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Bloom v. Azar

United States District Court, D. Vermont

January 29, 2018

ALEX AZAR, Secretary, United States Department of Health and Human Services, [1] Defendant.

          OPINION AND ORDER (DOCS. 34, 35)

          Geoffrey W. Crawford, Chief Judge United States District Court.

         Plaintiff Dr. Jonathan A. Bloom brings this action under 42 U.S.C. §§ 405(g) and l395ff(b)(1)(A), seeking judicial review of three decisions by the Medicare Appeals Council ("MAC") denying his requests for Medicare payment of claims relating to a continuous glucose monitor, which he asserts is the "standard of care" for individuals who, like himself, suffer from "brittle" diabetes. (See Doc. 21 (Amended Complaint); see also Doc. 21-1 (unfavorable MAC decision dated February 24, 2016 in No. M-15-4332); Doc. 21-2 (unfavorable MAC decision dated November 13, 2015 in No. M-15-1505); Doc. 21-8 (unfavorable MAC decision dated January 27, 2017 in No. M-16-10554).) Previously in this case, the court denied the Secretary's motion to remand under the sixth sentence of § 405(g). (Doc. 20.)

         The Secretary has filed the administrative records for each of the three MAC decisions at issue. (See Docs. 18, 27.)[2] Currently pending are Dr. Bloom's motion to reverse (Doc. 34) and the Secretary's motion to affirm (Doc. 35), both filed in accordance with Local Rule 9. The court held a hearing on those motions on December 19, 2017. (See Doc. 48 (hearing transcript).)


         Drawing largely on Dr. Bloom's testimony, the court begins with some background about Dr. Bloom and how he manages his diabetes. Additional facts and procedural history are set forth below.

         Dr. Bloom was born in 1944 and diagnosed with Type 1 diabetes[3] in 1974. (See AR1 at 282, 377.) His diabetes is "brittle, " (AR1 at 282, 377), meaning that he experiences "marked fluctuations in blood glucose [sugar] concentrations that are difficult to control." Stedman's Medical Dictionary 24315 0 (2014). Although he was able to recognize hypoglycemia (low blood sugar) when he was younger, Dr. Bloom currently has "hypoglycemic unawareness." (AR1 at 282; id. at 380 ("I just don't recognize hypoglycemia. . .. [W]hen I was younger ... I recognized it much more quickly.").)

         Dr. Bloom has used various technologies to help manage and control his diabetes. He testified that in 1978 he became one of the first people in America to have a home glucose monitoring system. (AR1 at 380.) That technology requires a "finger prick" (AR1 at 384) to obtain a sample of blood to be applied to a test strip that is read by a blood glucose meter. Dr. Bloom has continued checking his blood sugars that way for decades, progressing through "all of the generations" of home glucose monitors. (AR1 at 380.) The "finger prick" glucose monitoring technology measures glucose at a single point in time; Dr. Bloom testified that he checks his blood glucose this way between 10 and 15 times each day. (See AR1 at 380.) He is not able to check his blood glucose this way while he is busy at work or while he is asleep. (AR1 at 381.)

         Dr. Bloom was prescribed a Medtronic-Minimed "continuous" glucose monitor ("CGM") in 2006. (AR1 at 282, 381.) The CGM system that he uses includes a sensor, a transmitter, and a monitor. (See AR1 at 43, 379, 381.) The sensor is injected with a needle, and after the needle is removed the sensor is connected to the transmitter. (AR1 at 379.) 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 AR1 at 379-80.)

         The sensors have a limited lifespan and are not reusable. Earlier models of the sensors lasted for three days, and the current sensors work for six days. (AR1 at 391.) 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." (AR1 at 43-44.) When he is wearing his CGM system, Dr. Bloom receives "reliable alarms and is able to react appropriately." (AR1 at 47.)

         In addition to the CGM system, Dr. Bloom continues to check his blood sugar using a finger prick, test strip, and a blood glucose meter. (AR1 at 380.) He describes the test strips as "effective." (AR1 at 380.) According to Dr. Bloom, even when using a CGM, "you still need to monitor your blood sugar and prick your finger, " but the CGM "may help you spot patterns or trends easier." (AR1 at 385.)

         Dr. Richard Pratley at the Vermont Regional Diabetes Center has treated Dr. Bloom in recent years. (See AR1 at 45-46.) According to Dr. Pratley, Dr. Bloom "has had virtually no significant microvascular complications, due to his scrupulous glycemic control over the years." (Id. at 43.) Still, prior to acquiring his CGM system, Dr. Bloom experienced two hypoglycemic events resulting in loss of consciousness and requiring medical intervention. (See AR1 at 282 (recounting events in 1984 and 2005).) Dr. Pratley describes these past episodes as "life threatening." (AR1 at 286.)

