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HHS Publishes Final Rule on Confidentiality of Substance Use Disorder Patient Records

The Department of Health and Human Services has published its final rule on the Confidentiality of Substance Use Disorder Patient Records, altering Substance Abuse and Mental Health Services Administration (SAMHSA) regulations.

The aim of the update is to better align regulations with advances in healthcare delivery in the United States, while ensuring patient’s privacy is protected when treatment for substance abuse disorders is sought. The final rule addresses the permitted uses and disclosures of patient identifying information for healthcare operations, payment, audits and evaluations.

The last substantial changes to the Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR part 2) regulations were in 1987. In 2016, SAMHSA submitted a Notice of Proposed Rulemaking in the Federal Register proposing updates to 42 CFR part 2. The proposed updates reflected the development of integrated health care models and the use of electronic exchange of patient information, while still ensuring patient privacy was protected to prevent improper disclosures.

After considering public comments, a final rule was published by SAMHSA in January 2017, which incorporated greater flexibility for disclosures within the healthcare system while still continuing to protect the confidentiality of substance use disorder records.

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A supplemental notice of proposed rulemaking was also issued and public comments were sought on those additional proposals, which covered disclosures related to payment and healthcare operations that can be made to contractors, subcontractors, and legal representatives by lawful holders under the part 2 rule consent provisions, and disclosures for purposes of carrying out Medicaid, Medicare or Children’s Health Insurance Program (CHIP) audits or evaluations.

SAMHSA has now considered all 55 comments received, and has finalized its proposed revisions, taking those comments into consideration.

Several of the commenters sought better alignment with the Health Insurance Portability and Accountability Act (HIPAA) and/or the Health Information Technology for Economic and Clinical Health (HITECH) Act to promote better information flow, provide greater discretion for providers and administrators of services, the establishment of uniform workable regulations with respect to treatment, payment and operations, and to promote more innovative models of health care delivery.

SAMHSA has attempted to align the revisions with HIPAA and the HITECH Act as far as is possible, but explained, “It is important to note that part 2 and its authorizing statute are separate and distinct from HIPAA, the HITECH Act, and their implementing regulations.”

“Part 2 provides more stringent federal protections than other health privacy laws such as HIPAA and seeks to protect individuals with substance use disorders who could be subject to discrimination and legal consequences in the event that their information is improperly used or disclosed.”

Comments were received suggesting SAMHSA should make it easier for healthcare providers using alternative payment models to share records, as the lack of information about substance abuse disorders could negatively affect patient care.

There was considerable disagreement in the comments about whether care coordination and case management should be included in the list of permissible activities under payment and health care operations.

SAMHSA has decided not to include care coordination and case management and the list of permissible activities that SAMHSA considers to be payment and health care operations, and the list is ‘substantively unchanged.’

SAMHSA has also included language in the regulatory text that clarifies disclosures to contractors, subcontractors and legal representatives are not permitted for activities related to a patient’s diagnosis, treatment, or referral for treatment.

SAMHSA will continue to review all of the issues raised in the comments and will explore ways to better align Part 2 with HIPAA and HITECH, including future additional rulemaking for 42 CFR part 2.

A public meeting will also be held prior to March 21, 2018, to determine the effects of 42 CFR part 2 on patient care, health outcomes, and patient privacy. Stakeholders will be given the opportunity to provide input on implementation of part 2, including the changes adopted in the final rule.

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.