difficulties that affected its ability to comply;
(2) Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or patient safety activities; and
(3) The size of the respondent.
(f) Such other matters as justice may require.
§ 3.414 Limitations.
No action under this subpart may be entertained unless commenced by the Secretary, in accordance with § 3.420 of this subpart, within 6 years from the date of the occurrence of the violation.
§ 3.416 Authority to settle.
Nothing in this subpart limits the authority of the Secretary to settle any issue or case or to compromise any penalty.
§ 3.418 Exclusivity of penalty.
(a) Except as otherwise provided by paragraph (b) of this section, a penalty imposed under this part is in addition to any other penalty prescribed by law.
(b) Civil money penalties shall not be imposed both under this part and under the HIPAA Privacy Rule (45 CFR parts 160 and 164).
§ 3.420 Notice of proposed determination.
(a) If a penalty is proposed in accordance with this part, the Secretary must deliver, or send by certified mail with return receipt requested, to the respondent, written notice of the Secretary’s intent to impose a penalty. This notice of proposed determination must include:
(1) Reference to the statutory basis for the penalty;
(2) A description of the findings of fact regarding the violations with respect to which the penalty is proposed;
(3) The reason(s) why the violation(s) subject(s) the respondent to a penalty;
(4) The amount of the proposed penalty;
(5) Any factors described in § 3.408 of this subpart that were considered in determining the amount of the proposed penalty; and
(6) Instructions for responding to the notice, including a statement of the respondent’s right to a hearing, a statement that failure to request a hearing within 60 days permits the imposition of the proposed penalty without the right to a hearing under § 3.504 of this subpart or a right of appeal under § 3.548 of this subpart, and the address to which the hearing request must be sent.
(b) The respondent may request a hearing before an ALJ on the proposed penalty by filing a request in accordance with § 3.504 of this subpart.
§ 3.422 Failure to request a hearing.
If the respondent does not request a hearing within the time prescribed by § 3.504 of this subpart and the matter is not settled pursuant to § 3.416 of this subpart, the Secretary may impose the proposed penalty or any lesser penalty permitted by sections 921 through 926 of the Public Health Service Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail, return receipt requested, of any penalty that has been imposed and of the means by which the respondent may satisfy the penalty, and the penalty is final on receipt of the notice. The respondent has no right to appeal a penalty under § 3.548 of this subpart with respect to which the respondent has not timely requested a hearing.
§ 3.424 Collection of penalty.
(a) Once a determination of the Secretary to impose a penalty has become final, the penalty will be collected by the Secretary, subject to the first sentence of 42 U.S.C. 1320a-7a(f).
(b) The penalty may be recovered in a civil action brought in the United States district court for the district where the respondent resides, is found, or is located.
(c) The amount of a penalty, when finally determined, or the amount agreed upon in compromise, may be deducted from any sum then or later owing by the United States, or by a State agency, to the respondent.
(d) Matters that were raised or that could have been raised in a hearing before an ALJ, or in an appeal under 42 U.S.C. 1320a-7a(e), may not be raised as a defense in a civil action by the United States to collect a penalty under this part.
§ 3.426 Notification of the public and other agencies.
Whenever a proposed penalty becomes final, the Secretary will notify, in such manner as the Secretary deems appropriate, the public and the following organizations and entities thereof and the reason it was imposed: The appropriate State or local medical or professional organization, the appropriate State agency or agencies administering or supervising the administration of State health care programs (as defined in 42 U.S.C. 1320a-7(h)), the appropriate utilization and quality control peer review organization, and the appropriate State or local licensing agency or organization (including the agency specified in 42 U.S.C. 1395aa(a), 1396a(a)(33)).
§ 3.504 Hearings before an ALJ.
(a) A respondent may request a hearing before an ALJ. The parties to the hearing proceeding consist of—
(1) The respondent; and
(2) The officer(s) or employee(s) of HHS to whom the enforcement authority involved has been delegated.
(b) The request for a hearing must be made in writing signed by the respondent or by the respondent’s attorney and sent by certified mail, return receipt requested, to the address specified in the notice of proposed determination. The request for a hearing must be mailed within 60 days after notice of the proposed determination is received by the respondent. For purposes of this section, the respondent’s date of receipt of the notice of proposed determination is presumed to be 5 days after the date of the notice unless the respondent makes a reasonable showing to the contrary to the ALJ.
(c) The request for a hearing must clearly and directly admit, deny, or explain each of the findings of fact contained in the notice of proposed determination with regard to which the respondent has any knowledge. If the respondent has no knowledge of a particular finding of fact and so states, the finding shall be deemed denied. The request for a hearing must also state the circumstances or arguments that the respondent alleges constitute the grounds for any defense and the factual and legal basis for opposing the penalty.
(d) The ALJ must dismiss a hearing request where—
(1) On motion of the Secretary, the ALJ determines that the respondent’s hearing request is not timely filed as required by paragraph (b) or does not meet the requirements of paragraph (c) of this section;
(2) The respondent withdraws the request for a hearing;
(3) The respondent abandons the request for a hearing; or
(4) The respondent’s hearing request fails to raise any issue that may properly be addressed in a hearing.
§ 3.506 Rights of the parties.
(a) Except as otherwise limited by this subpart, each party may—
(1) Be accompanied, represented, and advised by an attorney;
(2) Participate in any conference held by the ALJ;
(3) Conduct discovery of documents as permitted by this subpart;
(4) Agree to stipulations of fact or law that will be made part of the record;
(5) Present evidence relevant to the issues at the hearing;
(6) Present and cross-examine witnesses;
(7) Present oral arguments at the hearing as permitted by the ALJ; and
(8) Submit written briefs and proposed findings of fact and conclusions of law after the hearing.
(b) A party may appear in person or by a representative. Natural persons who appear as an attorney or other representative must conform to the standards of conduct and ethics required of practitioners before the courts of the United States.
(c) Fees for any services performed on behalf of a party by an attorney are not subject to the provisions of 42 U.S.C. 406, which authorizes the Secretary to specify or limit their fees.
§ 3.508 Authority of the ALJ.
(a) The ALJ must conduct a fair and impartial hearing, avoid delay, maintain order, and ensure that a record of the proceeding is made.
(b) The ALJ may—
(1) Set and change the date, time and place of the hearing upon reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a reasonable period of time;
(3) Hold conferences to identify or simplify the issues, or to consider other matters that may aid in the expeditious disposition of the proceeding;
(4) Administer oaths and affirmations;
(5) Issue subpoenas requiring the attendance of witnesses at hearings and the production of documents at or in relation to hearings;
(6) Rule on motions and other procedural matters;
(7) Regulate the scope and timing of documentary discovery as permitted by this subpart;
(8) Regulate the course of the hearing and the conduct of representatives, parties, and witnesses;
(9) Examine witnesses;
(10) Receive, rule on, exclude, or limit evidence;
(11) Upon motion of a party, take official notice of facts;
(12) Conduct any conference, argument or hearing in person or, upon agreement of the parties, by telephone; and
(13) Upon motion of a party, decide cases, in whole or in part, by summary judgment where there is no disputed issue of material fact. A summary judgment decision constitutes a hearing on the record for the purposes of this subpart.
(c) The ALJ—
(1) May not find invalid or refuse to follow Federal statutes, regulations, or Secretarial delegations of authority and must give deference to published guidance to the extent not inconsistent with statute or regulation;
(2) May not enter an order in the nature of a directed verdict;
(3) May not compel settlement negotiations; or
(4) May not enjoin any act of the Secretary.
§ 3.510 Ex parte contacts.
No party or person (except employees of the ALJ’s office) may communicate in any way with the ALJ on any matter at issue in a case, unless on notice and opportunity for both parties to participate. This provision does not prohibit a party or person from inquiring about the status of a case or asking routine questions concerning administrative functions or procedures.
§ 3.512 Prehearing conferences.
(a) The ALJ must schedule at least one prehearing conference, and may schedule additional prehearing conferences as appropriate, upon reasonable notice, which may not be less than 14 business days, to the parties.
(b) The ALJ may use prehearing conferences to discuss the following—
(1) Simplification of the issues;
(2) The necessity or desirability of amendments to the pleadings, including the need for a more definite statement;
(3) Stipulations and admissions of fact or as to the contents and authenticity of documents;
(4) Whether the parties can agree to submission of the case on a stipulated record;
(5) Whether a party chooses to waive appearance at an oral hearing and to submit only documentary evidence (subject to the objection of the other party) and written argument;
(6) Limitation of the number of witnesses;
(7) Scheduling dates for the exchange of witness lists and of proposed exhibits;
(8) Discovery of documents as permitted by this subpart;
(9) The time and place for the hearing;
(10) The potential for the settlement of the case by the parties; and
(11) Other matters as may tend to encourage the fair, just and expeditious disposition of the proceedings, including the protection of confidentiality of identifiable patient safety work product that may be submitted into evidence or otherwise used in the proceeding, if appropriate.
(c) The ALJ must issue an order containing the matters agreed upon by the parties or ordered by the ALJ at a prehearing conference.
§ 3.514 Authority to settle.
The Secretary has exclusive authority to settle any issue or case without the consent of the ALJ.
§ 3.516 Discovery.
(a) A party may make a request to another party for production of documents for inspection and copying that are relevant and material to the issues before the ALJ.
(b) For the purpose of this section, the term “documents” includes information, reports, answers, records, accounts, papers and other data and documentary evidence. Nothing contained in this section may be interpreted to require the creation of a document, except that requested data stored in an electronic data storage system must be produced in a form accessible to the requesting party.
(c) Requests for documents, requests for admissions, written interrogatories, depositions and any forms of discovery, other than those permitted under paragraph (a) of this section, are not authorized.
(d) This section may not be construed to require the disclosure of interview reports or statements obtained by any party, or on behalf of any party, of persons who will not be called as witnesses by that party, or analyses and summaries prepared in conjunction with the investigation or litigation of the case, or any otherwise privileged documents.
(e)(1) When a request for production of documents has been received, within 30 days the party receiving that request must either fully respond to the request, or state that the request is being objected to and the reasons for that objection. If objection is made to part of an item or category, the part must be specified. Upon receiving any objections, the party seeking production may then, within 30 days or any other time frame set by the ALJ, file a motion for an order compelling discovery. The party receiving a request for production may also file a motion for protective order any time before the date the production is due.
(2) The ALJ may grant a motion for protective order or deny a motion for an order compelling discovery if the ALJ finds that the discovery sought—
(i) Is irrelevant;
(ii) Is unduly costly or burdensome;
(iii) Will unduly delay the proceeding; or
(iv) Seeks privileged information.
(3) The ALJ may extend any of the time frames set forth in paragraph (e)(1) of this section.
(4) The burden of showing that discovery should be allowed is on the party seeking discovery.
§ 3.518 Exchange of witness lists, witness statements, and exhibits.
(a) The parties must exchange witness lists, copies of prior written statements of proposed witnesses, and copies of proposed hearing exhibits, including copies of any written statements that the party intends to offer in lieu of live testimony in accordance with § 3.538, not more than 60, and not less than 15, days before the scheduled hearing.
(b)(1) If, at any time, a party objects to the proposed admission of evidence not exchanged in accordance with paragraph (a) of this section, the ALJ must determine whether the failure to comply with paragraph (a) of this section should result in the exclusion of that evidence.
(2) Unless the ALJ finds that extraordinary circumstances justified the failure timely to exchange the information listed under paragraph (a) of this section, the ALJ must exclude from the party’s case-in-chief—
(i) The testimony of any witness whose name does not appear on the witness list; and
(ii) Any exhibit not provided to the opposing party as specified in paragraph (a) of this section.
(3) If the ALJ finds that extraordinary circumstances existed, the ALJ must then determine whether the admission of that evidence would cause substantial prejudice to the objecting party.
(i) If the ALJ finds that there is no substantial prejudice, the evidence may be admitted.
(ii) If the ALJ finds that there is substantial prejudice, the ALJ may exclude the evidence, or, if he or she does not exclude the evidence, must postpone the hearing for such time as is necessary for the objecting party to prepare and respond to the evidence, unless the objecting party waives postponement.
(c) Unless the other party objects within a reasonable period of time before the hearing, documents exchanged in accordance with paragraph (a) of this section will be deemed to be authentic for the purpose of admissibility at the hearing.
§ 3.520 Subpoenas for attendance at hearing.
(a) A party wishing to procure the appearance and testimony of any person at the hearing may make a motion requesting the ALJ to issue a subpoena if the appearance and testimony are reasonably necessary for the presentation of a party’s case.
(b) A subpoena requiring the attendance of a person in accordance with paragraph (a) of this section may also require the person (whether or not the person is a party) to produce relevant and material evidence at or before the hearing.
(c) When a subpoena is served by a respondent on a particular employee or official or particular office of HHS, the Secretary may comply by designating any knowledgeable HHS representative to appear and testify.
(d) A party seeking a subpoena must file a written motion not less than 30 days before the date fixed for the hearing, unless otherwise allowed by the ALJ for good cause shown. That motion must—
(1) Specify any evidence to be produced;
(2) Designate the witnesses; and
(3) Describe the address and location with sufficient particularity to permit those witnesses to be found.
(e) The subpoena must specify the time and place at which the witness is to appear and any evidence the witness is to produce.
(f) Within 15 days after the written motion requesting issuance of a subpoena is served, any party may file an opposition or other response.
(g) If the motion requesting issuance of a subpoena is granted, the party seeking the subpoena must serve it by delivery to the person named, or by certified mail addressed to that person at the person’s last dwelling place or principal place of business.
(h) The person to whom the subpoena is directed may file with the ALJ a motion to quash the subpoena within 10 days after service.
(i) The exclusive remedy for contumacy by, or refusal to obey a subpoena duly served upon, any person is specified in 42 U.S.C. 405(e).
§ 3.522 Fees.
The party requesting a subpoena must pay the cost of the fees and mileage of any witness subpoenaed in the amounts that would be payable to a witness in a proceeding in United States District Court. A check for witness fees and mileage must accompany the subpoena when served, except that, when a subpoena is issued on behalf of the Secretary, a check for witness fees and mileage need not accompany the subpoena.
§ 3.524 Form, filing, and service of papers.
(a) Forms. (1) Unless the ALJ directs the parties to do otherwise, documents filed with the ALJ must include an original and two copies.
(2) Every pleading and paper filed in the proceeding must contain a caption setting forth the title of the action, the case number, and a designation of the paper, such as motion to quash subpoena.
(3) Every pleading and paper must be signed by and must contain the address and telephone number of the party or the person on whose behalf the paper was filed, or his or her representative.
(4) Papers are considered filed when they are mailed.
(b) Service. A party filing a document with the ALJ or the Board must, at the time of filing, serve a copy of the document on the other party. Service upon any party of any document must be made by delivering a copy, or placing a copy of the document in the United States mail, postage prepaid and addressed, or with a private delivery service, to the party’s last known address. When a party is represented by an attorney, service must be made upon the attorney in lieu of the party.
(c) Proof of service. A certificate of the natural person serving the document by personal delivery or by mail, setting forth the manner of service, constitutes proof of service.
§ 3.526 Computation of time.
(a) In computing any period of time under this subpart or in an order issued thereunder, the time begins with the day following the act, event or default, and includes the last day of the period unless it is a Saturday, Sunday, or legal holiday observed by the Federal Government, in which event it includes the next business day.
(b) When the period of time allowed is less than 7 days, intermediate Saturdays, Sundays, and legal holidays observed by the Federal Government must be excluded from the computation.
(c) Where a document has been served or issued by placing it in the mail, an additional 5 days must be added to the time permitted for any response. This paragraph does not apply to requests for hearing under § 3.504.
§ 3.528 Motions.
(a) An application to the ALJ for an order or ruling must be by motion. Motions must state the relief sought, the authority relied upon and the facts alleged, and must be filed with the ALJ and served on all other parties.
(b) Except for motions made during a prehearing conference or at the hearing, all motions must be in writing. The ALJ may require that oral motions be reduced to writing.
(c) Within 10 days after a written motion is served, or such other time as may be fixed by the ALJ, any party may file a response to the motion.
(d) The ALJ may not grant a written motion before the time for filing responses has expired, except upon consent of the parties or following a hearing on the motion, but may overrule or deny the motion without awaiting a response.
(e) The ALJ must make a reasonable effort to dispose of all outstanding motions before the beginning of the hearing.
§ 3.530 Sanctions.
The ALJ may sanction a person, including any party or attorney, for failing to comply with an order or procedure, for failing to defend an action or for other misconduct that interferes with the speedy, orderly or fair conduct of the hearing. The sanctions must reasonably relate to the severity and nature of the failure or misconduct. The sanctions may include—
(a) In the case of refusal to provide or permit discovery under the terms of this part, drawing negative factual inferences or treating the refusal as an admission by deeming the matter, or certain facts, to be established;
(b) Prohibiting a party from introducing certain evidence or otherwise supporting a particular claim or defense;
(c) Striking pleadings, in whole or in part;
(d) Staying the proceedings;
(e) Dismissal of the action;
(f) Entering a decision by default;
(g) Ordering the party or attorney to pay the attorney’s fees and other costs caused by the failure or misconduct; and
(h) Refusing to consider any motion or other action that is not filed in a timely manner.
§ 3.532 Collateral estoppel.
When a final determination that the respondent violated a confidentiality provision has been rendered in any proceeding in which the respondent was a party and had an opportunity to be heard, the respondent is bound by that determination in any proceeding under this part.
§ 3.534 The hearing.
(a) The ALJ must conduct a hearing on the record in order to determine whether the respondent should be found liable under this part.
(b)(1) The respondent has the burden of going forward and the burden of persuasion with respect to any challenge to the amount of a proposed penalty pursuant to §§ 3.404 and 3.408, including any factors raised as mitigating factors.
(2) The Secretary has the burden of going forward and the burden of persuasion with respect to all other issues, including issues of liability and the existence of any factors considered as aggravating factors in determining the amount of the proposed penalty.
(3) The burden of persuasion will be judged by a preponderance of the evidence.
(c) The hearing must be open to the public unless otherwise ordered by the ALJ for good cause shown, which may be that identifiable patient safety work product has been introduced into evidence or is expected to be introduced into evidence.
(d)(1) Subject to the 15-day rule under § 3.518(a) and the admissibility of evidence under § 3.540, either party may introduce, during its case in chief, items or information that arose or became known after the date of the issuance of the notice of proposed determination or the request for hearing, as applicable. Such items and information may not be admitted into evidence, if introduced—
(i) By the Secretary, unless they are material and relevant to the acts or omissions with respect to which the penalty is proposed in the notice of proposed determination pursuant to § 3.420 of this part, including circumstances that may increase penalties; or
(ii) By the respondent, unless they are material and relevant to an admission, denial or explanation of a finding of fact in the notice of proposed determination under § 3.420 of this part, or to a specific circumstance or argument expressly stated in the request for hearing under § 3.504, including circumstances that may reduce penalties.
(2) After both parties have presented their cases, evidence may be admitted in rebuttal even if not previously exchanged in accordance with § 3.518.
§ 3.538 Witnesses.
(a) Except as provided in paragraph (b) of this section, testimony at the hearing must be given orally by witnesses under oath or affirmation.
(b) At the discretion of the ALJ, testimony of witnesses other than the testimony of expert witnesses may be admitted in the form of a written statement. The ALJ may, at his or her discretion, admit prior sworn testimony of experts that has been subject to adverse examination, such as a deposition or trial testimony. Any such written statement must be provided to the other party, along with the last known address of the witness, in a manner that allows sufficient time for the other party to subpoena the witness for cross-examination at the hearing. Prior written statements of witnesses proposed to testify at the hearing must be exchanged as provided in § 3.518.
(c) The ALJ must exercise reasonable control over the mode and order of interrogating witnesses and presenting evidence so as to:
(1) Make the interrogation and presentation effective for the ascertainment of the truth;
(2) Avoid repetition or needless consumption of time; and
(3) Protect witnesses from harassment or undue embarrassment.
(d) The ALJ must permit the parties to conduct cross-examination of witnesses as may be required for a full and true disclosure of the facts.
(e) The ALJ may order witnesses excluded so that they cannot hear the testimony of other witnesses, except that the ALJ may not order to be excluded—
(1) A party who is a natural person;
(2) In the case of a party that is not a natural person, the officer or employee of the party appearing for the entity pro se or designated as the party’s representative; or
(3) A natural person whose presence is shown by a party to be essential to the presentation of its case, including a person engaged in assisting the attorney for the Secretary.
§ 3.540 Evidence.
(a) The ALJ must determine the admissibility of evidence.
(b) Except as provided in this subpart, the ALJ is not bound by the Federal Rules of Evidence. However, the ALJ may apply the Federal Rules of Evidence where appropriate, for example, to exclude unreliable evidence.
(c) The ALJ must exclude irrelevant or immaterial evidence.
(d) Although relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or by considerations of undue delay or needless presentation of cumulative evidence.
(e) Although relevant, evidence must be excluded if it is privileged under Federal law.
(f) Evidence concerning offers of compromise or settlement is inadmissible to the extent provided in Rule 408 of the Federal Rules of Evidence.
(g) Evidence of crimes, wrongs, or acts other than those at issue in the instant case is admissible in order to show motive, opportunity, intent, knowledge, preparation, identity, lack of mistake, or existence of a scheme. This evidence is admissible regardless of whether the crimes, wrongs, or acts occurred during the statute of limitations period applicable to the acts or omissions that constitute the basis for liability in the case and regardless of whether they were referenced in the Secretary’s notice of proposed determination under § 3.420.
(h) The ALJ must permit the parties to introduce rebuttal witnesses and evidence.
