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[DO NOT PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
No. 20-11454
Non-Argument Calendar
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D.C. Docket No. 5:20-cv-00565-LCB
EDWIN R. BANKS,
Plaintiff-Appellant,
versus
SECRETARY OF HEALTH AND HUMAN SERVICES,
Defendant-Appellee.
_______________________
Appeal from the United States District Court
for the Middle District of Florida
________________________
(July 26, 2021)
Before WILSON, MARTIN, and ROSENBAUM, Circuit Judges.
PER CURIAM:
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Edwin R. Banks, a Medicare recipient, appeals the district court’s grant of
summary judgment to the Secretary of Health and Human Services (“the
Secretary”) in his action for judicial review of the agency’s denial of coverage.
The Secretary argues for the first time on appeal that Banks lacks Article III
standing. Banks disagrees and asks this Court to take judicial notice of additional
evidence to support that he has standing. After careful consideration, we remand
this case to the district court for additional jurisdictional factfinding and a ruling on
the issue of Article III standing in the first instance. We further instruct that the
determination of standing proceed on an expedited basis.
I
Banks is a 76-year-old Medicare beneficiary living in Alabama. In 2009, he
was diagnosed with glioblastoma multiforme, a lethal form of brain cancer that
famously affected Senators Edward Kennedy and John McCain, as well as Beau
Biden. Following this diagnosis, Banks underwent surgery, chemotherapy, and
radiation. Despite this treatment, however, his cancer progressed. Banks was then
prescribed Optune, a type of medical device that provides tumor treating field
therapy (“TTFT”). The device sends “alternating electric fields—or tumor treating
fields—into the brain” in order to “slow[] or stop[] cancer growth.” The device
requires frequent servicing and is rented on a monthly basis.
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Banks receives coverage from Medicare Part B, which provides
supplemental medical insurance to cover health care costs. Recipients pay a
monthly premium in exchange for certain types of coverage, including for durable
medical equipment like Optune. See 42 U.S.C. § 1395k. Part B does not cover
services that “are not reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body member.” Id.
§ 1395y(a)(1)(A). The Secretary has interpreted “reasonable and necessary” to
mean that an item or service must be “[s]afe and effective” and “[n]ot
experimental” in order to qualify for reimbursement. See Medicare Program
Integrity Manual § 13.5.4 (2019).
Banks submitted claims for Medicare coverage of TTFT treatment in every
month of 2018. On June 3, 2019, Administrative Law Judge (“ALJ”) Bruce
Kelton denied Banks’s claims for the months of January, March, and April 2018,
because he determined that TTFT was not medically reasonable and necessary. As
a result, Novocure, the supplier of Optune, was liable for the cost of TTFT for
those months.1 Three days later, a different ALJ, Jeffrey Gulin, approved Banks’s
claims for the months of February and May through December 2018. Unlike ALJ
1
The claims processer determined that Novocure was financially liable for the cost of the
denied claims because Novocure “could have been expected to know these services were non-
covered” under Medicare. The claims processor found that Banks “could not have been
expected to know these services were non-covered” and therefore was not liable for the cost.
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Kelton, ALJ Gulin found that TTFT treatment was medically reasonable and
necessary and a covered Medicare benefit.
As relevant to this appeal, Banks sought judicial review of ALJ Kelton’s
unfavorable determination. See 42 C.F.R. § 405.1132. Banks argued collateral
estoppel prevented the Secretary from relitigating the issue of TTFT coverage in
the claims decided by ALJ Kelton, because ALJ Gulin’s decisions conclusively
determined an issue litigated between the same parties and became final before
ALJ Kelton’s decisions. The district court granted the Secretary’s motion for
summary judgment, concluding that the “Medicare scheme is incompatible with
the doctrine of collateral estoppel.”
On appeal, Banks argues the district court erred in finding collateral estoppel
inapplicable. In response, the Secretary argues for the first time that Banks lacks
Article III standing and that Banks “submitted no evidence” showing he was
injured by the claims denial. In reply, Banks filed a motion asking this Court to
take judicial notice of additional evidence supporting standing. We now address
the parties’ arguments on standing.
II
We review de novo questions concerning our subject matter jurisdiction.
Club Madonna, Inc. v. City of Miami Beach, 924 F.3d 1370, 1378 (11th Cir.
2019).
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III
Among the jurisdictional doctrines, “standing is perhaps the most
important.” Bischoff v. Osceola County, 222 F.3d 874, 878 (11th Cir. 2000)
(quotation marks omitted). Standing is a jurisdictional prerequisite to suit in
federal court and is not subject to waiver. See Alabama v. EPA, 871 F.2d 1548,
1554 (11th Cir. 1989); United States v. Hays, 515 U.S. 737, 742, 115 S. Ct. 2431,
2435 (1995). To establish standing, a litigant must show that she has “(1) suffered
an injury in fact, (2) that is fairly traceable to the challenged conduct of the
defendant, and (3) that is likely to be redressed by a favorable judicial decision.”
