Lewis v. Becerra

Decision Date28 April 2022
Docket NumberCivil Action 18-2929 (RBW)
PartiesCAROL A. LEWIS, et al., Plaintiffs, v. XAVIER BECERRA, [1] in his official capacity as Secretary of the Department of Health and Human Services, Defendant.
CourtU.S. District Court — District of Columbia

REGGIE B. WALTON, United States District Judge.

The plaintiffs, Carol Lewis and Douglas Sargent, bring this civil action on their own behalf, but also seek to bring it on behalf of all other similarly situated individuals, against the defendant, Xavier Becerra, in his official capacity as the Secretary (the “Secretary”) of the United States Department of Health and Human Services (the “Department”), pursuant to Title XVIII of the Social Security Act, 42 U.S.C. § 1395ff(b), see Class Action Complaint (“Compl.”) ¶ 8, ECF No. 1; the Administrative Procedure Act (“APA”), 5 U.S.C. § 706, as modified by 42 U.S.C. § 405(g) see id. ¶¶ 146-63; and the Declaratory Judgment Act, 28 U.S.C. §§ 2201, see id. ¶¶ 164-66.[2] Currently pending before the Court is the plaintiffs' class certification motion. See Plaintiffs' Re-Notice of Class Certification Motion (“Pls.' Re-Notice”), ECF No. 81. Upon careful consideration of the parties' submissions [3] the Court concludes for the following reasons that it must deny the plaintiffs' motion for class certification.


The Court previously discussed much of the relevant background of this case in detail, see Memorandum Opinion at 2-11 (Jan. 29, 2021), ECF No. 77, and therefore will not reiterate that information again here. The Court will, however, briefly discuss the background of this case as it relates to the issues the Court must now consider in deciding the plaintiffs' class certification motion.

A. Statutory and Regulatory Background Relating to CGMs

Medicare Part B is an optional supplemental insurance program that pays for medical items and services . . ., including . . . durable medical equipment.” Ne. Hosp. Corp. v. Sebelius, 657 F.3d 1, 2 (D.C. Cir. 2011) (citing 42 U.S.C. §§ 1395j-1395w-4). However, 42 U.S.C. § 1395y excludes from coverage items and services “not reasonable and necessary for the diagnosis or treatment of illness or injury[.] 42 U.S.C. § 1395y(a)(1)(A). The Secretary has issued regulations clarifying the definition of [d]urable medical equipment[, ] see 42 C.F.R. § 414.202, which states:

Durable medical equipment means equipment, furnished by a supplier or a home health agency that meets the following conditions:

(1) Can withstand repeated use.
(2) Effective with respect to items classified as [durable medical equipment] after January 1, 2012, has an expected life of at least 3 years.
(3) Is primarily and customarily used to serve a medical purpose.
(4) Generally is not useful to an individual in the absence of an illness or injury.
(5) Is appropriate for use in the home.

Id. The Medicare statute expressly designates “blood-testing strips and blood glucose monitors for individuals with diabetes” as “durable medical equipment” and, therefore, covered under 42 U.S.C. § 1395x(n). However, the Secretary does not consider continuous glucose monitors (“CGMs”) as “durable medical equipment.”

On January 12, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued CMS 1682-R, a ruling which concluded that “in all [] cases in which a CGM does not replace a blood glucose monitor for making diabetes treatment decisions, a CGM is not considered [durable medical equipment].” Centers for Medicare & Medicaid Services Ruling 1682-R (Jan. 12, 2017) at 15. CMS made this determination primarily because these so-called “non-therapeutic” CGMs serve as “adjunctive devices” to blood glucose monitors and are therefore “not considered to serve the medical purpose of making diabetes treatment decisions[.] Id. at 6-7. This ruling has applied to all claims for CGMs submitted on or after January 12, 2017, and [t]hus, after January 12, 2017, all levels of Medicare . . . were required to deny CGM cla[i]ms . . . whenever the presented CGM did not replace [a blood glucose monitor].” Id. at 7; Pls.' Mot. at 5.

