Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.
Under a proposed rule, devices given FDA's breakthrough designation would, upon receiving FDA market authorization, immediately be covered by Medicare.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
Issued this week, the proposed fee schedule would cut overall pathology service payments by 9 percent compared to 2020 and independent lab services by 5 percent.
