Arturo Porzecanski v. Alex Azar

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued September 5, 2019 Decided November 26, 2019

No. 18-5222

ARTURO C. PORZECANSKI,

APPELLANT

v.

ALEX MICHAEL AZAR, II, SECRETARY, UNITED STATES

DEPARTMENT OF HEALTH AND HUMAN SERVICES,

APPELLEE

Appeal from the United States District Court

for the District of Columbia

(No. 1:16-cv-02064)

Caroline L. Wolverton argued the cause for appellant.

With her on the briefs was Christopher L. Keough.

Jaynie Lilley, Attorney, U.S. Department of Justice,

argued the cause for appellee. With her on the brief was Alisa

B. Klein, Attorney. R. Craig Lawrence, Assistant U.S.

Attorney, entered an appearance.

Before: HENDERSON and KATSAS, Circuit Judges, and

SENTELLE, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge HENDERSON.

2

KAREN LECRAFT HENDERSON, Circuit Judge: Judicial

review of claims arising under the Medicare Act is carefully

circumscribed. A plaintiff must first present his claims to the

Secretary of the United States Department of Health and

Human Services (HHS) and exhaust administrative remedies,

unless doing so would foreclose access to federal court. In

this appeal we consider whether, after properly channeling a

single claim for “medical and other health services” benefits,

a Medicare beneficiary can obtain prospective equitable relief

mandating that HHS recognize his treatment as a covered

Medicare benefit in all future claim determinations. The

district court concluded it could not issue such relief. For the

reasons that follow, we affirm.

I. BACKGROUND

A

Medicare is a federally funded health insurance program

that serves qualified elderly and disabled individuals. See

Social Security Amendments of 1965 (Medicare Act), Pub. L.

No. 89-97, 79 Stat. 286 (1965) (codified as amended at 42

U.S.C. §§ 1395 et seq.). Medicare Part A primarily provides

inpatient hospital coverage and Part B covers outpatient

services. See 42 U.S.C. §§ 1395c, 1395j, 1395k. Eligible Part

B beneficiaries may submit claims for “medical and other

health services,” id. § 1395k(a)(2)(B), “including drugs and

biologicals . . . furnished as an incident to a physician’s

professional service,” id. § 1395x(s)(2)(A). But a drug or

biological 1 that otherwise qualifies as a “medical or other

1

Biological products, also known as biologics, “include a

wide range of products such as vaccines, blood and blood

components, allergenics, somatic cells, gene therapy, tissues, and

recombinant therapeutic proteins . . . [and] can be composed of

sugars, proteins, or nucleic acids or complex combinations of these

3

health service” will not be covered under Medicare Part B

unless it is also “reasonable and necessary for the diagnosis

or treatment of illness or injury.” Id. § 1395y(a)(1)(A)

(emphasis added). When a drug or biological is approved by

the United States Food and Drug Administration (FDA) but

administered for a use “that is not included as an indication”

on the official FDA label, the off-label use may be covered if

it is “medically accepted” as determined on a case-by-case

basis after consideration of “the major drug compendia,

authoritative medical literature and/or accepted standards of

medical practice.” Medicare Benefit Policy Manual § 50.4.2

(Rev. 1, Oct. 1, 2003)

https://www.cms.gov/Regulations-and-Guidance/Guidance/M

anuals/Downloads/bp102c15.pdf.

The individualized nature of many coverage decisions is

reflected in Medicare’s elaborate claim determination and

review regimen. To start, a Medicare Part B beneficiary must

submit a claim for an “initial determination” of whether “the

items and services furnished are covered or otherwise

reimbursable.” 42 C.F.R. § 405.920. Initial coverage

determinations are made by contractors HHS hires to manage

the preliminary claims administration process in designated

geographic areas. See 42 U.S.C. §§ 1395ff(a)(1)(C),

1395kk-1(a)(1)–(4); 42 C.F.R. §§ 405.920, 405.924(b). The

contractor can either review claims individually or act

pursuant to a “local coverage determination” (LCD). An LCD

sets forth “whether or not a particular item or service is

covered on a contractor-wide basis,” Medicare Program

Integrity Manual § 13.1.1 (Rev. 863, Feb. 12, 2019),

substances, or may be living entities such as cells and tissues.”

What Are “Biologics” Questions and Answers, U.S. FDA,

https://www.fda.gov/about-fda/center-biologics-evaluation-and-rese

arch-cber/what-are-biologics-questions-and-answers (last updated

Feb. 6, 2018).

4

https://www.cms.gov/Regulations-and-Guidance/Guidance/M

anuals/Downloads/pim83c13.pdf; see also 42 U.S.C.

§ 1395ff(f)(2)(B), and may reflect the LCD’s conclusion “that

a service is not reasonable and necessary for certain

diagnoses.” 42 C.F.R. § 400.202.

If the contractor denies the beneficiary’s claim, the

beneficiary is entitled to appeal his claim to HHS. See 42

U.S.C. § 1395ff(b)(1)(A). Initially, he must obtain a

“redetermination” from the same contractor. See id.

§ 1395ff(a)(3)(A); 42 C.F.R. § 405.940. If unsuccessful, the

beneficiary can seek “reconsideration” by a “qualified

independent contractor” who is wholly independent of the

initial determination contractor. See 42 U.S.C.

