PUBLISH
UNITED STATES COURT OF APPEALS
FOR THE TENTH CIRCUIT

________________ _________________ LINDA P. SMITH, Plaintiff - Appellant,

v. XAVIER BECERRA, in his capacity as Secretary of the United States Department of Health and Human Services, Defendant - Appellee. No. 22-4012

________________ _________________ Appeal from the United States District Court for the District of Utah (D.C. No. 1:21-CV-00047-HCN)

________________ _________________ James C. Pistorino, Parrish Law Office, P ittsburgh, Pennsylvania, (Phillip Wm. Lear, Lear & Lear PLLC, Salt Lake City, Utah, withhim on the briefs), for Plaintiff-Appellant. Joshua M. Koppel, Appellate St aff Attorney, Civil Division, United States Department of Justice, Washington, DC (Brian M. Boynt on, Principal Deputy Assistant Attorney General, Andrea T. Martinez, Interim Unite d States Attorney, and Abby C. Wright, Appellate Staff Attorney, Civil Division, United States Department of Justice, Washington, DC, and Of Counsel: Daniel J. Barry, Acting General Counsel, Gerard Keating and Linda Keyser, Attorneys, Department of Health and Human Services, with him on the brief), for Defendant-Appellee.

________________ _________________ Before TYMKOVICH , Chief Judge, EID , and CARSON , Circuit Judges.

________________ _________________ TYMKOVICH , Chief Judge.

________________ _________________ FILED United States Court of Appeals Tenth Circuit 

### August 12, 2022 Christopher M. Wolpert Clerk of Court Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 12 Like many diabetics, Linda Smith uses a prescribed continuous glucose monitor (CGM) to track and regulate her glucose levels. When Smith purchased her CGM and its necess ary supplies between 2016 and 2018, she sought reimbursement for her expenses th rough her medical insurance program, Medicare Part B. Medica re administrators denied her claims. Relying on a 2017 ruling issued by the Cent ers for Medicare and Medicaid Services (CMS), Medicare administrators concluded that Smith’s CG M is not “primarily and customarily used to serve a medical pur pose” and therefore is not covered by Medicare Part B. Smith a ppealed the denial of her reimbursement claims through the multistage Medicare claims review pr ocess. At each stag e, the respective adjudicator confirmed the denial of her claims. Smith then sued the Secretary of th e Department of Health and Human Services in federal court, seeking monetary, injunctive , and declaratory relief. Contending that her CGM and supplies sa tisfied the requireme nts for Medicare coverage, Smith requested that the district court (1) orde r the Secretary to pay her claims; (2) declare that CGMs are covered by Medica re; and (3) set aside the 2017 ruling as unlawful becau se it did not go through the proper rulemaking
process. Instead of asking the c ourt to uphold the denial of Smith’s claims, the Secretary admitted that Sm ith’s claims should have be en covered and that the agency erred by denying her claims. The Secretary re quested a remand so the agency could reimburse Smith’s claims. Rather than acce pt the Secretary’s Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 23 admission of error, Smith argued that the Secretary onl y admitted error to avoid judicial review of the legality of the 2017 ruling. During Smith’s litigation, CMS change d its Medicare coverage policy for CGMs. Prompted by several adverse dist rict court rulings, CMS promulgated a formal rule in December 2021 classifying CGMs as dur able medical equipment covered by Medicare Part B. But the ru le applied only to cl aims for equipment received after February 28, 2022, so pending claims fo r equipment received prior to that date were not c overed by the new rule. Considering the new rule and the Se cretary’s confessi on of error, the district court in Janua ry 2022 remanded the case to the Secretary with instructions to pay Smith’s claims. The district c ourt did not ru le on Smith’s pending motions regard ing her equitable relief clai ms; instead, the court denied them as moot. Smith moved to alter or amend the judgm ent, contending that her equitable claims were stil l live, but the district court denied the motion. Smith appealed, arguing that her equita ble claims are justiciable because the 2017 ruling has not been formally resc inded and Medicare administrators can still rely on the ruling to deny claims for equipm ent received prior to February 28, 2022. But in May 2022—shor tly before oral argument in this case—the Secretary issued a new ruling. The 2022 ruling expr essly rescinded the 2017 ruling and ordered Medica re administrators to approve CGM claims for equipment received prior to February 28, 2022. The Secretary asserted the 2022 ruling further rendered Smith’s claims moot. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 34 We agree with the Secretar y that Smith’s claims ar e moot. Taken together, the December 2021 final rule and the 2022 CMS ruling ensure that pending and future claims for CGMs, including th e equipment owned by Smith, will be covered by Medicare. Becau se the recent regulatory de velopments moot Smith’s equitable claims, we do not have jurisdiction to consid er Smith’s appeal. We further conclude that al though CMS voluntarily changed its CGM coverage policy during this litigation, the voluntary cessation doctrine to avoid mootness does not apply. 

