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From Health Law Daily, May 12, 2016

Court liberally construes compendium to allow coverage for symptom-controlling drug

By Patricia K. Ruiz, J.D.

Despite a less-than-ideal compendium entry recommending a drug for the treatment of symptoms including severe nausea, vomiting, and abdominal pain, the District of Massachusetts vacated a decision of the Medicare Appeals Council denying Part D coverage for a patient whose symptoms were controlled by the medication. The court reasoned that the Social Security Act is a remedial statute that should be broadly and liberally construed in favor of beneficiaries (Tangney v. Burwell, May 10, 2016, Young, W.).

Dronabinol to treat symptoms. Physicians of a patient suffering from severe nausea, vomiting, and abdominal pain following surgery to correct a partial intestinal obstruction and an abdominal wall hernia struggled to find a medication that would alleviate her symptoms, finally finding success when they administered Dronabinol. The patient’s insurance at the time covered it, but when she switched to Medicare several years later, Part D denied coverage because the off-label use prescribed to the patient was not supported by one or more citations in approved compendia. An administrative law judge disagreed with the initial determination and granted coverage of the drug, but the Medicare Appeals Council reversed.

Part D coverage. Medicare Part D supplements Medicare by partially covering certain prescription drugs. Specifically, any use of a prescription drug for a medically accepted indication is covered under the Social Security Act (42 U.S.C. sec. 1395w-102(e)(1)). “Medically accepted indication” means any use approved by the FDA or the use of which is supported by one or more citations included or approved for inclusion in certain compendia. The parties agreed that the patient’s use was not approved by the FDA and both assert that the Drugdex Information System (“Drugdex”) is among the listed compendia and is the compendium relevant to the court’s analysis.

Compendia entry. The Drugdex citation for Dronabinol does not have a section entitled “Uses Supported by Citation,” but it does have an entry entitled “Clinical Applications,” under which “Nausea and vomiting, Disease-related, treatment refractory” is listed as one of eight therapeutic uses. For this use, the Drugdex’s recommendation is “Evidence favors efficacy.” The use and recommendation are based on a single case study, in which the authors are not sure why or how Dronabinol worked to relieve the patient’s symptoms. The authors of the study concluded that “low doses of Dronabinol may be safe and effective when used in combination with other antiemetics for intractable cancer-related nausea and vomiting with no mechanical obstruction. Dronabinol should be considered a potentially useful agent in this setting.”

The ALJ issued a ruling finding that Part D covered the patient’s use of Dronabinol because the use was supported by a citation in Drugdex and because the plain meaning of the Drugdex entry supported the palliative use to treat her symptoms in this case. The Council reached the opposite conclusion, emphasizing that Drugdex is not written by a legislative body and is not “structured with the expectations and assumptions that underlie statutory drafting.” The Council also interpreted the underlying case study narrowly, as its authors did not know how the drug worked.

While the Council’s interpretation is internally consistent, it fails to engage with the patient’s argument that it does not matter how the drug works, because it is merely treating symptoms, not the underlying disease. The patient argues that, since she is receiving palliative care, like the patient in the underlying case study, the similarity of their symptoms should determine coverage. While the drug may logically be limited to a specific diagnosis, a drug that is used to treat symptoms should be more logically linked to the specific symptoms, she argued. The court identified this case as ambiguous, and citing previous case law stating, “[T]he Social Security Act . . . is a remedial statute, to be broadly construed and liberally applied in favor of beneficiaries,” the court vacated the decision of the Council.

The case is No. 14-14149-WGY.

Attorneys: Nancy J. Lorenz (Greater Boston Legal Services) for Elizabeth Tangney. Shelbey D. Wright, U.S. Attorney's Office, for Sylvia Mathews Burwell, Secretary, U.S. Department of Health and Human Services.

Companies: U.S. Department of Health and Human Services

MainStory: TopStory CaseDecisions CMSNews DrugBiologicNews ExclusionsNews PartDNews PrescriptionDrugNews MassachusettsNews

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