UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

____________________________________ ) CAROL A. L EWIS, et al. , ) ) Plaintiff s, ) ) v. ) Civil Action No. 18-2929 ( RBW ) ) XAV IER BECE RRA, in his capacity as ) Secretary of the United States Department ) of Health and Human Services , ) ) Defendant . ) )
MEMORANDUM OPINION The plaintiffs, Carol Lewis and Douglas Sargent, bring this civil acti on against X avier
Be cerra , in his official capacity as the Secretary (the “Secretary”) of the United States Department of Health and H uman Services (th e “Department”) , pursuant to Title XVIII of the Social Security Act, 42 U.S.C. § 1395ff(b), see Class Action Complaint (“Comp l.”) ¶ 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 Decla ratory Judgment Act, 28 U.S.C. §§ 2201, see id. ¶¶ 164–66. 1 Currently pending before the Court is t he Defenda nt’s Motion for Partial Entry of Judgment in Plaintiffs ’ Favor , an d to Dismiss Remaining Causes of Action and Cl aims for Relief on Mootness Grounds (“ Def. ’ s Mot. ” or the “ Secretary ’ s motion ”), ECF No. 120. Upon careful

1 On M ay 30, 2 019, the Secret ar y filed a partia l motion to dismiss for lack of jurisdiction, see Parti al Motion to Dis mi ss for Lack of Jur isdi ct ion and Failure to State a Cl a im at 1, ECF No. 2 2, wh ich the Cour t g ranted in par t and denie d in part on January 29, 2 02 1, see Order at 1 (Ja n. 29, 2021), ECF No. 78. The Court granted the motion to dismiss to the extent that it so ught t o dis miss Co unts I and II of the Com plaint, whi c h alleged violatio ns of 42 U.S.C. § 405(g) a nd 5 U.S.C. § 706 (1). Id. The Court deni e d the m o tion in a ll oth er respects. Id.2 consideration of the parti es ’ submiss io ns, 2 the Court conclud es for th e following reasons th at it

must grant the Secretary ’s motion.
I. BACKGROUND The Court previously set forth the factual background of this case in three prior
Mem orandum Opinions, w hich were issued on January 29, 2021, see Memorandum Opinion

at 2–11 (Jan. 29, 2021), ECF No. 77; January 13, 2022, see Lewis v. Becerra , No . 18- cv -2929 (RB W), 2022 WL 123909, at *1–3 (D.D.C. Jan. 13, 2022); and April 28, 2022, see Lewis v.
Be cerra , No. 18- cv -2929 (RBW), 2022 WL 1262122, at *2–4 ( D.D.C. Ap r. 28, 2022). Thus, the
Court will not reiterate it in full again here. The Court will , however, se t for th the factual background and procedural history that are perti nent to the resolution of the pending motion.
A. Stat utory and Regulat ory Backgro und Relating to Continuous Gluc ose Monitors
M edicare “Part B is an optional supplemental insurance program that pays for medical items and services . . . , including . . . dura ble medical equipment.” Ne. Hosp. Corp. v. Sebelius, 657 F.3d 1, 2 (D.C. Cir. 2 011) (citin g 42 U.S.C. §§ 1395j–1395w-4). The Secreta ry has issu ed a regulation clarifying the definition of “[d]ur able medical equipment [,] ” which state s: Durable medical equipment means equipment, furnished by a suppli er or a home health agency that m eets the following conditions: (1) Can withstand repeated use. (2) Effective with resp e ct to items classified as [durable medical equipment] after January 1, 2012, ha s an expected life of at least 3 years. (3) Is primarily and customarily used to s erve a medical purpose. (4) Genera lly is not useful to an indiv idual in the absence of an illness or injury. (5) Is appropriate for use in the home.

2 In add ition to the fil ings already ident ified, the Cou rt considered t h e follo wi ng submissions i n render ing it s dec is ion: (1) the Plaintiffs ’ Op position to the Secr e tar y’ s Motion (“ Pls. ’ O pp ’n” ), ECF No. 124; and ( 2) the defen dant ’ s Repl y in Support of Def endant ’ s Motion for Par t ial Entry of Judgment in Plaint iff s’ Favor, an d to Dis miss Remaining C au ses of Action and C laims for R elief on Mootness Grounds ( “ Def. ’ s Rep ly” ), ECF No. 125.3 42 C.F.R. § 414.202. The Medicare statute , 42 U.S.C. §§ 1395–1395lll, expressly designates “blood- te sting strips and blood glucose monitors for individua ls wit h diabetes” as “durable medical equipment” and , theref ore, covered under Medicare Part B . 42 U.S.C. § 1395x(n). However, the Centers for Medicare and Medicaid Services ( “ CMS ”) ha s not always app lied t he “durable medical equipment” designation to continuous glucose moni to rs ( “ CGM s”). CGM s are devices that consist of “disposable senso r [s] ” which “ [are] place d below the ski n in the space between tissues (interstitial space) that is filled with flui ds going to and from cells” and “ last for a week [,] [ ] measu r[ing] glucose level s every five to seven minutes ( i.e. , more than 200 times a day) without requiring patient interaction, including when the patient is sleeping.” Compl. ¶ 33.
1. CMS 1682-R On January 12, 2017, CMS issued CMS 1682- R, 3 a ruling which concluded that “in all [ ] cases in which a CGM does not replace a blood glucose monitor for maki n g diabetes treatment decisions, a CGM is not considered [durabl e medical equipme nt].” Centers for Medicare & Medicaid Serv ices Ruling 1682-R (“CMS 1682-R”) (Jan. 12, 2017) at 15. This ruling applied to all claims for CGMs submitted on or after January 1 2, 2017, and “[t]hus, after January 12, 2017, all levels of Medicare .

. . were require d to deny CGM cl a[i]ms . . . whenever the presented CGM did not replace [ a blood g lucose monitor].” Id. at 7. Although CMS ’ s former ongoing classification of CGMs as not constituting “ durable medical equipment” forme d the basis for all

c laims denials alleged in this cas e, CMS ’s application of CMS 1682- R speci fic ally formed th e

3 CM S 1682

- R is a “ CMS Rulin g.” See Centers for Medicare & Medicaid Serv ices Ruling 1682 -R (“ CMS 1682 -R”) (Jan. 12, 2017) at 1. CMS Rulings are “ precedent final opinion[s] or order[s] or statement[s] of policy or interpretation that ha[ ve] not been published in the Federal Reg ister a s a part of a regulation or of a notice imp lement ing regulat ions, but which ha [ve] been adopted by CMS as having precedent[.] ” 42 C.F.R. § 401.108(a). The se r ulings are “ binding on all CMS components[ and] on all [United States Department of Health and H uman Services] co mponen ts that adjudicate matters under the jurisdiction of CMS[.] ” § 401.108(c).4 basis for the Secretary ’ s denial of plaintiff Sargent ’ s second claim referenced in this case

. See infra Sectio n I.B.
2. Proposed and Final Rule s CMS has since rescinded and replaced CMS 1682-R. On November 4, 2020, C MS issued a pro posed rul e to, among other things, “ classi fy [all]

. . . [] CGM s [] as [durable medical equipment] under Medicare Part B [.] ” 85 F ed. Reg. 70,358, 70,358 (Nov. 4, 2020) ; see id. at 70,398–70,404. After proceeding through the notice- and

- comment rulem aking process, see 86 Fed. Reg. 73,860, 73,862–73,863 (De c. 28, 2021), CMS issued its f i nal rule on December 28 , 2021, formally replacing CMS 1682- R a nd “ class ify[ing] . . . [] CGMs[] as [d ur able medical equipment] under Medica re Part B [,] ” id. at 73,860 ; see id. at 73,896–73,902. This final rule

w ent into effect on February 28, 2022. S ee id. at 7 3,860.
3. T DL -220257 In order to ap ply th e December 28, 2021 final rule to claims for reimburseme nt which predated the February 28, 2022 effective date, on February 25, 2022, CMS issued a “ technical direction lette r, TD L-220257, 4 to its Durable Medical Equipm ent Medicare Adm inist ra t ive
Con tractors [,] ” Def. ’s Mot. a t 6, instructing contra ctor s to apply the n ew rule to reimbursement claims s ubmitted prior to February 28, 2022, see id., Exhibit (“ Ex. ” ) D (Techni cal Direction Letter) at 2 –3, ECF No. 120-7.
4. CMS Ruling 1738-R On Ma y 13, 2022, CMS issued CM S Ruling 1738-R, which “ res cind[s] . . . []CMS[]16 82-R . . . and instead applie s the terms of the December 28, 2021 final rule . . . to

