In the

United States Court of Appeals

For the Seventh Circuit ____________________ 

No. 20-3070 

ANNIKEN PROSSER, 

Plaintiff-Appellant, 

v.

XAVIER BECERRA, Secretary of the United States Department of 

Health and Human Services, 

Defendant-Appellee. 

____________________ 

Appeal from the United States District Court for the

Eastern District of Wisconsin. 

No. 1:20-cv-00194 — William C. Griesbach, Judge. 

____________________ 

ARGUED JANUARY 13, 2021 — DECIDED JUNE 25, 2021 

____________________ 

Before FLAUM, BRENNAN, and SCUDDER, Circuit Judges. 

SCUDDER, Circuit Judge. Anniken Prosser suffers from an 

aggressive brain cancer called glioblastoma multiforme. To 

treat her disease, Prosser uses a promising electric field treatment called tumor treating fields therapy. She will receive this 

therapy for the rest of her life. To pay for the therapy, Prosser 

enrolled in the supplemental insurance program within Medicare Part B. She files a benefits claim with Medicare for each 
2 No. 20-3070 

period she receives TTF therapy. Medicare denied coverage 

for the treatment period January to April 2018. Though 

Prosser received the therapy and owed nothing out of pocket, 

the denial left the supplier of the treatment, Novocure, Inc., 

with the bill. Prosser challenged this denial by availing herself 

of Medicare’s multilayer appeals process, losing at each level 

and eventually reaching federal court. 

The district court dismissed Prosser’s claim for Medicare 

Part B coverage, holding that she has suffered no injury-infact sufficient to satisfy Article III’s standing requirement. We 

agree. Prosser received—and continues to receive—the TTF 

therapy. She faces no financial liability for the treatment period Medicare denied coverage. And any future financial risk 

is too attenuated from the denial of the past coverage at issue 

here and far too speculative to establish standing. We therefore lack authority to hear Prosser’s claim and affirm the dismissal of her complaint. 

I 

A 

Anniken Prosser is a 37-year-old Medicare recipient who 

suffers from glioblastoma. The disease, which causes a tumor 

to grow and spread in the brain, is aggressive and deadly—

the five-year survival rate hovers around just 5%. As a reference point, this was the disease that took the lives of Senator 

John McCain and Beau Biden, the eldest son of the President 

of the United States. 

Though not curative, Prosser benefits from tumor treating 

fields therapy, commonly referred to as TTF therapy. The 

therapy, approved by the FDA in 2011, works by slowing the 

growth of brain tumors. For most of the day patients use a 
No. 20-3070 3

device that attaches to the head via four adhesive patches that 

connect to a mobile power supply. The device emits electrical 

fields to the tumor, which disrupt the division of cancer cells, 

thereby slowing tumor growth. Early studies show that the 

device holds promise in prolonging life. 

TTF therapy is available through a single supplier—a company called Novocure, which markets the device under the 

commercial name Optune. Patients rent the Optune device on 

a monthly basis. The therapy is expensive, and Prosser must 

file a benefits claim with Medicare for each period she uses 

the device for TTF therapy. 

B 

Prosser receives coverage from Medicare Part B, a supplementary medical insurance program administered by the Secretary of Health and Human Services through the Centers for 

Medicare and Medicaid Services, or CMS. Recipients pay a 

monthly premium in exchange for certain types of coverage, 

including for durable medical equipment like Novocure’s 

Optune system. 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 safe and effective, medically necessary and appropriate, and not experimental in order to qualify for reimbursement. See Medicare Program Integrity Manual § 13.5.4. 

CMS makes individual coverage decisions by determining 

whether a medical service is reasonable and necessary. While 

this determination often applies to each treatment decision, 
4 No. 20-3070 

there are ways to extend coverage determinations to specific 

courses of treatment. These so-called local coverage determinations (often shorthanded as LCDs) and national coverage 

determinations guide the individual claims decisions made 

by CMS. 

