HHS releases final rule on substance use confidentiality

Key Takeaways

In February, the U.S. Department of Health & Human Services (HHS) introduced a Final Rule amending the regulations governing the Confidentiality of Substance Use Disorder (SUD) Patient Records at 42 CFR part 2 (“Part 2”). The rule implements certain provisions of the 2020 Coronavirus Aid, Relief and Economic Security Act (CARES Act) and incorporates updates proposed in the 2022 Notice of Proposed Rulemaking. Now that the Final Rule has been published in the Federal Register, it will go into effect on April 16 and compliance with the rule will be required within 24 months following publication.

What is a "Part 2" Program?

Part 2 policy exists to protect patient records that are created or received by a Part 2 program. Part 2 programs are federally assisted individuals, entities or units of a general medical facility that provide substance use disorder diagnosis, treatment or referral services. One such example of a Part 2 program is an Opioid Treatment Program that provides Medication Assisted Treatment for individuals diagnosed with opioid use disorder. The Part 2 policy ensures the confidentiality of information such as identity, diagnosis, prognosis or treatment, thereby fostering an environment where individuals seeking help for substance use disorders can do so without fear of discrimination or legal repercussions.

What changes are being made due to this rule?

Part 2 programs can now rely on a single consent from a patient for sharing records related to treatment, payment and health care operations per HIPAA regulations. The consent remains valid until the patient revokes it in writing. Additional stipulations under the final rule include:

• HIPAA-covered entities can redisclose records received under this consent, following HIPAA regulations
• There are limitations on their use in legal proceedings without specific consent or a court order
• Each disclosure made with the patient’s written consent must be accompanied by a copy of the consent or a clear explanation of the scope of the consent provided
• When a patient’s written consent is used for a disclosure, it must be accompanied by either a copy of the consent or a clear explanation of the consent’s scope
• Separate patient consent is required for the use and disclosure of SUD counseling notes, similar to protections under HIPAA for psychotherapy notes
• Part 2 records may be disclosed with de-identified data without patient consent for public health purposes

How do these changes impact counties?

These changes will have a notable impact on counties due to their direct relevance to Medicaid programs as 22 percent of non-elderly adult Medicaid enrollees are dealing with substance use disorders (SUDs). The alignment of Part 2 with HIPAA rules simplifies coordination, streamlining procedures for county health services and SUD treatment providers. This simplification is crucial for county administrators and service providers aiming to offer comprehensive health services, particularly in the integration of mental health and SUD support. Importantly, the amendments strike a balance between patient confidentiality and necessary information sharing, contributing to improved confidentiality while enhancing the efficiency of care delivery for all residents.

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