Court Opinion

ID: 7800324
Source: CourtListenerOpinion
Date Created: 2022-08-12 20:01:52.411944+00
Date Added: 2024-06-11T16:29:04.052705
License: Public Domain

Appellate Case: 22-4012     Document: 010110723774        Date Filed: 08/12/2022    Page: 1
                                                                                   FILED
                                                                       United States Court of Appeals
                                        PUBLISH                                Tenth Circuit

                       UNITED STATES COURT OF APPEALS                         August 12, 2022

                                                                           Christopher M. Wolpert
                              FOR THE TENTH CIRCUIT                            Clerk of Court
                          _________________________________

  LINDA P. SMITH,

        Plaintiff - Appellant,

  v.                                                           No. 22-4012

  XAVIER BECERRA, in his capacity as
  Secretary of the United States Department
  of Health and Human Services,

        Defendant - Appellee.
                       _________________________________

                      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, Pittsburgh, Pennsylvania, (Phillip Wm. Lear,
 Lear & Lear PLLC, Salt Lake City, Utah, with him on the briefs), for Plaintiff-Appellant.

 Joshua M. Koppel, Appellate Staff Attorney, Civil Division, United States Department of
 Justice, Washington, DC (Brian M. Boynton, Principal Deputy Assistant Attorney
 General, Andrea T. Martinez, Interim United 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.
                   _________________________________
Appellate Case: 22-4012   Document: 010110723774      Date Filed: 08/12/2022     Page: 2

       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 necessary supplies between 2016 and 2018, she sought

 reimbursement for her expenses through her medical insurance program,

 Medicare Part B. Medicare administrators denied her claims. Relying on a 2017

 ruling issued by the Centers for Medicare and Medicaid Services (CMS),

 Medicare administrators concluded that Smith’s CGM is not “primarily and

 customarily used to serve a medical purpose” and therefore is not covered by

 Medicare Part B. Smith appealed the denial of her reimbursement claims through

 the multistage Medicare claims review process. At each stage, the respective

 adjudicator confirmed the denial of her claims.

       Smith then sued the Secretary of the Department of Health and Human

 Services in federal court, seeking monetary, injunctive, and declaratory relief.

 Contending that her CGM and supplies satisfied the requirements for Medicare

 coverage, Smith requested that the district court (1) order the Secretary to pay her

 claims; (2) declare that CGMs are covered by Medicare; and (3) set aside the

 2017 ruling as unlawful because it did not go through the proper rulemaking

 process.

       Instead of asking the court to uphold the denial of Smith’s claims, the

 Secretary admitted that Smith’s claims should have been covered and that the

 agency erred by denying her claims. The Secretary requested a remand so the

 agency could reimburse Smith’s claims. Rather than accept the Secretary’s

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 admission of error, Smith argued that the Secretary only admitted error to avoid

 judicial review of the legality of the 2017 ruling.

       During Smith’s litigation, CMS changed its Medicare coverage policy for

 CGMs. Prompted by several adverse district court rulings, CMS promulgated a

 formal rule in December 2021 classifying CGMs as durable medical equipment

 covered by Medicare Part B. But the rule applied only to claims for equipment

 received after February 28, 2022, so pending claims for equipment received prior

 to that date were not covered by the new rule.

       Considering the new rule and the Secretary’s confession of error, the

 district court in January 2022 remanded the case to the Secretary with

 instructions to pay Smith’s claims. The district court did not rule on Smith’s

 pending motions regarding her equitable relief claims; instead, the court denied

 them as moot. Smith moved to alter or amend the judgment, contending that her

 equitable claims were still live, but the district court denied the motion.

       Smith appealed, arguing that her equitable claims are justiciable because

 the 2017 ruling has not been formally rescinded and Medicare administrators can

 still rely on the ruling to deny claims for equipment received prior to

 February 28, 2022. But in May 2022—shortly before oral argument in this

 case—the Secretary issued a new ruling. The 2022 ruling expressly rescinded the

 2017 ruling and ordered Medicare 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.

