Edwin R. Banks v. Secretary, Department of Health and Human Services

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 1 of 22

[PUBLISH]

In the

United States Court of Appeals

For the Eleventh Circuit

____________________

No. 22-10072

____________________

EDWIN R. BANKS,

Plaintiff-Appellant,

versus

SECRETARY, DEPARTMENT OF HEALTH AND HUMAN

SERVICES,

Defendant-Appellee.

____________________

Appeal from the United States District Court

for the Northern District of Alabama

D.C. Docket No. 5:20-cv-00565-LCB

____________________

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 2 of 22

2 Opinion of the Court 22-10072

Before NEWSOM, MARCUS, Circuit Judges, and MIDDLEBROOKS,*

District Judge.

NEWSOM, Circuit Judge:

In this appeal, we must decide whether Edwin Banks has

standing to challenge a denial of Medicare coverage where the

costs of his treatment were imposed not on him, but rather on a

third-party supplier. The district court determined that Banks

hadn’t suffered an injury in fact and accordingly dismissed his case

for want of jurisdiction. We agree and affirm.

I

A

Banks is a 77-year-old Medicare beneficiary from Madison,

Alabama. In 2009, he was diagnosed with glioblastoma multiforme

(GBM), an aggressive form of brain cancer. Without treatment,

GBM patients typically don’t survive longer than three months.

And even with traditional forms of treatment, the five-year survival

rate is only 5%.

Banks, however, has defied the odds. Shortly after his diag-

nosis, he underwent surgery and chemotherapy. That helped for a

time, but unfortunately, Banks’s cancer progressed. In 2013,

Banks’s doctors prescribed him Optune, a groundbreaking medical

* Honorable Donald M. Middlebrooks, United States District Judge for the

Southern District of Florida, sitting by designation.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 3 of 22

22-10072 Opinion of the Court 3

technology that had recently received FDA approval for treating

recurrent GBM. Optune is a portable, wearable device that deliv-

ers tumor treating field therapy (TTFT) to inhibit cancer-cell repli-

cation. A company called Novocure is the sole supplier of the Op-

tune device, which is rented by patients on a monthly basis.

TTFT seems to have worked wonders for Banks. Despite

the grim prospects, his condition stabilized, and he has not experi-

enced a further tumor recurrence since beginning the treatment.

Banks relied on TTFT through 2019, at which point he “elected to

take a break” from the therapy because he had developed an allergy

to an adhesive gel used to secure the Optune device. He intends to

resume TTFT “if his condition changes” in the future—that is, if

his tumor progresses. Happily, that hasn’t happened in the three

years since Banks stopped the treatment.

B

Because Banks is a Medicare Part B beneficiary, he and No-

vocure asked Medicare to cover his TTFT from January 2018

through January 2019. As we will explain, some of Banks’s claims

were approved, and others were denied. But importantly, Banks

wasn’t held liable for any of the claims—Novocure was. Before we

get ahead of ourselves, though, some legal background is in order.

Medicare Part B is a supplemental insurance program “for

aged and disabled individuals who elect to enroll” in it. 42 U.S.C.

§ 1395j. The voluntary program is administered by the Secretary

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 4 of 22

4 Opinion of the Court 22-10072

of Health and Human Services through the Centers for Medicare

and Medicaid Services (CMS). Id. § 1395kk.

Part B enrollees pay monthly premiums in exchange for cer-

tain types of healthcare coverage. Id. §§ 1395k(a), 1395q(b)(2), (d).

Although Part B typically covers “durable medical equipment” like

Optune, see id. §§ 1395k(a)(1), 1395x(n), (s)(6), it excludes coverage

for 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).

There is no hard-and-fast rule for determining whether a

particular medical service is “reasonable and necessary.” Congress

has instead delegated that decision to the Secretary’s discretion.

See Heckler v. Ringer, 466 U.S. 602, 617 (1984). For his part, the

Secretary has defined “reasonable and necessary” to mean

(1) “[s]afe and effective,” (2) “[n]ot experimental or investiga-

tional,” and (3) “[a]ppropriate” in light of the prevailing “standards

of medical practice” and “the patient’s medical needs and condi-

tion.” Medicare Program Integrity Manual, CMS Pub. 100-08, ch.

13, § 13.5.4. Applying that standard often entails case-by-case adju-

dication. See Almy v. Sebelius, 679 F.3d 297, 300 (4th Cir. 2012).

