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August 23, 2019

HHS proposes changes to substance use disorder data sharing rules

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    HHS' Substance Abuse and Mental Health Services Administration (SAMHSA) on Thursday released a proposed rule intended to make it easier for providers to share the medical records of patients being treated for substance use disorders (SUDs).

    Substance use disorder: How to keep your patients and colleagues safe


    Under a current regulation known as 42 CFR Part 2, providers are prohibited from sharing a patient's SUD treatment information even if the patient grants access. The Part 2 rules differ from HIPAA, which allows providers to share records with a patient's consent.

    Providers and hospitals have said HHS should better align the current regulations regarding SUD treatment records with HIPAA and make it easier for providers to share records to improve care coordination. However, some experts have raised privacy concerns.

    Reps. Earl Blumenauer (D-Ore.) and Markwayne Mullin (R-Okla.) in April reintroduced a bill in the House that would align 42 CFR Part 2 with HIPPA, and Sens. Joe Manchin (D-W.Va.) and Shelley Moore Capito (R-W.Va.) have introduced a similar bill in the Senate. The National Association of Attorneys General this month called on Congress to pass the measures.

    Proposed rule details

    The proposed rule would revise 42 CFR Part 2 to allow primary care providers to note within a patient's medical record when the patient discloses an SUD treatment. Under 42 CFR Part 2, providers currently are required to maintain information that patients disclose about SUD treatments separate from the rest of their medical records if the records are shared with other providers.

    The proposed rule would not apply to SUD treatment records that federally assisted SUD treatment programs send to primary care providers. However, the proposed rule would loosen requirements on removing SUD records from electronic devices if a federally assisted SUD treatment program is discontinued by simply allowing the records to be deleted.

    In addition, the proposed rule would allow patients to send SUD treatment records to non-medical entities such as the Social Security Administration without specifying who will receive the records when they consent for the entity as a whole to receive the records. HHS Secretary Alex Azar said patients currently are required to specify who will receive the documents, which has caused lapses in the information exchange.

    The proposed rule also would clarify that disclosures for health care operations and payment are allowed with a patient's written consent.

    Further, the proposed rule would:

    • Allow providers who do not provide opioid treatments to search a central registry to determine whether patients are receiving opioid treatments;
    • Allow HIPPA-covered entities or business associates to exchange SUD information with non-HIPAA covered entities for research purposes;
    • Allow opioid treatment programs to enroll in a state prescription drug monitoring program to report information on Schedule II to V drugs being dispensed or prescribed;
    • Allow undercover agents to remain enrolled in federally funded treatment programs for up to one year—up from six months—to address concerns from the Department of Justice over regulations restricting ongoing operations;
    • Clarify under which circumstances—such as natural disasters—the  requirement for additional consent for SUD information sharing is suspended; and
    • Clarify when disclosing SUD information to and from government agencies and third-party payers is allowed for audits and evaluations.

    HHS Assistant Secretary Elinore McCance-Katz noted that, under the proposed rule, the information patients consent to release to their primary care providers would not become broadly available within their electronic health records. She explained that the proposed rule would limit the accessible information to include only what is related to a patient's care, diagnosis, prescriptions, and treatments. McCance-Katz added that the proposed rule would allow patients to keep their records private if they so choose.

    Further, the proposed rule would continue to bar law enforcement from using SUD patient records to pursue criminal prosecutions against patients, according to an HHS fact sheet.

    The proposed rule also would not completely align 42 CFR Part 2 with HIPPA privacy protections. Azar said the Trump administration would need Congress to fully align medical record confidentiality regulations for patients with SUDs with the less-strict requirements under HIPPA. However, he said, "We do believe the proposed changes are very commonsense, responsive changes to concerns by both patients and providers. We believe we're going as far as we can."

    HHS will accept public comments on the proposed rule for 60 days after it is published in the Federal Register.


    Observers expressed mixed reactions to the proposed rule.

    Reps. Greg Walden (R-Ore.), the ranking member on the House Energy & Commerce Committee, and Michael Burgess (R-Texas), the ranking member on the committee's health subcommittee, applauded the proposed rule, but called on the House to pass legislation to fully align 42 CFR Part 2 with HIPPA.

    American Hospital Association Executive Vice President Tom Nickels said the group welcomes the proposed rule, but "urge[s] Congress to further this progress by enacting legislation to align requirements for information sharing for the treatment of substance use disorder with HIPAA."

    However, Randy Anderson—founder of Bold North Recovery, an SUD treatment provider—said he is concerned the proposed rule would allow law enforcement to access sensitive information about substance use, which subsequently could penalize individuals seeking treatment. "I just see a whole host of problems that this could create," he said (Cirruzzo, Inside Health Policy, 8/22 [subscription required]; Luthi/Ross Johnson, "Transformation Hub," Modern Healthcare, 8/22; Alonso-Zaldivar, Associated Press, 8/22; Landi, FierceHealthcare, 8/22; HHS fact sheet, 8/22).

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