ACLA Commends Senators Hatch and Wyden on Bipartisan Letter on Proposed PAMA Rule

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today applauded Senate Finance Committee Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR) for their leadership in urging the Centers for Medicare and Medicaid Services (CMS) to implement the Clinical Laboratory Fee Schedule (CLFS) provisions of the Protecting Access to Medicare Act (PAMA) consistent with the intent of Congress. The letter takes issue with the Proposed Rule’s exclusion of hospital outreach laboratories from the data reporting process, noting hospital outreach laboratories are a “well defined market segment” that serve Medicare beneficiaries and compete directly in the marketplace with other labs.

Additionally, the Senate Finance Committee’s leading policymakers ask CMS to provide an appropriate reporting timeline that will allow laboratories sufficient time to comply with reporting requirements.

“The clinical laboratory community greatly appreciates the leadership of Senators Hatch and Wyden to underscore the importance of fairness and accuracy as CMS undertakes the complicated process of updating the CLFS,” said Alan Mertz, President of the ACLA. “It is clearly the intent of Congress that the entire clinical laboratory community report payment rates, including independent, physician, and hospital outreach laboratories. Leaving out major segments of the market, as the proposed CMS rule does, will only skew the data and lead to a misrepresentation of payment rates in the marketplace.”

The Hatch-Wyden letter dated January 6 and sent to Acting CMS Administrator Andrew Slavitt, states accuracy in determining marketplace payment rates from private payors is contingent upon CMS receiving “precise and complete private sector data” and specifies the need to include reporting from a broader section of the lab community.

The letter states:

It is critical that the laboratories reporting the private sector data used to determine Medicare payment rates are representative of the marketplace. CMS’ proposal to use Tax Identification Numbers (TINs) to identify laboratories that must report data is too limiting and will fall short of this goal. Use of the TIN methodology would result in Medicare payment rates that fail to reflect information from important segments of the laboratory market, especially hospital outreach laboratories paid under the Clinical Laboratory Fee Schedule.

We urge CMS establish an alternative, more expansive methodology for identifying laboratories that must report final payment rates in the final rule. The Clinical Laboratory Improvement Act (CLIA) number, which all laboratories are required to maintain, provides one such an option. We ask CMS to analyze whether there is a way to use these numbers while still meeting the statutory intent of only including laboratories that receive a majority of their Medicare revenues from the clinical laboratory or physician fee schedules.”

With regard to an appropriate reporting timeline, the Hatch-Wyden letter addresses the proposed reporting period as follows:

The March 31 deadline is particularly unrealistic given that a final rule containing information that laboratories will need to report has yet to be published.  

We urge that CMS establish a reporting deadline in the final rule that is after March 31 and permits laboratories appropriate time to accurately comply with the requirements in the final rule and in the subsequent sub-regulatory guidance.

“Senators Hatch and Wyden recognize the importance of patient access to critical diagnostic testing and the need to ensure that fair and logical public policy promotes diagnostic innovation and the highest quality of health care,” said Mertz.

To read the letter 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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