Federal Register/Vol. 85, No. 136/Wednesday, July 15, 2020
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42986 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Rules and Regulations DEPARTMENT OF HEALTH AND I. Medical Emergencies (§ 2.51) control, social impairment, risky use, HUMAN SERVICES J. Research (§ 2.52) and pharmacological tolerance and K. Audit and Evaluation (§ 2.53) withdrawal. For the purposes of part 2, Office of the Secretary L. Orders Authorizing the Use of this definition does not include tobacco Undercover Agents and Informants (§ 2.67) or caffeine use. 42 CFR Part 2 V. Collection of Information Requirements The regulations were first promulgated as a final rule in 1975 (40 [SAMHSA–4162–20] VI. Regulatory Impact Analysis A. Statement of Need FR 27802) and amended thereafter in RIN 0930–AA32 B. Overall Impact 1987 (52 FR 21796) and 1995 (60 FR C. Alternatives Considered 22296). On February 9, 2016, SAMHSA Confidentiality of Substance Use D. Conclusion published a notice of proposed Disorder Patient Records Acronyms rulemaking (NPRM) (81 FR 6988) (the AGENCY: Substance Abuse and Mental ‘‘2016 proposed rule’’), inviting ADAMHA Alcohol, Drug Abuse, and comment on proposals to update the Health Services Administration Mental Health Administration (SAMHSA), U.S. Department of Health regulations, to reflect the development CEHRT Certified Electronic Health Record of integrated health care models and the and Human Services (HHS). Technology growing use of electronic platforms to ACTION: Final rule. CFR Code of Federal Regulations DEA Drug Enforcement Agency exchange patient information, as well as SUMMARY: This final rule makes changes DOJ Department of Justice the new laws and regulations to the Department of Health and Human DS4P Data Segmentation for Privacy implemented since 1975, that more Services’ (HHS) regulations governing EHR Electronic Health Record broadly protect patient data. At the FAX Facsimile the Confidentiality of Substance Use same time, consistent with the FDA Food and Drug Administration authorizing statute, we (note that Disorder Patient Records. These changes FEMA Federal Emergency Management were prompted by the need to continue throughout this final rule, ‘‘we’’ refers to Agency SAMHSA) wished to preserve the aligning the regulations with advances FHIR Fast Healthcare Interoperability in the U.S. health care delivery system, Resources confidentiality protections that part 2 while retaining important privacy FR Federal Register establishes for patient identifying protections for individuals seeking HHS Department of Health and Human information originating from covered programs, because persons with SUDs treatment for substance use disorders Services HIPAA Health Insurance Portability and may encounter significant (SUDs). SAMHSA strives to facilitate Accountability Act of 1996 discrimination or experience other information exchange for safe and HIE Health Information Exchange negative consequences if their effective SUD care, while addressing the HIN Health Information Network information is improperly disclosed. legitimate privacy concerns of patients IHS Indian Health Service In response to public comments, on MAT Medication-Assisted Treatment seeking treatment for a SUD. Within the January 18, 2017, SAMHSA published a constraints of the authorizing statute, NPRM Notice of Proposed Rulemaking ONC Office of the National Coordinator for final rule (82 FR 6052) (the ‘‘2017 final these changes are also an effort to make rule’’), providing for greater flexibility the regulations more understandable Health Information Technology OTP Opioid Treatment Program in disclosing patient identifying and less burdensome. OUD Opioid Use Disorder information within the health care DATES: This final rule is effective August PDMP Prescription Drug Monitoring system, while continuing to protect the 14, 2020. Program confidentiality of SUD patient records. FOR FURTHER INFORMATION CONTACT: Ms. QIO Quality Improvement Organization SAMHSA concurrently issued a Deepa Avula, (240) 276–2542. TPO Treatment, Payment, and Health Care supplemental notice of proposed Operations rulemaking (SNPRM) (82 FR 5485) (the SUPPLEMENTARY INFORMATION: SAMHSA Substance Abuse and Mental ‘‘2017 proposed rule’’) to solicit public Table of Contents Health Services Administration SNPRM Supplemental Notice of Proposed comment on additional proposals. In I. Background Rulemaking response to public comments, SAMHSA II. Summary of the Major Provisions SUD Substance Use Disorder subsequently published a final rule on III. Overview of Public Comments U.S.C. United States Code January 3, 2018 (83 FR 239) (the ‘‘2018 IV. Final Modifications to 42 CFR Part 2 and final rule’’) that provided greater clarity I. Background Discussion of Public Comments regarding