American Clinical Laboratory Association v. Xavier Becerra, No. 21-5122 (D.C. Cir. 2022)
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In 2016, the Secretary of Health and Human Services (“HHS”) issued a final rule that implemented The Protecting Access to Medicare Act of 2014 (“PAMA” or “Act”), definition of “applicable laboratory” (“2016 Rule”). The American Clinical Laboratory Association (“ACLA”) filed a lawsuit challenging the 2016 Rule as arbitrary and capricious under the Administrative Procedure Act (“APA”) on the basis that it depresses Medicare reimbursement rates by excluding most hospital laboratories from PAMA’s reporting requirements. ACLA contended that because hospital laboratories tend to charge higher prices than standalone laboratories, their exclusion from reporting obligations results in an artificially low weighted median.
On remand, the parties cross-moved for summary judgment. The district court declined to reach the merits of ACLA’s APA challenge to the 2016 Rule, based on its determination that the Secretary had issued a new rule (“2018 Rule”) that superseded the 2016 Rule and mooted ACLA’s lawsuit.
The DC Circuit concluded that the case is not moot. Accordingly, the court reversed the district court’s dismissal for lack of subject matter jurisdiction and reached the merits of ACLA’s APA claim. The court explained that the 2016 Rule is arbitrary and capricious because the agency “failed to consider an important aspect of the problem.” The court wrote that PAMA provides that an applicable laboratory “means a laboratory that” receives “a majority” of its Medicare revenues from the Physician Fee Schedule or Clinical Laboratory Fee Schedule. Thus, hospital laboratories that provide outreach services may, in some instances, constitute “applicable laboratories” under PAMA.
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