When individuals first submit claims for coverage to Medicare Part B, they do so to local contractors who determine if 

the services or devices are covered or otherwise reimbursable 

under Medicare. See 42 C.F.R. § 405.920(a). Contractors may 

issue a local coverage determination that categorically decides whether a treatment is covered, a determination that becomes binding on the issuing contractor for future claims. See 

42 U.S.C. § 1395ff(f)(2)(B). 

A beneficiary disagreeing with the initial determination of 

coverage can appeal. Appeals proceed in four stages within 

the Medicare system. First, the beneficiary may request a redetermination from the Medicare contractor. See 42 U.S.C. 

§ 1395ff(a)(3); 42 C.F.R. § 405.940. At the second level, the beneficiary may seek reconsideration by a qualified independent 

contractor. See 42 U.S.C. § 1395ff(b)(1)(A). A local coverage 

determination is not binding once a beneficiary reaches this 

stage of review. Claimants still unsatisfied with a coverage 

determination may proceed to step three by requesting a 

hearing through the Office of Medicare Hearings and Appeals, at which point the dispute is assigned to an administrative law judge for decision. See 42 U.S.C. § 1395ff(b)(1)(A), (d). 

A claimant may appeal an unfavorable decision by an ALJ to 

the Medicare Appeals Council, which represents the final decision of the Secretary. If the Council either affirms the coverage denial or does not render a decision within a 90-day 

timeframe, a beneficiary may bring a claim in federal district 
No. 20-3070 5

court. See id. § 1395ff(b)(1)(A) (incorporating 42 U.S.C. 

§ 405(g)’s judicial review provisions). 

Even when a benefits claim is denied at any level of the 

appeals process, the beneficiary is not necessarily stuck paying a medical bill. If neither the supplier nor the beneficiary 

knew or could reasonably have been expected to know that 

the claim would not be covered, Medicare will nevertheless 

pay for the service. See id. § 1395pp; 42 C.F.R. § 411.400(a). 

This provision limits liability only once—after that, both the 

beneficiary and supplier are on notice that coverage is likely 

to be denied. In that way, § 1395pp provides suppliers and 

beneficiaries alike the benefit of the doubt and shields them 

both from financial liability the first time Medicare denies 

coverage. It seems that providers and participants call this 

one-time liability limitation the Medicare “mulligan.” 

But coverage denials are not always a risk-free proposition 

for a beneficiary. Suppliers may shift the risk of non-coverage 

solely to the beneficiary when they give advance written notice, often referred to as an Advance Beneficiary Notice, informing the beneficiary that Medicare is unlikely to cover the 

claim. See 42 C.F.R. § 411.404(a), (b). Medical device suppliers—as opposed to healthcare providers in general—bear an 

additional burden should they wish to shift the risk that coverage may be denied: they must obtain a written agreement 

by the patient that she will individually bear the cost of coverage denial. See 42 U.S.C. § 1395m(j)(4) (incorporating 42 

U.S.C. § 1395m(a)(18)(A)(ii)); Medicare Claims Processing 

Manual ch. 30, § 30.1. In these ways, suppliers like Novocure 

are able to limit their financial risk while still providing innovative healthcare solutions like TTF therapy.
6 No. 20-3070 

C 

Prosser was prescribed the TTF therapy in June 2016. The 

therapy generated monthly Medicare claims. TTF therapy is 

often covered by private insurers. Medicare, however, had a 

local coverage determination in place—LCD L34823—that denied coverage for TTF therapy performed on or after October 

1, 2015 as not reasonable and necessary for the treatment of 

glioblastoma. After requests for reconsideration of the LCD 

by patients and suppliers alike through a separate administrative review process, Medicare revised LCD L34823 to cover 

TTF therapy as reasonable and necessary as of September 1, 

2019. This revision of LCD L34823 did not come until after the 

ALJ decision denying coverage to Prosser. 

Prosser submits coverage claims to Medicare for every 

three-to-four-month period she receives the TTF therapy. She 

exhausted the administrative review process within the Medicare program each time. Along the way, Prosser received two 

favorable coverage decisions, including one in May 2019. 

