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A Deeper Dive

Amendments to 42 CFR, Part 2

The Federal Register is the official journal of the federal government of the United States; it records government agency rules, proposed rules, and public notices. The final rules promulgated by a federal agency and published in the Federal Register are ultimately reorganized by topic or subject matter and codified in the Code of Federal Regulations (CFR), which is updated quarterly.

In 2017, 42 CFR changes appeared to some observers to limit individuals’ ability to permit care providers to share information with other entities in the interest of care coordination. The LEAD Support Bureau established a framework under which LEAD case managers could still share information using a multi-party ROI, as they were participating in a local benefits program which qualified for an exception under the 2017 regulations. This complexity was resolved, however, with amendments and guidance published in 2020.

As recorded in the Federal Register Volume 85, No. 136, July 15, 2020, SAMHSA provides an explicit explanation regarding recent amendments it had made to 42 CFR, Part 2, enabling increased flexibility to share information across partners. SAMHSA wrote: “It is not SAMHSA’s intent to limit patients’ ability to consent to the disclosure of their own information or create barriers to care coordination. We wish, rather, to empower patients to consent to the release and use of their health information in whatever way they choose, consistent with statutory and regulatory protections designed to ensure the integrity of the consent process.

“Therefore, in this final rule, SAMHSA is amending the current regulations to clarify when patients may consent to disclosures of part 2 information to organizations without a treating provider relationship. In particular, SAMHSA has amended § 2.31(a)(4)(i), which previously required a written consent to include the names of individual(s) to whom a disclosure is to be made. The amended section inserts the words ‘‘or the name(s) of the entity(- ies)’’ to that section, so that a written consent must include the name(s) of the individual(s) or entity(-ies) to whom or to which a disclosure is to be made. SAMHSA believes that this language aligns more closely with the wording of the regulation before the January 2017 final rule changes, and would alleviate problems caused by the inability to designate by name an individual recipient at an entity. For example, if a patient wants a part 2 program to disclose impairment information to the Social Security Administration for a determination of benefits, such patient would only need to authorize this agency on the ‘‘to whom’’ section of the consent form, rather than identify a specific individual at the agency to receive such information. In addition, in response to the many comments requesting that SAMHSA provide more flexibility throughout the rule to facilitate care coordination and case management, the change at § 42 CFR 2.31(a)(4)(i) will also make it easier for patients to consent to the disclosure of their information for the purposes of care coordination and case management, including to contracted organizations of lawful holders, by naming such organizations on the consent form.”