         Since he began using the CGM, Dr. Bloom reports that he has experienced only one incident of undetected hypoglycemia, when he fell asleep on a 2008 transcontinental flight with his earphones in and did not hear the monitor go off. (AR1 at 282, 381.) According to Dr. Pratley, Dr. Bloom's use of a CGM system "has markedly improved his management, quality of life and overall safety." (AR1 at 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.) Dr. Pratley's opinion is that "it is essential that [Dr. Bloom] continue on insulin pump therapy with continuous glucose monitoring." (AR1 at 286-87.)

         MAC Decisions

         "The Medicare Act, 42 U.S.C. § 1395 et seq., establishes the federal program of health insurance for the elderly." Exec. Dir. of Office of Vt. Health Access ex rel. Carey v. Sebelius, 698 F.Supp.2d 436, 439 (D. Vt. 2010). Part "B" of the program generally covers, among other things, "medical and other health care services." 42 U.S.C. § l395k(a)(2)(B). "Medical and other health services" includes "durable medical equipment." Id. § l395x(s)(6). The statutory definition of "durable medical equipment" ("DME") is a list of certain equipment that is included and certain equipment that is excluded. Id. § l395x(n). DME is defined to include "blood-testing strips and blood glucose monitors for individuals with diabetes without regard to whether the individual has Type I or Type II diabetes or to the individual's use of insulin (as determined under standards established by the Secretary in consultation with the appropriate organizations)." Id. Generally excluded from coverage are "any expenses incurred for items or services . . . [which] are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." Id. § 1395y(a)(1)(A).

         Medicare program administrators make coverage determinations, and the law provides a multi-step administrative process for a beneficiary to challenge denials, progressing from the "initial determinations" (which include "redeterminations"), to "reconsideration, " to a hearing before an administrative law judge ("ALJ"), and finally to review by the Medicare Appeals Council ("MAC"). See 42 U.S.C. § l395ff; 42 C.F.R. § 405.904. After completion of the administrative review process, judicial review is available. See 42 U.S.C. § l395ff(b)(1)(A); 42 C.F.R. § 405.904.

         It is undisputed that Dr. Bloom is a Medicare beneficiary and that this action arises under Medicare Part B. (Doc. 21 ¶¶ 17, 21; Doc. 26 ¶¶ 17, 21.) In this case, Dr. Bloom seeks judicial review of three unfavorable MAC decisions issued after his requests for coverage relating to his CGM progressed through the earlier stages of the administrative appeals process. The court briefly summarizes each of the three unfavorable MAC decisions here, with additional details recited as necessary below.

         I. Unfavorable MAC Decision Dated November 13, 2015 in No. M-15-1505

         In its November 13, 2015 decision, the MAC, on its own motion, reviewed and reversed a June 23, 2015 favorable decision issued by ALJ Bennett Engelman. (AR2 at 20-28.) The ALJ had conducted a hearing (AR2 at 4-11), and issued a decision (AR2 at 38-46) concluding that disposable sensors for Dr. Bloom's CGM system provided on August 6, 2014 were covered by Medicare, and that Dr. Bloom was entitled to payment based on the billed amount of $473. The ALJ discussed National Coverage Determination (NCD) 280.1, NCD 40.2, Local Coverage Determination (LCD) LI 1530, and Local Coverage Article (LCA) A33614. (AR2 at 45.) The ALJ noted that LCA A33614 states that CGMs are considered "precautionary and therefore non-covered under the DME [durable medical equipment] benefit." (Id.) The ALJ found "extensive" justification in the record for departing from LCA A33614, noting that Dr. Bloom "suffers from a rare and dangerous combination of diabetic complications which may place his life in jeopardy without the use of a continuous blood glucose monitor and its required sensors." (Id. at 45-46.) According to the ALJ, "continuous blood glucose sensors are not 'precautionary' as the coverage article claims; these sensors are a reasonable and necessary element of his medical care." (Id. at 46.)

         The MAC reversed the ALJ's favorable determination, concluding that Medicare does not cover the sensors "because they do not fall within the statutory Durable Medical Equipment (DME) benefit category." (AR2 at 21.) The MAC concluded that CGM's are "precautionary" items, reasoning that "since the CGM does not substitute for the existing means of controlling insulin usage, or measure blood glucose directly, we conclude that it merely provides an added precaution and does not itself serve a primary medical purpose." (AR2 at 27.)

