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Lab Industry Organizations File Amicus Briefs in Support of ACLA's PAMA Lawsuit

NEW YORK (360Dx) – The College of American Pathologists and the American Association of Bioanalysts filed amicus briefs Tuesday supporting the American Clinical Laboratory Association's lawsuit over the implementation of new market-based Medicare pricing for lab tests under the Protecting Access to Medicare Act.

CAP, which was joined in its brief by the Advanced Medical Technology Association (AdvaMed) and the National Association for Support of Long Term Care, argued that less than 2,000 out of 58,593 laboratories reimbursed under Medicare Part B in 2016 were required to report market-based pricing under the definition of "applicable laboratory" used by the Department of Health and Human Services in PAMA's implementation. The brief also argued that only 21 hospital laboratories determined themselves to be "applicable" labs under the rule.

"The [HHS] Secretary's claim that he can exclude reporting from approximately 97 percent of laboratories strains credulity," the brief stated.

US District Judge Amy Berman dismissed ACLA's PAMA implementation lawsuit against Health and Human Services Secretary Alex Azar in September, citing "lack of subject matter jurisdiction." ACLA has appealed that decision and filed the opening brief of its appeal earlier this month.

In its amicus brief, AAB, which is the parent organization of the National Independent Laboratory Association, argued that the district court ruling was flawed.

"The District Court's holding effectively allows the Secretary to enact any regulation he sees fit, even one that expressly conflicts with a statutory provision, because any definition employed by the Secretary will impact the data collected and the rates of payment calculated," the AAB brief stated.

AAB said in its brief that its members, which include community and regional clinical laboratories, "have been and will continue to be negatively affected" by PAMA under its current implementation structure.

In addition to supporting the legal challenge to PAMA, CAP is working with Congress to amend PAMA to ensure that reimbursements for clinical laboratory tests are accurate and truly reflect the cost of patient care, the organization said in a statement.