contact the publishing agency. No consent allows SUD providers to receive read-only information from other facilities, but does not allow the provider to contribute patient information to the Collective Platform for access by others. SUBCHAPTER A - GENERAL PROVISIONS. The 42 CFR Part 2 regulations (Part 2) serve to protect patient records created by federally assisted programs for the treatment of substance use disorders (SUD). Choosing an item from HIPAA and Part 2 | HHS.gov site when drafting amendatory language for Federal regulations: The CARES Act of 2020 approved by Congress and signed into law made several changes to 42 C.F.R. These cookies ensure basic functionalities and security features of the website, anonymously. Copyright 2023 WisdomAnswer | All rights reserved. SAMHSA requires that the compliant consent 3 0 obj HIPAA and 42 CFR Part 2 rarely explicitly prohibit the exchange of information. endobj For example, when a non-part 2 provider is directly treating her own patient, and creates a . CFR Title 42 Public Health is one of fifty titles comprising the United States Code of Federal Regulations (CFR). % . result, it may not include the most recent changes applied to the CFR. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. 5600 Fishers Lane, Rockville, MD 20857 The regulations restrict the disclosure and use of alcohol and drug patient records which are maintained in connection with the performance of any federally assisted alcohol and drug abuse program (42 CFR 2.3(a)). Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register. (2) Reviews of appropriateness of medical care, medical necessity, and utilization of services. Search & Navigation (9) The date on which the consent is signed. Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Agree in writing that PII will not be re-disclosed except under strict conditions. Prohibit Part 2 programs from taking adverse action against patients who file complaints. Permit the redisclosure of Part 2 records as permitted by the HIPAA Privacy Rule by recipients that are Part 2 programs, HIPAA covered entities, and business associates, with certain exceptions. If you are human user receiving this message, we can add your IP address to a set of IPs that can access FederalRegister.gov & eCFR.gov; complete the CAPTCHA (bot test) below and click "Request Access". 42 CFR Part 2 Flashcards | Quizlet The in-page Table of Contents is available only when multiple sections are being viewed. This cookie is set by GDPR Cookie Consent plugin. 1 0 obj To facilitate appropriate disclosures for research, by streamlining overlapping requirements under Part 2, the HIPAA Privacy Rule and the Common Rule. 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. (f) Limitations on disclosure and use. View the most recent official publication: These links go to the official, published CFR, which is updated annually. Please do not provide confidential Visit SAMHSA on Instagram PDF FAQs About 42 CFR Part 2 - ASAM A .gov website belongs to an official government organization in the United States. If you have questions or comments regarding a published document please Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (enacted March 27, 2020) requires the Secretary to align certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health Information Technology for Economic and Clinical Health (HITECH) Act. (a) General rule. (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. Search & Navigation eCFR :: Title 42 of the CFR -- Public Health 42 CFR Part 2's general rule places privacy and confidentiality restrictions upon substance use disorder treatment records. A separate drafting site What is the intent of 42 CFR? - WisdomAnswer Declared emergencies resulting from natural disasters (e.g., hurricanes) that disrupt treatment facilities and services are considered a bona fide medical emergency, for the purpose of disclosing SUD records without patient consent under Part 2. 10 Exceptions to the general rule: 1. Choosing an item from (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. Modify the Part 2 confidentiality notice requirements (Patient Notice) to align with the HIPAA Notice of Privacy Practices. view historical versions Title 42 Chapter I Subchapter A Part 2 Subpart B 2.14 Previous Next Top eCFR Content 2.14 Minor patients. Medicare, Medicaid MCOs, commercial plans, etc. Under the current 42 CFR part 2 regulation, such disclosures of records by a part 2 program to a non-part 2 provider do not render all subsequent records on SUD caretaking activity undertaken by the non-part 2 provider subject to the part 2 regulation. KA 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. This contact form is only for website help or website suggestions. 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. 290dd2(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. Permit investigative agencies to apply for a court order to use or disclose Part 2 records after they unknowingly receive Part 2 records in the course of investigating or prosecuting a Part 2 program, when certain preconditions are met. is available with paragraph structure matching the official CFR (iii) Determine the need for adjustments to payment policies to enhance care or coverage for patients with SUD. The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. 1 CFR 1.1 2 0 obj Permit Part 2 programs to use and disclose Part 2 records based on a single prior consent signed by the patient for all future uses and disclosures for treatment, payment, and health care operations. the hierarchy of the document. If you want to request a wider IP range, first request access for your current IP, and then use the "Site Feedback" button found in the lower left-hand side to make the request. result, it may not include the most recent changes applied to the CFR. This process will be necessary for each IP address you wish to access the site from, requests are valid for approximately one quarter (three months) after which the process may need to be repeated. Toll Free Call Center: 1-877-696-6775, Content created by Office for Civil Rights (OCR), Other Administrative Simplification Rules, https://www.federalregister.gov/public-inspection/2022-25784/confidentiality-of-substance-use-disorder-patient-records. 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. https://www.youtube.com/watch?v=yvoqH2T5bRI. LII. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> If any circumstance exists under which disclosure is permitted, that circumstance acts to remove the prohibition on disclosure but it does not compel disclosure. <> user convenience only and is not intended to alter agency intent While the Department is undertaking this rulemaking, the current Part 2 regulations remain in effect. Q4. SUMMARY OF THE 42 CFR PART 2 REVISIONS BY SAMHSA SAMHSA Friday posted the long-awaited revisions to the 42 CFR Part 2 regulations governing confidentiality and disclosures of patient records for patients of substance abuse treatment programs. "Published Edition". The federal law protecting the confidentiality of SUD patient records was enacted in the 1970s to encourage those facing an addiction to start and continue treatment. However, patient data can still be added and viewed at the consenting facility. 