SAMHSA Issues New Rule on 42 CFR Part 2

By | Published On: July 17, 2020

On July 15, 2020, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) issued the latest changes to the regulations governing the Confidentiality of Substance Use Disorder Patient Records (“42 CFR Part 2” or “Part 2”).

The 2020 Final Rule, effective August 14, 2020, implements most of the changes SAMHSA proposed in August 2019.  It does not incorporate the changes Congress made to Part 2 in the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).  SAMHSA announced that it will go through a separate rulemaking process for the CARES Act changes, which will further align Part 2 with the Health Insurance Portability and Accountability Act (HIPAA).

Among the changes under the 2020 Final Rule are the following:

For Part 2 Programs:

  • With a patient’s consent, a Part 2 Program may disclose patient information orally to a non-Part 2 provider for treatment purposes and when the recipient records the information in its records, the patient’s substance use disorder information is no longer protected by Part 2.
  • With a patient’s consent, a Part 2 Program may disclose patient information to entity(-ies) named by the patient without requiring the patient to name a specific individual who will receive their information on behalf of a given entity.
  • With a patient’s consent, a Part 2 Program may report the substance use disorder medications prescribed or dispensed to a patient to a prescription drug monitoring program (PDMP), if required by applicable state law.
  • The longer notice to accompany disclosures of Part 2 records (found at 42 CFR § 2.32(a)(1)) has been revised.
  • During a temporary state of emergency (declared by a state or federal authority as the result of a natural or major disaster) in which a Part 2 Program is closed and unable to provide services or obtain the prior written consent of the patient, a Part 2 Program may disclose patient identifying information to medical personnel in compliance with 42 CFR § 2.51.

For Non-Part 2 Programs that Receive Part 2 Records:

  • Information received orally from a Part 2 Program may be recorded by a non-Part 2 Program without its record becoming subject to Part 2.
  • Information from paper or electronic Part 2 records that are segregated or segmented may be recorded by a non-Part 2 Program without its record becoming subject to Part 2. The segregated or segmented records remain subject to Part 2.
  • With a patient’s consent to disclose for payment or health care operations, a lawful holder of Part 2 records may further disclose the records to its contractors, subcontractors, or legal representatives for purposes of care coordination and/or case management services.

These changes provide some flexibility; however, the compliance challenges related to Part 2 remain.  Until the CARES Act changes go into effect (sometime after March 27, 2021), Part 2 Programs must update their consent forms, patient notices and disclosure notices to comply with the 2020 Final Rule.  Health centers, which often have teams, sites, or individual providers who meet the definition of a Part 2 Program, should also determine whether information from the Part 2 records can now be recorded in the health center’s other medical records without those records being subject to Part 2.

WEBINAR: On Tuesday, August 4, 2020 at 1 PM ET, FTLF is hosting a new webinar to explain what has changed, what hasn’t changed, and what’s to come with 42 CFR Part 2. Learn More or Register Here.

Ms. Pledgie is a member of the New York and Massachusetts Bars and is not licensed in Washington, DC. Her practice is limited to federal health care matters.