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Privacy Rule in 42 CFR Part 2 for Substance Abuse Records “Watered Down”?

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at January 17, 2017
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After months (if not years) of debate and commentary, the U.S. Department of Health and Human Services (HHS) finalized changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, (42 CFR Part 2) to, as SAMHSA suggests, “facilitate health integration and information exchange within new health care models while continuing to protect the privacy and confidentiality of patients seeking treatment for substance use disorders.”

Major provisions that have been finalized in today’s Final Rule include:

  • SAMHSA will allow any lawful holder of patient identifying information to disclose Part 2 patient identifying information to qualified personnel for purposes of conducting scientific research if the researcher meets certain regulatory requirements. SAMHSA also permits data linkages to enable researchers to link to data sets from data repositories holding Part 2 data if certain regulatory requirements are met. This change is intended to enable more needed research on substance use disorders.
  • SAMHSA will continue to apply Part 2 rules when a program is federally assisted and holds itself out as providing substance use disorder diagnosis, treatment, or referral for treatment.
  • SAMHSA will allow a patient to consent to disclosing their information using a general designation to individual(s) and/or entity(-ies)(e.g., “my treating providers”) in certain circumstances, rather than having to sign multiple waivers (or a waiver specifically waiving confidentiality under Part 2). This change is intended to allow patients to “benefit from integrated health care systems.” This provision is also intended to “ensure patient choice, confidentiality, and privacy as patients do not have to agree to such disclosures.” [Note – patients never “had to” agreed to such disclosures.]
  • SAMHSA has added a requirement allowing patients who have agreed to the general disclosure designation, the option to receive a list of entities to whom their information has been disclosed to, if requested.
  • SAMHSA has made changes that outline the audit or evaluation procedures necessary to meet the requirements of a CMS-regulated accountable care organization or similar CMS-regulated organizations (including CMS-regulated Qualified Entities). This change is intended to ensure CMS-regulated entities can perform necessary audit and evaluations activities, including financial and quality assurance functions critical to Accountable Care Organizations and other health care organizations.
  • SAMHSA has updated and modernized the rule to address both paper and electronic documentation.

In addition to the Final Rule issued last week, HHS also issued a “Supplemental Notice of Proposed Rulemaking” (SNPRM), seeking further public input on some additional clarifications and suggestions, especially regarding the important role of contractors, subcontractors and legal representatives in the health care system with respect to payment and health care operations.

Provisions being proposed in the SNPRM include:

  • A new provision clarifying and limiting circumstances in which disclosures to contractors, subcontractors and legal representatives of lawful holders may receive and utilize Part 2 data for purposes of carrying out the lawful holder’s payment and health care operations activities (i.e., collections on bills due).
  • An abbreviated alternative statement for the notice to accompany disclosure.
  • A new provision outlining CMS-regulated entities’ (e.g., ACO’s and QE’s) use of contractors, subcontractors and legal representatives to carry out audit and evaluation activities that are necessary to meet the requirements of a CMS-regulated program.

The current rules governing the confidentiality of substance use disorder records, often referred to as “Part 2,” were promulgated in 1975 because of the concern that if the identities of people in treatment for substance use were revealed those patients might be subject to criminal prosecution and a wide range of other serious social consequences. These harmful consequences could deter people from seeking needed treatment.  This was long before HIPAA (the Health Insurance Portability and Accountability Act of 1996) and was enacted, in part, as a result of the large number of persons returning from Vietnam with SUD who refused to get help our of fear of stigma and being ostracized by their communities.

All persons are invited to comment on the SNPRM proposed clarifications and must be received by SAMHSA no later than 5 p.m. on February 17, 2017.

The final rule was published last Friday, 1/13/17 and published in its unofficial form until tomorrow, 1/18/17, but can be viewed here.

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