Row 1 Inc ., D/ B / A Regenative Labs v. Xavier Becerra, Secretary of Health and Human Services , Solely in His Official Capacity

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued October 6, 2023 Decided February 16, 2024
No. 23-5020
R OW 1 INC ., D/ B / A R EGENATIVE LABS ,
APPELLANT
v.
XAVIER B ECERRA, S ECRETARY OF HEALTH AND H UMAN
S ERVICES , SOLELY IN HIS OFFICIAL CAPACITY , ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:22-cv-00718)
Patrick C. Gallagher argued the cause for appellant. With
him on the briefs were Brian H. Pandya, Frederick R. Ball, and
Robert M. Palumbos.
Caroline D. Lopez, Attorney, U.S. Department of Justice,
argued the cause for appellees. With her on the brief were
Brian M. Boynton, Principal Deputy Assistant Attorney
General, and Abby C. Wright, Attorney.
Before: P ILLARD and C HILDS , Circuit Judges, and
EDWARDS , Senior Circuit Judge.

-- 1 of 20 --

2
Opinion for the Court filed by Senior Circuit Judge
EDWARDS .
EDWARDS , Senior Circuit Judge: In establishing Medicare,
a federally funded health insurance program for the elderly and
disabled, see 42 U.S.C. §§ 1395 et seq. (“Medicare Act” or
“Act”), Congress enacted a “reticulated statutory scheme”
“detail[ing] the forum and limits of review” of all claims for
Medicare benefits, Bowen v. Mich. Acad. of Fam. Physicians,
476 U.S. 667, 675 (1986). The Medicare program is
administered by the Centers for Medicare and Medicaid
Services (“CMS”) on behalf of the Secretary of Health and
Human Services (“Secretary”). Section 405(h) of the Social
Security Act, incorporated into the Medicare Act by 42 U.S.C.
§ 1395ii, makes it clear that claims arising under the Medicare
Act – such as claims seeking Medicare reimbursement for a
particular treatment or product – must be pursued through
administrative procedures adopted by the Secretary. 42 U.S.C.
§ 405(h). Such claims may not be raised in judicial actions
purporting to rest on federal question jurisdiction under 28
U.S.C. § 1331 or federal defendant jurisdiction under 28 U.S.C.
§ 1346. Id. A claimant may seek judicial review only after
receiving a “final decision” from the Secretary. Id. § 405(g);
see also id. § 1395ff(b)(1)(A). This statutory scheme “assures
the [Secretary] greater opportunity to apply, interpret, or revise
policies, regulations, or statutes without possibly premature
interference by different individual courts.” Shalala v. Ill.
Council on Long Term Care, Inc., 529 U.S. 1, 13 (2000).
Appellant Row 1 Inc., d/b/a Regenative Labs
(“Regenative”), manufactures, markets, and distributes
medical products containing human cells, tissues, or cellular or
tissue-based products (“HCT/Ps”). In February 2022, CMS
issued two technical direction letters instructing Medicare

-- 2 of 20 --

3
contractors to deny reimbursement for claims for products
manufactured by Regenative. Without first exhausting its
administrative remedies, Regenative filed suit in the District
Court challenging the CMS letters, claiming that the Secretary
failed to engage in notice-and-comment rulemaking before
implementing a policy to automatically deny all reimbursement
claims for Regenative’s products. Regenative’s complaint
asked the District Court to, inter alia, enter injunctive,
declaratory, and mandamus relief that: vacates the Secretary’s
policy; declares that the Secretary’s policy determination was
arbitrary, capricious, an abuse of discretion, otherwise not in
accordance with law, in excess of authority granted by law, and
without observance of procedure required by law; and declares
that Regenative’s product is of a type that does not require FDA
approval and should be reimbursed as such to maintain the
status quo. Amended Verified Complaint (“Compl.”) Prayer
for Relief ¶ 1(a), Joint Appendix (“J.A.”) 134-35; see also
Compl. ¶ 25, J.A. 113. The District Court dismissed the case
for lack of subject matter jurisdiction under 28 U.S.C. § 1331
because Regenative had failed to exhaust its administrative
remedies. Row 1 Inc. v. Becerra, 2023 WL 183687, at *1
(D.D.C. Jan. 12, 2023). The court also found that Regenative
had not satisfied the jurisdictional requirements for mandamus
relief. Id. at *4.
On appeal, Regenative contends that Section 405(h) does
not bar federal question jurisdiction over its case, because it
seeks not to recover on claims for reimbursement but rather to
vindicate interests in procedural regularity and reputational
image. Regenative further claims that if it were required to
pursue administrative remedies, there would be “no [judicial]
review at all” of its claims. See Ill. Council, 529 U.S. at 19.
Separately, Regenative also argues that its claims meet the
threshold requirements for mandamus jurisdiction, and that
compelling equitable grounds justify the issuance of a writ of

