The American Clinical Laboratory Association (ACLA) in a lawsuit in
federal court in Washington, D.C., said the U.S. Centers for
Medicare & Medicaid Services (CMS) ignored Congressional intent by
implementing the new system following the passage of a 2014 law.
That law, the Protecting Access to Medicare Act (PAMA), aimed to
establish a market-based pricing for certain lab tests and required
laboratories to report information to ensure Medicare reimbursement
rates were closer to those private insurers pay.
CMS declined to comment on the litigation.
The lawsuit came after CMS last month rolled out deep cuts to
reimbursement rates for some lab tests under Medicare that could
save the government as much as $3 billion over five years but could
hurt laboratory companies' margins.
In its lawsuit, ACLA argued that while PAMA required all "applicable
laboratories" report market information on private payors, CMS had
arbitrarily exempted 99.3 percent of the laboratory market from the
reporting requirement.
The vast majority of the data was instead collected from the
country's two largest laboratory owners, including Quest Diagnostics
Inc, the lawsuit said.
As a result, CMS has implemented PAMA's reporting requirements in a
way that "cherry-picks data" from a small piece of the market that
receives the lowest private payor rates, the lawsuit said.
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"We have repeatedly advised CMS that there are significant,
substantive deficiencies in the final rule, which fails to follow
the specific commands of the PAMA statute," ACLA President Julie
Khani said in a statement.
Laboratory Corporation of America Holdings and Quest, who are both
members of ACLA, in separate statements said that they supported the
lawsuit.
"These rates, if allowed to take effect, will have significant
negative consequences for Medicare beneficiaries and throughout the
healthcare system," LabCorp Chief Executive David King said in a
statement.
The case is American Clinical Laboratory Association v. Hargan, U.S.
District Court, District of Columbia, No. 17-cv-2645.
(Reporting by Nate Raymond in Boston; Editing by Andrew Hay)
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