HHS proposes rule changes for records of substance use disorder patients

Physicians and other medical care providers could face new rules about disclosing patient records for substance use disorder.

The U.S. Department of Health and Human Services (HHS) announced proposed changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR part 2 (Part 2). The federal rules protect patient privacy and records concerning treatment related to substance use challenges from unauthorized disclosures, according to HHS.

The rule increases coordination among providers of treatment for substance use challenges while adding protections for patients concerning records disclosure to avoid discrimination.

“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 Notice of Proposed Rulemaking (NPRM) is scheduled to be published Dec. 2 in the Federal Register, which will open a 60-day public comment period. HHS has posted a copy of the notice online, with an online fact sheet, and comments may be submitted through regulations.gov.

HHS is publishing the NPRM through the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA).

The new rules follow years of physicians, patients, families, and society in general reeling from crisis levels of opioid addiction and overdose. This month, the U.S. Centers for Disease Control and Prevention updated the guidelines for physicians considering prescribing opioids for patients’ pain relief.

Align with HIPAA

The new rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that require HHS to bring Part 2 into greater alignment with certain aspects of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules, according to HHS.

Proposed changes include:

• Permitted use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
• Permitted redisclosure of Part 2 records in any manner permitted by the HIPAA 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 also 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, including the imposition of civil money penalties for violations of Part 2.
• Updated breach notification requirements to HHS and affected patients.
• Updated HIPAA Privacy Rule Notice of Privacy Practices requirements to address uses and disclosures of Part 2 records and individual rights with respect to those records.

Different standards

Part 2 currently imposes different requirements for SUD treatment records protected by Part 2 than the HIPAA Privacy Rule. That can create barriers to information sharing by patients and among health care providers and create dual obligations and compliance challenges for regulated entities, according to HHS.

The federal department understands it is critical for patients to better align the Part 2 rules and program with HIPAA, OCR Director Melanie Fontes Rainer said in the news release.

“This proposed rule helps decrease burdens on patients and providers, improves coordination and increases access to care and treatment, while protecting confidentiality of treatment records,” Rainer said.

SAMHSA has a priority to make effective treatments and recovery supports for SUD more accessible to all who need them, SAMHSA leader Miriam E. Delphin-Rittmon, PhD, said in the news release. Delphin-Rittmon also is HHS Assistant Secretary for Mental Health and Substance Use.

“Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care,” Delphin-Rittmon said. “At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”