-- 3 of 20 --

4
mandamus ordering Defendants to comply with administrative
rulemaking procedures.
We affirm the District Court’s dismissal of this case, in part
for lack of subject matter jurisdiction and in part on grounds of
mootness. CMS has already rescinded the two technical
direction letters, thus mooting Appellant’s request for the court
to vacate the contested policy. An order to vacate an already-
rescinded policy on grounds of procedural deficiencies will not
provide Appellant any meaningful relief, and this case is not
the appropriate vehicle to address Appellant’s interest in
clarification of or changes to the agency’s current policy
regarding HCT/Ps. While Appellant’s further allegation that
Medicare contractors have continued to apply the contested
terms of CMS’s two rescinded letters is not moot, it is
nonetheless barred because it arises under the Medicare Act
and therefore must be channeled through the agency.
I. B ACKGROUND
A. Statutory and Regulatory Framework
Enacted in 1965, the Medicare Act established a federal
program that provides health insurance for the elderly and
disabled. See Social Security Amendments of 1965, Pub. L.
No. 89-97, 79 Stat. 286 (codified as amended at 42 U.S.C.
§§ 1395 et seq.). The Medicare program is administered by
CMS on behalf of the Secretary. St. Luke’s Hosp. v. Sebelius,
611 F.3d 900, 901 n.1 (D.C. Cir. 2010). CMS contracts with
private entities known as Medicare administrative contractors,
who help with processing claims and administering benefits.
See 42 U.S.C. § 1395kk-1. The Medicare program covers only
items and services “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); see also

-- 4 of 20 --

5
42 C.F.R. § 411.15(k)(1). Absent a binding national policy or
direction from the Secretary, Medicare contractors make the
initial coverage decision as to whether an item or service is
reasonable and necessary. See 42 U.S.C. § 1395kk-1(a)(4)(A).
Generally, challenges to a Medicare contractor’s
reimbursement decision must first be raised and exhausted
pursuant to the administrative processes established by the
Secretary. Known as the channeling requirement, the Medicare
Act creates a “special review system” specifically designed for
Medicare claims, Ill. Council, 529 U.S. at 8, and “it demands
the ‘channeling’ of virtually all legal attacks through the
agency,” id. at 13. To such ends, Section 405(h) displaces
general federal question jurisdiction over actions seeking “to
recover on any claim arising under” the Medicare Act. 42
U.S.C. § 405(h); see also id. § 1395ii. A party may obtain
judicial review only after a “final decision of the [Secretary]
made after a hearing to which he was a party.” Id. § 405(g); see
also Ill. Council, 529 U.S. at 10 (“Section 405(h) purports to
make exclusive the judicial review method set forth in
§ 405(g).”). Those who can bring Medicare claims before the
agency include program beneficiaries and their providers. See
42 C.F.R. §§ 405.906(a), 405.912(a). Providers can either
assert claims on their own behalf or as assignees of the
beneficiaries. See id.
B. Factual and Procedural History
Plaintiff Regenative manufactures, markets, and distributes
medical products containing HCT/Ps. The products include
AmnioText (previously marketed as CoreText) and ProText,
which consist of a connective tissue found in the umbilical
cord. Compl. ¶ 1, J.A. 105. In its Complaint, Regenative asserts
its products have been registered and listed with the United
States Food and Drug Administration (“FDA”) as meeting the

