On October 14, 2022, President Joe Biden signed Executive Order 14036, directing the Department of Health and Human Services (“HHS”) to consider innovative actions to drive down certain single-source prescription drug costs as the Biden-Harris Administration works to implement the Inflation Reduction Act of 2022 (the “Act”).
On August 4, 2020, the Office of Inspector General for the United States Department of Health and Human Services (OIG) released an FAQ regarding whether a clinical laboratory may provide free antibody testing to federal health care program beneficiaries (e.g. Medicare/Medicaid beneficiaries). In its FAQ, the OIG acknowledged that providing such testing would implicate two federal anti-fraud statutes–the federal Anti-Kickback Statute (AKS) and the federal Civil Monetary Penalties Law (CMPL). However, so long as the laboratory implemented certain safeguards, the arrangement would pose a sufficiently low risk that OIG would not pursue an enforcement action.
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: