Congress passed the 2023 Omnibus Appropriations Bill on Dec. 23 and provided temporary relief from Medicare payment cuts to clinical laboratory services that would have otherwise gone into effect in January. However, Congress did not fully meet the priorities for which the American Clinical Laboratory Association (ACLA), the College of American Pathologists (CAP), and others have been advocating.

According to the ACLA, the bill provides a one-year reprieve from the previously expected Medicare cuts of up to 15 percent for more than 800 laboratory services.

“ACLA commends Congress for prioritizing a reprieve from deep Medicare laboratory payment cuts and data reporting, acknowledging that these repeated cuts are an unsustainable risk for patient access to quality clinical laboratory services, undermining innovation in the next generation of diagnostics and the nation’s clinical laboratory infrastructure,” ACLA President Susan Van Meter said in a statement.

The bill also includes provisions that mitigate Medicare payment cuts for physician services for the next two years, lift the 4 percent statutory Pay-As-You-Go payment cuts to Medicare in 2023, and extend Medicare coverage for telehealth services to 2025. According to the CAP, Congress failed to stop the entire 4.5 percent Medicare cut “stemming from the program’s policy to increase payment for evaluation and management services.” Instead, Congress reduced the cut by 2.5 percentage points for 2023 and by 1.5 percentage points for 2024. The CAP estimates that the average Medicare spending impact on pathology will be –1.1 percent.

“The CAP is pleased that Congress did pass critical legislation to prevent future pandemics and mitigate the impact of Medicare cuts for 2023, but we are still disappointed that Congress didn’t avert the entire cut facing pathologists and other physicians,” Emily E. Volk, M.D., president of the CAP, said in a statement. “Unfortunately, this issue will continue to threaten access to high-quality patient care.”

Congress also failed to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act in the omnibus legislation. The VALID Act would have established a regulatory framework for diagnostics and aims to “ensure quality laboratory testing for patients and minimize regulatory burden on laboratories, while allowing for continued innovation in laboratory testing,” according to the CAP. The CAP explains that the U.S. Food and Drug Administration is expected to regulate laboratory-developed tests in the absence of a legislative solution, as recently stated by Robert Califf, M.D., FDA commissioner, and Jeff Shuren, M.D., director of the FDA Center for Devices and Radiological Health.

In a statement, the ACLA said: “ACLA maintains that clarity and certainty on the regulatory requirements for clinical laboratories is needed and only through legislation to create a diagnostics-specific framework should new regulation of laboratory-developed tests move forward.”

Sources:

https://www.acla.com/acla-commends-2023-omnibus-appropriations-bill/

https://www.cap.org/advocacy/latest-news-and-practice-data/december-20-2022#story1