Teva Pharmaceuticals USA, Inc. v. ROBERT F. KENNEDY, JR. et al.

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 5, 2026 Decided August 18, 2026

No. 25-5425

TEVA PHARMACEUTICALS USA, INC., ET AL.,
APPELLANTS

v.

ROBERT F. KENNEDY, JR., IN HIS OFFICIAL CAPACITY AS
SECRETARY OF HEALTH AND HUMAN SERVICES AND MEHMET
OZ, IN HIS OFFICIAL CAPACITY AS ADMINISTRATOR OF THE
CENTERS FOR MEDICARE & MEDICAID SERVICES,
APPELLEES

Appeal from the United States District Court
for the District of Columbia
(No. 1:25-cv-00113)

Sean Marotta argued the cause for appellants. With him
on the briefs were Danielle Desaulniers Stempel, Dana A.
Raphael, and Katherine T. McKay.

Cesar Lopez-Morales, Lauren Shepard, Clement Seth
Roberts, Irena Royzman, and Andrew D. Silverman were on the
brief for amici curiae Bausch Health Companies Inc. et al. in
support of appellants.

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Brian T. Burgess was on the brief for amicus curiae
Association for Accessible Medicines in support of appellants.

Maxwell A. Baldi, Attorney, U.S. Department of Justice,
argued the cause for appellees. With him on the brief were Eric
J. Hamilton, Deputy Assistant Attorney General, Michael S.
Raab, Attorney, and Kenneth R. Whitley, Attorney, U.S.
Department of Health and Human Services.

Nandan M. Joshi and Wendy Liu were on the brief for
amici curiae Public Citizen, et al. in support of appellees.

Maame Gyamfi, Kelly Bagby, and William Alvarado
Rivera were on the brief for amici curiae AARP, et al. in
support of appellees.

Charles Gerstein was on the brief for amicus curiae
Patients for Affordable Drugs in support of appellees.

Before: HENDERSON, CHILDS and PAN, Circuit Judges.

Opinion for the Court filed by Circuit Judge CHILDS.
CHILDS, Circuit Judge: For years, federal law kept the
Centers for Medicare & Medicaid Services (CMS) out of the
bargaining room. Medicare paid for prescription drugs, but
CMS could not negotiate their prices. The Inflation Reduction
Act of 2022 (IRA) changed that arrangement. It created the
Drug Price Negotiation Program and directed CMS to identify
certain high-spending drugs and negotiate the prices available
under Medicare. This case concerns the line CMS has drawn
between drugs brought into the Negotiation Program and those
kept out, and, more importantly, whether Congress gave CMS
authority to draw that line where it did.

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Teva encounters those rules from both sides of the
pharmaceutical market. It sells branded medicines, including
Austedo and its extended-release formulation, Austedo XR. It
also develops generic versions of medicines sold by others.
CMS grouped Austedo and Austedo XR as one “qualifying
single source drug” because they share the same active moiety
and manufacturer, even though the FDA approved them under
separate applications. CMS also announced that it will
consider a generic as “marketed” only when the manufacturer
engages in “bona fide marketing.” Teva says both rules exceed
CMS’s statutory authority and that the Negotiation Program
deprives it of a protected property interest without due process.
The Government responds that the IRA bars courts from
reviewing Teva’s statutory claims.
We conclude that the review bar covers CMS’s
drug-specific determinations, not the generally applicable legal
standards that govern them. On the merits, we conclude that
the IRA permits CMS to treat Austedo and Austedo XR as one
statutory drug, and the Negotiation Program does not deprive
Teva of a protected property interest. Teva’s challenge to the
“bona fide” marketing requirement, however, is ripe for
review. We therefore affirm in part and reverse in part the
district court’s grant of summary judgment in favor of the
Government and remand Teva’s challenge to CMS’s “bona
fide marketing” requirement for the district court to consider in
the first instance.
I.
A.
1.
Medicare is a federally funded health-insurance program
that pays for covered medical care, including prescription

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drugs, for people aged 65 or older and people with disabilities.
See 42 U.S.C. §§ 426, 426a, 426-1, 1395 et seq. Congress
divided the program into five “Parts.” Ne. Hosp. Corp. v.
Sebelius, 657 F.3d 1, 2 (D.C. Cir. 2011). But two concern us
here. Part B provides supplemental insurance and covers,
among other things, certain drugs administered as part of a
physician’s service or furnished for use with specified durable
medical equipment. See 42 U.S.C. §§ 1395j–1395w-6; 42
C.F.R. § 414.900(b)(1). Part D, for its part, provides
beneficiaries with prescription-drug coverage. See 42 U.S.C.
§§ 1395w-101 et seq.
Part D relies on private insurers to deliver that coverage.
Eligible beneficiaries enroll in plans offered by those insurers,
known as plan sponsors. To participate, a plan sponsor must
submit a successful bid and comply with Medicare’s
requirements. See Pharm. Care Mgmt. Ass’n v. Mulready, 78
F.4th 1183, 1188 (10th Cir. 2023); 42 U.S.C. § 1395w-111.
CMS, in turn, reimburses plan sponsors for covered Part D
expenditures under a web of contracts and regulations. See 42
U.S.C. § 1395w-112(b); 42 C.F.R. §§ 423.301 et seq.
For years, the statute kept CMS out of the bargaining
room. It prohibited the agency from “interfer[ing] with the
negotiations between drug manufacturers” and plan sponsors.
42 U.S.C. § 1395w-111(i). But costs continued to climb. By
2019, Part D spending was “projected to increase faster than
any other category of health spending.” S. Rep. No. 116-120,
at 4 (2019). Congressional reports traced much of that growth
to specialty drugs facing “little or no competition,” with “a
relatively small number of drugs” accounting for “a
disproportionately large share of Medicare costs.” H.R. Rep.
No. 116-324, pt. 2, at 37 (2019). In the Inflation Reduction Act
of 2022, Congress changed course. It created a program
through which Medicare would negotiate the prices of certain