4 The “ technical direction letter ” was a letter sent from CMS to all Medicare Administrative Contractors, whi ch

“ provid e[d ] instructions . . . regarding Medi care benefit policy classification and paym ent for . . . []CGMs[] ” in light of the December 28, 20 21 final rule. See Def. ’ s Mot., Exhibit ( “ Ex. ” ) D (Technical Direction Letter) at 1, ECF No. 12 0- 7.5 Me dicar e Part B and Part C claims for payment of . . . []CGMs[]. ” Centers for Medicare &
Me dicaid Services Ruling 1738-R (“ CMS 1 738-R”) (May 13, 2022) at 1. The ruling fu rther provides that [ i]f a CGM monito r or receiver and/or its necessary supplies and ac cessories has been furnished to a Medicare beneficiary before the Febr uary 28, 2022 effe c tive date of the Decemb er 2021 final rule and payment f or the CGM is claimed un der Part B

. . . then the substantive C GM classification, coverage, and payment policies established by the December 2021 final rule and adopted in this Ruling shall be applied to claims for a CGM mon it or or receiver and/or its nece ssary supplies and acces sories where

. . . a valid CGM claim o r valid CGM appeal was pending as of February 28, 2022 [.] Id. at 9.
B. Th e Plaintiffs The two plaintiffs in this case are ind iv iduals wh o are M edicare eligible , see Compl. ¶¶ 20–21, have Type I brittle diabetes, see id. ¶¶ 97, 109, and were denied cover a ge for CGMs based on CMS ’s refusal to classify CGMs as “durable med ical equipment” under CMS 1682-R,

see id. ¶¶ 101 –04, 113–25. Sp ec ifically , three coverage den ials form the b asis of the p laintiff s’ claims against the Secretary

— Lewis ’s coverage claim was denied on March 31, 2016, see id. ¶ 101, and Sargent’ s two coverage claims were denied on September 9, 2016, see id. ¶ 113, and April 21, 2017, see id. ¶ 121. T he Secretary represent s—and the plaint iff s do not contest, see generally Pl s.’ Opp ’n—t hat , follo win g issuance of technical direction letter TD L-220257 on Februa ry 25, 2022, “ CMS directed its Medicare contractor [,] Noridian Healthcare Solutions, LLC ( [‘] Noridian [’]) [,] to pay the three Medicare re imbursement claims at issue in this case .” Def. ’ s Mo t. at 4. T he Secretary further represen ts —and the pla intiffs again do not cont est, see generally Pl s.’ Opp ’n—t hat “[o]n March 28, 2022, Noridian paid [ ] Sa rg ent’s August 2016 claim and Ap ril 2017 claim [,] ” Def. ’s Mot. at 4 (citing id., Ex. A (Declaration of Karen Grasso6 (“ Grasso Decl. ”)) ¶ 6, ECF No. 120-1 ); a nd “ [o] n June 3, 2022, Noridian sent [ ] Lewis payment for her October 2015 c laim [,] ” id. (citing id., Ex. A (Grasso Decl.) ¶ 8).
C. Applicable Pr ocedural History On July 14, 2022, the Secretary filed his motion that is the subject of this Memorandum Opinion. See Def. ’s Mot. at 1. The plaintiff s then file d their opposition to the Se cretary ’s motion on August 8, 2022, see Pl s. ’ Opp ’n at 1, and th e Secreta ry filed his reply on August 25, 2022, see Def. ’ s Reply at 1.
II. S TAN D ARD O F REVIEW
“ Federal [ district ] courts are courts of limited jurisdiction [,]” Kokkonen v. Gu ardian Life Ins. Co. of Am., 5 11 U.S. 375, 377 (1994), and therefore, “ [a] mot ion fo r d ism issal under [Rule] 12(b)(1) ‘presents a threshold c hallenge to the [C]ourt’s juri sdiction[,]’ ” Morrow v. United Sta tes , 723 F. Supp. 2d 71, 75 (D.D.C. 2010) (Walton, J.) (quoting Haase v. Sessi ons, 835 F.2d 902, 906 (D. C. Cir. 1987)). Thus, the C ourt is ob liga ted to d ism iss a claim if it “lack[s] [ ] subj ect

- matter j urisdiction[.]” Fed. R. Civ. P. 12(b)(1). And, beca use “it is presumed that a

c ause l ies outsi de [ ] [the Court’s] limited jurisdic tion,” Kokkonen, 511 U.S. at 377, the p laintiff bear s the burd en o f e sta bl ishing by a preponderance of the evide nce that a d istrict court has subject matte r jurisdiction, see Lujan v. Defs. of Wildlife, 504 U.S. 555, 561 (1992).
In decidin g a motion to di smiss based u pon l ack of subject matter jurisdi ction , the Cour t “n eed not limit itsel f to the allegations of the complaint.” Grand Lodge of the Fraternal Ord

. of Police v. A shcroft , 185 F. Supp. 2d 9, 14 (D.D.C. 2001) (citation omitted)

. Rather, the “ [C]ourt
may co ns id er su ch material s outsi de the plead ings as it deem s a pp rop riate to resolve the question [of] whet her it has j urisdiction to hear the case.” Scolaro v. D.C. Bd. of Elections and Ethics , 104 F. Supp. 2d 18, 22 (D.D. C. 2000) (ci tation omitt ed ) ; see also Jer o me S tevens Phar ms. , Inc.7 v. Food & Drug Admin., 402 F.3 d 1249, 1253 (D.C. Cir. 2005) (holding tha t a “ distric t court may consider materials outside [of] the p leadings” when deciding “to grant a motion to dismiss for lack of jurisdiction ”)

. Additionally, the Cour t must “assume the truth of all material factual allegations in the complaint and ‘constru e the compla int lib erally, g rantin g [the] plaintiff the b enef it of all i nfe r ences that can be derived fr o m th e facts alleged [.]’” Am . Nat’l Ins. Co. v. Fed. Depo sit Ins. Corp., 642 F.3d 1137, 1139 (D.C. Cir. 2011) (quoting Thomas v. Principi, 394 F.3d 970, 972 (D.C. Cir. 2005)). Ho wever, “the [ p]laintiff’s fa c tu al al legation s i n the complaint . . . will be a r cl ose r scr utiny in resolving a [Rule] 12(b)(1) motion than in resolving a [Rule] 12(b) (6)

m otion for failure to state a claim.” Grand Lodge, 185 F. Supp. 2d at 13–14 ( alterati ons in original ) (cit ation an d int ern al quotatio n marks omitted ).
III. A NALYSIS
T he Secretary asks the Cour t to “enter judgment in [the ] plaintif fs ’ fav or on Count III of their Complaint . . . and to vacate the three Administrativ e La w Judge ([ ‘] ALJ[ ’ ]) and Medica r e Ap peals Council dec isio ns from which [the] pl aintiff s a ppealed[,] ” Def. ’ s Mot. at 1 –2, which he
argues would obviate the need for the Court to reach the plaintiffs’ APA claims , see id. at 10 –11. Furth ermore, the Secre tary argues that the “ [] proposed parti al judgment in [the plaintiffs ’] favo r, and vacatur of th e final a gency decisions from whic h they appealed, provides the m with all the judicial relief to which they are entitled [,] ” and therefore, t he plaintiff s’ remaining claims should be dismissed as moot. Id. at 1 1. In response, the plainti ff s do not respon d to the Secretary ’ s proposal regarding Count III, but argue that their remaining claims are no t moot because the Secretary has fail ed to sa tisfy his burden to show t hat (1) “ his alleged ‘voluntary cessation’ has rendered this case moot[,] ” Pl s. ’ Opp ’ n at 14, and (2) th e claims in this cas e are not “ capable of
repe titio n while evading review[,]” id. at 20. T he Court will first co n sider whether it should8 enter judgment for the p lainti ff s as to Count III in light of the Secretary ’s concessions, before determinin g wh ether t h e r em aining claims in this case should be di smis sed as moot.
A. T he Secretary ’ s Request for Entry of Pa rtial Judgme nt for the Plaint iffs The Se cretary “ concedes that the final agency decisio ns from which the plaintiffs appealed are not in accordance with the agen cy ’ s current policy regarding CGMs [,] ” Def. ’s Mot.
at 8 –9 , because “[CMS 1738- R] made the policy of the December 2021 final r ule applicable to

an y pending or properly appealed claim for reimbursement of a CGM device or supplies, regardless of d ate of service , including [the ] plaintif fs ’ th ree reimbursement claims at issue in this case [,]” id. at 9. The Secret ary there f ore state s that “the Court should enter judgment in [the ] plaintiffs ’ favor on Count III[,]” id., in which the plaintiff s ask the Court to r e verse the Secretary’s [d] eci sions as arbitrary and capricious, an abuse of discretion, and o t herwise not in accordance wi t h the law, and issue an order finding that a CGM and its related supplies [are] covered durable medica l equipment and direct the Secretary t o make appropriate pay men t for the claims that are the subject of this case. Compl. ¶ 154. The Sec retary further “acknow ledges that vac atur of the (prior) final agency decisions may provide [the] plaintiffs with som e [] nominal r elie f” and “proposes that the Cour t

