HHS Proposed Rule Aims to Increase Privacy Protections and Care Coordination for SUD Patients

On November 28th, the U.S. Health and Human Services Department (HHS), through the Office for Civil Rights and the Substance Abuse and Mental Health Services Administration (SAMHSA), announced proposed changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR part 2 (Part 2), which protects patient privacy and records related to treatment for SUD. The proposed rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act requiring 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. The proposed rule would also increase coordination among SUD treatment providers and protect records from disclosure to avoid discrimination in treatment. 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.

In a press release, HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA, Dr. Miriam E. Delphin-Rittmon, said “One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans. 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 encourages stakeholders to submit public comments by January 31, 2023 here.

Articles & Resources

Federal Register Notice – Confidentiality of Substance Use Disorder (SUD) Patient Records

HHS – HHS Proposes New Protections to Increase Care Coordination and Confidentiality for Patients With Substance Use Challenges

Data Suggest Administration’s Overdose Prevention Strategy Increased OUD Treatment Prescribing and Access

Last week, the U.S. Department of Health and Human Services (HHS) marked the one-year anniversary of the Administration’s Overdose Prevention Strategy by announcing progress on expanding capacity to treat addiction, increasing lives saved from overdose, and improving commitment to long term recovery support. According to an HHS-authored research study, the number of health care providers with waivers to prescribe buprenorphine for opioid use disorder (OUD) increased by 19% over the last year, and suggested that this increase was linked to HHS’s efforts over the past year to remove barriers for clinicians seeking to obtain a waiver. Data also showed that the number of naloxone prescriptions increased by 37% and the average price of naloxone products purchased in pharmacies fell 12%. HHS Secretary Xavier Becerra announced that HHS will continue to build on the Overdose Prevention Strategy through several new efforts, including the Centers for Disease Control and Prevention allowing every state, local, and territorial awardee of the CDC Overdose Data to Action cooperative agreement to use a portion of their funds to purchase naloxone and the Food and Drug Administration publishing a Federal Register Notice stating that certain naloxone products have the potential to be safe and effective for over-the-counter use and encouraging applications for over-the-counter naloxone products.

Articles & Resources

Link to Study

HHS – One Year After Releasing its Groundbreaking Overdose Prevention Strategy, HHS Announces New Data Showing Nation Has Expanded its Ability to Treat Addiction and Save Lives

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

California Healthline – Addiction Treatment Proponents Urge Rural Clinicians to Pitch In by Prescribing Medication

CNN – Drug and alcohol deaths increasing among US adults 65 and older, CDC data shows

FDA Law Blog – CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care

New York Times – Deaths From Substance Abuse Rose Sharply Among Older Americans in 2020

Roll Call – Older adults face Medicare hurdles for substance use treatment

The Washington Post – The under-the-radar battle over opioid addiction treatment legislation

The White House – Remarks by Vice President Harris at the White House Tribal Nations Summit

Wall Street Journal – Naloxone Startup Pursues FDA Approval for Over-the-Counter Swab

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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