ACLA Calls on CMS to Modify the Protecting Access to Medicare Act (PAMA) Proposed Rule to Accurately Reflect Market Prices, Support Continued Innovation in Diagnostics

(WASHINGTON, DC) – The American Clinical Laboratory Association (ACLA) offered extensive comments today on the proposed rule addressing reimbursement methodology for clinical labs issued by the Centers for Medicare and Medicaid Services (CMS). In the comments, ACLA urged CMS to accurately define “applicable lab” in order to calculate market-based rates, as well as define Advanced Diagnostic Laboratory Test (ADLT) to include protein biomarkers, as Congress intended. In addition, ACLA stressed that labs are unable to comply with the proposed implementation timeline, and provided an alternative timeline to implement Section 216 of the Protecting Access to Medicare Act (PAMA), the first major overhaul of the Clinical Laboratory Fee Schedule (CLFS) in three decades.

“The proposed rule’s definition of ‘applicable laboratory’ would exclude much of the laboratory market in reporting pricing, and is at odds with both the statutory language and Congressional intent,” said Alan Mertz, President of ACLA. “This flawed definition will result in skewed data and Medicare rates that do not reflect the market.”

Mertz noted ACLA also takes issue with CMS’ definition of ADLT and stated, “We urge CMS to follow the plain reading of the statute and the unanimous recommendation of its own Advisory Panel and include protein biomarkers in the ADLT definition.”

Acknowledging the complicated task of updating the CLFS so it accurately recognizes clinical laboratory services and advanced diagnostic technology, Mertz said, “Reforming the lab fee schedule is a significant undertaking and must be done in a manner that results in fair market pricing, continued innovation, and most importantly, uninterrupted access to diagnostic testing for Medicare patients. Diagnostic innovation has brought medicine to a new frontier by heightening the ability of clinicians to address patient needs with precise treatments that eradicate disease and save lives. Public policy must enhance and not hinder the progress made and the promise it offers to patients now and in the future.”

ACLA’s comments on the proposed rule can be read in their entirety by clicking 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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