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          We agree with the Secretary that Smith’s claims are moot. Taken together,

 the December 2021 final rule and the 2022 CMS ruling ensure that pending and

 future claims for CGMs, including the equipment owned by Smith, will be

 covered by Medicare. Because the recent regulatory developments moot Smith’s

 equitable claims, we do not have jurisdiction to consider Smith’s appeal. We

 further conclude that although 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 disease that affects how the body handles glucose, a sugar

 that is the main source of energy for many cells and tissues. Glucose enters the

 bloodstream through food or after being produced in the liver. Insulin, which is

 produced by the pancreas, helps the body process glucose by moving glucose

 from the bloodstream to cells and tissues. When the body does not produce

 enough insulin, glucose can build up in the bloodstream, causing severe health

 problems, such as heart disease, stroke, kidney failure, or even death.

          To avoid a medical emergency, diabetics must constantly monitor their

 glucose levels. The traditional means of doing so is with a blood glucose test,

 which involves pricking a finger and placing a drop of blood on a test strip to

 determine current glucose levels. Depending on the results of the test, diabetics

 may need to take insulin or ingest glucose to adjust their blood sugar levels.

 While blood glucose tests are accurate, they can be painful and inconvenient for
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 many diabetics, some of whom must wake up several times throughout the night

 to perform a test.

       To address these issues, researchers developed CGMs, which are capable of

 automatically measuring blood glucose levels at short intervals—some monitors

 can take readings as frequently as every five minutes. To use a CGM, diabetics

 insert a disposable sensor underneath their skin. The sensor detects glucose

 levels and sends the data via a transmitter to a display monitor. Some CGM

 devices include insulin pumps, which dispense insulin automatically if there is a

 high glucose reading. Diabetics typically need to replace a sensor once a week, a

 transmitter once every few months, and a monitor after several years. CGMs are

 often preferred because they monitor glucose levels automatically and more

 frequently than blood glucose tests. More frequent readings decrease the risk that

 a sudden onset of symptoms will lead to a medical emergency. They also lead to

 better overall glucose-level control, which can prevent long-term health

 problems.

       Smith’s Medicare Claims

       Linda Smith has suffered from diabetes for over 55 years. Her condition is

 particularly dangerous because she has hypoglycemic unawareness, which means

 she is unable to physically sense when her blood glucose levels are too low.

 Smith is also prone to rapid and unpredictable changes in her glucose levels.

 Because Smith often has few physical warnings of an impending diabetic

 emergency, Smith must be vigilant in monitoring her glucose levels—failing to

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 do so could be catastrophic for her. On at least one occasion, Smith lost

 consciousness and had to be hospitalized.

       To better manage Smith’s diabetes, a doctor prescribed her a Medtronic

 MiniMed 630G CGM with disposable sensors. Smith, who has Medicare Part B

 health insurance, filed Medicare reimbursement claims for 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 specific monitor and supplies were not “durable medical

 equipment” covered by Medicare. Smith appealed her claims 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 ruling—which is binding on

 Medicare administrators and constitutes an “official statement[] of agency policy

 1
   Medicare reimbursement claims must go through the following administrative
 process before a beneficiary may seek judicial review: (1) initial coverage
 determination made by a CMS administrative contractor; (2) redetermination
 decision made by same contractor; (3) reconsideration by a qualified independent
 contractor; (4) review by an administrative law judge (ALJ) (subject to a
 minimum amount-in-controversy requirement); and (5) de novo review by the
 Medicare Appeals Council (MAC), which constitutes a final decision by the
 Secretary.

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 and interpretation”—explains that a CGM will only be covered by Medicare if it

 meets the definition of “durable 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 the following conditions:

              (1) Can withstand repeated use.

              (2) Effective with respect to items classified as [durable
              medical equipment] after January 1, 2012, has an
              expected life of at least 3 years.

              (3) Is primarily and customarily used to serve a medical
              purpose.

              (4) Generally is not useful to an individual in the absence
              of an illness or injury.

              (5) Is appropriate for use in the home.

 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, CMS concluded that such devices—which

 CMS refers to as “non-therapeutic” or “adjunctive” devices—are not “primarily

 and customarily used to serve a medical purpose” and thus do not meet the

 definition of durable medical 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 treatment decisions” are

 durable medical equipment. Id. at 92 (emphasis added).

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         Medicare administrators and an administrative law judge determined that

 CMS-1682-R precluded coverage for Smith’s claims because the Food and Drug

 Administration “has not approved the beneficiary’s CGM system . . . as a

 replacement for a blood glucose monitor.” App., Vol. 2 at 320. In a final agency

 decision, the Medicare Appeals Council adopted the reasoning of the

 administrative law judge, ruled that Smith’s claims were not covered by

 Medicare, and deemed Smith financially responsible for the incurred expenses.