. . . vacate the fina l agency actions from which [the plaintiffs] appealed. ” Def. ’s Mot. at 10 (noting t hat “ [t]he Court may order vacatur even though [the ] plaintiffs ’ Complaint did not explicitly d emand it ” and “ [v ]a catur of the ALJ and Medicare Appe a ls Co u ncil decisions is t he relief to which [the] plaintiffs are entitled ” (citing F ed. R. Civ. P. 54 (c) ). Finally, the Secret ary
argues that , based upon this propos al, “ th ere is no nee d for the Court to reach the plaint if fs ’ other [APA] causes of action ” because “[e]ntering judg ment for [the ] plai ntiffs base d on the government’ s conces s ion wit h respect to Co unt III, an d va cating the final agency decisions, provide s [the ] plaintiffs with complete relie f on their [APA] c laims. ” Id. at 11.9 In their oppos ition , t he plaintiff s do not address any of these proposals or arguments put forth b y the Se cretary. See generally Pl s. ’ Opp ’n. And, where “a party files an opposition to a motion and therein addresses only some of the movant’s arguments, the [C]ourt may treat the unaddressed arg uments as conc eded .” Wannal l v. Honeywell, Inc., 775 F.3d 425, 428 (D. C. Cir. 2014) (interpreting Di strict of Columbia Local Ci vil Rule 7(b)) ; see LCvR 7(b ) ( providing that “ [i]f [ ] a memorandu m [in opposition to a dispositive mo tion] is not filed within the prescribed time , the Cour t may tre a t the m otion as conceded ”). According ly, the Court will treat the Secretary ’ s request and arguments regarding the entry of judgment f or the plaintiffs as to Count III, and vacatur of the underlying a dministra tive decisions i n this cas e, as conceded. As a result , the Court wil l enter judgment in favor of the plaint iff s as to C ount III of the Complaint, except to the extent that Count III requests that the Court “d irect the Secretary t o make appropriate payment for the claims that are the subject of this case [,] ” Compl. ¶ 154. 5 C f. M CI
Commc ’ ns Serv s. , Inc. v. Fed. Deposit Ins. Co rp. , 808 F. Supp. 2d 24, 27 (D.D.C. 2011) (entering judgment in favor of the de fen dant as to one count of the Complaint ba sed sol ely u pon a concession by the plaintiff)

. R egarding the Secretary ’ s request f or voluntary vaca tur, the Co urt q uesti ons w hether it may vacate an administrative decision b as ed solely upon the Secreta ry ’ s re quest and the plaintiff ’ s implic i t conce ssion . Other members of this Court have disapproved of vacating agency rules based only upon an agency’ s request, s ee Carpenters Indus. Council v. Sala zar , 734
F. Supp. 2d 126, 136 (D.D.C. 2010) (concluding that a distri ct court “lacks the authority to grant

5 The Cou rt concludes that , because the Se cretary ha s com pleted payments for all of the plaintiffs ’ claims at issue in this case, see Def. ’ s Mot. at 4 (citing id. , E x . A ( Grasso Decl. ) ¶¶ 6, 8) , the plaintiffs ’ request in Count III that the Court “d irect the Secret ary t o make a ppropriate pay men t for the claims t hat are the subject of this case [,] ” Compl. ¶ 154 , is rendered moot. See Conservation Force, Inc. v. Jewell , 733 F.3d 1200, 1204 (D.C. Cir. 2013) ( “ In ge neral, a c [laim] becomes moot . . . when, among other things, the c ourt can provide no effective remedy because a party has already ‘ obtained all the relief [it has ] sought. ’” (quoting Monzillo v. Bi ller , 735 F.2d 1456, 1459 (D.C. C i r. 1984) (third alteration in original)).10 [an agency ’ s] request for vac a tur without a determinati on of t he merits ”) , because doing so, absent a judicial determi nation of legal error, “‘would allo w the [agencies] [ ] to do what they cannot do under the APA [— ]r epeal a rule without public notice and comment, without judicial consideration of the merits [,] ’” id. at 135 (quoting Nat ’l Parks Con ser vation Ass’n v. Sal a zar , 660 F. Supp. 2d 3, 5 (D.D.C. 2009 )). However, where, as here , the rul ing that formed th e basis for the administrative decisions has since been rescinded based upon the Se cretary ’ s admission of legal er ror , see CMS 1738- R ( May 13, 2022) at 1, the potential for an agency to bypass these requirements under the APA is not implicated , and the C ou rt therefore concludes that vacatur of administrative decisions made pursuant to the since-rescinded ruling is not inappro priate , cf. Endangered Species Comm . of Bldg. Indus. Ass’n of S. Cal. v. Babbitt, 852 F. Supp. 32, 38 (D.D.C. 1994) (vacating an administrative decision based upon a legally erron eous agency rule).
S ee Def. ’ s Mot. at 8 –10 (explaining th at CMS has resci nded and replaced CMS 1682-R and therefore, administrative dec isions based upon the e rro neous classificatio n of CGMs in CMS
1682- R ar e invalid ). The Cour t will the refore vacate the administrative deci sions which denied the plaintiffs ’ claims f o r coverage of their C GM s based upon CMS 1682- R. 6 A dditionally , the Court will enter judgment for the plaintiffs on Count II I of the C o mplaint , to the e xten t that it seeks : (1) “re vers[a l and vaca tur of] the Secretary’s [d] eci sions as arbitrary and capricious, an abuse of discretion, and ot herwise not in a ccordance wi t h the law ,” and (2) “ issu [ance of] an

6 As the Se cretary correctly no te s, se e Def .’ s M ot. at 10– 11 , in lig ht of the Cou rt ’ s decision t o vacate the underlying admini strative decision s, which den ied the plaint i ffs ’ clai ms on the basis a rti c ulate d in Count II I of the Complaint , the Court need not reac h the plaint iffs ’ ot her arg um e nts under alt er nati ve provisions of the APA , whic h request the same relief , see Compl. ¶¶ 1 55

– 63. See Dist. H osp. Par t ne rs, L.P. v. Se b elius , 932 F. Supp . 2d 19 4, 19 9 n.5 (D.D.C. 2013 ) ( declining to reach alternative ground s u nder the APA asserted by th e p laintiff in v acatin g a n administrative decision ). Therefore, and in light of the plai ntif fs ’ decision not t o address th e Secretary ’ s a rgument that the C ourt ne ed no t reach alternativ e grounds for entry of judgment and vacatur under the APA, see general ly Pls .’ Opp ’n , the Co urt enters judgment for the p laintiffs as t o Count III only.11 order finding that [ ] CGM [s , including those C GMs for which the plaintiffs sought coverage,] and its related supplies [are] covered durable medica l equipment [.] ” Compl. ¶ 154.
B. Whether the Remaining Claim s Must Be Dismissed as Moot Having entered judgment fo r the p l ainti ff s on Co unt III , the Court will nex t consider whether the plaintiffs ’ remaining cl aims are now moot. The Se cretary argue s that, “in light of the Se c retary ’s payment of [the ] plaintiffs ’ reimbursement cl a ims and the Secretary ’s policy ch anges, [the ] pla intiff s’ re maining claims f or relief beyond vacatur of the ALJ and Medica re App eals Council de cisions are mo ot [,] ” Def .’s Mot. at 12 , because “ [t] he ad d itional relief requested b y [the] plai ntiffs —including a Co urt order directing the Secretary to provide coverage for their CGM c laims, the invalidation of the now-rescinded policy CMS [] 1682-R, and a declaration that [the ] plainti ff s’ C GM devi ces are durabl e medical equipment—would have no
pra c tical effect ,” id. at 12 –13. The Secretary f urther argue s that neither the “voluntary cessation ” nor the “ capable of repetition , yet evading review” exceptions to the mootness do ctrine app ly to the pla intiffs ’ remaini n g claims for relief. See id. at 13. In response to the Secretary ’ s motion , t he plain tiff s start by ar ticula t in g their requests for relief a s the following: 1) An order setting aside CMS 1682- R; 2) A finding that CGMs are “durable medical equip ment” [ ] under both the statute and the Secretary’ s regulations; 3) A s pecific declaration t hat the Medtronic MiniM ed an d Dexcom C GMs are “durabl e medical equipment”; and 4) An order directing the Secretary to provide coverage of the claims- in -suit. Pls. ’ Opp ’n at 13. The plaintiffs ar g ue that , “ [o]t her tha n the last item, these r eques t s are not co

exte nsive wit h [the p]laintiffs ’ . . . coverage [claims ,]” and “ [t]he Secretary ’s proposed order grants none of the above requests for relief. ” Id. Further more, the plaintiffs ar gue that, not only are their clai ms not moot, but “ the Secre ta ry has failed to sustain his burden of showing th at his12 alleged ‘voluntary cessation ’ has rendered this case moot [,] ” id. at 14, or that the claims in this

case are not “c apable of repetition while eva ding review [,] ” id. at 20. 7
“ Article III of the Co nstit ution r estricts the fede ra l courts to decid ing only ‘a ctual , ongoing controversi es, ’” Nat ’ l Black Police A ss ’n v. District of Columbia, 108 F.3d 346, 349 (D.C. Cir. 1997) (quoting Honig v. Doe, 484 U.S. 305, 317 (1988)), and “a federal court has no ‘p ower t o render advisory opinio ns [or]

