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, 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. 

_________________________________ 

FILED 

United States Court of Appeals 

Tenth Circuit 

August 12, 2022

Christopher M. Wolpert 

Clerk of Court

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 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 CMS1682-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 CMS3

 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-glucosemonitor 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 CMS1682-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 CMS1682-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 CMS1738-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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21 

 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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23 

 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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24 

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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