But Prosser received an unfavorable coverage decision 

too. The decision came from a different ALJ in June 2019, just 

a month after a favorable decision granting coverage. The denial of coverage applied to TTF therapy provided by Novocure to Prosser from January through April 2018. Given the 

LCD in place at the time, the ALJ concluded, Novocure 

should have known that the therapy was not covered by Medicare. Although Medicare would not pay the claim, it was Novocure, not Prosser, that the ALJ left with the bill, as Prosser 

did not sign an advance beneficiary notice acknowledging her 

liability. This presents the only unfavorable decision Prosser 

received through the Medicare appeals process. 
No. 20-3070 7

Having exhausted her administrative remedies for the 

coverage denial for the period January through April 2018, 

Prosser filed a complaint against the Secretary in the Eastern 

District of Wisconsin in February 2020. Recall that Prosser had 

received a favorable ALJ decision a month before the subsequent ALJ decision denying coverage. This is the thrust of 

why Prosser escalated this appeal to federal court—she wants 

steady and consistent Medicare Part B coverage for TTF therapy on a going-forward basis. To Prosser’s mind, the initial 

favorable ALJ determinations should bind future coverage 

determinations, and she should not have to go through the 

Medicare claims review process every time she gets the TTF 

therapy.

Two months after filing in federal court, Prosser moved for 

partial summary judgment, seeking to prevent the Secretary 

from denying the TTF therapy for her glioblastoma because a 

previous ALJ decision had concluded it was medically reasonable and necessary. The Secretary moved for partial summary judgment too, insisting that ALJ-level decisions are 

case-by-case, nonprecedential decisions. 

In July 2020 the district court entered partial summary 

judgment for the Secretary, concluding that administrative 

Medicare coverage decisions made by ALJs did not bind future coverage decisions. Put another way, the doctrine of collateral estoppel does not apply to these administrative coverage decisions. 

In October 2020 the Secretary moved for full summary 

judgment, this time arguing that Prosser lacked Article III 

standing. The Secretary contended that Prosser had no interest in the case, since all along she received the TTF therapy yet 

paid nothing. The district court granted the Secretary’s 
8 No. 20-3070 

motion, concluding that Prosser lacked standing. Since suppliers are prohibited from charging beneficiaries the costs of 

denied claims without them signing in advance an acknowledgement of personal liability and there is no evidence that 

Prosser signed such a notice, it was the supplier Novocure—

not Prosser—who bore the costs of having provided the TTF 

therapy to Prosser. Nor, the district court added, did anything 

in the record suggest that Prosser has been unable to receive 

the therapy. In other words, because Prosser was receiving 

the therapy and faced no financial liability for the denial of 

coverage relating to past treatment, the district court concluded that she lacked an injury and therefore had no standing to sue. 

Prosser now appeals. 

II 

A 

We begin, as we must, with subject matter jurisdiction. 

Only if Prosser has standing can we proceed to the merits of 

her argument that ALJ coverage determinations bind future 

coverage determinations for the same type of treatment. 

The Constitution’s Case or Controversy requirement limits federal courts to resolving concrete disputes between adverse parties. See Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 

(1992). Article III, in short, “prevents federal courts from answering legal questions, however important, before those 

questions have ripened into actual controversies between 

someone who has experienced (or imminently faces) an injury 

and another whose action or inaction caused (or risks causing) that injury.” Sweeney v. Raoul, 990 F.3d 555, 559 (7th Cir. 

2021). 
No. 20-3070 9

The justiciability doctrines, including the doctrine of 

standing, give effect to this limitation. Standing “limits the 

category of litigants empowered to maintain a lawsuit in federal court to seek redress for a legal wrong,” and in that way, 

“confines the federal courts to a properly judicial role.” 

Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). To meet “the 

irreducible constitutional minimum of standing,” a plaintiff 

must have suffered an injury in fact traceable to the defendant 

that is capable of being redressed through a favorable judicial 

ruling. Lujan, 504 U.S. at 560–61. 