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high-cost drugs. See 42 U.S.C. §§ 1320f–1320f-7; 26 U.S.C.
§ 5000D.
2.
The IRA charges CMS with establishing a Drug Price
Negotiation Program and using it to “negotiate and, if
applicable, renegotiate maximum fair prices for such selected
drugs.” 42 U.S.C. § 1320f(a)(3). Congress stated the
Program’s aim plainly: to “achieve the lowest maximum fair
price for each selected drug.” Id. § 1320f-3(b)(1). That price
applies when eligible beneficiaries receive selected drugs
through Medicare Parts B and D. Id. §§ 1320f(c)(2), 1320f-
2(a)(1)–(3), 1320f-3(a).
Still, the IRA does not “pursue[] its stated purpose at all
costs.” Stanley v. City of Sanford, 606 U.S. 46, 58 (2025)
(quotation marks omitted). Congress instead prescribed rules
for the negotiations, including a requirement that a qualifying
single source drug has been approved for at least seven years.
42 U.S.C. § 1320f-1(e). Manufacturers retain a choice whether
to participate, but it is not a cost-free one. A manufacturer that
declines to negotiate must withdraw from Medicare and
Medicaid or face an excise tax on all sales of the selected drug.
See 26 U.S.C. § 5000D.
The Negotiation Program proceeds in calendar-year
cycles. See 42 U.S.C. § 1320f(b)(1)–(2). Each cycle centers
on an “initial price applicability year,” the calendar year in
which the negotiated price first applies. Id. § 1320f(b)(1). The
corresponding “price applicability period” begins on January 1
of that year and continues through the last year in which the
drug remains selected and subject to the negotiated price. Id.
§ 1320f(b)(1)–(2).

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3.
Before CMS can negotiate a drug’s price, it must decide
which drugs enter the negotiating room. Congress prescribed
a narrowing process. CMS begins with “qualifying single
source drugs,” identifies the highest-spending drugs among
them as “negotiation-eligible drugs,” and then selects a
specified number for negotiation. 42 U.S.C. § 1320f-1(a), (d)–
(e).
For a covered drug of the kind at issue here, three
conditions govern whether it qualifies as a single source drug.
First, the FDA must have approved the drug under 21 U.S.C.
§ 355(c), and the drug must be marketed under that approval;
second, at least seven years must have passed since the
approval; and third, the drug must not be the listed brand-name
drug for any generic that has been “approved and marketed”
under an abbreviated new drug application. 42 U.S.C. § 1320f-
1(e)(1)(A).
CMS next identifies the “negotiation-eligible drugs” from
that pool. Id. § 1320f-1(d)(1). For the 2026 and 2027 price
periods, those are the 50 qualifying single source drugs with
the highest total Part D expenditures during a specified
12-month period. Id. § 1320f-1(d)(1)(A). For later periods,
CMS identifies two sets: the 50 qualifying single source drugs
with the highest Part B expenditures and the 50 with the highest
Part D expenditures. Id. § 1320f-1(d)(1). Congress excluded
certain categories of drugs from both pools, but none of those
exclusions concerns us here. Id. § 1320f-1(d)(2), (e)(3).
From the resulting pool, CMS ranks the negotiation-
eligible drugs by total expenditures and, by a statutory
deadline, must “select and publish” a list of the highest-ranking
drugs. Id. § 1320f-1(a). In calculating expenditures, CMS
must aggregate the data “across dosage forms and strengths of

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the drug.” Id. § 1320f-1(d)(3)(B); see also id. § 1320f-5(a)(2).
Every drug placed on the published list becomes a “selected
drug” and “shall be subject to the negotiation process.” Id.
§ 1320f-1(a), (c).
The number of available slots increases over time. CMS
must select 10 drugs for 2026, 15 drugs for 2027 and 2028, and
20 drugs for each year after that. Id. § 1320f-1(a)–(b). If fewer
drugs qualify for negotiation in a given period than the statute
directs CMS to select, there is no further choice to make: CMS
must select them “all.” Id. § 1320f-1(a).
4.
The IRA also restricts review at each of the three steps in
this narrowing process. It provides that “[t]here shall be no
administrative or judicial review of . . . [t]he selection of drugs
under section 1320f-1(b) of this title, the determination of
negotiation-eligible drugs under section 1320f-1(d) of this title,
and the determination of qualifying single source drugs under
section 1320f-1(e) of this title.” 42 U.S.C. § 1320f-7(2).
5.
For a manufacturer whose drug makes the list, selection
sets the next stage in motion. The manufacturer must enter into
an agreement with CMS and submit pricing and other
information by deadlines fixed in the statute. 42 U.S.C.
§§ 1320f-2(a), 1320f-3(b)(2)(A). CMS must then make “a
written initial offer” proposing a maximum fair price and
providing “a concise justification” for it. Id. § 1320f-
3(b)(2)(B). The manufacturer has thirty days to accept or
counter. Id. § 1320f-3(b)(2)(C)(i). If it counters, CMS must
respond in writing. Id. § 1320f-3(b)(2)(D). Throughout this
exchange, CMS must consider the factors Congress specified.
Id. § 1320f-3(e). And the bargaining cannot continue

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indefinitely. For each price period, the statute fixes a date by
which negotiations “shall end.” Id. § 1320f-3(b)(2)(E).
Once the parties settle on a maximum fair price, the
manufacturer must make that price available beginning on
January 1 of the initial price applicability year. See 42 U.S.C.
§ 1320f-2(a)(1)–(3). The beneficiaries of that bargain include
eligible Medicare recipients and the pharmacies, hospitals,
physicians, and other providers that furnish them the selected
drug. Id. The negotiated price may travel further still, affecting
drug-price calculations under the 340B Drug Pricing Program
and state Medicaid programs. Id. §§ 1320f-2(d), 1396r-
8(c)(1)(C)(i)(V).
Congress attached consequences to missed deadlines. A
manufacturer that fails to enter the required agreement, or that
enters one but does not agree to a maximum fair price on time,
enters a statutory “noncompliance period.” 26 U.S.C.
§ 5000D(b). During that period, federal law imposes an excise
tax on sales of the selected drug. See id. § 5000D(a)–(b).
Once established, the maximum fair price governs during
the drug’s price applicability period. See 42 U.S.C.
§ 1320f(b)(2). The price may later be renegotiated in specified
circumstances. Id. § 1320f-3(f). Nor must a drug remain
selected forever. Ordinarily, it ceases to be a selected drug in
the first year beginning at least nine months after CMS
determines that a generic version has been “approved” and
“marketed.” Id. § 1320f-1(c)(1).
B.
Congress directed CMS to implement the Program’s
opening years through “program instruction or other forms of
program guidance.” Inflation Reduction Act of 2022, Pub. L.
No. 117-169, §§ 11001(c), 11002(c), 136 Stat. 1818, 1854,

