Edwin R. Banks v. Secretary, Department of Health and Human Services, No. 21-11454 (11th Cir. 2022)
Annotate this Case
Plaintiff’s doctors prescribed him Optune, a medical technology that had recently received FDA approval for treating recurrent GBM. The device delivers tumor treating field therapy (TTFT) to inhibit cancer-cell replication. A company called Novocure is the sole supplier of the Optune device, which is rented by patients on a monthly basis.
Because Plaintiff is a Medicare Part B beneficiary, he and Novocure asked Medicare to cover his TTFT. Novocure was held liable for the claims. Plaintiff and Novocure submitted 13 claims to Medicare, corresponding to 13 months of TTFT. The district court held that Plaintiff lacked standing because he hadn’t suffered an injury in fact.
The Eleventh Circuit was tasked with deciding whether Plaintiff has standing to challenge a denial of Medicare coverage where the costs of his treatment were imposed not on him, but rather on a third-party supplier. The court affirmed the district court’s determination that Plaintiff hadn’t suffered an injury in fact.
Here, Plaintiff’s alleged harm will only come to pass due to the challenged action if, at some indefinite point in the future: (1) his condition worsens, (2) he has paid his premiums and stayed on Medicare Part B, (3) he elects to resume TTFT, (4) his doctor prescribes the therapy (5) Plaintiff receives the treatment, (6) he files a claim, (7) which is denied at every level of the Medicare appeals process, (8) the adjudicators determine that Plaintiff’s hypothetical future case presents a “comparable situation,” and (9) they further find that the instant coverage denial and no other source put Plaintiff on notice that he could be held liable.
This opinion or order relates to an opinion or order originally issued on July 26, 2021.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.