But the Medicare Act establishes certain ways for the Secretary “to

extend coverage determinations to specific courses of treatment.”

Prosser v. Becerra, 2 F.4th 708, 711 (7th Cir. 2021). “These so-called

local coverage determinations (often shorthanded as LCDs) and

national coverage determinations guide the individual claims deci-

sions made by CMS.” Id.; see also 42 U.S.C. § 1395ff(f)(1)–(2).

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 5 of 22

22-10072 Opinion of the Court 5

Whether or not an LCD is in place, the Medicare claims-re-

view process proceeds in six steps. First, the beneficiary submits

his claim to a local contractor for an “initial determination.” See

42 U.S.C. § 1395ff(a); 42 C.F.R. § 405.920. Second, if the beneficiary

is dissatisfied with the initial determination, he may request a “re-

determination” by the contractor. See 42 U.S.C. § 1395ff(a)(3); 42

C.F.R. § 405.940. Third, the beneficiary can appeal his claim to a

“qualified independent contractor” for further review—known as

a “reconsideration.” See 42 U.S.C. § 1395ff(c); 42 C.F.R. § 405.960.

From this stage forward, an LCD is no longer binding, even if it

remains persuasive. See 42 U.S.C. § 1395ff(c)(3)(B)(ii)(II); 42 C.F.R.

§§ 405.976(b)(3), 405.1062. In addition, when the propriety of the

claim turns on “whether an item or service is reasonable and nec-

essary for the . . . treatment of illness,” the qualified independent

contractor’s review “shall include consideration of the facts and cir-

cumstances . . . by a panel of physicians or other appropriate health

care professionals.” 42 U.S.C. § 1395ff(c)(3)(B)(i). Fourth, the Med-

icare beneficiary may request a hearing regarding a denied claim

from an administrative law judge (ALJ), who must issue a decision

within 90 days. See id. § 1395ff(b)(1)(A), (d)(1); 42 C.F.R.

§ 405.1000(a). Fifth, the beneficiary can appeal an unfavorable ALJ

decision to the Medicare Appeals Council (MAC). See 42 U.S.C.

§ 1395ff(d)(2); 42 C.F.R. § 405.1100(a). And sixth, if the beneficiary

is still unsatisfied with the result—or if the MAC doesn’t act in a

timely manner—he can seek judicial review in federal court. See

42 U.S.C. §§ 405(g), 1395ff(b)(1)(A), (d)(3)(B).

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 6 of 22

6 Opinion of the Court 22-10072

Taking stock: A multi-level review process helps to ensure

that Medicare beneficiaries receive coverage for medically reason-

able and necessary treatment. But “[e]ven when a benefits claim is

denied at any level of the appeals process, the beneficiary is not

necessarily stuck paying a medical bill.” Prosser, 2 F.4th at 711.

The Medicare Act contains a handful of measures that serve to pro-

tect patients from liability. The most important for our purposes

is the one contained in 42 U.S.C. § 1395pp—a provision that the

parties have called the “Medicare mulligan.” 1

Here’s how § 1395pp works. Recall that Medicare normally

won’t pay for “items and services” that “are not reasonable and

necessary for the diagnosis or treatment of illness or injury.” 42

U.S.C. § 1395y(a)(1)(A). Nevertheless, if “both” the Medicare ben-

eficiary and the supplier “did not know, and could not reasonably

have been expected to know, that payment would not be made for

such items or services,” then Medicare will foot the bill. Id.

§ 1395pp(a). Alternatively, if the supplier knew that coverage

would be denied but the beneficiary didn’t, then the Secretary will

indemnify the beneficiary and impose the costs on the supplier. Id.

§ 1395pp(b); see also 42 C.F.R. § 411.402. Either way, § 1395pp pro-

vides a one-time allowance—a “mulligan” if you will. Following

the mulligan, the Secretary “shall notify” the beneficiary explaining

1 Forthose who have never had the misfortune of shanking a drive into the

woods, a “mulligan” is a golf term that refers to a player being permitted to

replay a stroke without penalty. It’s a freebie of sorts—traditionally permitted

only on the first tee.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 7 of 22

22-10072 Opinion of the Court 7

why payment or indemnification was made, “and in the case of

comparable situations arising thereafter,” the beneficiary “shall, by

reason of such notice . . . be deemed to have knowledge that pay-

ment cannot be made for such items or services or reasonably com-

parable items or services.” 42 U.S.C. § 1395pp(a), (b).

