Washington, D.C. – On November 1, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year 2018 Hospital Outpatient Prospective Payment System Final Rule, establishing a new policy for determining the billing rules (commonly referred to as the “date of service”) for precision medicine laboratory tests. The new policy will take effect January 1, 2018 and will enable laboratories to bill Medicare directly for many precision diagnostic tests performed on specimens collected from hospital outpatients. Current Medicare regulations frequently require hospitals to bill Medicare for tests that are performed separately by independent laboratories, creating unnecessary complexity and delayed patient access to test results and treatments.
The Coalition for 21st Century Medicine applauds CMS for supporting the development of precision medicine by modernizing these billing rules, which will remove these administrative burdens and inefficiencies in billing for innovative diagnostic tests. Eliminating these barriers will promote patient access to prompt precision diagnostic test results, giving physicians access to individualized information to drive treatment decisions. The agency’s policy was widely backed by broad stakeholder support for modernizing these policies to improve patient access to precision diagnostics.
C21 is concerned that while DNA- and RNA-based multianalyte assays with algorithmic analysis (MAAAs) are included in the new exception, certain protein-based tests that are similarly less connected to the outpatient service than most laboratory tests will be excluded from the new policy. We are encouraged, however, that CMS has stated that it will continue to review its laboratory date of service policies to promote patient access to accurate and prompt diagnostic information. We look forward to working with the agency to ensure that its policies on laboratory date of service protect patient access equally to MAAAs analyzing protein biomarkers as to DNA- and RNA-based precision diagnostics.
CMS’ welcome revisions to its laboratory date of service policy make the need for a pathway to ADLT designation especially important for those tests that are not DNA- or RNA-based.
We urge CMS to release the application for Advanced Diagnostic Laboratory Test (ADLT) designation under the new market-based payment system as required under Section 216 of the Protecting Access to Medicare Act of 2014. We thank the agency for its continued attention to this issue.
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 Aspira Labs, Assurex Health, Bioarray Genetics, Biocept, Biodesix, Biotheranostics, CardioDx, CareDx, Castle Biosciences, Counsyl, Crescendo Bioscience, Foundation Medicine, GE, Genetic Alliance, Genomic Health, Guardant Health, Helomics, Illumina, Kleiner Perkins Caufield & Byers, MDxHealth, Myriad Genetic Laboratories, Prometheus, Sera Prognostics, Vermillion, and Veracyte.