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ACLA v. Azar: What Was the Court Opinion?

September 1, 2018

Late last week, the U.S. District Court for the District of Columbia issued an opinion in ACLA v. Azar, the lawsuit filed by the American Clinical Laboratory Association (ACLA) that claims the US Department of Health and Human Services (HHS) is unlawfully implementing the 2014 Medicare legislation, jeopardizing beneficiaries’ access to critical lab services. The Court has dismissed the case citing lack of subject matter jurisdiction. The Court concluded that the challenge to data reporting is precluded by the bar on establishing rates. The Judge also rejected the argument that Congress distinguished between data reporting and payment of rates.

Earlier today, the ACLA issued a statement expressing disappointment in this ruling. We agree with ACLA president, Julie Khani, that this ruling “sets a harmful precedent that allows agencies to circumvent Congress’ express directions at the expense of patient care.” XiFin is, like the ACLA, concerned with HHS’s continued stance that “collecting data from less than one percent of laboratories nationwide meets the standards for a market-based system.” XiFin continues to support the work of the ACLA in terms of urging Congressional leaders to take immediate action to mitigate the harm caused by continuing reimbursement cuts to essential lab services.

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