HHS Proposes 42 CFR Part 2 Reforms
The confidentiality of patient records created by federally-assisted substance use disorder ("SUD") treatment programs is governed by 42 CFR Part 2 (commonly referred to as "Part 2"). On August 22, the Department of Health and Human Services ("HHS") released a proposed rule to modernize and reduce some of the burdens of Part 2. This Update highlights three of the major proposed changes to the rule that affect non-SUD providers, but a full summary of changes from the HHS Proposed Rule Fact Sheet is included below.
Non-SUD providers often have difficulty in determining when and how some medical records may become subject to Part 2. The proposed rule provides clarification. Oral statements made by a SUD provider to a non-SUD provider (with the requisite patient consent) are not records subject to Part 2 solely because they are put in writing by the non-SUD provider. This permits non-SUD providers to legally learn information from a protected SUD record, discuss the matter independently with the patient as relevant for treatment, and then incorporate all such information into the patient's medical record without such record being subject to Part 2. Moreover, while records subject to Part 2 received in writing by a non-SUD provider remain subject to Part 2, the proposed rules clarified that the receiving provider is permitted to segregate such records to avoid the patient's entire medical record from becoming subject to Part 2.
If the proposed rule is adopted, non-SUD providers will also have the ability to become eligible to access a centralized database to determine if their patients are receiving opioid treatment from a SUD provider. It is anticipated that access to this information will reduce the potential for opioid abuse and improve patient outcomes by better connecting providers with information needed for proper treatment.
Finally, under the proposed rule disclosure requirements for research involving Part 2 records would be altered to align with the Privacy Rule. This will ease the burden on non-SUD providers submitting records for research that are subject to different requirements.
The following is the full summary of the changes in the proposed rules from the HHS Fact Sheet: