In the face of the ongoing opioid crisis in the United States, the Office of the National Coordinator for Health Information Technology (“ONC”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”) recently released two fact sheets to clarify how the requirements of 42 CFR Part 2 apply in different provider contexts, including via electronic health information exchange (“HIE”). The Part 2 regulations were initially promulgated in 1975 to ensure the confidential treatment of records relating to the identity, diagnosis, prognosis or treatment of patients in federally assisted programs for substance use disorders (“SUD”). SAMHSA attempted to modernize the regulations in 2017, in part to account for the many advances in healthcare technology and care delivery models that impact how patient records are transmitted and maintained. However, many stakeholders continue to call for further changes, and a number of bills have been introduced in the House and Senate to further align the Part 2 regulations with HIPAA for the purposes of healthcare treatment, payment and operations.
The new Fact Sheets are intended to help remove barriers to choosing or providing appropriate SUD treatment and to guide stakeholders on how to access and securely share SUD-related health information with the patient’s consent. They are the first guidance documents that SAMHSA has issued since the Part 2 regulations were amended last year. Although they largely restate material in the Preamble of the Final Rule, they contain a series of useful fact patterns that illustrate when and how patient consent should be obtained, including by clarifying how a general designation in a patient consent form works in practice. The key takeaways and insights from the Fact Sheets, which are particularly helpful for stakeholders in mixed-use facilities, integrated care settings, or utilizing HIEs, are summarized below. Continue Reading