### I. Background
Diabetes is a di sease that affects how the body handles gluc ose, a sugar that is the main source of energy for many cells and tiss ues. Glucos e enters the bloodstream through food or afte r being produced in the live r. Insulin, which is produced by the pancreas, helps the body process glucose by moving glucose from the bloodstream to ce lls and tissues. When the body does not produce enough insulin, glucose can build up in the bloodstream , causing severe health problems, such as heart di sease, stroke, kidney failur e, or even death. To avoid a medical emerge ncy, diabetics must c onstantly monitor their glucose levels. The tradit ional means of doing so is with a blood glucose test, which involves pricking a fi nger and placing a drop of blood on a test strip to determine current glucose le vels. Depending on the resu lts of the te st, diabetics may need to take insulin or ingest glucose to adjust their blood sugar levels. While blood glucose tests are accurate, they can be pa inful and inconvenient for Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 45 many diabetics, some of w hom must wake up several times throughout the night to perform a test. To address these issues, researchers developed CGMs , which are capable of automatically measur ing blood glucose levels at s hort intervals—some monitors can take readings as freque ntly as every five minutes. To use a CGM, diabetics insert a disposable sensor underneath their skin. Th e sensor detects glucose levels and sends the data via a transmitter to a di splay monitor. Some CGM devices include insulin pumps, which dispense insulin automatically if there is a high glucose reading. Diabet ics typically need to repl ace a sensor once a week, a transmitter once every few m onths, and a monitor after se veral years. CGMs are often preferred because th ey monitor glucose levels automatically and more frequently than blood glucose te sts. More frequent readi ngs decrease th e risk that a sudden onset of symptoms wi ll lead to a medical emerge ncy. They also lead to better overall glucose-le vel control, which can pr event long-term health problems.
Smith’s Medicare Claims Linda Smith has suffered fr om diabetes for over 55 years. Her condition is particularly dangerous be cause she has hypoglycemic unawareness, which means she is unable to physically sense when her blood glucos e levels are too low. Smith is also prone to ra pid and unpredictabl e changes in her glucose levels. Because Smith often has few physical warnings of an impending diabetic emergency, Smith must be vigilant in monitoring he r glucose levels—failing to Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 56 do so could be catastrophic for her. On at least one o ccasion, Smith lost consciousness and had to be hospitalized. To better manage Smith’s diabetes, a doctor pres cribed her a Medtronic MiniMed 630G CGM with disposable sensor s. Smith, who has Medicare Part B health insurance, filed Medicare reim bursement claims fo r the monitor and sensors. Specifically, Smith sought reimbursement for a MiniMed monitor prescribed to her in December 2016, and disposable glucose sensors she received in November 2017 and May 2018. Medicare administrators denied Smith’s claims . The administrators determined that Smith’s sp ecific monitor and supplies were not “durable medical equipment” covered by Medica re. Smith appealed her cl aims all the way to the Medicare Appeals Council, but her claims were rejected. 1
Medicare administrators denied Smith’s claims based on CMS-1682-R, a ruling issued by CMS in January 2017. That ru ling—which is binding on Medicare administrato rs and constitutes an “officia l statement[] of agency policy

1 Medicare reimbursement claims must go through the following administrative process before a beneficiar y may seek judicial revi ew: (1) initial coverage determination made by a CM S administrative contract or; (2) redetermination decision made by same cont ractor; (3) reconsiderati on by a qualified independent contractor; (4) review by an administrative law ju dge (ALJ) (subject to a minimum amount-in-controve rsy requirement); and (5) de novo review by the Medicare Appeals Council (MAC), which constitutes a final decision by the Secretary. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 67 and interpretation”—explains that a CGM will only be c overed by Medicare if it meets the definition of “dur able medical equipment.” App., Vol. 2 at 314. The Medicare regulations define “durable medical equipment” as [E]quipment, furnished by a supplier or a home health agency that meets th e following conditions: (1) Can withstand repeated use. (2) Effective with re spect to items classi fied as [durable medical equipment] after January 1, 2012, has an expected life of at least 3 years. (3) Is primarily and customar ily 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 fo r use in the home. 42 C.F.R. § 414.202. In CMS-1682-R, CMS explained that some CGMs require a separate blood glucose test to confirm blood sugar levels before corrective measures can be taken. Because these CGMs cannot be used independently to make diabetes treatment decisions, CM S concluded that su ch devices—which CMS refers to as “non-ther apeutic” or “adj unctive” devices—ar e not “primarily and customarily used to serve a medi cal purpose” and thus do not meet the definition of durable medica l equipment. App., Vol. 1 at 85–87. CMS reasoned that only those CGMs “approved by the [Food and Drug Administration] for use in place of a blood glucose monitor for making diabetes treatmen t decisions” are durable medical equipment. Id. at 92 (emphasis added). Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 78 Medicare administrators and an administrative la w judge determined that CMS-1682-R precluded coverage for Smith’s claims because the Food and Drug Administration “has not a pproved the benefi ciary’s CGM system . . . as a replacement for a blood glucos e monitor.” App., Vol. 2 at 320. In a final agency decision, the Medicare Appeals C ouncil adopted the reasoning of the administrative law judge, ruled that Smith’s clai ms were not covered by Medicare, and deemed Smith financially responsible for the incurred expenses. Procedural Background Having exhausted her admi nistrative remedies, Smith sued the Secretary of the Department of Health and Hu man Services in federal court. 2 In addition to seeking monetary reimburseme nt for her claims, Smith also sought injunctive and declaratory relief. Specifically, she requested that th e district court (1) set aside CMS-1682-R because it di d not go through notice and comment rulemaking as required by statute; (2) declare that CGMs are dur able medical equipment, regardless of whether they replace blood glucose tests; and (3) declare that the Secretary’s denials of CGM claims we re unsupported by subs tantial evidence, arbitrary and capricious, abuses of discretion, and not in accordance with the law. Rather than contest Smith ’s claims, the Secretary admitted that Medicare administrators erred by denyi ng coverage. The Secretar y explained th at because Smith’s CGM also serves as an insulin pump, it meet s the definition of durable

