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DHHS Issues Proposed Rule Amending 42 CFR Part 2


DHHS Issues Proposed Rule Amending 42 CFR Part 2

On August 22, 2019, the Substance Abuse and Mental Health Services Administration of the United States Department of Health and Human Services (“SAMHSA”) issued a proposed rule amending the Confidentiality of Substance Use Disorder Patient Records regulations set forth at 24 CFR Part 2. These regulations were initially implemented to provide heightened protection of patient records covering the treatment of substance use disorder (“SUD”) provided by certain federally funded programs (“Part 2 programs”).

The proposed regulations do not modify the general requirements for the confidentiality of SUD patient records created by Part 2 programs. Part 2 continues to prohibit the disclosure of SUD records without patient consent except as specifically permitted in situations such as in the case of a bona fide medical emergency, for purposes of scientific research, audit or program evaluation, or with an appropriate court order after showing good cause.

The more significant changes made in the proposed regulations are described below.

  • Clarifies that a court may order disclosure of SUD records in connection with the investigation of a serious crime even if the crime was not allegedly committed by the patient. Existing regulations require that the crime be allegedly attributable to the patient.
  • Clarifies that non-Part 2 providers are subject to Part 2 only if the provider has received SUD records from a Part 2 program and the SUD records are incorporated in the medical records maintained by the non-Part 2 provider.
  • Permits Opioid Treatment Programs (“OPT”) to enroll in a State prescription drug monitoring program (“PDMP”) and to report data to the PDMP when prescribing or dispensing medications on Schedules II to V, subject to patient consent.
  • Permits non-OPT providers to search a central registry to determine whether a patient is receiving opioid treatment through another registry member program.
  • Permits an SUD patient to consent to disclosure of his or her Part 2 SUD records to an entity without identifying a specific person as the recipient. The premise is that this change would permit patients to have greater access to resources and benefits, such as Social Security benefits.
  • Relaxes current regulations to (a) permit primary care physicians to record their patients’ addiction treatment history in the patient’s general medical records and (b) require the physician only to delete patient texts rather than completely “sanitize” the phone.
  • Clarification of the meaning of the phrase disclosures for the purpose of “payment and health care operations” by inclusion of 17 example activities in the text of the regulations.
  • Clarification of the types of situations or activities that fall within the permitted disclosures for “audits and/or program evaluations.”
  • A court may order placement of an undercover agent or informant in a Part 2 program up to twelve months and may extend that period through a court order.

The proposed regulations were enacted not only to clarify certain provisions of Part 2 but also to address the increasing opioid crisis. The changes to Part 2 focus on facilitating law enforcement efforts to identify providers and others who are contributing to the crisis, particularly in situations where the patient is not involved in the alleged wrongdoing. The consensus was that the existing regulations were a hinderance to effective law enforcement. The proposed regulations attempt to find a balance between the continued protection of the confidentiality of SUD records while at the same time facilitating efforts to address the increasing use and illegal sale of opioids.

It is likely that efforts will continue in Congress to make additional changes to the confidentiality of SUD records through legislative action.

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