Coalition for 21st Century Medicine United in Opposition to the Centers for Medicare & Medicaid Services’ 2016 Preliminary Determination

Stakeholders are concerned about potential negative impact on precision medicine

Coalition’s message is loud and clear: innovation that improves patients’ outcomes is the way forward

Washington, D.C. – On Friday, September 25, 2015, the Centers for Medicare & Medicaid Services (CMS), which administers the Medicare program, released the Preliminary Determinations for the Calendar Year 2016 Clinical Laboratory Fee Schedule (CY2016 CLFS) for new test codes, including new codes for several well-established, Medicare covered advanced diagnostic laboratory tests (ADLTs) developed and performed by members of the Coalition for 21st Century Medicine (C21). In the CY2016 Preliminary Determinations, CMS recommended payment rates that, if finalized, would represent drastic reductions in payment rates of C21 company tests of up to 91-percent. These CMS proposed rates are contrary to the agency’s policies and precedent.

The CMS proposed rates depart from CMS’s own precedent over the past several years to delegate ratesetting for these complex tests to the local Medicare Administrative Contractors (MACs). The MACs have established rates for these tests through careful consideration of a number of factors, including market rates and resources. CMS can and should adopt the MAC-established rates for these tests. The MAC-established rates are consistent with the market-based ratesetting policies and procedures enacted by Congress under the Protecting Access to Medicare Act (PAMA), which are scheduled to go into effect in 2017.

The CMS proposed rates are not consistent with CMS’s own policies about ratesetting for new tests and are inconsistent with recommendations from nearly all stakeholders as well as CMS’s recently established Advisory Panel on Clinical Diagnostic Laboratory Tests.

CMS is seeking comments on the CY2016 CLFS Preliminary Determinations—these are not final rates. C21 is confident that we shall convince CMS to adopt the previously established MAC rates when the Final Determinations are published later this year. C21 will be responding to the proposed rates in writing and by meeting with CMS staff and other administration officials.

At a time when the White House is pressing forward with initiatives to advance precision medicine, it is surprising and troubling that CMS would propose drastic cuts to payment rates for some of the leading edge precision medicine tests.

Allowing the proposed rates to stand would seriously risk continued innovation in precision medicine, and will have a negative impact on patient management.

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