         Procedural Background

         Having exhausted her administrative remedies, Smith sued the Secretary of

 the Department of Health and Human Services in federal court. 2 In addition to

 seeking monetary reimbursement for her claims, Smith also sought injunctive and

 declaratory relief. Specifically, she requested that the district court (1) set aside

 CMS-1682-R because it did not go through notice and comment rulemaking as

 required by statute; (2) declare that CGMs are durable medical equipment,

 regardless of whether they replace blood glucose tests; and (3) declare that the

 Secretary’s denials of CGM claims were unsupported by substantial 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 denying coverage. The Secretary explained that because

 Smith’s CGM also serves as an insulin pump, it meets the definition of durable

 2
     CMS is part of the Department of Health and Human Services.
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 medical equipment under the Medicare statute and regulations. Based on this

 admission of error, the Secretary requested that the district court enter judgment

 in favor of Smith and remand to the agency for payment of Smith’s claims. 3

       Despite the Secretary’s confession of error, the district court allowed the

 case to proceed. Shortly after the Secretary filed his answer, Smith moved for

 summary judgment. Smith argued that the district court should vacate CMS-

 1682-R because the ruling did not go through the notice and comment process as

 required by 42 U.S.C. § 1395hh. In a separate summary judgment motion, Smith

 argued that the Secretary should be collaterally estopped from litigating the issue

 of whether Smith’s CGM is durable medical equipment because an administrative

 law judge had previously ruled that Smith’s monitor was covered.

       In response, the Secretary contended that the district court does not have

 the power to vacate CMS-1682-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 court 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 CMS-

 3
    The Secretary initially said that only Smith’s claim for the monitor itself should
 be paid on remand. While the Secretary acknowledged that administrators erred
 in denying Smith’s other two claims for the sensors, the Secretary explained that
 it had yet to be determined “whether the sensors should be covered as reasonable
 and necessary for the operation of the insulin pump.” App., Vol. 1 at 38. The
 Secretary later amended his position based on intervening regulation changes and
 requested that the district court “remand to the Secretary for payment of [all]
 three claims.” Id. at 271.
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  1682-R, the new rule would classify CGMs as durable medical equipment

  regardless of whether they can be relied on to make diabetes treatment decisions

  without the use of a separate blood glucose test. See 85 Fed. Reg. 70,358

  (Nov. 4, 2020). The Secretary explained to the district court that the “proposed

  rule would supersede [CMS-1682-R], if finalized, and in doing so would moot

  Mrs. Smith’s claim for vacatur.” App., Vol. 1 at 263.

        Following a public comment period, CMS issued a final rule in December

  2021 classifying CGMs, transmitters, and sensors as durable medical equipment

  covered by Medicare Part B. See 86 Fed. Reg. 73,860 (Dec. 28, 2021) (“Final

  Rule”). Based on this regulatory change, the Secretary renewed his request for

  the court to enter judgment in favor of Smith and to remand the case. In January

  2022, the district court entered a judgment remanding the matter to the Secretary

  with instructions to pay Smith’s three claims. In a docket text order, the court

  denied Smith’s pending summary judgment motions regarding CMS-1682-R and

  collateral estoppel as moot.

        Finding the court’s order and judgment inadequate, Smith moved to alter or

  amend the judgment, arguing that her motions were not moot because she sought

  equitable relief and collateral estoppel, both of which the court had not addressed,

  and the Secretary’s concession did not resolve. Smith contended that the Final

  Rule issued by CMS did not moot her claims because the rule only applies to

  claims for CGMs and supplies received after February 28, 2022. Smith informed

  the court that she had other reimbursement claims pending before the agency for

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  CGM sensors she received on July 14, 2021. Since Medicare administrators had

  denied those July 2021 claims even after the Secretary confessed error as to

  Smith’s 2016, 2017, and 2018 claims, Smith asserted there was a reasonable

  probability that the Secretary would continue to deny pending CGM claims based

  on CMS-1682-R. Therefore, Smith argued her equitable relief claims still

  presented a live controversy.