§ 1395ff(c)(1)–(2); 42 C.F.R. § 405.960. If the beneficiary

remains unsatisfied, he can request a hearing before an

administrative law judge (ALJ). See 42 C.F.R. § 405.1000.

The ALJ’s decision is binding on the parties unless reviewed

by the Medicare Appeals Council (Council). Id. § 405.1048.

If Council review is sought, the Council must either issue a

decision, dismiss the case or remand to the ALJ, ordinarily

within ninety days of receipt of the request for review. Id.

§ 405.1100(c). If it fails to do so, the beneficiary is entitled to

request that his appeal be escalated to federal court. Id.

§ 405.1132(a). Upon receipt of the request, the Council must

act within five calendar days or, alternatively, notify the

beneficiary that it is unable to issue a decision within the time

allotted. Id. § 405.1132(a)(1)–(2). The beneficiary then has

sixty days to file an action. Id. § 405.1132(b).

B

Arturo Porzecanski was diagnosed with systemic

capillary leak syndrome (SCLS) in 2005. SCLS, also known

as Clarkson’s disease, is a rare, life-threatening condition,

5

“characterized by debilitating episodes in which blood and

proteins shift from blood vessels into nearby body cavities

and muscles.” Porzecanski v. Azar, 316 F. Supp. 3d 11, 14

(D.D.C. 2018). SCLS has no known cure. Following his

diagnosis, Porzecanski began a preventive course of

theophylline and terbutaline but, within a few years, his

episodes occurred more frequently. Id. at 15.

In 2009 Porzecanski started an experimental regimen of

intravenous immune globulin (IVIG), a biological product. Id.

The FDA has approved IVIG for certain indications; IVIG for

the treatment of SCLS, however, is considered an off-label

use. Although the body of research at that time comprised

only a few published articles, anecdotal reports and

unpublished case studies, IVIG showed promising results for

controlling SCLS symptoms. The dearth of scientific testing

is unsurprising: SCLS’s deadliness and rarity render clinical

trials virtually impossible. Since starting on IVIG,

Porzecanski has been symptom-free. Id. at 16. According to

the National Institutes of Health, IVIG is now “the best

available treatment” for SCLS patients. Id. at 19 n.4.

Porzecanski’s physicians recommend that he continue his

IVIG infusion schedule—two consecutive days every four

weeks—indefinitely.

On December 16, 2014, Porzecanski underwent a round

of IVIG therapy at Georgetown University Medical Center,

for which the Medical Center billed $29,860.95. Id. at 16. He

submitted a Medicare Part B claim for the treatment. 2 The

2

Since 2009, Porzecanski’s private, employer-sponsored

health insurance has covered his IVIG infusions and continues to do

so. Porzecanski became eligible for Medicare in November 2014.

Anticipating retirement—and the resulting loss of his private

insurance—he began designating Medicare as his secondary

6

initial contractor—Novitas Solutions—denied coverage.

Novitas’ LCD then in effect did not include SCLS as an

approved indication for IVIG. Id. at 16 & n.2, 20.

As mandated by the regulatory scheme, Porzecanski

requested a redetermination and Novitas affirmed its initial

denial. Id. at 16. He then sought a reconsideration by

Maximus Federal Services, a qualified independent

contractor. Id. Maximus also rejected his claim, in a decision

the district court described as “not entirely clear.” Id.

Porzecanski fared no better before an ALJ, who denied

coverage as well. Id. Porzecanski then appealed to the

Council and, after the ninety-day review period lapsed,

informed the Council of his desire to escalate the appeal to

federal court. Id. The Council acknowledged his request and

confirmed it could not issue a decision within the required

time frame, which permitted Porzecanski to proceed to federal

court.

While Porzecanski pursued his claim through the lengthy

administrative appeals process, he underwent monthly IVIG

therapy and submitted Medicare claims for each treatment.

Initial contractors continued to deny coverage. Unlike the

December 2014 claim, however, each subsequent denial was

eventually overturned by either a qualified independent

contractor or an ALJ, obviating the need for judicial review of

those claims. Id. Yet Porzecanski’s success on agency review

did not interrupt the initial denials. Because the review

generally binds only the parties unless specifically designated

as precedential, a favorable determination in one proceeding

does not ensure that future claims will be approved. See 42

C.F.R. §§ 401.109, 405.1130, 405.1048.

insurer. The December 16 treatment was the first IVIG claim

submitted to Medicare after Porzecanski became eligible therefor.

7

Porzecanski filed suit in district court on October 17,

2016. On summary judgment, Porzecanski sought to reverse

the denial of benefits for his December 16, 2014 claim and,

because HHS’s favorable coverage rulings had done nothing

to stem the flow of adverse initial determinations, also

requested “declaratory and injunctive relief . . . confirming his

entitlement to Medicare coverage for his medically necessary

and life-saving treatment, and requiring the Secretary, his

agency, and its contractors to honor the agency’s obligation to

provide the Medicare benefits to which he is entitled.”

Plaintiff’s Memorandum in Support of Motion for Summary

Judgment at 2–3, Porzecanski, 316 F. Supp. 3d 11 (No.

