HHS’s Substance Abuse and Mental Health Services Administration (“SAMHSA”) proposed updated rules to clarify the scope of perceived barriers to sharing information regarding treatment for substance use disorders (SUDs) among providers, with research entities, and for law enforcement purposes. The proposed changes to the 42 C.F.R. Part 2 (“Part 2”) regulations appear in two Notices of Proposed Rulemaking (“NPRMs”), which are also summarized in a Fact Sheet. These proposals are part of HHS’s Regulatory Sprint to Coordinated Care, an agency-wide effort to remove regulatory obstacles to care coordination and information-sharing. HHS is anticipated to release proposed rules on HIPAA, the Physician Self-Referral Law and Anti-Kickback Statute by the end of 2019 as part of this effort as well.
The proposed Part 2 updates could have significant impacts on how health care providers, researchers, and health technology companies protect and share SUD information with each other, so interested parties should submit comments on the NPRMs before the deadlines, and prepare to submit comments in response to HHS’s other Regulatory Sprint to Coordinated Care efforts in the coming months.
The Part 2 regulations were initially intended to protect access to patient records for the treatment of SUDs by “federally assisted alcohol or drug abuse programs” (“Part 2 programs”). These regulations were initially promulgated decades before the passage of HIPAA and before electronic health records were available.
Part 2 programs can be entities, identified units within a larger medical facility, or even specific medical personnel or other staff within a medical facility whose primary function is the provision of SUD diagnosis, treatment, or referral for treatment. These regulations impact both Part 2 programs and non-Part 2 entities that need to coordinate care and share information with Part 2 programs.
Highlights from the Proposed Rules
First, SAMHSA’s longer NPRM (“Records NPRM”) proposes numerous changes to Part 2’s regulations that are intended to better facilitate care coordination for individuals with SUD conditions, especially for practitioners and provider entities that are not Part 2 programs. These proposed changes are meant to address outstanding concerns regarding issues such as:
- How providers and entities not subject to Part 2’s requirements can generate, maintain, and re-disclose their own records about a patient’s SUD without being subject to Part 2’s restrictions regarding patient consent.
- How patients may consent to disclosures of information subject to Part 2 to organizations without a treating provider relationship (e.g., for Social Security benefits or halfway house programs).
- The scope of permissible activities encompassing payment and health care operations for which Part 2 information may be re-disclosed.
- The ability of providers, pharmacies, and opioid treatment programs to access prescription drug monitoring program databases and central registries.
- How Part 2 data that has not been de-identified may be disclosed and used for research purposes and for audit and evaluation purposes.
Non-Part 2 entities still must consider how HIPAA and the Common Rule may restrict uses and disclosures of SUD information from patients. However, the Records NPRM provides some relief from the additional burden that the Part 2 regulations often impose with respect to SUD records. Of note, SAMHSA considered, then declined to adopt a formal definition of segmentation that could apply to maintaining information subject to Part 2 apart from those generated by non-Part 2 entities, because that “might have unforeseen technical ramifications for [electronic health records] and [health information exchange] systems implementation in the future.” These provisions may be important for any technology vendor that supports Part 2 programs or non-Part 2 entities that frequently coordinate care with Part 2 programs.
SAMHSA’s shorter NPRM (“Communications NPRM”) focuses on clarifying that a court may authorize disclosure of confidential communications made by a patient to a Part 2 program when the disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, even if the extremely serious crime was not allegedly committed by the patient.” This clarification, achieved by reverting the language in 42 C.F.R. § 2.63(a)(2) back to what was in the 1987 regulation, is directly in response to the current opioid-related public health emergency. SAMSHA believes that this change allows “the prompt investigation and prosecution, if warranted, of opioid-related crimes allegedly committed by individuals other than patients.”
Both NPRMs are anticipated to be published in the Federal Register on Monday, August 26th. Parties that handle information subject to Part 2 and seek additional clarification on the regulations’ restrictions on the sharing of SUD information should prepare to submit comments to SAMHSA on the Communications NPRM by September 25th, and to submit comments to the Records NPRM by October 25th.