(i) All documents and other evidence offered or taken for the record must be open to examination by both parties, unless otherwise ordered by the ALJ for good cause shown.
§ 3.542 The record.
(a) The hearing must be recorded and transcribed. Transcripts may be obtained following the hearing from the ALJ. A party that requests a transcript of hearing proceedings must pay the cost of preparing the transcript unless, for good cause shown by the party, the payment is waived by the ALJ or the Board, as appropriate.
(b) The transcript of the testimony, exhibits, and other evidence admitted at the hearing, and all papers and requests filed in the proceeding constitute the record for decision by the ALJ and the Secretary.
(c) The record may be inspected and copied (upon payment of a reasonable fee) by any person, unless otherwise ordered by the ALJ for good cause shown, which may include the presence in the record of identifiable patient safety work product.
(d) For good cause, which may include the presence in the record of identifiable patient safety work product, the ALJ may order appropriate redactions made to the record.
§ 3.544 Post hearing briefs.
The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief. The ALJ must fix the time for filing the briefs. The time for filing may not exceed 60 days from the date the parties receive the transcript of the hearing or, if applicable, the stipulated record. The briefs may be accompanied by proposed findings of fact and conclusions of law. The ALJ may permit the parties to file reply briefs.
§ 3.546 ALJ’s decision.
(a) The ALJ must issue a decision, based only on the record, which must contain findings of fact and conclusions of law.
(b) The ALJ may affirm, increase, or reduce the penalties imposed by the Secretary.
(c) The ALJ must issue the decision to both parties within 60 days after the time for submission of post-hearing briefs and reply briefs, if permitted, has expired. If the ALJ fails to meet the deadline contained in this paragraph, he or she must notify the parties of the reason for the delay and set a new deadline.
(d) Unless the decision of the ALJ is timely appealed as provided for in § 3.548, the decision of the ALJ will be final and binding on the parties 60 days from the date of service of the ALJ’s decision.
§ 3.548 Appeal of the ALJ’s decision.
(a) Any party may appeal the decision of the ALJ to the Board by filing a notice of appeal with the Board within 30 days of the date of service of the ALJ decision. The Board may extend the initial 30 day period for a period of time not to exceed 30 days if a party files with the Board a request for an extension within the initial 30 day period and shows good cause.
(b) If a party files a timely notice of appeal with the Board, the ALJ must forward the record of the proceeding to the Board.
(c) A notice of appeal must be accompanied by a written brief specifying exceptions to the initial decision and reasons supporting the exceptions. Any party may file a brief in opposition to the exceptions, which may raise any relevant issue not addressed in the exceptions, within 30 days of receiving the notice of appeal and the accompanying brief. The Board may permit the parties to file reply briefs.
(d) There is no right to appear personally before the Board or to appeal to the Board any interlocutory ruling by the ALJ.
(e) The Board may not consider any issue not raised in the parties’ briefs, nor any issue in the briefs that could have been raised before the ALJ but was not.
(f) If any party demonstrates to the satisfaction of the Board that additional evidence not presented at such hearing is relevant and material and that there were reasonable grounds for the failure to adduce such evidence at the hearing, the Board may remand the matter to the ALJ for consideration of such additional evidence.
(g) The Board may decline to review the case, or may affirm, increase, reduce, reverse or remand any penalty determined by the ALJ.
(h) The standard of review on a disputed issue of fact is whether the initial decision of the ALJ is supported by substantial evidence on the whole record. The standard of review on a disputed issue of law is whether the decision is erroneous.
(i) Within 60 days after the time for submission of briefs and reply briefs, if permitted, has expired, the Board must serve on each party to the appeal a copy of the Board’s decision and a statement describing the right of any respondent who is penalized to seek judicial review.
(j)(1) The Board’s decision under paragraph (i) of this section, including a decision to decline review of the initial decision, becomes the final decision of the Secretary 60 days after the date of service of the Board’s decision, except with respect to a decision to remand to the ALJ or if reconsideration is requested under this paragraph.
(2) The Board will reconsider its decision only if it determines that the decision contains a clear error of fact or error of law. New evidence will not be a basis for reconsideration unless the party demonstrates that the evidence is newly discovered and was not previously available.
(3) A party may file a motion for reconsideration with the Board before the date the decision becomes final under paragraph (j)(1) of this section. A motion for reconsideration must be accompanied by a written brief specifying any alleged error of fact or law and, if the party is relying on additional evidence, explaining why the evidence was not previously available. Any party may file a brief in opposition within 15 days of receiving the motion for reconsideration and the accompanying brief unless this time limit is extended by the Board for good cause shown. Reply briefs are not permitted.
(4) The Board must rule on the motion for reconsideration not later than 30 days from the date the opposition brief is due. If the Board denies the motion, the decision issued under paragraph (i) of this section becomes the final decision of the Secretary on the date of service of the ruling. If the Board grants the motion, the Board will issue a reconsidered decision, after such procedures as the Board determines necessary to address the effect of any error. The Board’s decision on reconsideration becomes the final decision of the Secretary on the date of service of the decision, except with respect to a decision to remand to the ALJ.
(5) If service of a ruling or decision issued under this section is by mail, the date of service will be deemed to be 5 days from the date of mailing.
(k)(1) A respondent’s petition for judicial review must be filed within 60 days of the date on which the decision of the Board becomes the final decision of the Secretary under paragraph (j) of this section.
(2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for judicial review filed in any U.S. Court of Appeals challenging the final decision of the Secretary must be sent by certified mail, return receipt requested, to the General Counsel of HHS. The petition copy must be a copy showing that it has been time-stamped by the clerk of the court when the original was filed with the court.
(3) If the General Counsel of HHS received two or more petitions within 10 days after the final decision of the Secretary, the General Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation of any petitions that were received within the 10 day period.
§ 3.550 Stay of the Secretary’s decision.
(a) Pending judicial review, the respondent may file a request for stay of the effective date of any penalty with the ALJ. The request must be accompanied by a copy of the notice of appeal filed with the Federal court. The filing of the request automatically stays the effective date of the penalty until such time as the ALJ rules upon the request.
(b) The ALJ may not grant a respondent’s request for stay of any penalty unless the respondent posts a bond or provides other adequate security.
(c) The ALJ must rule upon a respondent’s request for stay within 10 days of receipt.
§ 3.552 Harmless error.
No error in either the admission or the exclusion of evidence, and no error or defect in any ruling or order or in any act done or omitted by the ALJ or by any of the parties is ground for vacating, modifying or otherwise disturbing an otherwise appropriate ruling or order or act, unless refusal to take such action appears to the ALJ or the Board inconsistent with substantial justice. The ALJ and the Board at every stage of the proceeding must disregard any error or defect in the proceeding that does not affect the substantial rights of the parties.
PART 4—NATIONAL LIBRARY OF MEDICINE
§ 4.1 Programs to which these regulations apply.
(a) The regulations of this part govern access to the National Library of Medicine’s facilities and library collections and the availability of its bibliographic, reproduction, reference, and related services. These functions are performed by the Library directly for the benefit of the general public and health-sciences professionals as required by sections 465(b) (3)-(6) of the Act (42 U.S.C. 286(b) (3)-(6)).
(b) The regulations of this part do not apply to:
(1) The Library’s internal functions relating to the acquisition and preservation of materials and the organization of these materials as required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1) and (2)).
(2) The availability of “records” under the Freedom of Information Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are covered in 45 CFR parts 5 and 5b.
(3) Federal assistance for medical libraries and other purposes which are authorized by sections 469-477 of the Act (42 U.S.C. 286b to 286b-8). (See parts 59a, 61 and 64 of this chapter.)
(4) The availability of facilities, collections, and related services of Regional Medical Libraries established or maintained under the authority in section 475 of the Act (42 U.S.C. 286b-6). (See part 59a, subpart B of this chapter.)
§ 4.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.).
Collections means all books, periodicals, prints, audiovisual materials, films, videotapes, recordings, manuscripts, and other resource materials of the library. It does not include data processing tapes or programs used solely for internal processing activities to generate reference materials, nor does it include “records” of the Library as defined in 45 CFR 5.5. Records of the Library are available in accordance with the regulations under the Freedom of Information Act and Privacy Act of 1974. (See 45 CFR parts 5 and 5b.)
Director means the Director of the National Library of Medicine or the Director’s delegate.
Health-sciences professional means any person engaged in: (1) The administration of health activities; (2) the provision of health services; or (3) research, teaching, or education concerned with the advancement of medicine or other sciences related to health or improvement of the public health.
Historical collection means: (1) Materials in the collections published or printed prior to 1914; (2) manuscripts and prints; (3) the archival film collection; and (4) other materials of the collections which, because of age, or unique or unusual value, require special handling, storage, or protection for their preservation, as determined by the Director.
Library means the National Library of Medicine, established by section 465 of the Act (42 U.S.C. 286).
Regional Medical Library means a medical library established or maintained as a regional medical library under section 475 of the Act (42 U.S.C. 286b-6).
§ 4.3 Purpose of the Library.
The purpose of the Library is to assist the advancement of medical and related sciences and aid the dissemination and exchange of scientific and other information important to the progress of medicine and the public health. The Library acquires and maintains library materials pertinent to medicine, including audiovisual materials; compiles, publishes, and disseminates catalogs, indices, and bibliographies of these materials, as appropriate; makes available materials, through loan or otherwise; provides reference and other assistance to research; and engages in other activities in furtherance of this purpose.
§ 4.4 Use of Library facilities.
(a) General. The Library facilities are available to any person seeking to make use of the collections. The Director may prescribe reasonable rules to assure the most effective use of facilities by health-sciences professionals and to protect the collections from misuse or damage. These rules must be consistent with the regulations in this part and applicable Department regulations and policies on nondiscrimination.
(b) Reading rooms. Public reading rooms are available for obtaining and reading materials from the collections. The Director may prescribe reasonable rules designed to provide adequate reading space and orderly conditions and procedures.
(c) Study rooms. Upon request a limited number of study rooms may be made available to individuals requiring extensive use of Library materials. Requests for study rooms shall be addressed in writing to the Director. The Director shall give priority, in the following order, for study room use to:
(1) Persons engaged in “special scientific projects” under section 473 of the Act (42 U.S.C. 286b-4),
(2) Health-sciences professionals, and
(3) The general public.
§ 4.5 Use of materials from the collections.
(a) Unrestricted materials. Except as otherwise provided in this section, materials from the collections are generally available to any interested person only in facilities provided by the Library for this purpose. The Director may prescribe additional reasonable rules to assure the most effective use of the Library’s resources by health-sciences professionals and to protect the collections from misuse or damage. The rules must be consistent with the regulations in this part and applicable Department regulations and policies on nondiscrimination. Materials in the collections are available upon each request which assures, to the Director’s satisfaction, that the materials will be safeguarded from misuse, damage, loss, or misappropriation, and will be returned promptly after use or upon request of the Library.
(b) Restricted materials—(1) Historical collection. Materials from the historical collection are available only as the Director may permit to assure their maximum preservation and protection. Copies of these materials may be made available in the form of microfilm and other copies, for which reasonable fees may be charged.
(2) Gifts. Materials in the collections are available only in accordance with any limitations imposed as a condition of the acquisition of those materials, whether the acquisition was by gift or purchase.
(c) Loans—(1) General. Requests for loans of materials must assure the Library that (i) the materials will be safeguarded from misuse, damage, loss, or misappropriation and (ii) the materials will be returned promptly after use or upon request of the Library. The Library may provide copies in lieu of original materials, which need not be returned unless otherwise stated at the time of the loan.
(2) Loans of audiovisual materials. Audiovisual materials are available for loan under the same general terms as printed materials.
(3) Loans to other libraries. Upon request materials or copies are available for use through libraries of public or private agencies or institutions. The requesting library must assure that it has first exhausted its own collection resources, those of other local libraries in the geographic area, and those of the Regional Medical Library network (including Regional and Resource Libraries) before making a request for a loan.
(4) Loans to health-sciences professionals. The Director may make loans of materials directly to health-sciences professionals. An individual wishing a loan of library materials must assure to the satisfaction of the Director that the individual is geographically isolated, in terms of distance or available transportation, from medical literature resources likely to contain the desired material.
§ 4.6 Reference, bibliographic, reproduction, and consultation services.
(a) General. To the extent resources permit, the Library will make available, upon request, reference, bibliographic, reproduction, and consultation services. Priority will be given to requests from health-sciences professionals for services not reasonably available through local or regional libraries.
(b) Specialized bibliographic services. The Director may provide bibliographies on individually selected medical or scientific topics upon request where it is consistent with the Library’s purpose. The Director may publish and make available for general distribution by the Library, bibliographic searches determined to be of general interest. The Library may also produce and distribute a limited number of bibliographies on topics of general interest to public or nonprofit health-related professional societies, research organizations, and other group users. These bibliographies may be produced on a regularly recurring or intermittent basis under contract between the Library and public or nonprofit agencies, when determined in each case by the Director to be necessary to assure more effective distribution of the bibliographic information.
(c) Information retrieval system computer tapes. To the extent Library resources permit and in order to further the Library’s purpose, the Director may make available upon request by agencies, organizations, and institutions copies of all or part of the Library’s magnetic tapes.
§ 4.7 Fees.
The Director may charge reasonable fees for any service provided by the Library under this part, in accordance with a schedule available at the Library upon request, which are designed to recover all or a portion of the cost to the Library of providing the service.
§ 4.8 Publication of the Library and information about the Library.
Lists of bibliographies, Library publications sold by the Government Printing Office, necessary application forms, and other information concerning the organization, operation, functions, and services of the Library, are available from the National Library of Medicine, Bethesda, Maryland 20894.
PART 5—DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS
§ 5.1 Purpose.
These regulations establish criteria and procedures for the designation of geographic areas, population groups, medical facilities, and other public facilities, in the States, as health professional(s) shortage areas.
§ 5.2 Definitions.
Act means the Public Health Service Act, as amended.
Health professional(s) shortage area means any of the following which the Secretary determines has a shortage of health professional(s): (1) An urban or rural area (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the delivery of health services); (2) a population group; or (3) a public or nonprofit private medical facility.
Health service area means a health service area whose boundaries have been designated by the Secretary, under section 1511 of the Act, for purposes of health planning activities.
Health systems agency or HSA means the health systems agency designated, under section 1515 of the Act, to carry out health planning activities for a specific health service area.
Medical facility means a facility for the delivery of health services and includes: (1) A community health center, public health center, outpatient medical facility, or community mental health center; (2) a hospital, State mental hospital, facility for long-term care, or rehabilitation facility; (3) a migrant health center or an Indian Health service facility; (4) a facility for delivery of health services to inmates in a U.S. penal or correctional institution (under section 323 of the Act) or a State correctional institution; (5) a Public Health Service medical facility (used in connection with the delivery of health services under section 320, 321, 322, 324, 325, or 326 of the Act); or (6) any other Federal medical facility.
Metropolitan area means an area which has been designated by the Office of Management and Budget as a standard metropolitan statistical area (SMSA). All other areas are “non-metropolitan areas.”
Poverty level means the povery level as defined by the Bureau of the Census, using the poverty index adopted by a Federal Interagency Committee in 1969, and updated each year to reflect changes in the Consumer Price Index.
Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department to whom the authority involved has been delegated.
State includes, in addition to the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands.
State health planning and development agency or SHPDA means a State health planning and development agency designated under section 1521 of the Act.
§ 5.3 Procedures for designation of health professional(s) shortage areas.
(a) Using data available to the Department from national, State, and local sources and based upon the criteria in the appendices to this part, the Department will annually prepare listings (by State and health service area) of currently designated health professional(s) shortage areas and potentially designatable areas, together with appropriate related data available to the Department. Relevant portions of this material will then be forwarded to each health systems agency, State health planning and development agency, and Governor, who will be asked to review the listings for their State, correct any errors of which they are aware, and offer their recommendations, if any, within 90 days, as to which geographic areas, population groups, and facilities in areas under their jurisdiction should be designated. An information copy of these listings will also be made available, upon request, to interested parties for their use in providing comments or recommendations to the Secretary and/or to the appropriate HSA, SHPDA, or Governor.
(b) In addition, any agency or individual may request the Secretary to designate (or withdraw the designation of) a particular geographic area, population group, or facility as a health professional(s) shortage area. Each request will be forwarded by the Secretary to the appropriate HSA, SHPDA, and Governor, who will be asked to review it and offer their recommendations, if any, within 30 days. An information copy will also be made available to other interested parties, upon request, for their use in providing comments or recommendations to the Secretary and/or to the appropriate HSA, SHPDA, or Governor.
(c) In each case where the designation of a public facility (including a Federal medical facility) is under consideration, the Secretary will give written notice of the proposed designation to the chief administrative officer of the facility, who will be asked to review it and offer their recommendations, if any, within 30 days.
(d) After review of the available information and consideration of the comments and recommendations submitted, the Secretary will designate health professional(s) shortage areas and withdraw the designation of any areas which have been determined no longer to have a shortage of health professional(s).
§ 5.4 Notification and publication of designations and withdrawals.
(a) The Secretary will give written notice of the designation (or withdrawal of designation) of a health professional(s) shortage area, not later than 60 days from the date of the designation (or withdrawal of designation), to:
(1) The Governor of each State in which the area, population group, medical facility, or other public facility so designated is in whole or in part located;
(2) Each HSA for a health service area which includes all or any part of the area, population group, medical facility, or other public facility so designated;
(3) The SHPDA for each State in which the area, population group, medical facility, or other public facility so designated is in whole or in part located; and
(4) Appropriate public or nonprofit private entities which are located in or which have a demonstrated interest in the area so designated.
(b) The Secretary will periodically publish updated lists of designated health professional(s) shortage areas in the
(c) The effective date of the designation of an area shall be the date of the notification letter to the individual or agency which requested the designation, or the date of publication in the
(d) Once an area is listed in the
Appendix A to Part 5—Criteria for Designation of Areas Having Shortages of Primary Medical Care Professional(s)
A geographic area will be designated as having a shortage of primary medical care manpower if the following three criteria are met:
1. The area is a rational area for the delivery of primary medical care services.
2. One of the following conditions prevails within the area:
(a) The area has population to full-time-equivalent primary care physician ratio of at least 3,500:1.
(b) The area has a population to full-time-equivalent primary care physician ratio of less than 3,500:1 but greater than 3,000:1 and has usually high needs for primary care services or insufficient capacity of existing primary care providers.
3. Primary medical care manpower in contiguous areas are overutilized, excessively distant, or inaccessible to the population of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Primary Medical Care Services.
(a) The following areas will be considered rational areas for the delivery of primary medical care services:
(i) A county, or a group of contiguous counties whose population centers are within 30 minutes travel time of each other.
(ii) A portion of a county, or an area made up of portions of more than one county, whose population, because of topography, market or transportation patterns, distinctive population characteristics or other factors, has limited access to contiguous area resources, as measured generally by a travel time greater than 30 minutes to such resources.
(iii) Established neighborhoods and communities within metropolitan areas which display a strong self-identity (as indicated by a homogeneous socioeconomic or demographic structure and/or a tradition of interaction or interdependency), have limited interaction with contiguous areas, and which, in general, have a minimum population of 20,000.
(b) The following distances will be used as guidelines in determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available: 20 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 15 miles.
(iii) In flat terrain or in areas connected by interstate highways: 25 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 30 minutes travel time.
2. Population Count.
The population count used will be the total permanent resident civilian population of the area, excluding inmates of institutions, with the following adjustments, where appropriate:
(a) Adjustments to the population for the differing health service requirements of various age-sex population groups will be computed using the table below of visit rates for 12 age-sex population cohorts. The total expected visit rate will first be obtained by multiplying each of the 12 visit rates in the table by the size of the area population within that particular age-sex cohort and adding the resultant 12 visit figures together. This total expected visit rate will then be divided by the U.S. average per capita visit rate of 5.1, to obtain the adjusted population for the area.
| Sex | Age groups | |||||
|---|---|---|---|---|---|---|
| Under 5 | 5-14 | 15-24 | 25-44 | 45-64 | 65 and over | |
| Male | 7.3 | 3.6 | 3.3 | 3.6 | 4.7 | 6.4 |
| Female | 6.4 | 3.2 | 5.5 | 6.4 | 6.5 | 6.8 |
(b) The effect of transient populations on the need of an area for primary care professional(s) will be taken into account as follows:
(i) Seasonal residents, i.e., those who maintain a residence in the area but inhabit it for only 2 to 8 months per year, may be included but must be weighted in proportion to the fraction of the year they are present in the area.
(ii) Other tourists (non-resident) may be included in an area’s population but only with a weight of 0.25, using the following formula: Effective tourist contribution to population = 0.25 × (fraction of year tourists are present in area) × (average daily number of tourists during portion of year that tourists are present).
(iii) Migratory workers and their families may be included in an area’s population, using the following formula: Effective migrant contribution to population = (fraction of year migrants are present in area) × (average daily number of migrants during portion of year that migrants are present).
3. Counting of Primary Care Practitioners.
(a) All non-Federal doctors of medicine (M.D.) and doctors of osteopathy (D.O.) providing direct patient care who practice principally in one of the four primary care specialities—general or family practice, general internal medicine, pediatrics, and obstetrics and gynecology—will be counted. Those physicians engaged solely in administration, research, and teaching will be excluded. Adjustments for the following factors will be made in computing the number of full-time-equivalent (FTE) primary care physicians:
(i) Interns and residents will be counted as 0.1 full-time equivalent (FTE) physicians.
(ii) Graduates of foreign medical schools who are not citizens or lawful permanent residents of the United States will be excluded from physician counts.
