ACLA Submits Comments on Next Generation Sequencing National Coverage Determination

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed national coverage determination (NCD), “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.”  In its comments, the association expressed support for Foundation Medicine’s original request for a NCD for its comprehensive genomic profiling test, but voiced deep concern with the proposal by CMS to expand the scope of the NCD to all laboratory tests using NGS technology.

“ACLA supports pathways to coverage of molecular diagnostics,” said Julie Khani, president of ACLA.  “However, by creating a de facto requirement that each laboratory test using NGS technology would need approval or clearance as a medical device by the FDA before receiving Medicare coverage, this NCD, if finalized as drafted, could deprive Medicare beneficiaries of currently available laboratory tests.”

ACLA joined other laboratory stakeholders on a letter in December of last year expressing concern with the expanded scope of the proposed NCD and the limited opportunity to provide comments.  While CMS provided an extension, the additional time granted was still insufficient for stakeholder feedback.  ACLA’s comments note:

“Despite the extension of the comment period, stakeholders have not had adequate time to review and understand the full implications of what would be non-coverage for all but a small handful of laboratory tests that use NGS technology – an important factor in the acceleration of personalized medicine.   Finalizing the NCD as proposed effectively would “slam on the brakes” with respect to advances that have allowed clinicians to tailor medical treatment to the individual characteristics of each patient.”

“ACLA does not believe CMS should finalize the proposed NCD as drafted,” said Khani.  “Restricting conditions of coverage for other tests using NGS technology would have a chilling effect on the development of cutting-edge tests using NGS technology, and would deny Medicare beneficiaries access to innovative, medically necessary testing.”

To view ACLA’s comments in their entirety, click here

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.





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