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COLA, a nationally recognized private, non-profit laboratory accreditation organization, recently sent a letter to the U.S. Government Accountability Office (GAO) requesting an expansion of its recent report on the implementation of rate cuts to the Clinical Laboratory Fee Schedule (CLFS). The GAO, in a November 2018 report entitled, “Medicare Laboratory Tests: Implementation of New Rates May Lead to Billions in Excess Payments” (GAO-19-67), did not include an analysis of how the new payment methodology has impacted Medicare beneficiary access to laboratory services.

COLA is a leader in gathering data related to the value of near-patient testing to physicians in their practice as well as data about how, specifically, PAMA-related cuts are impacting laboratories and their patients. In 2017, COLA conducted a summative evaluation study to better understand both the value of near-patient testing and the impact of current reimbursement trends on patient access to testing. In 2018, COLA conducted a survey to gather data from all types of laboratories on the impact of the PAMA-related cuts in the CLFS for Medicare.

“The 2017 summative evaluation study revealed valuable knowledge of how laboratory information supports physicians in the diagnosis, treatment, and care of their patients,” said Dr. John Daly, Chief Medical Officer of COLA. “Several unique features of the study included in-depth interviews and a National Physician Practice Survey to gather quantitative and qualitative data from practicing physicians who perform in-office testing across the U.S. We have offered to share our preliminary data with GAO as a supplement to their published report.”

In the 2018 COLA follow-up survey, just over 56% of participants reported that further cuts in the CLFS will likely cause them to stop providing laboratory services. “We are deeply concerned about the impact of PAMA-related cuts on near-patient testing especially in rural communities. In some cases, near-patient testing in those communities saves lives,” stated Dr. Daly.

In 2014, Congress passed PAMA to direct the Centers for Medicare and Medicaid Services (CMS) to develop a market-based methodology for determining the future rates Medicare will pay for tests under the CLFS, and in 2018, CMS rolled out its first round of cuts impacting many routine tests that physicians use every day to diagnosis and treat patients.  Additional cuts were implemented in January 2019.

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