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1862 (codified at 42 U.S.C. §§ 1320f note, 1320f-1 note). After
soliciting public comment and revising its proposals, CMS
issued guidance for the 2026 and 2027 initial price applicability
years. See CMS, Medicare Drug Price Negotiation Program:
Revised Guidance (June 30, 2023) (2026 Guidance),
https://perma.cc/J2VZ-F5BZ; CMS, Medicare Drug Price
Negotiation Program: Final Guidance (Oct. 2, 2024) (2027
Guidance), https://perma.cc/TK33-JX9S. Teva challenges two
features of that Guidance.
1.
The first concerns what counts as one qualifying single
source drug. The IRA directs CMS, when calculating
expenditures, to use data aggregated across a drug’s dosage
forms and strengths, “including new formulations of the drug.”
42 U.S.C. § 1320f-1(d)(3)(B); see 2026 Guidance § 30.1, at
100; 2027 Guidance § 30.1, at 169. CMS says its Guidance
carries that command into the process of identifying qualifying
single source drugs. It groups together “all dosage forms and
strengths of the drug with the same active moiety and the same
holder of a New Drug Application (NDA),” even when the
products are “marketed pursuant to different NDAs.” 2026
Guidance § 30.1, at 99; 2027 Guidance § 30.1, at 167.
Simply put, separate NDAs do not necessarily mean
separate drugs. If the products share an active moiety and an
NDA holder, CMS treats them as a qualifying single source
drug. CMS deemed that approach “appropriate” because
manufacturers sometimes obtain approval for new dosage
forms or routes of administration involving the same active
moiety through different NDAs. 2027 Guidance § 30.1, at 169;
see also 2026 Guidance § 30.1, at 100.

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2.
The second provision concerns when an approved generic
“is marketed.” 42 U.S.C. § 1320f-1(e)(1)(A)(iii). That
determination carries consequences. Once an approved generic
is marketed, its brand-name counterpart no longer qualifies as
a qualifying single source drug.
In CMS’s view, a generic has not necessarily been
“marketed” simply because it has reached the market. The
Guidance instead asks whether “the totality of the
circumstances” shows that the manufacturer “is engaging in
bona fide marketing of that drug.” 2026 Guidance § 30.1, at
102; see also 2027 Guidance § 30.1, at 170. To make that
judgment, CMS considers Prescription Drug Event data
submitted by Part D plan sponsors and Average Manufacturer
Price data reported by manufacturers. See 2026 Guidance
§ 30.1, at 101–02; 2027 Guidance § 30.1, at 170–71; see also
2026 Guidance at 76 n.23; 2027 Guidance at 205 n.103.
But no single dataset controls. CMS describes the analysis
as a “holistic inquiry” that “will not necessarily turn on any one
source of data.” 2027 Guidance § 30.1, at 171; see also 2026
Guidance § 70, at 169. Other considerations may include
whether the generic remains “regularly and consistently
available for purchase” and whether licensing or other
agreements restrict its availability or distribution. 2027
Guidance § 30.1, at 171. The Guidance thus asks not merely
whether a generic has made a sale, but whether it has entered
the market in earnest.
C.
With the statutory and regulatory framework now in place,
we turn to the facts. Teva operates on both sides of the
pharmaceutical market. It manufactures branded medicines of

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its own and develops generic versions of medicines made by
others.
Among Teva’s branded medicines are Austedo and
Austedo XR, drugs used to treat involuntary muscle
movements. Austedo XR is an extended-release formulation
of Austedo. The FDA approved the two products under
separate NDAs, but they share the same active moiety, and
Teva holds both applications. Under CMS’s grouping rule,
those features cause the products to be treated as one qualifying
single source drug. Teva has also developed generic versions
of five innovator drugs selected for the 2027 initial price
applicability year (IPAY 2027): Xtandi, Ofev, Linzess,
Xifaxan, and Otezla.
In response to CMS’s selection of Austedo, Teva sued in
the United States District Court for the District of Columbia. It
alleged that CMS had exceeded its statutory authority. In
Teva’s view, both the bona fide marketing requirement and
CMS’s definition of a qualifying single source drug constituted
agency action in excess of statutory jurisdiction, authority, or
limitations, or short of statutory right, in violation of 5 U.S.C.
§ 706(2)(C). Because the Guidance rested on those allegedly
erroneous interpretations, Teva further contended that
implementing it would be unlawful, arbitrary, capricious, an
abuse of discretion, or contrary to law under 5 U.S.C.
§ 706(2)(A).
Teva also raised a constitutional claim, alleging that both
the IRA and CMS’s interpretation of it violated the Fifth
Amendment’s guarantee against deprivations of property
without due process of law. For relief, Teva sought vacatur of
the challenged Guidance under the APA, a declaration that
CMS’s interpretations were unlawful, and declaratory and
injunctive relief on its due process claim.

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The Government and Teva each moved for summary
judgment. The district court granted summary judgment in
favor of the Government, denying Teva’s motion. It first held
that the IRA’s review bar did not foreclose Teva’s challenges
to the generally applicable Guidance. On the merits, however,
the district court upheld CMS’s definition of a qualifying single
source drug as consistent with the IRA. It declined to consider
Teva’s challenge to the bona fide marketing standard,
concluding that the claim was not yet ripe. And it rejected
Teva’s constitutional claim because Teva had identified no
protected property interest. Teva timely appealed.
II.
Because the district court granted summary judgment,
“[w]e have jurisdiction under 28 U.S.C. § 1291.” Capitol Hill
Grp. v. Pillsbury, Winthrop, Shaw, Pittman, LLC, 569 F.3d
485, 488 (D.C. Cir. 2009). Our review of the district court’s
grant of summary judgment is de novo. Ward v. McDonald,
762 F.3d 24, 31 (D.C. Cir. 2014). In conducting that review,
we afford “no particular deference” to the district court’s
review of an agency action under the APA. NACS v. Bd. of
Governors of Fed. Rsrv. Sys., 746 F.3d 474, 482 (D.C. Cir.
2014) (citation modified).
We consider several issues on appeal: (1) whether Teva
has standing to challenge CMS’s interpretation of “qualifying
single source drug”; (2) whether Congress barred judicial
review of Teva’s statutory challenges to the Negotiation
Program; (3) whether the district court correctly rejected
Teva’s statutory challenges to the Negotiation Program; and (4)
whether the district court correctly rejected Teva’s due process
challenge to the Negotiation Program. We address each
argument in turn.