. . . decide qu estions that canno t affect the rights of litigants in the ca se before them[,] ’” id. (quoting Preiser v. Newkirk , 422 U.S. 395, 401 (1975)) (alteration s i n ori ginal) (internal quotation marks om itted) (first and second a lterations in original). Moreov er, “[e]ve n where litig ation poses a live controversy when filed, . . . [the C] ourt [must] refrain from deciding it if ‘events have so transpired that the decision wil l neither presently affect the parties ’ rights nor have a more- than

- speculative chance of af fecting them in the future.’” Clarke v. United States , 915 F. 2d 699, 701 (D.C. Cir. 1990) (quoting Transwestern Pipeline Co. v. Fed. Energy Regul. Comm’n, 897 F.2d 570, 575 (D.C. Cir. 1990)). F or example ,

“ [a] party may lack a leg ally cogn izable in ter e st i n the outcome [of a case ] ‘when, among other things, the court can provide no effective remedy because a party has already obtained all the relief it has so ught [.] ’” Indian River Cnty. v. Rogoff, 254 F. Supp. 3d 15, 18 (D.D.C. 2017) (qu oting Con serv ation F orce, I nc. v. Jewell , 733 F.3d 1200, 1204 (D.C. Cir. 2013)) (internal quotation marks omitted).

7 The plai ntiff s also refer to the Secretary ’s purported “ bad faith ” conduct t hroughout their opposition. See generally Pls. ’ Opp ’ n at 1

– 9, 14

– 20. However, these “ bad fa ith ” allegations appear to s tem from one district court ’ s ruling that the Secretary acted in ba d faith by “ mich ara cteriz[ing] [ ] the justification of the denial of co verage [for C GMs] ” and that , bas ed upon this and other determinations made by th at court, the Secretary ’ s conduct “ me et s the high threshold for an awar d of bad

- faith fees .” Olsen v. B ecerra , No. 20

- cv - 374 (SMJ), 2021 WL 3683360, at *2 (E .D. Wash. Apr. 4, 2020) (internal quotation marks omitted) ; see Pls. ’ Opp ’n at 1 ( citing Olsen , 2021 WL 3683360, at *2 ). H o wever, whet her or not the Court accept s the plaintiffs ’ c ontention that the Se cretary ’ s denials of coverage for C GMs were made in bad faith, any such determination would be irrel ev ant to the question of whether the plaintiffs ’ c laims in this case are moot. Ra ther , the applicable standards regarding mootn ess will be addressed i nfra Section III.B.1

– 2.13 There are two exceptions to the mo o tness doctrine. First, under th e “ capable o f
rep etition , yet evading review” exception, a case is not rende red moo t wher e “ (1) th e ch a llenge d action was in its duration too short to b e fully litigated prior to its cessation or expiration, and (2) there was a reasonable expectation that the same com plaining party would be subjected to the same action again .” Il l. E lect ions Bd. v . Social ist Workers Party , 440 U.S. 173, 187 (1979) (quoting Weinstein v. Bradford, 423 U.S. 147, 149 (1975) (per curiam) ). Second, under the “voluntary ces sation ” exception , “voluntary cessation of allegedly illegal conduct does not deprive [a c ou rt] o f powe r to he ar and determine the case ,” an d volunta ry cessa tion will only

mo ot a case if “ there is no reasonable expectation

. . . that the alleged violation will recur ,” and “interim relief or events have completely and irrevocably eradicated the e ffect s of t h e al l eged violation .” Cnty. of L.A. v. Davis, 440 U.S. 625, 631 (1979) (internal quotation marks omitted)

. “The party seeking jurisdict ional dismissal must establish mo otness, while the opposing party has the burden to prove th at a mootnes s exc eption applies .” Reid v. Hurwitz, 920 F.3d 828, 832 (D.C. Cir. 2019). Accordingly, the Cou rt will firs t analyze whether the Secretar y has met his burden to establish mootness, b efore considering whether the plaintiffs have demonstrated that either of the

two exceptions to the mootn ess doctrine applies.
1. Mootnes s The Court must first determine whether the Secretary ha s sa tisfied his “ initial heavy burden of establishing mootness[,]” Hone ywell Int ’l, Inc. v. Nuclear Regul. Comm’n, 628 F.3d 568, 576 (D.C. Cir. 2010) (internal quotat ion marks omitted). The Secretary cont ends that the relief requested by the plaintiff s through their remaining clai ms “would have no p ractic al effect ” an d thus those claims are moot. Def .’s Mot. at 13. Specific ally, it is noted that (1) “ [t]he
Se c retar y has already pro vided c overag e for [ the ] p laintiffs ’ CGM claims ;” (2) “ the Secretary14 has already recognized that [th e] plaintiffs ’ CGM devic es are durable medical equipment [;] ” and (3) CMS 1682- R “ has been rescin ded by [ ] CMS []1738- R and replaced b y the December 2021
fin al rule .” Id

. Based upon these events , the Secretary argues that “[f]urther adjudication would not be proper becau se i t would not result in ‘ action ’ or ‘cessation of action [,] ’” id. (q uoting Hewitt v. Hel ms , 482 U.S. 755, 761 (1987)), “[n]or would the grant of declaratory relief achieve a useful objective[,]” id

. “ A case is moot ‘ when the issues presented are no longer live or the parties lack a leg ally cognizable interest in the outcome.’” Akiachak Nat i ve C mty. v. U.S. Dep’ t of Inte rio r, 827 F.3d 100, 105 (D.C. Cir. 2016) (quoting U.S . Parol e Comm ’n v. Geraghty, 445 U.S. 388, 396 (1980)) (intern al quotation marks omitte d). In other word s, for a ca se to be justi ciable, the Court’s disposition of the cl aims must “ affect the rig hts of lit igants in the case before [it ,]” Preiser , 422 U.S. at 401 , and “ [the C] ourt [must] refrain from deciding it if ‘events have so transpired that the decision will nei ther presently affect the parties ’ rights nor have a

m ore than speculative chance of affecti ng them in the future [,] ’” Clarke , 91 5 F. 2d at 701 (quoting Transwestern Pipeline Co., 897 F.2d at 575). Moreover, where t he claims ar e founded on the inv alidity o f a policy or regulation and “ that regulation no longer exists, [the Court] can do nothing to affect [the plaintiffs ’] rights relative to it, thus making th [e] case classicall y
moot for lack of a live controversy.” Akiachak Na tiv e Cmty. , 827 F.3d at 106 ; see Larsen v.
U.S . Navy, 525 F.3d 1, 4 (D.C. Ci r. 2008) (“ [B] ecause the [agency has] already e liminated the [challenged p]olicy and [the] plai ntiffs never allege that the [agency] will reinstitut e it , any injunction or order dec laring it illegal w ould accomplish nothing—amounting to exactly the type of advisory opinion Article III prohibits.” ). This rule applies with e qual force to claims for declaratory relief. See Diffenderfer v. Cent. Baptist Church of Mia. In c., 404 U.S. 412, 414–1515 (1972 ) (d ismissing as moot a request for a declarator y judgment re garding the uncons titutionalit y of a statute because the “relief [was], of course, inappro priate [given] that the statute ha [d] been

r epeale d” ). Here, as a preliminary matter, the Court notes that i t has already granted the plaintiffs ’

se cond and third requests for relief

— namely, a finding that CGMs are “durable medical equip ment” and a s pecific declaration that the Medtronic MiniM ed an d Dexcom CGMs are “durable medical equipment [,] ” see Pl s. ’ Opp ’n at 13 —through its entry of judgment for the plaintiffs as to Cou nt III of the Complaint, s ee supra Section III .A. S pecifically, the Court has concluded that it will enter judgment for the plaintiffs as to Cou nt III of the C o mplaint to the extent that it s eeks the issu ance of an order finding that CGM s, including those CGMs for which the plaintiffs sought coverage, and their related supplies are covered durable medica l equipment. See supra Section III.A. Therefore, the plaintiffs second and third requests for relief, see Pls. ’ Opp ’n at 13, have already been granted.
R egarding the plaintiffs’ re maining requests for rel ief

