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Medicare must cover off-label use of prescription drug says 11th Circuit

Donald Dobson has Medicare. He also has intractable and severe nausea and vomiting, which interfere with his ability to function and threaten other aspects of his medical condition. He was diagnosed with Central Spinal Cord Syndrome and Eagle Syndrome. Nothing worked to improve his condition until his doctors prescribed dronabinol. Unfortunately, the FDA hasn’t approved dronabinol for use in this way. As a result, Mr. Dobson’s Medicare Part D plan refused to reimburse Dobson for it’s use.

In Dobson v. Secretary of HHS (2/11/2022), the Eleventh Circuit Court of Appeals considered whether Medicare should be forced to cover this off-label use of a prescription drug and concluded Dobson should have coverage. Medicare Part D pays for drugs with a “medically accepted indication”  and “medically acepted indication” includes those off-label uses for which an approved medical compendium tends to show or helps prove the efficacy and safety of the prescribed off-label use.

A Medicare Part D plan will cover the cost of only those prescription drugs that are considered “covered part D drugs.” Id. § 1395w-102(e)(1). The statute defines “covered part D drug[s]” as those that are used “for a medically accepted indication.” Id. In turn, the statute defines “medically accepted indication” as “any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i).” 42 U.S.C. §
1396r-8(k)(6); see also id. § 1395w-102(e)(4)(A)(ii) (incorporating definition from § 1396r-8(k)(6)).

One of the approved compendia is called the DRUGDEX and it lists one of six off-label uses of dronabinol as for “nausea and vomiting, disease-related treatment refractory.” The compendia, unfortunately, limited its described use to situations involving metastatic cancer and Dobson’s condition was a spinal court injury. Thus, Medicare denied his administrative appeals since treatment for spinal cord injury was not in the compendia. Dobson lost every administrative appeal and was denied coverage in the District Court on this basis. He then appealed to the Eleventh Circuit which reviewed the decision below de novo.

The 11th Circuit framed the dispute as follows:

The only question at issue is whether Dobson’s use of the drug dronabinol to alleviate his constant nausea and vomiting meets the standard Congress set for coverage under Medicare Part D—that is, whether it is “supported by [at least one] citation[] included . . . in [DRUGDEX].” 42 U.S.C. § 1396r-8(k)(6).

Initially, the Court found no need to defer to Medicare interpretation of the statute because “the intent of Congress here is clear and 42 U.S.C.
§ 1396r-8(k)(6) is not genuinely ambiguous.” Thus, Chevron USA v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) and Skidmore v. Swift & Co., 323 U.S. 134 (1944) did not apply. “The Supreme Court has explained that “our inquiry begins with the statutory text,” and if that is “unambiguous,” it “ends there as well.” Nat’l Ass’n of Mfrs. v. Dep’t of Def., 138 S. Ct. 617, 631 (2018). Dictionary definitions and canons of construction are helpful in examining the plain meaning of the text.

The Court found that nothing in § 1396r-8(k)(6) requires hyperspecficity in describing how off-label use supports treatment. The Court found the compendia ranged from specific entries to general entries and the “nausea-and-vomiting entry, at least by its title, encompasses nausea and vomiting that are related to any kind of disease, as long as the nausea and vomiting are stubborn and otherwise unmanageable.”

The Court found it necessary to determine whether the summary in DRUGDEX was a description potential off-label use or a limitation on which off-label use was appropriate. It found there was no limitation, so viewing the DRUGDEX entry as a summary of potential use for intractable and severe nausea and vomiting was more appropriate than strictly limiting it to metastatic cancer treatement.

“Overall, we think the common understanding of “support,” especially in conjunction with a review of the types of entries contained in DRUGDEX and the particular citation involved here, requires the conclusion that the DRUGDEX citation must tend to show or help prove the efficacy and safety of the prescribed offlabel use. It does not, as the Medicare Appeals Council concluded, demand that every aspect of the DRUGDEX citation must match the prescribed off-label use precisely. Had that been Congress’s desire, Congress easily could have used those terms in its definition of “medically accepted indication.” But it didn’t.”

Ultimately, the Court ruled in Dobson’s favor. “We think the DRUGDEX citation for dronabinol titled “Nausea and vomiting, Disease-related,  treatment refractory” satisfies that requirement as it pertains to Dobson’s use of the drug to treat his Central-Cord-Syndrome and Eagle-Syndrome-related refractory nausea and vomiting.” It vacated the decision below and remanded the case to the District Court with instructions to enter summary judgment in Dobson’d favor.



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