United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued October 6, 2023 Decided February 16, 2024

No. 23-5020

ROW 1 INC., D/B/A REGENATIVE LABS,

APPELLANT

v.

XAVIER BECERRA, SECRETARY OF HEALTH AND HUMAN 

SERVICES, 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: PILLARD and CHILDS, Circuit Judges, and 

EDWARDS, Senior Circuit Judge.
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 
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 
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 alreadyrescinded 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. BACKGROUND

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
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 
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 
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-byclaim 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 
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 
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 
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 
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-byclaim 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.
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.
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 federalquestion 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 “fauxceas[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 
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, nowrescinded 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 reputationalinjury 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.
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 
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. 
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 
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 
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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-andcomment 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 noticeand-comment rulemaking, it has demonstrated neither a clear 
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.