(iii) Those graduates of foreign medical schools who are citizens or lawful permanent residents of the United States, but do not have unrestricted licenses to practice medicine, will be counted as 0.5 FTE physicians.
(b) Practitioners who are semi-retired, who operate a reduced practice due to infirmity or other limiting conditions, or who provide patient care services to the residents of the area only on a part-time basis will be discounted through the use of full-time equivalency figures. A 40-hour work week will be used as the standard for determining full-time equivalents in these cases. For practitioners working less than a 40-hour week, every four (4) hours (or
(c) In some cases, physicians located within an area may not be accessible to the population of the area under consideration. Allowances for physicians with restricted practices can be made, on a case-by-case basis. However, where only a portion of the population of the area cannot access existing primary care resources in the area, a population group designation may be more appropriate (see part II of this appendix).
(d) Hospital staff physicians involved exclusively in inpatient care will be excluded. The number of full-time equivalent physicians practicing in organized outpatient departments and primary care clinics will be included, but those in emergency rooms will be excluded.
(e) Physicians who are suspended under provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act for a period of eighteen months or more will be excluded.
4. Determination of Unusually High Needs for Primary Medical Care Services.
An area will be considered as having unusually high needs for primary health care services if at least one of the following criteria is met:
(a) The area has more than 100 births per year per 1,000 women aged 15-44.
(b) The area has more than 20 infant deaths per 1,000 live births.
(c) More than 20% of the population (or of all households) have incomes below the poverty level.
5. Determination of Insufficient Capacity of Existing Primary Care Providers.
An area’s existing primary care providers will be considered to have insufficient capacity if at least two of the following criteria are met:
(a) More than 8,000 office or outpatient visits per year per FTE primary care physician serving the area.
(b) Unusually long waits for appointments for routine medical services (i.e., more than 7 days for established patients and 14 days for new patients).
(c) Excessive average waiting time at primary care providers (longer than one hour where patients have appointments or two hours where patients are treated on a first-come, first-served basis).
(d) Evidence of excessive use of emergency room facilities for routine primary care.
(e) A substantial proportion (2/3 or more) of the area’s physicians do not accept new patients.
(f) Abnormally low utilization of health services, as indicated by an average of 2.0 or less office visits per year on the part of the area’s population.
6. Contiguous Area Considerations.
Primary care professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Primary care professional(s) in the contiguous area are more than 30 minutes travel time from the population center(s) of the area being considered for designation (measured in accordance with paragraph B.1(b) of this part).
(b) The contiguous area population-to-full-time-equivalent primary care physician ratio is in excess of 2000:1, indicating that practitioners in the contiguous area cannot be expected to help alleviate the shortage situation in the area being considered for designation.
(c) Primary care professional(s) in the contiguous area are inaccessible to the population of the area under consideration because of specified access barriers, such as:
(i) Significant differences between the demographic (or socio-economic) characteristics of the area under consideration and those of the contiguous area, indicating that the population of the area under consideration may be effectively isolated from nearby resources. This isolation could be indicated, for example, by an unusually high proportion of non-English-speaking persons.
(ii) A lack of economic access to contiguous area resources, as indicated particularly where a very high proportion of the population of the area under consideration is poor (i.e., where more than 20 percent of the population or the households have incomes below the poverty level), and Medicaid-covered or public primary care services are not available in the contiguous area.
C. Determination of Degree of Shortage.
Designated areas will be assigned to degree-of-shortage groups, based on the ratio (R) of population to number of full-time equivalent primary care physicians and the presence or absence of unusually high needs for primary health care services, according to the following table:
| High needs not indicated | High needs indicated | |
|---|---|---|
| Group 1 | No physicians | No physicians; or R≥5,000 |
| Group 2 | R≥5,000 | 5,000>R≥4,000 |
| Group 3 | 5,000>R≥4,000 | 4,000>R≥3,500 |
| Group 4 | 4,000>R≥3,500 | 3,500>R≥3,000 |
D. Determination of size of primary care physician shortage. Size of Shortage (in number of FTE primary care physicians needed) will be computed using the following formulas:
(1) For areas without unusually high need or insufficient capacity:
(2) For areas with unusually high need or insufficient capacity:
A. Criteria.
1. In general, specific population groups within particular geographic areas will be designated as having a shortage of primary medical care professional(s) if the following three criteria are met:
(a) The area in which they reside is rational for the delivery of primary medical care services, as defined in paragraph B.1 of part I of this appendix.
(b) Access barriers prevent the population group from use of the area’s primary medical care providers. Such barriers may be economic, linguistic, cultural, or architectural, or could involve refusal of some providers to accept certain types of patients or to accept Medicaid reimbursement.
(c) The ratio of the number of persons in the population group to the number of primary care physicians practicing in the area and serving the population group is at least 3,000:1.
2. Indians and Alaska Natives will be considered for designation as having shortages of primary care professional(s) as follows:
(a) Groups of members of Indian tribes (as defined in section 4(d) of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are automatically designated.
(b) Other groups of Indians or Alaska Natives (as defined in section 4(c) of Pub. L. 94-437) will be designated if the general criteria in paragraph A are met.
B. Determination of Degree of Shortage.
Each designated population group will be assigned to a degree-of-shortage group, based on the ratio (R) of the group’s population to the number of primary care physicians serving it, as follows:
Population groups which have received “automatic” designation will be assigned to degree-of-shortage group 4 if no information on the ratio of the number of persons in the group to the number of FTE primary care physicians serving them is provided.
C. Determination of size of primary care physician shortage. Size of shortage (in number of primary care physicians needed) will be computed as follows:
Primary care physician shortage = number of persons in population group/3,000−number of FTE primary care physicians
A. Federal and State Correctional Institutions.
1. Criteria.
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of primary medical care professional(s) if both the following criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of FTE primary care physicians serving the institution is at least 1,000:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-stay are not specified, or if the information provided does not indicate that intake medical examinations are routinely performed upon entry, then—Number of internees = average number of inmates.
(ii) If the average length-of-stay is specified as one year or more, and intake medical examinations are routinely performed upon entry, then—Number of internees = average number of inmates + (0.3) × number of new inmates per year.
(iii) If the average length-of-stay is specified as less than one year, and intake examinations are routinely performed upon entry, then—Number of internees = average number of inmates + (0.2) × (1 + ALOS/2) × number of new inmates per year where ALOS = average length-of-stay (in fraction of year). (The number of FTE primary care physicians is computed as in part I, section B, paragraph 3 above.)
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-shortage groups based on the number of inmates and/or the ratio (R) of internees to primary care physicians, as follows:
Group 1—Institutions with 500 or more inmates and no physicians.
Group 2—Other institutions with no physicians and institutions with R greater than (or equal to) 2,000:1.
Group 3—Institutions with R greater than (or equal to) 1,000:1 but less than 2,000:1.
B. Public or Non-Profit Medical Facilities.
1. Criteria.
Public or non-profit private medical facilities will be designated as having a shortage of primary medical care professional(s) if:
(a) the facility is providing primary medical care services to an area or population group designated as having a primary care professional(s) shortage; and
(b) the facility has insufficient capacity to meet the primary care needs of that area or population group.
2. Methodology
In determining whether public or nonprofit private medical facilities meet the criteria established by paragraph B.1 of this Part, the following methodology will be used:
(a) Provision of Services to a Designated Area or Population Group.
A facility will be considered to be providing services to a designated area or population group if either:
(i) A majority of the facility’s primary care services are being provided to residents of designated primary care professional(s) shortage areas or to population groups designated as having a shortage of primary care professional(s); or
(ii) The population within a designated primary care shortage area or population group has reasonable access to primary care services provided at the facility. Reasonable access will be assumed if the area within which the population resides lies within 30 minutes travel time of the facility and non-physical barriers (relating to demographic and socioeconomic characteristics of the population) do not prevent the population from receiving care at the facility.
Migrant health centers (as defined in section 319(a)(1) of the Act) which are located in areas with designated migrant population groups and Indian Health Service facilities are assumed to be meeting this requirement.
(b) Insufficient capacity to meet primary care needs.
A facility will be considered to have insufficient capacity to meet the primary care needs of the area or population it serves if at least two of the following conditions exist at the facility:
(i) There are more than 8,000 outpatient visits per year per FTE primary care physician on the staff of the facility. (Here the number of FTE primary care physicians is computed as in Part I, Section B, paragraph 3 above.)
(ii) There is excessive usage of emergency room facilities for routine primary care.
(iii) Waiting time for appointments is more than 7 days for established patients or more than 14 days for new patients, for routine health services.
(iv) Waiting time at the facility is longer than 1 hour where patients have appointments or 2 hours where patients are treated on a first-come, first-served basis.
3. Determination of Degree of Shortage.
Each designated medical facility will be assigned to the same degree-of-shortage group as the designated area or population group which it serves.
Appendix B to Part 5—Criteria for Designation of Areas Having Shortages of Dental Professional(s)
A geographic area will be designated as having a dental manpower shortage if the following three criteria are met:
1. The area is a rational area for the delivery of dental services.
2. One of the following conditions prevails in the area:
(a) The area has a population to full-time-equivalent dentist ratio of less than 5,000:1 or
(b) The area has a population to full-time-equivalent dentist ratio of less than 5,000:1 but greater than 4,000:1 and has unusually high needs for dental services or insufficient capacity of existing dental providers.
3. Dental manpower in contiguous areas are over utilized, excessively distant, or inaccessible to the population of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1. Rational Area for the Delivery of Dental Services.
(a) The following areas will be considered rational areas for the delivery of dental health services:
(i) A county, or a group of several contiguous counties whose population centers are within 40 minutes travel time of each other.
(ii) A portion of a county (or an area made up of portions of more than one county) whose population, because of topography, market or transportation patterns, distinctive population characteristics, or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to such resources.
(iii) Established neighborhoods and communities within metropolitan areas which display a strong self-identity (as indicated by a homogenous socioeconomic or demographic structure and/or a traditional of interaction or intradependency), have limited interaction with contiguous areas, and which, in general, have a minimum population of 20,000.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 40 minutes travel time.
2. Population Count.
The population count use will be the total permanent resident civilian population of the area, excluding inmates of institutions, with the following adjustments:
(a) Seasonal residents, i.e., those who maintain a residence in the area but inhabit it for only 2 to 8 months per year, may be included but must be weighted in proportion to the fraction of the year they are present in the area.
(b) Migratory workers and their families may be included in an area’s population using the following formula: Effective migrant contribution to population = (fraction of year migrants are present in area) × (average daily number of migrants during portion of year that migrants are present).
3. Counting of Dental Practitioners.
(a) All non-Federal dentists providing patient care will be counted, except in those areas where it is shown that specialists (those dentists not in general practice or pedodontics) are serving a larger area and are not addressing the general dental care needs of the area under consideration.
(b) Full-time equivalent (FTE) figures will be used to reflect productivity differences among dental practices based on the age of the dentists, the number of auxiliaries employed, and the number of hours worked per week. In general, the number of FTE dentists will be computed using weights obtained from the matrix in Table 1, which is based on the productivity of dentists at various ages, with different numbers of auxiliaries, as compared with the average productivity of all dentists. For the purposes of these determinations, an auxiliary is defined as any non-dentist staff employed by the dentist to assist in operation of the practice.
Table 1—Equivalency Weights, by Age and Number of Auxiliaries
| 55-59 | 60-64 | 65 + | ||
|---|---|---|---|---|
| No auxiliaries | 0.8 | 0.7 | 0.6 | 0.5 |
| One auxiliary | 1.0 | 0.9 | 0.8 | 0.7 |
| Two auxiliaries | 1.2 | 1.0 | 1.0 | 0.8 |
| Three auxiliaries | 1.4 | 1.2 | 1.0 | 1.0 |
| Four or more auxiliaries | 1.5 | 1.5 | 1.3 | 1.2 |
If information on the number of auxiliaries employed by the dentist is not available, Table 2 will be used to compute the number of full-time equivalent dentists.
Table 2—Equivalency Weights, by Age
| 55 | 55-59 | 60-64 | 65 + | |
|---|---|---|---|---|
| Equivalency weights | 1.2 | 0.9 | 0.8 | 0.6 |
The number of FTE dentists within a particular age group (or age/auxiliary group) will be obtained by multiplying the number of dentists within that group by its corresponding equivalency weight. The total supply of FTE dentists within an area is then computed as the sum of those dentists within each age (or age/auxiliary) group.
(c) The equivalency weights specified in tables 1 and 2 assume that dentists within a particular group are working full-time (40 hours per week). Where appropriate data are available, adjusted equivalency figures for dentists who are semi-retired, who operate a reduced practice due to infirmity or other limiting conditions, or who are available to the population of an area only on a part-time basis will be used to reflect the reduced availability of these dentists. In computing these equivalency figures, every 4 hours (or
4. Determination of Unusually High Needs for Dental Services.
An area will be considered as having unusually high needs for dental services if at least one of the following criteria is met:
(a) More than 20% of the population (or of all households) has incomes below the poverty level.
(b) The majority of the area’s population does not have a fluoridated water supply.
5. Determination of Insufficient Capacity of Existing Dental Care Providers.
An area’s existing dental care providers will be considered to have insufficient capacity if at least two of the following criteria are met:
(a) More than 5,000 visits per year per FTE dentist serving the area.
(b) Unusually long waits for appointments for routine dental services (i.e., more than 6 weeks).
(c) A substantial proportion (
6. Contiguous Area Considerations.
Dental professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Dental professional(s) in the contiguous area are more than 40 minutes travel time from the center of the area being considered for designation (measured in accordance with Paragraph B.1.(b) of this part).
(b) Contiguous area population-to-(FTE) dentist ratios are in excess of 3,000:1, indicating that resources in contiguous areas cannot be expected to help alleviate the shortage situation in the area being considered for designation.
(c) Dental professional(s) in the contiguous area are inaccessible to the population of the area under consideration because of specified access barriers, such as:
(i) Significant differences between the demographic (or socioeconomic) characteristics of the area under consideration and those of the contiguous area, indicating that the population of the area under consideration may be effectively isolated from nearby resources. Such isolation could be indicated, for example, by an unusually high proportion of non-English-speaking persons.
(ii) A lack of economic access to contiguous area resources, particularly where a very high proportion of the population of the area under consideration is poor (i.e., where more than 20 percent of the population or of the households have incomes below the poverty level) and Medicaid-covered or public dental services are not available in the contiguous area.
C. Determination of Degree of Shortage.
The degree of shortage of a given geographic area, designated as having a shortage of dental professional(s), will be determined using the following procedure:
Designated areas will be assigned to degree-of-shortage groups, based on the ratio (R) of population to number of full-time-equivalent dentists and the presence or absence of unusually high needs for dental services, or insufficient capacity of existing dental care providers according to the following table:
| High needs or insufficient capacity not indicated | High needs or insufficient capacity indicated | |
|---|---|---|
| Group 1 | No dentists | No dentists or R≥8,000. |
| Group 2 | R≥8,000 | 8,000>R≥6,000. |
| Group 3 | 8,000>R≥6,000 | 6,000>R≥5,000. |
| Group 4 | 6,000>R≥5,000 | 5,000>R≥4,000. |
D. Determination of size of dental shortage. Size of Dental Shortage (in number of FTE dental practitioners needed) will be computed using the following formulas:
(1) For areas without unusually high need:
(2) For areas with unusually high need:
A. Criteria.
1. In general, specified population groups within particular geographic areas will be designated as having a shortage of dental care professional(s) if the following three criteria are met:
a. The area in which they reside is rational for the delivery of dental care services, as defined in paragraph B.1 of part I of this appendix.
b. Access barriers prevent the population group from use of the area’s dental providers.
c. The ratio (R) of the number of persons in the population group to the number of dentists practicing in the area and serving the population group is at least 4,000:1.
2. Indians and Alaska Natives will be considered for designation as having shortages of dental professional(s) as follows:
(a) Groups of members of Indian tribes (as defined in section 4(d) of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are automatically designated.
(b) Other groups of Indians or Alaska Natives (as defined in section 4(c) of Pub. L. 94-437) will be designated if the general criteria in paragraph 1 are met.
B. Determination of Degree of Shortage.
Each designated population group will be assigned to a degree-of-shortage group as follows:
C. Determination of size of dental shortage. Size of dental shortage will be computed as follows:
A. Federal and State Correctional Institutions.
1. Criteria
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of dental professional(s) if both the following criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of FTE dentists serving the institution is at least 1,500:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-stay are not specified, or if the information provided does not indicate that intake dental examinations are routinely performed by dentists upon entry, then—Number of internees = average number of inmates.
(ii) If the average length-of-stay is specified as one year or more, and intake dental examinations are routinely performed upon entry, then—Number of internees = average number of inmates + number of new inmates per year.
(iii) If the average length-of-stay is specified as less than one year, and intake dental examinations are routinely performed upon entry, then—Number of internees = average number of inmates +
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-shortage groups based on the number of inmates and/or the ratio (R) of internees to dentists, as follows:
Group 1—Institutions with 500 or more inmates and no dentists.
Group 2—Other institutions with no dentists and institutions with R greater than (or equal to) 3,000:1.
Group 3—Institutions with R greater than (or equal to) 1,500:1 but less than 3,000:1.
B. Public or Non-Profit Private Dental Facilities.
1. Criteria.
Public or nonprofit private facilties providing general dental care services will be designated as having a shortage of dental professional(s) if both of the following criteria are met:
(a) The facility is providing general dental care services to an area or population group designated as having a dental professional(s) shortage; and
(b) The facility has insufficent capacity to meet the dental care needs of that area or population group.
2. Methodology.
In determining whether public or nonprofit private facilities meet the criteria established by paragraph B.1. of this part, the following methodology will be used:
(a) Provision of Services to a Designated Area or Population Group.
A facility will be considered to be providing services to an area or population group if either:
(i) A majority of the facility’s dental care services are being provided to residents of designated dental professional(s) shortage areas or to population groups designated as having a shortage of dental professional(s); or
(ii) The population within a designated dental shortage area or population group has reasonable access to dental services provided at the facility. Reasonable access will be assumed if the population lies within 40 minutes travel time of the facility and non-physical barriers (relating to demographic and socioeconomic characteristics of the population) do not prevent the population from receiving care at the facility.
Migrant health centers (as defined in section 319(a)(1) of the Act) which are located in areas with designated migrant population groups and Indian Health Service facilities are assumed to be meeting this requirement.
(b) Insufficient Capacity To Meet Dental Care Needs.
A facility will be considered to have insufficient capacity to meet the dental care needs of a designated area or population group if either of the following conditions exists at the facility.
(i) There are more than 5,000 outpatient visits per year per FTE dentist on the staff of the facility. (Here the number of FTE dentists is computed as in part I, section B, paragraph 3 above.)
(ii) Waiting time for appointments is more than 6 weeks for routine dental services.
3. Determination of Degree of Shortage.
Each designated dental facility will be assigned to the same degree-of-shortage group as the designated area or population group which it serves.
Appendix C to Part 5—Criteria for Designation of Areas Having Shortages of Mental Health Professionals
A. Criteria. A geographic area will be designated as having a shortage of mental health professionals if the following four criteria are met:
1. The area is a rational area for the delivery of mental health services.
2. One of the following conditions prevails within the area:
(a) The area has—
(i) A population-to-core-mental-health-professional ratio greater than or equal to 6,000:1 and a population-to-psychiatrist ratio greater than or equal to 20,000:1, or
(ii) A population-to-core-professional ratio greater than or equal to 9,000:1, or
(iii) A population-to-psychiatrist ratio greater than or equal to 30,000:1;
(b) The area has unusually high needs for mental health services, and has—
(i) A population-to-core-mental-health-professional ratio greater than or equal to 4,500:1 and
A population-to-psychiatrist ratio greater than or equal to 15,000:1, or
(ii) A population-to-core-professional ratio greater than or equal to 6,000:1, or
(iii) A population-to-psychiatrist ratio greater than or equal to 20,000:1;
3. Mental health professionals in contiguous areas are overutilized, excessively distant or inaccessible to residents of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Mental Health Services.
(a) The following areas will be considered rational areas for the delivery of mental health services:
(i) An established mental health catchment area, as designated in the State Mental Health Plan under the general criteria set forth in section 238 of the Community Mental Health Centers Act.
(ii) A portion of an established mental health catchment area whose population, because of topography, market and/or transportation patterns or other factors, has limited access to mental health resources in the rest of the catchment area, as measured generally by a travel time of greater than 40 minutes to these resources.
(iii) A county or metropolitan area which contains more than one mental health catchment area, where data are unavailable by individual catchment area.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 40 minutes travel time.
2. Population Count.
The population count used will be the total permanent resident civilian population of the area, excluding inmates of institutions.
3. Counting of mental health professionals. (a) All non-Federal core mental health professionals (as defined below) providing mental health patient care (direct or other, including consultation and supervision) in ambulatory or other short-term care settings to residents of the area will be counted. Data on each type of core professional should be presented separately, in terms of the number of full-time-equivalent (FTE) practitioners of each type represented.
(b) Definitions:
(i) Core mental health professionals or core professionals includes those psychiatrists, clinical psychologists, clinical social workers, psychiatric nurse specialists, and marriage and family therapists who meet the definitions below.
(ii) Psychiatrist means a doctor of medicine (M.D.) or doctor of osteopathy (D.O.) who
(A) Is certified as a psychiatrist or child psychiatrist by the American Medical Specialities Board of Psychiatry and Neurology or by the American Osteopathic Board of Neurology and Psychiatry, or, if not certified, is “broad-eligible” (i.e., has successfully completed an accredited program of graduate medical or osteopathic education in psychiatry or child psychiatry); and
(B) Practices patient care psychiatry or child psychiatry, and is licensed to do so, if required by the State of practice.
