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Tangney v. Burwell

United States District Court, D. Massachusetts

May 10, 2016





Elizabeth Tangney is very sick, suffering from severe nausea, vomiting, and abdominal pain. For several years, a team of physicians struggled to find something that would alleviate her symptoms. They finally succeeded in 2011 when they administered Dronabinol. Her insurance at the time covered it. When Tangney switched to Medicare in May 2014, however, its Part D program denied coverage on the ground that the off-label use prescribed to Tangney was not “supported by one or more citations in [approved] . . . compendia[.]” 42 U.S.C. § 1396r- 8(k)(6). An Administrative Law Judge (“hearing officer”)[1]disagreed with this initial determination and granted coverage, but the Medicare Appeals Council (the “Council”) then reversed. As a result, Tangney is again without coverage for her Dronabinol prescription.

The parties agree[2] that Tangney’s use of Dronabinol has been successful in treating her symptoms. Compare Mem. Law. Supp. Def.’s Mot. Order Affirming Dec. Sec. (“Def.’s Mem.”) 12, ECF No. 21, with Pl.’s Mem. Supp. Mot. Reverse or Remand Dec. Sec. (“Pl.’s Mem.”) 1, ECF No. 18. They also agree on the regulatory requirements for coverage. Compare Def.’s Mem. 8, with Pl.’s Mem. 10. Based on the plain language of the statute and the undisputed facts in this case, Tangey’s prescription must be covered by Part D; accordingly, the Court grants her motion to reverse the Council’s decision.

A. Undisputed Facts

The parties agree on the underlying facts. Compare Def.’s Mem. 2-3 with Pl.’s Mem. 4. This section briefly summarizes the pertinent ones, drawing from the findings of the hearing officer as adopted by the Council.

In 2004, Tangney underwent surgery “to correct a partial intestinal obstruction and an abdominal wall hernia.” Administrative R. (“Admin. R.”) 0008, ECF No. 14-1.[3] After this surgery, she developed increasingly severe “abdominal pain, nausea, and vomiting.” Id. at 0009. Her surgeon and gastroenterologist prescribed her various anti-nausea treatments and medications, but “none of them worked.” Id. In August 2011, her doctors prescribed her Dronabinol, which significantly relieved her nausea and vomiting. Id. Her insurer at the time covered the treatment, and for three years thereafter she continued to take Dronabinol and her symptoms were lessened. See id.

Then, in May 2014, Tangney enrolled in Medicare Part D, which declined coverage for Dronabinol. See id. After Tangney ran out of Dronabinol, she became dehydrated, lost weight, and was hospitalized for three weeks. See id.

B. Procedural History

Tangney requested reconsideration of the initial determination declining coverage, which request was denied. Admin. R. 0009-0010. She appealed this determination to a hearing officer. Id. at 0125. On June 26, 2014, the hearing officer found that Tangney’s Dronabinol “was prescribed for a ‘medically accepted indication’ . . . based on support in the compendia[, ]” and ruled that her “Medicare Part D Plan must cover Dronabinol[.]” Id. at 0132-0133. The next month, Maximus Federal Services, a contractor tasked with reviewing Medicare determinations, petitioned the Council for review of the June decision. Id. at 0007. On review, the Council noted that “[Tangney’s] physician and attorney, and the [hearing officer], have presented compelling arguments that the enrollee’s use of Dronabinol is medically supported by testimony and the record.” See id. at 0023. In its September 2014 decision, the Council nonetheless reversed, concluding that Tangney’s use of Dronabinol was not covered. See id.

Tangney filed a complaint in this Court in November 2014. Compl., ECF No. 1. Before the Court now are the parties’ cross-motions: Tangney’s asking for either reversal or a remand to the Secretary, Pl.’s Mot. Reverse or Remand Decision Sec’y, ECF No. 17; and the Secretary’s requesting an affirmance, Def.’s Mot. Order Affirming Decision Sec’y, ECF No. 20. The issues have been thoroughly briefed. See Pl.’s Mem.; Def.’s Mem.; Pl.’s Reply Mem. Opp. Def.’s Mot. Order Affirming Dec. Sec. (“Pl.’s Reply”), ECF No. 22.


The Court first briefly sketches the statutory framework surrounding Tangney’s claim before discussing the underlying compendium entry at issue.

A. Medicare Part D Prescription Drug Coverage

Medicare Part D supplements Medicare[4] by partially covering certain prescription drugs. First Med. Health Plan, Inc. v. Vega-Ramos, 479 F.3d 46, 48 (1st Cir. 2007) (citing Pub. L. No. 173, Tit. I (2003) (Part D); 42 U.S.C. § 1395u-102(b)). “[A]ny use of a [prescription] drug for a medically accepted indication” is covered. 42 U.S.C. §§ 1395w-102(e)(1) (emphasis supplied). “‘[M]edically 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 any of the [listed] compendia[.]” 42 U.S.C. § 1396r-8(k)(6).

As mentioned at the outset, the parties, by their briefing, have narrowed the Court’s inquiry. They agree that Tangney’s use is not one approved by the FDA. Compare Def.’s Mem. 3, with Pl.’s Mem. 10. They both assert that the Drugdex Information System (“Drugdex”) is among the listed compendia, [5] 42 U.S.C. § 1396r-8(g)(B)(i)(III), and is the relevant one for the Court’s analysis. Compare Def.’s Mem. 8, with Pl.’s Mem. 10. Neither party suggests that there is a relevant citation “approved for inclusion” in Drugdex. In other words, whether this use of Dronabinol is “supported by one or more citations” in Drugdex, the parties agree, is the crucial inquiry. See Def.’s Mem. 8 (citing 42 U.S.C. § 1296r-8(g)(1)(B)(i)); Pl.’s Reply 2.

B. The Compendium and Citation at Issue

Before beginning its analysis, the Court summarizes both the relevant Drugdex entry and the study it cites. Both of these are relevant to the issue of whether Tangney’s use is “supported by” a citation in Drugdex.[6]

1. Drugdex Entry

Drugdex is a “listing of drugs that includes evidence regarding the drug's effectiveness, clinical indications, and proper dosing.” Lindsey Gabrielsen, Bias at the Gate?: The Pharmaceutical Industry's Influence on the Federally Approved Drug Compendia, 40 Am. J.L. & Med. 141, 141 (2014) (internal citation omitted). The Drugdex entry at issue is for Dronabinol. See Admin. R. 0168. Unfortunately, as has been noted by another court, Drugdex does not have “a section entitled ‘Uses Supported by Citation’ (i.e., tracking the language of the statute), ” Edmonds v. Levine, 417 F.Supp.2d 1323, 1332-33 (S.D. Fla. 2006). The parties thus focus on the section of the Dronabinol entry entitled “Clinical Applications[.]” Admin. R. 0179. This section lists eight “Therapeutic Uses, ”[7] the relevant one being: “Nausea and vomiting, Disease-related, treatment refractory” (the “Therapeutic Use”). Id. at 0181-0186. Drugdex states its recommendation for the Therapeutic Use as “Evidence favors efficacy[, ]” in contrast to its recommendation for two other uses, which have a rated “Efficacy” of “inconclusive.” See Id. at 0181-0186. Drugdex classifies the ...

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