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ASCLS Government Affairs Committee Update

Allied Health Personnel Shortage Act of 2019 – Patrick Cooney, ASCLS Legislative Affairs Consultant, is working on this legislation with Representative Cicilline (D-RI); once approval is received from the House Committee, the legislation will be introduced. Bipartisan co-sponsors are still needed for this bill. Additional funding for Medical Laboratory Science programs and students, along with other allied health personnel, would be available with the passage of this legislation.

Laboratory Access for Beneficiaries Act (H.R. 3584) or LAB Act – The bill has 15 bipartisan co-sponsors, with several from the key Energy and Commerce Committee. This legislation will put a 1-year delay on the Protecting Access to Medicare Act of 2014 (PAMA) requirement for market-based rates for Medicare reimbursement for clinical laboratory services. This will allow time to evaluate current data collection and implementation methods, and establish a truly market-based system and appropriate rate-setting that will protect Medicare beneficiary access.

Affordable Care Act (ACA) Device Tax – Proposed legislation would eliminate this tax, which was a part of the Affordable Care Act. This tax has been assessed for only a few years since the ACA was passed, and is currently being waived. Assuming industry passes the tax on to laboratories, it is felt that eliminating this tax would ensure that clinical laboratories aren’t again seeing increased costs of operation. ASCLS has agreed to sign on to a collaborative letter with other industry groups supporting the repeal of this tax.

Verifying Accurate Leading-edge IVCT Development (VALID Act) 2018 – This legislation would address laboratory developed tests and other currently unregulated testing available to the public. This legislation was proposed when the Food and Drug Administration (FDA) discontinued work on regulating this type of testing. Currently, many in the clinical laboratory industry want something quite different than what this bill proposes, so there is little incentive to work on it at this time.

The American Clinical Laboratory Association (ACLA) lawsuit to overturn PAMA has been reinstated at the appellate court level, and will go back to the district court for adjudication. ACLA has put significant resources toward winning this lawsuit. The Commission on Laboratory Accreditation (COLA) is attempting to gather data on the effect of PAMA cuts on laboratories.

A CDC think tank has put together 26 workforce needs/questions, and is asking think tank members to rank the top ten (10) needs, which would then prioritize these issues to determine where resources should be used to alleviate the shortage of clinical laboratory professionals.

The ASCLS Government Affairs Committee is developing a series of webinars regarding advocacy. The first in this series, Advocacy 101, was held Thursday, October 3, and was free to members and PACE approved. Sessions will be recorded, to be available at Other topics in the series will include specific legislative or regulatory issues, how and why to lobby, and many other topics.

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