Spokeo, Inc. v. Robins, 578 U.S. __, 136 S. Ct. 1540, 1547 (2016).
The party invoking federal jurisdiction bears the burden of proving standing.
Lujan v. Defs. of Wildlife, 504 U.S. 555, 561, 112 S. Ct. 2130, 2136 (1992). Each
element of standing “must be supported in the same way as any other matter on
which the plaintiff bears the burden of proof, i.e., with the manner and degree of
evidence required at the successive stages of the litigation.” Id. Therefore, when
standing is raised at the summary judgment stage, “the plaintiff can no longer rest
on mere allegations.” Id. at 561, 112 S. Ct. at 2137 (quotation marks omitted)).
Instead, the plaintiff must “set forth by affidavit or other evidence specific facts,”
which for purposes of the summary judgment motion “will be taken to be true.”
Id. (quotation marks omitted).
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We begin by setting forth the parties’ arguments on standing. The Secretary
argues Banks lacks standing because he failed to show two elements: injury in fact
and redressability. The Secretary cites to the claims processor’s finding that
Novocure, and not Banks, was liable for the cost of the TTFT treatment for the
January, March, and April 2018 claims. The Secretary says that because Banks
was not financially liable for these claims, he cannot show injury or redressability.
Banks makes two arguments in support of his standing to bring this suit.
First, he argues the violation of his statutory right to Medicare coverage alone is
sufficient to establish standing. Second, he argues he has standing because the
denial of claims exposes him to a risk of harm. Specifically, he says the agency
will rely on the denial of the January, March, and April 2018 claims to hold him
financially liable for other claims. We address each argument in turn.
We make quick work of Banks’s first argument, which is foreclosed by
circuit precedent. This Court has rejected the assertion that the allegation of a
statutory violation alone is sufficient to confer standing. See Muransky v. Godiva
Chocolatier, Inc., 979 F.3d 917, 924 (11th Cir. 2020) (en banc) (“[W]e know one
thing to be true—alleging a mere statutory violation is not enough to show injury
in fact.”). Under Muransky, we instead must first ask if the statutory violation
caused a direct harm to the plaintiff—if so, the plaintiff has stated an injury in fact.
Id. at 926. In the absence of any direct harm, a plaintiff can still establish an injury
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in fact “by showing that a statutory violation created a ‘risk of real harm.’” Id. at
927 (quoting Spokeo, 136 S. Ct. at 1549). Banks’s argument that the statutory
violation itself is sufficient to confer standing fails because it overlooks these
requirements. Novocure, and not Banks, is liable for the cost of the January,
March, and April 2018 claims. Because he does not have to pay these claims,
Banks has not shown how the statutory violation caused a direct harm.
Banks’s second argument is different. He says he faces a substantial risk of
harm because he will be expected to pay future claims based on these denials. See
Muransky, 979 F.3d at 927. Banks says losing his appeal from the denial of
benefits allows the agency to impute knowledge to him of possible non-coverage.
He argues the agency will hold him liable for the cost of future TTFT treatment
based on this imputed knowledge. 2 He characterizes this as losing a “Medicare
mulligan.” See 42 C.F.R. § 411.404(b)(3) (“After a beneficiary is notified that
there is no Medicare payment for a service that is not covered by Medicare, he or
she is presumed to know that there is no Medicare payment for any form of
subsequent treatment for the non-covered condition.”). Put another way, although
Novocure was deemed liable for the cost of the January, March, and April 2018
2
Banks says he is all but certain to submit additional claims for TTFT coverage in light
of his present and consistent reliance on the device to treat his glioblastoma multiforme. See
Appellant’s Br. at 2 (Banks has used the TTFT device since 2013 and believes his “medical need
for TTFT treatment has been the same.”); R. Doc. 1 ¶ 17 (“[P]atients prescribed TTFT treatment
will have to continue that treatment for the rest of their . . . lives.”).
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claims, Banks argues he will be liable for the cost of treatment going forward
based on his knowledge of non-coverage. Thus he argues losing the Medicare
mulligan confers standing because it exposes him to financial liability. In support
of this argument, Banks moves for this Court to take judicial notice of an agency
decision issued by ALJ Leslie Holt (the “Holt Decision”). Banks says the Holt
Decision supports his Medicare mulligan argument because ALJ Holt found that a
Medicare recipient “knew that his TTFT would not be covered by Medicare” based
on a prior claim denial and was “therefore personally liable for the cost of the
TTFT treatment.” Banks argues unless the January, March, and April 2018 claims
denials are “reversed now, [he has] no ability to challenge the denial of coverage in
this case when his right to receive payment on subsequent claims is adjudicated.”
Cf. Jayne v. Sherman, 706 F.3d 994, 1000 (9th Cir. 2013) (concluding that litigants
have standing to challenge an agency decision that essentially “pre-determines the
future,” and that “plaintiffs must, at some point, have standing to challenge” the
decision and “[t]hat point is now, or it is never”) (quotation marks omitted).