16-2064), ECF No. 15-1. The proposed order accompanying

Porzecanski’s motion asked the court to order the Secretary to

“take all timely and appropriate actions necessary to ensure

that [HHS], its contractors, and its administrative review

officials will not deny Medicare Part B coverage

for . . . future IVIG treatments furnished to [Porzecanski] for

SCLS pursuant to a physician’s order and incident to a

physician’s service to [Porzecanski].” Proposed Order at 2,

Porzecanski, 316 F. Supp. 3d 11 (No. 16-2064), ECF No.

15-6 (emphasis added).

On May 30, 2018, the district court granted Porzecanski’s

motion in part, concluding that the ALJ committed “clear

error” by denying the claim even though the IVIG treatment

at issue “met all requirements for coverage.” 316 F. Supp. 3d

at 19. Accordingly, it reversed the denial of benefits and

“direct[ed] HHS to take all steps necessary to reflect

Medicare coverage for Porzecanski’s IVIG treatment of

December 16, 2014.” Id. at 21. But it denied further

declaratory and injunctive relief. The district court viewed

Porzecanski’s proposed remedy as “an advance decision on

whether Medicare covers [his] other claims” and declined to

make such a determination because:

8

For benefits claims “arising under” the

Medicare statute, “the sole avenue for judicial

review” is 42 U.S.C. § 405(g), which requires

beneficiaries to first pursue their claims

through the Medicare claims process before

seeking review in federal court. Heckler v.

Ringer, 466 U.S. 602, 615 (1984); see also 42

U.S.C. §§ 405(h), 1395ff(b)(1)(A). That is, the

Medicare statute “demands the ‘channeling’ of

virtually all legal attacks through the agency.”

Shalala v. Ill. Council on Long Term Care,

Inc., 529 U.S. 1, 13 (2000).

Id. at 22. Porzecanski was therefore required to “initiate his

claims for other IVIG treatments through the Medicare claims

process.” Id. The district court noted, however, that

Porzecanski was not “without recourse”: he could challenge

the LCD “under which contractors have summarily denied his

claims” 3 or request that HHS issue a national coverage

determination (NCD).4 Id. Porzecanski appeals the denial of

his request for declaratory and injunctive relief.

3 A beneficiary who objects to an LCD “provision” can seek

administrative review of its reasonableness. 42 C.F.R. § 426.300(a);

see 42 U.S.C. § 1395ff(f)(2)(A). The beneficiary can also obtain

judicial review, 42 U.S.C. § 1395ff(f)(2)(A)(iv), including, in some

cases, “without otherwise exhausting other administrative

remedies,” id. § 1395ff(f)(3).

4 An NCD is “a determination by the Secretary with respect to

whether or not a particular item or service is covered nationally,”

42 U.S.C. § 1395ff(f)(1)(B), which “ensure[s] that similar

claims . . . are covered in the same manner,” 78 Fed. Reg. 48,164,

48,165 (Aug. 7, 2013). When no NCD has been made for a

particular item or service, an eligible beneficiary may request that

the Secretary issue one. 42 U.S.C. § 1395ff(f)(4)(A).

9

Porzecanski also heeded the district court’s advice. After

filing this appeal, Porzecanski requested that Novitas revise

its LCD to reflect coverage for IVIG when used to treat

SCLS. Novitas updated its LCD, effective for services

performed on or after September 9, 2018, and added SCLS as

a covered indication for IVIG, albeit in limited circumstances.

Appellee’s Addendum at 8, 13. Although HHS does not argue

with the partial grant of summary judgment ordering coverage

for the December 16, 2014 IVIG treatment, it does maintain

that the revised LCD has mooted Porzecanski’s appeal. We

must therefore consider whether Porzecanski’s appeal is moot

before we determine whether the district court correctly

declined to grant the requested equitable relief. We address

each issue in turn.

II. MOOTNESS

HHS argues that the appeal “appears to be moot” as a

result of Novitas’ revised LCD. Appellee’s Br. at 11.

Although HHS’s brief cites no caselaw on this point, we have

an “independent obligation” to ensure that cases before us are

not moot. Am. Freedom Def. Initiative v. WMATA, 901 F.3d

356, 361 (D.C. Cir. 2018) (quotation marks omitted). This

duty arises from Article III’s requirement that federal courts

“only adjudicate actual, ongoing controversies.” Honig v.

Doe, 484 U.S. 305, 317 (1988). In general, “a case becomes

moot when the issues presented are no longer live or the

parties lack a legally cognizable interest in the outcome.”

Conservation Force, Inc. v. Jewell, 733 F.3d 1200, 1204

(D.C. Cir. 2013) (quotation marks omitted). For example, a

case is moot if intervening events make it impossible “to grant

any effectual relief,” Church of Scientology of Cal. v. United

States, 506 U.S. 9, 12 (1992) (quotation marks omitted), or if

“a party has already obtained all the relief that it has sought,”

10

Conservation Force, 733 F.3d at 1204 (quotation marks and

brackets omitted).

This case is not moot. Porzecanski seeks an equitable

remedy to stop the nearly automatic coverage denials that

have been, and continue to be, issued for his monthly IVIG

treatments. The district court’s order reversing the denial of

the December 16, 2014 claim has done nothing to stop the

repetitive denials underlying Porzecanski’s claim for

declaratory and injunctive relief. Nor has the revised Novitas

LCD given Porzecanski the full relief he requested.

