Clinical Laboratories, Laboratory Professionals, Physicians Urge HHS to Delay PAMA Implementation

– Challenges with Data Reporting Requirements, Problems with CMS Reporting Portal Cause Rate Calculation Integrity Concerns; Threaten to Reduce Clinical Lab Infrastructure and Limit Patient Access to Vital Laboratory Test Services –

WASHINGTON, D.C. –  Ten organizations representing a diverse cross section of the clinical laboratory community – including the American Clinical Laboratory Association – today sent a joint letter to U.S. Department of Health and Human Services (HHS) Secretary Tom Price calling for a one-year delay of the Medicare Clinical Laboratory Fee Schedule (CLFS) reform implementation as outlined in the Protecting Access to Medicare Act of 2014 (PAMA).

In calling for the delay, the clinical laboratory community expressed significant and ongoing concerns that the new program will not reflect accurate private market rates for clinical laboratory services, and that the rates issued could limit patient access to vital laboratory test services.

“While our organizations have worked closely with our members and the Centers for Medicare and Medicaid Services (CMS) toward PAMA implementation, we believe that under the current regulatory requirements, the new program will not reflect accurate private market rates for clinical laboratory services as required by PAMA,” the letter states. “Given the significance of these concerns, we respectfully request CMS delay the implementation of the CLFS reform under PAMA for one year to resolve these issues. By ensuring smooth and successful implementation, we can maintain Medicare beneficiary access to clinical laboratory services without disruption.”

Although the data reporting period for PAMA is scheduled to conclude on March 31, 2017, many clinical laboratories are still in the data collection phase as laboratories struggle with CMS regulatory requirements and ongoing operational problems with CMS’ data collection system.

“CMS and laboratories simply must have more time to address data collection concerns, collect, and ensure accurate submission of all applicable data as this will impact final PAMA rates,” the letter states.

The clinical laboratory community also urged CMS to reassess and redefine the “applicable laboratory” definition to appropriately capture the true laboratory market.

“PAMA payment reforms depend on an accurate measurement of true private market rates; however, the HHS OIG analysis of the current CMS definition for “applicable laboratory” assessed that only 5 percent of clinical laboratories will report data, with an estimated complete exclusion of hospital laboratories,” the letter states. “The exclusion of an entire laboratory sector, particularly hospitals operating large outreach laboratories, negatively affects the integrity of rate calculations under PAMA.”

“Given the widespread impact of these issues, we respectfully ask that CLFS reform implementation under PAMA be delayed for one year to allow an opportunity for all stakeholders to work with the Administration on solutions. We are committed to working on partnership with you to address these concerns,” the letter concluded.

Signatories of the letter, including ACLA, represent a diverse cross section of clinical laboratory stakeholders, including national, community, and regional independent laboratories, hospital laboratories, physician office laboratories, academic laboratories, manufacturers of IVD test kits and supplies, and the physician community more broadly.

To view the letter, click here.


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The American Clinical Laboratory Association (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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