ACLA Commends Senate Effort to Combat Proposed Gapfill Measures, Protect Medicare Patient Access to Advanced Diagnostic Tests

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today applauded the patient advocacy efforts of Sen. Richard Burr (R-NC), Sen. Michael Bennet (D-CO) and other U.S. Senators who penned a bipartisan public letter to the Centers for Medicare & Medicaid Services (CMS), cautioning CMS against proposed rate cuts for necessary diagnostic tests.

Earlier this year, CMS unveiled its 2016 Preliminary Gapfill Payment Determinations. The proposal would slash Medicare reimbursement rates for two types of vital advanced laboratory diagnostic tests by up to 90 percent.  These innovative, molecular diagnostics include Multianalyte Assays with Algorithmic Analyses (MAAAs) and Genomic Sequencing Procedures (GSPs).  Both types of lab tests are crucial aspects of the federal government’s Precision Medicine Initiative, as they uncover individualized genetic information that allows physicians to better treat conditions such as cancer, cardiovascular disease, and rheumatoid arthritis.

As the Senators write in their letter, such severe payment cuts to vital diagnostic tests could “have a negative and potentially harmful impact on patient care” and “stifle the very innovation that is necessary to fulfill the promise of precision medicine.”

The Senators also expressed concern regarding the lack of transparency in CMS’ payment proposal process, stating that “while the agency is supposed to provide a public explanation as to how gapfill criteria is applied, CMS has yet to provide an explanation for the recently proposed preliminary pricing by its Medicare Administrative Contractors (MACs).” The lawmakers also noted a wide disparity in preliminary payment rates, which suggests an inconsistent application of the gapfill criteria.

“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,” the letter notes.

Additionally, the lawmakers asserted that drastic cuts in reimbursement rates could conflict with the policy aims of the market-based Protecting Access to Medicare Act (PAMA), which “sought to ensure patient access to existing laboratory tests by establishing a transition period that would limit pricing reductions year-to-year.”  To read the letter in its entirety, click here.

“We applaud this bipartisan group of legislators for calling attention to the negative consequences of severe Medicare cuts for vital diagnostic tests,” said Alan Mertz, President of the ACLA. “We hope that CMS will carefully consider the harm these cuts pose and provide adequate pricing for these tests for the benefit of Medicare patients who rely on innovative lab testing to enhance treatments decisions and improve health outcomes.”



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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