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SAMHSA Revises Confidentiality Regulations for SUD Patient Records

July 16, 2020

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Phoebe Ramsey, Sr. Regulatory Analyst, Quality & Payment Policy
Gayle Lee, Director, Physician Payment & Quality

The Substance Abuse and Mental Health Services Agency (SAMHSA) published a final rule to revise the 42 CFR Part 2 regulations to further facilitate better care coordination in response to the opioid epidemic while maintaining confidentiality protections for patient records created by federally assisted programs for the treatment of substance use disorders (SUDs). The final rule goes into effect on Aug. 14.

SAMHSA largely finalized the changes proposed last summer, which seek to modernize the confidentiality regulations to better facilitate the exchange of information for individuals in treatment for SUDs. The AAMC commented in broad support of these important policy changes and clarifications [see Washington Highlights, Oct. 25, 2019].

Revisions to the Part 2 regulations include:

  • Applicability for Non-Part 2 Providers and Re-disclosure. SAMHSA clarifies that treatment records created by non-Part 2 providers based on their own patient encounters are explicitly not covered by Part 2, unless any SUD records previously received from a Part 2 program are incorporated into such records. The rule allows segmentation or holding a part of any Part 2 patient record previously received to ensure that new records created by non-Part 2 providers will not become subject to Part 2 regulations.
  • Disclosures Permitted With Written Consent. To reduce confusion about which activities fall under the “payment and health care operations” umbrella for permitted disclosures, SAMHSA moves the illustrative list of 18 examples that was previously in the preamble into regulation text and expands the list to include care coordination and case management activities.
  • Research. SAMHSA streamlines overlapping requirements under Part 2, the HIPAA Privacy Rule, and the Common Rule to facilitate appropriate disclosures for research. Disclosures for research under Part 2 are permitted by a HIPAA-covered entity or business association to individuals and organizations who are neither HIPAA-covered entities nor subject to the Common Rule regarding research on human subjects.

In addition, SAMHSA discussed the connection of this final rule to Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136), which substantially amends sections of the Part 2 authorizing statute and provides greater flexibility for patients and providers to share SUD records and align more with HIPAA requirements than currently allowed under statute. The CARES Act delays Section 3221 from taking effect before March 2021, and SAMHSA makes clear that in issuing this final rule, it intends for these changes to serve as an interim and transitional standard until it issues regulations conforming with the CARES Act through future rulemaking.

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