— namely, an order setting aside CMS 1682-R and an order directing the Secretary to provide coverage for the p laintiffs ’ claims —the Secre t ary has met his initial burden of es tablish ing that the se claims are moot. First , the Secretary has res cinded CMS 1682-R, see C MS 1738- R ( May 13, 2022) at 1 (expli citly

resc inding CMS 1682- R) , w hich renders “ [a] n order setting aside CMS 1682-R [, ]” as requested by the plaintiffs, see Pls. ’ Opp ’n at 13, of no p ractical effect because “ [the Court] can do nothing to affect [t he plaintif fs ’] rights relative to ” the resc inded rule, Akiachak Native Cmty ., 827 F.3d
at 106 (dismissing as moot a claim challeng in g a regulation which was subsequently rescinded).
S econd, the Secreta ry has “provide [d] coverage of the claims

- in -suit” as requested by the plaintiffs, Pl s.’ Op p’n at 13; see Def .’ s Mot. at 4 ( stating that “[o] n March 28, 2022, Noridian16 paid [ ] Sargent’s August 2016 claim and Ap ril 2017 claim ” and “ [o] n June 3, 2022, Norid ian

sent [ ] Le wis payment for her October 2015 claim” (citing id., Ex. A (Grasso Decl. ¶¶ 6, 8)) , and thus, wi th respect to the plaintiffs ’ individual coverage claims, “ the [C ]ourt can provide no effective remedy becaus e [the plaintiffs] ha [v e] alrea dy obtained all th e relief [ ] [they] ha [ve] sought[,]” Co nservat ion Force, Inc. , 733 F.3d at 1204 ( inte rnal quotation marks omit ted)

. 8 Accordingly, the Court concludes that the Secretary has met his initial burd en to establis h that the pla inti ffs ’ remaining claims a re moot. Having re ached this conclu sion, the Cou rt must next determine whether the plaintiffs have demonstrated that either of the exceptions to the mootness doctrine apply in this case. 2. Ex ce ptions to the Mootness Doctrine

a. Capa ble of Re p etit ion, Yet Evading Revi ew Exception Having concluded that th e Secre t ary has me t his initial burd en of es tablish ing that the plaintiffs ’ remaining claims are moot, see supra Section III.B .1, the C ourt must next determine whether the first of two exceptions to the mootness doctrine— the “ capa ble of repetition, yet

8 In response to the Secreta ry’s argu men ts regarding mo otness , the plaint iffs ar gue t hat (1) “ [t]he req uested relief

. . . would have the effect o f [] stopping the Secretary fro m c ontending [t hat C GM s are not durable medical equipment ] in fu ture claims by [ ] Lewis and [ ] Sargent[,] ” Pls. ’ Opp ’n at 13, and (2) b ecause “ there is no order tha t the Secretary provide coverage of the claims

- in

- sui t [,] ” i d. , “ the Secretar y could see k rec oupment of p ayment s m ade, which he can enforce by automati cal ly deducting it from Social Security payment s [,] ” id. at 14

. However, “[ a] lthough the vo l untary r epea l of a regulation d oes not moot a case if there is reason to believe the agen cy will reinstit ute it, ‘ the mere pow er to reenact a challeng ed [rule] is not a sufficient basis on which a court can con c lude that a reasonable expe c tation of recurr e nce exis ts ’ a bsent ‘ evidence in dicating that the challenged [rule] likely will be reenact ed. ’” Akiach ak , 827 F.3d at 106 ( q uo ting Nat ’ l Black Police Ass ’n , 108 F. 3d at 349) (alterations in original). Here , th e plaintiff s have not put fo r th evidence that the Secretar y is likely to eith er re instat e a r ule prohibiting classification o f CGMs as durable medic al equipment or recou p p ayments made to the plai ntiffs

. Rath er, the plaintiffs have put forth a speculat ive and concluso r y allegatio n of future bad faith by t h e Secre tary , see Pl s.’ Op p’ n a t 14, and otherw is e rely on the Secr e tary ’ s au thority to re - classify CGMs or recoup payments , but w ithout more this is insuffic ient to create a “ reasonable expec tatio n” that thes e actions wi ll occur, see Nat ’ l B lack Police Ass ’n , 108 F.3 d at 349 (finding the legis lature ’ s “ power to reenact a cha ll enged law ” is an insufficient basis to find a re asona ble expectation of recurrence, w ith out “ evidence indicating that the challenged law likely will be reenacted ” (emphasis added))

. Thus, these arguments by the plaintiffs do not de tract fr om the Secretary ’ s initial establishm ent of mo otness in this cas e . The Court will dis c us s l ater the plaint iffs ’ argume nts regarding potential recurrence in greater detail in the context of its d eterm inatio ns regarding the “ ca pable of repetition , yet eva ding review ” and

“ volun t ary cessation ” except i ons t o the m ootness doctrine

. See infra S ection III .B.2.17 evadin g review” exceptio n— applies in this case . In evaluating the application of this exception, the Court is mind ful of the fac t that the plaintiffs , as “the opposing party [,] ha [ve] the burden to prove tha t a mootness exception ap plies.” Reid , 920 F.3d at 832. “[E]ven thou gh the specific a c tion that the plaintiff challenges has ceased, a cl aim fo r declaratory relief will not be moot” if “the specific claim fits the exception for cases that are capable o f rep etition , yet evading re vi ew .” Del Monte Fresh Produce Co. v. United States , 570 F.3 d 316, 321 (D.C. Cir. 2009). “ The capable of repeti ti on but evading review exception

a

pplies if ‘(1) the challenged action was in its duration too short to be fully l itigated prior to its

cessat ion or expiration,’” i .e. , “ the evading re view ” prong, and “‘( 2) there was a reasonable expectation that the same complaining party would be subjec ted to the same action again [,] ’” i .e. , the “ capa ble of repetition ” prong. J.T. v . Distric t of Columbia, 983 F.3d 516, 523 (D.C. Cir. 2020) (quoting W einstein , 423 U.S. at 149 ). Regarding the first prong of the analysis, “ [t] o e vade review, the challenged action must be incapable of surviving long enough to unde rgo Su preme Court review.” United Bhd. of Carpenters & Joiners of Am. v . Operati v e Plasterer s’ & Cement Masons ’ Int’ l Ass ’n of the U.S.
& Ca n., 721 F.3d 678, 688 (D. C. Ci r. 2013). Generally, “ agency actio ns of less than two years’ duration cannot be full y liti gated prior to cess ati on or expiration, so long as the short duration is ty p ica l of the challenged action. ” Del Monte Fresh Produce Co., 570 F.3d at 322 (interna l
q uotation marks omitte d). However, “Circuit precedent [also] requires [the Court ] to determine whether the a c tivity cha llenged is inherently of a so r t that evades rev i ew [.]” Campbell v. Clinton , 203 F.3d 19, 34 (D.C. Cir. 2000) (internal quotation marks o mitte d) (em phasis added). Thus, th e challen ged action must, in and of itself, be so time -bound t hat it eva des review. See
Gran t v. Vilsack , 892 F. S upp. 2d 252, 258 (D.D.C . 2012 ) ( “ The ‘ capable of rep etition [, yet18 ev ading review]’ exception applies to c laims that are inherently short- live d. ”) ; compare , e.g., id. at 257–58 (concluding that th e cha lle nged acti on did not evade review because “ the allege d

wro ng”— namely, an agency ’ s d ereg ulation decision— was not time -bound), with Jenkins v. Squillacote , 935 F.2d 303, 307 (D.C. Cir. 1991) (“ [T] here can be no doubt that a one- year placement order un der the [Individua ls with Disabilities Education Act] is, by its nat u re , too short [in dur atio n] to be fully litigated prior to i ts . . . expiration.” ( internal quo tation marks omi tted) (em phasis added)). Moreover, th is Circuit “also adds in an additional requirement that a given action mu st meet before it re sults in an applicati on of thi s ex ception: that ‘the short duration is typical of the challenged action.’” People for th e Ethical Treatment of An imals, Inc.
v. U.S . Fish & Wildlife S e rv. , 59 F. Supp. 3d 91, 97 (D.D.C. 2014) (quoting Del Monte Fresh Produc e Co., 570 F.3d at 322 ).
Here , the underlying ac tion challe nged by the plaintiffs is neither “ inheren tly shortlived[,]” Grant , 892 F. Supp. 2d a t 258, nor t ypicall y short in duration. The plain tiffs argue that