payment, health care A. General Comments on the Proposed The Confidentiality of Substance Use operations, and audit or evaluation- Rule Disorder Patient Records regulations (42 related disclosures, and provided 1. General Feedback on the Proposed Rule CFR part 2) implement section 543 of language for an abbreviated prohibition a. General Support for the Proposed Rule the Public Health Service Act, 42 U.S.C. b. General Opposition for the Proposed on re-disclosure notice. Rule 290dd–2. The regulations were In both the 2017 and 2018 final rules, c. General Request for Clarification and originally issued to ensure the SAMHSA signaled its intent to continue Guidance Related to Part 2 confidentiality of patient records for the to monitor implementation of 42 CFR 2. General Comments on Realigning the treatment of substance use disorder, at part 2, and to explore potential future Part 2 Rule to the HIPAA Privacy Rule a time when there was no broader rulemaking to better address the B. Definitions (§ 2.11) privacy and data security standard for complexities of health information C. Applicability (§ 2.12) protecting health care data. Under the technology, patient privacy, and D. Consent Requirements (§ 2.31) regulations, a ‘‘substance use disorder’’ interoperability, within the constraints E. Prohibition on Re-Disclosure (§ 2.32) is a defined term, which refers to a of the statute. The emergence of the F. Disclosures Permitted With Written Consent (§ 2.33) cluster of cognitive, behavioral, and opioid crisis, with its catastrophic G. Disclosures To Prevent Multiple physiological symptoms indicating that impact on individuals, families, and Enrollments (§ 2.34) an individual continues using a caregivers, and corresponding clinical H. Disclosures to Prescription Drug substance, despite significant substance- and safety challenges for providers, has Monitoring Programs (§ 2.36) related problems such as impaired highlighted the need for thoughtful VerDate Sep<11>2014 18:13 Jul 14, 2020 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\15JYR2.SGM 15JYR2 khammond on DSKJM1Z7X2PROD with RULES2 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Rules and Regulations 42987 updates to 42 CFR part 2. The laws and After consideration of the public as interim and transitional standards, regulations governing the comments received in response to the until regulations conforming to the confidentiality of substance abuse NPRM, SAMHSA is issuing this final CARES Act legislation can be records were originally written out of rule substantially as proposed, with one promulgated. concern for the potential for misuse of caveat. On March 27, 2020, President II. Summary of the Major Provisions those records against patients in Trump signed the Coronavirus Aid, treatment for a SUD, thereby Relief and Economic Security Act Proposed modifications to 42 CFR undermining trust and leading (‘‘CARES Act’’) into law (Pub. L. 116– part 2 were published as an NPRM on individuals with SUDs not to seek 136). The CARES Act was enacted to August 26, 2019 (84 FR 44568). After treatment. As observed in the 1983 provide emergency assistance to consideration of the public comments proposed rule, the purpose of 42 CFR individuals, families and businesses received in response to the NPRM, part 2 is to ensure that patients affected by the COVID–19 pandemic; to SAMHSA is issuing this final rule as receiving treatment for a SUD in a part support the U.S. health care system; and follows: 2 program ‘‘are not made more to make emergency appropriations to Definitions (§ 2.11) revises the vulnerable to investigation or the Executive Branch. Section 3221 of definition of ‘‘Records’’ to create an prosecution because of their association the CARES Act, Confidentiality and exception so that information conveyed with a treatment program than they Disclosure of Records Relating to orally by a part 2 program to a non-part would be if they had not sought Substance Use Disorder, substantially 2 provider for treatment purposes with treatment’’ (48 FR 38763). amended several sections of the part 2 consent of the patient does not become In recent years, the devastating authorizing statute; specifically, a record subject to part 2 regulations consequences of the opioid crisis have sections 42 U.S.C. 290dd–2(b), (c) and merely because that part 2 information resulted in an unprecedented spike in (f), which specify requirements for is reduced to writing by that non-part 2 overdose deaths related to both patient consent, restrict the use of provider. Applicability (§ 2.12) revises the prescription and illegal opioids records in legal proceedings, and set 1 regulatory text to state that the recording including heroin and fentanyl, as well penalties for violations of the statute, of information about an SUD and its as correspondingly