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III.
A.
We first address the Government’s argument that Teva
lacks standing to bring its challenge against the Guidance
“identify[ing] a potential qualifying single source drug
using . . . all dosage forms and strengths of the drug with the
same active moiety and the same holder of a New Drug
Application (NDA), inclusive of products that are marketed
pursuant to different NDAs.” 2026 Guidance § 30.1, at 99;
2027 Guidance § 30.1, at 167.
To have standing, Teva “must have (1) suffered an injury
in fact, (2) that is fairly traceable to the challenged conduct of
the defendant, and (3) that is likely to be redressed by a
favorable judicial decision.” Spokeo, Inc. v. Robins, 578 U.S.
330, 338 (2016). As a general rule, a plaintiff may challenge
an agency decision resting on an erroneous legal premise
although the agency “might later, in the exercise of its lawful
discretion, reach the same result for a different reason.” FEC
v. Akins, 524 U.S. 11, 25 (1998) (citation omitted). Indeed,
“those adversely affected by a discretionary agency decision
generally have standing to complain that the agency based its
decision upon an improper legal ground.” Id. More still, when
a rule regulates the plaintiff, “there is ordinarily little question”
that those requirements are met. Lujan v. Defs. of Wildlife, 504
U.S. 555, 561–62 (1992). The parties’ dispute concerns
redressability alone. The Government accepts that the
Guidance governs the selection of Austedo and regulates Teva.
According to the Government, “[t]o the extent Teva seeks only
prospective vacatur of CMS’s guidance,” that relief would not
remedy any injury arising from the selection of Austedo.
Appellee’s Br. 32 n.5.

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At first blush, that argument has a certain logic. Teva
cannot ask us to overturn the selection of Austedo because
Congress barred review of that determination. But if Teva
urges us only to vacate the legal standard CMS used, the
Government says, Austedo remains selected and Teva gains
nothing. So from that premise, one form of relief is forbidden
and the other is futile. The Government attempts to construct
a jurisdictional vise: Seek relief that overturns the selection of
Austedo, and the review bar forecloses suit; seek anything less,
and Article III does.
We have heard a similar argument before. In American
Clinical Laboratory Ass’n v. Azar (ACLA), Congress had
barred review of “the establishment of payment amounts”
under Medicare. 931 F.3d 1195, 1199 (D.C. Cir. 2019). The
association challenged an antecedent data-collection rule that
allegedly drove the unreviewable payment amounts downward.
See id. at 1201–03. The Secretary responded that because
Congress had insulated the payment amounts from review,
those amounts could not supply a redressable injury. See id. at
1204.
We rejected that argument because it “conflate[d] two
issues.” Id. True, the association could not “challenge the rates
themselves under the statute’s jurisdiction-stripping
provision.” Id. But that did not mean the rates could not “be
the source of ACLA’s members’ injury in a challenge to the
data-collection rule.” Id. The relevant question was whether
the reviewable rule was “sufficiently linked” to the injury
produced by the unreviewable payment amounts. Id. It was.
Requiring the Secretary to collect the data the statute demanded
and use that data to calculate a new weighted median
“appear[ed] sufficiently likely to increase Medicare
reimbursement rates to establish redressability.” Id.

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The same is true here. CMS continues to rely on the
Guidance to treat Austedo and Austedo XR as one statutory
drug, and Austedo’s negotiated maximum fair price has yet to
take effect. Prospective vacatur would remove the legal rule
governing that ongoing treatment and require CMS to proceed
under the proper statutory construction. That is enough to
establish redressability. See id. at 1204. The possibility that
CMS might reach the same result on remand does not change
that analysis. See Akins, 524 U.S. at 25.
Moreover, the Government’s authorities do not support a
different result. In Dobbin Plantersville Water Supply Corp. v.
Lake, the state commission had completed the challenged
decertification, had nothing left to enforce, and need not
authorize the competing utilities before they began service.
108 F.4th 320, 326 (5th Cir. 2024). An injunction against
future enforcement therefore would have been “pointless.” Id.
And Steel Co. v. Citizens for a Better Environment involved no
continuing or imminent violation that prospective relief could
prevent. See 523 U.S. 83, 108 (1998). The Court explained
that such relief could have redressed the plaintiff’s injury had
an ongoing or threatened violation been alleged. See id.
For those reasons, Teva has standing to bring its challenge
against the Guidance “identify[ing] a potential qualifying
single source drug using . . . all dosage forms and strengths of
the drug with the same active moiety and the same holder of a
New Drug Application (NDA), inclusive of products that are
marketed pursuant to different NDAs,” 2026 Guidance § 30.1,
at 99; 2027 Guidance § 30.1, at 167.
B.
With standing resolved, we turn to the Government’s
contention that 42 U.S.C. § 1320f-7(2) bars Teva’s statutory
challenges. Neither the provision’s text nor the IRA’s structure

16

bears the weight the Government places on it. We therefore
reject its reading of the review bar.
Congress, of course, controls the “subject-matter
jurisdiction” of the lower federal courts. Kontrick v. Ryan, 540
U.S. 443, 452 (2004). But Congress controls it not CMS. An
agency cannot expand a review bar simply by declaring its own
conduct unreviewable.
That division of authority reflects a rule with longstanding
pedigree. A court must “independently determine for itself
whether the agency’s interpretation of a statute is correct.”
McLaughlin Chiropractic Assocs., Inc. v. McKesson Corp.,
606 U.S. 146, 155 (2025). The rule does not vanish when
Congress “delegates discretionary authority” to the Executive
Branch. Trump v. Cook, No. 25A312, 2026 WL 1855613, at
*7 (U.S. June 29, 2026) (quotation marks omitted). Put plainly,
agencies administer statutes, but courts determine what those
statutes mean. We are not bound by CMS’s interpretation
because “Congress expects courts to handle technical statutory
questions.” Loper Bright Enters. v. Raimondo, 603 U.S. 369,
402 (2024). Nor does the complexity of the Medicare program
alter our duty. After all, a “mass of technical detail” is “the
ordinary diet of the law.” Egelhoff v. Egelhoff, 532 U.S. 141,
161 (2001) (Breyer, J., dissenting).
These principles yield a familiar starting point in the
“strong presumption favoring judicial review of administrative
action.” Salinas v. U.S. R.R. Ret. Bd., 141 S. Ct. 691, 698
(2021) (quotation marks omitted). That rule is “well-settled,”
so we presume Congress legislates with it “in mind.” Id.
(quotation marks omitted). To overcome that presumption, the
Government must produce “clear and convincing evidence”
that Congress intended to preclude review of the particular
agency action challenged. Amgen, Inc. v. Smith, 357 F.3d 103,

