ACLA Praises House Bipartisan Dear Colleague 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 Democrats and Republicans in the U.S. House of Representatives 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, led by Representatives Bill Pascrell (D-NJ09) and Patrick Meehan (R-PA07), expresses concern with many provisions of the proposed rule, and urges CMS to “make changes to the proposed policy to reflect Congressional intent, provide clinical laboratories with sufficient time to implement these important changes, and preserve market competition to ensure continued access to laboratory services.” The letter addresses similar concerns to those recently articulated by nineteen Senators.

ACLA commends the bipartisan nature of the Dear Colleague letter, and appreciates the commitment of Members of Congress in ensuring a smooth PAMA implementation. “This Dear Colleague letter vigorously illustrates 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.

ACLA also applauds the clear call made by the Dear Colleague letter urging CMS to revise the definition of Advanced Diagnostic Laboratory Tests (ADLTs) to reflect statutory intent. Specifically, the letter states “CMS should revise the ADLT definition to reflect the statute’s inclusion of proteins.” “Protein-based diagnostics are being used in laboratories today to impact patient care and many more are under development,” stated Mertz. “It is critical that CMS follow the statutory language in this area.”

The letter, signed by 44 U.S. Representatives and delivered to Andy Slavitt, Acting Administrator for CMS, notes:

“[U]nder CMS’s current proposal, a number of laboratories are prohibited from participating in the reporting process. We are deeply concerned that this prohibition will skew market data, resulting in Medicare rates that are not reflective of true market prices.”

It goes on to state:

“ . . .CMS must reconsider the proposed timeline. . . . The proposed timeline presents a significant challenge to the laboratory community as it provides little time to prepare, certify, and submit upwards of millions of data point based on a yet-to-be released Agency requirements. Accurate reporting is essential to establishing appropriate reimbursement rates.”

Mertz added “This strong, bipartisan statement is in alignment with the position of clinical lab community, strongly urging CMS to delay implementation of the PAMA CLFS reforms until improvements can be made, not only to protect access to clinical laboratory services for Medicare beneficiaries, but also to ensure continued diagnostic innovation.”

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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