Bloom v. Burwell

Filing 20

OPINION AND ORDER denying 9 Motion to Remand to HHS Pursuant to the Sixth Sentence of 42 U.S.C 405(g). Signed by Judge Geoffrey W. Crawford on 1/17/2017. (esb)

U.S. DISTHiCT COURT
OISTRlCT OF VERMONT
UNITED STATES DISTRICT COURT
FOR THE
DISTRICT OF VERMONT

FH.~Efj

2017 JAN 17 PM 2: 05

JONATHAN A. BLOOM,

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

Case No. 5:16-cv-121

OPINION AND ORDER
(Doc. 9)
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.P.R.§ 414.202. (See Doc. 17.) The Secretary
filed the administrative record on December 16, 2016. (See Doc. 18.)
1

"Brittle" diabetes is a form of diabetes "in which there are marked fluctuations in blood
glucose concentrations that are difficult to control." Stedman's Medical Dictionary 243150
(28th ed. 2006) (Westlaw).

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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 40206), 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? 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/cdrh_ docs/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/cdrhicfdocs/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.)
2

In a few instances, the court also refers to documents subject to judicial notice. The
most relevant facts for present purposes, however, concern how Dr. Bloom uses the CGM
system, since the MAC's decision in both appeals was based on its conclusion that the CGM
system is not used for a "primary medical purpose." (Doc. 1-1 at 11; Doc. 1-2 at 12.)
3

The court may take judicial notice of FDA publications available on its website.
See Fed. R. Evid. 201; Sekisui Am. Corp. v. Hart, 15 F. Supp. 3d 359, 363 n.29 (S.D.N.Y. 2014).
2

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 12l 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 of2015, 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.)
4

According to the 1999 Approval Order, the sensor measures "interstitial glucose levels."
Approval Order at 1. Interstitial fluid (also called tissue fluid) is "the fluid in spaces between the
tissue cells, constituting about 16% of the weight of the body; closely similar in composition to
lymph." Stedman's Medical Dictionary 341120 (28th ed. 2006) (Westlaw).
3

Dr. Bloom enters the results ofhis 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." (!d.)
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. (!d.) That has resulted in
hospitalization and other instances in which he was in "substantial jeopardy." (!d.) According to
Dr. Pratley, Dr. Bloom's use of a CGM system "has markedly improved his management, quality
oflife 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 ofhypoglycemia." (!d.)

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

5

There are two types of sentence-six remands: "(1) remands for good cause which do not
require additional evidence; and (2) remands for the purpose of taking new evidence, but only
upon a showing of good cause." Longey v. Sullivan, 812 F. Supp. 453, 456 n.3 (D. Vt. 1993).
4

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." (Jd.) 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.P.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).

5

(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 and Whitcomb do not
support the Secretary's position regarding sufficiency of the administrative record; the remands
were ordered in those cases because oflegal error regarding the weight given to policy articles. 6
The Secretary says that she "acknowledges the outcomes" in Finigan and Whitcomb, and
that "rather than pursuing litigation that is likely to result in a remand for further proceedings,
asks this Court to remand the case before answer." (Doc. 11 at 5.) In a prior order, the court
found the issue of weight given to Policy Article A33614 was not likely to be "good cause" for a
sentence-six remand because the Secretary had not actually conceded that the weight given was
legal error. (See Doc. 17 at 2.) The court continues to hold that "good cause" for a sentence-six
remand is lacking in this case.
Here, unlike in Finigan and Whitcomb, the MAC did not actually say that it was giving
the policy article "substantial deference." The Secretary concedes as much. (Doc. 9 at 12;

see also Doc. 11 at 3.) What the MAC did do was to state that it had "[h]istorically" given
substantial deference to policy articles (Doc. 1-1 at 10; Doc. 1-2 at 10); to discuss Policy Article
A33614; and to ultimately agree with the article's conclusion that CGMs are "precautionary."
(Doc. 1-1 at 11; Doc. 1-2 at 11-12). Therefore, the Secretary's discussion of the weight the
6

In Finigan, the MAC had stated that the record was "insufficient to depart from the
coverage standards" articulated in Policy Article A33614. Finigan, 2016 WL 2930905, at *6.
But according to the court, the MAC "did not explain what more would have rendered the record
sufficient." Id. at *4. The court did not expressly analyze the sufficiency of the record because
the MAC's assertion about insufficient evidence incorporated a "false premise": that the policy
article was entitled to substantial deference. Id. at *6.
6

MAC afforded to the policy article was necessarily hedged; the Secretary could not acknowledge
that "substantial deference" was in fact erroneously given because it is unclear from the record
whether that is so.
The Secretary does acknowledge that affording "substantial deference" to a policy article
is legal error. (Doc. 11 at 4.) Generally, when it is not clear from the record whether the
decision-maker below applied the wrong standard, the proper course is to vacate and remand.

Cf Manzur v. US. Dep 't ofHomeland Sec., 494 F .3d 281, 289 (2d Cir. 2007) ("This Court also
will not hesitate to vacate and remand where the BIA or IJ analysis is insufficient to determine
whether the correct legal standard was applied."); United States v. Adlman, 134 F.3d 1194, 1203
(2d Cir. 1998) (vacating and remanding where it was unclear what standard the district court
used to find the work-product doctrine inapplicable); Schaal v. Apfel, 134 F.3d 496, 505 (2d Cir.
1998) (vacating and remanding in social security disability appeal, partly because court was
unable to determine what legal standard ALJ applied in weighing physician's opinion).
But there is an exception where "application of the correct legal standard could lead to
only one conclusion." Schaal, 134 F.3d at 504; see also Johnson v. Bowen, 817 F.2d 983, 986
(2d Cir. 1987) ("[W]here application of the correct legal principles to the record could lead to
only one conclusion, there is no need to require agency reconsideration."). Dr. Bloom's position
appears to be that this case fits the exception. (See Doc. 10 at 10 ("[A] remand will not 'cure'
the improper deference to the Article to the extent the decisions rely on it.").) The court
concludes that Dr. Bloom is entitled to an Answer from the Secretary, and to test whether this is
such an exceptional case.
The court is mindful of Dr. Bloom's concerns about delay--one reason he opposes
remand in this case is because he views the administrative process as likely to result in excessive

7

delay. (See Doc. 10 at 11.) The court in Finigan expressed similar concem. 7 Ifthe court
ultimately determines that remand is necessary, this court case would probably seem to be only
one more source of delay. By objecting to the Secretary's Motion for Remand, however,
Dr. Bloom has signaled his willingness to accept that possibility in exchange for judicial review
on the existing factual record developed through the administrative process. Since the court
agrees with Dr. Bloom that this record is substantial and may provide a basis for a ruling on the
merits in one direction or the other, the court will deny the request for a sentence-six remand and
proceed with the appeal.

Conclusion
The Secretary's Motion to Remand (Doc. 9) is DENIED.
Dated at Rutland, in the District of Vermont, this J2day of January, 2017.

Geom;y~
United States District Court

7

In that case, the court stated:

By the Court's count, it will be at least the sixth decision-maker to weigh in on
this coverage issue. And, because of the relief ordered ... , it unfortunately will
not be the last. Is this too much process? Would those like Finigan be better off
with fewer levels of review, but with more resources dedicated to each level?
These are important questions obviously outside the scope of this decision and the
Court's power, but that are raised every time the Court details a Social Security
petitioner's bureaucratic appeals-on-appeals path to the Court. The Court has
previously lamented the myriad delays faced by claimants.

Finigan, 2016 WL 2930905, at *2 n.2.
8