The U.S. Supreme Court declined to hear an appeal challenging HHS' site-neutral pay policy, in today's bite-sized hospital and health industry news from the District of Columbia, Indiana, and Oregon.
- District of Columbia: The U.S. Supreme Court on June 28 chose not to hear an appeal that challenged HHS' site-neutral pay policy, enabling the long-contested policy to move forward. According to Modern Healthcare, the policy—which reduces payments for clinic visits at hospital outpatient departments—was struck down by a trial court in 2019. However, the U.S. Court of Appeals for the District of Columbia Circuit reversed the decision in 2020, ruling the policy was legal because the "changes were volume-control measures that don't have to be budget-neutral," Modern Healthcare reports. In its decision, the Supreme Court did not elaborate on why it chose not to hear the appeal. (Modern Healthcare, 6/28; Paavola, Becker's Hospital Review, 6/28)
- Indiana: Eli Lilly plans to submit its Alzheimer's drug, donanemab, to FDA for accelerated approval later this year. According to Eli Lilly, FDA recently gave donanemab a "breakthrough therapy" designation, which is used to speed up the development and review of drugs that may perform better than treatments that are currently available. Although the company is currently conducting a Phase 3 study, it is requesting approval based on the results of a Phase 2 clinical trial, which involved 272 patients. Eli Lilly's move follows FDA's controversial decision to grant accelerated approval Biogen's similar Alzheimer's drug, Aduhelm, earlier this year. (Cooper, Wall Street Journal, 6/24; Vinluan, MedCity News, 6/24; Weixel, The Hill, 6/24)
- Oregon: The Oregon legislature passed the Equal Access to Care Act, a bill that would increase oversight into health care mergers and acquisitions. Under the new bill, the Oregon Health Authority must approve any mergers, partnerships, or acquisitions that would increase an organization's net patient revenue by $1 million or more. If health care entities cannot show that a transaction would reduce patient costs or increase access to services, regulators could deny the transaction. The bill—which would apply only to health care organizations that reported a minimum of $25 million in net patient revenue in the three years prior to the proposed deal under review—is part of larger efforts from state and federal regulators to curtail anticompetitive transactions, Modern Healthcare reports. (Kacik, Modern Healthcare, 6/28)