ACLA Praises Senate Bipartisan Dear Colleague Letter on PAMA Proposed Rule, Letter Expresses Concern with Implementation Timeline, Stresses Importance of Preserving Patient Access to Important Diagnostics

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today applauded both Democratic and Republican Senators for signing onto a Dear Colleague letter delivered to the Centers for Medicare and Medicaid Services (CMS) that requests a delay in the implementation of the Clinical Laboratory Fee Schedule (CLFS) provisions of the Protecting Access to Medicare Act (PAMA) of 2014. The letter expresses concern with many provisions in the proposed rule, and urges CMS delay implementation until a data reporting system can be established that will result in accurate reimbursement rates and uninterrupted access to care for Medicare beneficiaries.

ACLA commends the Dear Colleague, and appreciates the broad, bipartisan support articulated for the carefully measured implementation of PAMA. “The Dear Colleague letter forcefully points out that the proposed timeline for reporting data and pricing will result in skewed data and Medicare rates that do not reflect the market,” said Alan Mertz, President of ACLA, “The proposed rule excludes much of the laboratory market in reporting pricing and is at odds with both the statutory language and Congressional intent.”

The letter, signed by 19 U.S. senators and delivered to Andy Slavitt, Acting Administrator for CMS, notes:

We believe the proposed rule fails to provide the clinical laboratory community with the information and time frame necessary to meet the goals of PAMA. We are also concerned with the proposed rule’s approach on other issues, including how, under the current proposal, a significant part of the laboratory market is excluded from participation, limiting the market data CMS will have for review, and how Advanced Diagnostic Laboratory Tests (ADLTs) are defined.”

It goes on to state:

“Under CMS’ current proposal clinical laboratories are expected to establish new information systems, collect, assess, and validate data sets according to regulations that have yet to be finalized, and quickly report 2015 data to CMS from as late as December 31, 2015 between January 1, 2016 and March 31, 2016, or face penalties in the amount of $10,000 per day. This unrealistic timeline provides the laboratory community with less than two months to prepare, certify, and report complex sets of data through a reporting system that had not been tested in the field and submit millions of data sets that follow a set of agency requirements CMS has not yet finalized.”

“The strong, bipartisan agreement of Senators with the clinical lab community is indicative of the need for CMS to delay the proposed PAMA rule and to be mindful of protecting patient access to diagnostic innovations, which must be the priority in any public policy impacting clinical laboratory services,” said Mertz.

To read the Dear Colleague in its entirety, click here.

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The 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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