(iii) Clinical psychologist means an individual (normally with a doctorate in psychology) who is practicing as a clinical or counseling psychologist and is licensed or certified to do so by the State of practice; or, if licensure or certification is not required in the State of practice, an individual with a doctorate in psychology and two years of supervised clinical or counseling experience. (School psychologists are not included.)
(iv) Clinical social worker means an individual who—
(A) Is certified as a clinical social worker by the American Board of Examiners in Clinical Social Work, or is listed on the National Association of Social Workers’ Clinical Register, or has a master’s degree in social work and two years of supervised clinical experience; and
(B) Is licensed to practice as a social worker, if required by the State of practice.
(v) Psychiatric nurse specialist means a registered nurse (R.N.) who—
(A) Is certified by the American Nurses Association as a psychiatric and mental health clinical nurse specialist, or has a master’s degree in nursing with a specialization in psychiatric/mental health and two years of supervised clinical experience; and
(B) Is licensed to practice as a psychiatric or mental health nurse specialist, if required by the State of practice.
(vi) Marriage and family therapist means an individual (normally with a master’s or doctoral degree in marital and family therapy and at least two years of supervised clinical experience) who is practicing as a marital and family therapist and is licensed or certified to do so by the State of practice; or, if licensure or certification is not required by the State of practice, is eligible for clinical membership in the American Association for Marriage and Family Therapy.
(c) Practitioners who provide patient care to the population of an area only on a part-time basis (whether because they maintain another office elsewhere, spend some of their time providing services in a facility, are semi-retired, or operate a reduced practice for other reasons), will be counted on a partial basis through the use of full-time-equivalency calculations based on a 40-hour week. Every 4 hours (or
(d) In some cases, practitioners located within an area may not be accessible to the general population of the area under consideration. Practitioners working in restricted facilities will be included on an FTE basis based on time spent outside the facility. Examples of restricted facilities include correctional institutions, youth detention facilities, residential treatment centers for emotionally disturbed or mentally retarded children, school systems, and inpatient units of State or county mental hospitals.
(e) In cases where there are mental health facilities or institutions providing both inpatient and outpatient services, only those FTEs providing mental health services in outpatient units or other short-term care units will be counted.
(f) Adjustments for the following factors will also be made in computing the number of FTE providers:
(i) Practitioners in residency programs will be counted as 0.5 FTE.
(ii) Graduates of foreign schools who are not citizens or lawful permanent residents of the United States will be excluded from counts.
(iii) Those graduates of foreign schools who are citizens or lawful permanent residents of the United States, and practice in certain settings, but do not have unrestricted licenses to practice, will be counted on a full-time-equivalency basis up to a maximum of 0.5 FTE.
(g) Practitioners suspended for a period of 18 months or more under provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act will not be counted.
4. Determination of unusually high needs for mental health services. An area will be considered to have unusually high needs for mental health services if one of the following criteria is met:
(a) 20 percent of the population (or of all households) in the area have incomes below the poverty level.
(b) The youth ratio, defined as the ratio of the number of children under 18 to the number of adults of ages 18 to 64, exceeds 0.6.
(c) The elderly ratio, defined as the ratio of the number of persons aged 65 and over to the number of adults of ages 18 to 64, exceeds 0.25.
(d) A high prevalence of alcoholism in the population, as indicated by prevalence data showing the area’s alcoholism rates to be in the worst quartile of the nation, region, or State.
(e) A high degree of substance abuse in the area, as indicated by prevalence data showing the area’s substance abuse to be in the worst quartile of the nation, region, or State.
5. Contiguous area considerations. Mental health professionals in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Core mental health professionals in the contiguous area are more than 40 minutes travel time from the closest population center of the area being considered for designation (measured in accordance with paragraph B.1(b) of this part).
(b) The population-to-core-mental-health-professional ratio in the contiguous area is in excess of 3,000:1 and the population-to-psychiatrist ratio there is in excess of 10,000:1, indicating that core mental health professionals in the contiguous areas are overutilized and cannot be expected to help alleviate the shortage situation in the area for which designation is being considered. (If data on core mental health professionals other than psychiatrists are not available for the contiguous area, a population-to-psychiatrist ratio there in excess of 20,000:1 may be used to demonstrate overutilization.)
(c) Mental health professionals in contiguous areas are inaccessible to the population of the requested area due to geographic, cultural, language or other barriers or because of residency restrictions of programs or facilities providing such professionals.
C. Determination of degree of shortage. Designated areas will be assigned to degree-of-shortage groups according to the following table, depending on the ratio (R
* Note: “gte” means “greater than or equal to”.
D. Determination of Size of Shortage. Size of Shortage (in number of FTE professionals needed) will be computed using the following formulas:
(1) For areas without unusually high need:
(2) For areas with unusually high need:
A. Criteria. Population groups within particular rational mental health service areas will be designated as having a mental health professional shortage if the following criteria are met:
1. Access barriers prevent the population group from using those core mental health professionals which are present in the area; and
2. One of the following conditions prevails:
(a) The ratio of the number of persons in the population group to the number of FTE core mental health professionals serving the population group is greater than or equal to 4,500:1 and the ratio of the number of persons in the population group to the number of FTE psychiatrists serving the population group is greater than or equal to 15,000:1; or,
(b) The ratio of the number of persons in the population group to the number of FTE core mental health professionals serving the population group is greater than or equal to 6,000:1; or,
(c) The ratio of the number of persons in the population group to the number of FTE psychiatrists serving the population group is greater than or equal to 20,000:1.
B. Determination of degree of shortage. Designated population groups will be assigned to the same degree-of-shortage groups defined in part I.C of this appendix for areas with unusually high needs for mental health services, using the computed ratio (R
C. Determination of size of shortage. Size of shortage will be computed as follows:
Medium to maximum security Federal and State correctional institutions and youth detention facilities will be designated as having a shortage of psychiatric manpower if both of the following criteria are met:
(a) The institution has more than 250 inmates, and
(b) The ratio of the number of internees per year to the number of FTE psychiatrists serving the institution is at least 1,000:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-stay are not specified, or if the information provided does not indicate that intake psychiatric examinations are routinely performed upon entry, then—
Number of internees=average number of inmates
(ii) If the average length-of-stay is specified as one year or more, and the intake psychiatric examinations are routinely performed upon entry, then—
Number internees=average number of inmates+number of new inmates per year
(iii) If the average length-of-stay is specified as less than one year, and intake psychiatric examinations are routinely performed upon entry, then—
Number of internees=average number of inmates+
where ALOS=average length-of-stay (in fraction of year) (The number of FTE psychiatrists is computed as in Part I, Section B, paragraph 3 above.)
Designated correctional institutions will be assigned to degree-of-shortage groups, based on the number of inmates and/or the ration (R) of internees to FTE psychiatrists, as follows:
Group 1—Institutions with 500 or more inmates and no psychiatrist.
Group 2—Other institutions with no psychiatrists and institutions with R greater than (or equal to) 3,000:1.
Group 3—Institutions with R greater than (or equal to) 2,000:1 but less than 3,000:1.
B. State and County Mental Hospitals.
1. Criteria.
A State or county hospital will be designated as having a shortage of psychiatric professional(s) if both of the following criteria are met:
(a) The mental hospital has an average daily inpatient census of at least 100; and
(b) The number of workload units per FTE psychiatrists available at the hospital exceeds 300, where workload units are calculated using the following formula:
Total workload units = average daily inpatient census + 2 × (number of inpatient admissions per year) + 0.5 × (number of admissions to day care and outpatient services per year).
2. Determination of Degree of Shortage.
State or county mental hospitals will be assigned to degree-of-shortage groups, based on the ratio (R) of workload units to number of FTE psychiatrists, as follows:
Group 1—No psychiatrists, or R>1,800.
Group 2—1,800>R>1,200.
Group 3—1,200>R>600.
Group 4—600>R>300.
C. Community Mental Health Centers and Other Public or Nonprofit Private Facilities.
1. Criteria.
A community mental health center (CMHC), authorized by Pub. L. 94-63, or other public or nonprofit private facility providing mental health services to an area or population group, may be designated as having a shortage of psychiatric professional(s) if the facility is providing (or is responsible for providing) mental health services to an area or population group designated as having a mental health professional(s) shortage, and the facility has insufficient capacity to meet the psychiatric needs of the area or population group.
2. Methodology.
In determining whether CMHCs or other public or nonprofit private facilities meet the criteria established in paragraph C.1 of this Part, the following methodology will be used.
(a) Provision of Services to a Designated Area or Population Group.
The facility will be considered to be providing services to a designated area or population group if either:
(i) A majority of the facility’s mental health services are being provided to residents of designated mental health professional(s) shortage areas or to population groups designated as having a shortage of mental health professional(s); or
(ii) The population within a designated psychiatric shortage area or population group has reasonable access to mental health services provided at the facility. Such reasonable access will be assumed if the population lies within 40 minutes travel time of the facility and nonphysical barriers (relating to demographic and socioeconomic characteristics of the population) do not prevent the population from receiving care at the facility.
(b) Responsibility for Provision of Services.
This condition will be considered to be met if the facility, by Federal or State statute, administrative action, or contractual agreement, has been given responsibility for providing and/or coordinating mental health services for the area or population group, consistent with applicable State plans.
(c) Insufficient capacity to meet mental health service needs. A facility will be considered to have insufficient capacity to meet the mental health service needs of the area or population it serves if:
(i) There are more than 1,000 patient visits per year per FTE core mental health professional on staff of the facility, or
(ii) There are more than 3,000 patient visits per year per FTE psychiatrist on staff of the facility, or
(iii) No psychiatrists are on the staff and this facility is the only facility providing (or responsible for providing) mental health services to the designated area or population.
3. Determination of Degree-of-Shortage.
Each designated facility will be assigned to the same degree-of-shortage group as the designated area or population group which it serves.
Appendix D to Part 5—Criteria for Designation of Areas Having Shortages of Vision Care Professional(s)
A. Criteria.
A geographic area will be designated as having a shortage of vision care professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of vision care services.
2. The estimated number of optometric visits supplied by vision care professional(s) in the area is less than the estimated requirements of the area’s population for these visits, and the computed shortage is at least 1,500 optometric visits.
3. Vision care professional(s) in contiguous areas are excessively distant, overutilized, or inaccessible to the population of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by paragraph A of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Vision Care Services.
(a) The following areas will be considered rational areas for the delivery of vision care services:
(i) A county, or a group of contiguous counties whose population centers are within 40 minutes travel time of each other;
(ii) A portion of a county (or an area made up of portions of more than one county) whose population, because of topography, market or transportation patterns, or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the distance corresponding to 40 minutes travel time.
2. Determination of Estimated Requirement for Optometric Visits.
The number of optometric visits required by an area’s population will be estimated by multiplying each of the following visit rates by the size of the population within that particular age group and then adding the figures obtained together.
| Age | Annual number of optometric visits required per person, by age | |||||
|---|---|---|---|---|---|---|
| Under 20 | 20-29 | 30-39 | 40-49 | 50-59 | 60 and over | |
| Number of visits | 0.11 | 0.20 | 0.24 | 0.35 | 0.41 | 0.48 |
For geographic areas where the age distribution of the population is not known, it will be assumed that the percentage distribution, by age groups, for the area is the same as the distribution for the county of which it is a part.
(3) Determination of Estimated Supply of Optometric Visits.
The estimated supply of optometric services will be determined by use of the following formula:
(4) Determination of Size of Shortage.
Size of shortage (in number of optometric visits) will be computed as follows:
Optometric visit shortage = visits required − visits supplied
(5) Contiguous Area Considerations.
Vision care professional(s) in area contiguous to an area being considered for designation will be considered execessively distant, overutilized or inaccessible to the population of the area if one of the following conditions prevails in each contiguous area:
(a) Vision care professional(s) in the contiguous area are more than 40 minutes travel time from the center of the area being considered for designation (measured in accordance with paragraph B.1(b) of this part).
(b) The estimated requirement for vision care services in the contiguous area exceeds the estimated supply of such services there, based on the requirements and supply calculations previously described.
(c) Vision care professional(s) in the contiguous area are inaccessible to the population of the area because of specified access barriers (such as economic or cultural barriers).
C. Determination of Degree-of-Shortage.
Designated areas (and population groups) will be assigned to degree-of-shortage groups, based on the ratio of optometric visits supplied to optometric visits required for the area (or group), as follows:
Group 1—Areas (or groups) with no optometric visits being supplied (i.e., with no optometrists or ophthalmologists).
Group 2—Areas (or groups) where the ratio of optometric visits supplied to optometric visits required is less than 0.5.
Group 3—Areas (or groups) where the ratio of optometric visits supplied to optometric visits required is between 0.5 and 1.0.
A. Criteria.
Population groups within particular geographic areas will be designated if both the following criteria are met:
(1) Members of the population group do not have access to vision care resources within the area (or in contiguous areas) because of non-physical access barriers (such as economic or cultural barriers).
(2) The estimated number of optometric visits supplied to the population group (as determined under paragraph B.3 of part I of this Appendix) is less than the estimated number of visits required by that group (as determined under paragraph B.2 of part I of this Appendix), and the computed shortage is at least 1,500 optometric visits.
B. Determination of Degree of Shortage.
The degree of shortage of a given population group will be determined in the same way as described for areas in paragraph C of part I of this appendix.
Appendix E to Part 5—Criteria for Designation of Areas Having Shortages of Podiatric Professional(s)
A. Criteria.
A geographic area will be designated as having a shortage of podiatric professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of podiatric services.
2. The area’s ratio of population to foot care practitioners is at least 28,000:1, and the computed podiatrist shortage to meet this ratio is at least 0.5.
3. Podiatric professional(s) in contiguous areas are overutilized, excessively distant, or inaccessible to the population of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by paragraph A of this Part, the following methodology will be used:
1. Rational Areas for the Delivery of Podiatric Services.
(a) The following areas will be considered rational areas for the delivery of podiatric services:
(i) A county or a group of contiguous counties whose population centers are within 40 minutes travel time of each other.
(ii) A portion of a county, or an area made up of portions of more than one county, whose population, because of topography, market and/or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes from its population center to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the area corresponding to 40 minutes travel time.
2. Population Count.
The population count used will be the total permanent resident civilian population of the area, excluding inmates of institutions, adjusted by the following formula to take into account the differing utilization rates of podiatric services by different age groups within the population:
3. Counting of Foot Care Practitioners.
(a) All podiatrists providing patient care will be counted. However, in order to take into account productivity differences in podiatric practices associated with the age of the podiatrists, the following formula will be utilized:
(b) In order to take into account the fact that orthopedic surgeons and general and family practitioners devote a percentage of their time to foot care, the total available foot care practitioners will be computed as follows:
4. Determination of Size of Shortage.
Size of shortage (in number of FTE podiatrists) will be computed as follows:
5. Contiguous Area Considerations.
Podiatric professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant, overutilized or inaccessible to the population of the area under consideration if one of the following conditions prevails in each contiguous area:
(a) Podiatric professional(s) in the contiguous area are more than 40 minutes travel time from the center of the area being considered for designation.
(b) The population-to-foot care practitioner ratio in the contiguous areas is in excess of 20,000:1, indicating that contiguous area podiatric professional(s) cannot be expected to help alleviate the shortage situation in the area for which designation is requested.
(c) Podiatric professional(s) in the contiguous area are inaccessible to the population of the area under consideration because of specified access barriers (such as economic or cultural barriers).
C. Determination of Degree of Shortage.
Designated areas will be assigned to groups, based on the ratio (R) of adjusted population to number of foot care practitioners, as follows:
Appendix F to Part 5—Criteria for Designation of Areas Having Shortages of Pharmacy Professional(s)
A. Criteria.
A geographic area will be designated as having a shortage of pharmacy professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of pharmacy services.
2. The number of pharmacists serving the area is less than the estimated requirement for pharmacists in the area, and the computed pharmacist shortage is at least 0.5.
3. Pharmacists in contiguous areas are overutilized or excessively distant from the population of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by paragraph A of this Part, the following methodology will be used:
1. Rational Areas for the Delivery of Pharmacy Services.
(a) The following areas will be considered rational areas for the delivery of pharmacy services:
(i) A county, or a group of contiguous counties whose population centers are within 30 minutes travel time of each other; and
(ii) A portion of a county, or an area made up of portions of more than one county, whose population, because of topography, market or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 30 minutes to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available: 20 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 15 miles.
(iii) In flat terrain or in areas connected by interstate highways: 25 miles.
Within inner portions of metropolitan areas, information on the public transportation system will be used to determine the area corresponding to 30 minutes travel time.
2. Counting of Pharmacists.
All active pharmacists within the area will be counted, except those engaged in teaching, administration, or pharmaceutical research.
3. Determination of Estimated Requirement for Pharmacists.
(a) Basic estimate. The basic estimated requirement for pharmacists will be calculated as follows:
(b) Adjusted estimate. For areas with less than 20,000 persons, the following adjustment is made to the basic estimate to compensate for the lower expected productivity of small practices.
4. Size of Shortage Computation.
The size of the shortage will be computed as follows:
5. Contiguous Area Considerations.
Pharmacists in areas contiguous to an area being considered for designation will be considered excessively distant or overutilized if either:
(a) Pharmacy professional(s) in contiguous areas are more than 30 minutes travel time from the center of the area under consideration, or
(b) The number of pharmacists in each contiguous area is less than or equal to the estimated requirement for pharmacists for that contiguous area (as computed above).
C. Determination of Degree-of-Shortage.
Designated areas will be assigned to degree-of-shortage groups, based on the proportion of the estimated requirement for pharmacists which is currently available in the area, as follows:
Group 1—Areas with no pharmacists.
Group 2—Areas where the ratio of available pharmacists to pharmacists required is less than 0.5.
Group 3—Areas where the ratio of available pharmacists to pharmacists required is between 0.5 and 1.0.
Appendix G to Part 5—Criteria for Designation of Areas Having Shortages of Veterinary Professional(s)
A. Criteria for Food Animal Veterinary Shortage.
A geographic area will be designated as having a shortage of food animal veterinary professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of veterinary services.
2. The ratio of veterinary livestock units to food animal veterinarians in the area is at least 10,000:1, and the computed food animal veterinarian shortage to meet this ratio is at least 0.5.
3. Food animal veterinarians in contiguous areas are overutilized or excessively distant from the population of the area under consideration.
B. Criteria for Companion Animal Veterinary Shortage.
A geographic area will be designated as having a shortage of companion animal veterinary professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of veterinary services.
2. The ratio of resident civilian population to number of companion animal veterinarians in the area is at least 30,000:1 and the computed companion animal veterinary shortage to meet this ratio is at least 0.5.
3. Companion animal veterinarians in contiguous areas are overutilized or excessively distant from the population of the area under consideration.
C. Methodology.
In determining whether an area meets the criteria established by paragraphs A and B of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Veterinary Services.
(a) The following areas will be considered rational areas for the delivery of veterinary services:
(i) A county, or a group of contiguous counties whose population centers are within 40 minutes travel time of each other.
(ii) A portion of a county (or an area made up of portions of more than one county) which, because of topography, market and/or transportation patterns or other factors, has limited access to contiguous area resources, as measured generally by a travel time of greater than 40 minutes to these resources.
(b) The following distances will be used as guidelines in determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways: 30 miles.
2. Determination of Number of Veterinary Livestock Units (VLU) Requiring Care.
Since various types of food animals require varying amounts of veterinary care, each type of animal has been assigned a weight indicating the amount of veterinary care it requires relative to that required by a milk cow. Those weights are used to compute the number of “Veterinary Livestock Units” (VLU) for which veterinary care is required.
The VLU is computed as follows:
3. Counting of Food Animal Veterinarians.
The number of food animal veterinarians is determined by weighting the number of veterinarians within each of several practice categories according to the average fraction of practice time in that category which is devoted to food animal veterinary care, as follows:
4. Counting of Companion Animal Veterinarians (that is, those who provide services for dogs, cats, horses, and any other animals maintained as companions to the owner rather than as food animals).
The number of full-time equivalent companion animal veterinarians is determined by weighting the number of veterinarians within each of several practice categories by the average portion of their practice which is devoted to companion animal care by the practitioners within that category, as follows:
5. Size of Shortage Computation.
The size of shortage will be computed as follows:
(a) Food animal veterinarian shortage = (VLU/10,000)−(number of food animal veterinarians).
(b) Companion animal veterinarian shortage = (resident civilian pop./30,000)−(number of companion animal veterinarians).
6. Contiguous Area Considerations.
Veterinary professional(s) in areas contiguous to an area being considered for designation will be considered excessively distant from the population of the area or overutilized if one of the following conditions prevails in each contiguous area:
(a) Veterinary professional(s) in the contiguous area are more than 60 minutes travel time from the center of the area being considered for designation (measured in accordance with paragraph C.1.(b) of this part).
(b) In the case of food animal veterinary professional(s), the VLU-to-food animal veterinarian ratio in the contiguous area is in excess of 5,000:1.
(c) In the case of companion animal veterinary professional(s), the population-to-companion animal veterinarian ratio in the contiguous area is in excess of 15,000:1.
C. Determination of Degree-of-Shortage.
Designated areas will be assigned to degree-of-shortage groups as follows:
Group 1—Areas with a food animal veterinarian shortage and no veterinarians.
Group 2—Areas (not included above) with a food animal veterinarian shortage and no food animal veterinarians.
Group 3—All other food animal veterinarian shortage areas.
Group 4—All companion animal shortage areas (not included above) having no veterinarians.
Group 5—All other companion animal shortage areas.
