HHS Proposes Changes to 42 CFR Part 2 to Increase Care Coordination, Patient Confidentiality

The US Department of Health and Human Services (HHS) announced on Monday proposed changes to the confidentiality of substance use disorder (SUD) patient records under 42 CFR Part 2. The proposed rule change would increase coordination among SUD treatment providers and improve protections for patients concerning records disclosure to avoid discrimination in treatment, according to an HHS news release.

The Notice of Proposed Rulemaking (NPRM) would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which requires HHS to bring Part 2 into greater alignment with certain HIPAA privacy, breach notification, and enforcement rules. The requirements for SUD treatment records protected by Part 2 currently differ from the HIPAA privacy rule. The discrepancy creates dueling obligations and compliance challenges, which can make information sharing by patients and between providers a challenge.

“Varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges,” HHS Secretary Xavier Becerra said in a news release. “This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure.”

The changes proposed this week by HHS include the following:

• Permitted use and disclosure of Part 2 records based on a single patient consent given for all future uses and disclosures for treatment, payment, and healthcare operations
• Permitted redisclosure of Part 2 records in any manner permitted by HIPAA’s privacy rule, with certain exceptions
• New patient rights under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as granted by the HIPAA privacy rule
• Expanded prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings
• New HHS enforcement authority, which would include civil monetary penalties for Part 2 violations
• Updated breach notification requirements
• Updated HIPAA privacy rule notice of privacy practices requirements to address uses and disclosures of Part 2 records and individual rights with respect to records

“One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans,” Miriam E. Delphin-Rittmon, PhD, the HHS assistant secretary for mental health and substance use and the leader of the Substance Abuse and Mental Health Services Administration, said. “Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care. At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”  

HHS is now accepting public comments on the proposed rule changes. Interested stakeholders can submit comments at regulations.gov.

>> View the full NPRM

>> View an HHS fact sheet on proposed changes

Reference

HHS proposes new protections to increase care coordination and confidentiality for patients with substance use challenges. News release. HHS. November 28, 2022. Accessed November 29, 2022.