The Secretary disagrees with Banks’s version of the facts and argues Banks
would receive additional notice before he is held financially liable. The Secretary
asserts that a Medicare recipient is typically given an “Advance Beneficiary
Notice” of non-coverage and a request for the beneficiary to agree to pay if
coverage is denied. However, Banks says the Holt Decision “rebuts the erroneous
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factual assertion” regarding the role of the Advance Beneficiary Notice and an
agreement to pay that the Secretary makes on appeal. In this respect, the parties’
arguments on standing require resolving factual disputes.
We think the parties’ factual disputes are material to resolving the standing
question. The Secretary urges this Court to adopt the holding in a Seventh Circuit
ruling in a similar appeal, but the posture of that case is different. In Prosser v.
Becerra, 2 F.4th 708, 2021 WL 2621119 (7th Cir. 2021), which was decided after
Banks’s appeal was fully briefed, the Seventh Circuit ruled that a Medicare
recipient lacked standing to challenge the denial of TTFT coverage. Unlike the
parties here, however, the parties in Prosser had an opportunity to develop a record
on standing. The Seventh Circuit found that Prosser failed to show that the typical
“layer[s] of protection for recipients of medical equipment and devices” would not
apply in her case. Id. at *5–6. These protections include an “advance notice that
Medicare is likely to deny coverage for the treatment” and a request for a “written
agreement from the beneficiary[] acknowledging that the recipient will be
personally liable if Medicare denies coverage for the treatment.” Id. at *5–6
(citing 42 U.S.C. § 1395m(j)(4); Medicare Claims Processing Manual ch. 30,
§ 30.1).
Here, however, Banks says he “has not previously had the opportunity” to
provide evidence rebutting the Secretary’s assertions and now asks this Court to
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take judicial notice of the Holt Decision. Because Banks disputes a central factual
finding relied on in Prosser, we decline the Secretary’s invitation to adopt the
holding in Prosser at this stage. Cf. U.S. ex rel. Miss. Rd. Supply Co. v. H. R.
Morgan, Inc., 528 F.2d 986, 987 (5th Cir. 1976) (per curiam) (noting that, where
“prior cases . . . have turned on [a particular] factual fulcrum, it is vital to a proper
determination of the jurisdictional issue for the record to be properly developed”); 3
see also Appellant’s Motion for Judicial Notice at 5–6 (“Secretary Becerra did not
challenge Mr. Bank’s Article III standing in the District Court, and therefore Mr.
Banks never had the opportunity to present the Holt Decision.”); Steele v. Nat’l
Firearms Act Branch, 755 F.2d 1410, 1415 (11th Cir. 1985) (noting that the
record’s “inadequacy [was] due, in part, to the appellees’ failure to raise the
standing argument in the court below”).
Therefore, we remand this case to the district court for additional
jurisdictional factfinding and a ruling on the issue of Article III standing in the first
instance. Remand is appropriate where, as here, the record before us is incomplete
and the question of standing was not litigated before the district court. See Steele,
755 F.2d at 1415 (remanding the “to allow appellant to establish the factual
3
In Bonner v. City of Prichard, 661 F.2d 1206 (11th Cir. 1981) (en banc), we adopted as
binding precedent all decisions of the former Fifth Circuit handed down before October 1, 1981.
Id. at 1209.
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background necessary to permit the district court to resolve the standing question”
in the first instance); Bischoff, 222 F.3d at 885 (reversing grant of summary
judgment and remanding for further record development on standing); H. R.
Morgan, 528 F.2d at 987 (holding “it is vital to a proper determination of the
jurisdictional issue for the record to be properly developed” and remanding “for
the appropriate factual development”). Of course, if the district court finds Banks
to have standing, a ruling on the parties’ cross-motions for summary judgment
would be appropriate, and an appeal may again follow. At this juncture, however,
we will not pass on the merits of Banks’s collateral estoppel argument in light of
the outstanding jurisdictional issue.
In sum, we vacate the grant of summary judgment to the Secretary and
remand this case to the district court to make a determination on standing, with
consideration of supplemental evidence submitted by the parties as appropriate.4
We further direct that the determination of standing proceed on an expedited
basis. 5
VACATED AND REMANDED.
4
Banks’s motion to take judicial notice of the Holt Decision is DENIED as moot.
5
This Court granted Banks’s motion to expedite the appeal filed pursuant to 28 U.S.C.
§ 1657(a) (“[E]ach court of the United States . . . shall expedite the consideration of . . . any . . .
action if good cause therefor is shown.”) and Federal Rule of Appellate Procedure 27. See also
11th Cir. R. 34-4(f) (“The court may, on its own motion or for good cause shown on motion of a
party, advance an appeal for hearing and prescribe an abbreviated briefing schedule.”). In light
of Banks’s health condition, we instruct an expedited consideration of Banks’s case on remand.
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