PART 6—FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS
§ 6.1 Applicability.
This part applies to entities and individuals whose acts and omissions related to the performance of medical, surgical, dental, or related functions are covered by the Federal Tort Claims Act (28 U.S.C. 1346(b) and 2671-2680) in accordance with the provisions of section 224(g) of the Public Health Service Act (42 U.S.C. 233(g)).
§ 6.2 Definitions.
Act means the Public Health Service Act, as amended.
Attorney General means the Attorney General of the United States and any other officer or employee of the Department of Justice to whom the authority involved has been delegated.
Covered entity means an entity described in § 6.3 which has been deemed by the Secretary, in accordance with § 6.5, to be covered by this part.
Covered individual means an individual described in § 6.4.
Effective date as used in § 6.5 and § 6.6 refers to the date of the Secretary’s determination that an entity is a covered entity.
Secretary means the Secretary of Health and Human Services (HHS) and any other officer or employee of the Department of HHS to whom the authority involved has been delegated.
Subrecipient means an entity which receives a grant or a contract from a covered entity to provide a full range of health services on behalf of the covered entity.
§ 6.3 Eligible entities.
(a) Grantees. Entities eligible for coverage under this part are public and nonprofit private entities receiving Federal funds under any of the following grant programs:
(1) Section 329 of the Act (relating to grants for migrant health centers);
(2) Section 330 of the Act (relating to grants for community health centers);
(3) Section 340 of the Act (relating to grants for health services for the homeless); and
(4) Section 340A of the Act (relating to grants for health services for residents of public housing).
(b) Subrecipients. Entities that are subrecipients of grant funds described in paragraph (a) of this section are eligible for coverage only if they provide a full range of health care services on behalf of an eligible grantee and only for those services carried out under the grant funded project.
§ 6.4 Covered individuals.
(a) Officers and employees of a covered entity are eligible for coverage under this part.
(b) Contractors of a covered entity who are physicians or other licensed or certified health care practitioners are eligible for coverage under this part if they meet the requirements of section 224(g)(5) of the Act.
(c) An individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of a covered entity will not be covered for acts or omissions occurring after receipt by the entity employing such individual of notice of a final determination by the Attorney General that he or she is no longer covered by this part, in accordance with section 224(i) of the Act.
§ 6.5 Deeming process for eligible entities.
Eligible entities will be covered by this part only on and after the effective date of a determination by the Secretary that they meet the requirements of section 224(h) of the Act. In making such determination, the Secretary will receive such assurances and conduct such investigations as he or she deems necessary.
§ 6.6 Covered acts and omissions.
(a) Only acts and omissions occurring on and after the effective date of the Secretary’s determination under § 6.5 and before the later date specified in section 224(g)(3) of the Act are covered by this part.
(b) Only claims for damage for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions are covered by this part.
(c) With respect to covered individuals, only acts and omissions within the scope of their employment (or contract for services) are covered. If a covered individual is providing services which are not on behalf of the covered entity, such as on a volunteer basis or on behalf of a third-party (except as described in paragraph (d) of this section), whether for pay or otherwise, acts and omissions which are related to such services are not covered.
(d) Only acts and omissions related to the grant-supported activity of entities are covered. Acts and omissions related to services provided to individuals who are not patients of a covered entity will be covered only if the Secretary determines that:
(1) The provision of the services to such individuals benefits patients of the entity and general populations that could be served by the entity through community-wide intervention efforts within the communities served by such entity;
(2) The provision of the services to such individuals facilitates the provision of services to patients of the entity; or
(3) Such services are otherwise required to be provided to such individuals under an employment contract or similar arrangement between the entity and the covered individual.
(e) Examples. The following are examples of situations within the scope of paragraph (d) of this section:
(1) A community health center deemed to be a covered entity establishes a school-based or school-linked health program as part of its grant supported activity. Even though the students treated are not necessarily registered patients of the center, the center and its health care practitioners will be covered for services provided, if the Secretary makes the determination in paragraph (d)(1) of this section.
(2) A migrant health center requires its physicians to obtain staff privileges at a community hospital. As a condition of obtaining such privileges, and thus being able to admit the center’s patients to the hospital, the physicians must agree to provide occasional coverage of the hospital’s emergency room. The Secretary would be authorized to determine that this coverage is necessary to facilitate the provision of services to the grantee’s patients, and that it would therefore be covered by paragraph (d)(2) of this section.
(3) A homeless health services grantee makes arrangements with local community providers for after-hours coverage of its patients. The grantee’s physicians are required by their employment contracts to provide periodic cross-coverage for patients of these providers, in order to make this arrangement feasible. The Secretary may determine that the arrangement is within the scope of paragraph (d)(3) of this section.
(4) For the specific activities described in this paragraph (e)(4), when carried out by an entity (and its eligible personnel) that has been covered under paragraph (c) of this section, the Department has determined that coverage is provided under paragraph (d) of this section, without the need for specific application for an additional coverage determination under paragraph (d) of this section, if the activity or arrangement in question fits squarely within these descriptions; otherwise, the health center should seek a particularized determination of coverage.
(i) Community-Wide Interventions. (A) School-Based Clinics: Health center staff provide primary and preventive health care services at a facility located in a school or on school grounds. The health center has a written affiliation agreement with the school.
(B) School-Linked Clinics: Health center staff provide primary and preventive health care services, at a site not located on school grounds, to students of one or more schools. The health center has a written affiliation agreement with each school.
(C) Health Fairs: On behalf of the health center, health center staff conduct or participate in an event to attract community members for purposes of performing health assessments. Such events may be held in the health center, outside on its grounds, or elsewhere in the community.
(D) Immunization Campaigns: On behalf of the health center, health center staff conduct or participate in an event to immunize individuals against infectious illnesses. The event may be held at the health center, schools, or elsewhere in the community.
(E) Migrant Camp Outreach: Health center staff travel to a migrant farmworker residence camp to conduct intake screening to determine those in need of clinic services (which may mean health care is provided at the time of such intake activity or during subsequent clinic staff visits to the camp).
(F) Homeless Outreach: Health center staff travel to a shelter for homeless persons, or a street location where homeless persons congregate, to conduct intake screening to determine those in need of clinic services (which may mean health care is provided at the time of such intake activity or during subsequent clinic staff visits to that location).
(ii) Hospital-Related Activities. Periodic hospital call or hospital emergency room coverage is required by the hospital as a condition for obtaining hospital admitting privileges. There must also be documentation for the particular health care provider that this coverage is a condition of employment at the health center.
(iii) Coverage-Related Activities. As part of a health center’s arrangement with local community providers for after-hours coverage of its patients, the health center’s providers are required by their employment contract to provide periodic or occasional cross-coverage for patients of these providers.
(iv) Coverage in Certain Individual Emergencies. A health center provider is providing or undertaking to provide covered services to a health center patient within the approved scope of project of the center, or to an individual who is not a patient of the health center under the conditions set forth in this rule, when the provider is then asked, called upon, or undertakes, at or near that location and as the result of a non-health center patient’s emergency situation, to temporarily treat or assist in treating that non-health center patient. In addition to any other documentation required for the original services, the health center must have documentation (such as employee manual provisions, health center bylaws, or an employee contract) that the provision of individual emergency treatment, when the practitioner is already providing or undertaking to provide covered services, is a condition of employment at the health center.
PART 7—DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS
§ 7.1 Applicability.
The provisions of this part are applicable to private entities requesting from the Centers for Disease Control and Prevention (CDC) reference biological Standards and Biological preparations for use in their laboratories.
§ 7.2 Establishment of a user charge.
Except as otherwise provided in § 7.6, a user charge shall be imposed to cover the cost to CDC of producing and distributing reference biological standards and biological preparations.
§ 7.3 Definitions.
Biological standards means a uniform and stable reference biological substance which allows measurements of relative potency to be made and described in a common currency of international and national units of activity.
Biological preparations means a reference biological substance which may be used for a purpose similar to that of a standard, but which has been established without a full collaborative study, or where a collaborative study has shown that it is not appropriate to establish the preparation as an international standard.
§ 7.4 Schedule of charges.
The charges imposed in § 7.2 are based on the amount published in CDC’s price list of available products. These changes will reflect direct costs (such as salaries and equipment), indirect costs (such as rent, telephone service, and a proportionate share of management and administrative costs), and the cost of particular ingredients. Charges may vary over time and between different biological standards or biological preparations, depending upon the cost of ingredients and the complexity of production. An up-to-date schedule of charges is available from the Division of Scientific Resources, Centers for Disease Control, 1600 Clifton Road NE., MS C-17, Atlanta, Georgia, 30333 or 404-639-3466.
§ 7.5 Payment procedures.
An up-to-date fee schedule and instructions for terms of payment are available from the Division of Scientific Resources, Centers for Disease Control and Prevention, 1600 Clifton Road, MS C-17, Atlanta, Georgia 30333 or 404-639-3466. Any changes in the fee schedule will be published in the
§ 7.6 Exemptions.
State and local health departments, governmental institutions (e.g., State hospitals and universities), the World Health Organization, and ministries of health of foreign governments may be exempted from paying user charges, when using biological standards or biological preparations for public health purposes.
PART 8—MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER
Subpart A—General Provisions
§ 8.1 Scope.
(a) Scope. This subpart and subparts B through D of this part establish the procedures by which the Secretary of Health and Human Services (the Secretary) will determine whether an applicant seeking to become an Opioid Treatment Program (OTP) is qualified under section 303(h) of the Controlled Substances Act (CSA) (21 U.S.C. 823(h)) to dispense Medications for Opioid Use Disorder (MOUD) in the treatment of Opioid Use Disorder (OUD), and establishes the Secretary’s standards regarding the appropriate quantities of MOUD that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(h)). Under this subpart and subparts B through D, an applicant seeking to become an OTP must first obtain from the Secretary or, by delegation, from the Assistant Secretary for Mental Health and Substance Use, a certification that the applicant is qualified under the Secretary’s standards and will comply with such standards. Eligibility for certification will depend upon the applicant obtaining accreditation from an Accreditation Body that has been approved by the Secretary. This subpart and subparts B through D also establish the procedures whereby an entity can apply to become an approved Accreditation Body, and the requirements and general standards for Accreditation Bodies to ensure that OTPs are consistently evaluated for compliance with the Secretary’s standards for treatment of OUD with MOUD.
(b) Severability. Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, shall be construed so as to give it the maximum effect permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event such provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.
§thnsp;8.2 Definitions.
The following definitions apply to this part:
Accreditation Body or “the Body” means an organization that has been approved by the Secretary in this part to accredit OTPs dispensing MOUD.
Accreditation Body application means the application filed with the Secretary for purposes of obtaining approval as an Accreditation Body, as described in § 8.3(b).
Accreditation elements mean the elements or standards that are developed and adopted by an Accreditation Body and approved by the Secretary.
Accreditation survey means an onsite or virtual review and evaluation of an OTP by an Accreditation Body for the purpose of determining compliance with the Federal opioid use disorder treatment standards described in § 8.12.
Accredited OTP means an OTP that is the subject of a current, valid accreditation from an Accreditation Body approved by the Secretary under § 8.3(d).
Behavioral health services means any intervention carried out in a therapeutic context at an individual, family, or group level. Interventions may include structured, professionally administered clinical interventions (e.g., cognitive behavior therapy or insight-oriented psychotherapy) delivered in-person, or remotely via telehealth or telemedicine, which has been shown to facilitate treatment outcomes, or non-clinical interventions.
Care plan means an individualized treatment and/or recovery plan that outlines attainable treatment goals that have been identified and agreed upon between the patient and the OTP clinical team, and which specifies the services to be provided, as well as the proposed frequency and schedule for their provision.
Certification means the process by which the Secretary determines that an OTP is qualified to provide OUD treatment under the Federal Opioid Use Disorder treatment standards.
Certification application means the application filed by an OTP for purposes of obtaining certification from the Secretary, as described in § 8.11(b).
Certified opioid treatment program means an OTP that is the subject of a current, valid certification under § 8.11.
Comprehensive treatment is treatment that includes the continued use of MOUD provided in conjunction with an individualized range of appropriate harm reduction, medical, behavioral health, and recovery support services.
Conditional certification is a type of temporary certification granted to an OTP that has requested renewal of its certification and that has received temporary accreditation for one year by an approved Accreditation Body. The one-year accreditation period is to allow the OTP to address areas of significant non-conformance with accreditation standards that do not involve immediate, high-risk health and/or safety concerns.
Continuous medication treatment means the uninterrupted treatment for OUD involving the dispensing and administration of MOUD at stable dosage levels for a period in excess of 21 days.
Dispense means to deliver a controlled medication to an ultimate user by, or pursuant to, the lawful order of, a practitioner, including the prescribing and administering of a controlled medication.
Diversion control plan means a set of documented procedures that reduce the possibility that controlled medications will be transferred or otherwise shared with others to whom the medication was not prescribed or dispensed.
Federal Opioid Use Disorder treatment standards means the standards established by the Secretary in § 8.12 that are used to determine whether an OTP is qualified to engage in OUD treatment. The Federal Opioid Use Disorder treatment standards established in § 8.12 also include the standards established by the Secretary regarding the quantities of MOUD which may be provided for unsupervised, take-home use.
For-cause inspection means an inspection, by the Secretary, an Accreditation Body, or a State authority, of an OTP that may be operating in violation of Federal Opioid Use Disorder treatment standards, may be providing substandard treatment, may be serving as a possible source of diverted medications, or where patient well-being is at risk.
Harm reduction refers to practical and legal evidence-based strategies, including: overdose education; testing and intervention for infectious diseases, including counseling and risk mitigation activities forming part of a comprehensive, integrated approach to address human immunodeficiency virus (HIV), viral hepatitis, sexually transmitted infections, and bacterial and fungal infections; distribution of opioid overdose reversal medications; linkage to other public health services; and connecting those who have expressed interest in additional support to peer services.
Individualized dose means the dose of a medication for opioid use disorder, ordered by an OTP practitioner and dispensed to a patient, that sufficiently suppresses opioid withdrawal symptoms. Individualized doses may also include split doses of a medication for opioid use disorder, where such dosing regimens are indicated.
Interim treatment means that on a temporary basis, a patient may receive some services from an OTP, while awaiting access to more comprehensive treatment services. The duration of interim treatment is limited to 180 days.
Long-term care facilities mean those facilities that provide rehabilitative, restorative, and/or ongoing services to those in need of assistance with activities of daily living. Long-term care facilities include: extended acute care facilities; rehabilitation centers; skilled nursing facilities; permanent supportive housing; assisted living facilities; and chronic care hospitals.
Medical director means a physician, licensed to practice medicine in the jurisdiction in which the OTP is located, who assumes responsibility for all medical and behavioral health services provided by the program, including their administration. A medical director may delegate specific responsibilities to authorized program physicians, appropriately licensed non-physician practitioners with prescriptive authority functioning under the medical director’s supervision, or appropriately licensed and/or credentialed non-physician healthcare professionals providing services in the OTP, in compliance with applicable Federal and State laws. Such delegations will not eliminate the medical director’s responsibility for all medical and behavioral health services provided by the OTP.
Medication for Opioid Use Disorder or MOUD means medications, including opioid agonist medications, approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), for use in the treatment of OUD. As used in this part, “continuous medication treatment” is intended to be synonymous with the term “maintenance” treatment as used in 21 U.S.C. 823(h)(1), and the term “withdrawal management” is intended to be synonymous with the term “detoxification” as used in 21 U.S.C. 823(h)(1).
Medication unit means an entity that is established as part of, but geographically separate from, an OTP from which appropriately licensed OTP practitioners, contractors working on behalf of the OTP, or community pharmacists may dispense or administer MOUD, collect samples for drug testing or analysis, or provide other OTP services. Medication units can be a brick-and-mortar location or mobile unit.
Nationally recognized evidence-based guidelines mean a document produced by a national or international medical professional association, public health agency, such as the World Health Organization, or governmental body with the aim of assuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions for the management of OUD and other health conditions that are widely recognized within the United States.
Opioid Treatment Program or OTP means a program engaged in OUD treatment of individuals with MOUD registered under 21 U.S.C. 823(h)(1).
Opioid Treatment Program certification means the process by which the Secretary determines that an OTP applicant is qualified to provide Opioid Use Disorder treatment under the Federal Opioid Use Disorder treatment standards described in § 8.12.
Opioid Use Disorder means a cluster of cognitive, behavioral, and physiological symptoms associated with a problematic pattern of opioid use that continues despite clinically significant impairment or distress within a 12-month period.
Opioid Use Disorder treatment means the dispensing of MOUD, along with the provision of a range of medical and behavioral health services, as clinically necessary and based on an individualized assessment and a mutually agreed-upon care plan, to an individual to alleviate the combination of adverse medical, psychological, or physical effects associated with an OUD.
Patient, for purposes of this part, means any individual who receives continuous treatment or withdrawal management in an OTP.
Physical and behavioral health services include services such as medical and psychiatric screening, assessments, evaluations, examinations, and interventions, counseling, health education, peer support services, and social services (e.g., vocational and educational guidance, employment training), that are intended to help patients receiving care in OTPs achieve and sustain remission and recovery.
Practitioner, for purposes of this part, means a health care professional who is appropriately licensed by a State to prescribe and/or dispense medications for opioid use disorders and, as a result, is authorized to practice within an OTP.
Program sponsor means the person named in the application for certification described in § 8.11(b) as responsible for the operation of the OTP and who assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, behavioral health, or social services at the program or any of its medication units. The program sponsor need not be a licensed physician but shall ensure that an actively licensed physician occupies the position of medical director within an OTP.
Recovery support services means:
(1) Recovery is the process of change through which people improve their health and wellness, live self-directed lives, and strive to reach their full potential.
(2) Recovery support services can include, but are not limited to, community-based recovery housing, peer recovery support services, social support, linkage to and coordination among allied service providers and a full range of human services that facilitate recovery and wellness contributing to an improved quality of life. The services extend the continuum of care by strengthening and complementing substance use disorder (SUD) treatment interventions in different settings and stages.
Split dosing means dispensing of a single dose of MOUD as separate portions to be taken within a 24-hour period. Split dosing is indicated among, but not limited to, those patients who: possess a genetic variant which increases methadone metabolism; concurrently take other medications or drink alcohol that also induce hepatic enzymes leading to more rapid metabolism of methadone; who are pregnant; or for whom methadone or buprenorphine are being used to treat a concurrent pain indication in addition to the diagnosis of OUD. This leads to more stable, steady-state medication levels.
State Opioid Treatment Authority (SOTA) is the agency designated by the Governor of a State, or other appropriate official designated by the Governor, to exercise the responsibility and authority within the State or Territory for governing the treatment of OUD with MOUD in OTPs.
Telehealth or telemedicine, for purposes of this part, is the delivery and facilitation of health and health-related services including medical care, counseling, practitioner, provider and patient education, health information services, and self-care via telecommunications and digital communication technologies. This includes Health Insurance Portability and Accountability Act (HIPAA)-compliant video and audio-only communication platforms.
Withdrawal management means the dispensing of a MOUD in decreasing doses to an individual to alleviate adverse physical effects incident to withdrawal from the continuous or sustained use of an opioid and as a method of bringing the individual to an opioid-free state within such period. Long-term withdrawal management refers to the process of medication tapering that exceeds 30 days.
Subpart B—Accreditation of Opioid Treatment Programs
§ 8.3 Application for approval as an Accreditation Body.
(a) Eligibility. Private nonprofit organizations, State or territorial governmental entities, or political subdivisions thereof, and Indian Tribes as defined by the Federally Recognized Indian Tribe List Act of 1994, that are capable of meeting the requirements of this part may apply for approval as an Accreditation Body.
(b) Application for initial approval. Electronic copies of an Accreditation Body application form [SMA-167] shall be submitted to: https://dpt2.samhsa.gov/sma163/. Accreditation Body applications shall include the following information and supporting documentation:
(1) Name, address, and telephone number of the applicant and a responsible official for the Accreditation Body. The application shall be signed by the responsible official;
(2) Evidence of the nonprofit status of the applicant (i.e., of fulfilling Internal Revenue Service requirements as a nonprofit organization) if the applicant is not a State or territorial governmental entity, Indian Tribe, or political subdivision;
(3) A set of the accreditation elements or standards and a detailed discussion showing how the proposed accreditation elements or standards will ensure that each OTP surveyed by the applicant is qualified to meet or is meeting each of the Federal opioid use disorder treatment standards set forth in § 8.12;
(4) A detailed description of the applicant’s decision-making process, including:
(i) Procedures for initiating and performing onsite accreditation surveys of OTPs;
(ii) Procedures for assessing OTP personnel qualifications;
(iii) Copies of an application for accreditation, guidelines, instructions, and other materials the applicant will send to OTPs during the accreditation process, including a request for a complete history of prior accreditation activities and a statement that all information and data submitted in the application for accreditation is true and accurate, and that no material fact has been omitted;
(iv) Policies and procedures for notifying OTPs and the Secretary of deficiencies, for monitoring corrections of deficiencies by OTPs and for reporting corrections to the Secretary;
(v) Policies and procedures for determining OTPs level of adherence to this part and Accrediting Body standards and level of accreditation;
(vi) Policies and procedures for suspending or revoking an OTP’s accreditation;
(vii) Policies and procedures that will ensure processing of applications for accreditation and applications for renewal of accreditation within a timeframe approved by the Secretary; and
(viii) A description of the applicant’s appeals process to allow OTPs to contest adverse accreditation decisions;
(5) Policies and procedures established by the Accreditation Body to avoid conflicts of interest, or the appearance of conflicts of interest, by the applicant’s board members, commissioners, professional personnel, consultants, administrative personnel, and other representatives;
(6) A description of the education, experience, and training requirements for the applicant’s professional staff, accreditation survey team membership, and the identification of at least one licensed physician with experience treating OUD with MOUD on the applicant’s staff;
(7) A description of the applicant’s survey team training policies;
(8) Fee schedules, with supporting cost data;
(9) Satisfactory assurances that the Body will comply with the requirements of § 8.4, including a contingency plan for investigating complaints under § 8.4(e);
(10) Policies and procedures established to protect confidential information the applicant will collect or receive in its role as an Accreditation Body; and
(11) Any other supporting information the Secretary may require.