2 CMS is part of the Department of Health and Human Services. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 89 medical equipment under the Medicare statute and regul ations. Based on this admission of error, the Secr etary requested that the di strict court enter judgment in favor of Smith and remand to the ag ency for payment of Smith’s claims. 3 Despite the Secretary’s confession of error, the di strict court allowed the case to proceed. Shortly after the Secretar y filed his answer, Smith moved for summary judgment. Smith argued that the district court should vacate CMS1682-R because the ruling did not go thr ough the notice and comment process as required by 42 U.S.C. § 1395hh. In a separate summary judgment motion, Smith argued that the Secretary s hould be collaterally estoppe d from litigating the issue of whether Smith’s CGM is durable medi cal equipment because an administrative law judge had previously ruled that Sm ith’s monitor was covered. In response, the Secretar y contended that the dist rict court does not have the power to vacate CMS-168 2-R because the Medicare statute does not authorize a court to set aside agency actions such as CMS rulings, citing 42 U.S.C. §§ 405(g), 1395ii. The Secretary also alerted the district c ourt to the fact that in November 2020, CMS published a notice of proposed rulemaking stating that the agency planned to change its policy regarding coverage of CGMs. Unlike CMS3 The Secretary initially sa id that only Smith’s claim for the monitor itself should be paid on remand. While the Secretary acknowledged th at administrators erred in denying Smith’s other two claims for the sensors, th e Secretary explained that it had yet to be determined “whether the sens ors should be cove red as reasonable and necessary for the operati on of the insulin pump.” A pp., Vol. 1 at 38. The Secretary later amended hi s position based on interven ing regulation changes and requested that the district court “remand to the Secr etary for payment of [all] three claims.” Id. at 271. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 910 1682-R, the new rule would classify CGMs as durable medical equipment regardless of whether they ca n be relied on to make di abetes treatment decisions without the use of a sepa rate blood glucose test. See 85 Fed. Reg. 70,358 (Nov. 4, 2020). The Secretar y explained to the district court that the “proposed rule would supersede [CMS-1682-R], if fi nalized, and in doi ng so would moot Mrs. Smith’s claim for vacatu r.” App., Vol. 1 at 263. Following a public comment period, CM S issued a final rule in December 2021 classifying CGMs, transm itters, and sensors as dur able medical equipment covered by Medicare Part B. See 86 Fed. Reg. 73,860 (Dec. 28, 2021) (“Final Rule”). Based on this regul atory change, the Secretar y renewed his request for the court to enter judgment in favor of Smith and to re mand the case. In January 2022, the district co urt entered a judgment remanding the matter to the Secretary with instructions to pay Smith’s three cl aims. In a docket te xt order, the court denied Smith’s pending summary judgm ent motions regarding CMS-1682-R and collateral estoppel as moot. Finding the court’s order and judgment in adequate, Smith mo ved to alter or amend the judgment, arguing that her moti ons were not moot because she sought equitable relief and collatera l estoppel, both of which th e court had not addressed, and the Secretary’s concessi on did not resolve. Smith contended that the Final Rule issued by CMS did not moot her cl aims because the ru le only applies to claims for CGMs an d supplies received afterFebruary 28, 2022. Smith informed the court that she had othe r reimbursement claims pendi ng before the agency for Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1011 CGM sensors she received on July 14, 2021. Since Medicare administrators had denied those July 2021 claims even after the Secretar y confessed error as to Smith’s 2016, 2017, and 2018 claims, Smith asserted there was a reasonable probability that the Secret ary would continue to deny pending CGM claims based on CMS-1682-R. Therefore, Smith argued her equitabl e relief claims still presented a live c ontroversy. The district court denied Smith’s motion to alter or amend the judgment. It explained that Smith’s pe nding motions were moot be cause the court granted judgment in Smith’s favor. The court further explai ned that “while [Smith] appears to desire additional relief . . . the court grante d [Smith] all of the relief authorized by statute.” A pp., Vol. 1 at 11 (citing 42 U.S.C. §§ 405(g), 1395ii). Subsequent Developments After Smith filed her notice of app eal, CMS sent a Technical Direction Letter to all Medicare ad ministrative contractors. The Letter explained that although the coverage and payment provisi ons of the Final Rule only apply to CGMs and supplies received after February 28, 2022, contractors s hould approve valid reimbursement claims for equi pment received befo re that date. See Technical Direction Lett er 220257, Docket 20-1, Olsen v. Becerra , No. 21-cv-326 Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1112 (E.D. Wash. Feb. 25, 2022). 4The Letter said that by applying the coverage provisions of the Final Ru le retroactively to pendi ng claims, CMS will “avoid expending administrative resources on further applic ation of [CMS-1682-R] on CGMs and additional appe als challenging applicatio n of [CMS-1682-R].” Id. at 2. Even though the Letter is not bindi ng on Medicare contract ors, the Secretary contends on appeal that the Letter serves as fu rther evidence that Smith’s remaining claims are moot because “future va lid claims for continuous-glucosemonitor supplies should be cove red regardless of the date of service. ” Resp. Br. at 26 n.2. Smith insists that because the Letter is no t binding and CMS-1682-R has not been formally resc inded, there is no guarant ee that pending claims for CGMs will be approved. On May 13, 2022—four days before the parties’ oral argument in this case—CMS issued a binding ruling to formally implem ent its policy of applying the Final Rule retroactively to claims for CGM supplies received prior to February 28, 2022. See CMS-1738-R, available at https://www.cms.gov/ regulations-and-guidancegui dancerulingscms-rulings/c ms-1738-r. In CMS-1738-

