Federal Court Issues Favorable Off-label Part D Drug Coverage Decision
The Medicare Advocacy Project of Greater Boston Legal Services recently received a favorable decision from the U.S. District Court in Massachusetts for “off-label” coverage of the drug Dronabinol. This is a welcome development given how difficult it has been to obtain coverage for medications that prescribing doctors agree are necessary, but that are not FDA-approved for the particular diagnosis of the beneficiary. In some cases the off-label medication provides critical relief of severe conditions or symptoms.
In Tangney v. Burwell, 2016 WL 2732157 (D. Mass., May 10, 2016), the beneficiary was suffering from severe nausea, vomiting, and abdominal pain following surgery to correct a partial intestinal obstruction and hernia. After failing to get relief from numerous medications, Ms. Tangney was prescribed Dronabinol, which significantly relived her nausea and vomiting. When the beneficiary became eligible for Medicare Part D, her plan denied coverage for Dronabinol. She was hospitalized for three weeks for dehydration and weight loss after she ran out of Dronabinol.
Ms. Tangney appealed for coverage. An ALJ found in her favor but the Medicare Appeals Council reversed. She then appealed to federal court. The judge examined whether the beneficiary’s use of the Dronabinol to control her nausea and vomiting was, as required by statute, a use for a “medically accepted indication” that was “supported by” a citation in one of the approved compendia, namely Drugdex. 42 USC §§ 1395w-102(e), 1396r-8(k)(6). The government interpreted the relevant Drugdex citation narrowly, stating that because it was based on a single case study which involved “cancer-related nausea,” it could not be used to support use for the beneficiary’s non-cancer-related nausea. The beneficiary argued that since she and the patient in the case study were both receiving palliative care, the similarity of their symptoms should control. The judge followed well-established case law in concluding that the decision of the Medicare Appeals Council was not entitled to extreme deference under the Chevron doctrine, but that it should be afforded “Skidmore deference,” meaning its reasoning had to be persuasive.
Courts often accept the government’s reasoning when conducting a Skidmore analysis, but in this case, the court found that its reasoning was not persuasive. The drug was not being used to cure a condition, but to relieve the beneficiary’s treatment-resistant nausea, just as it was for the patient in the Drugdex case study, who was also receiving palliative care. The underlying cause of the nausea was not relevant. The court therefore held that the government’s reasoning was too narrow and without justification for its limited scope. The court reversed the Medicare Appeals Council’s decision.
The Tangney decision is a welcome but rare example of success in an appeal for coverage of off-label medication by Medicare Part D. The judge understood how critically important the drug was to Ms. Tangney, noting the ALJ’s finding that without it she would “either have to remain in the hospital indefinitely or possibly die.” Tangney, 2016 WL at *5. He even described the situation she was facing as “Kafkaesque.” Id. at *10 n. 22.
As a general matter, the Center believes that Medicare’s reliance on proprietary compendia, such as Drugdex, which is not accessible to the general public, raises serious due process questions. For Medicare to then parse the entries in those compendia to find the narrowest possible grounds for coverage thwarts the very purpose of the Part D program. Ms. Tangney should not have had to go to federal court to obtain coverage, but the arguments she needed to win are available to someone with access to advocates with a sophisticated understanding of both Medicare and administrative law. The Center congratulates the Medicare Advocacy Project and Greater Boston Legal Services for its excellent advocacy in this case, and supports measures that would ease access to medically necessary off-label medications.
May 18, 2016 – A. Bers