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ACLA Seeks Summary Judgment in PAMA Lawsuit

NEW YORK (360Dx) – The American Clinical Laboratory Association filed a motion yesterday requesting a summary judgment in its lawsuit claiming the data on which new Medicare rates for laboratory tests are based was not collected in the way that Congress intended.

The motion, asking US District Judge Emmet Sullivan to rule on the issue without trial, was filed in US District Court for the District of Columbia. The government has until March 16 to issue a reply.

In the motion, ACLA states that the Secretary of Health and Human Services had an "unambiguous directive" from Congress to collect prices broadly from across the laboratory industry in creating new market-based Medicare pricing for lab tests under the Protecting Access to Medicare Act.

The new rates went into effect on Jan. 1.

"One of PAMA's central features is a congressional mandate that the Secretary collect information from all 'applicable laboratories' regarding the private sector payments they receive. The statute defines 'applicable laboratory' broadly to include any laboratory that obtains a majority of its Medicare revenues from fee schedules used to reimburse laboratories for testing services provided to beneficiaries who are not registered hospital patients," the motion stated.

HHS excluded "virtually all hospital laboratories" by defining an applicable laboratory as a laboratory that bills Medicare under its own National Provider Identifier, while most hospital labs do not have their own NPI and instead bill for lab services under the NPI of the hospital, the motion stated. Out of 7,000 hospital laboratories that billed Medicare for services provided to non-hospital patients in 2016, only 21 reported information to HHS, according to the motion.

ACLA claims that this misinterpretation of the directive led to the establishment of payment rates that are "far below private-sector rates," the motion stated, and will force labs to scale back services, or in some cases close, denying patients the care they need.

ACLA's lawsuit, which was originally filed in December, names Secretary of Health and Human Services Alex Azar as defendant.

In requesting summary judgement, ACLA asked Sullivan to "set aside" or correct the HHS definition of applicable laboratory to make it more inclusive of the laboratory industry.