4 Because the Letter was issued after the district court’s entr y of final judgment, it was not before the distri ct court and is not part of the record on appeal. Nevertheless, we may ta ke judicial notice of this publicly filed letter for the first time on appeal. See Winzler v. Toyota Motor Sales U.S.A., Inc. , 681 F.3d 1208, 1213 (10th Cir. 2012). Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1213 R, CMS expressly rescinde d CMS-1682-R and prohibited its further application to pending claims. 5 

### II. Analysis
Smith contends the distri ct court erred by denying her equitable claims as moot. The Secretary counters that even if Smith’s equita ble claims were still live when the district co urt declined to address them, they have since become moot due to the recent regulator y changes affecting coverage of CGMs. The Secretary also argues that the voluntary cessation doctr ine—which obviates mootness— does not apply here because there is no indication that the Secretary changed his coverage policy in re sponse to this litiga tion or that he will reverse course once this litigation concludes. We dismiss the appeal as moot. The Final Rule concerning future claims for CGMs, coupled with th e recent issuance of Techni cal Direction Letter 220257

5 Specifically, CMS-1738-R states: This Ruling provides notice of the CMS Administrator’s determination to rescind a January 17, 2017 CMS Ruling (CMS-1682-R) . . . the substa ntive CGM classification, coverage, and payment pol icies established by the December 2021 final rule shall be applied to claims for a CGM monitor or receiver a nd/or its nece ssary supplies and accessories where either : (1) a valid CGM claim or valid CGM appeal was pending as of February 28, 2022; or (2) the right to submit a va lid CGM claim or file a valid CGM appeal had not expired as of February 28, 2022.
CMS-1738-R at 1–2. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1314 and CMS-1738-R, fully redress Smith’s equitable claims. Vacating CMS-1682-R and declaring that CGMs are durable medical equipm ent covered by Medicare would have no effect be cause CMS has already rescinded CMS-1682-R and issued a formal ru le classifying CGMs and thei r supplies as dur able medical equipment. In short, Smith no longer suffers from an ac tual or imminent injury that can be redressed by this court. We also conclude that the voluntar y cessation doctrine does not apply. Although CMS changed its CGM coverage pol icy during this litigation, mooting Smith’s claims, the Secretary has met hi s burden of establis hing that the policy change will not be rescinded after this case concludes.
A. Mootness Article III of the Consti tution limits the jurisdicti on of federal courts to actual “Cases” and “Controversies.” U.S. Const. art. III, § 2; Genesis Healthcare Corp. v. Symczyk , 569 U.S. 66, 71 (2013). The ca se-or-controversy requirement “ensures that the Federal J udiciary confines itself to its constitutionally limited role of adjudicating actual and concrete disputes, the resoluti ons of which have direct consequences on the parties involved.” Genesis Healthcare , 569 U.S. at 71. “This means that, througho ut the litigation, the plai ntiff ‘must have suffered, or be threatened with, an actual injury tr aceable to the defendant and likely to be redressed by a favorable judicial decision.’” Spencer v. Kemna , 523 U.S. 1, 7 (1998) (quoting Lewis v. Cont’l Bank Corp. , 494 U.S. 472, 477 (1990)). The Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1415 case-or-controversy requireme nt applies “through all stag es of federal judicial proceedings, trial and appellate.” Id. As Article III requires an actual controversy, we lack subject-matter jurisdiction over a case that is moot. Prison Legal News v. Fed. Bureau of
Prisons , 944 F.3d 868, 879 (10th Cir. 2019). We review mootness determinations de novo. Id. at 878. A case becomes moot “w hen the issues presented are no longer ‘live’ or the parties lack a legally cognizable in terest in the outcome.” City of Erie v. Pap’s A.M. , 529 U.S. 277, 287 (2000) (quoting Cty. of Los Angeles
