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ACLA Files Lawsuit Against the US Dept. of Health and Human Services

Over the past six months, the American Clinical Laboratory Association (ACLA) expressed serious concerns with the Protecting Access to Medicare Act proposed Medicare payment rates for clinical laboratory tests. On Monday, the ACLA filed a lawsuit  against United States Department of Health and Human Services (DHHS) challenging the process for setting the Clinical Laboratory Fee Schedule (CLFS) which goes into effect on January 1, 2018 

Filed in the United States District Court for the District of Columbia, the lawsuit argues that the Centers for Medicare and Medicaid Services  (CMS) final rule resulted in a flawed process that failed to protect access to laboratory services for Medicare beneficiaries and violated Congress’ statutory directives. The lawsuit asserts that (CMS), operating under the purview of DHHS, ignored congressional intent and instituted a highly flawed data reporting process in advance of setting market rates under (PAMA).  Contrary to Congress’s directives, the overwhelming majority of laboratories were prohibited from reporting private payer data. The flawed process could cause serious financial harm to potentially thousands of hospital and independent  clinical laboratories, and make it harder for Medicare beneficiaries to get access to laboratory testing, particularly in remote rural areas and nursing homes. 

ACLA supports modernizing the CLFS under PAMA, assuming the process would be based on the clear direction of Congress to establish a Medicare payment system based on the collection of private payor rates across the wide spectrum of the clinical laboratory community.  In the lawsuit, ACLA seeks declaratory and injunctive relief that would require the secretary to comply with the statutory requirements and set aside the provisions in the final rule from that exempt thousands of laboratories from the reporting obligations.


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SOURCE American Clinical Laboratory Association (ACLA)


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