“ given the Secretary ’s contention that he c an is su e ‘rulings’ at any time that render multi- year cases moot, it is h ard to see how a case is capable of surviving through Supreme Court review [,] ” and “the matter [at issue in this case] will evade review bec ause, even if the insur ed survives through the appe al process bef ore the Depar tm ent, the Secretary could choose to evade review at

a ny time ” b y re sc inding the ruling a t issu e. Pls. ’ Opp ’n at 20–21. But the mere fac t that the Secretary h as the power to instate and rescind rulings such as CMS 1682-R does not mak e the duration o f s uch ru lings’ ap pli cability to Medicare cl aims inherently time -bound. See generally
CMS 1682-R (Jan . 12, 2017) (s pecifying no time limit to the applicability of the Secretary ’ s ruling). Rather, s uch rulings remain in place for an in definite p eri od of time, unless they are replac ed, as was the case here. Se e CMS 1738-R (Ma y 13, 2022) at 6 (describing the rescission19 p rocess as ap plied to CMS 1682- R). Furthermore, the plain t iffs have submitted no evidence of typicality, i .e. , that the all e ged “short du ration is typical of the chall enged action [,] ” Del Monte Fresh Produce Co., 570 F.3d at 322. S ee ge nerally Pls. ’ Opp ’n at 20 –21. In fact, here , the challenged ruli ng was o perable for over two years , from January 2017 to Decemb er 2021. See
CMS 1682-R (Jan. 12, 2017) at 16 (designating a n effective d ate of January 12, 2017); CMS
1738- R (May 1 2, 2022) at 6 (stating that “[t]he December 2021 f inal rule replac ed the 2017
C MS Ruling , CMS 1682 -R” ). T hus, the plaintiffs have not shown that the a lleged wrong in this

case

— the allege dly invalid ruling and its app l ication to the plaintiff s’ claims

— lasted for l ess than two y ears, s ee Del Monte F resh Pr oduce C o. , 570 F.3d at 322 (a rticulat ing the general rule that “agency actions of less than two years’ dura tion cannot be fully litigated prior to cessation or expirat ion” ( internal q uotation marks omi tted) ), much less that the alleged “short duration is

t ypical of the challenged action [,] ” id. (emphasis added). See P eople for the Ethical Treatment of A ni mals , Inc. , 59 F . Supp. 3d at 97 (concluding that the plaintiff ’ s chal l enge to Se cretary ’s issua nce o f certain permits did no t evade review , ba sed upon th e plain tiff ’ s failure to establish typicality, even where the plaintiff presented evidence that “21 o f [ a t ot al of 95 p ermitting applications] had durations of less than three yea rs ” ).
Fo r t h e fo regoing reasons, the Cour t concludes that the plaintif fs have not met their burden of establish ing that “ the challe nged action was in its duration too short to be fu lly litigated prior to its cessation or expiration [.] ” Weinst ei n, 423 U.S. at 149. And, b ecau s e the

“ capable of repeti tion, yet evading review” te st “requ ires that the challenged action be both capable of repeti tion and ev ading review [, ]” People for t he Ethical Treatment of
Ani mals , Inc. , 59 F. Supp. 3d at 97 ( citing W einstein , 423 U.S. at 149) (emphasis in original), and “ a def i cie n cy in one area renders t he exception itself moot [,]” id., th e Court need not reach20 the second prong of t he anal ysis—n amely , whether the cha ll enged action is capa ble of repetition.
See id. 97–98 (basing the court’ s decision a s to the “ capable of repe titi on, yet evading review” exception on its dispositi ve determin ation rega rding the “evading review” prong). Accordingly, the Court concludes that the “ capable of repetition, yet evading re view ” excepti on does not apply in this c ase. b. Volu ntary Cessation Having concluded that the “ capable of repetition , yet evading review” exception does not
app ly in this case , see s upra S ection III.B. 2.i, the Court must next considers whether the second

exce ption to the mootness doctrine— the “voluntary cessat ion” exception —applies. Again, in evaluating the application of exceptions to the mootness doctrine, the Court is mind ful of the fact that the pla intiffs , as “the opposing party[,] ha [ve] the burden to prov e that a mootness exceptio n applies .” 9 Reid , 920 F.3d at 832. The “voluntary cessation ” exception to the mootness doctrine “ prevent[s] a private defendant from manipulating the judicial proces s by voluntarily c easing the com plained of activity, and then seeking a dismissal of th e case, t hus securing freedom to ‘re turn to his old

wa ys.’” Clarke , 915 F.2d at 705. Under this exception, “ [a] defendant ’s voluntary decis ion to

cease the activities that gave rise to the suit extin guishes the live controversy [ ] ‘only if (i) there is no reasona ble expectation that the al leged violation wi ll recur, and (ii) interi m relief or events have completely and irrevocably eradicated the effects of the alleged v iolation.’” Citi z ens for Resp . & Ethics in Wa sh. v. Wheeler , 352 F. Supp. 3d 1, 13 (D.D.C. 2019) (quoting A ref v.

9 T he C ourt notes that, although it is the plaintif fs’ burden to establish t hat a n exception a pplies, wit h resp ec t to the re currence prong of the “ volun tary cessat io n” ex ceptio n analysis, the pa rt y asserting mo otness , i.e. , the Secretary , “ bears the ‘ heav y’ bu rd en of showin g it is ‘ absolutely clear that th e allegedly wrongful be ha v ior could not be reasonab ly e x pect ed to recur. ’” Aref , 833 F.3d at 251 (quoting Frie n ds of the Earth, Inc. v. Laidlaw Envtl. Servs., Inc. , 528 U.S . 167 , 189 (2000)).21 Lynch, 833 F.3d 242, 251 (D.C. Cir. 2016) ). However , th is Cir cuit has been skeptical of applying this except ion to agency a ctions. See Alaska v. U.S. Dep’ t of Agric ., 17 F.4th 1224, 1227 ( D. C. Cir. 2021) (stating that the Circuit has express ed “‘serious doubts’ abou t whether the ‘voluntar y cessation ’ rationale appl [ ies ] to cases . . . [involving agency action ]: ‘ it would seem inappro priate f or

the courts either to impute such manipul at ive conduct to a coordinate branch o f government, or to apply agai n st that bran ch a doctrine that appears to rest on the likelihood of a manipulative purpose’” (quoting Clarke , 915 F.2d at 705)). Regarding the fir st prong of the “volun tary cessation ” ex ce ption, namely, whether “ there is no r easonable expectation [ ] tha t th e alleged violation will recur ,” Aref , 8 33 F.3d at 251, where “the defendant is a government actor— and not a p rivate litiga nt— there is less c oncern about the recurrence of objectionab le behavior [,] ” Citizens for Resp . & Ethics in Wash. v. Secs. & Exch. Comm’n, 858 F. Su pp. 2d 51, 61 (D.D.C. 2012). The mere power to put in place a particular rule or regul ation is “no t a sufficient ba sis on which a court can conclude that a

re asonable e xpectation of recurrence ex ists. ” Nat ’ l Black Police Ass ’n, 108 F.3d at 349.

“ Ra ther, there must be evidence indicating that the challe nged [rule] likely will be re[instate d].” Id. (emphasis added). “No entity of the federal government can ever guarante e that a statute, a
regu lation, or an executive order, af ter b eing repealed or wi thdra wn, wil l not be reenacted or reissued [,] ” but “ [c]ourts have noted that structural obst acles to reimposing a challe nged law

— such as a full repeal and the nee d to undertak e new lawmaking

— generall y moot a case .” Alaska , 17 F.4th at 1229 n.5. Similarly , whe re an agency would have to “ proceed through notice- and

- comment rulemaking ” to reinst ate a rescinded rule, co urts in this jurisdiction have declined to “ impute voluntary c essation where noth ing sugges ts it. ” Id. ; see , e.g., Citi z ens for Resp . & E thics in Wash ., 352 F. Supp. 3d at 14 (concluding that the “volun tary cessation ”22 e xce ption did not apply to the Environ mental P rotection Agency’s revision of a challenged policy where “to resume its challenged conduct, [ ] it would have to decide to promulgate a new policy”) ; Cierco v. Lew , 190 F. Supp. 3d 16, 23–24 (D.D.C. 2016), aff ’d su b. nom., Cierco v. Mnuchin, 857 F.3d 407 (D.C. Cir. 2017) ( conclu ding th at an agency ’ s “ wi thdra wal [of t he challen g ed ] notices th emselves co nvincingly establish that the ‘ alleg ed violation’ . . . is not likely

to recur ”) ; cf. Nat ’l Black Police A ss ’n , 108 F.3d at 349–50 (“ There is no evidence in the record to suggest that the D.C. Council might repe al the ne w legislat ion and reenact strict con trib u tion limits. The Counci l has n ot ‘announced . . . such an intention,’ and indeed its enactment of the

n ew le g islation evinces an intent to the contrary. ” (q uoting City of Mesquite v. Aladdin ’s Castle , Inc ., 455 U.S. 283, 289 n.11 (1982) (alteration in original) ). 10

