Officials Release Highly Anticipated Substance Abuse and Mental Health Final Rule
The long-awaited final rule concerning the exchange of mental health and substance abuse records was published January 18 in the Federal Register. The rule finalizes changes to Confidentiality of Alcohol and Drug Abuse Patient Records regulations—42 CFR Part 2—often referred to as Part 2, to facilitate health integration and information exchange within new healthcare models.
According to the final rule, the Substance Abuse and Mental Health Services Administration (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,” the agency said in a statement accompanying the rule’s release. Additionally, the rule allows “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. This change is intended to allow patients to benefit from integrated health care systems. This provision also ensures patient choice, confidentiality, and privacy as patients do not have to agree to such disclosures.”
The original rule governing substance abuse and mental health records was released in 1975 due to concern from health privacy advocates that such sensitive information would wind up in the hands of employers, or subject patients to criminal prosecution. Advocates worried that this could deter patients from seeking treatment.
The rule’s release also included a Supplemental Notice of Proposed Rulemaking, which seeks input from stakeholders in regard to the following proposed provisions. According to SAMHA’s press release, those proposals 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 healthcare operations activities.
- SAMHSA also seeks public comment on an abbreviated alternative statement for the notice to accompany disclosure.
- A new provision outlining CMS-regulated entities’ (e.g., ACOs and QEs) 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 deadline for submitting comments is no later than 5 p.m. on February 17, 2017.
Click here for the text of the final rule in the Federal Register.