Novitas’ September 2018 revisions expanded coverage of

IVIG for SCLS “on a trial basis when associated with

monoclonal gammopathy and used for prophylaxis,” although

“prophylaxis should be tapered to the lowest dose

obtainable.” Appellee’s Addendum at 13–14. HHS argues the

case is moot because coverage is no longer “categorically

unavailable.” Appellee’s Br. at 11–12. But Novitas has

continued to deny Porzecanski’s claims after Novitas’ revised

LCD’s effective date and he maintains that the “lowest dose

obtainable” limitation is arbitrary and dangerous.5 Appellant’s

Reply Br. at 12–13. Shortly before oral argument in this case,

Novitas again revised its LCD, replacing “lowest dose

obtainable” with “lowest effective dose.” Local Coverage

Determination (LCD): Intravenous Immune Globulin (IVIG)

(L35093), CTRS. FOR MEDICARE & MEDICAID SERVS.,

https://www.cms.gov/medicare-coverage-database/details/lcd-

details.aspx?LCDId=35093 (last updated Aug. 22, 2019). 6

5

Porzecanski has brought a separate action in district court

challenging the revised LCD. See Porzecanski v. Azar, No.

19-cv-661 (D.D.C. filed Mar. 8, 2019) [hereinafter Porzecanski II].

6 Both the impetus and the effect of this change are not

entirely clear. On March 15, 2019, Porzecanski requested

reconsideration of certain language in Novitas’ revised LCD. See

11

Although the impact of this most recent change remains to be

seen, it appears to support, if anything, coverage for

Porzecanski. In any event, neither LCD revision has mooted

this case.

Assuming, arguendo, that the current Novitas LCD

manifests that Porzecanski’s IVIG treatments are covered

under Medicare Part B, he still would not have “obtained all

the relief [he] sought.” Conservation Force, 733 F.3d at 1204

(quotation marks omitted). An LCD binds only the issuing

contractor. See 42 U.S.C. § 1395ff(f)(2)(B). That is, if

Porzecanski receives treatment in a geographic region

administered by another contractor, the Novitas LCD would

not control the determination.7 An LCD is also binding only

at the initial determination stage and does not dictate the

qualified independent contractor’s reconsideration decision.

Id. § 1395ff(c)(3)(B)(ii)(II). Likewise, notwithstanding LCDs

are afforded “substantial deference . . . if they are applicable

to a particular case,” ALJs and the Council are not bound to

follow the determination made by the issuing contractor. 42

Attachment, Letter from Jaynie Lilley, Counsel for HHS, to Mark J.

Langer, Clerk of Court (Sept. 4, 2019) (pursuant to Fed. R. App. P.

28(j)). Novitas responded on August 16 and rejected his assertion

that “lowest dose obtainable” was ambiguous. Id. Nevertheless,

within a week of its response, Novitas in fact substituted “effective”

for “obtainable,” a change it described as “non-substantive” and

“made for clarification.” Local Coverage Determination (LCD):

Intravenous Immune Globulin (IVIG) (L35093), CTRS. FOR

MEDICARE & MEDICAID SERVS.,

https://www.cms.gov/medicare-coverage-database/details/lcd-detail

s.aspx?LCDId=35093 (last updated Aug. 22, 2019).

7 Indeed, to date Porzecanski has fared better with contractors

operating in other jurisdictions. See Complaint, Exhibit 2 at 27,

Porzecanski II, No. 19-cv-661 (D.D.C. filed Mar. 8, 2019), ECF

No. 1-3.

12

C.F.R. § 405.1062(a). In sum, other initial contractors,

qualified independent contractors, ALJs and the Council are

not bound by the Novitas LCD when deciding whether

Porzecanski’s IVIG treatments are covered under Medicare

Part B. They would, however, be bound by the equitable relief

he seeks. Accordingly, Porzecanski’s appeal is not moot.

III. PORZECANSKI’S REQUESTED RELIEF

Porzecanski contends the district court had authority to

issue equitable relief because the December 16, 2014 claim

was properly before it. We note as a preliminary matter that

Porzecanski has narrowed the scope of his proposed remedy

on appeal. In district court, his proposed order requested, in

part, “that [HHS], its contractors, and its administrative

review officials will not deny Medicare Part B coverage

for . . . future IVIG treatments furnished to [Porzecanski].”

Proposed Order at 2, Porzecanski, 316 F. Supp. 3d 11 (No.

16-2064), ECF No. 15-6. Before us, however, he contends the

requested injunction would not in fact require HHS to

approve his future claims. Tr. of Oral Arg. 10:13–10:17.

Instead, it would merely effectuate the district court’s ruling

that his December 16, 2014 claim was a covered Medicare

Part B benefit by precluding the Secretary—and any HHS

adjudicators and contractors—from denying future claims on

the same rejected grounds. However Porzecanski frames his

request, we believe the district court correctly declined to

grant equitable relief.

A

Federal jurisdiction is extremely limited for claims

arising under the Medicare Act. Generally, a beneficiary must

first channel his claim “into the administrative process which

Congress has provided for the determination of claims for

benefits” before obtaining judicial review. Heckler v. Ringer,

13

466 U.S. 602, 614 (1984). Three statutory provisions

elucidate this channeling requirement.

