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Center for Medicare Advocacy Sues Over Medicare “Self-Administered Drug” Problems

September 11, 2023

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On September 8, 2023, the Center for Medicare Advocacy and Community Legal Services at the McGeorge School of Law filed a class action lawsuit in federal court on behalf of Medicare beneficiaries who have lost coverage for medically necessary, very expensive drugs with no warning.

The lead plaintiff, George Beitzel, 84, of California, requires Stelara, an injectable drug that – for years – was administered to him in a clinic by a health care professional to treat symptoms of Crohn’s disease. Mr. Beitzel also has Parkinson’s disease and cannot administer the drug himself due to his disability. The drug was covered under a provision that allows Medicare Part B to pay for drugs that are furnished “incident to the services of a physician.” Unbeknownst to Mr. Beitzel, Medicare changed its policy and deemed Stelara to be “usually self-administered by the patient,” meaning it would no longer be covered for him as it had been, under Part B.

Medicare provided no notice of this change and does not require medical practitioners to provide notice. Only after Mr. Beitzel received multiple additional injections from the clinic did he learn that the drug was no longer covered by Part B and that he was responsible for its full cost. He received four injections, which cost over $40,000 each. Moreover, since Mr. Beitzel cannot self-administer Stelara due to his disability, he lost safe access to the drug and has been forced to rely on a friend for administration.

The two named plaintiffs challenge Medicare’s policy of providing no notice when a drug that was covered by Part B is added to the “self-administered drug list” and thus excluded from such coverage. They raise due process and statutory claims to ensure that beneficiaries can make informed decisions about whether and how to receive these medications, and can be shielded from financial liability if they do not receive proper notice. The plaintiffs also seek to ensure that beneficiaries who cannot self-administer do not face greater barriers to accessing these drugs because of their disabilities. The complaint estimates that thousands of Medicare beneficiaries are affected by these problems nationwide.

While patients may be able get coverage of these “self-administered” drugs from their Medicare Part D plans, they need to be notified in advance to ensure they can meet their plans’ individual conditions, like formulary requirements, pharmacy networks, and prior authorizations. If the cost to beneficiaries under Part D is too high – as it can be for many injectable drugs – advance notice is essential to allow them to discuss treatment alternatives with their doctors or explore other sources of coverage.

“What happened to Mr. Beitzel and others is wrong and a clear violation of due process. Patients should not be lulled into thinking that Medicare coverage of an expensive drug is continuing, only to learn after the fact that they are responsible for exorbitant costs,” said Alice Bers, Litigation Director for the Center for Medicare Advocacy.

The Center for Medicare Advocacy is pleased to be partnering with the Community Legal Services clinic at the University of the Pacific, McGeorge School of Law in representing the plaintiffs in this case. Read the complaint in Beitzel v. Becerra, Case No. 2:23-CV-01932-DB.

Filed Under: Press Release Tagged With: litigation update

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