4. (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. A "lawful holder" of patient identifying Part 2 information is an individual or entity who has received such information as the result of a Part 2 compliant patient consent (along with a notice of prohibition on re-disclosure) or as a result of one of Part 2's limited exceptions to the consent requirements. 4 0 obj 42 CFR Part 2 (1987 Rule) 42 CFR Part 2 (Updated Final Rule) HIPAA provider relationship, is not a third party, but includes the name of specific participants, name of the entity participants that have a treating provider relationship, or general designation ("all treating providers"). To ensure clinically appropriate communications and access to SUD care, in the context of declared emergencies resulting from natural disasters. (c) Procedures. Part 2 continues to prohibit law enforcements use of SUD patient records in criminal prosecutions against patients, absent a court order. Regulations for this law are found in 42 CFR (Code of Federal Regulations) Part 2 commonly referred to as "Part 2." developer resources. EptP5 \ Non-identifying information 4. Collective uses the information you provide to us to contact you about relevant content, products and services. (7) The date, event, or condition upon which the consent will expire if not revoked before. endobj (5) If a disclosure to an individual or entity 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 individual or entity may further 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 disclose the information to that individual or entity (or, to such individual's or entity's contractors, subcontractors, or legal representatives, but only for the purposes of this section). What is the 42 code of federal regulations? The adoption of this revised rule represents a historic step in expanding care coordination and quality through the Deputy . Context in source publication. Switch to Chrome, Edge, Firefox or Safari. A lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. Require Part 2 programs to establish a process to receive complaints of Part 2 violations. 49 CFR 172.101 What Has Not Changed Under the New Part 2 Rule: The revised rule does not alter the basic framework for confidentiality protection of substance use disorder (SUD) patient records created by federally assisted SUD treatment programs. PDF 42 CFR Part 2 - Final Rule - ASAM (2) Data repositories. Washington, D.C. 20201 PDF 42 CFR 2 Part 2 ("Part 2"): Confidentiality of Alcohol and Drug Abuse Public Health Service, Department of Health and Human Services, Confidentiality of Substance Use Disorder Patient Records, https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-2/subpart-A/section-2.2, Public Health Service, Department of Health and Human Services. (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) 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. To sign up for updates or to access your subscriber preferences, please enter your contact information. The eCFR is displayed with paragraphs split and indented to follow On November 28, 2022, the U.S. Department of Health & Human Services, through the Office for Civil Rights (OCR) in coordination with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a Notice of Proposed Rulemaking to revise the Confidentiality of Substance Use Disorder Patient Records regulations. Protecting the privacy of these vulnerable patients has never been more relevant. 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 . 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. This cookie is set by GDPR Cookie Consent plugin. (4) Subpart E of this part: Court Orders Authorizing Disclosure and Use, including disclosures and uses of patient records which may be made with an authorizing court order and the procedures and criteria for the entry and scope of those orders. The in-page Table of Contents is available only when multiple sections are being viewed. As a result, it may not include the most recent . (3) May include part 2 data in research reports only in aggregate form in which patient identifying information has been rendered non-identifiable such that the information cannot be re-identified and serve as an unauthorized means to identify a patient, directly or indirectly, as having or having had a substance use disorder. Substance Abuse Confidentiality Regulations | SAMHSA A "lawful holder" of Patient-identifying Part 2 information is an individual or entity who has received such information as the result of a Part 2 compliant Patient consent (along with a notice of prohibition on re-disclosure) or as a result of one of Part 2's limited exceptions to the consent requirements. Yet, lingering stigmas surrounding substance use disorder (SUD) make it hard for individuals to begin, and remain in treatment. What Is 42 CFR Part 2? Contact USA.gov. (eg: Public Health Service, Department of Health and Human Services, Confidentiality of Substance Use Disorder Patient Records, https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-2/subpart-D, Subpart DDisclosures Without Patient Consent, Public Health Service, Department of Health and Human Services. 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 entity, in order to: (i) Identify actions the agency or third-party payer entity can make, such as changes to its policies or procedures, to improve care and outcomes for patients with SUDs who are treated by part 2 programs; (ii) Ensure that resources are managed effectively to care for patients; or. H# &,+-B}\#[ES-`_AYYz -]l%,`4&' EJj&b32CAPif+[A!^}J ^Dsc gbUVGIP~h=@Y3ALd9h:+PdXvuO@wr ^QHvUvWz`\((? U]. [82 FR 6115, Jan. 18, 2017, as amended at 83 FR 252, Jan. 3, 2018; 85 FR 43039, July 15, 2020]. citations and headings information or personal data. A separate drafting site Visit the SAMHSA YouTube channel, Visit SAMHSA on LinkedIn As a Electronic Code of Federal Regulations (e-CFR) Title 42 - Public Health. These cookies will be stored in your browser only with your consent. The official, published CFR, is updated annually and available below under Final Rule: 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records. (a) Notwithstanding other provisions of this part, including paragraph (b)(2) of this section, patient identifying information may be disclosed for the purposes of the recipient conducting scientific research if: (1) The individual designated as director or managing director, or individual otherwise vested with authority to act as chief executive officer or their designee, of a part 2 program or other lawful holder of part 2 data, 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 the HIPAA Privacy Rule at 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.