Lewis v. Azar

District Court, District of Columbia·Decided April 28, 2022·No. Civil Action No. 2018-2929·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

)

CAROL A. LEWIS, et al., )

)

Plaintiffs, )

)

v. ) Civil Action No. 18-2929 (RBW)

)

XAVIER BECERRA, 1 in his official ) capacity as Secretary of the Department of ) Health and Human Services, )

)

)

Defendant. )

)

MEMORANDUM OPINION

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

1 Xavier Becerra is the current Secretary of the United States Department of Health and Human Services, and he is therefore substituted for Alex M. Azar II as the proper party defendant pursuant to Federal Rule of Civil Procedure 25(d). 2 On May 30, 2019, the defendant filed a partial motion to dismiss for lack of jurisdiction, see Partial Motion to Dismiss for Lack of Jurisdiction and Failure to State a Claim at 1, ECF No. 22, which the Court granted in part and denied in part on January 29, 2021, see Order at 1 (Jan. 29, 2021), ECF No. 78. The Court granted the motion to dismiss to the extent that it sought to dismiss Counts I and II of the Complaint, which alleged violations of 42 U.S.C. § 405(g), and 5 U.S.C. § 706(1). Id. The Court denied the motion in all other respects. Id.

careful consideration of the parties’ submissions, 3 the Court concludes for the following reasons that it must deny the plaintiffs’ motion for class certification.

I. BACKGROUND

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.

3 In addition to the filings already identified, the Court considered the following submissions in rendering its decision: (1) plaintiffs Carol Lewis and Douglas B. Sargent’s Motion for Class Certification and Appointment of Class Counsel (“Pls.’ Mot.”), ECF No. 63; (2) the defendant’s Memorandum in Opposition to Class Certification (“Def.’s Opp’n”), ECF No. 65; (3) plaintiffs Carol Lewis’s and Douglas Sargent’s Reply Re: Motion for Class Certification and Appointment of Class Counsel (“Pls.’ Reply”), ECF No. 67; (4) the defendant’s Surreply in Opposition to Class Certification (“Def.’s Surreply”), ECF No. 69; (5) plaintiffs Carol Lewis’s and Douglas Sargent’s Surreply Re: Motion for Class Certification and Appointment of Class Counsel (“Pls.’ Surreply”), ECF No. 71; (6) the defendant’s Memorandum in Opposition to Plaintiffs’ Renewed Motion for Class Certification (“Def.’s 2d Opp’n”), ECF No. 84; and (7) plaintiffs Carol Lewis’s and Douglas Sargent’s Reply Re: Motion to Certify Class and Appoint Counsel (“Pls.’ 2d Reply”), ECF No. 86.

(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).

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