C

With the legal landscape in view, we return to Banks’s case.

As already explained, Banks and Novocure submitted 13 claims to

Medicare, corresponding to 13 months of TTFT. In accordance

with the LCD then in effect, those claims were denied at the initial

stages of review and by a qualified independent contractor as not

medically reasonable and necessary. In each case, Novocure—not

Banks—was required to bear the costs. This was because Novo-

cure presumably knew that coverage would be denied based on the

LCD, but the record didn’t show that Banks had received advance

notice that Medicare would likely deny payment. Accordingly, he

was relieved of any liability for those claims.

Banks further appealed the denials, at which point his claims

were, for reasons unexplained, split between two different ALJs.

On June 3, 2019, ALJ Bruce Kelton ruled that the TTFT provided

in January, March, and April 2018 wasn’t medically reasonable and

necessary to treat Banks’s condition. Even so, Banks didn’t have to

pay; Novocure was held solely liable for the denied charges. Three

days later, Banks and Novocure received a favorable decision from

another ALJ, Jeffrey Gulin, for the remaining 10 claims. Unlike ALJ

Kelton, ALJ Gulin found that TTFT “was medically reasonable and

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 8 of 22

8 Opinion of the Court 22-10072

necessary” for treating Banks’s recurrent GBM—at least for the

months of service before him. As a result, ALJ Gulin ordered that

Medicare pay for the treatment.

Banks and Novocure appealed ALJ Kelton’s unfavorable de-

cision to the MAC. And when the MAC didn’t issue a decision

within 90 days, Banks sought judicial review.

In the district court, Banks argued that ALJ Gulin’s decision

collaterally estopped the Secretary from denying the claims for

TTFT coverage that were adjudicated by ALJ Kelton. But the dis-

trict court saw things differently and granted the Secretary’s cross-

motion for summary judgment. In doing so, the court concluded

that the “Medicare scheme is incompatible with the doctrine of col-

lateral estoppel.”

Banks then appealed for the first of two times to this Court.

In the previous appeal, “the Secretary argue[d] for the first time

that Banks lack[ed] Article III standing and that [he] ‘submitted no

evidence’ showing he was injured by the claims denial.” Banks v.

Sec’y of Health & Hum. Servs. (Banks I), ___ F. App’x ___, 2021

WL 3138562, at *2 (11th Cir. 2021) (per curiam). Banks responded

with two theories of standing. We made “quick work of Banks’s

first argument”—that “the violation of his statutory right to Medi-

care coverage alone is sufficient to establish standing.” Id. at *2–3.

But because Banks’s “Medicare mulligan” theory could have “re-

quire[d] resolving factual disputes,” we vacated the district court’s

ruling and remanded “for additional jurisdictional factfinding.” Id.

at *3–4.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 9 of 22

22-10072 Opinion of the Court 9

On remand, the district court held that Banks lacked stand-

ing because he hadn’t suffered an injury in fact. It thus dismissed

the case without prejudice, and Banks timely appealed. 2

II

A plaintiff has Article III standing only if he can demonstrate

(1) an injury in fact that is both (2) fairly traceable to the defend-

ant’s conduct and (3) likely redressable by a favorable decision. See

Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992). “To estab-

lish an injury in fact at step one, the plaintiff must demonstrate that

[he] suffered an invasion of a legally protected interest which is

(a) concrete and particularized; and (b) actual or imminent, not

conjectural or hypothetical.” Laufer v. Arpan LLC, 29 F.4th 1268,

1272 (11th Cir. 2022) (cleaned up). This can be done in either of

two ways. First, the plaintiff can “point[] to a direct harm,” which

can be either “tangible or intangible.” Muransky v. Godiva Choc-

olatier, Inc., 979 F.3d 917, 926 (11th Cir. 2020) (en banc). Second,

he can show that the defendant’s actions “created a ‘risk of real

harm’” that is “‘sufficient to meet the concreteness requirement.’”

Id. at 927 (quoting Spokeo, Inc. v. Robins, 578 U.S. 330, 341, 343

(2016)).

Here, the Secretary argues—and the district court agreed—

that “Banks suffered no injury because he is not financially liable

for the denied claims.” Br. of Appellee at 16. Banks doesn’t dispute

2 “We review de novo a district court’s dismissal of a case for lack of standing.”

Sierra v. City of Hallandale Beach, 996 F.3d 1110, 1112 (11th Cir. 2021).