B. Judicial Review of Medicare Coverage Denial

In order to obtain judicial review, a Medicare beneficiary whose claim has been denied must first exhaust multiple levels of administrative review. Specifically, the beneficiary must first request a “redetermination” by the administrative contractor that issued the initial denial and may subsequently request a “reconsideration” by a “qualified independent contractor, ” see Porzecanski v. Azar, 316 F.Supp.3d 11, 15 (D.D.C. 2018) (citing 42 C.F.R. § 405.940, § 405.960), then request a hearing with an administrative law judge (“ALJ”), see id. (citing 42 C.F.R. § 405.1000(a)), and finally appeal any adverse ruling by the ALJ to the Medicare Appeals Council (the Appeals Council), see 42 C.F.R. § 405.1102. The Appeals Council may then “decide on its own motion to review a decision or dismissal issued by an [ALJ], ” id. § 405.1110(a), and the Appeals Council's decision serves as the Secretary's “final” decision regarding the beneficiary's claim, see id. § 405.1130. If the Appeals Council-the final arbiter within the Medicare appeals process-“does not issue a decision, dismissal, or remand within [ninety] days of the beneficiary's request for review, the beneficiary may escalate the appeal to a federal district court.” Porzecanski, 316 F.Supp.3d at 15 (citing 42 C.F.R. §§ 405.1132(a), 405.1100(c)). Only beneficiaries who have exhausted this Medicare administrative coverage determination and appeals process may seek “judicial review of the Secretary's final decision[.] 42 U.S.C. § 1395ff(b)(1)(A).

Additionally, “judicial review shall not be available to [an] individual if the amount in controversy is less than [$1, 000].” 42 U.S.C. § 1395ff(b)(1)(E)(i). Because this amount is indexed to inflation, a beneficiary seeking judicial review in 2018 was required to satisfy an amount-in-controversy requirement of $1, 600. See Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019, 83 Fed.Reg. at 47, 620 (Sept. 20, 2018).

C. Factual Background
1. The Named Plaintiffs

The two named plaintiffs in this case, Carol Lewis and Douglas Sargent, are individuals who are Medicare eligible, see Compl. ¶¶ 20-21, have Type I brittle diabetes, see id. ¶¶ 97, 109, and have been denied coverage for CGMs based on the refusal to classify CGMs as “durable medical equipment” under CMS 1682-R, see id. ¶¶ 101-04, 113-25. It is undisputed that the two named plaintiffs have also fully exhausted their administrative remedies. See id. ¶ 8 (“Lewis is filing suit after a final decision of the Medicare Appeals Council . . . denying coverage of her Medicare claim (and, therefore, has exhausted her administrative remedies) ....Likewise, [ ] Sargent is filing suit after final decisions of the Medicare Appeals Council . . . denying coverage of his Medicare claim (and, therefore, has exhausted his administrative remedies)[.]); Def.'s 2d Opp'n at 38 (arguing that the named plaintiffs are not representative of the proposed class in part “because the requirement to exhaust and timely file is no bar to recovery by the named plaintiffs).[4]

2. The Putative Class

The plaintiffs seek to certify a class consisting of [a]ll persons whose claims for Medicare CGM coverage (whether Part B or Part C) were denied on the grounds that a CGMs are not durable medical equipment, and [were] not subsequently reversed on appeal, from December 13, 2012[, ] through the conclusion of this case.” Pls.' Mot. at 13-14. Thus, the putative class “consists of only those persons/claims that were/are rejected on the grounds that a CGM is not ‘durable medical equipment[, ]' i.e., the grounds articulated in CMS 1682-R. Id. at 14. The plaintiffs state that “the class of persons whose claims for Medicare CGM coverage has been rejected on the grounds that a CGM is not ‘durable medical equipment' is readily ascertainable” because “each claim so rejected was coded by the Secretary using” five specific codes. Id. According to the plaintiffs, this class would consist “of some 90, 000 people whose claims for CGM coverage were improperly denied.” Id. at 15.

D. Procedural Background

On March 23, 2020, the plaintiffs filed their class certification motion. See id. at 1. The Secretary filed his opposition on April 21, 2020, see Def's Opp'n at 1, the plaintiffs filed their reply on May 12, 2020, see Pls.' Reply at 1, the Secretary was permitted to file a surreply on May 22, 2020 see Def.'s Surreply at 1, and the plaintiffs were also permitted to file a surreply on May 29, 2020, see Pls.' Surreply at 1. On January 29, 2021, the Court granted in part and denied in part the Secretary's motion to dismiss, which had been filed a year before the plaintiffs filed their class certification motion on May 30, 2019. See Memorandum Opinion at 32 (Jan. 29, 2021), ECF No. 77. The Court dismissed Count I of the Complaint for failure to state a claim for which the plaintiffs would be entitled to relief under § 405(g) of the Medicare statute, finding that, while the plaintiffs had properly alleged violations of the APA later in their Complaint, there was no basis for them to receive relief under § 405(g) itself. See id. at 22 ([B]ecause Count I fails to allege the violation of any federal substantive law, the plaintiffs have failed to demonstrate entitlement to the relief requested.”). The Court also dismissed Count II of the Complaint also for failure to state a claim, finding that there was no viable entitlement to relief under § 706(1), “because this is not a case of agency inaction; it is instead a case of an agency's denial of coverage[, ] and [d]enials are final agency actions that may be...

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