The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. SUBPART - Subpart CDisclosures With Patient Consent - GovRegs 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. A diagnosis prepared by a part 2 provider for the purpose of treatment or referral for treatment, but which is not so used, is covered by the regulations in this part. contact the publishing agency. The eCFR is displayed with paragraphs split and indented to follow The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. 2.19 Disposition of records by discontinued programs. Please do not provide confidential 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. eCFR :: 42 CFR 1002.213 -- Appeals of exclusions. An application must use a fictitious name such as John Doe, to refer to any patient and may not contain or otherwise disclose patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny. Using the eCFR Point-in-Time System. (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. The term does not include a number assigned to a patient by a part 2 program, for internal use only by the part 2 program, if that number does not consist of or contain numbers (such as a social security, or driver's license number) that could be used to identify a patient with reasonable accuracy from sources external to the part 2 program. 1 CFR 1.1 Information obtained by patient access to his or her patient record is subject to the restriction on use of this information 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). 82 FR 6115, Jan. 18, 2017, unless otherwise noted. The name(s) of the individual(s) or the name(s) of the entity(-ies) to which a disclosure is to be made. (ii) Notwithstanding paragraph (d)(2)(i)(C) of this section, a non-part 2 treating provider may record information about a substance use disorder (SUD) and its treatment that identifies a patient. (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. This document is available in the following developer friendly formats: Information and documentation can be found in our (3) Include such other measures as are necessary to limit 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 disclosure of a patient's record has been ordered. Substance Abuse Confidentiality Regulations | SAMHSA Those records are governed by 38 U.S.C. 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. The restrictions on 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: (ii) Between a part 2 program and an entity that has direct administrative control over the program. 49 CFR 172.101 (iii) An entity with direct administrative control over the part 2 program or lawful holder. (b) Federal assistance. (c) Lawful holders who wish to disclose patient identifying information pursuant to paragraph (b) 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 part 2 upon receipt of the patient identifying information. (c) Criteria. (i) Creating, receiving, maintaining, and transmitting such records; (ii) Destroying such records, including sanitizing the electronic media on which such records are stored, to render the patient identifying information non-retrievable; (iii) Using and accessing electronic records or other electronic media containing patient identifying information; and. Facts relevant to reducing a substantial threat to the life or physical well-being of the minor applicant or any other individual may be disclosed to the parent, guardian, or other individual authorized under state law to act in the minor's behalf if the part 2 program director judges that: (1) A minor applicant for services lacks capacity because of extreme youthor 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 individual authorized under state law to act in the minor's behalf; and. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third-party payer. 2.31 Consent requirements. (2) The specific name (s) or general designation (s) of the part 2 program (s), entity (ies), or . A central registry and any withdrawal management or maintenance treatment program to which information is disclosed to prevent multiple enrollments may not re-disclose or use 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. (b) State law requiring parental consent to treatment. In the case of a patient who has been adjudicated as lacking the capacity, for any reason other than insufficient age, to manage their own affairs, any consent which is required under the regulations in this part may be given by the guardian or other individual authorized under state law to act in the patient's behalf. (f) Limitations on disclosure and use. You are using an unsupported browser. eCFR :: 42 CFR Part 2 Subpart A -- Introduction (1) Restriction on use of information. 290dd-2(g), the regulations in this part impose restrictions upon the disclosure and use of substance use disorder patient records which are maintained in connection with the performance of any part 2 program. Yes, the consent forms designed by NYSDOH meet the SAMHSA requirements. (3) Other ways of obtaining the information are not available or would not be effective. (d) Criteria for entry of order. (a) Required elements for written consent. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. will bring you directly to the content. An order under this section must be entered in accordance with, and comply with the requirements of, paragraphs (d) and (e) of 2.64. Each disclosure made with the patient's written consent must be accompanied by one of the following written statements: (1) This record which has been disclosed to you is protected by federal confidentiality rules (42 CFR part 2). 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. SECTION 2.66. 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. (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. This is an automated process for (2) Data repositories. If a part 2 program discontinues operations or is taken over or acquired by another 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. user convenience only and is not intended to alter agency intent information or personal data. Confidentiality restrictions and safeguards. A disclosure may not be made on the basis of a consent which: (2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section; (4) Is known, or through reasonable diligence could be known, by the individual or entity holding the records to be materially false. (g) Audits and evaluations mandated by statute or regulation. (2) Has entered into a written agreement with a part 2 program under which that individual or entity: (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. Any disclosure made under the regulations in this part must be limited to that information which is necessary to carry out the purpose of the disclosure. 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. (d) Permitted disclosure by a central registry to a non-member treating provider, to prevent a multiple enrollment. (a) Restrictions on placement. 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. "Published Edition". P:\Peer Assistance\dana\Releases - Blank\employer release.doc eCFR :: 42 CFR Part 2 -- Confidentiality of Substance Use Disorder Pursuant to 42 U.S.C. Court Orders Authorizing Disclosure and Use. (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. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. (eg: Treatment means the care of a patient suffering from a substance use disorder, a condition which is identified as having been caused by the substance use disorder, or both, in order to reduce or eliminate the adverse effects upon the patient. HIPAA and Part 2 | HHS.gov 2.15 Incompetent and deceased patients. (5) Crimes on part 2 program premises or against part 2 program personnel. In accordance with 2.13(a), the disclosure must be limited to that information which is necessary to carry out the stated purpose. (4) How type of diagnosis affects coverage. (7) The date, event, or condition upon which the consent will expire if not revoked before. If a written consent to the disclosure is required, that consent may be given by an executor, administrator, or other personal representative appointed under applicable state law. Regulation Y "To Whom" Consent Requirements (2.31): The Patient must include certain language in the "To Whom" section of the consent form in order for the (3) The part 2 program is not responsible for compliance with this paragraph (d); the entity that serves as an intermediary, as described in 2.31(a)(4)(ii)(B), is responsible for compliance with the requirement. [82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43039, July 15, 2020]. Unless an order under 2.66 is sought in addition to an order under this section, the person holding the records must be provided: (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. 