Smith v. Becerra

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.
_________________________________
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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 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.
27