        The district court denied Smith’s motion to alter or amend the judgment. It

  explained that Smith’s pending motions were moot because the court granted

  judgment in Smith’s favor. The court further explained that “while [Smith]

  appears to desire additional relief . . . the court granted [Smith] all of the relief

  authorized by statute.” App., Vol. 1 at 11 (citing 42 U.S.C. §§ 405(g), 1395ii).

        Subsequent Developments

        After Smith filed her notice of appeal, CMS sent a Technical Direction

  Letter to all Medicare administrative contractors. The Letter explained that

  although the coverage and payment provisions of the Final Rule only apply to

  CGMs and supplies received after February 28, 2022, contractors should approve

  valid reimbursement claims for equipment received before that date. See

  Technical Direction Letter 220257, Docket 20-1, Olsen v. Becerra, No. 21-cv-326

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  (E.D. Wash. Feb. 25, 2022). 4 The Letter said that by applying the coverage

  provisions of the Final Rule retroactively to pending claims, CMS will “avoid

  expending administrative resources on further application of [CMS-1682-R] on

  CGMs and additional appeals challenging application of [CMS-1682-R].” Id. at

  2. Even though the Letter is not binding on Medicare contractors, the Secretary

  contends on appeal that the Letter serves as further evidence that Smith’s

  remaining claims are moot because “future valid claims for continuous-glucose-

  monitor supplies should be covered regardless of the date of service.” Resp. Br.

  at 26 n.2. Smith insists that because the Letter is not binding and CMS-1682-R

  has not been formally rescinded, there is no guarantee 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 implement 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-guidanceguidancerulingscms-rulings/cms-1738-r. In CMS-1738-

  4
     Because the Letter was issued after the district court’s entry of final judgment,
  it was not before the district court and is not part of the record on appeal.
  Nevertheless, we may take 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).
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  R, CMS expressly rescinded CMS-1682-R and prohibited its further application

  to pending claims. 5

                                      II. Analysis

          Smith contends the district court erred by denying her equitable claims as

  moot. The Secretary counters that even if Smith’s equitable claims were still live

  when the district court declined to address them, they have since become moot

  due to the recent regulatory changes affecting coverage of CGMs. The Secretary

  also argues that the voluntary cessation doctrine—which obviates mootness—

  does not apply here because there is no indication that the Secretary changed his

  coverage policy in response to this litigation 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 the recent issuance of Technical 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 substantive CGM classification,
                coverage, and payment policies established by the
                December 2021 final rule shall be applied to claims for a
                CGM monitor or receiver and/or its necessary 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 valid CGM claim or file a valid
                CGM appeal had not expired as of February 28, 2022.

  CMS-1738-R at 1–2.

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  and CMS-1738-R, fully redress Smith’s equitable claims. Vacating CMS-1682-R

  and declaring that CGMs are durable medical equipment covered by Medicare

  would have no effect because CMS has already rescinded CMS-1682-R and

  issued a formal rule classifying CGMs and their supplies as durable medical

  equipment. In short, Smith no longer suffers from an actual or imminent injury

  that can be redressed by this court.

        We also conclude that the voluntary cessation doctrine does not apply.

  Although CMS changed its CGM coverage policy during this litigation, mooting

  Smith’s claims, the Secretary has met his burden of establishing that the policy

  change will not be rescinded after this case concludes.

        A. Mootness

        Article III of the Constitution limits the jurisdiction 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 case-or-controversy requirement

  “ensures that the Federal Judiciary confines itself to its constitutionally limited

  role of adjudicating actual and concrete disputes, the resolutions of which have

  direct consequences on the parties involved.” Genesis Healthcare, 569 U.S. at

  71. “This means that, throughout the litigation, the plaintiff ‘must have suffered,

  or be threatened with, an actual injury traceable 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

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  case-or-controversy requirement applies “through all stages 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 “when the issues presented are no

  longer ‘live’ or the parties lack a legally cognizable interest 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 other words, “[i]f an intervening

  circumstance deprives the plaintiff of a ‘personal stake in the outcome of the

  lawsuit,’ at any point during litigation, the action 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 crucial question is whether granting a present determination

  of the issues offered . . . will have some effect in the real world.” Citizens for

  Responsible Gov’t State Political Action Comm. v. Davidson, 236 F.3d 1174,

  1182 (10th Cir. 2000) (quotations and citation omitted). “No matter how

  vehemently the parties continue to dispute the lawfulness of the conduct that

  precipitated the lawsuit, the case is moot if the dispute is no longer embedded in

  any actual controversy about the plaintiffs’ particular legal rights.” Already, LLC

  v. Nike, Inc., 568 U.S. 85, 91 (2013) (quotations and citation omitted).

