December 18, 2017

ACLA Files Lawsuit Challenging CMS Implementation of PAMA

BY Dr. Keith J. Kaplan

As reported by GenomeWeb among many media outlets, in an anticipated move, the American Clinical Laboratory Association filed a lawsuit last Monday against Acting Secretary of the US Department of Health and Human Services Eric Hargan, challenging the process by which the Centers for Medicare & Medicaid Services set prices for laboratory tests under the Protecting Access to Medicare Act.

The lawsuit, filed in the US District Court for the District of Columbia, argues that CMS, operating under the purview of HHS, ignored congressional intent to implement a market-based laboratory payment system by instituting a flawed data reporting process that excluded the majority of laboratories from reporting private payer data.

“The Secretary has carved out large categories of laboratories — ultimately resulting in the exclusion of some 99.3 percent of the laboratory market — from the statutory reporting requirements,” the lawsuit states.

Specifically, the lawsuit noted that while 7,000 hospital laboratories billed Medicare for laboratory services in 2015, representing 24 percent of the Medicare payments made under the Clinical Laboratory Fee Schedule, no more than 21 hospital labs reported payer information. The suit noted that hospital labs are often the only labs available to patients in certain parts of the country.

Read more here.

See filing here.

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