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Mark E. Brager
(202) 434-7244
June 17, 2016

AdvaMedDx Statement on CMS Clinical Diagnostic Lab Test Payment System Final Rule


WASHINGTON, D.C. – Wanda Moebius, spokesperson for AdvaMedDx, issued the following statement on CMS’s final rule implementing the new Clinical Diagnostic Lab Test Payment System that was established under the Protecting Access to Medicare Act (PAMA) of 2014:

“AdvaMedDx is pleased CMS has issued its long-awaited final rule implementing historic reforms of Medicare’s Clinical Laboratory Fee Schedule under PAMA. These reforms will provide for a more transparent process for establishing lab test payments, ensure greater stakeholder and expert input, and better recognize the value of innovative diagnostics, which are vital to earlier disease detection and improved patient outcomes.

“We commend CMS for delaying implementation of the new payment system for one year – until Jan. 1, 2018 – as recommended by AdvaMedDx and other stakeholders. The delay will help to ensure that there is time for accurate data collection and implementation of the new payment system.

“In addition, while we are still reviewing the details of the final regulation, we are pleased that CMS is amending the definition of applicable laboratories in the final rule to include hospital outreach laboratories with a separate National Provider Identifier number. We are encouraged by this change and hope that it will provide for more accurate rates based on the full spectrum of laboratory providers.

“We look forward to working with CMS, the laboratory community and all other stakeholders to ensure smooth implementation of the new payment system.”


AdvaMedDx member companies produce innovative, safe and effective in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies both in the United States and abroad.