        We take a claim-by-claim approach to mootness and “must decide whether

  a case is moot as to ‘each form of relief sought.’” Prison Legal News, 944 F.3d

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  at 880 (quoting Collins v. Daniels, 916 F.3d 1302, 1314 (10th Cir. 2019)). The

  defendant bears the burden of establishing that a “once-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 “plaintiff’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 citation 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) (quotations and citation omitted); Jordan, 654 F.3d at 1025

  (“[I]n the context of an action 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 court enter an order

  providing the following relief:

               (1) setting aside CMS-1682-R and its determination that
               CGMs that do not completely replace finger prick/test
               strips are not [durable medical equipment] within the
               meaning of 42 U.S.C. § 1395x(n) and 42 C.F.R.
               § 414.202;
               (2) finding that CGMs (whether they completely replace
               finger prick/test strips or not) are [durable medical
               equipment] within the meaning 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

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               arbitrary and capricious, an abuse of discretion, and not
               in accordance with the law.

  App., Vol. 1 at 35. 6

        The Secretary contends that intervening events during this litigation have

  rendered Smith’s claims moot. We agree. The Final Rule, the Technical

  Direction Letter, and CMS-1738-R already classify CGM systems as durable

  medical equipment and mandate coverage for pending and future Medicare

  reimbursement claims. Thus, granting Smith any of the relief requested above

  would have no real-world effect.

        We begin with Smith’s first request for relief. Smith alleges that CMS-

  1682-R should be set aside because it was issued “without observance of the

  procedure required by law (e.g., notice and comment [rulemaking]).” Id. at 32–

  34. Smith argues that because her Medicare reimbursement claims have been

  continuously denied based on CMS-1682-R, invalidating 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 Final Rule and CMS-1738-R, both of which mandate

  Medicare coverage for CGMs. The Final Rule, which became effective on

  6
    Smith also requested that the district court order “the Secretary to provide
  coverage for the CGM claims at issue in this case.” App., Vol. 1 at 35. Because
  the district court indisputably ruled in Smith’s favor on that claim, we need not
  address whether the claim is moot.
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  February 28, 2022, ensures coverage for CGM supplies received 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 February 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 claims for her CGM supplies are now covered by

  Medicare, invalidating 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 occurs while a case is pending on appeal

  that makes it impossible for the court to grant ‘any effectual relief whatever’ to a

  prevailing party, the appeal must be dismissed.” (citation omitted)).

        For similar reasons, Smith’s second claim for declaratory relief is also

  moot. Smith asked the district court to declare that all 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 become moot until CMS issued
  CMS-1738-R in May 2022, the district court should not have found those claims
  moot in January 2022. The district court apparently denied Smith’s pending
  motions as moot in part because the Final Rule rescinded CMS-1682-R. But the
  Final Rule only applies to claims for equipment received after February 28, 2022.
  Claims for equipment received before that date—such as Smith’s July 2021
  claims that were pending before the agency—could still be denied under CMS-
  1682-R. Since Smith still faced a risk that her pending claims would be denied,
  Smith retained a legally cognizable interest in the outcome of the case and her
  equitable claims remained live. It was not until CMS issued CMS-1738-R—
  applying the Final Rule retroactively to claims for equipment supplied prior to
  February 28, 2022, and expressly 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 her claims being denied.
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  has standing to challenge the denial of her specific CGM because a declaration

  that other glucose monitors are covered by Medicare would not redress any injury

  suffered by Smith. See Warth v. Seldin, 422 U.S. 490, 499 (1975) (“[T]he

  plaintiff generally must assert his own legal rights and interests, and cannot rest

  his claim to relief on the legal rights or interests of third parties.”). Regardless,

  the Final Rule and CMS-1738-R address Smith’s concerns and grant Smith the

  full relief she seeks. The Final Rule recognizes that CGMs—irrespective of

  whether they complement a blood glucose test—are “primarily and customarily

  used to serve a medical purpose” and therefore meet the definition of durable

  medical equipment. 86 Fed. Reg. at 73,899. Similarly, CMS-1738-R adopts the

  Final Rule’s coverage provisions and expressly rescinds CMS-1682-R. See CMS-

  1738-R at 11 (“CMS-1682-R, is hereby rescinded and shall not be applied to any

  additional CGM claims under Part B or Part C, as applicable, or to any further

  administrative appeals of CGM claims.”). These regulatory changes make clear

  that CMS now classifies CGMs as durable medical equipment. Smith’s

  declaratory relief claim is moot.

