Hospitals: Proposed updates to 42 CFR Part 2 don't go far enough

Both the American Hospital Association (AHA) and the American Medical Informatics Association (AMIA), weighing in on a February proposal by the Substance Abuse and Mental Health Services Administration (SAMHSA) to revise 42 CFR Part 2, say the rule does not do enough to remove current barriers impeding the exchange of substance use disorder information between providers.

AHA, in a letter to SAMHSA Acting Administrator Kana Enomoto, says the proposed revision would not be an improvement over the status quo, and calls for "full alignment of the Part 2 regulation with" HIPAA. SAMHSA, AHA believes, could do "much more immediately to align" 42 CFR Part 2 and HIPAA. In addition, AHA says, SAMHSA must put more of a focus on educating federal lawmakers about the barriers created by the Part 2 regulation.

"The separate privacy structure under 42 CFR Part 2 especially creates challenges for the integration of behavioral and physical healthcare simply because patient data related to behavioral health cannot be handled like all other healthcare data," AHA says. "Evidence confirms that integrating mental health, substance abuse and primary care services produces the best outcomes and proves the most effective approach to caring for people with multiple healthcare needs."

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AMIA agrees, saying that while it supports the stated goals of SAMHSA's proposal, the modifications would not be enough to achieve those outcomes.

"Part 2 regulations have had the effect of erecting a 'brick wall' that blocks information exchange between Part 2 programs and other health system elements," the AMIA letter says. "Technically, Part 2 programs can share information with appropriate patient consent or under narrowly defined circumstances, but on a practical level, information exchange is incomplete and infrequent. Logistical barriers and widespread confusion about the regulatory requirements often paralyze organizations from exchanging data or coordinating care with Part 2 programs."

SAMHSA proposes several modifications to the rule, including:

  • The addition of a requirement that, upon request, patients who include a general designation of their information in the "To Whom" section of their consent form, be provided with a list of entities to which their data has been disclosed
  • To allow, in certain circumstances, a patient to include a general designation in the "To Whom" section of the consent form, in conjunction with requirements that: (1) The consent form include an explicit description of the amount and kind of substance use disorder treatment information that may be disclosed; and (2) the "From Whom" section of the consent form specifically name the Part 2 program or other lawful holder of the patient identifying information permitted to make the disclosure
  • Part 2 programs or other lawful holders of patient identifying information to include a statement on the consent form that the patient understands the terms of their consent and, when using a general designation in the "To Whom" section of the consent form, they have a right to obtain, upon request, a list of entities to which their information has been disclosed pursuant to the general designation
  • To permit electronic signatures to the extent that they are not prohibited by any applicable law
  • To permit an audit to meet the requirements of a Centers for Medicare & Medicaid Services-regulated accountable care organization ... or similar CMS-regulated organization ... under certain conditions

To learn more:
- here's the AHA letter (.pdf)
- check out the AMIA letter (.pdf)
- read through SAMHSA's proposal

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