17

111 (D.C. Cir. 2004) (quoting Abbott Lab’ys v. Gardner, 387
U.S. 136, 141 (1967)). Even when Congress “expressly
prohibits judicial review,” we construe that prohibition
“narrowly.” El Paso Nat. Gas Co. v. United States, 632 F.3d
1272, 1276 (D.C. Cir. 2011).
And the presumption is “particularly strong” when a party
contends, as Teva does here, that an agency has acted “in
excess of delegated authority.” Amgen, 357 F.3d at 111. The
reason is practical as well as doctrinal. If agencies could decide
for themselves whether their actions fall within a review bar,
they could enlarge their own authority merely by relabeling
what they had done. See id. at 113. Congress rarely builds
such a one-way ratchet into a statute. Put differently, “the
jurisdiction-stripping provision does not apply” if the agency’s
action fails to qualify as the kind of action for which review is
barred. Sw. Airlines Co. v. TSA, 554 F.3d 1065, 1071 (D.C.
Cir. 2009).
Determining a review bar’s reach requires attention to the
whole statutory setting. “Whether and to what extent a
particular statute precludes judicial review is determined not
only from its express language, but also from the structure of
the statutory scheme, its objectives, its legislative history, and
the nature of the administrative action involved.” ACLA, 931
F.3d at 1204 (quoting Block v. Cmty. Nutrition Inst., 467 U.S.
340, 345 (1984)). Any genuine ambiguity cuts in favor of
judicial review. “[W]hen a statutory provision is reasonably
susceptible to divergent interpretation, we adopt the reading
that accords with” the traditional and basic principle that
“executive determinations generally are subject to judicial
review.” Guerrero-Lasprilla v. Barr, 589 U.S. 221, 229 (2020)
(internal quotation marks omitted). With those rules in hand,
we look to the text of 42 U.S.C. § 1320f-7(2) and the structure

18

of the IRA to determine whether it precludes Teva’s statutory
challenges to CMS’s statutory interpretation.
C.
In determining the meaning of a statutory provision, we
start with “the text of the statute.” Van Buren v. United States,
593 U.S. 374, 381 (2021). In doing so, we give the words “their
ordinary meaning.” Artis v. District of Columbia, 583 U.S. 71,
83 (2018) (quotation marks omitted). And we “give effect, if
possible, to every clause and word of a statute.” Parker
Drilling Mgmt. Servs., Ltd. v. Newton, 587 U.S. 601, 611
(2019) (quotation marks omitted). We read those words “in
their context and with a view to their place in the overall
statutory scheme.” Roberts v. Sea-Land Servs., Inc., 566 U.S.
93, 101 (2012) (quoting Davis v. Mich. Dep’t of Treasury, 489
U.S. 803, 809 (1989)). Accordingly, we construe 42 U.S.C.
§ 1320f-7(2) as precluding review of CMS’s drug-specific
determinations while leaving its interpretation of the relevant
IRA provisions reviewable.
For starters, § 1320f-7(2) provides that “[t]here shall be no
administrative or judicial review of . . . the determination of
qualifying single source drugs under section 1320f-1(e) of this
title,” or “the determination of negotiation-eligible drugs.” 42
U.S.C. § 1320f-7(2). Based on this text, the object of the
review bar, in each instance, is “the determination.” That term
describes a single, discrete act rather than “a group of decisions
or a practice or procedure employed in making decisions.” See
McNary v. Haitian Refugee Ctr., Inc., 498 U.S. 479, 492 (1991)
(similarly construing “a determination” to describe a single act
covered by the review bar while leaving challenges to the
agency’s generally applicable practices and policies
reviewable).

19

Basic grammar supports that understanding. A definite
article paired with a singular noun, as here, ordinarily identifies
a discrete thing—not “an ongoing endeavor.” Niz-Chavez v.
Garland, 593 U.S. 155, 166 (2021); see also Gates & Fox Co.
v. OSHRC, 790 F.2d 154, 156 (D.C. Cir. 1986) (explaining that
“the definite article” suggests that some specific thing is
referred to, rather than merely that thing in general); The
Chicago Manual of Style § 5.75 (18th ed. 2024) (“A definite
article points to a definite object.”).
And the text of subsection (e) provides context. That
subsection provides that “[f]or purposes of this part, the term
‘qualifying single source drug’ means” a drug satisfying
specified criteria. 42 U.S.C. § 1320f-1(e)(1). One of the
criteria requires that the “qualifying single source drug” be a
“covered part D drug (as defined in [42 U.S.C. §] 1395w-
102(e)).” Id. Congress hence supplied the definition of
“qualifying single source drug” and tasked CMS with deciding
whether a particular drug satisfies its definition. Making the
required drug-specific “determination” and interpreting the
IRA are distinct tasks.
CMS cannot collapse those tasks by embedding its
interpretation of the relevant term into each drug evaluation
and then calling the whole package a “determination.” Were
that enough, CMS could shield even an interpretation
exceeding its delegated authority simply by using it to make an
unreviewable decision. Suppose subsection (e) requires that a
qualifying single source drug be approved for at least seven
years, but CMS decides that five will do. Once CMS applies
that interpretation to a five-year-old drug, the Government’s
theory would place its interpretation beyond review because it
now forms part of an unreviewable determination. A neat trick,
but not one Congress authorized. CMS could rewrite the
statute and then shield its rewrite merely by applying it. The

20

review bar would no longer constrain the agency’s discretion;
the agency would control the review bar. Its scope would then
turn on the agency’s label for its own conduct.
To be sure, the Supreme Court in Mullin v. Doe, 146 S. Ct.
2121 (2026) recently explained that “determination” “may be
used as a synonym for ‘decision’” or “may also be used to
describe the chain of events leading up to a decision.” Id. at
2133 (collecting sources). Although it is “common to use the
term ‘determination’ in this broad sense,” context decides
which sense the term bears. See id.; see also Pulsifer v. United
States, 601 U.S. 124, 133 (2024) (explaining that courts must
read “text in context”).
Unlike the one in this case, the review bar in Mullin swept
broadly. The statute barred review of “any determination”
made “with respect to” the designation, extension, or
termination of temporary protected status. 146 S. Ct. at 2136.
The phrase “with respect to” “generally has a broadening
effect, ensuring that the scope of a provision covers not only its
subject but also matters relating to that subject.” Patel v.
Garland, 596 U.S. 328, 339 (2022) (internal quotation marks
omitted) (treating “regarding” and “with respect to” as
synonymous). And in Mullin, the word “determination” was
modified by “any.” Mullin, 146 S. Ct. at 2133. The Supreme
Court has “repeatedly explained” that word “has an expansive
meaning.” Patel, 596 U.S. at 338. Together, those textual
signals brought the entire decisional process within the ambit
of the review bar.
In enacting the IRA, however, Congress barred review not
of “any determination” made “with respect to” the negotiation
program, but of “the determination” specified in each
subsection. See 42 U.S.C. § 1320f-7(2) (emphasis added).
That difference is consequential under Mullin itself. The Court

