ASCP Members Help Block the VALID Act as Lab Community Secures Key Legislative Wins

Publication Date: Jan 5, 2023

Congress provides wins on VALID Act, PREVENT Pandemics Act, Medicare Payment
Thousands of letters from ASCP members to members of Congress helped make a big difference as a well-organized laboratory community blocked Congress from enacting the flawed VALID Act. That victory was just one of several wins ASCP members scored as Congress wrapped up the end of its legislative session. The massive Omnibus spending bill signed into law by President Joe Biden on December 29 also provided key advocacy wins on such issues as payment, workforce, and pandemic preparedness.

The VALID Act
When Congress wrapped up negotiations on the Omnibus Bill in mid-December, it clarified that the VALID Act, or the Verifying Accurate Leading-Edge IVCT Development Act, would not become law—at least not in the immediate future. The VALID Act would have changed the way the U.S. Food and Drug Administration (FDA) regulates laboratory tests, giving the agency expansive authority over laboratory developed tests and exposing many LDTs to burdensome premarket review requirements. This legislation would have impeded the ability of many clinical laboratories, particularly those at academic medical centers, to develop and use LDTs to advance quality patient care.

In an effort to block enactment of the VALID Act, ASCP partnered with other laboratory stakeholders, including the American Association of Bioanalysts/National Independent Laboratory Association, American Association for Clinical Chemistry, American Society for Microbiology, Association for Molecular Pathology, Association of Pathology Chairs. During this time, ASCP wrote congressional leadership, urging them not to pass the VALID Act. In addition, ASCP members acting on ASCP Action Alerts sent more than 10,000 letters to members of Congress to educate them on the importance of LDTs to patient care and to urge them not to stymie patient access to these tests. ASCP would like to thank all the individuals, clinical laboratories, associations, hospitals, academic medical centers, etc., whose efforts made this win possible.

While efforts to pass the legislation in 2023 are sure to continue, ASCP will continue our work to ensure that any future policy initiatives by Congress or the FDA does not pose unreasonable burdens on our patients or clinical laboratories.

PREVENT Pandemics Act

Another 2022 legislative priority for ASCP concerned the PREVENT Pandemics Act, or The Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act. The PREVENT Pandemics Act is a package of bipartisan proposals designed to strengthen the nation’s public health and medical preparedness and response infrastructure. ASCP wrote congressional leadership urging them to include the measure in the Omnibus spending bill.

This measure included the Tracking Pathogens Act, which will strengthen and expand the use of genomic sequencing and surveillance activities to identify dangerous pathogens. The measure also includes the BIO Preparedness Workforce Pilot Program, which will incentivize healthcare professionals to pursue careers in infectious disease and bio-preparedness in underserved communities and health professional shortage areas via a targeted loan forgiveness program. ASCP is pleased to report that Congress followed ASCP’s recommendations to enable laboratory professionals working in public health settings to qualify for this loan forgiveness program. (ASCP will provide more details on this program in the next issue of ePolicy).

Clinical Laboratory Fee Schedule
ASCP also helped attain another significant legislative accomplishment for the laboratory and pathology community by helping to get Congress to block a series of significant cuts to the Clinical Laboratory Fee Schedule (CLFS). The Centers for Medicare and Medicaid Services (CMS) had planned to cut payment for about 800 laboratory services by 10 percent. Instead, Congress extended a 2022 moratorium on laboratory payment cuts by CMS through 2023. Congress also has extended the current prohibition on CMS requiring clinical laboratories to report payment rate and test volume data.

To achieve this victory, ASCP worked closely with the American Clinical Laboratory Association (ACLA) and other laboratory and pathology organizations in urging congressional leaders to address laboratory payment issues. ASCP plans to work this year with its laboratory association partners to get Congress to address the CLFS’s inadequate payment rates.

Physician Fee Schedule
Lastly, ASCP also worked closely with the American Medical Association to get Congress to address a projected 4.5 percent cut in the 2023 Medicare Physician Fee Schedule (PFS). ASCP urged Congress to extend several temporary payment updates that Congress had provided though the end of 2022. The loss of these updates prompted CMS to cut the PFS decrease by 4.5 percent, on average, for all physicians in 2023. Under the provisions just signed into law, Congress has reversed more than half of these cuts such that base physician payment rates will decrease only 2 percent in 2023. As a result, ASCP anticipates that overall reimbursement rates, which differs by medical specialty, will increase for pathologists and independent laboratories approximately 1 percent and 2 percent in 2023.

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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.
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