To establish injury in fact, Prosser must show that she suffered “an invasion of a legally protected interest” that is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.” Id. at 560 (cleaned up). Concreteness 

demands that an injury “actually exist,” but it need not be tangible or financial. Spokeo, 136 S. Ct. at 1548–49. A plaintiff may 

have standing to enforce an intangible injury, so long as it is 

concrete. See id. When considering an allegation of intangible 

harm, the Supreme Court instructs us to look to the history of 

the common law and the judgment of Congress. See id. at 

1549. Though Congress has “the power to define intangible 

harms as legal injuries for which a plaintiff can seek relief,” 

Casillas v. Madison Ave. Assoc., Inc., 926 F.3d 329, 333 (7th Cir. 

2019), a plaintiff does not “automatically satisf[y] the injuryin-fact requirement whenever a statute grants a person a statutory right and purports to authorize that person to sue to 

vindicate that right.” Spokeo, 136 S. Ct. at 1549. Even in the 

context of an alleged statutory violation, then, a plaintiff must 

identify a concrete injury. See id.

In the absence of an actual injury, standing may still exist 

in the face of a threatened injury if that future injury is 
10 No. 20-3070 

certainly impending—in a word, imminent. See Lujan, 

504 U.S. at 564 n.2 (“Although ‘imminence’ is concededly a 

somewhat elastic concept, it cannot be stretched beyond its 

purpose, which is to ensure that the alleged injury is not too 

speculative for Article III purposes—that the injury is ‘certainly impending.’” (quoting Whitmore v. Arkansas, 495 U.S. 

149, 158 (1990))); Dep’t of Com. v. New York, 139 S. Ct. 2551, 2565 

(2019) (explaining that imminence requires a showing that 

“there is a substantial risk that the harm will occur”). The Supreme Court has “repeatedly reiterated that threatened injury 

must be certainly impending to constitute injury in fact, and 

that allegations of possible future injury are not sufficient.” 

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

up). 

B 

Our inquiry begins and ends with Article III standing’s injury-in-fact requirement. Prosser received TTF therapy for the 

relevant period of January through April 2018 at no cost to 

herself. She is not out of pocket anything for the therapy and 

does not contend that Novocure (or any other supplier) has a 

claim against her. Nor has she alleged facts suggesting that 

any personal liability for past TTF therapy is imminent. To the 

contrary, the supplier Novocure has shouldered the treatment 

costs. Even more, the ALJ found that the cost of the TTF therapy would be borne solely by Novocure, as the company 

never presented Prosser with an advanced beneficiary notice. 

On these facts, Prosser has not demonstrated the requisite 

injury to establish Article III standing. While this dooms 

Prosser’s present appeal, should her situation change—say, 

for example, if she signs an advanced beneficiary notice and 

Medicare denies coverage for a treatment in the future—so, 
No. 20-3070 11

too, may a future court’s analysis of her standing to sue 

change. Here, however, we can do nothing but dismiss 

Prosser’s claim for want of jurisdiction. 

Prosser responds by contending that she receives supplemental insurance coverage from Medicare. With that coverage, she claims, comes a substantive statutory right to payment by Medicare. The denial of coverage for the treatment 

period January to March 2018, in her view, infringes that substantive right and therefore amounts to an injury for Article 

III standing purposes. 

Not so. Congress, in enacting Medicare, did not endow an 

individual with a substantive right to payment by Medicare 

each and every time they submit a claim. After all—and as the 

facts here show—Medicare payments most often go to the 

supplier or provider, not the recipient of care.

Congress may create and elevate rights by statute while 

also providing a cause of action to sue in federal court to enforce these rights. But that alone is not enough to establish 

constitutional standing under Article III. See Spokeo, 136 S. Ct. 

at 1549. Beneficiaries like Prosser can obtain review of a coverage denial in federal court after exhausting the Medicare appeals process. But mere use of that process cannot, in and of 

itself, create an injury in fact. 