(c) Application for renewal of approval. An Accreditation Body that intends to continue to serve as an Accreditation Body beyond its current term shall apply to the Secretary for renewal, or notify the Secretary of its intention not to apply for renewal, in accordance with the following procedures and schedule:
(1) At least 9 months before the date of expiration of an Accreditation Body’s term of approval, the Body shall inform the Secretary in writing of its intent to seek renewal.
(2) The Secretary will notify the applicant of the relevant information, materials, and supporting documentation required under paragraph (b) of this section that the applicant shall submit as part of the renewal procedure.
(3) At least 3 months before the date of expiration of the Accreditation Body’s term of approval, the applicant shall send to the Secretary electronically a renewal application containing the information, materials, and supporting documentation requested by the Secretary under paragraph (c)(2) of this section.
(4) An Accreditation Body that does not intend to renew its approval shall so notify the Secretary at least 9 months before the expiration of the Body’s term of approval.
(d) Rulings on applications for initial approval or renewal of approval. (1) The Secretary will grant an application for initial approval or an application for renewal of approval if it determines the applicant substantially meets the Accreditation Body requirements of this subpart.
(2) If the Secretary determines that the applicant does not substantially meet the requirements set forth in this subpart, the Secretary will notify the applicant of the deficiencies in the application and request that the applicant resolve such deficiencies within 90 days of receipt of the notice. If the deficiencies are resolved to the satisfaction of the Secretary within the 90-day time period, the Body will be approved as an Accreditation Body. If the deficiencies have not been resolved to the satisfaction of the Secretary within the 90-day time period, the application for approval as an Accreditation Body will be denied.
(3) If the Secretary does not reach a final decision on a renewal application before the expiration of an Accreditation Body’s term of approval, the approval will be deemed extended until the Secretary reaches a final decision, unless an Accreditation Body does not rectify deficiencies in the application within the specified time period, as required in paragraph (d)(2) of this section.
(e) Relinquishment of approval. An Accreditation Body that intends to relinquish its accreditation approval before expiration of the Body’s term of approval shall submit a letter of such intent to the Secretary, at the address in paragraph (b) of this section, at least 9 months before relinquishing such approval.
(f) Notification. An Accreditation Body that does not apply for renewal of approval, or is denied such approval by the Secretary, relinquishes its accreditation approval before expiration of its term of approval, or has its approval withdrawn, shall:
(1) Transfer copies of records and other related information as required by the Secretary to a location, including another Accreditation Body, and according to a schedule approved by the Secretary; and
(2) Notify, in a manner and time period approved by the Secretary, all OTPs accredited or seeking accreditation by the Body that the Body will no longer have approval to provide accreditation services.
(g) Term of approval. An Accreditation Body’s term of approval is for a period not to exceed 5 years.
(h) State, territorial, or Indian Tribe Accreditation Bodies. State, territorial, and Indian Tribe entities, including political subdivisions thereof, may establish organizational units that may act as Accreditation Bodies, provided such units meet the requirements of this section, are approved by the Secretary under this section, and have taken appropriate measures to prevent actual or apparent conflicts of interest, including cases in which State or Federal funds are used to support MOUD.
§ 8.4 Accreditation Body responsibilities.
(a) Accreditation surveys and for cause inspections. (1) Accreditation Bodies shall conduct routine accreditation surveys for initial accreditation, and then at least every three years to allow for renewal of certification.
(2) Accreditation Bodies must agree to conduct for-cause inspections upon the request of the Secretary.
(3) Accreditation decisions shall be fully consistent with the policies and procedures submitted as part of the approved Accreditation Body application.
(b) Response to noncompliant programs. (1) If an Accreditation Body receives or discovers information that suggests that an OTP is not meeting applicable accreditation or certification standards established or authorized under this part, or if a survey of the OTP by the Accreditation Body demonstrates that such standards are not being met, the Accreditation Body shall, within 60 days following discovery of the non-compliant condition(s) or applicable survey date:
(i) Provide written notice to the OTP that identifies each area of non-compliance, categorizes each non-compliant condition as either “minor” or “significant” as determined by the Accrediting Body, and requires the OTP to take corrective action to address the area(s) of non-compliance within a schedule, not to exceed 180 days, that the Accrediting Body deems appropriate based on the severity of the non-compliant conditions; and
(ii) Provide the Secretary with a copy of the written notice required under paragraph (b)(1)(i) of this section.
(2) Once an Accreditation Body provides an OTP with the notice described in paragraph (b)(1)(i) of this section, it shall verify the implementation of the corrective measures by the OTP within the specified schedule. Within 30 days following the last day of the specified schedule, the Accreditation Body shall provide written notice to the Secretary regarding whether the OTP has implemented the corrective measures.
(3) OTPs that are meeting the requirements of § 8.12, but are only required to correct minor non-compliant conditions shall be granted a three-year accreditation, beginning from the end date of the current and expiring accreditation period. Minor non-compliant conditions, found at the time of the survey that are not resolved, as determined by the Accreditation Body, within the OTP’s three-year accreditation period and that remain areas of non-compliance during the OTP’s subsequent three-year accreditation renewal survey, shall automatically be categorized as “significant” non-compliant conditions for purposes of the renewal survey and must be corrected in accordance with paragraph (b)(1)(i) of this section.
(4) OTPs that are required to correct significant non-compliant conditions shall be granted a one-year accreditation, beginning from the end date of the current and expiring accreditation period. An OTP’s accreditation must be revoked if it fails to correct significant non-compliant conditions within the schedule provided under paragraph (b)(1)(i) of this section. If an Accrediting Body verifies that an OTP has corrected the significant non-compliant conditions identified within the specified schedule, it shall extend the OTP’s accreditation period by an additional two years.
(5) In cases of severe non-compliance with the requirements of § 8.12 that pose immediate risks to patient health and safety, the Accreditation Body shall inform the OTP and Secretary within 48 hours and provide a detailed written report of the non-compliance within 5 business days. The Accreditation Body shall give the OTP 30 days from the date of the non-compliance report to correct the non-compliance issue(s). A follow-up survey shall be conducted by the Accreditation Body within 30 days of the expected correction date to ensure successful remediation. Should the OTP not rectify the non-compliance within the 30-day period, the Accreditation Body shall revoke the OTP’s accreditation. The Secretary will then make a decision regarding the OTP’s certification in accordance with the procedures under § 8.13.
(c) Recordkeeping. (1) Accreditation Bodies shall maintain, and make available as requested by the Secretary, records of their accreditation activities for at least 5 years from the creation of the record. Such records must contain sufficient detail to support each accreditation decision made by the Accreditation Body.
(2) Accreditation Bodies shall establish procedures to protect confidential information collected or received in their role as Accreditation Bodies that are consistent with, and that are designed to ensure compliance with, all Federal and State laws, including 42 CFR part 2.
(i) Information collected or received for the purpose of carrying out Accreditation Body responsibilities shall not be used for any other purpose or disclosed, other than to the Secretary or its duly designated representatives, unless otherwise required by law or with the consent of the OTP.
(ii) Nonpublic information that the Secretary shares with the Accreditation Body concerning an OTP shall not be further disclosed except with the written permission of the Secretary.
(d) Reporting. (1) Accreditation Bodies shall provide to the Secretary any documents and information requested by the Secretary within 5 days of receipt of the request.
(2) Accreditation Bodies shall submit a summary of the results of each accreditation survey to the Secretary within 90 days following the survey visit. Such summaries shall contain sufficient detail to justify the accreditation action taken.
(3) Accreditation Bodies shall provide the Secretary a list of each OTP surveyed, and the identity of all individuals involved in the conducting and reporting of survey results.
(4) Accreditation Bodies shall submit to the Secretary the name of each OTP for which the Accreditation Body accredits conditionally, denies, suspends, or revokes accreditation, and the basis for the action, within 48 hours of the action.
(5) Notwithstanding any reports made to the Secretary under paragraphs (d)(1) through (4) of this section, each Accreditation Body shall submit to the Secretary semiannually, on January 15 and July 15 of each calendar year, a report consisting of a summary of the results of each accreditation survey conducted in the past year. The summary shall contain sufficient detail to justify each accreditation action taken.
(6) All reporting requirements listed in this section shall be provided to the Secretary at the address specified in § 8.3(b).
(e) Complaint response. Accreditation Bodies shall have policies and procedures in place to respond to complaints received from the Secretary, patients, facility staff, and others within 5 business days from the receipt of the complaint. Accreditation Bodies shall also agree to notify the Secretary within 5 business days of receipt of a complaint from a patient, facility, staff or others, and to inform the Secretary of their response to the complaint.
(f) Modifications of accreditation elements. Accreditation Bodies shall obtain the Secretary’s written authorization prior to making any substantive (i.e., noneditorial) change in accreditation elements.
(g) Conflicts of interest. The Accreditation Body shall maintain and apply policies and procedures that the Secretary has approved in accordance with § 8.3 to reduce the possibility of actual conflict of interest, or the appearance of a conflict of interest, on the part of individuals who act on behalf of the Accreditation Body. Individuals who participate in accreditation surveys or otherwise participate in the accreditation decision or an appeal of the accreditation decision, as well as their spouses and minor children, shall not have a financial interest in the OTP that is the subject of the accreditation survey or decision.
(h) Accreditation teams. (1) An Accreditation Body survey team shall consist of healthcare professionals with expertise in OUD treatment. The Accreditation Body shall consider factors such as the size of the OTP, the anticipated number of survey non-compliance issues, and the OTP’s accreditation history in determining the composition of the team. At a minimum, survey teams shall consist of at least two healthcare professionals whose combined expertise includes:
(i) The dispensing and administration of medications subject to control under the Controlled Substances Act (21 U.S.C. 801 et seq.);
(ii) Medical issues relating to the dosing and administration of MOUD for the treatment of OUD;
(iii) Psychosocial counseling of individuals receiving OUD treatment; and
(iv) Organizational and administrative issues associated with OTPs.
(2) Members of the accreditation team must be able to recuse themselves at any time from any survey in which either they or the OTP believes there is an actual conflict of interest or the appearance of a conflict of interest. Conflict or perceived conflict of interest must be documented by the Accreditation Body and made available to the Secretary.
(i) Accreditation fees. Fees charged to OTPs for accreditation shall be reasonable. the Secretary generally will find fees to be reasonable if the fees are limited to recovering costs to the Accreditation Body, including overhead incurred. Accreditation Body activities that are not related to accreditation functions are not recoverable through fees established for accreditation.
(1) The Accreditation Body shall make public its fee structure, including those factors, if any, contributing to variations in fees for different OTPs.
(2) At the Secretary’s request, Accreditation Bodies shall provide to the Secretary financial records or other materials, in a manner specified by the Secretary, to assist in assessing the reasonableness of Accreditation Body fees.
§ 8.5 Periodic evaluation of Accreditation Bodies.
The Secretary will periodically evaluate the performance of Accreditation Bodies primarily by inspecting a selected sample of the OTPs accredited by the Accrediting Body, and by evaluating the Accreditation Body’s reports of surveys conducted, to determine whether the OTPs surveyed and accredited by the Accreditation Body are in compliance with applicable standards under this part. The evaluation will include a determination of whether there are major deficiencies in the Accreditation Body’s performance that, if not corrected, would warrant withdrawal of the approval of the Accreditation Body under § 8.6.
§ 8.6 Withdrawal of approval of Accreditation Bodies.
If the Secretary determines that an Accreditation Body is not in substantial compliance with this subpart, the Secretary shall take appropriate action as follows:
(a) Major deficiencies. If the Secretary determines that the Accreditation Body has a major deficiency, such as commission of fraud, material false statement, failure to perform a major accreditation function satisfactorily, or significant noncompliance with the requirements of this subpart, the Secretary shall withdraw approval of that Accreditation Body.
(1) In the event of a major deficiency, the Secretary shall notify the Accreditation Body of the agency’s action and the grounds on which the approval was withdrawn.
(2) An Accreditation Body that has lost its approval shall notify each OTP that has been accredited or is seeking accreditation that the Accreditation Body’s approval has been withdrawn. Such notification shall be made within a time period and in a manner approved by the Secretary.
(b) Minor deficiencies. If the Secretary determines that the Accreditation Body has minor deficiencies in the performance of an accreditation function, that are less serious or more limited than the types of deficiencies described in paragraph (a) of this section, the Secretary will notify the Body that it has 90 days to submit to the Secretary a plan of corrective action. The plan must include a summary of corrective actions and a schedule for their implementation. The Secretary may place the Body on probationary status for a period of time determined by the Secretary, or may withdraw approval of the Body if corrective action is not taken.
(1) If the Secretary places an Accreditation Body on probationary status, the Body shall notify all OTPs that have been accredited, or that are seeking accreditation, of the Accreditation Body’s probationary status within a time period and in a manner approved by the Secretary.
(2) Probationary status will remain in effect until such time as the Body can demonstrate to the satisfaction of the Secretary that it has successfully implemented or is implementing the corrective action plan within the established schedule, and the corrective actions taken have substantially eliminated all identified problems.
(3) If the Secretary determines that an Accreditation Body that has been placed on probationary status is not implementing corrective actions satisfactorily or within the established schedule, the Secretary may withdraw approval of the Accreditation Body. The Accreditation Body shall notify all OTPs that have been accredited, or are seeking accreditation, of the Accreditation Body’s loss of the Secretary’s approval within a time period and in a manner approved by the Secretary.
(c) Reapplication. (1) An Accreditation Body that has had its approval withdrawn may submit a new application for approval if the Body can provide information to the Secretary to establish that the problems that were grounds for withdrawal of approval have been resolved.
(2) If the Secretary determines that the new application demonstrates that the Body satisfactorily has addressed the causes of its previous unacceptable performance, the Secretary may reinstate approval of the Accreditation Body.
(3) The Secretary may request additional information or establish additional conditions that must be met before the Secretary approves the reapplication.
(4) The Secretary may refuse to accept an application from a former Accreditation Body whose approval was withdrawn because of fraud, material false statement, or willful disregard of public health.
(d) Hearings. An opportunity to challenge an adverse action taken regarding withdrawal of approval of an Accreditation Body shall be addressed through the relevant procedures set forth in subpart C of this part, except that the procedures in § 8.28 for expedited review of an immediate suspension would not apply to an Accreditation Body that has been notified under paragraph (a) or (b) of this section of the withdrawal of its approval.
Subpart C—Certification and Treatment Standards for Opioid Treatment Programs
§ 8.11 Opioid Treatment Program certification.
(a) General. (1) An OTP must be the subject of a current, valid certification from the Secretary to be considered qualified by the Secretary under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 823(h)(1)) to dispense MOUD in the treatment of OUD. An OTP must be determined to be qualified under section 303(g)(1) of the Controlled Substances Act, and must be determined to be qualified by the Attorney General under section 303(g)(1), to be registered by the Attorney General to dispense MOUD to individuals for treatment of OUD.
(2) To obtain certification from the Secretary, an OTP must meet the Federal Opioid Use Disorder treatment standards in § 8.12, must be the subject of a current, valid accreditation by an Accreditation Body or other entity designated by the Secretary and must comply with any other conditions for certification established by the Secretary.
(3) OTPs are expected to maintain certification with the Secretary and to comply with any other conditions for certification established by the Secretary. Certification shall be granted for a term not to exceed 3 years, except that certification may be renewed during the final certification year if the OTP applies for certification renewal in accordance with the steps outlined in paragraph (a)(4) of this section.
(4) OTPs which satisfy the criteria for certification under this section may apply for renewal of their certification. OTPs are expected to apply for certification renewal during the final year of the OTP’s certification period. OTPs should take steps to ensure that administrative tasks associated with renewal are completed before the OTP’s certification expires. OTPs may apply for certification renewal in accordance with the procedures as outlined in paragraph (b) of this section. If an OTP anticipates any delays in routine certification renewal, an extension may be requested by submitting to the Secretary a statement justifying the extension in accordance with paragraph (e) of this section.
(5) OTPs that are certified and are seeking certification renewal, and who have been granted accreditation for one year by an Accreditation Body as provided under § 8.4(b)(1)(iii), may receive a conditional certification for one year unless the Secretary determines that such conditional certification would adversely affect patient health. An OTP must obtain a standard 3-year certification, as described in paragraph (a)(3) of this section, within the 1-year conditional certification period. If standard accreditation is not obtained by the OTP within the 1-year conditional certification period, the OTP’s conditional certification will lapse, and the Attorney General will be notified that the OTP’s registration should be revoked.
(6) OTPs whose certification has expired, and who seek re-certification, will be considered “new” programs and will be required to apply for provisional certification in accordance with paragraph (d) of this section.
(b) Application for initial or renewal certifications and re-certification. Applications for certification must be submitted by the OTP using form SMA-162. The application for initial or renewal of certification shall include, as determined by the Secretary:
(1) A description of the current accreditation status of the OTP;
(2) A description of the organizational structure of the OTP;
(3) The names of the persons responsible for the OTP;
(4) The addresses of the OTP and of each medication unit or other facility under the of the OTP;
(5) The sources of funding for the OTP and the name and address of each governmental entity that provides such funding;
(6) A statement that the OTP will comply with the conditions of certification set forth in paragraph (g) of this section; and
(7) The application shall be signed by the program sponsor who shall certify that the information submitted in the application is truthful and accurate.
(8) Applications for re-certification shall include an explanation of why the OTP’s most recent certification expired and information regarding the schedule for an accreditation survey.
(c) Action on application. (1) Following the Secretary’s receipt of an application for certification of an OTP, and after consultation with the appropriate State authority regarding the qualifications of the applicant, the Secretary may grant the application for certification, or renew an existing certification, if the Secretary determines that the OTP has satisfied the requirements for certification or renewal of certification in this section.
(2) The Secretary may deny the application if the Secretary determines that:
(i) The application for certification is deficient in any respect;
(ii) The OTP will not be operated in accordance with the Federal Opioid Use Disorder treatment standards established under § 8.12;
(iii) The OTP will not permit an inspection or a survey to proceed, or will not permit in a timely manner access to relevant records or information; or
(iv) The OTP has made misrepresentations in obtaining accreditation or in applying for certification.
(3) Within 5 days after it reaches a final determination that an OTP meets the requirements for certification in this section, the Secretary will notify the Drug Enforcement Administration (DEA) that the OTP has been determined to be qualified to provide OUD treatment under section 303(g)(1) of the Controlled Substances Act.
(d) Provisional certification. New OTPs that have not received the Secretary’s certification previously, except as provided in paragraph (a)(6) of this section, who are applying for certification from the Secretary, and who have applied for accreditation with an Accreditation Body, are eligible to receive provisional certification for up to 1 year. To receive provisional certification, an OTP shall submit the information required by paragraph (b) of this section to the Secretary along with a statement identifying the Accreditation Body to which the OTP has applied for accreditation, the date on which the OTP applied for accreditation, the dates of any accreditation surveys that have taken place or are expected to take place, and the expected schedule for completing the accreditation process. Provisional certification for up to 1 year will be granted, following receipt of the information described in this paragraph (d), unless the Secretary determines that patient health would be adversely affected by the granting of provisional certification.
(e) Requirements for certification. (1) OTPs shall comply with all pertinent Federal and State laws and regulations. Nothing in this part is intended to limit the authority of State and, as appropriate, local governmental entities to regulate the use of MOUD in the treatment of OUD. The provisions of this section requiring compliance with requirements imposed by State law, or the submission of applications or reports required by the State authority, do not apply to OTPs operated directly by the Department of Veterans Affairs, the Indian Health Service, or any other department or agency of the United States.
(2) OTPs shall allow, in accordance with Federal controlled substances laws and Federal confidentiality laws, inspections and surveys by duly authorized employees of the Department of Health and Human Services (HHS) or Substance Abuse and Mental Health Services Administration (SAMHSA), by Accreditation Bodies, by the Drug Enforcement Administration (DEA), and by authorized employees of any other Federal governmental entity with legal authority to conduct inspections or surveys on an OTP’s premises.
(3) Disclosure of patient records maintained by an OTP is governed by the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164, and every program must comply with these regulations, as applicable. Records on the receipt, storage, and distribution of MOUD are also subject to inspection under Federal controlled substances laws and under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). Federally sponsored treatment programs are subject to applicable Federal confidentiality statutes.
(4) An OTP or medication unit or any part thereof, including any facility or any individual, shall permit a duly authorized employee of the Department of Health and Human Services or SAMHSA to have access to and to copy all records on the use of MOUD in accordance with the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164.
(5) OTPs shall notify the Secretary in writing within 3 weeks of any replacement or other change in the status of the program sponsor or medical director.
(6) OTPs shall comply with all regulations enforced by the DEA under 21 CFR chapter II and must be registered by the DEA before administering or dispensing MOUD.
(7) OTPs must operate in accordance with Federal Opioid Use Disorder treatment standards and approved accreditation elements.
(f) Conditions for interim treatment program approval. (1) Before an OTP may provide interim treatment, the OTP must receive the approval of both the Secretary and the SOTA of the State in which the OTP operates.