First, 42 U.S.C. § 1395ii—part of the Medicare

Act—incorporates the judicial review scheme set forth in 42

U.S.C. § 405(h) 8 and elsewhere in Title II of the Social

Security Act, mandating that these provisions “shall also

apply” to the Medicare Act “to the same extent as they are

applicable with respect to” Title II, with any reference to the

“Commissioner of Social Security” deemed a reference to the

HHS Secretary as well. In the Medicare context, then,

§ 405(h) “divests the district courts of federal-question

jurisdiction ‘on any claim arising under’” the Medicare Act

and prohibits judicial review of any decision by the HHS

Secretary, “‘except as herein provided’ in other Title II

provisions.” Am. Hosp. Ass’n v. Azar, 895 F.3d 822, 825

(D.C. Cir. 2018) (quoting 42 U.S.C. § 405(h)). The judicial

review procedure set forth in 42 U.S.C. § 405(g)9 “creat[es]

8 “The findings and decision of the Commissioner of Social

Security after a hearing shall be binding upon all individuals who

were parties to such hearing. No findings of fact or decision of the

Commissioner of Social Security shall be reviewed by any person,

tribunal, or governmental agency except as herein provided. No

action against the United States, the Commissioner of Social

Security, or any officer or employee thereof shall be brought under

section 1331 or 1346 of Title 28 to recover on any claim arising

under this subchapter.” 42 U.S.C. § 405(h). In administering the

Medicare review provisions, all references to the “Commissioner of

Social Security” in § 405(h) are considered references to the HHS

Secretary. Id. § 1395ii.

9

“Any individual, after any final decision of the

Commissioner of Social Security made after a hearing to which he

was a party, irrespective of the amount in controversy, may obtain a

review of such decision by a civil action commenced within sixty

days after the mailing to him of notice of such decision . . . .” 42

14

the exception ‘herein provided.’” Id. Although § 405(g) is not

one of the Title II provisions specifically incorporated by

§ 1395ii, it has been consistently interpreted as such. Id.

(“[T]hese decisions treat it as such, presumably on the theory

that expressly incorporating the judicial-review bar in

§ 405(h) also effectively incorporates the exception ‘herein

provided’ in § 405(g).”).

In relevant part, § 405(g) provides that any person may

“obtain a review” of “any final decision” of the Secretary

“made after a hearing to which he was a party,” by filing a

civil action in federal court. See also 42 U.S.C.

§ 1395ff(b)(1)(A). The United States Supreme Court has

interpreted this provision to impose two distinct requirements

that a beneficiary must satisfy before obtaining judicial

review of a Medicare claim. First, “a claim for benefits shall

have been presented to the Secretary.” Mathews v. Eldridge,

424 U.S. 319, 328 (1976). This precondition is nonwaivable

because without presentment “there can be no ‘decision’ of

any type,” as is required by § 405(g). Id. Presentment is thus

“an absolute prerequisite” for jurisdiction. Nat’l Kidney

Patients Ass’n v. Sullivan, 958 F.2d 1127, 1130 (D.C. Cir.

1992). Second, “the plaintiff must fully exhaust all available

administrative remedies, though this more demanding

requirement is waivable.” Am. Hosp. Ass’n, 895 F.3d at 826.

Accordingly, § 405(h)’s bar on judicial review, as

modified by § 405(g), “demands the ‘channeling’ of virtually

all legal attacks through the agency.” Shalala v. Ill. Council

on Long Term Care, Inc., 529 U.S. 1, 13 (2000). Channeling

extends “beyond ordinary administrative law principles of

ripeness and exhaustion of administrative remedies” in order

to “assure[] the agency greater opportunity to apply, interpret,

U.S.C. § 405(g). As noted, “Commissioner of Social Security”

refers to the HHS Secretary in the Medicare context. Id. § 1395ii.

15

or revise policies, regulations, or statutes without possibly

premature interference by different individual courts.” Id. at

12–13 (quotation marks omitted). That said, the preconditions

do not apply “where application of § 405(h) would not simply

channel review through the agency, but would mean no

review at all.” Id. at 19; see also Am. Hosp. Ass’n, 895 F.3d at

825 (“[F]ederal-question jurisdiction remains available where

necessary to preserve an opportunity for judicial review.”).

We have held that the exception recognized in Illinois

Council “applies not only when administrative regulations

foreclose judicial review, but also when roadblocks

practically cut off any avenue to federal court.” Am.

Chiropractic Ass’n v. Leavitt, 431 F.3d 812, 816 (D.C. Cir.

2005). A party may not circumvent the channeling

requirement “by showing merely that postponement of

judicial review would mean added inconvenience or cost in an

isolated, particular case.” Council for Urological Interests v.

Sebelius, 668 F.3d 704, 708 (D.C. Cir. 2011) (quotation

marks and brackets omitted). Rather, the “difficulties must be

severe enough to render judicial review unavailable as a

practical matter.” Am. Chiropractic Ass’n, 431 F.3d at 816.

B

We review de novo the district court’s conclusion that it

was precluded by § 405(g) from issuing the requested

declaratory and injunctive relief. See, e.g., Am. Hosp. Ass’n,

895 F.3d at 825.

A beneficiary seeking to establish a right to future benefit

payments must be considered to have brought a claim that

“arises under” the Medicare statute. Ringer, 466 U.S. at 615.

