HHS proposes reforms to 42 CFR Part 2 to improve substance use disorder treatment

Category: Department of Health and Human Services, HHS, substance abuse, privacy

HHS proposes reforms to 42 CFR Part 2 to improve substance use disorder treatment


To broaden provider access to patients’ substance use records, the Department of Health and Human Services (HHS) recently proposed reforms to the 42 CFR Part 2 regulations.

Currently, 42 CFR Part 2 restricts access to patient records from substance use treatment programs that receive federal funding. While the rule initially sought to protect these patients from the stigma surrounding substance use treatment, the outdated regulations pose many challenges for providers to safely treat patients struggling with addiction and coordinate care among all treating providers of a patient.  

For example, 42 CFR Part 2 only applies to federally funded providers, while all other providers treating substance abuse only have to comply with HIPAA. Having these two inconsistent privacy standards has inhibited providers’ abilities to share information regarding substance abuse treatments and identify common patients suffering from substance use disorders.  Thus, the proposed revisions to 42 CFR Part 2 seek to reduce these regulatory barriers that hinder coordinated care among providers for patients with substance abuse disorders.  

 This notice of proposed rulemaking is the first released out of HHS’s four-part initiative to amend federal regulations that restrict coordinated care.  Notable changes to 42 CFR Part 2 under the proposed rule include:

  • Updating the definition of what constitutes a Part 2 record to exempt substance use treatment records created by non-Part 2 providers that do not incorporate any Part 2 records. Thus, a record is not subject to the regulation merely because a healthcare provider had information about a patient’s substance use treatment. Additionally, non-Part 2 providers are not required to redact information in their records as long as the Part 2 record previously received is segregated.
  • Revising central registry and prescription drug monitoring program (PDMP) restrictions to permit opioid treatment programs to disclose information to PDMP and non-Part 2 providers to access central registries.
  • Permitting patients to consent to the disclosure of their treatment records without having to name a specific recipient, and disclosure of patient records would not require patient consent in the event of a medical emergency.
  • Permitting research disclosures by a HIPAA covered entity to a non-HIPAA covered entity.
  • Revising the standard for court-ordered disclosures of substance use records for purposes of investigating serious crimes to exclude the phrase “allegedly committed by the patient,” and extending the period of time allowed for a court-ordered placement of an informant within a Part 2 program to 12 months.

Under HHS’s proposed rule, however, 42 CFR Part 2 will maintain several of its important privacy controls, including protecting patient records from being used in criminal proceedings and requiring patient consent for initial disclosure unless a statutory exception applies.

Comments on the proposed rule may be submitted for consideration up until 5:00 pm EST on October 25, 2019. For more information, visit https://federalregister.gov/d/2019-17817.

Belmont Law student Paige Goodwin contributed to this report.

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