(2) Before the Secretary may grant such approval, the OTP must provide the Secretary with documentation from the SOTA of the State in which the OTP operates demonstrating that:
(i) Such officer does not object to the providing of interim treatment in the State;
(ii) The OTP seeking to provide such treatment is unable to provide access for patients in a comprehensive treatment program within a reasonable geographic area within 14 days of the time patients seek treatment for OUD;
(iii) The authorization of the OTP to provide interim treatment will not otherwise reduce the capacity of comprehensive treatment programs in the State to admit individuals (relative to the date on which such officer so certifies); and
(iv) OTPs providing interim treatment will arrange for each individual’s transfer to a comprehensive treatment program no later than 180 days from the date on which each individual first requested treatment. Individuals enrolled in interim treatment shall not be discharged without the approval of an OTP practitioner, who shall consider on-going and patient-centered treatment needs, which are to be documented in the patient record, while awaiting transfer to a comprehensive treatment program.
(3) The Secretary will provide notice to the OTP denying or approving the request to provide interim treatment. The OTP shall not provide such treatment until it has received such notice from the Secretary.
(g) Exemptions. An OTP may, at the time of application for certification or any time thereafter, request from the Secretary exemption from the regulatory requirements set forth under this section and § 8.12. An example of a case in which an exemption might be granted would be for a private practitioner who wishes to treat a limited number of patients in a non-metropolitan area with few physicians and no OUD treatment services geographically accessible, and requests exemption from some of the staffing and service standards. The OTP shall support the rationale for the exemption with thorough documentation, to be supplied in an appendix to the initial application for certification or in a separate submission. The Secretary will approve or deny such exemptions at the time of application, or any time thereafter, if appropriate. The Secretary shall consult with the appropriate State authority prior to taking action on an exemption request.
(h) Medication units, long-term care facilities and hospitals. (1) Certified OTPs may establish medication units that are authorized to dispense MOUD. Before establishing a medication unit, a certified OTP must notify the Secretary by submitting form SMA-162. The OTP must also comply with the provisions of 21 CFR part 1300 before establishing a medication unit. Medication units shall comply with all pertinent State laws and regulations. Medication units include both mobile and brick and mortar facilities.
(2) Specifically, any services that are provided in an OTP may be provided in the medication unit, assuming compliance with all applicable Federal, State, and local law, and the use of units that provide appropriate privacy and have adequate space.
(3) Certification as an OTP under this part is not required for the initiation or continuity of medication treatment or withdrawal management of a patient who is admitted to a hospital, long-term care facility, or correctional facility, that is registered with the Drug Enforcement Administration as a hospital/clinic, for the treatment of medical conditions other than OUD, and who requires treatment of OUD with methadone during their stay, when such treatment is permitted under applicable Federal law.
(i) The term “long-term care facility” is defined in § 8.2. Nothing in this section is intended to relieve hospitals, or long-term care facilities and correctional facilities that are registered with the Drug Enforcement Administration as a hospital/clinic, from their obligations to obtain appropriate registration from the Attorney General, under section 303(g) of the Controlled Substances Act. Treatment provided under this section should always comply with applicable Federal laws.
(ii) [Reserved]
§ 8.12 Federal Opioid Use Disorder treatment standards.
(a) General. OTPs must provide treatment in accordance with the standards in this section and must comply with these standards as a condition of certification.
(b) Administrative and organizational structure. (1) An OTP’s organizational structure and facilities shall be adequate to ensure quality patient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director. The program sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in this part.
(2) The medical director shall assume responsibility for all medical and behavioral health services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable Federal, State, and local laws and regulations.
(c) Continuous quality improvement. (1) An OTP must maintain current quality assurance and quality control plans that include, among other things, annual reviews of program policies and procedures and ongoing assessment of patient outcomes.
(2) An OTP must maintain a current “Diversion Control Plan” or “DCP” as part of its quality assurance program that contains specific measures to reduce the possibility of diversion of dispensed MOUD, and that assigns specific responsibility to the OTP providers and administrative staff for carrying out the diversion control measures and functions described in the DCP.
(d) Staff credentials. Each person engaged in the treatment of OUD must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. All practitioners and other licensed/certified health care providers, including counselors, must comply with the credentialing and maintenance of licensure and/or certification requirements of their respective professions.
(e) Patient admission criteria—(1) Comprehensive treatment. An OTP shall maintain current procedures designed to ensure that patients are admitted to treatment by qualified personnel who have determined, using accepted medical criteria, that: The person meets diagnostic criteria for a moderate to severe OUD; the individual has an active moderate to severe OUD, or OUD in remission, or is at high risk for recurrence or overdose. Such decisions must be appropriately documented in the patient’s clinical record. In addition, a health care practitioner shall ensure that each patient voluntarily chooses treatment with MOUD and that all relevant facts concerning the use of MOUD are clearly and adequately explained to the patient, and that each patient provides informed consent to treatment.
(2) Comprehensive treatment for persons under age 18. Except in States where State law grants persons under 18 years of age the ability to consent to OTP treatment without the consent of another, no person under 18 years of age may be admitted to OTP treatment unless a parent, legal guardian, or responsible adult designated by the relevant State authority consents in writing to such treatment.
(3) Withdrawal management. An OTP shall maintain current procedures that are designed to ensure that those patients who choose to taper from MOUD are provided the opportunity to do so with informed consent and at a mutually agreed-upon rate that minimizes taper-related risks. Such consent must be documented in the clinical record by the treating practitioner.
(f) Required services—(1) General. OTPs shall provide adequate medical, counseling, vocational, educational, and other screening, assessment, and treatment services to meet patient needs, with the combination and frequency of services tailored to each individual patient based on an individualized assessment and the patient’s care plan that was created after shared decision making between the patient and the clinical team. These services must be available at the primary facility, except where the program sponsor has entered into a documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients.
(2) Initial medical examination. (i) OTPs shall require each patient to undergo an initial medical examination. The initial medical examination is comprised of two parts:
(A) A screening examination to ensure that the patient meets criteria for admission and that there are no contraindications to treatment with MOUD; and
(B) A full history and examination, to determine the patient’s broader health status, with lab testing as determined to be required by an appropriately licensed practitioner. A patient’s refusal to undergo lab testing for co-occurring physical health conditions should not preclude them from access to treatment, provided such refusal does not have potential to negatively impact treatment with medications.
(ii) Assuming no contraindications, a patient may commence treatment with MOUD after the screening examination has been completed. Both the screening examination and full examination must be completed by an appropriately licensed practitioner. If the licensed practitioner is not an OTP practitioner, the screening examination must be completed no more than seven days prior to OTP admission. Where the examination is performed outside of the OTP, the written results and narrative of the examination, as well as available lab testing results, must be transmitted, consistent with applicable privacy laws, to the OTP, and verified by an OTP practitioner.
(iii) A full in-person physical examination, including the results of serology and other tests that are considered to be clinically appropriate, must be completed within 14 calendar days following a patient’s admission to the OTP. The full exam can be completed by a non-OTP practitioner, if the exam is verified by a licensed OTP practitioner as being true and accurate and transmitted in accordance with applicable privacy laws.
(iv) Serology testing and other testing as deemed medically appropriate by the licensed OTP practitioner based on the screening or full history and examination, drawn not more than 30 days prior to admission to the OTP, may form part of the full history and examination.
(v) The screening and full examination may be completed via telehealth for those patients being admitted for treatment at the OTP with either buprenorphine or methadone, if a practitioner or primary care provider, determines that an adequate evaluation of the patient can be accomplished via telehealth. When using telehealth, the following caveats apply:
(A) In evaluating patients for treatment with schedule II medications (such as Methadone), audio-visual telehealth platforms must be used, except when not available to the patient. When not available, it is acceptable to use audio-only devices, but only when the patient is in the presence of a licensed practitioner who is registered to prescribe (including dispense) controlled medications. The OTP practitioner shall review the examination results and order treatment medications as indicated.
(B) In evaluating patients for treatment with schedule III medications (such as Buprenorphine) or medications not classified as a controlled medication (such as Naltrexone), audio-visual or audio only platforms may be used. The OTP practitioner shall review the examination results and order treatment medications as indicated.
(3) Special services for pregnant patients. OTPs must maintain current policies and procedures that reflect the special needs and priority for treatment admission of patients with OUD who are pregnant. Pregnancy should be confirmed. Evidence-based treatment protocols for the pregnant patient, such as split dosing regimens, may be instituted after assessment by an OTP practitioner and documentation that confirms the clinical appropriateness of such an evidence-based treatment protocol. Prenatal care and other sex-specific services, including reproductive health services, for pregnant and postpartum patients must be provided and documented either by the OTP or by referral to appropriate healthcare practitioners. Specific services, including reproductive health services, for pregnant and postpartum patients must be provided and documented either by the OTP or by referral to appropriate healthcare practitioners.
(4) Initial and periodic physical and behavioral health assessment services. (i) Each patient admitted to an OTP shall be given a physical and behavioral health assessment, which includes but is not limited to screening for imminent risk of harm to self or others, within 14 calendar days following admission, and periodically by appropriately licensed/credentialed personnel. These assessments must address the need for and/or response to treatment, adjust treatment interventions, including MOUD, as necessary, and provide a patient-centered plan of care. The full, initial psychosocial assessment must be completed within 14 calendar days of admission and include preparation of a care plan that includes the patient’s goals and mutually agreed-upon actions for the patient to meet those goals, including harm reduction interventions; the patient’s needs and goals in the areas of education, vocational training, and employment; and the medical and psychiatric, psychosocial, economic, legal, housing, and other recovery support services that a patient needs and wishes to pursue. The care plan also must identify the recommended frequency with which services are to be provided. The plan must be reviewed and updated to reflect responses to treatment and recovery support services, and adjustments made that reflect changes in the context of the person’s life, their current needs for and interests in medical, psychiatric, social, and psychological services, and current needs for and interests in education, vocational training, and employment services.
(ii) The periodic physical examination should occur not less than one time each year and be conducted by an OTP practitioner. The periodic physical examination should include review of MOUD dosing, treatment response, other substance use disorder treatment needs, responses and patient-identified goals, and other relevant physical and psychiatric treatment needs and goals. The periodic physical examination should be documented in the patient’s clinical record.
(5) Counseling and psychoeducational services. (i) OTPs must provide adequate substance use disorder counseling and psychoeducation to each patient as clinically necessary and mutually agreed-upon, including harm reduction education and recovery-oriented counseling. This counseling shall be provided by a program counselor, qualified by education, training, or experience to assess the psychological and sociological background of patients, and engage with patients, to contribute to the appropriate care plan for the patient and to monitor and update patient progress. Patient refusal of counseling shall not preclude them from receiving MOUD.
(ii) OTPs must provide counseling on preventing exposure to, and the transmission of, human immunodeficiency virus (HIV), viral hepatitis, and sexually transmitted infections (STIs) and either directly provide services and treatments or actively link to treatment each patient admitted or readmitted to treatment who has received positive test results for these conditions from initial and/or periodic medical examinations.
(iii) OTPs must provide directly, or through referral to adequate and reasonably accessible community resources, vocational training, education, and employment services for patients who request such services or for whom these needs have been identified and mutually agreed-upon as beneficial by the patient and program staff.
(6) Drug testing services. When conducting random drug testing, OTPs must use drug tests that have received the Food and Drug Administration’s (FDA) marketing authorization for commonly used and misused substances that may impact patient safety, recovery, or otherwise complicate substance use disorder treatment, at a frequency that is in accordance with generally accepted clinical practice and as indicated by a patient’s response to and stability in treatment, but no fewer than eight random drug tests per year patient, allowing for extenuating circumstances at the individual patient level. This requirement does not preclude distribution of legal harm reduction supplies that allow an individual to test their personal drug supply for adulteration with substances that increase the risk of overdose.
(g) Recordkeeping and patient confidentiality. (1) OTPs shall establish and maintain a recordkeeping system that is adequate to document and monitor patient care. This system is required to comply with all Federal and State reporting requirements relevant to MOUD approved for use in treatment of OUD. All records are required to be kept confidential in accordance with all applicable Federal and State requirements.
(2) OTPs shall include, as an essential part of the recordkeeping system, documentation in each patient’s record that the OTP made a good faith effort to determine whether the patient is enrolled in any other OTP. A patient enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in circumstances involving an inability to access care at the patient’s OTP of record. Such circumstances include, but are not limited to, travel for work or family events, temporary relocation, or an OTP’s temporary closure. If the medical director or program practitioner of the OTP in which the patient is enrolled determines that such circumstances exist, the patient may seek treatment at another OTP, provided the justification for the particular circumstances are noted in the patient’s record both at the OTP in which the patient is enrolled and at the OTP that will provide the MOUD.
(h) Medication administration, dispensing, and use. (1) OTPs must ensure that MOUD are administered or dispensed only by a practitioner licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense MOUD, or by an agent of such a practitioner, supervised by and under the order of the licensed practitioner and if consistent with Federal and State law.
(2) OTPs shall use only those MOUD that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of OUD. In addition, OTPs who are fully compliant with the protocol of an investigational use of a drug and other conditions set forth in the application may administer a drug that has been authorized by the Food and Drug Administration under an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act for investigational use in the treatment of OUD. Currently the following MOUD will be considered to be approved by the Food and Drug Administration for use in the treatment of OUD:
(i) Methadone;
(ii) Buprenorphine and buprenorphine combination products that have been approved for use in the treatment of OUD; and
(iii) Naltrexone.
(3) OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial dosing requirements are met:
(i) Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral misuse.
(ii) For each new patient enrolled in an OTP, the initial dose of methadone shall be individually determined and shall include consideration of the type(s) of opioid(s) involved in the patient’s opioid use disorder, other medications or substances being taken, medical history, and severity of opioid withdrawal. The total dose for the first day should not exceed 50 milligrams unless the OTP practitioner, licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense MOUD, finds sufficient medical rationale, including but not limited to if the patient is transferring from another OTP on a higher dose that has been verified, and documents in the patient’s record that a higher dose was clinically indicated.
(4) OTPs shall maintain current procedures adequate to ensure that each MOUD used by the program is administered and dispensed in accordance with its FDA approved product labeling. The program must ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient’s record.
(i) Unsupervised or “take-home” medication doses. Unsupervised or “take-home” medication doses may be provided under the following circumstances:
(1) Any patient in comprehensive treatment may receive their individualized take-home doses as ordered for days that the clinic is closed for business, including one weekend day (e.g., Sunday) and State and Federal holidays, no matter their length of time in treatment.
(2) OTP decisions on dispensing MOUD to patients for unsupervised use beyond that set forth in paragraph (i)(1) of this section shall be determined by an appropriately licensed OTP medical practitioner or the medical director. In determining which patients may receive unsupervised medication doses, the medical director or program medical practitioner shall consider, among other pertinent factors that indicate that the therapeutic benefits of unsupervised doses outweigh the risks, the following criteria:
(i) Absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of patient harm as it relates to the potential for overdose, or the ability to function safely;
(ii) Regularity of attendance for supervised medication administration;
(iii) Absence of serious behavioral problems that endanger the patient, the public or others;
(iv) Absence of known recent diversion activity;
(v) Whether take-home medication can be safely transported and stored; and
(vi) Any other criteria that the medical director or medical practitioner considers relevant to the patient’s safety and the public’s health.
(3) Such determinations and the basis for such determinations consistent with the criteria outlined in paragraph (i)(2) of this section shall be documented in the patient’s medical record. If it is determined that a patient is safely able to manage unsupervised doses of MOUD, the dispensing restrictions set forth in paragraphs (i)(3)(i) through (iii) of this section apply. The dispensing restrictions set forth in paragraphs (i)(3)(i) through (iii) of this section do not apply to buprenorphine and buprenorphine products listed under paragraph (h)(2)(ii) of this section.
(i) During the first 14 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is limited to 7 days. It remains within the OTP practitioner’s discretion to determine the number of take-home doses up to 7 days, but decisions must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient’s clinical record, consistent with paragraph (g)(2) of this section.
(ii) From 15 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is limited to 14 days. It remains within the OTP practitioner’s discretion to determine the number of take-home doses up to 14 days, but this determination must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient’s clinical record, consistent with paragraph (g)(2) of this section.
(iii) From 31 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) provided to a patient is not to exceed 28 days. It remains within the OTP practitioner’s discretion to determine the number of take-home doses up to 28 days, but this determination must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient’s clinical record, consistent with paragraph (g)(2) of this section.
(4) OTPs must maintain current procedures adequate to identify the theft or diversion of take-home medications, including labeling containers with the OTP’s name, address, and telephone number. Programs also must ensure that each individual take-home dose is packaged in a manner that is designed to reduce the risk of accidental ingestion, including child-proof containers (see Poison Prevention Packaging Act, Pub. L. 91-601 (15 U.S.C. 1471 et seq.)). Programs must provide education to each patient on: Safely transporting medication from the OTP to their place of residence; and the safe storage of take-home doses at the individual’s place of residence, including child and household safety precautions. The provision of this education should be documented in the patient’s clinical record.
(j) Interim treatment. (1) The program sponsor of an OTP may admit an individual, who is eligible for admission to comprehensive treatment, into interim treatment if comprehensive services are not readily available within a reasonable geographic area and within 14 days of the individual’s seeking treatment. At least two drug tests shall be obtained from patients during the maximum of 180 days permitted for interim treatment. A program shall establish and follow reasonable criteria for establishing priorities for moving patients from interim to comprehensive treatment. These transition criteria shall be in writing and shall include, at a minimum, prioritization of pregnant patients in admitting patients to interim treatment and from interim to comprehensive treatment. Interim treatment shall be provided in a manner consistent with all applicable Federal and State laws, including sections 1923, 1927(a), and 1976 of the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11).
(2) The program shall notify the SOTA when a patient begins interim treatment, when a patient leaves interim treatment, and before the date of transfer to comprehensive services, and shall document such notifications.
(3) The Secretary may revoke the interim authorization for programs that fail to comply with the provisions of this paragraph (j). Likewise, the Secretary will consider revoking the interim authorization of a program if the State in which the program operates is not in compliance with the provisions of § 8.11(h).
(4) All requirements for comprehensive treatment apply to interim treatment with the following exceptions:
(i) A primary counselor is not required to be assigned to the patient, but crisis services, including shelter support, should be available;
(ii) Interim treatment cannot be provided for longer than 180 days in any 12-month period;
(iii) By day 120, a plan for continuing treatment beyond 180 days must be created, and documented in the patient’s clinical record; and
(iv) Formal counseling, vocational training, employment, economic, legal, educational, and other recovery support services described in paragraphs (f)(4) and (f)(5)(i) and (iii) of this section are not required to be offered to the patient. However, information pertaining to locally available, community-based resources for ancillary services should be made available to individual patients in interim treatment.
§ 8.13 Revocation of accreditation and Accreditation Body approval.
(a) The Secretary’s action following revocation of accreditation. If an Accreditation Body revokes an OTP’s accreditation, the Secretary may conduct an investigation into the reasons for the revocation. Following such investigation, the Secretary may determine that the OTP’s certification should no longer be in effect, at which time the Secretary will initiate procedures to revoke the program’s certification in accordance with § 8.14. Alternatively, the Secretary may determine that another action or combination of actions would better serve the public health, including the establishment and implementation of a corrective plan of action that will permit the certification to continue in effect while the OTP seeks reaccreditation.
(b) Accreditation Body approval. (1) If the Secretary withdraws the approval of an Accreditation Body under § 8.6, the certifications of OTPs accredited by such Body shall remain in effect for a period of 1 year after the date of withdrawal of approval of the Accreditation Body, unless the Secretary determines that to protect public health or safety, or because the Accreditation Body fraudulently accredited treatment programs, the certifications of some or all of the programs should be revoked or suspended or that a shorter time period should be established for the certifications to remain in effect. The Secretary may extend the time in which a certification remains in effect under this paragraph (b)(1) on a case-by-case basis.
(2) Within 1 year from the date of withdrawal of approval of an Accreditation Body, or within any shorter period of time established by the Secretary, OTPs currently accredited by the Accreditation Body must obtain accreditation from another Accreditation Body. The Secretary may extend the time period for obtaining reaccreditation on a case-by-case basis.
§ 8.14 Suspension or revocation of certification.
(a) Revocation. Except as provided in paragraph (b) of this section, the Secretary may revoke the certification of an OTP if the Secretary finds, after providing the program sponsor with notice and an opportunity for a hearing in accordance with this subpart, that the program sponsor, or any employee of the OTP:
(1) Has been found to have engaged in misrepresentation in obtaining the certification;
(2) Has failed to comply with the Federal Opioid Use Disorder treatment standards in any respect;
(3) Has failed to comply with reasonable requests from the Secretary or from an Accreditation Body for records, information, reports, or materials that are necessary to determine the continued eligibility of the OTP for certification or continued compliance with the Federal Opioid Use Disorder treatment standards; or
(4) Has refused a reasonable request of a duly designated inspector, Drug Enforcement Administration (DEA) Inspector, State Inspector, or Accreditation Body representative for permission to inspect the program or the program’s operations or its records.
(b) Suspension. Whenever the Secretary has reason to believe that revocation may be required and that immediate action is necessary to protect public health or safety, the Secretary may immediately suspend the certification of an OTP, and notify the Attorney General that the OTP’s registration should be suspended, before holding a hearing under this subpart. The Secretary may immediately suspend as well as propose revocation of the certification of an OTP before holding a hearing under this subpart if the Secretary makes a finding described in paragraph (a) of this section and also determines that:
(1) The failure to comply with the Federal Opioid Use Disorder treatment standards presents an imminent danger to the public health or safety;
(2) The refusal to permit inspection makes immediate suspension necessary; or
(3) There is reason to believe that the failure to comply with the Federal Opioid Use Disorder treatment standards was intentional or was associated with fraud.