v. Davis , 440 U.S. 625, 631 (1979)). In othe r words, “[i]f an intervening circumstance deprives the pl aintiff of a ‘personal stak e in the outcome of the lawsuit,’ at any point during litigation, the acti on can no longer proceed and must be dismissed as moot.” Genesis Healthcare , 569 U.S. at 72 (quoting Lewis , 494 U.S. at 472). “The crucia l question is whether granti ng a present determination of the issues offered . . . will have some effect in the real world.” Citizens for Responsible Gov’t State Politi cal Action Comm. v. Davidson , 236 F.3d 1174, 1182 (10th Cir. 2000) (quotat ions and citation omitte d). “No matter how vehemently the parties cont inue to dispute the lawful ness of the conduct that precipitated the laws uit, the case is moot if the dispute is no longer embedded in any actual controversy a bout the plaintiffs’ part icular legal rights.” Already, LLC v. Nike , Inc. , 568 U.S. 85, 91 (2013) (quota tions and cita tion omitted). We take a claim-by-claim approach to mootness a nd “must decide whether a case is moot as to ‘each form of relief sought.’” Prison Legal News , 944 F.3d Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1516 at 880 (quoting Collins v. Daniels , 916 F.3d 1302, 1314 (10th Cir. 2019)). The defendant bears the burden of establishing that a “o nce-live case has become
moot.” West Virginia v. Env’t Prot. Agency , 142 S. Ct. 2587, 2607 (2022). An injunctive relief claim becomes moot when the “plain tiff’s continued susceptibility to injury ” is no longer “reasonably certain” or is based on “speculation and conjecture.” Jordan v. Sosa , 654 F.3d 1012, 1024 (10th Cir. 2011) (quotations and ci tation omitted). Similarly, a declaratory relief claim is moot if the relief would not affect “the behavior of the defendant toward the plaintiff.” Rio Grande Silvery Minnow v. Bureau of Reclamation , 601 F.3d 1096, 1110 (10th Cir. 2010) (quotati ons and citation omitted); Jordan , 654 F.3d at 1025 (“[I]n the context of an ac tion for declaratory relief, a plaintiff must be seeking more than a retrospective opinion that he was wrongly harmed by the defendant.”). In her complaint, Smith requested that the district cour t enter an order providing the following relief: (1) setting aside CMS-1682-R a nd its determination that CGMs that do not completely replace finger prick/test strips are not [durable medi cal equipment] within the meaning of 42 U.S.C. § 1395x(n) and 42 C.F.R. § 414.202; (2) finding that CGMs (wheth er they completely replace finger prick/test st rips or not) are [durable medical equipment] within the mean ing of 42 U.S.C. § 1395x(n) and 42 C.F.R. § 414.202; (3) finding the Secretary’s denials of CGM coverage on the grounds that a CGM is not [durable medical equipment] is not supported by substantial evidence, are Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1617 arbitrary and capricious, an ab use of discretion, and not in accordance with the law. App., Vol. 1 at 35. 6 The Secretary contends that interveni ng events during this litigation have rendered Smith’s claims m oot. We agree. The Fi nal Rule, the Technical Direction Letter, and CM S-1738-R already classify CGM systems as durable medical equipment and ma ndate coverage for pend ing and future Medicare reimbursement claims. T hus, granting Smith any of the relief requested above would have no real-w orld effect. We begin with Smith’s first request for relief. Smith alleges that CMS1682-R should be set aside be cause it was issued “w ithout observance of the procedure required by la w (e.g., notice and co mment [rulemaking]).” Id. at 32– 34. Smith argues that beca use her Medicare reimburs ement claims have been continuously denied base d on CMS-1682-R, invali dating the ruling would eliminate any basis for the Secretary to deny her claims for CGM supplies in the future. Smith’s argument fails because CMS formally rescinded CMS-1682-R and replaced it with the Fi nal Rule and CMS-1738-R, both of which mandate Medicare coverage for CG Ms. The Final Rule, wh ich became effective on