Our reasoning parallels the Supreme Court’s standing 

analysis in Thole v. U.S. Bank N.A., 140 S. Ct. 1615 (2020). In 

Thole, the Court concluded that a pair of retirees lacked Article 

III standing to bring an ERISA claim against a bank for mismanaging a retirement plan, despite the statute providing a 

cause of action, because the plaintiffs’ monthly payouts from 

the defined benefit plan would be unaffected by a ruling, win 
12 No. 20-3070 

or lose. See id. at 1619. The Court underscored that it has repeatedly “rejected the argument that ‘a plaintiff automatically 

satisfies the injury-in-fact requirement whenever a statute 

grants a person a statutory right and purports to authorize

that person to sue to vindicate that right.’” Id. at 1620 (quoting 

Spokeo, 136 S. Ct. at 1549). 

What this means here is that Prosser must still identify a 

concrete injury, notwithstanding the statutory right Congress 

supplied her to appeal a Medicare coverage decision. See id.

at 1620–21; Spokeo, 136 S. Ct. at 1549. She has not done so.

Nor does Prosser’s alleged loss of the one-time limitation 

of liability under 42 U.S.C. § 1395pp amount to a concrete injury. Section 1395pp states that Medicare will pay a claim if 

neither the supplier nor the beneficiary knew or could reasonably have been expected to know that the particular treatment 

would not be covered. This provision alone does not show 

that Prosser suffered a concrete injury. For one, the prior version of LCD L34823 may have already triggered the one-time 

liability limitation—that protection is gone regardless of the 

ALJ’s June 2019 decision denying coverage. And recall that 

the ALJ concluded that the previous version of LCD L34823 

denying coverage for TTF therapy put Novocure on notice 

that the therapy it chose to provide Prosser was not covered 

under Medicare Part B. Novocure itself would be financially 

liable in the event of coverage denial, not Prosser. Remember, 

too, that Prosser is protected by another layer of insulation 

from financial liability. Medicare regulations prevent suppliers from charging beneficiaries the costs incurred after a denial of coverage except in cases where they provide the beneficiary with advance notice that Medicare is likely to deny 

coverage for the treatment. See 42 C.F.R. § 411.404. 
No. 20-3070 13

In addition to the advance notice requirement, there is yet 

a further layer of protection for recipients of medical equipment and devices. Medical device suppliers must also obtain 

a written agreement from the beneficiary, acknowledging that 

the recipient will be personally liable if Medicare denies coverage for the treatment. See 42 U.S.C. § 1395m(j)(4) (incorporating 42 U.S.C. § 1395m(a)(18)(A)(ii)); Medicare Claims Processing Manual ch. 30, § 30.1. Here, Novocure never obtained 

that agreement from Prosser, which means Prosser owes the 

company nothing. 

Prosser makes one final go at establishing an injury in fact, 

positing that she may incur financial liability in future coverage determinations for TTF therapy. But that suggestion is far 

too attenuated from the instant appeal and far too speculative 

at this juncture to suffice for an imminent injury. True, Prosser 

suffers from an incurable condition and will likely need TTF 

therapy for the remainder of her life. But the many favorable 

ALJ decisions—and even the unfavorable decision on appeal—show that the risk of financial liability is speculative at 

best. 

Far too many steps lay between the instant coverage denial and any future liability. Novocure would need to require 

Prosser to sign an advanced beneficiary notice, acknowledging her own financial liability should Medicare deny coverage 

for the therapy. The company has not done so, and there is 

nothing in the record to suggest it might do so in the future. 

Most fatal to Prosser’s imminent injury argument, however, is the Medicare program’s own recent activity. The recently revised LCD L34823, effective as of September 2019, 

provides that TTF therapy is presumed reasonable and necessary for the treatment of glioblastoma. At this point, then, we 
14 No. 20-3070 

have no facts before us suggesting that Prosser is at imminent 

risk of being denied coverage. 

* * * 

By all accounts, TTF therapy has shown great promise in 

fighting glioblastoma. The record before us shows that, during the period at issue, Prosser received the therapy and owes 

nothing for it even though Medicare denied one of her coverage claims. If for some reason she does not receive coverage 

in the future and as a result is denied the therapy or faces financial liability, Prosser will be able to avail herself of the appeals process, and if necessary, seek judicial review from 

there.

For these reasons, we AFFIRM.