Judicial review is therefore limited by the interplay between

§ 405(h) and § 405(g), subject to the exception expounded by

the Supreme Court in Illinois Council. Here, Porzecanski has

16

not shown that judicial review will be “foreclose[d]” or

“practically cut off” if he is forced to channel future claims

through the HHS administrative process. See Am.

Chiropractic Ass’n, 431 F.3d at 816. To the contrary, he can

obtain judicial review of any future claim denial just as he has

done in this case. And to the extent he desires broader relief

outside the case-by-case adjudicatory model, he has a clear

administrative path to challenge an LCD or to request an

NCD, see 42 U.S.C. § 1395ff(f)(2)(A), (f)(4)(A), subject, in

both cases, to judicial review after final agency action. 42

U.S.C. § 1395ff(f)(1)(A)(v), (f)(2)(A)(iv). Postponing judicial

review would delay—but not deprive—Porzecanski of access

to federal court. Until then, he has an adequate remedy that

seems to work. Indeed, except for the December 16, 2014

claim, HHS has ultimately approved his IVIG treatments. He

understandably wants to end the cycle of initial denials and

agency appeals but “occasional individual, delay-related

hardship” does not override “the judgment of Congress”

encapsulated in § 405(h). Illinois Council, 529 U.S. at 13.

Accordingly, Porzecanski must present and exhaust each of

his future benefit claims.

Porzecanski cannot satisfy § 405(g)’s presentment

requirement with respect to future claims because those

claims have not yet arisen. Under the Medicare scheme, a

claim can be filed “only after the medical service for which

payment is sought has been furnished.” Ringer, 466 U.S. at

621. Moreover, § 405(g) contemplates appeals from

“decision[s]” of the Secretary. Here, the Secretary has not

decided Porzecanski’s future claims because—to state the

obvious—none has been submitted. Porzecanski attempts to

avoid this conclusion, arguing that he does not in fact seek “a

declaration of entitlement to Medicare benefits on specific

future claims,” even as he admits his requested relief would

“preclud[e] the agency from applying its invalidated

17

conclusions that the treatments for his rare condition are not a

Medicare-covered benefit and not medically necessary.”

Appellant’s Br. at 32.

Porzecanski’s strained position is at odds with Supreme

Court precedent. In Ringer, the Court held that § 405(g)

barred a patient from obtaining declaratory and injunctive

relief compelling the Secretary to conclude that his future

surgery was “reasonable and necessary” under the Medicare

Act. 466 U.S. at 620–21, 626–27. The equitable nature of the

relief did not mean that the claim was different from

“essentially one requesting the payment of benefits.” Id. at

620. Indeed, as the Court explained, “[a]lthough it is true that

Ringer is not seeking the immediate payment of benefits, he is

clearly seeking to establish a right to future payments” which

“must be construed as a ‘claim arising under’ the Medicare

Act because any other construction would allow claimants

substantially to undercut Congress’ carefully crafted scheme

for administering the Medicare Act.” Id. at 621. And for the

three patients who had already had the surgery at issue, the

Court affirmed “[i]t is of no importance” that they “sought

only declaratory and injunctive relief and not an actual award

of benefits as well” because “only essentially ministerial

details will remain before respondents would receive

reimbursement.” Id. at 615. In Illinois Council, the Supreme

Court again declared that a “claim for future benefits is a

§ 405(h) claim” and that “all aspects” of any future claim

“must be channeled through the administrative process.” 529

U.S. at 12 (quotation marks and citation omitted); see also

Ringer, 466 U.S. at 614.

Ringer and Illinois Council directly foreclose

Porzecanski’s attempt to recast the requested relief as

anything other than a claim for future benefits. An order

requiring HHS to conclude that future IVIG treatments are

18

both a “Medicare-covered benefit” and “medically necessary”

runs headlong into the Supreme Court’s instruction that “all

aspects” of a claim be first channeled through the agency.

Illinois Council, 529 U.S. at 12 (emphasis added). Moreover,

the issues Porzecanski attempts to resolve through judicial

decree are not merely related to his claim; they are his claim.

Granted, Porzecanski would still need to provide appropriate

documentation in connection with his claims but the ultimate

issue of whether his treatments are covered under Medicare

Part B would be predetermined by the relief he seeks. In other

words, “only essentially ministerial details [would] remain

before [he] would receive reimbursement” in the future.

Ringer, 466 U.S. at 615. Porzecanski “is clearly seeking to

establish a right to future payments” outside the appropriate

channels and we therefore must reject his request for

prospective relief. Ringer, 466 U.S. at 621. We believe the

district court correctly rejected Porzecanski’s attempt to

circumvent the Medicare Act’s channeling requirement. 10

Because we hold that Porzecanski runs afoul of § 405(g)’s

jurisdictional presentment precondition, we need not decide

whether he exhausted administrative remedies or whether

exhaustion is otherwise waived.