(c) Written notification. In the event that the Secretary suspends the certification of an OTP in accordance with paragraph (b) of this section or proposes to revoke the certification of an OTP in accordance with paragraph (a) of this section, the Secretary shall promptly provide the sponsor of the OTP with written notice of the suspension or proposed revocation by facsimile transmission, personal service, commercial overnight delivery service, or certified mail, return receipt requested. Such notice shall state the reasons for the action, state that the OTP may seek review of the action in accordance with the procedures in this subpart, and identify the reviewing official to whom a written request for review may be submitted.
(d) Procedure. (1) If the Secretary suspends certification in accordance with paragraph (b) of this section:
(i) The Secretary will immediately notify DEA that the OTP’s registration should be suspended under 21 U.S.C. 824(d); and
(ii) the Secretary will provide an opportunity for a hearing under this subpart.
(2) Suspension of certification under paragraph (b) of this section shall remain in effect until the agency determines that:
(i) The basis for the suspension cannot be substantiated;
(ii) Violations of required standards have been corrected to the agency’s satisfaction; or
(iii) The OTP’s certification shall be revoked.
§ 8.15 Forms.
(a) SMA-162—Application for Certification to Use Medications for Opioid Use Disorder.
(b) SMA-163—Application for Becoming an Accreditation Body under § 8.3.
Subpart D—Procedures for Informal Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body
§ 8.21 Applicability.
The procedures in this subpart apply when:
(a) The Secretary has notified an OTP in writing that its certification under the regulations in subpart B of this part has been suspended or that the Secretary proposes to revoke the certification; and
(b) The OTP has, within 30 days of the date of the notification or within 3 days of the date of the notification when seeking an expedited review of a suspension, requested in writing to the reviewing official, an opportunity for an informal review of the suspension or proposed revocation.
(c) The Secretary has notified an Accreditation Body of an adverse action taken regarding withdrawal of approval of the Accreditation Body under the regulations in subpart A of this part; and
(d) The Accreditation Body has, within 30 days of the date of the notification, requested in writing an opportunity for a review of the adverse action.
§ 8.22 Definitions.
The following definitions apply to this subpart:
Appellant means:
(1) The OTP which has been notified of its suspension or proposed revocation of its certification under the regulations of this part and has requested a review of the suspension or proposed revocation; or
(2) The Accreditation Body which has been notified of adverse action regarding withdrawal of approval under the regulations of this subpart and has requested a review of the adverse action.
Respondent means SAMHSA.
Reviewing official means the person or persons designated by the Secretary who will informally review the suspension or proposed revocation. The reviewing official may be assisted by one or more Department of Health and Human Services (HHS) officers or employees or consultants in assessing and weighing the scientific and technical evidence and other information submitted by the appellant and respondent on the reasons for the suspension and proposed revocation.
§ 8.23 Limitation on issues subject to review.
The scope of this informal review shall be limited to the facts relevant to any suspension, or proposed revocation, or adverse action, the necessary interpretations of the facts, the regulations in this subpart, and other relevant law.
§ 8.24 Specifying who represents the parties.
The appellant’s request for an informal review shall specify the name, address, and phone number of the appellant’s representative. In its first written submission to the reviewing official, the respondent shall specify the name, address, and phone number of the respondent’s representative.
§ 8.25 Informal review and the reviewing official’s response.
(a) Request for review. Within 30 days of the date of the notice of the suspension or proposed revocation, the appellant must submit a written request to the reviewing official seeking review, unless some other time period is agreed to by the parties. A copy must also be sent to the respondent. The request for review must include a copy of the notice of suspension, proposed revocation, or adverse action, a brief statement of why the decision to suspend, propose revocation, or take an adverse action is incorrect, and the appellant’s request for an oral presentation, if desired.
(b) Acknowledgment. Within 5 days after receiving the request for review, the reviewing official will send an acknowledgment and advise the appellant of the next steps. The reviewing official will also send a copy of the acknowledgment to the respondent.
§ 8.26 Preparation of the review file and written arguments.
The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. The procedures for development of the review file and submission of written argument are:
(a) Appellant’s documents and brief. Within 30 days after receiving the acknowledgment of the request for review, the appellant shall submit to the reviewing official the following (with a copy to the respondent):
(1) A review file containing the documents supporting appellant’s argument, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages, explaining why respondent’s decision to suspend or propose revocation of appellant’s certification or to take adverse action regarding withdrawal of approval of the Accreditation Body is incorrect (appellant’s brief).
(b) Respondent’s documents and brief. Within 30 days after receiving a copy of the acknowledgment of the request for review, the respondent shall submit to the reviewing official the following (with a copy to the appellant):
(1) A review file containing documents supporting respondent’s decision to suspend or revoke appellant’s certification, or approval as an Accreditation Body, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in length, explaining the basis for suspension, proposed revocation, or adverse action (respondent’s brief).
(c) Reply briefs. Within 10 days after receiving the opposing party’s submission, or 20 days after receiving acknowledgment of the request for review, whichever is later, each party may submit a short reply not to exceed 10 double-spaced pages.
(d) Cooperative efforts. Whenever feasible, the parties should attempt to develop a joint review file.
(e) Excessive documentation. The reviewing official may take any appropriate steps to reduce excessive documentation, including the return of or refusal to consider documentation found to be irrelevant, redundant, or unnecessary.
(f) Discovery. The use of interrogatories, depositions, and other forms of discovery shall not be allowed.
§ 8.27 Opportunity for oral presentation.
(a) Electing oral presentation. If an opportunity for an oral presentation is desired, the appellant shall request it at the time it submits its written request for review to the reviewing official. The reviewing official will grant the request if the official determines that the decision-making process will be substantially aided by oral presentations and arguments. The reviewing official may also provide for an oral presentation at the official’s own initiative or at the request of the respondent.
(b) Presiding official. The reviewing official or designee will be the presiding official responsible for managing the oral presentations.
(c) Preliminary conference. The presiding official may hold a prehearing conference (usually a telephone conference call) to consider any of the following: Simplifying and clarifying issues; stipulations and admissions; limitations on evidence and witnesses that will be presented at the hearing; time allotted for each witness and the hearing altogether; scheduling the hearing; and any other matter that will assist in the review process. Normally, this conference will be conducted informally and off the record; however, the presiding official may, at the presiding official’s discretion, produce a written document summarizing the conference or transcribe the conference.
(d) Time and place of oral presentation. The presiding official will attempt to schedule the oral presentation within 45 days of the date appellant’s request for review is received or within 15 days of submission of the last reply brief, whichever is later. The oral presentation will be held at a time and place determined by the presiding official following consultation with the parties.
(e) Conduct of the oral presentation—(1) General. The presiding official is responsible for conducting the oral presentation. The presiding official may be assisted by one or more HHS officers or employees or consultants in conducting the oral presentation and reviewing the evidence. While the oral presentation will be kept as informal as possible, the presiding official may take all necessary steps to ensure an orderly proceeding.
(2) Burden of proof/standard of proof. In all cases, the respondent bears the burden of proving by a preponderance of the evidence that its decision to suspend, propose revocation, or take adverse action is appropriate. The appellant, however, has a responsibility to respond to the respondent’s allegations with evidence and argument to show that the respondent is incorrect.
(3) Admission of evidence. The rules of evidence do not apply, and the presiding official will generally admit all testimonial evidence unless it is clearly irrelevant, immaterial, or unduly repetitious. Each party may make an opening and closing statement, may present witnesses as agreed upon in the pre-hearing conference or otherwise, and may question the opposing party’s witnesses. Since the parties have ample opportunity to prepare the review file, a party may introduce additional documentation during the oral presentation only with the permission of the presiding official. The presiding official may question witnesses directly and take such other steps necessary to ensure an effective and efficient consideration of the evidence, including setting time limitations on direct and cross-examinations.
(4) Motions. The presiding official may rule on motions including, for example, motions to exclude or strike redundant or immaterial evidence, motions to dismiss the case for insufficient evidence, or motions for summary judgment. Except for those made during the hearing, all motions and opposition to motions, including argument, must be in writing and be no more than 10 double-spaced pages in length. The presiding official will set a reasonable time for the party opposing the motion to reply.
(5) Transcripts. The presiding official shall have the oral presentation transcribed. Either party may request a copy of the transcript and the requesting party shall be responsible for paying for its copy of the transcript.
(f) Obstruction of justice or making of false statements. Obstruction of justice or the making of false statements by a witness or any other person may be the basis for a criminal prosecution under 18 U.S.C. 1001 or 1505.
(g) Post-hearing procedures. At the presiding official’s discretion, the presiding official may require or permit the parties to submit post-hearing briefs or proposed findings and conclusions. Each party may submit comments on any major prejudicial errors in the transcript.
§ 8.28 Expedited procedures for review of immediate suspension.
(a) Applicability. When the Secretary notifies an OTP in writing that its certification has been immediately suspended, the appellant may request an expedited review of the suspension and any proposed revocation. The appellant must submit this request in writing to the reviewing official within 10 days of the date the OTP received notice of the suspension. The request for review must include a copy of the suspension and any proposed revocation, a brief statement of why the decision to suspend and propose revocation is incorrect, and the appellant’s request for an oral presentation, if desired. A copy of the request for review must also be sent to the respondent.
(b) Reviewing official’s response. As soon as practicable after the request for review is received, the reviewing official will send an acknowledgment with a copy to the respondent.
(c) Review file and briefs. Within 10 days of the date the request for review is received, but no later than 2 days before an oral presentation, each party shall submit to the reviewing official the following:
(1) A review file containing essential documents relevant to the review, tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages, explaining the party’s position concerning the suspension and any proposed revocation. No reply brief is permitted.
(d) Oral presentation. If an oral presentation is requested by the appellant or otherwise granted by the reviewing official in accordance with § 8.27(a), the presiding official will attempt to schedule the oral presentation within 20 to 30 days of the date of appellant’s request for review at a time and place determined by the presiding official following consultation with the parties. The presiding official may hold a pre-hearing conference in accordance with § 8.27(c) and will conduct the oral presentation in accordance with the procedures of § 8.27(e), (f), and (g).
(e) Written decision. The reviewing official shall issue a written decision upholding or denying the suspension or proposed revocation and will attempt to issue the decision within 7 to 10 days of the date of the oral presentation or within 3 days of the date on which the transcript is received or the date of the last submission by either party, whichever is later. All other provisions set forth in § 8.33 apply.
(f) Transmission of written communications. Because of the importance of timeliness for the expedited procedures in this section, all written communications between the parties and between either party and the reviewing official shall be sent by facsimile transmission, personal service, or commercial overnight delivery service.
§ 8.29 Ex parte communications.
For the purposes of maintaining the equity of informal review proceedings, except for routine administrative and procedural matters or as described in §§ 8.22(2) and 8.27(e), a party shall not communicate with the reviewing or presiding official without notice to the other party.
§ 8.30 Transmission of written communications by reviewing official and calculation of deadlines.
(a) Timely review. Because of the importance of a timely review, the reviewing official should normally transmit written communications to either party by facsimile transmission, personal service, or commercial overnight delivery service, or certified mail, return receipt requested, in which case the date of transmission or day following mailing will be considered the date of receipt. In the case of communications sent by regular mail, the date of receipt will be considered 3 days after the date of mailing.
(b) Due date. In counting days, include Saturdays, Sundays, and holidays. However, if a due date falls on a Saturday, Sunday, or Federal holiday, then the due date is the next Federal working day.
§ 8.31 Authority and responsibilities of the reviewing official.
In addition to any other authority specified in this subpart, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify the procedures in this subpart in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of the procedures in this subpart.
§ 8.32 Administrative record.
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
§ 8.33 Written decision.
(a) Issuance of decision. The reviewing official shall issue a written decision upholding or denying the suspension, proposed revocation, or adverse action. The decision will set forth the reasons for the decision and describe the basis for that decision in the record. Furthermore, the reviewing official may remand the matter to the respondent for such further action as the reviewing official deems appropriate.
(b) Date of decision. The reviewing official will attempt to issue the decision within 15 days of the date of the oral presentation, the date on which the transcript is received, or the date of the last submission by either party, whichever is later. If there is no oral presentation, the decision will normally be issued within 15 days of the date of receipt of the last reply brief. Once issued, the reviewing official will immediately communicate the decision to each party.
(c) Public notice and communications to the Drug Enforcement Administration (DEA). (1) If the suspension and proposed revocation of OTP certification are upheld, the revocation of certification will become effective immediately and the public will be notified by publication of a notice in the
(2) If the suspension and proposed revocation of OTP certification are denied, the revocation will not take effect and the suspension will be lifted immediately. Public notice will be given by publication in the
§ 8.34 Court review of final administrative action; exhaustion of administrative remedies.
Before any legal action is filed in court challenging the suspension, proposed revocation, or adverse action, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal law. The reviewing official’s decision, under § 8.28(e) or § 8.33(a), constitutes final agency action as of the date of the decision.
Subpart E [Reserved]
PART 9—STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY SUPPORTED SANCTUARY SYSTEM
§ 9.1 Applicability and purpose.
(a) General. The standards of care set forth in this part apply to the chimpanzee sanctuaries that are contracted (or subcontracted) to the Federal Government to operate the federally supported chimpanzee sanctuary system authorized by section 481C of the Public Health Service (PHS) Act, as amended (42 U.S.C. 287a-3a).
(b) What is the purpose of the federally supported chimpanzee sanctuary system and the authority for establishing these standards of care regulation? The Chimpanzee Health Improvement, Maintenance, and Protection Act (Pub. L. 106-551, referred to as the “CHIMP Act” or “Chimpanzee Retirement Act”) was enacted by Congress to provide for the establishment and operation of a sanctuary system to provide lifetime care for chimpanzees that have been used, or were bred or purchased for use, in research conducted or supported by the agencies of the Federal Government, and that are determined to be no longer needed for such research. The CHIMP Act also mandates that standards of care for chimpanzees in the sanctuary shall be developed to ensure the well-being of chimpanzees and the health and safety of the chimpanzees.
(c) To what chimpanzee sanctuaries do the standards of care in this part apply? The standards of care set forth in this part apply to only those sanctuaries that are contracted or subcontracted to the Federal Government to operate the federally supported chimpanzee sanctuary system.
§ 9.2 Definitions.
As used in this part:
Adequate veterinary care means a program directed by a veterinarian qualified through training and/or experience to provide professional medical care to the chimpanzees within the Sanctuary and with the appropriate authority to provide this care. The program also provides guidance to all caregivers on all matters relating to the health and well-being of the chimpanzees.
American Zoo and Aquarium Association (AZA) means the professional society composed of individuals with various backgrounds and interests that are devoted to advancing the knowledge and understanding of zoo animals and the management of zoos in the United States.
American Zoo and Aquarium Association (AZA) Accreditation Standards are those standards developed by the AZA that are used to review, evaluate, and accredit zoos or zoological gardens. These standards cover a variety of areas including facilities, policies and procedures, training, staff qualifications, medical and animal care, husbandry and well-being procedures, and conservation, along with other specific areas.
Animal Care and Use Committee means the Institutional Animal Care and Use Committee established under section 13(b) of the Animal Welfare Act of 1985 and the Health Research Extension Act of 1985. For the purpose of these Standards of Care, it shall consist of at least five (5) members including the Chairperson, a Doctor of Veterinary Medicine (D.V.M. or V.M.D.) knowledgeable in nonhuman primate care and diseases and with delegated program responsibility, a member not affiliated with the Sanctuary, a scientist, and a member of the animal protection community. The requirement that a member of the ACUC must be from an animal protection organization is unique to this part and is not required under the Animal Welfare Regulations or the Public Health Service Policy on the Humane Care and Use of Laboratory Animals. This Committee must be established if research as defined by the Animal Welfare Act Regulations and the Public Health Service Policy (research, teaching, testing, exhibition) is to be conducted at the sanctuary.
Animal protection organization means a nonprofit organization whose primary mission is protection of animals through positive advocacy and action.
Animal Resource Manager (or Animal Resource Supervisor) means the individual employee responsible for managing the nonprofessional staff providing care for the chimpanzees at the sanctuary. This individual may perform other duties as assigned by the Sanctuary Contractor.
Animal Welfare Act/Regulations means the Act of August 24, 1966 (Pub. L. 89-544, commonly known as the Laboratory Animal Welfare Act), as amended by the Act of December 24, 1970 (Pub. L. 91-579, the Animal Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-279, the Animal Welfare Act of 1976), and the Act of December 23, 1985 (Pub. L. 99-198, the Food Security Act of 1985), and as may be subsequently amended, and the United States Department of Agriculture (USDA) regulations implementing the Animal Welfare Act in title 9, chapter 1, subchapter A of the CFR.
Animal Welfare Assurance means the documentation from an institution assuring compliance with the PHS Policy on Humane Care and Use of Laboratory Animals. This policy is administered by the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health.
Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) means the nonprofit organization that is recognized in the United States and abroad as being the body responsible for the accreditation of laboratory animal programs.
Behaviorist means a person hired by the sanctuary to administer or oversee the enrichment and behavioral program for the chimpanzees at the sanctuary. This individual must be qualified through training or experience.
Biosafety Officer means the individual responsible for establishing and monitoring workplace safety procedures designed to minimize or prevent injury or loss due to biohazards in accordance with policies established by the sanctuary administration.
Board of Directors (BOD) means the individuals selected by the Contractor to govern the nonprofit institution responsible for operating the federally supported chimpanzee Sanctuary system. The board members must meet the qualifications and criteria stated in the CHIMP Act.
Chair of the Board of Directors means the individual chosen by the BOD or other legally empowered entity to carry out such action, who is responsible for chairing meetings and acting on behalf of the board. This individual reports directly to the Board.
Chief Executive Officer (CEO) means the principal person responsible for overall accomplishment of the mission of the chimpanzee sanctuary.
CHIMP Act means the Chimpanzee Health Improvement, Maintenance, and Protection Act of December 20, 2000 (Pub. L. 106-551) commonly known as the “CHIMP Act” or “Chimpanzee Retirement Act,” and any future amendments.
Chimpanzee means a member of Pan troglodytes. It excludes the pygmy chimpanzee (Pan paniscus or bonobo).
Chimpanzee caregivers (caregivers) mean all sanctuary technical and husbandry staff providing long-term care and services for the chimpanzees.
Contractor/Primary Contractor/Sanctuary Contractor means the nonprofit entity awarded a contract by the Federal Government to establish and operate the chimpanzee sanctuary system.
Euthanasia means the humane death of a chimpanzee accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress. The method must be consistent with the recommendations of the American Veterinary Medical Association Panel on Euthanasia.
Exhibition means exhibiting chimpanzees to the public for compensation. This definition excludes limited viewing for educational purposes that are not disruptive to the chimpanzees.
Facility director means the individual responsible for directing the overall activities at the Sanctuary site.
Facility Veterinarian means a person who has graduated from a veterinary school accredited by the American Veterinary Medical Association (AVMA) Council on Education, or who has a certificate issued by the AVMA’s Education Commission for Foreign Veterinary Graduates; has training and/or experience in the care and management of nonhuman primates; and has direct or delegated authority for activities involving chimpanzees at the federally funded chimpanzee sanctuary.
Federal Acquisition Regulations (FAR) means the codified rules applicable to contracts, specifically those sections of the FAR (48 CFR chapter 1, part 52) that are applicable to contracts between the Federal Government and a contractor (in this case a private, nonprofit entity under contract to operate the chimpanzee sanctuary system).
Federal agency means an executive agency as such term is defined in section 105 of title 5, United States Code, and refers to the agency from which the research facility receives a Federal award for projects involving animals.
Federally owned chimpanzees mean chimpanzees that have been purchased by, bred by, or donated to a federal agency for use in biomedical/behavioral research. Chimpanzees whose ownership was subsequently transferred from Federal ownership via written transfer agreements are no longer federally owned.
Guide means The Guide for the Care and Use of Laboratory Animals, published by the National Academy of Sciences, Institute for Laboratory Animal Research of the National Research Council, 1996, International Standard Book Number 0-309-05377-3.
Housing facility means any land, premises, shed, barn, building, trailer, or other structure or area housing intended to house chimpanzees.
Indoor housing facility refers to any structure or enclosure (for example, cages, pens, rooms) for maintaining animals in a controlled environment that provides for normal physiological and behavioral needs.
Interstate air transport live animals (IATA) regulations means those regulations and standards covering the air transportation of nonhuman primates developed and implemented by the International Air Transportation Association.
Invasive research (studies) utilizes those procedures that cause more than momentary pain, distress, fear, discomfort, injury, or other negative modalities to a chimpanzee. Any procedure that enters or exposes a body cavity is considered to be invasive. Sanctuary chimpanzees may not be used in invasive research. This definition excludes any invasive procedure that is a part of veterinary, medical, or surgical care that is performed by or under the direction of the Sanctuary Veterinarian using acceptable veterinary practices. Some examples of invasive studies are:
(1) Experimental exposure to a substance that may be detrimental to a chimpanzee’s health (e.g., infectious disease, radiation). This does not include accidental exposures to infectious diseases transmitted from cage mates or from radiation or other exposures at the time of regularly scheduled or necessary veterinary examinations and treatments;
(2) Any invasion of a body cavity;
(3) Surgery and surgical implantation of devices that are not a part of a veterinary medical treatment or colony management purposes.
(4) Behavioral studies that cause distress or discomfort, such as induction of a fear response;
(5) Testing of any drug;
(6) Purposeful manipulation of social groups or t