The United States District Court for the Eastern District of Texas ruled in favor of the Texas Medical Association and vacated portions of the final rule adopted in August 2022 that applied to the Independent Dispute Resolution process created by the No Surprises Act.
An opinion was issued in one of the three federal Appeals Court cases addressing contract pharmacy restrictions. The Court found that HHS could not require drug manufacturers to provide 340B pricing on drugs shipped to an unlimited number of contract pharmacies.
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. A District Court issued an opinion in AHA v. Becerra remanding the issue of remedies. 7 cases will remain stayed pending a decision in AHA v. Becerra
Tuesday, December 29, 2020
A federal court has ordered EPA to make extensive changes to its Chemical Data Reporting rule (CDR) with respect to asbestos reporting. While the ruling in
ADAO v. Wheeler is limited to CDR reporting of asbestos, it sets the stage for targeted reporting requirements by manufacturers and possibly processors for other substances being considered for prioritization or that are the subjects of risk evaluations. Such requirements might include elimination of the exemptions for substances in articles or present only as impurities and reporting by processors. It will be up to the incoming Biden Administration to decide whether to appeal the decision to the Ninth Circuit or to conduct rulemaking, at least for asbestos.