United States District Court, D. Vermont
JONATHAN A. BLOOM, Plaintiff,
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.
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. (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.)
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.
record includes the following facts about Dr. Bloom's CGM
system and how he uses it. 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,
[hereinafter "Approval Order"]. 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,
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.)
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.) 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
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.
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.)
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
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.)
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). 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.)
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."
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 ...