The Center for Medicare Advocacy and the Community Legal Services clinic at the University of the Pacific, McGeorge School of Law filed a class action lawsuit (Case 2:23-cv-01932-DB) against HHS on Sept. 8 on behalf of Medicare beneficiaries who have lost coverage of certain Medicare Part B drugs. Plaintiffs were receiving the Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) in an outpatient clinic, where the agent was administered by health care professionals and covered under Part B as an agent provided “incident to” a physician’s service due to disabilities that prevent them from self-administration. In October 2021, HHS denied coverage of Stelara under Part B because it had determined that the drug is “usually self-administered by the patient.” HHS did not notify patients about the change, and it did not require providers to issue a notice. One plaintiff had four injections of more than $40,000 each, while another had two injections of about $58,000 each, before they realized that they were responsible for the full cost of the drug. Plaintiffs are seeking “timely, adequate notice” be required when a Part B drug that has been furnished incident to a practitioner’s service is added to the self-administered drug (SAD) list, as well as a modification to Medicare allowing beneficiaries who cannot self-administer a medically necessary drug due to a disability to be able to receive Medicare-covered medications administered by a health care professional, among other requests.