-- 5 of 20 --

6
criteria necessary for lighter-touch regulation under Section
361 of the Public Health Service Act, 42 U.S.C. § 264, as
opposed to the more demanding requirements of Section 351
of the Public Health Service Act, 42 U.S.C. § 262. Id. ¶ 3, J.A.
105-06. To be subject solely to Section 361 oversight, the
product must satisfy four criteria, including minimal
manipulation. See 21 C.F.R. § 1271.10(a). Regenative believes
its products are minimally manipulated and fit these criteria,
and the Complaint asserts that, “[t]o date, the FDA has not . . .
indicated any disagreement.” Compl. ¶ 3, J.A. 106. Regenative
claims it sold its products as Section 361 HCT/Ps from
February 14, 2020 to late 2021 and had been reimbursed by
Medicare contractors as such. Id. ¶¶ 4-5, J.A. 106. According
to Regenative, its Section 361 products, unlike products
regulated under Section 351, are exempt from licensing and
pre-market approval from the FDA. Id. ¶ 2, J.A. 105.
In February 2022, CMS issued two non-public technical
direction letters to the Medicare contractors. The first
instructed Medicare contractors to automatically “deny
payments for claims of manipulated amniotic and/or placental
tissue biologics for injections.” J.A. 200. The letter noted the
FDA’s concern that these products were “illegally marketed”
and had “not been shown to be safe or effective.” Id. The
second letter provided specific instructions to deny claims
bearing certain codes, including the code that corresponded
with the products manufactured by Regenative. See J.A. 205-
06; see also Compl. ¶ 4, J.A. 106. Following CMS’s issuance
of these two February letters, Medicare contractors proceeded
to automatically deny reimbursement claims for Regenative’s
products. Compl. ¶¶ 74-80, J.A. 121-22.
On March 15, 2022, Regenative filed a Complaint in the
District Court against the Secretary in his official capacity, the
Department of Health and Human Services, the Administrator

-- 6 of 20 --

7
of CMS in her official capacity, CMS, and several Medicare
contractors (together, “Government”). The Complaint alleged
that the Government improperly held Regenative’s Section 361
products to the more stringent Section 351 requirements, and
that it did so without following proper procedures. See Verified
Complaint ¶ 10, J.A. 15. Specifically, the Complaint
challenged the Government’s policy as (1) being arbitrary and
capricious, (2) exceeding statutory authority, (3) contradicting
Congressional intent, and (4) violating procedural
requirements and Regenative’s due process rights by failing to
provide an opportunity for notice and comment. Id.
On March 25, 2022, ten days after Regenative filed its
initial Complaint, CMS issued a third technical direction letter
rescinding the two February letters. J.A. 211. In this third letter,
CMS instructed the Medicare contractors to institute claim-by-
claim review rather than automatic denial for amniotic and
placental tissue product injections, to reopen any claims that
had been automatically denied, and to delete all related
coverage articles and educational materials issued in accord
with the February letters. Id. On July 12, 2022, Regenative
amended its Complaint, alleging that the Government’s
rescinded policy remained in full effect in practice despite the
policy’s formal recission. Compl. ¶ 11, J.A. 110. As the
remedy, Regenative asked the court to vacate the policy,
declare it unlawful, and “[d]eclare[] that Regenative is a
Section 361 product that does not require FDA approval and
should be reimbursed as such to maintain the status quo.”
Compl. Prayer for Relief ¶ 1(a), J.A. 134-35.
The District Court dismissed the Complaint for lack of
subject matter jurisdiction. Row 1 Inc., 2023 WL 183687, at *1.
Reasoning that Regenative’s claims arise under the Medicare
Act and finding the no-review exception inapplicable, the court
determined that Section 405(h) required Appellant’s claims to

-- 7 of 20 --

8
be channeled through the Secretary’s administrative processes.
Id. at *2-3. Accordingly, the court held it lacked federal
question jurisdiction under 28 U.S.C. § 1331 over Appellant’s
claims. Id. The court further found mandamus jurisdiction
under 28 U.S.C. § 1361 inappropriate, on grounds that
Regenative failed to establish that it met the threshold
jurisdictional requirements for mandamus relief. Id. at *4. We
affirm the District Court’s order dismissing Appellant’s case,
in part for want of subject matter jurisdiction and in part on
grounds of mootness.
II. ANALYSIS
A. Standard of Review
We review a District Court’s dismissal for lack of subject
matter jurisdiction de novo, “assuming the truth of all well-pled
material factual allegations in the complaint and granting the
plaintiff the benefit of all reasonable inferences from the
alleged facts.” RICU LLC v. U.S. Dep’t of Health & Hum.
Servs., 22 F.4th 1031, 1034 (D.C. Cir. 2022). With respect to
mandamus jurisdiction, we review a District Court’s legal
determination about whether the plaintiff met the jurisdictional
requirements de novo, whereas we review a District Court’s
assessment of the equities for abuse of discretion. In re
Medicare Reimbursement Litig., 414 F.3d 7, 10 (D.C. Cir.
2005).
B. Mootness
Although the District Court did not reach the question of
mootness, we are obliged to address the issue “because
mootness goes to the jurisdiction of this court.” Mine
Reclamation Corp. v. FERC, 30 F.3d 1519, 1522 (D.C. Cir.
1994). “Without jurisdiction the court cannot proceed at all in

-- 8 of 20 --

9
any cause. Jurisdiction is power to declare the law, and when it
ceases to exist, the only function remaining to the court is that
of announcing the fact and dismissing the cause.” Steel Co. v.
Citizens for a Better Env’t, 523 U.S. 83, 94 (1998) (quoting Ex
parte McCardle, 7 Wall. 506, 514 (1869)). The Government
raised the issue of mootness in the District Court and again on
appeal, arguing that Appellant’s claims are moot because CMS
has already rescinded the challenged instructions. See Compl.
¶ 11, J.A. 110; Brief (“Br.”) for Appellees 52-58; Def’s Mem.
Supp. Mot. Dismiss 26-29. We agree in part. The
Government’s recission of the contested February letters moots
Appellant’s request for the court to vacate the policy
announced in the letters.
Article III of the Constitution grants federal courts power
to “adjudicate only actual, ongoing cases or controversies.”
Lewis v. Cont’l Bank Corp., 494 U.S. 472, 477 (1990). A case
is moot “when the issues presented are no longer ‘live’ or the
parties lack a legally cognizable interest in the outcome.”
Already, LLC v. Nike, Inc., 568 U.S. 85, 91 (2013) (quoting
Murphy v. Hunt, 455 U.S. 478, 481 (1982) (per curiam)).
However, it is well-settled that “[m]ere voluntary cessation of
allegedly illegal conduct does not moot a case.” United States
v. Concentrated Phosphate Exp. Ass’n, 393 U.S. 199, 203
(1968). “[I]f it did, the courts would be compelled to leave
‘[t]he defendant . . . free to return to his old ways.’” Id. (second
alteration in original) (quoting United States v. W. T. Grant
Co., 345 U.S. 629, 632 (1953)). Therefore, a defendant
claiming mootness due to voluntary cessation “bears the
formidable burden” of demonstrating (1) “that it is absolutely
clear the allegedly wrongful behavior could not reasonably be
expected to recur,” Friends of the Earth, Inc. v. Laidlaw Env’t
Servs. (TOC), Inc., 528 U.S. 167, 190 (2000); and (2) that
“interim relief or events have completely and irrevocably

-- 9 of 20 --

10
eradicated the effects of the alleged violation,” County of Los
Angeles v. Davis, 440 U.S. 625, 631 (1979).
Regarding Appellant’s request for the court to vacate the
contested policy, the Government’s recission of CMS’s two
letters gives Appellant what it seeks. In CMS’s third technical
direction letter, CMS explicitly informed the Medicare
contractors that the third letter “rescind[ed]” the two February
letters. J.A. 211. The third letter directed the Medicare
contractors to “suspend automatic denials” of Appellant’s
category of products and to instead “institute claim-by-claim
review.” Id. The third letter further instructed the Medicare
contractors to reopen and evaluate claims that had been
automatically denied under the previous policy, as well as
delete all related materials issued in accord with the February
letters. Id.
As this court has recognized, “the government’s
abandonment of a challenged [policy] is just the sort of
development that can moot an issue.” Friends of Animals v.
Bernhardt, 961 F.3d 1197, 1203 (D.C. Cir. 2020). Appellant
challenges CMS’s two February letters as unlawful under both
the Medicare Act and the Administrative Procedure Act, and it
requests that the court declare the policy announced in the
letters as such and set it aside. But the Government has already
rescinded the automatic-denial policy that Appellant
challenges. And the Government has not indicated any
intention to reinstate the February letters. The recission of the
contested policy has “completely and irrevocably eradicated
the effects” from the alleged procedural and substantive
violations committed by CMS in its issuance of the first two
letters. Davis, 440 U.S. at 631. Claims that had been
automatically denied must now, pursuant to the third letter, be
subject to claim-by-claim review. Additionally, coverage
articles and educational materials describing the products at

-- 10 of 20 --

11
stake as unsafe and ineffective, issued in accord with the first
two letters, must be deleted. In short, CMS has made explicitly
clear that Medicare contractors should no longer be following
the automatic-denial policy.
“Since we can do nothing to affect [Appellant’s] rights
relative to those now-withdrawn [letters], [Appellant’s]
challenges to them are ‘classically moot.’” Friends of Animals,
961 F.3d at 1203 (quoting Akiachak Native Cmty. v. U.S. Dep’t
of the Interior, 827 F.3d 100, 106 (D.C. Cir. 2016)). An order
requiring notice and comment on a rescinded policy would
provide Appellant no meaningful relief. This case is not an
appropriate vehicle to address Appellant’s interest in
prospective clarification of or changes to CMS’s current,
claim-by-claim approach to HCT/Ps.
Appellant contends that, despite CMS’s clear instructions
to scrap the automatic-denial system and institute claim-by-
claim review, Medicare contractors still apply the rescinded
policy. Appellant claims that “the Policy [from the February
letters] continues and is in effect behind the scenes.” Compl.
¶ 118, J.A. 128. Thus, according to Appellant, there remains a
live controversy over whether Medicare contractors are
improperly denying reimbursement claims for Appellant’s
products on the belief that CMS continues to endorse sub
silentio the policy outlined in the two February 2022 letters.
We agree that Appellant’s challenge to the Medicare
contractors’ alleged mishandling of reimbursement claims is
not moot. Indeed, Appellant may have a legitimate concern
over these alleged practices. However, as we explain in the next
section, any challenge to the contractors’ contested practices is
barred in this case because of the Medicare Act’s channeling
requirement.

-- 11 of 20 --

12
C. Federal Question Jurisdiction
1. “Arising Under” the Medicare Act
Section 405(h), as incorporated by 42 U.S.C. § 1395ii,
provides that “[n]o action against the United States, the
[Secretary], or any officer or employee thereof shall be brought
under section 1331 or 1346 of Title 28 to recover on any claim
arising under” the Medicare Act. 42 U.S.C. § 405(h). The
Supreme Court has interpreted this provision to “demand[] the
‘channeling’ of virtually all legal attacks through the agency.”
Ill. Council, 529 U.S. at 13. The Court rejected proposals to
limit these channeling provisions “based upon the ‘potential
future’ versus the ‘actual present’ nature of the claim, the
‘general legal’ versus the ‘fact-specific’ nature of the
challenge, the ‘collateral’ versus ‘noncollateral’ nature of the
issues, or the ‘declaratory’ versus ‘injunctive’ nature of the
relief sought.” Id. at 13-14. The Court also rejected “a
distinction that [would] limit[] the scope of § 405(h) to claims
for monetary benefits.” Id. at 14.
The Supreme Court’s capacious understanding of the scope
of Section 405(h) bars this action. Appellant’s assertion that
certain types of injuries – for example, procedural and
reputational – are not subject to Medicare Act channeling fails
because those injuries are “inextricably intertwined” with the
underlying Medicare claims. See, e.g., Heckler v. Ringer, 466
U.S. 602, 614 (1984). At its core, Appellant’s challenge is to
the Government’s Medicare reimbursement decisions, and
Appellant seeks for the court to declare that its products
“should be reimbursed.” Compl. Prayer for Relief ¶ 1(a), J.A.
134-35. Such claims for reimbursement “aris[e] under the
Medicare Act,” and accordingly “must be channeled through
the agency.” Ill. Council, 529 U.S. at 23.

-- 12 of 20 --

13
That Appellant brings a challenge to the procedural
irregularity of the policy, rather than challenging only the
Government’s substantive decision to deny the claims, is
irrelevant to the Section 405(h) jurisdictional analysis on the
facts presented here. In Heckler v. Ringer, several individuals
who had been or anticipated being denied Medicare
reimbursement for surgeries “assert[ed] objections [in federal
court before administrative exhaustion] to the Secretary’s
‘procedure’ for reaching her decision.” Ringer, 466 U.S. at 614.
Bringing procedural claims, the plaintiffs “challenge[d] [the
Secretary’s] decision to issue a generally applicable rule rather
than to allow individual adjudication,” as well as “her alleged
failure to comply with the rulemaking requirements of the
[Administrative Procedure Act].” Id. The Supreme Court held
that Section 405(h) barred the plaintiffs’ action and declined to
distinguish between procedural and substantive claims. Id. at
613-14. The Court reasoned that “it ma[de] no sense to
construe the claims . . . as anything more than, at bottom, a
claim that [plaintiffs] should be paid” for their surgery. Id. at
614. Finding the plaintiffs’ procedural claims “inextricably
intertwined” with their claims for benefits, the Court instructed
that “the inquiry in determining whether § 405(h) bars federal-
question jurisdiction must be whether the claim ‘arises under’
the Act, not whether it lends itself to a ‘substantive’ rather than
a ‘procedural’ label.” Id. at 614-15.
As in Ringer, although Appellant here makes a facially
procedural claim, at bottom, the relief that Appellant seeks is a
substantive declaration that its products are reimbursable under
the Medicare Act. Appellant protests that Medicare contractors
continue to apply the rescinded policy in full force, Compl.
¶ 11, J.A. 110, claiming that the Government merely “faux-
ceas[ed]” the policy, id. ¶ 120, J.A. 129. In Appellant’s view,
because CMS promulgated its February letters without notice
and comment, CMS foreclosed input from Appellant that could

-- 13 of 20 --

14
have averted adoption of the policy and attendant harms,
including the alleged continued application of the rescinded
policy by Medicare contractors. As discussed above,
Appellant’s request to vacate the February policy on procedural
grounds is moot, because the policy has already been
rescinded. To the extent Appellant believes the harms from the
procedural deficiency linger in the Medicare contractors’
incorrect processing of reimbursements, such procedural
challenges are “inextricably intertwined” with claims for
Medicare benefits and therefore must be channeled through the
agency. See Ringer, 466 U.S. at 614.
For similar reasons, Section 405(h)’s channeling
requirement also bars Appellant’s reputational-injury claim.
Appellant contends that CMS’s characterization of its products
as potentially unsafe, ineffective, and illegally marketed
damaged its reputation and caused it financial harm beyond the
Medicare system. Appellant claims that non-Medicare doctors
no longer use its products because of the contested, now-
rescinded policy. But, as with Appellant’s procedural
argument, Appellant’s reputational argument is “inextricably
intertwined” with the claim for Medicare benefits. See Ringer,
466 U.S. at 614. Appellant’s perceived reputational harm
derives directly from the Government’s reimbursement policy.
Under Appellant’s theory of reputational injury, approval of
Medicare reimbursement indicates the product’s safety and
effectiveness, whereas continued denial of reimbursement
signifies a lack thereof. In short, Appellant’s reputational-
injury claim cannot be separated from the claim that
Regenative’s products should be reimbursed, and accordingly
it is subject to the Medicare Act’s requirements of presentation
to and exhaustion before the agency. See Ill. Council, 529 U.S.
at 13.

-- 14 of 20 --

15
2. Illinois Council’s No-Review Exception to Section
405(h)
Appellant argues that even if Section 405(h) might
otherwise bar review, the exception to Section 405(h)
enunciated in Illinois Council applies. In Illinois Council, the
Supreme Court observed that Section 405(h) does not apply
when its application “would not simply channel review through
the agency, but would mean no review at all.” Ill. Council, 529
U.S. at 19. The Court characterized Section 405(h) as “a
channeling requirement, not a foreclosure provision.” Id.
However, the Court emphasized that “added inconvenience or
cost in an isolated, particular case” is insufficient to trigger this
exception. Id. at 22. The hardship must result in “complete
preclusion of judicial review.” Id. at 23.
In Council for Urological Interests v. Sebelius, this court
explained that “the Illinois Council exception is primarily
concerned with whether a particular claim can be heard through
Medicare Act channels.” Council for Urological Ints. v.
Sebelius, 668 F.3d 704, 712 (D.C. Cir. 2011). It noted that “the
Illinois Council exception is not intended to allow section 1331
federal question jurisdiction in every case where section 405(h)
would prevent a particular individual or entity from seeking
judicial review.” Id. at 711. If another party can bring the
general claim through the administrative channels, and has
sufficient incentive to do so, the Illinois Council exception does
not apply. See id. at 712; see also Fam. Rehab., Inc. v. Azar,
886 F.3d 496, 505 (5th Cir. 2018) (“[W]e have required
channeling so long as there potentially were other parties with
an interest and a right to seek administrative review.”)
(footnote omitted) (quotation marks omitted). Some of our
sister circuits have held that the plaintiff carries the “heavy
burden of showing that the Illinois Council exception applies.”
Sw. Pharmacy Sols., Inc. v. Centers for Medicare & Medicaid

