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SAMHSA is finalizing broad changes to Confidentiality of Alcohol and Drug Abuse Patient Records, 42 Code of Federal Regulations (CFR) 2, also known as 42 CFR part 2, to remove barriers to coordinated care and permit additional sharing of information among providers and part 2 programs assisting patients with substance use disorders (SUDs).

Statement of Need:

The emergence of the opioid crisis, with its catastrophic impact on individuals, families, and caregivers, and corresponding clinical and safety challenges for providers, has highlighted the need for thoughtful updates to 42 CFR part 2.  More specifically, the opioid crisis has resulted in an unprecedented spike in overdose deaths related to both prescription and illegal opioids including heroin and fentanyl,  as well as correspondingly greater pressures on the SUD treatment system, and heightened demand for SUD treatment services. The revisions to 42 CFR part 2 will better align the regulation with the needs of individuals with SUD and of those who treat SUD patients, while facilitating the provision of well-coordinated care, and ensuring appropriate confidentiality protection for persons in treatment through part 2 programs.

Summary of the Legal Basis:

42 U.S.C. 290dd2(g) provides that the Secretary shall prescribe regulations to carry out the purposes of this section. Such regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.

Alternatives:

The alternatives include not making these changes or making changes to part 2 more limited in scope (i.e., only in one or two sections).

Anticipated Costs and Benefits:

The rule is not expected to be economically significant. Estimates of the cost and benefits of these provisions will be included in the rule.

Risks:

SAMHSA believes the many stakeholders will support efforts to make it easier for patients and providers to share information under part 2. However, some may believe these changes will further undermine privacy protection under part 2 and lead individuals who may seek treatment to not seek treatment for fear of disclosure of their SUD.