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. 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. If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below. (3) Information to which restrictions are applicable. 2.65 Procedures and criteria for orders authorizing disclosure and use of records to criminally investigate or prosecute patients. If paragraph (a)(2) of this section applies: (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; and. (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. 290dd -2 (g), the regulations in this part impose restrictions upon the disclosure and use of substance use disorder patient records which are maintained in connection with the performance of any part 2 program. The federal rules prohibit you from making any further disclosure of this record unless further disclosure is expressly permitted by the written consent of the individual whose information is being disclosed in this record or, is otherwise permitted by 42 CFR part 2. PDF Summary of the Rule (Title 42 CFR Part 2 - Confidentiality of Alcohol 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. (ii) Ensure that patient identifying information obtained under paragraph (a) of this section is not provided to law enforcement agencies or officials. In making any such disclosures, 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. (3) Relevant dates of any such administration or prescription. (3) The disclosure is in connection with litigation or an administrative proceeding in which the patient offers testimony or other evidence pertaining to the content of the confidential communications. Disposition of records by discontinued programs. The application may be filed separately, as part of an application for a subpoena or other compulsory process, or in a pending criminal action. In this written summary, the part 2 program also may include information concerning state law and any of the part 2 program's policies that are not inconsistent with state and federal law on the subject of confidentiality of substance use disorder patient records. (a) Effect. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. Examples of permissible payment or health care operations activities under this section include: (1) Billing, claims management, collections activities, obtaining payment under a contract for reinsurance, claims filing, and/or related health care data processing; (2) Clinical professional support services (e.g., quality assessment and improvement initiatives; utilization review and management services); (i) The training of student trainees and health care professionals; (ii) The assessment of practitioner competencies; (iii) The assessment of provider or health plan performance; and/or. Confidentiality restrictions and safeguards. (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). On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) finalized modifications to the Confidentiality of Substance Use Disorder Patient Records regulations, 42 CFR Part 2 ("Part 2"). 702 (a) and 702 (b) (1) (A) ), the Maternal and Child Health (MCH) Federal Set-Aside project grant programs. The name(s) of the individual(s) or the name(s) of the entity(-ies) to which a disclosure is to be made. (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. Any other disclosure of information identifying a deceased patient as having a substance use disorder is subject to the regulations in this part. 49 CFR 172.101 The eCFR is displayed with paragraphs split and indented to follow guide. 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. 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 his or her medical status, as soon thereafter as the patient attains such capacity, each part 2 program shall: (1) Communicate to the patient that federal law and regulations protect the confidentiality of substance use disorder patient records; and. 6041, 6042) and thereby eligible to administer a program for individuals with mental illness. (e) Medicare, Medicaid, Children's Health Insurance Program (CHIP), or related audit or evaluation. (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. 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. (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. (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. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999; 72 FR 10619, Mar. Yes. (2) Give to the patient a summary in writing of the federal law and regulations. Under 42 CFR Part 2 (hereafter referred to as "Part 2"), a patient can revoke consent to one or more parties named in a multi-party consent form while leaving the rest of the consent in effect. Consent requirements. A written consent to a disclosure under the regulations in this part may be paper or electronic and must include: ( 1) The name of the patient. (c) Acknowledging the presence of patients: Responding to requests. On July 15, 2020, a final rule revising the federal regulations governing the Confidentiality of Substance Use Disorder Patient Records, 42 CFR Part 2 (Part 2), was released by the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services. 2.31 Consent requirements. This content is from the eCFR and may include recent changes applied to the CFR. Navigate by entering citations or phrases This date, event, or condition must ensure that the consent will last no longer than reasonably necessary to serve the purpose for which it is provided. 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. 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 disclosure. 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 his or her medical status, as soon thereafter as the patient attains such capacity, each part 2 program shall: result, it may not include the most recent changes applied to the CFR. HHS Adopts Changes to 42 CFR Part 2 Regulations to Improve Care 2.62 Order not applicable to records disclosed without consent to researchers, auditors and evaluators. (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 . (ii) 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. The Department proposes to add language to paragraph (b) of 2.2 to conform that paragraph to changes proposed to 2.3(b) that would compel disclosures to the Secretary that are necessary for . This contact form is only for website help or website suggestions. HealtheConnections uses the NYSDOH-approved model consent form and is, therefore, compliant with the 42 CFR Part 2 requirements. A written consent to a disclosure under the regulations in this part may be paper or electronic and must include: (1) The name of the patient. Orders authorizing the use of undercover agents and informants to investigate employees or agents of a part 2 program in connection with a criminal matter. This web site is designed for the current versions of (a) Required elements for written consent. (b) Notice not required. (e) Limitation on use of information. . If a 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. 2.3 Criminal penalty for violation . The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. (b) Notice. Choosing an item from An order authorizing the disclosure of patient records for purposes other than criminal investigation or prosecution may be applied for by any person having a legally recognized interest in the disclosure which is sought. or existing codification. The part 2 program must devise a notice to comply with the requirement to provide the patient with a summary in writing of the federal law and regulations.
