Justia Opinion Summary and Annotations

The formula that the Department of Health and Human Services must employ annually to set reimbursement rates for certain outpatient prescription drugs provided by hospitals to Medicare patients, 42 U.S.C. 1395l(t)(14)(A)(iii), provides two options. If HHS has conducted a survey of hospitals’ acquisition costs for each covered outpatient drug, it may set reimbursement rates based on the hospitals’ “average acquisition cost” for each drug, and may “vary” the reimbursement rates “by hospital group.” Absent a survey, HHS must set reimbursement rates based on “the average price” charged by manufacturers for the drug as calculated and adjusted by the Secretary. For 2018 and 2019, HHS did not conduct a survey but issued a final rule establishing separate reimbursement rates for hospitals that serve low-income or rural populations through the “340B program” and all other hospitals. The district court concluded that HHS had acted outside its statutory authority. The D.C. Circuit reversed.

A unanimous Supreme Court reversed. The statute does not preclude judicial review of HHS’s reimbursement rates. Absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful. HHS’s power to increase or decrease the price is distinct from its power to set different rates for different groups of hospitals and HHS’s interpretation would make little sense given the statute’s overall structure. Congress, when enacting the statute, was aware that 340B hospitals paid less for covered prescription drugs and may have intended to offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities.

Annotation

Primary Holding

The Medicare statute does not preclude judicial review of HHS’s reimbursement rates. Absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals.