Anniken Prosser v. Xavier Becerra

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 treat-
ment 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 Med-
icare 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-in-
fact 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 pe-
riod 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 there-
fore lack authority to hear Prosser’s claim and affirm the dis-
missal 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 refer-
ence 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 com-
pany 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 supple-
mentary medical insurance program administered by the Sec-
retary 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 diag-
nosis or treatment of illness or injury or to improve the func-
tioning 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, med-
ically necessary and appropriate, and not experimental in or-
der to qualify for reimbursement. See Medicare Program In-
tegrity 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 determi-
nations (often shorthanded as LCDs) and national coverage
determinations guide the individual claims decisions made
by CMS.
When individuals first submit claims for coverage to Med-
icare 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 de-
cides whether a treatment is covered, a determination that be-
comes 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 re-
determination from the Medicare contractor. See 42 U.S.C.
§ 1395ff(a)(3); 42 C.F.R. § 405.940. At the second level, the ben-
eficiary 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 Ap-
peals, at which point the dispute is assigned to an administra-
tive 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 de-
cision of the Secretary. If the Council either affirms the cover-
age 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 pay-
ing 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 no-
tice, often referred to as an Advance Beneficiary Notice, in-
forming the beneficiary that Medicare is unlikely to cover the
claim. See 42 C.F.R. § 411.404(a), (b). Medical device suppli-
ers—as opposed to healthcare providers in general—bear an
additional burden should they wish to shift the risk that cov-
erage may be denied: they must obtain a written agreement
by the patient that she will individually bear the cost of cov-
erage 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 inno-
vative 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 de-
nied 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 adminis-
trative 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 Med-
icare 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 de-
nial of coverage applied to TTF therapy provided by Novo-
cure 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 Med-
icare. Although Medicare would not pay the claim, it was No-
vocure, 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 subse-
quent 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 ther-
apy 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 rea-
sonable and necessary. The Secretary moved for partial sum-
mary 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 fu-
ture coverage decisions. Put another way, the doctrine of col-
lateral estoppel does not apply to these administrative cover-
age 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 inter-
est 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 sup-
pliers are prohibited from charging beneficiaries the costs of
denied claims without them signing in advance an acknowl-
edgement 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 con-
cluded that she lacked an injury and therefore had no stand-
ing 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 lim-
its federal courts to resolving concrete disputes between ad-
verse parties. See Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61
(1992). Article III, in short, “prevents federal courts from an-
swering 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 caus-
ing) 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 fed-
eral 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 suf-
fered “an invasion of a legally protected interest” that is “con-
crete and particularized” and “actual or imminent, not con-
jectural or hypothetical.” Id. at 560 (cleaned up). Concreteness
demands that an injury “actually exist,” but it need not be tan-
gible 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 injury-
in-fact requirement whenever a statute grants a person a stat-
utory 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 ‘cer-
tainly 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 Su-
preme 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 in-
jury-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 ther-
apy 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 supple-
mental insurance coverage from Medicare. With that cover-
age, she claims, comes a substantive statutory right to pay-
ment by Medicare. The denial of coverage for the treatment
period January to March 2018, in her view, infringes that sub-
stantive 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 en-
force 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 cov-
erage denial in federal court after exhausting the Medicare ap-
peals 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 mis-
managing 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 re-
peatedly “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 in-
jury. Section 1395pp states that Medicare will pay a claim if
neither the supplier nor the beneficiary knew or could reason-
ably 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 ver-
sion 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 suppli-
ers from charging beneficiaries the costs incurred after a de-
nial of coverage except in cases where they provide the bene-
ficiary 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 equip-
ment 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 cov-
erage for the treatment. See 42 U.S.C. § 1395m(j)(4) (incorpo-
rating 42 U.S.C. § 1395m(a)(18)(A)(ii)); Medicare Claims Pro-
cessing 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 cover-
age 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 ap-
peal—show that the risk of financial liability is speculative at
best.
Far too many steps lay between the instant coverage de-
nial and any future liability. Novocure would need to require
Prosser to sign an advanced beneficiary notice, acknowledg-
ing 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, how-
ever, is the Medicare program’s own recent activity. The re-
cently revised LCD L34823, effective as of September 2019,
provides that TTF therapy is presumed reasonable and neces-
sary 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, dur-
ing the period at issue, Prosser received the therapy and owes
nothing for it even though Medicare denied one of her cover-
age claims. If for some reason she does not receive coverage
in the future and as a result is denied the therapy or faces fi-
nancial liability, Prosser will be able to avail herself of the ap-
peals process, and if necessary, seek judicial review from
there.
For these reasons, we AFFIRM.