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Finigan v. Burwell

United States District Court, D. Massachusetts

May 19, 2016

SYLVIA M. BURWELL, Secretary of Health and Human Services, Defendant.




         Patricia Finigan, a diabetic, brings this action under 42 U.S.C. § 405(g) to challenge her Medicare Part C plan’s denial of coverage for disposable sensors, which are used as part of a Continuous Glucose Monitoring System (“CGMS”).

         A. Factual Background

         The underlying facts in this case are not in dispute, as Finigan’s claims on appeal relate solely to legal issues. See Pl.’s Mem. Supp. Mot. Reverse Remand Decision Secretary Leave File Granted Jan. 21, 2016 (“Pl.’s Mem.”) 8-13, ECF No. 24. The Court thus sketches only a brief history of the facts, as found by the hearing officer.

         Finigan has type 1 diabetes. Admin. R. 0058. She “has been insulin dependent for the past thirty-five years” and has also suffered from a variety of other medical ailments during that time span. Id. To treat her diabetes, Finigan’s physician “established a blood glucose testing regimen requiring the use of a [CGMS.]” Id. at 0062. The hearing officer summarized the effects of the CGMS on her health:

[Finigan has] had severe medical issues before [she began using the CGMS, including an] episode of a seizure during sleep, episodes of passing out in public and an episode of awaking during the night and injuring her hand in a fan due to low blood sugar and confusion. Before use of the [CGMS, Finigan] suffered harm from low blood sugars and has required multiple emergency room visits and hospitalizations. Since ceasing use of [the CGMS, Finigan] has had episodes of testing at home before a short walk and then experiencing significant decreases in blood glucose levels requiring assistance only minutes later. The use of the [CGMS] allowed [Finigan] to control her blood sugars and to avoid anxiety, symptoms[, ] and injury. . . . [Finigan’s] physician determined [Finigan] required [the CGMS] with sensors due to [her] fluctuating blood sugar and that the supplies [for the CGMS] were critical[.]

Id. at 0059 (internal citation omitted). Although the language of her initial request for coverage does not appear to be in the record, the parties agree that she requested coverage for supplies for her CGMS from her insurer (under a Medicare Advantage Plan, explained infra Part II-A). Compare Pl.’s Mem. 2, with Mem. Law Supp. Def.’s Mot. Affirm Decision Medicare Appeals Council (“Def.’s Mem.”) 10, ECF No. 28. Finigan’s insurer denied her request. See Admin. R. 0145.

         B. Procedural History

         After this initial denial, Finigan embarked on a journey into the Medicare appeals process, making six stops on her way to this Court. Finigan appealed her insurer’s initial determination internally on December 31, 2013, and, on January 2, 2014, her insurer affirmed its initial denial of coverage for her CGMS. Admin. R. 0141. Next, she began the external appeals process, which, for her, started with Maximus Federal Services, a contractor hired by Medicare to conduct preliminary appeals. Id. at 127. Maximus affirmed her insurer’s denial, relying solely on Local Coverage Determination L11530, which, it claimed, “incorporates [Policy] Article A33614, ” the latter of which states that CGMS’s are not covered. Id. at 0139.

         Onwards she went, to a hearing officer, [1] who, in contrast to the three previous decision-makers, granted Finigan coverage on July 17, 2014. Id. at 0047. Her insurer then successfully petitioned for review before the Medicare Appeals Council (the “Council”). Id. at 0008. On January 20, 2015, the Council issued a decision reversing the hearing officer’s determination and declining coverage for Finigan’s CGMS. Id. at 0012. Four-and-a-half months later, Finigan filed a complaint in this Court, challenging the Council’s decision.[2] See Compl., ECF No. 1.


         Finigan’s claim for coverage implicates an intricate statutory and regulatory scheme. It also involves the interpretation of two particular documents. The Court will first sketch out the basic framework, then will describe the two documents at issue here.

         A. Statutory and Regulatory Scheme

         The First Circuit has provided an overview of Medicare and Parts A, B, and C:

Enacted in 1965, Medicare is a federally run health insurance program benefitting primarily those who are 65 years of age and older. Before the recent extension of Medicare to cover a portion of prescription drug costs, Medicare covered only inpatient care through Part A and outpatient care through Part B. Parts A and B are fee-for-service insurance programs operated by the federal government. 42 U.S.C. § 1395c et seq. (Part A); 42 U.S.C. § 1395j et seq. (Part B). In 1997, Congress enacted Medicare Part C to allow Medicare beneficiaries to opt out of traditional fee-for-service coverage under Parts A and B. 42 U.S.C. § 1395w-21 et seq. (Part C). Under Part C, beneficiaries can, inter alia, enroll in “Medicare Advantage” plans, privately-run managed care plans that provide coverage for both inpatient and outpatient services. Id. § 1395w-22(a)(1).

First Med. Health Plan, Inc. v. Vega-Ramos, 479 F.3d 46, 48 (1st Cir. 2007) (internal footnote omitted). Finigan is enrolled in one such Medicare Advantage Plan, namely AARP Medicare Complete (the “Plan”). Admin. R. 0137. Although privately run, the Plan is heavily regulated. It must cover all services under Medicare Parts A and B (or those covered solely by Part B). See 42 C.F.R. § 422.101(a). At issue here is what Finigan claims is “durable medical equipment, ” Pl.’s Reply 4, which, if it is also “reasonable and necessary for the diagnosis or treatment of illness or injury, ” is covered under Part B, 42 U.S.C. § 1395y(a)(1)(A)-(B). The sole issue with regard to Finigan’s appeal is whether her CGMS supplies qualify as “durable medical equipment.”

         “Durable medical equipment” is a listed term in the “Definitions” section of the Medicare statute, but there is no definition provided. See 42 U.S.C. § 1395x(n). Instead, the statute (mistakenly?) provides examples of “durable medical equipment, ” most of which are irrelevant to the current case, except for “blood-testing strips and blood glucose monitors for individuals with diabetes.” Id. The regulations do provide a definition for “durable medical equipment” in the form of a five-part test:

         Durable medical equipment means equipment, furnished by a supplier or a home health agency ...

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