21

there distinguished McNary because the narrower language in
that case referred to “a single act” and emphasized that the
result “turned on the specific wording of the provision at
issue.” Mullin, 146 S. Ct. at 2134. So too here. The definite
article identifies a particular determination, and the words that
follow identify its object: whether specified drugs qualify
under subsection (e). Here, Congress also did not bar review
of every decision “with respect to” those determinations.
What’s more, Teva’s APA claims also differ from those in
Mullin. There, the respondents challenged how adequately the
Secretary had “consulted the State Department about
conditions in Syria.” Mullin, 146 S. Ct. at 2134. As the Court
understood the claims, they attacked a series of procedural
choices: the Secretary communicated with the State
Department “by email,” sent a “terse and unspecific email,”
and terminated Syria’s temporary protected status designation
after receiving a “laconic answer.” Id. Those objections went
to the Secretary’s exercise of discretion. They concerned “the
quality of the [agency’s] reasoning rather than the scope of its
authority.” Ardelyx, Inc. v. Kennedy, 179 F.4th 947, 963 (D.C.
Cir. 2026) (holding that the court lacked jurisdiction to review
an arbitrary-and-capricious claim when a review bar applied).
Teva, by contrast, challenges CMS’s generally applicable
interpretation of the IRA announced in its Guidance rather than
any particular drug-specific determination. Its claim therefore
concerns the scope of CMS’s statutory authority, not the
quality of the reasoning underlying any such determination.
For those reasons, we reject the Government’s reading of
§ 1320f-7(2).
D.
The Government raises several arguments resisting our
review of CMS’s statutory interpretation, but none are sound.

22

1.
The Government sees things differently. As it explains,
CMS “determines the list of qualifying single source drugs by
applying the statutory definition” of that term. Appellee’s Br.
28. And because “CMS has no discretion over which drugs it
determines are qualifying,” “[d]etermining the drugs” simply
means “generating the list of drugs that meet the definition.”
Id. From that premise, the Government concludes that Teva’s
challenge to CMS’s interpretation is “inextricably intertwined”
with the resulting drug determinations and therefore
unreviewable. But that reasoning moves too quickly. Of
course CMS must interpret the statutory definition before
applying it. It does not follow that the interpretation and the
resulting determination are the same act. As mentioned above,
an agency cannot make its statutory interpretation
unreviewable simply by using it in an unreviewable
determination.
And the Government’s cases do not carry that argument.
Each involved an agency action within a task Congress has
entrusted to the agency. The claims in those cases accordingly
concerned “the quality of the [agency’s] reasoning rather than
the scope of its authority.” Ardelyx, 179 F.4th at 963.
Start with Texas Alliance for Home Care Services v.
Sebelius, 681 F.3d 402 (D.C. Cir. 2012). Congress directed the
Secretary to formulate financial standards for bidders and
barred review of both contract awards and “the bidding
structure.” See id. at 405, 409–11. The standards appeared in
every request for bids, dictated what bidders had to submit, and
determined which bidders were eligible for a contract. See id.
at 410–11. We therefore held that they were “integral to” and
“inextricably intertwined with the bidding structure.” Id. at
411. Here, by contrast, Congress itself defined “qualifying

23

single source drug.” 42 U.S.C. § 1320f-1(e)(1). Teva asks
whether CMS’s rule grouping those drugs fits within the
definition that Congress supplied.
Florida Health Sciences Center, Inc. v. Secretary of
Health & Human Services, 830 F.3d 515 (D.C. Cir. 2016), and
DCH Regional Medical Center v. Azar (DCH), 925 F.3d 503
(D.C. Cir. 2019), fit the same mold. Florida Health concerned
the Secretary’s choice between March and April data in
calculating an estimate that all agreed was unreviewable. See
830 F.3d at 517–18, 521. The claim thus invited “case-by-case
review of the reasonableness or procedural propriety” of that
choice and disclosed no “patent violation” of statutory
authority. Id. at 522 (quoting Amgen, 357 F.3d at 113). DCH,
in turn, challenged the methodology used to produce payment
estimates Congress had expressly shielded from review. See
925 F.3d at 505–07. Because the hospital sought a new
calculation under a different methodology, it was “trying to
undo” an unreviewable estimate. Id. at 508. And the statute
there barred review of “any estimate,” language broad enough
to preclude estimates adopted “across-the board and by rule.”
Id. at 506 (citation modified).
The text of § 1320f-7(2), however, speaks more precisely.
It bars review of “the determination” identified in each listed
subsection. “Any” sweeps across a category; whereas “the”
identifies a particular determination. See supra Section III.C.
These cases therefore leave untouched the question Teva
raises—whether CMS’s governing rules fall within the
authority Congress granted.
ACLA also informs the “inextricably intertwined”
question. See 931 F.3d at 1206–07. There, the challenged data-
collection process supplied the information later used to
establish unreviewable payment amounts. See id. at 1205. We

