The Substance Abuse and Mental Health Services Administration (SAMHSA), part of the U.S. Department of Health and Human Services (HHS), announced the adoption of the revised Confidentiality of Substance Use Disorder Patient Records regulation, 42 CFR Part 2. HHS asserts that these changes were prompted by the need to continue aligning the regulations with advances in the U.S. health care delivery system, while retaining important privacy protections for individuals seeking treatment for substance use disorders (SUDs). Two key changes include the following:
- Applicability and Re-Disclosure: Treatment records created by non-Part 2 providers based on their own patient encounter(s) are explicitly not covered by Part 2, unless any SUD records previously received from a Part 2 program are incorporated into such records. Segmentation or holding a part of any Part 2 patient record previously received can be used to ensure that new records created by non-Part 2 providers will not become subject to Part 2.
- Disclosures to Central Registries and PDMPs: Non-OTP (opioid treatment program) and non-central registry treating providers are now eligible to query a central registry, in order to determine whether their patients are already receiving opioid treatment through a member program. OTPs are permitted to enroll in a state prescription drug monitoring program (PDMP), and permitted to report data into the PDMP when prescribing or dispensing medications on Schedules II to V, consistent with applicable state law.
View the Fact Sheet for SAMHSA 42 CFR Part 2 Revised Rule, including the full listing of changes. This final rule is effective August 14, 2020.