10 The plain tiffs re ly heavily upon Trinity Luthe ran Church of Columbia, Inc. v. Comer, 137 S. Ct. 2012 (2017), and City of Mes quite v. Aladdin ’ s Castle , 455 U.S. 283 (1983), in arguing to the contrary that “ gov ern ment actors are put to the same heavy burden, formidab le burden, and stringent standard as pr ivate actors. ” Pl s. ’ Opp ’ n at 12. For several reasons, the plain tiffs are incorrect. First, the plaintiff s reference a single footnote from Trinity Lutheran Church of C olumbi a, Inc. , in which the Supreme Court opin ed that the Miss ouri governor ’ s voluntary recission of the challenged policy did not moot the petitioners ’ claims becau se “ [t]he [respondent] ha[d] not carried the ‘ heavy burden ’ of making ‘ abs olutely clear ’ that it could n ot revert to [t he challenged] pol icy[.] ” 137 S. Ct. at 458 n.1 (quoting Friends of the Earth, Inc. v. Laidlaw En vironmental Services (TOC), I nc. , 528 U.S. 167, 189 (2000)); see Pl s. ’ Opp ’ n at 12. However, as the basis for this con clusion , the Supreme Court cited to a letter from the res pondent which explicit ly stated that “ there [was] no clearly effective barrier that would prevent the [respondent] from reinstating [its] policy in the future [,] ” Trinity Lutheran Church of Columbia, Inc. , 137 S. C t. at 458 n.1 (third alteration in or igina l) , as well as a letter from the petition er stat in g that “ [t ]he policy change d[id] nothing to remedy the sou rce of the [re spondent ’ s] original policy

— the Missouri Supreme Court ’ s interpretation of [a Missour i state con stitutional provision ,] ” id. Second, the plaintiffs reference the Supreme Court ’ s holding in City of Mesqui te that the amendment of a challenged city ordi n ance did not moot the case. See Pl s. ’ Opp ’ n at 12. However, in that case, the Supreme Court noted the city ’ s past conduct of rescinding and then reenacting a challenged o rd i nance in app arent manipulation of th e judicial process. City of Mesquite , 102 S. Ct. at 289 ( “ In this ca s e the city ’ s rep eal of the [ challenged ordinance provision] would not precl ude it from reenacting pre cisely the same provision if the District Cour t’ s judgment were vacated. The city followed that course with respect to [another challenged provision ;]

. . . then, in obvious respon se to the stat e court ’ s judgment, the exemption w as eliminated. There is no certainty that a similar course would not be pursued if its most recent amend ment were effective to defeat federal jurisdiction. ” ). Furtherm ore, the Supreme Cour t noted that “ [i ]ndeed the city ha[d] announced . . . an intention ” to reenact the rescinded provision that was the subject of that litigation. Id. at 289 n.11.
U nlike the two cases relied upon by the plaintiffs, here , the Secretary has not stated an intent ion to, o r ev en the pos sibility that he w ill reinstate CMS 1682 -R

. S ee Trinity Lutheran Churc h of C olumbia, Inc. , 137 S. Ct. at 458 n

. 1; City of Mesquite , 102 S. Ct. at 289 n.11

. Rather, the Secretary has explicitly con ceded that the plain tiffs ’ coverage denials based upon CMS 1682

- R are “ not in accordance with law [,] ” Def. ’ s Mot. at 9 ; see infra n. 11 , and expressly states that “ [t]here is no indication that the Secretary intends to rescind the resciss ion of CMS[]1682 -R,” id. at 15

. Furtherm ore, there h ave been no allega tio ns that the Secretary has engaged in this type of conduct in the past, i.e ., (co ntinued . . .)23 He re, the Se cretary has “ formal ly rescinded and replaced CMS []1682-R” and represents that “ [t]here is no indication th at [he] intends to rescind the re[s]cission of CMS[]1682- R. ” Def .’s Mo t. at 15. Moreover, the Secretary st ates that “reverting to h is p rior policy would involve an unlikely sequence of events including rescinding not just CMS [] 1738-R but also the Decemb er 2021 final rule, and engaging in a new round of notice- and

- commen t ru lemaking.” Def .’ s Reply at 14. The r efore, based on the Sec reta ry’ s representations , s ee Citizens for Resp

. & Ethics in Wa sh ., 352 F. Supp. 3d at 14 (finding the agency ’ s a ffirmation that it would not re vert back to the challenge d policy was “ suff icient to carry [the d]efendant’s burd en ” ), as well as the lack of “evidence indicating that [C MS 1682- R] likely will be re[instated ,] ” 11 Nat ’ l Black Police

(. .

. contin ued) res cinding a ruling in response to litigation only to reinstat e it after the litigat ion has been rendered moot , as was the case in City of Mesquite

. See 102 S. Ct. at 289; see generally Pl s. ’ Opp ’n. Accordingly, the Court concludes that the ca se s cite d by the plaint iffs are inapposite given the specific facts of this case.

11 The plaintiffs ar gue that th e Secretary ha s failed to show th at the challenged decision in t h is case cannot be reas onab l y ex pected to recur because (1) “ the tim ing of the Secre tar y’ s ch ange screams mere tactics to avoid judi cial r eview[, ]” Pls. ’ Opp ’ n at 1 5; (2) “ the Secre ta ry continue s to defend his illegal conduct [, ]” id. ; and (3) “ the chall e nged practice is deeply r oote d a nd lon g[ -] stand ing ” because “ the Secre tary has been d enying CG M cl aims i mproperly for more than a decade [,] ” i d. a t 16. However , the Court concludes for several reasons that the in ferences the plaintiffs ask the C ourt to draw are too at ten uated fo r it to conclude that the Secretary is likely to revert to the challen ged position in this case. First, while a finding that the Secr eta ry rescinded and replaced CMS 16 82 -R “ in direct response to this litigation [] . .

. [would] make [] it more difficult for the [Secretary] to demonstrate recurrence is unlikely[,] ” DL v. Di stric t of Columbia , 187 F. Supp. 3d 1, 11 (D.D.C. 201 6), the Court is without a sufficient basis to make this finding.

“ Whether the [Secretary ’ s] cessat ion was timed in anticipation of [ or in response to this] lawsu it [,] or mo tivated by a genuine change o f hea rt is relevant to the voluntary cessation analysis .” Id. An d, in this case , the Secretary ’ s r escission of CM S 1682

- R could be a direct response to ongoing litigation, as the plaintiff suggests, see Pl s. ’ Opp ’ n at 15, or it could “ reflect [] the Secr e tary ’ s consistent effor ts to expand coverage for CGM devices and s upplies, ” as the Secretary asser ts, Def. ’ s Reply at 7, especially given the lengthy proposal and notice

- and

- comment rulema king processes required to rescin d and replace a n administrative ru l e. However , without more convincing direct evidence of a ma nipulative intent, se e , e.g. , DL , 187 F. Supp. 2d at 11

– 12 (citing to evidence of email correspondence and statements by the defendant indicat ing that the po licy changes at iss ue were in direct re sponse to pending li tigation) , the Court cannot definit ively conclude that thi s t ype of intent played a role in the S ecretary ’ s actions. Moreover, as noted earlier, this Circuit has found it “ inappr o priate f or [ ] courts either to impute [ ] manipu lative conduct to a coordinate branch o f gove rnment, or to apply agai n st that branch a doctrin e that appea rs to rest on the likelihood of a manipulative purpose .’” Clarke , 9 15 F. 2 d at 705

. In fa ct , the Secretary ’ s rescission of CMS 1682

- R may have even been “ me rely a p rudent response to ” the ruling s of other court s regarding the coverage stat us of C GMs , a response whic h th e Circuit has condoned

. Nat ’l Wildlife Fed ’ n v. Hodel , 839 F.2d 694, 742 ( D.C. Cir. 1988). (co ntinued . . .)24 Ass ’n , 108 F.3d a t 3 49 (emphasis added) ; see id. (stating that the mere power to reinstate a policy is “not a sufficient basis on which a cou rt can conclude that a reason able expectation of

recurrence exists ” ), the Court concludes that th e Secretary has me t his burden to show that “ there is no reasonable expectatio n [ ] that the alleged violation will rec ur, ” Are f, 833 F.3d at 251. Regarding the second prong of the “volun tary cessat ion” excepti on, namely, whether

“ interim relief or event s have completely and irrevocab ly eradicated the effects of the alleged violation [,] ” A ref , 833 F.3d at 251 (quoting Am. Bar A ss ’n v. F ed . T rade Comm’n, 636 F.3d 641, 648 (D.C. Cir. 2011)), “ [t]he determination w hether suffici e nt effects [of the allege d vio lation] remain

. . . wil l turn o n the availability of meaningful relief [,] ” Cierco , 190 F. Supp. 3d

at 24 ( second alteration in or iginal) . In other words, “a case is not moot if a court can provide an effective remedy [, ]” Larsen , 525 F.3d at 4, bu t “co urts may not decide a co ntroversy where

(. .

