ACLA Expresses Concern that CMS’ Gapfill Payment Rates Will Compromise Patient Access to Advanced Diagnostic Tests

October 03, 2016 Categories: ACLA News, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today stated its strong opposition to the 2016 Final Gapfill Payment Determinations, which include drastic cuts to Medicare payment rates for some Multianalyte Assays with Algorithmic Analyses (MAAAs), and Genomic Sequencing Procedures (GSPs). These reductions are far out of line with what the Medicare program has historically paid for these tests, and if implemented, will hamper innovation and turn back the clock on advances in precision medicine.

“The clinical lab community is urging CMS to reconsider these drastic payment rate cuts,” said Alan Mertz, President of ACLA. “Implementing these cuts will threaten Medicare patients’ access to these groundbreaking diagnostics that lead to more effective treatments.”

CMS’ 2016 Final Gapfill Payment Determinations slash Medicare reimbursement rates for some MAAAs and GSPs, two types of vital advanced laboratory diagnostic tests considered crucial aspects of the federal government’s Precision Medicine Initiative. Today, many of the tests falling into these categories are recognized as the standard of care for the diagnosis of certain conditions, or for the high-value prediction or monitoring of therapeutic response. MAAA and GSP tests are used to uncover individualized genetic information that allows physicians to better treat conditions such as cancer, cardiovascular disease, and rheumatoid arthritis.

Prior to the release of the final determinations, Sen. Richard Burr (R-NC), Sen. Michael Bennet (D-CO) and other U.S. Senators questioned the process by which the proposed preliminary rate cuts to these tests by CMS were determined and noted a wide disparity in preliminary payment rates that suggests an inconsistent application of the gapfill criteria. In a bipartisan letter sent last week to CMS’ Acting Director Andrew Slavitt, the senators stated, “We are concerned with the lack of transparency in the process by which these cuts have been proposed and the impact such significant cuts would have on patients’ access to these advanced tests.”

“Moving forward with draconian cuts to these critical tests is truly a step backward for medical science and patients,” said Mertz. “ACLA’s position remains steadfast in that reimbursement for diagnostic tests should reflect the true value of the service and impact it provides to patient care.”


About the American Clinical Laboratory Association
The American Clinical Laboratory Association (ACLA) is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.

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