Coalition for 21st Century Medicine Commends CMS for Issuing the Application and Designation Process for Advanced Diagnostic Laboratory Tests as Part of PAMA Implementation

Washington, D.C. – On March 23, the Centers for Medicare & Medicaid Services (CMS) released the long awaited application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs) as required by the market-based payment reforms enacted in Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). The Coalition for 21st Century Medicine (C21) strongly supported the enactment of these PAMA requirements to establish transparent, predictable and market-based pricing for new innovative clinical diagnostic laboratory tests.

New ADLTs will be paid at a rate equal to their actual list charge during an initial period of three calendar quarters. After the initial period, the payment amount for a new ADLT will be based on the weighted median of private payor rates from data collected by the laboratory.

“C21 commends CMS for finalizing the ADLT application and designation process,” said Hannah Murphy, Executive Director of C21. “We believe the ADLT process can serve as a catalyst for innovative tests that benefit patients by personalizing critical medical treatment decisions.”

C21 will review the additional guidance for laboratories on ADLT determination from CMS and plans to provide comment to the agency on topics such as the evidence requested to demonstrate that a test provides new clinical diagnostic information.

About the Coalition for 21st Century Medicine

The Coalition for 21st Century Medicine’s mission is to improve the quality of healthcare by encouraging research, development, and commercialization of innovative diagnostic technologies that will personalize patient care, improve patient outcomes, and substantially reduce healthcare costs. The group’s members include Bioarray Genetics, Biocept, Biodesix, Biotheranostics, CardioDx, CareDx, Castle Biosciences, Counsyl, Foundation Medicine, GE, Genetic Alliance, Genomic Health, Guardant Health, Illumina, Inivata, Kleiner Perkins Caufield & Byers, MDxHealth, Myriad Genetic Laboratories, Prometheus, Sera Prognostics, Vermillion, and Veracyte.