In an effort to reduce barriers to coordination of care, the U.S. Department of Health and Human Services (“HHS”) is considering changes to Federal restrictions on the sharing of substance use disorder (“SUD”) records. The proposed changes would modify 42 C.F.R. Part 2 (“Part 2”) regulations that place restrictive conditions on the disclosure of SUD patient records—limitations that go above and beyond Health Insurance Portability and Accountability Act (“HIPAA”) restrictions.
The barriers imposed by these rules—which have been in place since the 1970s—have become the focus of particular attention in light of the opioid crisis, as members of Congress and other stakeholders have raised concerns about how the Part 2 statute and implementing regulations may inhibit efforts to respond and coordinate care. Members of Congress have called for reform, but have been unsuccessful at seeking legislative fixes thus far.
Although the proposed rule does not seek to alter Part 2’s basic framework, it would make the following significant clarifications and modifications:
- To alleviate burdens associated with the sharing of Part 2-covered records, the proposed rule clarifies that recipients of Part 2 information need not apply Part 2 restrictions to all information about SUD patients from their records regardless of origin. Rather, the proposed rule clarifies that recipients (or “lawful holders”) may segregate Part 2 records from non-Part 2 records and apply Part 2 restrictions only to the former. Under the Part 2 regulations, Part 2-protected information retains its protected status as it is passed from a “Part 2 program” to another “lawful holder.” The proposal clarifies that treatment records created by non-Part 2 providers based on their own patient encounters are not covered by Part 2, unless any SUD records previously received from a Part 2 program are incorporated into such records. The proposal therefore emphasizes entities’ ability to segregate Part 2-covered SUD records from non-covered records. While segregating records does not require using a separate server to maintain them, as the proposed rule expressly notes, it might involve using a Data Segmentation for Privacy (DS4P)-compliant electronic health records platform. The proposal makes other conforming changes as well.
- To allow patients to apply for benefits and resources more easily, the proposed rule permits a patient to consent to the disclosure of his or her SUD-related records to organizations without a treating provider relationship with the patient without naming a specific person as the recipient for the disclosure.
- To clarify what activities are considered “payment and healthcare operations” under Part 2, a list of 17 examples of such activities will be moved into the regulatory text from the preamble. Such examples include, but are not limited to: billing, claims management and filing, underwriting, premium rating, collections activities, obtaining payment under a contract for reinsurance, healthcare data processing, clinical professional support services (e.g., quality assessment and improvement initiatives), and utilization review and management services.
- To prevent duplicative enrollments in SUD care, the proposed rule would permit non-OTP (opioid treatment program) providers with a treating provider relationship with the patient to query a central registry to determine whether their patients are already receiving opioid treatment through a member program.
- Similarly, to prevent duplicative prescriptions for SUD treatment and adverse drug events related to SUD treatment, the proposed rule would permit OTPs to enroll in a state prescription drug monitoring program (PDMP), and specifies that they may report data into the PDMP when prescribing or dispensing medications on Schedules II to V, consistent with applicable state law.
The proposal makes other changes as well, including to clarify provisions relating to research uses and audits and evaluations, as well as to expand the exception applicable to emergencies relating to natural disasters.
If finalized, this proposed rule would mark the third set of changes to the Part 2 regulations in two years. (HHS revised the Part 2 rules in 2017 and made further modifications in 2018.) HHS will accept comments on the proposed rule until October 25, 2019.