Final Rule to Implement the Bipartisan CARES Act Legislation

February 9, 2024 - On Thursday, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes.

Today’s rule was informed by the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.

“Patient confidentiality is one of the bedrock principals in health care. People who are struggling with substance use disorders must have the same ability to keep their information private as anyone else. This new rule helps to ensure that happens, by strengthening confidentiality protections and improving the integration of behavioral health with other medical records,” said HHS Secretary Xavier Becerra. “The Biden-Harris Administration has made it a priority to end the stigmatization of those living with substance use disorders and give health care providers the tools they need so they can treat the whole patient while continuing to protect patient privacy. We will not rest until behavioral health is fully integrated into health care and those struggling with behavioral health challenges get the best treatment available.”

“The Final Rule strengthens confidentiality protections while improving care coordination for patients and providers. Patients can seek needed treatment and care for substance use disorder knowing that greater protections are in place to keep their records private, and providers can now better share information to improve patient care,” said OCR Director Melanie Fontes Rainer.

“One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans,” said Miriam E. Delphin-Rittmon, Ph.D., the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “The Final Rule supports access to care and treatment and mitigates the discrimination and stigmatization that we know too often people with SUD experience while continuing to apply stringent privacy protections.”

The final rule includes the following modifications to Part 2:

• Permits 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.
• Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
• Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
• Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
• Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
• Outlines new breach notification requirements applying to Part 2 records.

A fact sheet on the final rule may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html
Source: HHS