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Center Appeals Dismissal of Self-Administered Drug Lawsuit

June 6, 2024

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On June 3, 2024, the Center for Medicare Advocacy and Community Legal Services at the McGeorge School of Law appealed the dismissal of a class action filed on behalf of beneficiaries who lose coverage of very expensive, medically-necessary drugs with no warning. The lawsuit challenges Medicare’s policy of not requiring any notice when a drug that was covered by Medicare Part B is added to the “self-administered drug list” (SAD List) and thus excluded from such coverage.

Lead plaintiff George Beitzel, 85, requires Stelara, an injectable drug that – for years – was administered to him in a clinic to treat symptoms of Crohn’s disease. He also has Parkinson’s disease and cannot administer the drug himself. Medicare Part B covered the drug as one that was furnished “incident to the services of a physician.” But then, unbeknownst to Mr. Beitzel, Medicare determined that Stelara is “usually self-administered by the patient,” meaning it could no longer be covered as it had been, under Part B. Medicare provided no notice to beneficiaries of this change in coverage terms, and it did not require medical practitioners to provide notice. Only after Mr. Beitzel received multiple additional scheduled injections from the clinic did he learn that the drug was no longer covered by Part B. He tried appealing, but Medicare’s decisions held him financially responsible for the drug’s full cost, which was over $40,000 per injection.

The plaintiffs raised due process and statutory claims challenging Medicare’s policies and practices with regard to self-administered drugs. The federal court for the Eastern District of California dismissed the case in April 2024 on the grounds that it lacked jurisdiction over the claims of two plaintiffs and that the third plaintiff had failed to state a claim for which relief could be granted. The appeal will be heard by the U.S. Court of Appeals for the Ninth Circuit.

June 6, 2024 – A. Bers

Filed Under: Article Tagged With: litigation update, Weekly Alert

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