        Smith’s final request for relief—declaring that the Secretary’s repeated

  denials of CGM claims was wrongful—is also moot. Smith requested that the

  district court declare that “the Secretary’s denials of CGM coverage on the

  grounds that a CGM is not [durable medical equipment] [are] not supported by

  substantial evidence, are arbitrary and capricious, an abuse of discretion, and not

  in accordance with the law.” App., Vol. 1 at 35. Smith asserts that this

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  declaration would prevent the Secretary from denying future CGM claims based

  on an improper interpretation of the regulatory definition of “durable medical

  equipment.” Like Smith’s other requests for relief, this request is moot because

  Smith no longer suffers from an imminent injury that would be redressed by

  declaring that the Secretary’s previous denials of coverage were improper. In

  short, Smith seeks “a retrospective opinion that [s]he 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, federal courts

  do not adjudicate hypothetical or abstract disputes.”).

        Smith also requested a separate ruling on the issue of whether the Secretary

  is collaterally estopped from litigating CGM coverage because an administrative

  law judge previously determined that Smith’s CGM and supplies are covered by

  Medicare. As Smith notes, CMS-1738-R and the Final Rule do not address the

  issue of whether prior administrative law judge or district court decisions

  preclude the Secretary from re-litigating the coverage of CGMs. But the “crucial

  question” for mootness is whether “granting a present determination of the issues

  offered . . . will have some effect in the real world.” Davidson, 236 F.3d at 1182

  (quotations and citation omitted). Because a ruling on collateral estoppel would

  not redress any actual or imminent injury suffered by Smith, we do not have

  jurisdiction to consider the issue.

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        In sum, Smith has won all the relief she sought when she commenced this

  litigation. The Secretary has agreed to pay Smith’s denied claims, 8 rescinded

  CMS-1682-R, and recognized CGMs as durable medical 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 whether the voluntary cessation doctrine

  applies.

        Although a live controversy must exist at all stages of litigation, “a

  defendant cannot automatically moot a case simply by ending its unlawful

  conduct once sued.” Already, 568 U.S. at 91. “Otherwise, a defendant could

  engage in unlawful conduct, stop when sued to have the case declared moot, then

  pick up where he left off, repeating this cycle until he achieves all his unlawful

  ends.” Id. To address this concern, the Supreme Court has held that “a defendant

  claiming that its voluntary compliance moots a case bears the formidable burden

  of showing that it is absolutely clear the allegedly wrongful behavior 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 claim for disposable sensors received in July 2021 after
  the filing of this case. See Resp. Br. at 24 (“CMS reprocessed and paid plaintiff’s
  claim for disposable sensors received on July 14, 2021); Aple. Supp. Br. at 13
  (“[T]he claims under review have been paid.”).
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        Although the defendant faces a heavy burden in undermining the plaintiff’s

  invocation of the voluntary cessation doctrine, we do not require a defendant to

  show that it would be impossible for him to resume his allegedly wrongful

  conduct. “For the voluntary cessation exception to apply, ‘we must be convinced

  that the allegedly wrongful 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 controversy 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 amendments 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 legislative body has the power to

  reenact an ordinance or statute, ordinarily an amendment or repeal of it moots a

  case challenging the ordinance or statute.”).

  9
    We have opined in past mootness cases that we may afford a government
  official’s voluntary conduct “more solicitude” than that 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 still bear the “heavy” burden
  of making “absolutely clear that the allegedly wrongful behavior could not
  reasonably be expected to recur.” West Virginia, 142 S. Ct. at 2607 (quotations
  and citation omitted).
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        Smith claims (1) the Secretary changed his policy regarding coverage of

  CGMs solely for the purpose of evading judicial review; and (2) it can be

  reasonably expected that the Secretary will resume denying CGM claims once

  this litigation concludes. We disagree for two reasons. First, the timing of the

  Secretary’s policy change toward CGMs suggests that the Secretary did not

  voluntarily change his conduct to moot Smith’s litigation. Second, there is a

  minimal risk that the Secretary will suddenly revert to his rescinded policy of

  denying CGM claims given the wholesale change in policy that has developed

  over the past several years. To undo his policy recognizing CGMs as durable

  medical equipment, the Secretary would need to take the unlikely steps of

  disavowing his previous support for the coverage of CGMs, replacing the Final

  Rule—which can only be done after a notice and comment period, rescinding the

  Technical Direction Letter, and withdrawing CMS-1738-R.