10

The district court did not explicitly state whether it declined

to grant equitable relief under the nonwaivable presentment

requirement or the waivable exhaustion requirement. It appears,

however, that the court based its decision on jurisdictional

presentment grounds. See Porzecanski, 316 F. Supp. 3d at 22

(“Porzecanski must initiate his claims for other IVIG treatments

through the Medicare claims process, and the Court cannot provide

an advance decision on whether Medicare covers the other

claims.”) (emphasis added). We read this language, as well as the

court’s corresponding discussion of channeling, id., to reflect its

conclusion that Porzecanski has not yet presented his future claims

to the Secretary.

19

We note that Porzecanski construes his case as one

implicating the court’s authority to issue equitable relief, not

its jurisdiction of the underlying claim. There is no dispute

that the December 16, 2014 claim was properly channeled

through HHS before reaching the district court.

Understandably, then, Porzecanski frames the equitable relief

he seeks as “effectuat[ing] the district court’s invalidation of

the Secretary’s conclusions” so that the Secretary and the

attendant components of HHS cannot deny his future claims

for the same reasons. Appellant’s Reply Br. at 5–6. As he sees

it, the properly channeled claim secured jurisdiction, thereby

authorizing the district court to issue equitable relief. We

disagree with his characterization. Properly channeling one

claim does not permit a plaintiff to resolve other claims or

causes of action that have not been channeled. See S. Rehab.

Grp., P.L.L.C. v. Sec’y of HHS, 732 F.3d 670, 677–79 (6th

Cir. 2013).

Porzecanski cites Califano v. Yamasaki, 442 U.S. 682

(1979), where the Supreme Court recognized that § 405(g)

authorizes injunctive relief. In Yamasaki, the Court upheld

class-wide injunctive relief ordering the Secretary to provide

class members with an opportunity for a hearing before

recouping erroneous overpayments of Social Security

benefits. Id. at 705. Relevant here, the Court noted that

injunctive relief remains available because § 405(g) does not

strip federal courts of their equitable power. Id. at 705–06.

But the fact that equitable relief is not categorically foreclosed

under § 405(g) says nothing about when it is available. The

Yamasaki opinion itself provides only two examples of when

equitable relief is appropriate: to preserve the status quo

pendente lite and, in class actions, to protect absent class

members and prevent repetitive litigation. Id. at 705.

Harmonizing Yamasaki with Ringer and Illinois Council, we

conclude the fact that a federal court may issue equitable

20

relief in some circumstances does not mean equitable relief is

appropriate in all cases. We recognize there may be situations

where equitable relief is appropriate and necessary to carry

out a decision. But when prospective relief would functionally

determine future claims, we cannot ignore the restrictive

mandate of the Medicare Act’s channeling requirement.

Porzecanski’s reliance on Lion Health Services, Inc. v.

Sebelius, 635 F.3d 693 (5th Cir. 2011), and Los Angeles

Haven Hospice, Inc. v. Sebelius, 638 F.3d 644 (9th Cir. 2011),

is similarly misplaced. In both cases, hospice care providers

challenged the so-called “hospice cap regulation,” 42 C.F.R.

§ 418.309, under which they were ordered to repay excess

reimbursement amounts. 635 F.3d at 697; 638 F.3d at 649.

The respective district courts declared the regulation invalid

and enjoined the Secretary from enforcing it. 635 F.3d at 698;

638 F.3d at 649. But the posture of those cases differs

considerably from this one. The district courts in Lion Health

and Los Angeles Haven Hospice exercised jurisdiction under

42 U.S.C. § 1395oo(f)(1), which sets out a judicial review

scheme that deviates from § 1395ii and § 405(g) in important

ways. Indeed, § 1395oo(f)(1) confers jurisdiction of “any

action of the fiscal intermediary which involves a question of

law or regulations relevant to the matters in controversy

whenever the Board determines . . . that it is without authority

to decide the question.” The court can then review the

regulation “notwithstanding any other provisions in section

405.” Id. Thus, in both Lion Health and Los Angeles Haven

Hospice, the challenged regulation’s validity was squarely

presented and properly before the court. Put differently,

enjoining enforcement of the hospice cap regulation did not

“mak[e] premature refund determinations for unexhausted

years”—it simply prevented HHS from relying on an

unlawful regulation. Lion Health, 635 F.3d at 702. By

contrast, Porzecanski’s requested remedy would functionally

21

require HHS to cover claims that have neither been presented

to the Secretary nor administratively exhausted.

Accordingly, we also reject Porzecanski’s argument that

the Administrative Procedure Act (APA), 5 U.S.C. §§ 701 et

seq., authorizes the remedy he seeks. Although he frames

Lion Health and Los Angeles Haven Hospice as affirming

equitable relief granted pursuant to the APA, neither held that

the APA independently permits prospective relief where the

Medicare Act’s jurisdictional prerequisites have not been

satisfied. See, e.g., Lion Health, 635 F.3d at 701 (“The district

court may only hear a claim and grant relief pursuant to the

specific jurisdictional provisions of the Medicare Act.”).

