Protecting Access to Medicare Act

ACLA Expresses Serious Concerns with Proposed PAMA Medicare Payment Rates for Clinical Laboratory Tests; Renews Call for Delay and Reform

Draft rates demonstrate failure by CMS to follow Congressional intent, consider full laboratory market in setting rates

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) president, Julie Khani, issued the following statement today in response to the Centers for Medicare and Medicaid Services (CMS) publication of proposed CY2018 Medicare reimbursement rates for clinical laboratory tests under the Protecting Access to Medicare Act (PAMA):

“ACLA has conducted an initial review of the draft PAMA rates published by CMS today.  With few exceptions, these rates are not market-based. If finalized, these rates will inflict severe cuts — well beyond those ever envisioned by Congress — and ACLA believes the impact will be unprecedented and far reaching. These rates will devastate many of our members and create severe disruptions in access to laboratory services, particularly for the most vulnerable Medicare beneficiaries.

ACLA supported the Clinical Laboratory Fee Schedule (CLFS) provisions of PAMA when it was passed by Congress in 2014.  We did so because we shared the clear goals of Congress: the development of a market-based fee schedule that would provide predictability and rationality in payment for lab services, a system that would reward innovation, and most importantly, a reimbursement policy that would maintain Medicare beneficiary access to lab services.  Congress has been very clear that the market data collected by CMS was to include all segments of the clinical laboratory market – independent labs, hospital labs and physician office labs.

The draft rates published today make clear that the intention of PAMA has been disregarded and its goals have not been achieved.  Despite concerns voiced by organizations representing independent labs, hospitals, and physicians with the substance of the rule, the accuracy and integrity of the laboratory payment data provided to CMS, and the severe consequences for a critical industry, CMS has pressed forward with a flawed approach and produced a flawed outcome. It is imperative that the implementation of the rates published today be delayed, allowing time for Congress, CMS, and stakeholders to achieve PAMA’s intent: a true market-based payment solution for laboratory services.

ACLA is continuing to evaluate the draft rates and will advocate before all branches of government, including the courts if necessary, for a fair and effective market-based policy solution that encourages innovation and protects Medicare beneficiary access to lab services.”

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The ACLA is a not-for-profit association representing the nation’s leading national, regional, specialty, ESRD and nursing home laboratories on key issues of common concern, including reimbursement and regulatory policies. The clinical laboratory industry is at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

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