-- 15 of 20 --

16
Servs., 718 F.3d 436, 439 (5th Cir. 2013); see also Retina Grp.
of New England, P.C. v. Dynasty Healthcare, LLC, 72 F.4th
488, 497 (2d Cir. 2023). We need not decide the question of
burden in the context of Illinois Council, because the record in
this case makes it clear that there are potentially other parties
with an interest and a right to seek administrative review.
We see no basis on this record to apply the Illinois Council
exception. Reviewed under our precedents, this record suggests
there are adequate proxies for Appellant that have the incentive
to seek administrative review. In Council for Urological
Interests, this court found the exception applied to a council of
urologist-owned joint ventures that challenged a regulation
prohibiting physicians from referring patients to hospitals that
compensated physicians for use of certain equipment or from
receiving reimbursement for procedures performed at such
hospitals. Council for Urological Ints., 668 F.3d at 705-06.
Though the council’s claims could be brought through the
administrative process by its client hospitals, the court noted
“several unique characteristics of the hospitals’ relationship to
the Council and to the challenged regulations” that rendered the
hospitals unlikely to do so. Id. at 713. Specifically, the hospitals
resented the council’s control over the purchase of medical
equipment, and the new regulations afforded the hospitals an
opportunity to reassert control. Id. Furthermore, the new
regulations financially benefited the hospitals by allowing
them to purchase expensive laser equipment from the council
at fire-sale prices. Id. The court also credited the fact that, “[i]n
the three years since the Secretary announced the regulations,
not one of the 5,795 hospitals in the United States has brought
an administrative challenge to those regulations.” Id.
Unlike in Council for Urological Interests, Appellant has
not alleged any facts indicating a lack of alignment in
incentives between itself and the providers using its products.

-- 16 of 20 --

17
Presumably, providers that purchase Appellant’s products
would also wish to be reimbursed by Medicare, and Appellant
has not demonstrated otherwise. Rather, Appellant argues that
many healthcare providers will simply no longer purchase and
use its products because of the confusion with the
reimbursement policy. While there might be some force to the
claim that the volume of future purchases may decrease, we
cannot conclude that no providers would be incentivized to
seek reimbursement.
For instance, Appellant acknowledges that there are
providers who had successfully submitted reimbursement
claims after February 2020. These providers would have later
been subject to having their claims reopened and automatically
denied pursuant to CMS’s two February letters. In other words,
there appears to be no dispute over the fact that there are
providers who purchased Appellant’s products, had their
claims denied, and consequently would have incentive to
challenge any misapplication of the current policy requiring
that their cases be reopened for claim-by-claim review.
In addition, Appellant’s Complaint recounts that one
provider had contacted a Medicare contractor after the third
letter and inquired about reimbursement, indicating that at least
one provider has sufficient incentive to submit a concrete
claim. Compl. ¶ 108, J.A. 127; see RICU LLC, 22 F.4th at
1038-39 (holding that supplier’s client hospitals were
“adequate proxies” for bringing supplier’s claims, because the
client hospitals had inquired about being reimbursed for
supplier’s services and thus had demonstrated sufficient
incentive to submit a concrete claim for payment).
Indeed, contrary to Appellant’s assertions that no proxy is
sufficiently incentivized to bring suit, some providers have
already challenged the contested letters from CMS on