        We begin by examining the timing of the Secretary’s voluntary cessation of

  the challenged conduct. Based on the sequence of events that led to CMS

  changing its CGM coverage policy, we cannot conclude that 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 indicated that mootness is

  more likely if . . . the case in question was the catalyst for the agency’s adoption

  of the new policy.” (quoting Rosebrock v. Mathis, 745 F.3d 963, 972 (9th Cir.

  2014))). Although CMS did not issue the Final Rule providing Medicare

  coverage for CGMs until after this case commenced, CMS initiated the

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  rulemaking process well before this litigation. In November 2020—several

  months before the Medicare Appeals Council 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 district 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 outcome of other cases seems

  to have prompted the proposed rule change, the timing of the proposed rule in

  relation to Smith’s case forecloses the possibility that the Secretary stopped

  denying CGM claims solely to avoid judicial review in Smith’s case.

        While we agree with Smith 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 timing 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, the Secretary has denied thousands of other CGM claims,

  forcing other beneficiaries 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 litigation. 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 litigation may actually make

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  it more likely the policy will be followed, especially with respect to the plaintiffs

  in that particular case.” Id. (emphasis added). CMS stated in CMS-1738-R that

  it decided to change its policy on pending CGM claims “to bring an orderly

  conclusion to pending (and potentially forthcoming) administrative claims and

  appeals relating to the requirements 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 ruling after Smith’s case concludes would

  reopen the floodgates for other beneficiaries to challenge the denial of their CGM

  claims. Such a shift in policy would impede CMS’s stated goal of “avoid[ing] the

  expenditure of administrative resources on further application of [CMS-1682-R].”

  Id.

        Second, we consider whether it can be reasonably expected that the

  Secretary will resume his allegedly wrongful conduct once this litigation ends.

  Smith contends that as soon as the Secretary is no longer under the watchful eye

  of the federal judiciary, the Secretary will revive CMS-1682-R and Medicare

  administrators will resume denying CGM claims.

        We find this argument entirely speculative. 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 lengthy rulemaking process and concluded in

  the Final Rule, Technical Direction Letter, and CMS-1738-R that CGMs are

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  durable medical equipment covered by Medicare. Unraveling those regulatory

  changes seems improbable, especially given that CMS has determined it to be

  more cost effective to pay pending CGM claims rather than continue litigating

  them. See Brown, 822 F.3d at 1167 (“Most cases that deny mootness following

  government officials’ voluntary cessation rely on clear showings of reluctant

  submission by governmental actors and a desire to return to the old ways.”

  (cleaned up)).

        To be sure, the Letter and CMS-1738-R could be rescinded with relative

  ease. But we think it unlikely that the Secretary would rescind both and resume

  applying CMS-1682-R when that ruling directly conflicts with the coverage

  provisions of the Final Rule, which could only be replaced after another notice

  and comment period. See id. at 1171 (finding mootness because the risk that the

  county attorney’s office “will revoke or ignore” its new policy is “minimal at

  best”). Although not set in stone, the Final Rule, Technical Direction Letter, and

  CMS-1738-R collectively “foreclose a reasonable chance of recurrence of the

  challenged conduct.” See Prison Legal News, 944 F.3d at 884 (citation omitted).

        Finally, Smith argues the voluntary cessation doctrine should apply

  because the Final Rule and CMS-1738-R have not “completely and irrevocably

  eradicated the effects” 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 pending and future claims,

  Smith contends the rulings provide no relief to the thousands of Medicare

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  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 injuries suffered by other beneficiaries have

  no bearing on whether Smith’s claims are 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 conduct towards Smith, the only

  plaintiff in this case.

         In sum, the Secretary took concrete steps to implement a new policy—

  through formal rulemaking and a binding CMS ruling—that cannot be easily

  reversed. The voluntary cessation doctrine does not apply.

                                  III. Conclusion

         For the foregoing reasons, we dismiss the appeal as moot.

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