6 Smith also requested that the district cour t order “the Secr etary to provide coverage for the CGM claims at issue in this case.” App., Vol. 1 at 35. Because the district court indisputab ly ruled in Smith’s favor on that claim, we need not address whether the claim is moot. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1718 February 28, 2022, ensures co verage for CGM supplies rece ived after that date. CMS-1738-R applies the same coverage provisions to CGM claims that were pending as of February 28, 2022, or where the right to submit a claim or appeal had not expired as of Febr uary 28, 2022. Collectively, these changes mean that the Secretary no longer has any basis upon which to deny Smith’s pending or future claims. 7 Because Smith’s clai ms for her CGM supplie s are now covered by Medicare, invalidati ng CMS-1682-R would provide Smith no further relief. Her first claim is therefore moot. See Church of Scientology of Cal. v. United States , 506 U.S. 9, 12 (1992) (“[I]f an event occu rs while a case is pending on appeal that makes it impossible for the court to grant ‘any effect ual relief whatever’ to a prevailing party, the appe al must be dismissed. ” (citation omitted)). For similar reasons, Smith’s second claim for declar atory relief is also moot. Smith asked the distri ct court to declare that al l CGMs are durable medical equipment under the Medicare statute and regulations. To begin with, Smith only

7 Because Smith’s equitable relief claims did not beco me moot until CMS issued CMS-1738-R in May 2022, the district c ourt should not have found those claims moot in January 2022. Th e district court apparently denied Smith’s pending motions as moot in part because the Final Rule resc inded CMS-1682-R. But the Final Rule only applies to cl aims for equipment received afterFebruary 28, 2022. Claims for equipment recei ved before that date—suc h as Smith’s July 2021 claims that were pendi ng before the agency—could still be denied under CMS1682-R. Since Smith still fa ced a risk that her pending claims would be denied, Smith retained a legally cognizable intere st in the outcome of the case and her equitable claims remained live. It was not un til CMS issued CMS-1738-R— applying the Final Rule retr oactively to claims for equipment supplied prior to February 28, 2022, and e xpressly rescinding CMS-1682- R—that Smith’s claims became moot. After that ruling went into effect, Smith no longer faced a risk of imminent harm from he r claims being denied. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1819 has standing to challenge the denial of her specific CGM because a declaration that other glucose monitors are covered by Medi care would not redress any injury suffered by Smith. See Warth v. Seldin , 422 U.S. 490, 499 (1975) (“[T]he plaintiff generally mu st assert his own legal rights and interests, and cannot rest his claim to relief on the le gal rights or interests of th ird parties.”). Regardless, the Final Rule and CMS-173 8-R address Smith’ s concerns and grant Smith the full relief she seeks. The Final Rule recognizes th at CGMs—irrespective of whether they complement a blood glucose test—are “p rimarily and customarily used to serve a medical pur pose” and therefore meet the definition of durable medical equipment. 86 Fe d. Reg. at 73,899. Simi larly, CMS-1738-R adopts the Final Rule’s coverage provisions a nd expressly resci nds CMS-1682-R. See CMS1738-R at 11 (“CMS-1682-R, is hereby rescinded and shall not be applied to any additional CGM claims under Pa rt B or Part C, as app licable, or to any further administrative appeals of CGM claims.”). These regulatory changes make clear that CMS now classifies CGMs as dur able medical equi pment. Smith’s declaratory relief claim is moot. Smith’s final request for relief—decl aring that the Secr etary’s repeated denials of CGM claims wa s wrongful—is also moot. Smith requested that the district court declare that “the Secretary’s denial s of CGM coverage on the grounds that a CGM is not [durable me dical equipment] [a re] not supported by substantial evidence, are arbi trary and capricious, an a buse of discretion, and not in accordance with the law. ” App., Vol. 1 at 35. Smith asserts that this Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 1920 declaration would prevent the Secretary from denying fu ture CGM claims based on an improper interpretati on of the regulatory defini tion of “durable medical equipment.” Like Smith’s ot her requests for reli ef, this request is moot because Smith no longer suffers from an imminent injury that would be redressed by declaring that the Secretary’s previous de nials of coverage we re improper. In short, Smith seeks “a retr ospective opinion that [s]h e was wrongly harmed by the defendant.” See Jordan , 654 F.3d at 1025. Without a redressable injury, such a declaration would be nothing more than an advisory opinion. See TransUnion
LLC v. Ramirez , 141 S. Ct. 2190, 2203 (2021) (“Under Article III, fe deral courts do not adjudicate hypothetical or abstract disputes.”). Smith also requested a separate ruli ng on the issue of whether the Secretary is collaterally estopped from litigating CGM coverage because an administrative law judge previously dete rmined that Smith’s CGM and supplies ar e covered by Medicare. As Smith notes , CMS-1738-R and the Final Ru le do not address the issue of whether prior admi nistrative law j udge or district court decisions preclude the Secretar y from re-litigating the coverage of CGMs. But the “crucial question” for mootness is wh ether “granting a present de termination of the issues offered . . . will ha ve some effect in the real world.” Davidson , 236 F.3d at 1182 (quotations and citation omitted). Because a ruling on coll ateral estoppel would not redress any actual or imminent injury suffered by Smith, we do not have jurisdiction to consider the issue. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2021 In sum, Smith has won all the relie f she sought when sh e commenced this litigation. The Secretary has agr eed to pay Smith’s denied claims, 8 rescinded CMS-1682-R, and recognized CGMs as durable medi cal equipment covered by Medicare. Based on Smith’s alleged injuries, there is no further relief that can be afforded to Smith. B. Voluntary Cessation We now turn to the question of wh ether the voluntary cessation doctrine applies. Although a live controversy must exist at all stag es of litigation, “a defendant cannot automatically moot a case simply by ending its unlawful conduct once sued.” Already , 568 U.S. at 91. “Other wise, a defendant could engage in unlawful conduct, st op when sued to have the case declared moot, then pick up where he left off, repeating this cycle until he achie ves all his unlawful ends.” Id. To address this con cern, the Supreme Court ha s held that “a defendant claiming that its voluntary compliance moots a case bear s the formidable burden of showing that it is abso lutely clear the allegedly wrongful behavi or could not reasonably be expected to recur.” Id. (citation omitted).

