41-37 Letter to the Editor

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Letter to the Editor

Dear Editor,

We are writing to clarify a few points in your Oct. 2 article, “CMS to Trim Spending on Diagnostic Lab Tests,” as it mistakenly intertwines two issues.

On Friday, Sept. 25, 2015, the Centers for Medicare & Medicaid Services (CMS) released three separate items related to molecular diagnostics: 1) the 2015 Final Gapfill rates; 2) the Preliminary Determinations for the Calendar Year 2016 Clinical Laboratory Fee Schedule; and, 3) the Medicare Clinical Diagnostic Laboratory Tests Payment System Proposed Rule (as required under PAMA Section 216).

In the 2015 Gapfill rates the payment rate for Oncotype DX test for breast was reduced. Yesterday, CMS announced a technical correction to this payment rate and Genomic Health issued a release.

In the CY2016 Preliminary Determinations, CMS recommended payment rates that, if finalized, would represent drastic reductions of 30% up to 90% in payment rates for several well-established, Medicare covered advanced diagnostic laboratory tests. CMS has since announced a public expert Advisory Panel meeting on October 19th. The Coalition and member companies plan to present and we believe this an opportunity for CMS to correct the rates and issue a Final Determiantion of gapfill for 2016. The gapfill recommendation would have the effective of leaving pricing to the Medicare contractors, thus allowing MACs to continue with their current pricing. We think this is consistent with CMS policy, the August Advisory Panel recommendation, and the PAMA statute.

In the Clinical Diagnostic Laboratory Tests Payment System Proposed Rule CMS included a restrictive definition for Advanced Diagnostic Laboratory Tests (ADLTs) that would exclude tests based on an analysis of proteins. These advanced diagnostic tests provide physicians with specific information for managing the care of patients with complex conditions, like cancer, heart transplants, cardiovascular disease and rheumatoid arthritis. C21 plans to submit comments in the next month on the Proposed Rule.

Sincerely,

The Coalition for 21st Century Medicine

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