24

nevertheless held that the data collection and rate setting were
not “inextricably intertwined” because the statute governed
data collection through a separate, cross-referenced provision
outside the review bar. See id. at 1205–08. We therefore
rejected the Government’s argument that Congress could not
have intended to bar review of the “basic math” while
“permitting review of every discretionary step that preceded
that math.” See id. at 1207 (citation omitted).
The same reasoning applies here. Section 1320f-1(e)(1)
defines a qualifying single source drug through
cross-references to the Medicare statute’s definition of a
“covered part D drug,” 42 U.S.C. § 1395w-102(e), and the
Medicaid statute’s definition of a “covered outpatient drug,” id.
§ 1396r-8(k)(2). Section 1320f-7(2) bars review of the
resulting “determination of qualifying single source drugs.”
Teva challenges CMS’s construction of the incorporated
definitions. We may resolve that legal question while leaving
CMS to apply those definitions to particular drugs. The two
agency actions therefore remain distinct, and the usual rule
permitting review of the “practices and policies” governing
individual determinations applies. McNary, 498 U.S. at 492.
All told, CMS’s interpretation and its drug determinations
are connected. Of course they are. One supplies the governing
legal rule, and the other applies that rule to a particular drug.
But connected does not mean “inextricably intertwined.” True,
applying Teva’s reading to the statute may cause CMS to
reconsider its treatment of Austedo and Austedo XR as one
selected drug. Such a result, nevertheless, “is a mere
by-product of th[e] court’s primary function of reviewing [the
agency]’s interpretation of federal law” and “[t]he District
Court’s jurisdiction to award complete relief . . . is not barred
by the possibility.” Bowen v. Massachusetts, 487 U.S. 879, 910
(1988).

25

Given all of those reasons, we reject the Government’s
argument that CMS’s interpretation of qualifying single source
drug is “inextricably intertwined” with its individual
determination under that interpretation.
2.
Moving past our precedent, the Government turns to the
Third Circuit’s. It warns that ruling for Teva would create a
split with Novo Nordisk Inc. v. Secretary United States
Department of Health & Human Services, 154 F.4th 105 (3d
Cir. 2025). But our approach in construing review bars has
long differed from our sister circuit’s.
The Third Circuit follows Bakran, which holds that “when
a statute prohibits review of a particular ‘determination,’ the
bar extends to the ultimate decision and ‘the process by which
[the agency] reaches this decision.’” Novo Nordisk, 154 F.4th
at 111–12 (alteration in original) (quoting Bakran v. Sec’y, U.S.
Dep’t of Homeland Sec., 894 F.3d 557, 563 (3d Cir. 2018)).
Our precedent takes the other path. Castaneira v. Noem
rejected the Government’s reliance on Bakran as “grammatical
gymnastics” and held that Congress may shield an agency’s
ultimate determination without also shielding the standards that
govern it. 138 F.4th 540, 549–50 (D.C. Cir. 2025). Grace v.
Barr reflects the same divide; the majority applied McNary to
permit review of the governing policies, while the dissent
acknowledged that Bakran, among other out-of-circuit cases,
took a different approach. Contrast Grace v. Barr, 965 F.3d
883, 892–93 (D.C. Cir. 2020), with id. at 914–15 (Henderson,
J., dissenting).
The cases differ in another respect. Novo Nordisk
challenged CMS’s treatment of six identified insulin products
as one negotiation-eligible drug. See Novo Nordisk, 154 F.4th
at 109–12. Its claim thus ran straight at a completed, drug-

26

specific determination. Teva’s claims do not. Teva seeks
prospective vacatur of the challenged legal standards
announced in CMS’s Guidance, not an order reversing any
particular drug determination. So our ruling need not conflict
with Novo Nordisk’s result. And to the extent its reasoning
points elsewhere, Castaneira controls ours.
For all those reasons, we hold that the review bar covers
CMS’s drug-specific determinations, but not the generally
applicable legal standards that govern them.
IV.
Having settled the scope of the review bar, we turn to the
merits. Teva contends that CMS misconstrued “qualifying
single source drug” and grafted a “bona fide” marketing
requirement onto the statute. It also contends that the
Negotiation Program violates the Due Process Clause. We
address each of Teva’s arguments in turn.
A.
Teva’s first challenge concerns the statutory unit that
counts as a “qualifying single source drug.” Its argument
begins with the IRA’s definition, which requires such a drug to
be a “covered part D drug” under the Medicare statute. 42
U.S.C. § 1320f-1(e)(1). The Medicare statute then directs the
reader to the Medicaid Drug Rebate Program, defining a
“covered part D drug” as “a drug that may be dispensed only
upon a prescription” and qualifies as a “covered outpatient
drug” under that program. Id. § 1395w-102(e)(1). Medicaid
continues the chain by defining a “covered outpatient drug” as
“a drug which may be dispensed only upon a prescription” and
“which is approved for safety and effectiveness as a
prescription drug under [21 U.S.C. § 355] of the Federal Food,
Drug, and Cosmetic Act.” Id. § 1396r-8(k)(2). Section 355, in

27

turn, governs FDA approval of NDAs for prescription drugs.
21 U.S.C. § 355.
Teva draws a one-to-one relationship between a drug and
its NDA from this chain of cross-references. In its view, “two
drugs, approved under two NDAs, cannot be one qualifying
single source drug.” Appellant’s Br. 20. CMS takes a broader
view. Its Guidance instructs the agency to “identify a potential
qualifying single source drug using . . . all dosage forms and
strengths of the drug with the same active moiety and the same
holder of a New Drug Application (NDA), inclusive of
products that are marketed pursuant to different NDAs.” 2026
Guidance § 30.1, at 99; 2027 Guidance § 30.1, at 167. Teva
contends that this approach conflicts with the statutory
definition and asks us to vacate it.
Several IRA provisions undercut Teva’s NDA-specific
theory. In negotiating a maximum fair price, CMS must
consider the “applications and approvals under section 355(c)
of title 21 or section 262(a) of this title for the drug.” 42 U.S.C.
§ 1320f-3(e)(1)(D). The terms “applications” and “approvals”
are plural; and the term “the drug” is singular. The negotiation
provision then recognizes that a single “drug” can have
multiple corresponding “approvals” and “applications.” Id.
Teva responds that the plural terms refer to an original NDA
and later supplements. But Congress referred generally to
applications and approvals under § 355(c), not to “an
application and its supplements.” Separate NDAs are
applications under § 355(c) too.
The surrounding provisions make the point clearer. When
calculating a drug’s Medicare expenditures, CMS must
aggregate data “across dosage forms and strengths of the drug,
including new formulations of the drug, such as an extended
release formulation,” without relying on “the specific