Indeed, the Fifth Circuit made clear that the APA only

provided authority to craft the equitable remedy at issue once

the challenged regulation’s validity was properly before the

district court. Id. at 701–02. And in both cases, our sister

circuits emphasized that the underlying claim had been

channeled through the agency. See L.A. Haven Hospice, 638

F.3d at 662 (Haven Hospice “fully complied with the

requirements of Illinois Council” to challenge the

reimbursement regulation); Lion Health, 635 F.3d at 701

(Lion Health satisfied the statutory “prerequisites to judicial

review”). But Porzecanski’s future claims have not

“proceed[ed] through the special administrative review

procedures set forth in the Medicare statute,” L.A. Haven

Hospice, 638 F.3d at 662, and the APA does not excuse the

failure to channel such claims.11

11

Porzecanski’s brief invocation of the Declaratory Judgment

Act, 28 U.S.C. § 2201, is no different. Without an independent

basis for jurisdiction of his future claims, the Declaratory Judgment

Act does not authorize the requested equitable remedy. See Lovitky

v. Trump, 918 F.3d 160, 161 (D.C. Cir. 2019) (“[Section]

2201 . . . ‘is not an independent source of federal jurisdiction.’”)

22

Finally, we consider the practical effects of his requested

relief. In district court, Porzecanski challenged no generally

applicable regulation or policy. Instead, his complaint

challenged only a single ALJ decision. The district court

reversed the claim denial because the ALJ, despite

determining that Porzecanski’s IVIG treatment was

“reasonable and necessary,” nevertheless denied coverage due

to multiple interpretative missteps. Porzecanski, 316 F. Supp.

3d at 19. And because the ALJ’s “reasonable and necessary”

decision was conclusive, see 42 U.S.C. § 405(g) (on judicial

review of a final decision of the HHS Secretary, the

Secretary’s factual findings, “if supported by substantial

evidence, shall be conclusive”), the district court’s

determination that the IVIG treatment was “reasonable and

necessary” was not required for its holding. See 316 F. Supp.

3d at 19 & n.4. Therefore, it is not clear how Porzecanski’s

proposed relief would effectuate the district court’s

invalidation of the ALJ’s reasoning. First, there is no

indication that the invalidated reasoning was relied on in any

subsequent claim determination. Nor could it have been, as

ALJ decisions are non-precedential. See 42 C.F.R. § 401.109

(“The Chair of the [HHS] Departmental Appeals

Board . . . may designate a final decision of the Secretary

issued by the Medicare Appeals Council . . . as

precedential.”); id. § 405.1063 (only “[p]recedential decisions

designated by the Chair of the Departmental Appeals

Board . . . are binding on all CMS components [and] all HHS

components that adjudicate matters under the jurisdiction of

CMS”). And, in every subsequent claim appeal, HHS has

(quoting Metz v. BAE Sys. Tech. Sols. & Servs. Inc., 774 F.3d 18,

25 n.8 (D.C. Cir. 2014)); see also Randall D. Wolcott, M.D., P.A. v.

Sebelius, 635 F.3d 757, 767 (5th Cir. 2011) (Declaratory Judgment

Act is not “independent basis for subject matter jurisdiction” if

there is “no jurisdiction under 42 U.S.C. § 405(g) or 28 U.S.C.

§ 1331”).

23

found that Porzecanski’s IVIG treatment is in fact covered

under Medicare Part B.

Second, the injunction is not limited to ensuring coverage

for the single claim that was properly before the district court.

Rather, it attempts to stretch the outcome of a single claim

dispute to foreclose a contrary decision in any future

determination. This is at odds with the Medicare regime.

Porzecanski wants a declaration that his treatments are

“medically necessary” in all future cases but Medicare policy

provides that for off-label uses—such as IVIG for the

treatment of SCLS—a determination that the treatment is

“medically accepted” is to be made on a “case-by-case basis.”

Medicare Benefit Policy Manual § 50.4.2 (Rev. 1, Oct. 1, 2003)

https://www.cms.gov/Regulations-and-Guidance/Guidance/M

anuals/Downloads/bp102c15.pdf. Medical science changes.

An accepted practice may be obsolete in a few years.

Ordering HHS to cover Porzecanski’s treatments indefinitely

can hardly be necessary to effectuate the district court’s

judgment regarding one treatment at a particular point in time.

If Porzecanski disputes a future adverse determination, he has

agency review—and, eventually, federal court—to vindicate

his position.

Porzecanski’s real problem seems to be with Novitas. To

the extent he wants the Secretary to instruct Novitas to cover

his treatments pursuant to its LCD, he cannot do so through

the claim appeals process. There is a distinct path provided

for beneficiaries to secure broader coverage determinations

and Porzecanski cannot circumvent those procedures by

obtaining an injunction as part of a single claim appeal.12

12

An LCD challenge is “distinct from the claims appeal

processes,” 42 C.F.R. § 426.310, and cannot be used to review “an

individual claim determination,” id. § 426.325(b)(11). Conversely,

24

For the foregoing reasons, the district court’s partial grant

of summary judgment to HHS is affirmed.

So ordered.

a claim appeal is an improper mechanism by which to “set aside or

review the validity of an . . . LCD.” Id. § 405.1062. LCD and NCD

review is intended to provide an alternative path for beneficiaries to

challenge claim denials, not to replace the claims appeal process.

See Medicare Program: Review of National Coverage

Determinations and Local Coverage Determinations, 68 Fed. Reg.

63,692, 63,693 (Nov. 7, 2003). Accordingly, it would be odd if the

separate statutory framework governing LCD and NCD review

could be contravened by using equitable relief to effectuate the

judgment of a single favorable determination.