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 10 of 22

10 Opinion of the Court 22-10072

that Novocure was stuck with the bill. But he presents three other

theories of standing. First, he contends that he suffered an “eco-

nomic injury” because he paid premiums for coverage that Medi-

care didn’t provide. Second, he asserts that the agency’s adverse

decision deprives him of a “Medicare mulligan” that might enable

him to receive one free TTFT treatment in the future. And third,

he insists that he has standing due to the government’s denial of a

“substantive statutory right.” We hold that none of Banks’s theo-

ries is availing.

A

We begin with Banks’s economic-injury argument. And at

the outset, it’s important to clarify precisely what relief Banks

seeks: an order “directing the Secretary to cover the claims at issue

in this case.” 3 Doc. 1 at 14. Banks “bears the burden of showing

that he has standing” to pursue this “type of relief.” Summers v.

Earth Island Inst., 555 U.S. 488, 493 (2009).

The problem for Banks is that he hasn’t suffered a cognizable

injury at the hands of the Secretary that “would be redressed by a

3 Banks also seeks attorney’s fees and a declaration that the Secretary acted

unlawfully. But an “interest in attorney’s fees is . . . insufficient to create an

Article III case or controversy where none exists on the merits of the underly-

ing claim.” Lewis v. Cont’l Bank Corp., 494 U.S. 472, 480 (1990). And a re-

quest for declaratory relief “cannot alone supply jurisdiction otherwise ab-

sent.” California v. Texas, 141 S. Ct. 2104, 2116 (2021); see also Steel Co. v.

Citizens for a Better Env’t, 523 U.S. 83, 107 (1998) (“Relief that does not rem-

edy the injury suffered cannot bootstrap a plaintiff into federal court . . . .”).

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 11 of 22

22-10072 Opinion of the Court 11

decision in [his] favor.” Support Working Animals, Inc. v. Gover-

nor of Fla., 8 F.4th 1198, 1206 (11th Cir. 2021). It is undisputed that

Banks “received the therapy and owes nothing for it even though

Medicare denied [some] of [his] coverage claims.” Prosser, 2 F.4th

at 716. And “[w]inning or losing this suit would not change” that.

Thole v. U.S. Bank N.A., 140 S. Ct. 1615, 1622 (2020); see Prosser,

2 F.4th at 714.

To be sure, Banks’s requested relief would require the Sec-

retary to pay Novocure for the cost of treatment that it had to ab-

sorb. But “[t]o invoke federal jurisdiction, a plaintiff must show a

‘personal stake’ in the outcome of the action.” United States v.

Sanchez-Gomez, 138 S. Ct. 1532, 1537 (2018) (quotation omitted).

Because Novocure—not Banks—is the only one “on the hook,”

Banks does not himself “have a concrete stake in this suit.” Thole,

140 S. Ct. at 1620; see Steel Co. v. Citizens for a Better Env’t, 523

U.S. 83, 106–07 (1998).

Banks nevertheless insists that, because he paid his insurance

premiums, 4 he has standing on the ground that he is statutorily en-

titled “to have qualifying claims paid by Medicare.” Br. of

4Banks disavows any request for a “return of his insurance premiums (i.e.,

recission),” seeking only “an order requiring the Secretary to cover [his]

claims.” Reply Br. of Appellant at 8 n.3. That comes as no surprise. It is pre-

cisely because he paid his Medicare premiums that the Secretary was able to

relieve Banks of liability and hold Novocure responsible. See 42 U.S.C.

§§ 1395pp(a)–(b); 1395q(b)(2), (d). Were Banks to obtain recission, he’d be on

the hook to Novocure for the cost of treatment.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 12 of 22

12 Opinion of the Court 22-10072

Appellant at 24. We’re unconvinced. “Congress, in enacting Med-

icare, did not endow an individual with a substantive right to pay-

ment by Medicare each and every time [he] submit[s] a claim.”

Prosser, 2 F.4th at 714. After all, “Medicare payments most often

go to the supplier or provider, not the recipient of care.” Id.; see

also 42 U.S.C. § 1395k(a)(1) (providing that a beneficiary is “enti-

tle[d] to have payment made to him or on his behalf (subject to the

provisions of [Medicare Part B]) for medical and other health ser-

vices” (emphasis added)). And so it would be here if Banks were to

prevail. That unique feature of this case matters in our assessment

of standing. The Secretary’s refusal to pay Novocure on Banks’s

behalf didn’t cause him to personally suffer a concrete harm be-

cause, importantly, the Secretary simultaneously held that Banks

isn’t liable for any of the treatment costs.