         II. Unfavorable MAC Decision Dated February 24, 2016 in No. M-15-4332

         In its February 24, 2016 decision, the MAC reviewed and adopted two separate unfavorable ALJ decisions: one dated March 31, 2015 and one dated April 8, 2015. (AR1 at 3-12.) In the March 31, 2015 decision, ALJ Charles Wm. Dorman, after a hearing (AR1 at 402-06), concluded that Dr. Bloom's disposable COM sensors and the external transmitter for use with the COM system are not covered by Medicare. (AR1 at 84.) ALJ Dorman followed LCA A33614 and concluded that Dr. Bloom's CGM system is not "durable medical equipment." (See AR1 at 85.) In the April 8, 2015 decision, ALJ Pere J. Jarobe, after a hearing (AR1 at 376-95), concluded that "[t]here can be no coverage for the disposable Sensors for use with continuous glucose monitors . . . because they are explicitly excluded from Medicare coverage by the relevant LCA as precautionary." (AR1 at 57.)

         The total cost of the sensors and transmitter for which ALJs Dorman and Jarobe denied coverage was $1, 976. (AR1 at 168, 314, 316.) In adopting both of the unfavorable ALJ decisions, the MAC concluded that "CGMs do not fall within the DME benefit category, and, therefore, supplies for such devices are also non-covered." (AR1 at 12.)

         III. Unfavorable MAC Decision Dated January 27, 2017 in No. M-16-10554

         In its January 27, 2017 decision, the MAC reviewed an August 23, 2016 unfavorable decision issued by ALJ Steven C. Goga. (AR3 at 3.) The ALJ had conducted a hearing (AR3 at 809-26), and issued a decision (AR3 at 53-74) concluding, among other things, that Dr. Bloom's CGM sensors "are excluded from coverage under the Medicare Durable Medical Equipment (DME) benefit." (AR3 at 54.) The cost of the sensors for which ALJ Goga denied coverage was $1, 419. (AR3 at 317.) The MAC agreed with the ALJ that Medicare does not cover the sensors, reasoning that "the CGM system in this case is not DME and therefore the supplies are not covered as supplies for DME." (AR3 at 9.)

         Standard of Review

         Under 42 U.S.C. § 1395ff(b)(1)(A), an individual is entitled to judicial review of the final decision of the Secretary of Health and Human Services as provided in 42 U.S.C. § 405(g). Under § 405(g), the court reviews the administrative record to determine if there is "substantial evidence" to support the agency's decision. The court may set aside the agency's determination if it is not supported by substantial evidence or if it is based on a legal error. See Keefe ex rel. Keefe v. Shalala, 71 F.3d 1060, 1062 (2d Cir. 1995).

         The court's review of legal conclusions is de novo. Id.; see also Carey, 698 F.Supp.2d at 439 (court is not bound by Secretary's conclusions or interpretations of law, or to application of incorrect legal standard). On the other hand, review of factual findings is deferential because it is limited to whether the findings are supported by substantial evidence. "Substantial evidence is 'more than a mere scintilla' and 'means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.'" Lesterhuis v. Colvin, 805 F.3d 83, 87 (2d Cir. 2015) (per curiam) (quoting Richardson v. Perales, 402 U.S. 389, 401 (1971)) (referring to a final decision of the Commissioner of Social Security). "In determining whether substantial evidence exists the reviewing court analyzes the record as a whole." Carey, 698 F.Supp.2d at 439 (quoting State of N.Y.ex rel. Bodnar v. Sec 'y of Health & Human Servs., 903 F.2d 122, 126 (2d Cir. 1990)). The remedial purpose of the Medicare Act requires that it be construed broadly. Carey, 698 F.Supp.2d at 440. Still, the claimant bears the burden of proving his or her entitlement to Medicare coverage. Keefe, 71 F.3d at 1062.

         The court rejects Dr. Bloom's suggestion that review is governed by the provisions of the Administrative Procedure Act, and specifically 5 U.S.C. § 706. As the Second Circuit has observed, "Section l395ff(b) specifies 42 U.S.C. § 405(g) as the sole avenue for judicial review for all claim[s] arising under the Medicare Act." Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71, 78 (2d Cir. 2006) (alteration in original; internal quotation marks omitted). The court conducts its review in this case under § 405(g).


         The parties have presented two main issues in their competing motions. First, the Secretary challenges the court's jurisdiction to review two of the three unfavorable MAC decisions for failure to meet the requisite amount in controversy. Second, the parties disagree about whether a CGM qualifies as DME. The court begins with the jurisdictional question.

         I. ...

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