The American Association of Bioanalysts (AAB), and the National Independent Laboratory Association (NILA), both in St. Louis, have provided a joint statement to the Centers for Medicare and Medicaid Services (CMS) alleging that the agency used an unlawful method to implement Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA) by double-counting Part C Medicare Advantage payments as both Medicare and private payor revenues.

Submitted in response to CMS’s proposed physician fee schedule for 2019, the associations’ comments address the federal agency’s inclusion of Part C Medicare Advantage plans as both ‘Medicare revenues’ to determine the definition of an applicable laboratory, and as ‘private payor revenues’ that laboratories were required to report to the agency. The erroneous method resulted in double-counting Part C Medicare Advantage revenues, ultimately affecting the number of laboratories required to report their revenues under PAMA’s definition of an ‘applicable laboratory.’

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Mark Birenbaum, American Association of Bioanalysts and National Independent Laboratory Association.

“It is deeply concerning to AAB and NILA that CMS’s categorization of Part C Medicare Advantage plans as Medicare revenue from the outset was in conflict with the clear statutory directive, and therefore unlawful,” the associations comment. Additionally, the groups observe, the PAMA statute clearly defines ‘private payor’ to include Part C Medicare Advantage plans.

AAB and NILA further argue that CMS’s proposal to remove Part C Medicare Advantage plans from the calculation of Medicare revenues used to determine the qualifications of an applicable laboratory does not go far enough to address the agency’s fundamentally flawed implementation of Section 216 of PAMA.

“Double-counting Part C Medicare Advantage revenues is not just an error, it is unlawful, and it means the 2018–2020 Clinical Laboratory Fee Schedule (CLFS) rates established by CMS cannot be sustained and must be halted until accurate data can be collected,” says Mark Birenbaum, administrator of AAB and NILA. “CMS must remedy its mistake before it is too late and Medicare beneficiaries are left without access to routine clinical diagnostic tests.”

AAB and NILA also highlight their concern that CMS is continuing to limit the types of laboratories that are required to report laboratory reimbursement data. AAB and NILA support using CMS-1450 bill type 14x to identify Medicare revenues from hospital outreach laboratories as a way of ensuring that hospital outreach laboratories are included as applicable laboratories for reporting purposes.

Although CMS has argued that inclusion of hospital outreach laboratories goes against Section 216 of the PAMA statute, AAB and NILA provide statements from two US senators who explicitly acknowledge that private payor data from hospital outreach laboratories were intended to be included in CMS’s CLFS calculations, so that all sectors of the laboratory market would be represented.

Founded in 1956, AAB is a professional association representing bioanalysts (clinical laboratory owners, directors, managers, and supervisors), medical technologists, medical laboratory technicians, and physician office laboratory technicians. NILA members are independent community and regional clinical laboratories working with physician practices, hospitals, outpatient care settings, skilled nursing facilities and home health patients to provide essential clinical laboratory services to Medicare beneficiaries, particularly those in underserved communities and hard to reach care settings.

For additional information, visit AAB and NILA.