Coalition for 21st Century Medicine Submits Comments on the PAMA Proposed Rule and Supports the 2016 CLFS Final Determinations

Coalition’s message is to promote innovation in Advanced Diagnostic Laboratory Tests that improves patients’ outcomes

Washington, D.C. – Yesterday, the Coalition for 21st Century Medicine (C21) submitted comments (found here) to the Centers for Medicare & Medicaid Services (CMS) on proposed changes to how the agency determines payments for clinical laboratory services under Medicare’s Clinical Diagnostic Laboratory Fee Schedule. C21 has been a strong supporter of the market based payment reforms mandated by Section 216 of the Protecting Access to Medicare Act (PAMA), which this Proposed Rule seeks to implement. C21’s comments focus on ensuring that this new system is implemented in a manner that allows advancements in diagnostic innovation by establishing a pathway for predictable pricing decisions based on market values and unique coding for all advanced diagnostics.

C21 commends the efforts of CMS in drafting the Proposed Rule to implement section 216 of PAMA, but also raises concerns with certain provisions in the Proposed Rule. In particular, C21 urged CMS to follow the statutory definitions for an Advanced Diagnostic Laboratory Test (ADLT) as Congress intended and not limit the ADLT category by adding eligibility criteria outside of the statutory framework and excluding tests based on protein biomarkers. Additionally, C21 proposed a clear process for designating ADLTs. C21 also believes that CMS should allow for a permanent HCPCS test-specific code set so there is a singular code set to be used by private payors and Medicare to uniquely identify lab tests. Lastly, C21 recommended that in order to provide laboratories sufficient notice the data collection period should start in 2016 and data reporting begin in January 1, 2017.

In addition, to submitting comments, C21 is pleased that the Calendar Year 2016 CLFS Final Determinations (found here) released on November 17, 2015 reversed the preliminary payment cuts for new codes for seven well-established, Medicare covered ADLTs developed and performed by C21 member companies. CMS’s decision to establish payment for these tests using the “gapfill” methodology is consistent with C21’s recommendations, CMS precedent, and the recommendation from CMS’s recently established Advisory Panel on Clinical Diagnostic Laboratory Tests. C21 agrees that the gapfill methodology will allow CMS and its contractors the opportunity to gather current information about the tests and the resources necessary to perform them, so that CMS can set appropriate payment rates for these tests.

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