The Substance Abuse and Mental Health Services (“SAMHSA”) recently issued two Proposed Rules which, if finalized, would bring additional changes to 42 CFR Part 2 (“Part 2”), the federal regulations which require additional confidentiality protections for certain substance use disorder records. In 2017 and 2018, SAMHSA issued Final Rules updating Part 2. As health centers have responded to the opioid epidemic by developing substance use disorder programs and hiring additional staff, many have grappled with determining whether Part 2 applies and meeting the compliance requirements. The Proposed Rules do not include changes to the definition of a Part 2 “program;” however, SAMHSA has proposed changes to the definition of “records” and applicability of Part 2, along with a host of other changes. Below we summarize some of the proposed changes.

1. The first Proposed Rule includes various changes to Part 2, including:

• Receipt of Information from Part 2 Program by Non-Part 2 Program: The Proposed Rule would change the definition of a “record” under 42 CFR § 2.11 to state specifically “that information conveyed orally by a Part 2 program to a non-Part 2 provider for treatment purposes with the consent of the patient does not become a record subject to [Part 2]…merely because that information is reduced to writing by that non-Part 2 provider” (84 Fed. Reg. 44587). Under the Proposed Rule, 42 CFR § 2.12 would state that, if a non-Part 2 provider records information about a patient’s substance use disorder treatment from a Part 2 program, it “does not constitute a record that has been re-disclosed under Part 2, provided that any SUD records received from a Part 2 program or other lawful holder are segregated or segmented” (84 Fed. Reg. 44587). In comments to the Proposed Rule, SAMHSA stated that “the records created by the non-Part 2 provider in its direct patient encounter(s) would not be subject to Part 2, unless the records received from the Part 2 program are incorporated into such records” (84 Fed. Reg. 44572).

It is unclear whether health centers will benefit from this proposed change, especially if their electronic medical record auto-populates information from their Part 2 Program.  For example, is the information considered “incorporated” into the record when diagnosis and prescription information from the Part 2 Program is auto-populated in a primary care chart or is the separate Part 2 Program note considered “segregated”? It is also unclear what effect segregating the health center’s Part 2 Program records would have on medical decision-making and quality of care.

• Disclosures to Entities without a Treating Provider Relationship: The Proposed Rule would permit patients to consent to the disclosure of their Part 2-protected records to additional entities without requiring the patient to name a specific person as the recipient of that disclosure. Under the current rule, if a patient does not have a treating provider relationship with an entity, the patient must name both the entity and the specific individual who would receive the information (unless the entity is a third-party payor).  According to comments in the Proposed Rule, SAMHSA has received complaints that the current rule has created frustration and delays in patients applying for and receiving services and benefits from entities, such as the Social Security Administration, in which no one individual is designated to receive Part 2 records.
• Disclosures Permitted during Natural and Major Disasters: The Proposed Rule would permit a Part 2 Program to disclose patient identifying information to medical personnel to “(m)eet a bona fide medical emergency in which a Part 2 program is closed and unable to provide services or obtain the prior written consent of the patient, during a temporary state of emergency declared by a state and/or federal authority as a result of a natural or major disaster, until such time that the Part 2 program resumes operations” (84 Fed. Reg. 44588). The Part 2 Program would have to document such disclosures in compliance with 42 CFR § 2.51(c). In comments to the Proposed Rule, SAMHSA acknowledges the difficulties patients face in accessing services and medications during natural and major disasters. SAMHSA also states that, if at all feasible, consent should still be obtained prior to disclosure.

Changing Part 2 requires a formal rulemaking process. SAMHSA has requested comments from the public. All comments for the first Proposed Rule must be received by October 25, 2019.

2. The second Proposed Rule would amend 42 CFR § 2.63(a)(2) to permit a court to authorize the disclosure of Part 2-protected information when the disclosure is necessary in connection with any investigation or prosecution of an extremely serious crime, even if that crime was not allegedly committed by the patient. The current rule permits courts to authorize the disclosure of Part 2-protected information if “necessary in connection with investigation or prosecution of an extremely serious crime allegedly committed by the patient…” The proposed change removes the phrase “allegedly committed by the patient” from the regulation, a phrase that SAMHSA said was erroneously added in the 2017 Final Rule. SAMHSA believes that the phrase may prevent enforcement efforts targeting programs, individual prescribers, and pill mills.

Comments for the second Proposed Rule must be received by September 25, 2019.

Feldesman Tucker Leifer Fidell LLP’s Privacy and Confidentiality Team will watch developments closely and will continue to post relevant updates. If you have any questions about this or other patient privacy and confidentiality issues, please contact Dianne Pledgie.

Interested in learning more about Part 2? FTLF is hosting a small group workshops on Managing Patient Privacy & Confidentiality in two weeks: October 2 – 3, 2019. We also conducted a three-part webinar series on 42 CFR Part 2 Compliance in June 2019.  Learn More or Purchase the Recording Here.