8 According to the Secretary, Smith’s previously denied CGM claims have all been paid, including her clai m for disposable sensors re ceived in July 2021 after the filing of this case. See Resp. Br. at 24 (“CMS reproc essed and paid plaintiff’s claim for disposable sensor s received on July 14, 2 021); Aple. Supp. Br. at 13 (“[T]he claims under review have been paid.”). Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2122 Although the defendant face s a heavy burden in underm ining the plaintiff’s invocation of the voluntary cessation doctrin e, we do not require a defendant to show that it would be impossible for him to resu me his allegedly wrongful conduct. “For the voluntar y cessation exception to appl y, ‘we must be convinced that the allegedly wrongf ul behavior could not reasonably be expected to recur . . . not that there is no possibility.’” Prison Legal News , 944 F.3d at 881 n.20 (quoting Brown v. Buhman , 822 F.3d 1151, 1175 (10th Cir. 2016)). For that reason, “[a] case ceases to be a live controvers y if the possibility of recurrence of the challenged conduct is only a speculative contingency.” Rio Grande Silvery
Minnow , 601 F.3d at 1117 (quotations omitted and alterations incorporated). When a plaintiff seeks to set aside the policy of a government agency, the rescission or modification of that policy can moot the challenge. 9 Id. Further, the “mere possibility that an agency might rescind ame ndments to its actions or regulations does not enliven a moot controversy.” Id. (quotations and citation omitted); see also id. at 1116 (“[E]ven when a legi slative body has the power to reenact an ordinance or stat ute, ordinarily an amendmen t or repeal of it moots a case challenging the ordina nce or statute.”).