Banks fails to explain why ordering the Secretary to cover

the claims at issue—and thereby pay Novocure—would “redress a

cognizable Article III injury” that is personal to him. Steel Co., 523

U.S. at 107. His only response is the “collateral source rule,” a fea-

ture of tort law under which “a plaintiff is entitled to recover the

full value of the damages caused by a tortfeasor, without offset for

any amounts received in compensation for the injury from a third

party.” Higgs v. Costa Crociere S.P.A. Co., 969 F.3d 1295, 1310

(11th Cir. 2020) (emphases added). But as our italicization might

suggest, that rule is inapposite here. Banks didn’t receive any com-

pensation through Novocure’s good graces; it was the Secretary

who ordered Novocure to absorb the cost—in the very same ruling

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 13 of 22

22-10072 Opinion of the Court 13

in which he determined that Banks wasn’t liable. As a result, the

challenged administrative action didn’t cause Banks to suffer an in-

jury in fact.

In the end, Banks’s first theory of standing falls short. He “is

not out of pocket anything for the therapy and does not contend

that Novocure (or any other supplier) has a claim against [him].”

Prosser, 2 F.4th at 714. Accordingly, he has “failed to plausibly and

clearly allege,” Thole, 140 S. Ct. at 1621, that he “personally suf-

fered a concrete and particularized injury in connection with the

conduct about which he complains,” Trump v. Hawaii, 138 S. Ct.

2392, 2416 (2018) (cleaned up).

B

Next, Banks says that he “separately has standing based on

the loss of his right to the Medicare ‘mulligan.’” Br. of Appellant at

28. He doesn’t meaningfully contend that the abstract loss of a po-

tential mulligan is by itself sufficient to confer standing. Nor could

he do so without identifying a resultant concrete harm. See, e.g.,

ASARCO Inc. v. Kadish, 490 U.S. 605, 616 (1989) (“[C]laims of in-

jury that are purely abstract . . . do not provide the kind of particu-

lar, direct, and concrete injury that is necessary to confer standing

to sue in the federal courts.”); see also TransUnion LLC v. Ramirez,

141 S. Ct. 2190, 2210–11 (2021). Still, Banks argues that, without

the prospect of the mulligan, he “faces the risk of being held finan-

cially liable for future treatments.” Br. of Appellant at 31.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 14 of 22

14 Opinion of the Court 22-10072

Such an allegation of future injury “may suffice” for standing

purposes “if the threatened injury is certainly impending, or there

is a substantial risk that the harm will occur.” Dep’t of Commerce

v. New York, 139 S. Ct. 2551, 2565 (2019) (quotation omitted).

That, we have stressed, is a “high standard,” which demands “a ro-

bust judicial role in assessing [the] risk” of harm. Muransky, 979

F.3d at 927. Here, even after drawing all reasonable inferences in

Banks’s favor, we conclude that “[t]here is at most a ‘perhaps’ or

‘maybe’ chance” that his claimed harm will transpire. Bowen v.

First Fam. Fin. Servs., 233 F.3d 1331, 1340 (11th Cir. 2000) (quota-

tion omitted). For reasons we will explain, whether the Secretary’s

denial of coverage in this particular case will result in Banks having

to shoulder a TTFT bill in the future “involves a significant degree

of guesswork.” Trump v. New York, 141 S. Ct. 530, 536 (2020) (per

curiam). And because Banks’s theory of standing requires us to ac-

cept a “speculative chain of possibilities,” his claimed future injury

is—at least under the Court’s current standing framework—insuf-

ficiently “concrete” and “imminent” to invoke the judicial power.

Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409, 414 (2013).

For starters, Banks admits that in 2019, he “elected to take a

break” from TTFT—and he doesn’t contend that he has any im-

mediate plans to resume the therapy. Rather, he says that he “in-

tends to resume use if his condition changes.” Though not dispos-

itive, “[s]uch ‘some day’ intentions—without any description of

concrete plans, or indeed even any specification of when the some

day will be”—usually “do not support a finding of the ‘actual or

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 15 of 22

22-10072 Opinion of the Court 15

imminent’ injury that [the Supreme Court’s] cases require.” Lujan,

504 U.S. at 564.

This case is no exception. Banks has apparently remained

stable for three years. See Oral Arg. at 04:45–07:00. And even if his

condition does worsen at “some indefinite future time,” Lujan, 504

U.S. at 564 n.2—which, thankfully, isn’t necessarily a guarantee—

his claimed injury resulting from the Secretary’s decision in this

case still depends on several contingencies. For instance, at that

unknown point in the future, Banks will still have to be enrolled in

Medicare Part B and to have paid his premiums, such that he would

otherwise qualify for Medicare coverage. See 42 U.S.C.

