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Bloom v. Burwell

United States District Court, D. Vermont

January 17, 2017

JONATHAN A. BLOOM, Plaintiff,
v.
SYLVIA BURWELL, in her official capacity as Secretary, United States Department of Health and Human Services, Defendant.

          OPINION AND ORDER (DOC. 9)

          Geoffrey W. Crawford Judge.

         Plaintiff Dr. Jonathan A. Bloom brings this action under 42 U.S.C. §§ 405(g) and 1395ff(b)(1)(A), seeking judicial review of two separate decisions by the Medicare Appeals Council ("MAC") denying his request for Medicare payment of claims relating to a continuous glucose monitor ("CGM"), which he asserts is the "standard of care" for individuals who, like himself, suffer from "brittle" diabetes.[1] (See Doc. 1; see also Docs. 1-1; 1-2 (unfavorable MAC decisions).) The Secretary has filed a Motion for Remand under the sixth sentence of § 405(g), asserting that there is "good cause" for remand. After hearing argument on September 29, 2016, the court ordered the Secretary to file a certified copy of the administrative record so that the court could evaluate the Secretary's contention that the record is insufficient to determine whether a CGM qualifies as "durable medical equipment" covered by Medicare under 42 U.S.C. §§ 1395k(a)(1), 1395x(n), 1395x(s)(6), and 42 C.F.R. § 414.202. (See Doc. 17.) The Secretary filed the administrative record on December 16, 2016. (See Doc. 18.)

         Background

         The administrative record includes the MAC and Administrative Law Judge (ALJ) files from the relevant administrative proceedings, as well as transcripts of the separate March 31, 2015 hearings before ALJ Pere J. Jarboe (AR 376-95) and ALJ Charles W. Dorman (AR 402-06), and the June 16, 2015 hearing before ALJ Bennett Engelman (Supp. AR 4-14). ALJ Jarboe and ALJ Dorman issued unfavorable decisions (AR 89-94, 260-70), which the MAC ultimately adopted (Doc. 1-1). ALJ Engelman issued a favorable decision (Supp. AR 38-46), which the MAC ultimately reversed (Doc. 1-2). Dr. Bloom represented himself at each of the ALJ hearings.

         The record includes the following facts about Dr. Bloom's CGM system and how he uses it.[2] Dr. Bloom has been using continuous glucose monitoring since 2006. (See AR 43, 45, 381, 384, 403; Supp. AR 5.) He currently uses a Medtronic MiniMed Paradigm Revel insulin pump with continuous glucose monitoring. (AR 45, 63; Supp. AR 10.) The FDA approved MiniMed's Continuous Glucose Monitoring System on June 15, 1999. FDA, Approval Order, http://www.accessdata.fda.gov/cdrhdocs/pdf/P980022A.pdf [hereinafter "Approval Order"].[3] The 1999 Approval Order has been supplemented numerous times since then, including approvals for later generations of the system marketed under the Paradigm Revel trade name. See FDA, Premarket Approval, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/ pma.cfm?id=P980022 (listing supplements). The system is prescribed by Dr. Bloom's treating physician, and the prescription has to be renewed annually. (Supp. AR 12.)

         Dr. Bloom's CGM system consists of a sensor, a transmitter, and a monitor. The user injects the sensor with a needle, and after the needle is removed the sensor is connected to the wireless transmitter. (See AR 379.) The sensor does not directly measure blood sugar, but supplies information that amounts to a "guide to what your blood sugar would be." (Supp. AR 12.)[4] The transmitter sends the sensor's readings to the monitor and also to an insulin pump, which is integrated with Dr. Bloom's CGM system. (See AR 379-80.)

         The sensors have a limited lifespan and are not reusable; when a patient is done using a sensor, it is taken out and thrown away. (AR 391.) Dr. Bloom orders sensors for his CGM system once a month or once every three months. (AR 385.) Each sensor lasts about six days, so five sensors last about a month. (AR 386, 391.) As of 2015, Dr. Bloom paid about $470 for a set of five sensors. (AR 386; see also Supp. AR 8.)

         The transmitter is an external device that is connected to the sensor. As of June 2014, Minimed Distribution Corporation charged $659 for the transmitter component of the CGM system. (See AR 316.) The monitor displays the data collected from the sensor and has hypoglycemic alarms that allow Dr. Bloom to "detect, check and treat impending hypoglycemia, particularly when it occurs during sleep." (AR 43-44.) When he is wearing his CGM system, Dr. Bloom receives "reliable alarms and is able to react appropriately." (AR 47.)