9 We have opined in past mootness cases that we may afford a government official’s voluntary conduct “more solicitude” than th at of private actors. Rio Grande Silvery Minnow , 601 F.3d at 1116 n.15 (quoting Ragsdale v. Turnock , 841 F.2d 1358, 1365 (7th Cir. 1988)); Prison Legal News , 944 F.3d at 881. But as the Supreme Court reminds us, government actors stil l bear the “heavy” burden of making “absolutely clea r that the allegedly wrongf ul behavior could not reasonably be expected to recur.” West Virginia , 142 S. Ct. at 2607 (quotations and citation omitted). Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2223 Smith claims (1) the Secretary cha nged his policy regard ing coverage of CGMs solely for the purpos e of evading judicial re view; and (2) it can be reasonably expected that the Secretary will re sume denying CGM claims once this litigation concludes. We disagree for tw o reasons. First, the timing of the Secretary’s policy change toward CGMs suggests that the Secretary did not voluntarily change hi s conduct to moot Smith’s liti gation. Second, there is a minimal risk that the Secr etary will suddenly revert to his rescinded policy of denying CGM claims given th e wholesale change in po licy that has developed over the past several year s. To undo his policy rec ognizing CGMs as durable medical equipment, the S ecretary would need to ta ke the unlikely steps of disavowing his previous support for the c overage of CGMs, re placing the Final Rule—which can only be done after a not ice and comment peri od, rescinding the Technical Direction Letter, and withdrawing CMS-1738-R. We begin by examining the timing of the Secretary’s volunt ary cessation of the challenged conduct. Based on the sequence of events that led to CMS changing its CGM coverage policy, we cannot conclude th at the Secretary voluntarily ceased denying CGM claims as a temporary measure to moot Smith’s claims. See Brown , 822 F.3d at 1171 (“[W]e have i ndicated that mootness is more likely if . . . the case in question wa s the catalyst for th e agency’s adoption of the new policy.” (quoting Rosebrock v. Mathis , 745 F.3d 963, 972 (9th Cir. 2014))). Although CMS did not issue th e Final Rule providing Medicare coverage for CGMs until after this case commen ced, CMS initiated the Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2324 rulemaking process well be fore this litigation. In November 2020—several months before the Medicare Appeals C ouncil had even denied Smith’s claims— CMS published a proposed rule to classify CGMs as durable medical equipment under Medicare Part B. See 85 Fed. Reg. at 70,358. CMS explained that the proposed change in policy was due in part to several dist rict courts rejecting the reasoning of CMS-1682-R that CGMs “are not primarily and customarily used to serve a medical purpose.” Id. at 70,401. While the outco me of other cases seems to have prompted the propos ed rule change, the timing of the proposed rule in relation to Smith’s case fo recloses the possibility th at the Secretary stopped denying CGM claims solely to avoid judicial revi ew in Smith’s case. While we agree with Sm ith that the timing of CMS-1738-R—issued four days before oral argument— invites greater scrutiny than the timing of the Final Rule, we conclude that the timi ng of CMS-1738-R does not support an application of the voluntary cessation doctrine. First of all, Smith’s case is not the only case affected by the Final Rule or CMS-1738-R. As Smith repeatedly points out in her briefs, th e Secretary has deni ed thousands of other CGM claims, forcing other benefici aries to litigate their claims . We find it unlikely that the Secretary would issue CMS-1738-R merely to moot Smith’s claims given the abundance of other CGM claims and related litigati on. But even if the change in policy was prompted by Smith’s litigation, “that does not necessarily make it suspect.” See Brown , 822 F.3d at 1171. We have found that a “government official’s decision to adopt a policy in the context of li tigation may actually make Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2425 it more likely the policy will be followed, especially with respect to the plaintiffs in that particular case.” Id. (emphasis added). CMS st ated in CMS-1738-R that it decided to change it s policy on pending CGM clai ms “to bring an orderly conclusion to pending (and potentially fo rthcoming) administrative claims and appeals relating to the requi rements for classification, coverage, and payment of CGM claims.” CMS-1738-R at 6. While issuing CMS- 1738-R may have mooted Smith’s current claims, rescinding the ru ling after Smith’s ca se concludes would reopen the floodgates for other beneficiaries to challenge the denial of their CGM claims. Such a shift in policy would impe de CMS’s stated goal of “avoid[ing] the expenditure of administrati ve resources on further app lication of [CMS-1682-R].” Id. Second, we consider whether it can be reasonably e xpected that the Secretary will resu me his allegedly wr ongful conduct once this litigation ends. Smith contends that as s oon as the Secretary is no l onger under the watchful eye of the federal judiciary, the Secretary wi ll revive CMS-1682-R and Medicare administrators will resu me denying CGM claims. We find this argument entirely specula tive. While it is true that the Secretary long refused to recognize CGMs as durable medical equipment, the Secretary has spent the past two years formally revoking that policy. It cannot “reasonably be expected” that CMS would suddenly revert to denying CGM claims when it has gone through the lengt hy rulemaking process and concluded in the Final Rule, Technical Direction Letter, and CMS-1738-R that CGMs are Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2526 durable medical equipment covered by Medica re. Unraveling those regulatory changes seems improbable, especially give n that CMS has determined it to be more cost effective to pa y pending CGM claims rather than continue litigating them. See Brown , 822 F.3d at 1167 (“Most cases that deny mootness following government officials’ vol untary cessation rely on clear showings of reluctant submission by governmental ac tors and a desire to return to the old ways.” (cleaned up)). To be sure, the Letter and CMS-1738-R could be rescinde d with relative ease. But we think it un likely that the Secretary wo uld rescind both and resume applying CMS-1682-R when th at ruling directly conflic ts with the coverage provisions of the Final Rule , which could only be repl aced after another notice and comment period. See id. at 1171 (finding mootness be cause the risk that the county attorney’s office “w ill revoke or ignor e” its new policy is “minimal at best”). Although not set in stone, the Final Rule, Techni cal Direction Letter, and CMS-1738-R collectively “foreclose a re asonable chance of r ecurrence of the challenged conduct.” See Prison Legal News , 944 F.3d at 884 (citation omitted). Finally, Smith argues the volunta ry cessation doctr ine should apply because the Final Rule and CMS-1738-R ha ve not “completely and irrevocably eradicated the effect s” of the Secretary’ s wrongful conduct. See Rio Grande Silvery Minnow , 601 F.3d at 1115 (quoting Davis , 440 U.S. at 631). Even if the Final Rule and CMS-1738-R provide coverage for pe nding and future claims, Smith contends the rulings provide no re lief to the thousa nds of Medicare Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2627 beneficiaries whose claims were denied in the past and the thousands more who never submitted claims or requested equipment due to the prohibitive coverage provisions of CMS-1682-R. But the injuri es suffered by other beneficiaries have no bearing on whether Smith’s claims ar e live. Intervening events—which include the district court’s order for the Secretary to pay Smith’s claims, the Final Rule, the Technical Direction Letter , and CMS-1738-R—have remedied the effects of the Secretary’ s allegedly wrongful conduc t towards Smith, the only plaintiff in this case. In sum, the Secr etary took concrete steps to implement a new policy— through formal rulemaking and a binding CMS ruling—that cannot be easily reversed. The voluntary cessat ion doctrine does not apply. 

### III. Conclusion For the foregoing reasons, we dism iss the appeal as moot. Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 27