§ 1395q(b)(2), (d). So too will Banks have to follow through with

his intention to use TTFT, even though we don’t—and he

doesn’t—know what the range of treatment options will be at that

unspecified time.

Then there are the contingencies that depend on the con-

duct of others. The Supreme Court has consistently expressed “re-

luctance to endorse standing theories that rest on speculation

about the decisions of independent actors.” Clapper, 568 U.S. at

414; see also California v. Texas, 141 S. Ct. 2104, 2117 (2021); Lujan,

504 U.S. at 562 (collecting cases). And the possibility of Banks’s

claimed injury coming to fruition requires the coalescence of sev-

eral decisions by at least three independent actors.

First, Banks’s doctors will have to prescribe him TTFT.

That might seem likely, given that Banks has received such a pre-

scription in the past. Cf. Dep’t of Commerce, 139 S. Ct. at 2566

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 16 of 22

16 Opinion of the Court 22-10072

(reasoning that a plaintiff can help his case for standing if he can

“show[] that third parties will likely react in predictable ways”).

But because we don’t know when Banks will seek treatment, it’s

more speculative than at first it may appear. As Banks’s prescribing

doctor explained, TTFT was, in his opinion, “the best FDA ap-

proved option at th[at] time for treating [Banks’s] gliobastoma.”

But that was several years ago. We don’t know what the medical

landscape will look like in the future, as “the practice of medicine

is an ever-evolving and advancing field.” Cospito v. Heckler, 742

F.2d 72, 87 n.24 (3d Cir. 1984). We can only speculate. TTFT may

no longer be the preferred method of treatment when, if ever,

Banks’s condition worsens. And even if future scientific develop-

ments serve to demonstrate the efficacy or superiority of TTFT,

that would only increase the chance that Banks would receive cov-

erage—because TTFT would be deemed medically reasonable and

necessary—and thereby diminish the odds that his claimed injury

will materialize.

Second, even if Banks eventually resumes TTFT, his

claimed injury can occur only if—at that unknown point in the fu-

ture—both (1) his claim is ultimately denied as not reasonable and

necessary, and (2) the adjudicator determines that the case presents

a “comparable situation[].” 42 U.S.C. § 1395pp(a), (b). As the Su-

preme Court has warned, however, “[i]t is just not possible for a

litigant to prove in advance that the judicial system will lead to any

particular result in his case.” Clapper, 568 U.S. at 413–14 (alteration

in original) (quoting Whitmore v. Arkansas, 495 U.S. 149, 159–60

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 17 of 22

22-10072 Opinion of the Court 17

(1990)). And this case is a perfect illustration of that principle. After

all, Banks has received favorable coverage decisions for 10 of his 13

claims. 5 Because the agency could very well rule the same way

with respect to future claims, “the risk of financial liability is spec-

ulative at best.” Prosser, 2 F.4th at 715. 6

Third, even if all the above-described dominoes fall into

place, Banks’s claimed injury will still likely depend on the inde-

pendent actions of Novocure. When medical-device suppliers

have reason to believe that Medicare will deny coverage, they can

and often do shift the financial risk of non-coverage to “a benefi-

ciary by providing [him] with advance written notice that a device

will probably not be covered by Medicare.” Almy, 679 F.3d at 311

n.4; see also Medicare Claims Processing Manual (MCPM), CMS

Pub. 100-04, ch. 30, §§ 20, 40. This is known as an advance benefi-

ciary notice, or ABN. A “valid ABN” generally establishes

knowledge on the beneficiary’s part that his claim won’t be cov-

ered. MCPM ch. 30, §§ 30, 30.1, 50; see also 42 C.F.R. § 411.404;

Int’l Rehab. Scis., Inc. v. Sebelius, 688 F.3d 994, 998 (9th Cir. 2012).