-- 17 of 20 --

18
substantive and procedural grounds. In April 2023, about a year
after Appellant’s initial Complaint was filed and two weeks
before Appellant’s opening brief in this court was due, some
providers filed a suit “request[ing] review of final decisions of
[the Secretary] that denied Medicare coverage and
reimbursement” for similar products manufactured by another
company. Compl. ¶ 1, Greiner Orthopedics, LLC v. Becerra,
No. 1:23-cv-01047 (D.D.C. Apr. 14, 2023). As amended, the
providers’ complaint asserted claims comparable to those
raised by Appellant, including that the Secretary’s denial of
Medicare coverage was “arbitrary, capricious, and not in
accordance with the law,” as well as “in violation of the notice
and comment requirements” under the Medicare Act and the
Administrative Procedure Act. Amended Compl. ¶¶ 161, 164,
180, Greiner Orthopedics, LLC v. Becerra, No. 1:23-cv-01047
(D.D.C. Jun. 16, 2023). Like Appellant, the providers seek
declaratory and injunctive relief. Id. ¶ 5.
In sum, this record does not establish that Appellant’s
providers so lack incentive to seek reimbursement for its
products such that invoking Section 405(h) would “turn[] what
appears to be simply a channeling requirement into complete
preclusion of judicial review.” Ill. Council, 529 U.S. at 22-23.
Because the Illinois Council exception does not apply, we
therefore conclude that Section 405(h) bars the exercise of
federal question jurisdiction over Appellant’s claims.
D. Mandamus Jurisdiction
Appellant also invokes the District Court’s jurisdiction
pursuant to the Mandamus Act. Under the Mandamus Act,
“[t]he district courts shall have original jurisdiction of any
action in the nature of mandamus to compel an officer or
employee of the United States or any agency thereof to perform
a duty owed to the plaintiff.” 28 U.S.C. § 1361. Appellant

-- 18 of 20 --

19
contends mandamus is necessary to enforce CMS’s “clear
statutory duty to promulgate regulations following the required
notice-and-comment procedure.” Br. of Appellant 29. Contrary
to Appellant’s view, we agree with the District Court that
Appellant has failed to show eligibility for mandamus relief.
Although Section 405(h) does not preclude mandamus
jurisdiction under 28 U.S.C. § 1361, Monmouth Med. Ctr. v.
Thompson, 257 F.3d 807, 813 (D.C. Cir. 2001), “[t]he remedy
of mandamus is a drastic one, to be invoked only in
extraordinary situations,” Kerr v. U.S. Dist. Ct. for N. Dist. of
Cal., 426 U.S. 394, 402 (1976). To establish mandamus
jurisdiction under 28 U.S.C. § 1361, a plaintiff “must
demonstrate (1) a clear and indisputable right to relief, (2) that
the government agency or official is violating a clear duty to
act, and (3) that no adequate alternative remedy exists.” Am.
Hosp. Ass’n v. Burwell, 812 F.3d 183, 189 (D.C. Cir. 2016).
These requirements are jurisdictional, and failure to meet these
threshold criteria requires dismissal of the case. Id. “Even when
the legal requirements for mandamus jurisdiction have been
satisfied, however, a court may grant relief only when it finds
compelling equitable grounds.” Id. (quoting In re Medicare
Reimbursement Litig., 414 F.3d at 10).
The District Court held that Appellant failed to meet its
burden of showing that the jurisdictional requirements for
mandamus relief are satisfied. Row 1 Inc., 2023 WL 183687, at
*4. We agree. First, as discussed above, Appellant’s request
that the court order the Government to undertake notice-and-
comment rulemaking on its automatic-denial policy is moot.
The contested policy has been rescinded.
To the extent Appellant wishes to compel CMS to further
clarify or change its current approach to HCT/Ps via notice-
and-comment rulemaking, it has demonstrated neither a clear

-- 19 of 20 --

20
and indisputable right to such relief nor a governmental
violation of a clear duty to act. Appellant has not identified any
legal basis that would confer upon it a right to require CMS to
promulgate across-the-board regulations concerning the
reimbursement eligibility of HCT/P products. To the contrary,
CMS’s current policy of individual review falls squarely within
the agency’s longstanding ability to adjudicate claims on a
case-by-case basis, and the policy fully comports with CMS’s
statutory duty under the Medicare Act to cover only items and
services that are “reasonable and necessary.” 42 U.S.C.
§ 1395y(a)(1)(A); see also 42 C.F.R. § 411.15(k)(1).
Because Appellant has failed to demonstrate “a clear and
indisputable right” to the relief it requests and that the
Government “is violating a clear duty to act,” see Am. Hosp.
Ass’n, 812 F.3d at 189, we need not consider the third threshold
requirement of mandamus jurisdiction that no adequate
alternative remedy exists. Regardless of the third requirement,
Appellant has failed to demonstrate that it has met the threshold
requirements for mandamus jurisdiction.
III. CONCLUSION
For the reasons set forth above, we affirm the District
Court’s dismissal of this action.
So ordered.

-- 20 of 20 --