. contin ued) Second, whil e the plaintiffs are correc t that a defendant ’ s “ decision to contest liability a lso makes it more difficult to show there could be no reasonable expectation of recurren ce[,] ” DL , 187 F. Supp. 2d at 12 ( citing Knox v. Serv. Emps. Int ’ l Union , Local 1000 , 567 U.S. 298 (2012)) , the Secre tary c annot reasonably be said to hav e “ continue[d] to defend the legality [of the Department ’ s prior decision,] ” Knox , 567 U.S. at 307, of CMS 16 82 -R. The Secretary has explicitly con ceded that the plain tiffs ’ coverage denials are “ not in accordance with law [, ]” and , therefore , requested that judgment be entered for the plaintiffs on C ou nt III of their Complaint . Def. ’ s Mot. at 9. Thus, the Secretar y clearly does not m aintain the legality of CMS 1682

- R. A n d, to the extent that the Secre tary continues to defe nd against allegations of bad faith, see Pls. ’ Opp ’ n at 15 ( referencing the Secre ta ry ’ s oral argument in Sm ith v. Becerra , Civ. Action No. 21

- 47 (D. Utah)), the se ar gument s are distinct from contesti ng the legality of CMS 1682

- R. Finally, while the plaint iffs are cor rect that a “ long period of uninterr upted [alleged ] violations weighs h eavily against [a ] defendant[,] ” DL , 187 F. Supp. 2d at 12 , C MS 168 2- R was effective from 2017 to early 2022 , when it was replaced by the December 2021 ruling , se e supra Sec tion I.A.1 –2

. However, “ [n] ew notice

- and

- comment rulemaking[] . . . take[s] time. ” Al aska , 1 7 F. 4th at 1229 . And , “ [i] ntervening events , such as electio ns or changes in policy priorities, bearing on these processes are unpredictable. ” Id. The Court th erefore concludes that mere ly because CMS 1682

- R was in place for approximately three to four y ears before the Secretary began the pro cess of re scinding it , see Def. ’ s Reply at 7 (stating that “t he Secretary ’ s consistent efforts to expand coverage for CGM devi ces and s upplies [] beg[an] with his proposed rule in November 2020, 85 F ed. Reg . 70, 358, 70 ,3 98, 70,403

– 70,40 4 (Nov. 4, 2020) ”) , does not weigh signific antly in favor of finding that recurrence is likely. Moreover , in applying the voluntary cessation exception to agency action, th is C ircuit has concluded that manipulative inten t is the most impo r tant consideration. See Alaska , 17 F. 4th at 1 229 ( “ The esta blished law of this [C]ircuit is that ‘ the voluntary cessation exception to mootness has no play ’ w he n [an] age ncy did not act ‘ in order to avoid litigation. ’” ( quoting Am. Bar Ass ’n, 636 F.3d at 648 (internal quotation marks omitted)). A ccordin gly , having di scerned no manipulative intent based upon either of the plaintiffs ’ previous two a rguments , the Court also concludes that the plaintiffs ’ a rgumen ts c oncerning the leng t h of time that the Secr etary denied coverage for CGMs does n ot alone demonstrate v olu ntary cessation in this case. See id. at 122 9– 30.25 post-filing events ‘ make[ ] it impossible for the court to grant any effectua l relief whatever [,]’” Cierco , 190 F. Supp. 3d at 24 (quoting Church of Scientology of Cal. v. Un ited Sta tes , 506 U.S . 9, 12 (1992)) (internal quotation marks omit ted) (alterations and emphasis in original). Thus, this exception to mo otness does not apply where an “ agency ’s subsequent actions have given [th e] plaintiffs the most they would be entitle d to if they won this ca se. ” Mi dcoast Fisherman ’s As s’n v. Blank, 948 F. Supp. 2d 4, 8 (D.D.C. 2013). Here, as discussed with respec t to the mootness of th e plaint iffs ’ remai ning claims in this

case, see supra Section III. B.1, the Secre tary ’s actions subsequent to the filing of this case have effective ly provided the plainti ffs with the ultimate r elief “they would be entitl ed to if they won this case [,] ” Mi dco ast Fi sherman ’s Ass ’n , 948 F. Supp. 2d at 8. The Secretary ’s rescission of CMS 1682-R and re- cla ssification of all CG Ms as “du rable medical equipment ” under CMS
1738-R renders any subsequent “order setting aside CMS 1682-R [,] ” see Pls. ’ Opp ’n at 13, that the Court would issue compl etely in effec tual. 12 See Cierco , 190 F. Supp. 3d at 24 (“ [C]ourts
may not decide a controversy where post- filing ev ents ‘m ake[ ] it impossibl e fo r the court to
gran t any effectual relief whatever [.]’” (quoting Church of Scientology of Cal., 506 U.S. a t 12) (emphasi s in original)). In other words, the plaintiffs have already been “provide [d] coverage of the clai ms - in -suit [,] ” Pl s.’ Op p’n at 13, and therefore, they “ ha [ve ] alr eady obtained all t he relief that [ they ] sought [,] ” Con servati on Forc e, Inc. , 733 F.3d at 1204 ( inter nal qu otation marks omitted) , with respect to their in dividual coverage claims. For these reasons, the Cour t

co n cludes that the Se cretary ’ s rescission of CMS 1682- R, re -c lass ification of all C GMs as

12 The Court notes, however, tha t granting t he Se cretary ’ s request that judgment be entered for the plaintiffs on C ount III of the Comp laint and thereby ruling that CGM s constitute dura ble medic al equipment , see supra Section III.A, impose s a significant roadblock to any potential reinstateme nt of CMS 16 82

- R. That impediment results from the fact that any reinstatement of th e rescinded rul e— or promulgation of a substanti ally similar ruling

— would be in violation of this Co urt ’ s O rder if it de

- classified CGMs as durable medical equip ment

.26 “durable medical e quip me nt,” and reimbur sement of the plaintiffs ’ previously denied coverage claims “ have co mpletely and irrevocably eradi c ated the effects of the a lleg ed violation [,] ” Ar ef , 833 F.3d at 251, and the “voluntary cess ation ” exception to mootness does not apply in this

case. 13
Acc ordingly, having concluded that the Secretary has met his bu rden of es tablish ing that the plaintiffs ’ re maining claims are moot and t hat the plaintiff s failed to est ablish that either of the exceptions to mootne ss apply in this c ase, the Court conc ludes that it must dismiss th e plai n tiffs remaining claims as moot.
I. C ONCLU SIO N
For th e forego ing reasons, the Court co ncludes th at i t must grant the S ecretary ’s motion.
SO O RDERED this 8th day of June, 2023. 14

REGG IE B. WA LTON Unite d States Dis trict Ju dge

13 The plaintiffs argue th a t “ the Secretary has not sho wn that the effects of his illegal conduct has been completel y and i rrevoc ably eradicated ” because (1) “ [h e] ref uses to revisit and gra nt all the claim s for CGM co verage that were denied on the ba sis of the illegally is sued and bad faith CMS 1682 -R[,]” Pls .’ Opp ’ n at 19, and (2) many Medicare beneficiaries may not b e aware that they may submit coverage claims be cause “ CMS 1738

- R is a secr et policy [,] ” id

. at 19

– 20. However, the plaintiffs have previously failed to estab lish their entitlement to class certification, see Order at 1 (Apr. 28, 2022), ECF No. 115, and the Court may not order th e Secretary to reimburse ind i vidual s who are not parties in this case . M oreover, regard less of the practical effects of the Secretar y’s rescission of CMS 1682

- R and instatem ent of CMS 1738

- R, the Secretary ’ s a ctions have e ffectively satisfied the name d plaintif fs ’ request s for relief , see supra Sec tion I II.B.2, which is the rele vant consideration in determining whether their claims are moot , see C on servati on Force, Inc. , 7 33 F.3d at 1204 (st at ing that a case is mo ot where a part y “ ha s alrea dy obtained all the relief that [ he or she has] sought ”).

14 The C ou rt w il l contemporaneously issu e an Order co nsiste nt with t hi s Me m orandum O pinio n.