5 Inthis unusual situation, it isn’t entirely clear whether Banks will be charged

with knowledge “that payment would not be made” for a future TTFT claim

based on ALJ Kelton’s decision. 42 U.S.C. § 1395pp(a)(2). ALJ Gulin’s decision

three days later, which ordered full coverage of the treatment, suggests that

payment will be made for such a claim.

6 Banks will also be able to present his collateral-estoppel theory to the agency

as an additional reason for Medicare to cover his TTFT. Though we express

no view on the merits of that theory, it presents an open question that, to our

knowledge, hasn’t been addressed by any court of appeals.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 18 of 22

18 Opinion of the Court 22-10072

And in that case, the Medicare mulligan is unavailable—no matter

whether the beneficiary had a previous coverage denial. See 42

U.S.C. § 1395pp(a); 42 C.F.R. § 411.406(d); MCPM ch. 30, § 50.9.

At least as things stand, it seems reasonably likely that No-

vocure will provide an ABN to Banks before he resumes TTFT (if

he ever does). Indeed, the Seventh Circuit has held that Novocure,

as a medical-device supplier, “must” obtain an ABN “from the ben-

eficiary[] acknowledging that the recipient will be personally liable

if Medicare denies coverage for the treatment.” Prosser, 2 F.4th at

715 (citing 42 U.S.C. § 1395m(j)(4)). Otherwise, that court said, the

supplier alone bears the financial risk if Medicare denies a claim as

not reasonable and necessary. See id. at 711–12, 715; accord Cal.

Clinical Lab. Ass’n v. Sec’y of HHS, 104 F. Supp. 3d 66, 80 (D.D.C.

2015) (Jackson, J.). The parties here dispute whether that’s true.

But we needn’t decide. For even if an ABN isn’t required to shift

liability to Banks, we still think it fairly likely that Novocure will

provide one. After all, the company presumably knows that TTFT

has been denied with some frequency. See, e.g., Prosser, 2 F.4th at

712; Oxenberg v. Sec’y U.S. Dep’t of Health & Hum. Servs., ___ F.

App’x ___, 2022 WL 336996, at *2 (3d Cir. 2022). And the only

circuit court to have addressed this issue has held that failure to

provide an ABN “prevent[s] suppliers from charging beneficiaries

the costs incurred after a denial of coverage.” Prosser, 2 F.4th at

715. As a profit-driven corporation, Novocure will presumably act

to minimize that risk.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 19 of 22

22-10072 Opinion of the Court 19

And if Banks does receive an ABN before future treatment,

that creates a potential traceability problem. The notice would

probably provide an independent reason—aside from the Secre-

tary’s refusal of coverage in this case—for denying Banks a mulli-

gan. See Bennett v. Spear, 520 U.S. 154, 167 (1997) (explaining that

an injury cannot be “the result of the independent action of some

third party not before the court”). That is, armed with a valid ABN

from Novocure, Banks would likely be held to “know,” or “reason-

ably have been expected to know, that payment would not be

made.” 42 U.S.C. § 1395pp(a)(2); see also 42 C.F.R. § 411.404;

MCPM ch. 30, § 30.1. That makes it even more speculative that

Banks’s claimed injury—if it were to ever occur—would be fairly

traceable to the present denial. See Simon v. E. Ky. Welfare Rts.

Org., 426 U.S. 26, 42–43 (1976). 7

7 The Secretary appears to make one last “speculation”-based argument

grounded in a recent update to the applicable LCD. See Oxenberg, 2022 WL

336996, at *2 (noting that the relevant LCD “was revised [in 2019] to cover

TTFT for newly diagnosed GBM patients”). But as Banks rightly argues, the

updated LCD doesn’t purport to cover “recurrent” GBM patients like him.

