On February 8, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) finalized long-awaited modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2, which requires individuals or entities that receive federal funding and provide SUD treatment to implement additional privacy protections and obtain specific consent before using and disclosing SUD treatment records (see 42 C.F.R. § 2.11).
Background
On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.” In its guidance, HHS granted licensed pharmacists immunity when administering or ordering FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and Preparedness Act (PREP Act) when taking such actions. The PREP Act confers immunity for covered persons, from claims arising out of state law. For more background information about the April 8, 2020 HHS guidance, see our previous post available here.
On April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to order and administer COVID-19 tests. Immediately following this guidance, on April 9, 2020, the HHS Office of Civil Rights (OCR) announced that it will exercise its enforcement discretion and will refrain from imposing penalties for violations of HIPAA for covered entities or business associates participating, in good faith, in the operation of COVID-19 Community-Based Testing Sites (CBTS) during the nationwide public health emergency. The guidance regarding pharmacists testing for COVID-19 and the notice related to the relaxation of HIPAA rules comes on the heels of pharmacies, such as CVS and Walgreens, taking on a more active and critical role in the fight against the COVID-19 pandemic.
On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.” HHS noted that it recognized that most Americans are relatively close to a retail pharmacy and they interact with pharmacists more frequently than other healthcare professionals. Allowing pharmacists to administer the tests should reduce travel to testing locations – an important mitigation step. HHS Secretary Alex Azar issued the following statement: