In a recent speech outlining the Trump Administration’s healthcare regulatory reform efforts, Secretary of Health and Human Services (HHS) Alex Azar announced that the Administration will soon begin considering changes to federal health privacy regulations. Secretary Azar indicated that current regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and those governing substance use disorder (SUD) treatment records at 42 C.F.R. Part 2 (Part 2), are impeding efforts to combat opioid addiction and expand value-based care, both of which are top priorities for the Administration. Secretary Azar expects HHS to issue a request for information (RFI) soliciting stakeholder feedback on modifications to HIPAA and Part 2 in the coming months and to take subsequent regulatory action to implement reforms.
The Secretary’s announcement follows two rounds of changes to the Part 2 regulations that sought to improve the sharing of SUD treatment information among healthcare providers. Treatment advocates and policy makers have maintained that, among other things, further harmonization of the HIPAA and Part 2 requirements is necessary to improve the sharing of patient treatment information. The final report issued by the President’s Commission on Combating Drug Addiction and the Opioid Crisis in November of 2017 recommended similar regulatory changes and also noted that changes could be implemented through bipartisan legislation introduced in Congress. In June of this year, the House passed bipartisan legislation (by a vote of 357 to 57) that would, among other changes, allow disclosure of SUD treatment records without a patient’s written consent to covered entities for purposes of treatment, payment, and healthcare operations in accordance with HIPAA privacy regulations. While similar, albeit narrower, legislation has been introduced in the Senate, it is unclear whether such changes will be included in final legislation.
The forthcoming RFI presents an opportunity for stakeholders to engage with HHS on health privacy issues, and to seek reforms designed to account for recent shifts in the industry as well as the potential value of enhanced data sharing with appropriate safeguards.