Accordingly, we agree with Banks that the new LCD doesn’t affect the likeli-

hood of his claimed injury materializing. There are, however, a couple of

LCD-related things to note. First, we know that ALJ Gulin departed from the

LCD, citing (1) “FDA findings and recent studies,” (2) “general acceptance in

the medical community,” and (3) the fact that Banks had survived six years

with the device despite a life expectancy of six months as evidence that TTFT

was “medically reasonable and necessary” for treating his condition. It is thus

speculative to think that the agency would rule differently in the future, even

though the LCD doesn’t yet cover recurrent GBM. See Clapper, 568 U.S. at

413–14. Second, the updated LCD reinforces the point made above—that the

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 20 of 22

20 Opinion of the Court 22-10072

In sum, “[f]ar too many steps lay between the instant cover-

age denial and any future liability.” Prosser, 2 F.4th at 715. Banks’s

alleged harm will only come to pass due to the challenged action

if, at some indefinite point in the future: (1) his condition worsens,

(2) he has paid his premiums and stayed on Medicare Part B, (3) he

elects to resume TTFT, (4) his doctor prescribes the therapy, even

though we can’t know what the range of potential treatment op-

tions in the future will be, (5) Banks receives the treatment, (6) he

files a claim, (7) which, contrary to 10 of the 13 claims he has sub-

mitted, is denied at every level of the Medicare appeals process,

(8) the adjudicators determine that Banks’s hypothetical future

case presents a “comparable situation,” and (9) they further find

that the instant coverage denial and no other source (such as an

ABN) put Banks on notice that he could be held liable. That “the-

ory of standing, which relies on a highly attenuated chain of possi-

bilities,” doesn’t present the type of concrete and imminent injury

that Banks needs to show to invoke our jurisdiction. Clapper, 568

U.S. at 410.

To be clear, we don’t foreclose the possibility that if Banks’s

situation were to change, then he might be able to show a suffi-

ciently concrete and imminent harm. But at this point, based on

science on (and medical acceptance of) TTFT is evolving. By the time Banks

resumes treatment, the LCD may be updated again to direct coverage for his

condition. We have no way of knowing.

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 21 of 22

22-10072 Opinion of the Court 21

the alleged facts before us, Banks “has not demonstrated the requi-

site injury to establish Article III standing.” Prosser, 2 F.4th at 714.

C

Finally, Banks asserts that the denial of his “substantive stat-

utory right” to have Medicare pay for his treatment gives him

standing. Br. of Appellant at 33. There are two problems with his

argument.

First, it is barred by the law of the case. That doctrine pro-

vides that, notwithstanding some inapplicable exceptions, “conclu-

sions of law by an appellate court are . . . binding in all subsequent

proceedings in the same case.” Lebron v. Sec’y of the Fla. Dep’t of

Child. & Fams., 772 F.3d 1352, 1360 (11th Cir. 2014) (quotation

omitted). In Banks I, we made “quick work” of Banks’s “argument

that the statutory violation itself is sufficient to confer standing.”

2021 WL 3138562, at *3. Instead, we held that because “Novocure,

and not Banks, is liable for the cost of the January, March, and April

2018 claims,” Banks had “not shown how the statutory violation

caused a direct harm.” Id. There’s no reason to “revisit[] [that]

issue[] that [was] already decided.” Cambridge Univ. Press v. Al-

bert, 906 F.3d 1290, 1299 (11th Cir. 2018) (alteration adopted) (quo-

tation omitted).

Second, even assuming that Banks’s substantive-statutory-

violation theory isn’t barred by the law of the case, it fails as a mat-

ter of law. In fact, this Court rejected almost the exact same argu-

ment in Muransky. There, the plaintiff argued that the “violation

USCA11 Case: 22-10072 Date Filed: 06/21/2022 Page: 22 of 22

22 Opinion of the Court 22-10072

of a substantive right, unlike a procedural right, automatically”

confers standing. 979 F.3d at 929. We disagreed, explaining that

“arguments grounded in a distinction between substantive and

procedural rights miss the point and are ‘unconvincing’ because

they depend ‘entirely on the framing of the right.’” Id. at 930 (quo-

tation omitted). We then clarified that “[t]he question, always, is

whether an injury in fact accompanies a statutory violation.” Id.;

accord TransUnion, 141 S. Ct. at 2205.

For reasons already explained, Banks hasn’t alleged such an

injury. He hasn’t shown “that the statutory violation itself caused”

him—as opposed to Novocure—a concrete and particularized

harm. Id. at 926; see also Banks I, 2021 WL 3138562, at *3 (“Because

he does not have to pay these claims, Banks has not shown how

the statutory violation caused a direct harm.”). Nor has he shown

a sufficiently substantial risk of future harm. See Clapper, 568 U.S.

at 410–14. He therefore lacks standing.

* * *

Edwin Banks is, by all accounts, a very sympathetic plaintiff.

He has waged—and is continuing to wage—a heroic battle against

a dreadful disease. And as we have said, circumstances could well

change such that one of the Medicare-related injuries he alleges

materializes in a way that satisfies current standing doctrine. As

matters currently stand, though, he has not alleged an injury in fact

sufficient to satisfy Article III. Accordingly, we must AFFIRM.