         In addition to his continuous glucose monitoring, Dr. Bloom manually checks his blood sugar between five and fifteen times per day. (AR 45; see also AR 47, AR 380.) At a September 2008 consultation-after Dr. Bloom had been referred to him-Dr. Richard Pratley noted that Dr. Bloom's fingers showed "evidence of frequent glucose monitoring." (AR 46.) Dr. Bloom enters the results of his manual blood sugar checks into his CGM system. (AR 47.) According to Dr. Bloom's testimony, he continues to manually check his blood sugar because the CGM system is only a "guide to what your blood sugar would be, it's not an absolute." (Supp. AR 12.) According to Dr. Bloom, "[t]here are times when your blood sugar is different from what the sensor tells you, but that's when you change your sensor and put a new one in that's more accurate." (Id.)

         According to Dr. Pratley, despite Dr. Bloom's "scrupulous glycemic control, " the fact that Dr. Bloom is "well versed in self care and management, " and Dr. Bloom's "self monitoring of blood glucose, " he still has "markedly labile blood sugars with frequent hypoglycemia." (AR 43.) Dr. Bloom has "severe hypoglycemic unawareness, " which makes it impossible for him to detect when he is experiencing an unexpected low. (Id.) That has resulted in hospitalization and other instances in which he was in "substantial jeopardy." (Id.) According to Dr. Pratley, Dr. Bloom's use of a CGM system "has markedly improved his management, quality of life and overall safety." (AR 44.) Also according to Dr. Pratley, the CGM system "has provided a clinically significant benefit in terms of [Dr. Bloom's] diabetes management and especially with respect to the avoidance of hypoglycemia." (Id.)

         Analysis

         Under the sixth sentence of 42 U.S.C. § 405(g), the Secretary may move for a remand before filing an answer, and upon such a motion the court may remand the case "for good cause shown." 42 U.S.C. § 405(g).[5] Here, the Secretary seeks a sentence-six remand, arguing that "the administrative record lacks evidence pertaining to the functionality of a CGM system and whether it qualifies as [durable medical equipment]." (Doc. 9 at 13.) According to the Secretary, "the administrative record as a whole lacks substantive information concerning the functionality of a CGM, including its functionality in conjunction with or in comparison to a traditional blood glucose monitor." (Id.) Dr. Bloom faults the Secretary for not articulating what evidence (if any) is missing from the administrative record that might warrant a remand. (See Doc. 10 at 8.) According to Dr. Bloom, neither of the MAC decisions at issue can be cured by a remand. (See Id. at 9.)

         The court has reviewed the administrative record to evaluate the quantity and quality of evidence it contains bearing on whether Dr. Bloom's CGM system meets the definition of "durable medical equipment." The applicable regulations define "durable medical equipment" to mean equipment that (1) "[c]an withstand repeated use"; (2) "[i]s primarily and customarily used to serve a medical purpose"; (3) is generally "not useful to an individual in the absence of an illness or injury"; and (4) is "appropriate for use in the home." 42 C.F.R. § 414.202. In both of the MAC decisions from which Dr. Bloom has appealed, the MAC concluded that the second element was not satisfied. (See Doc. 1-1 at 11; Doc. 1-2 at 12.) The court finds that the administrative record is sufficient for the court to evaluate whether "substantial evidence" supports the Secretary's determination that Dr. Bloom's CGM system is not "primarily and customarily used to serve a medical purpose."

         The Secretary contends that a remand would be consistent with two court decisions regarding CGM systems where, according to the Secretary, the administrative record was similarly lacking in evidence bearing on whether a CGM system qualifies as durable medical equipment: Finigan v. Burwell, No. 15-12246-WGY, 2016 WL 2930905 (D. Mass. May 19, 2016), and Whitcomb v. Burwell, No. 13-CV-990, 2015 WL 3397697 (E.D. Wis. May 26, 2015). (See Doc. 9 at 14-15; Doc. 11 at 5.) The courts in each of those cases remanded after concluding that the MAC had improperly given deference to a policy article. See Finigan, 2016 WL 2930905, at *6 (according "substantial deference" to policy article was legal error); Whitcomb, 2015 WL 3397697, at *4 (policy article was not entitled to substantial deference; remanding to permit the Secretary to apply the proper legal standard). But Finigan ...


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