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Legislators Urge CMS to Delay PAMA Implementation

NEW YORK (GenomeWeb) – Several legislators have penned a letter to the Centers for Medicare & Medicaid Services, asking the government payor to delay the implementation of a law that will establish a market-based payment system for clinical lab tests.

The Protecting Access to Medicare Act of 2014 (PAMA) seeks to implement this payment system using private payor rates by Jan. 1, 2017. But CMS hasn't yet issued a final rule, so legislators are concerned that the agency will "improperly rush" implementation in the coming months.

"Updating the [clinical lab fee schedule] is a highly complex task with significant implications for all stakeholders, with a reach far beyond the Medicare program," House Ways and Means Health Subcommittee Chairman Pat Tiberi (R-OH) wrote in a letter to CMS Acting Administrator Andy Slavitt, co-signed by more than two dozen other Republican and Democratic committee members.

"We believe the critical alterations to the CLFS must be accomplished in a deliberate and measured manner, so that laboratories have sufficient time, once the final rule and subregulatory guidance are issued, to comply," the letter said. "Given the delays in the rulemaking process, the January 1, 2017 effective date for the new CLFS payment methodology is not feasible and should be delayed."

CMS's initial proposal for implementing PAMA, released last September, received a critical response from industry. In the letter, legislators pointed out that PAMA included other deadlines ahead of final implementation that CMS hasn't yet met, such as publishing a final rule by June 30, 2015, and initiating price reporting from labs beginning on Jan.1, 2016.

"Obviously, neither of these deadlines has been met," the legislators wrote. "Congress set up this specific set of milestones to ensure laboratories and CMS would have sufficient time to collect, report, submit, and analyze private payor data, and establish new reimbursement rates." The lawmakers urged CMS to ensure that PAMA is implemented "in a fair and reasonable manner," allowing labs and the agency the "best opportunity to construct this market-based system."

Large reference labs, such as Quest and the Laboratory Corporation of America have expressed similar concerns about PAMA implementation timelines.

The American Clinical Laboratory Association lauded the legislators' letter. “A successful transition — marked by reasonable and achievable milestones for clinical laboratories — is in the best interest of patients, clinical laboratories, and the Medicare program as whole," ACLA President Alan Mertz said in a statement.