28

formulation or package size or package type.” 42 U.S.C.
§ 1320f-1(d)(3)(B). Congress likewise directed CMS to apply
the negotiated price across a selected drug’s “different
strengths and dosage forms.” Id. § 1320f-5(a)(2).
Teva notes that the aggregation provision operates after
CMS identifies a qualifying single source drug. Even so, we
do not read § 1320f-1(e) in isolation. Cf. United States v.
Morton, 467 U.S. 822, 828 (1984) (“We do not . . . construe
statutory phrases in isolation; we read statutes as a whole.”).
Subsection (e) supplies the conditions for qualification, while
§ 1320f-1(d)(3)(B) tells CMS what formulations belong to the
drug whose expenditures it must calculate. Nothing in either
provision draws a line at the edge of an NDA, especially after
reading that “text in context,” Pulsifer, 601 U.S. at 133.
Teva’s interpretation also sits uneasily with the statute’s
treatment of new formulations. If CMS could consider only
one NDA, Congress’s instruction to account for Austedo’s
extended-release version—or any other “new formulations of
the drug”—would add little to the expenditure calculation. 42
U.S.C. § 1320f-1(d)(3)(B) (requiring CMS to include
expenditures for new formulations). A supplement to a
§ 355(b)(2) application, after all, cannot seek approval of a
different drug from the one covered by the original NDA. See
21 U.S.C. § 355(b)(4)(A) (limiting supplemental applications
to changes involving the same drug). So on Teva’s view, any
formulation approved through a supplement would already fall
within the NDA-defined drug. CMS could simply identify that
drug by its NDA and total the expenditures associated with it.
See 42 U.S.C. § 1320f-1(d)(1) (directing CMS to rank drugs by
total expenditures); id. § 1320f-1(e)(1) (defining a qualifying
single source drug). But Congress went further. It told CMS
to aggregate expenditures across dosage forms, strengths, and
“new formulations of the drug,” rather than calculate them by

29

“specific formulation.” Id. § 1320f-1(d)(3)(B). That
instruction makes more sense if a single statutory drug may
include formulations approved under different NDAs.
Applying Teva’s one-NDA, one-drug rule would therefore
create substantial tension with the IRA’s treatment of new
formulations.
Teva’s reliance on the IRA’s seven-year requirement rests
on the same disputed premise. A qualifying single source drug
must have been approved for at least seven years. See id.
§ 1320f-1(e)(1)(A)(ii). Some of the NDAs that CMS groups
together, including the NDA for Austedo XR, are less than
seven years old. Teva reasons that CMS therefore cannot
group those products with an older qualifying single source
drug. But that conclusion depends on treating each NDA as a
separate statutory “drug,” which is the very premise under
dispute. The seven-year requirement measures the age of the
drug once it has been identified. Whether that drug may
encompass formulations approved under several NDAs comes
first. Teva’s argument therefore assumes its answer.
CMS’s active-moiety and same NDA-holder requirements
also align with our reading of the statute. Certainly, the IRA
does not use the phrase “active moiety,” and CMS may not
“rewrite a statute just to serve a perceived statutory ‘spirit.’”
Landstar Express Am., Inc. v. FMC, 569 F.3d 493, 500 (D.C.
Cir. 2009). But CMS uses “active moiety” as a marker for the
pharmacologically active substance that remains constant
across changes in strength, dosage form, or release mechanism.
That term also comports with the ordinary meaning of “drug.”
See Drug, Black’s Law Dictionary (12th ed. 2024) (“A
substance intended for use in diagnosis, cure, treatment, or
prevention of disease.”); Drug, Merriam-Webster’s Collegiate
Dictionary (12th ed. 2025) (“[A] substance used as a
medication or in the preparation of medication”). Patients take

30

drugs, not NDAs, after all. We have also recognized that active
moiety “has long played a key role” in determining when a drug
is new and when it instead uses “an approved moiety in a new
way.” Otsuka Pharm. Co. v. Price, 869 F.3d 987, 989–90
(D.C. Cir. 2017). And limiting the group to one NDA holder
accords with the IRA’s repeated direction that CMS negotiate
with “the manufacturer” of the selected drug. See 42 U.S.C.
§§ 1320f(c)(1), 1320f-2(a)(1), (4)(A).
Teva next enlists the canon against surplusage to challenge
the Government’s definition of “qualifying single source
drug.” But where Teva sees surplusage, the IRA offers
continuity. Teva takes the position that if a “qualifying single
source drug” already includes all “dosage forms and strengths,”
Congress had no reason to direct CMS to aggregate those same
dosage forms and strengths when identifying
negotiation-eligible drugs, 42 U.S.C. § 1320f-1(d)(3)(B), or to
apply the negotiated price “across different strengths and
dosage forms of a selected drug,” id. § 1320f-5(a)(2).
Appellant’s Br. 33 (quotation marks omitted). Those
provisions, however, govern different decisions made at
different points in the Negotiation Program. Section 1320f-
1(d)(3)(B) governs selection. Section 1320f-3(e)(1)(D)
governs the negotiation offer. And § 1320f-5(a)(2) governs
how the final negotiated price applies. Congress thus carried
the same aggregation principle through each stage of the
process. Teva offers no persuasive account of how its
one-NDA, one-drug rule fits those repeated statutory
directives.
Lastly, Teva leans on United States v. Generix Drug Corp.,
460 U.S. 453 (1983) for support, but that case does not help its
cause. There, interpreting a statute concerned with safety and
effectiveness, the Court held that a “drug” could encompass the
finished product, including its active and inactive ingredients.

31

See id. at 459–61. But the Court expressly left open whether
products containing the same active ingredients could “under
some circumstances be the same drug.” See id. at 461 (internal
quotation marks omitted). Generix therefore does not make the
NDA’s application number dispositive under the IRA.
We therefore reject Teva’s first statutory challenge and
decline to vacate CMS’s definition of a qualifying single
source drug.
B.
Teva next challenges CMS’s requirement that a generic
drug be marketed on a “bona fide” basis. Those words, Teva
says, are CMS’s, not Congress’s. Not reaching the merits of
this issue, the district court held the claim prudentially unripe
because Teva had not shown that the FDA had approved the
relevant generics—a prerequisite, in the district court’s view,
to any CMS determination that a generic is “marketed” and the
corresponding brand-name drug should be removed from the
Negotiation Program. See Teva Pharms. USA, Inc. v. Kennedy,
No. 25-113, 2025 WL 3240267, at *13–14 (D.D.C. Nov. 20,
2025). We disagree.
1.
Teva begins with forfeiture. The Government does not
defend the district court’s sua sponte ripeness ruling. And
Teva says the Government forfeited the issue through its
silence. It points to Stolt-Nielsen S.A. v. AnimalFeeds
International Corp., where the Supreme Court treated a
prudential-ripeness argument as “waived.” 559 U.S. 662, 670
n.2 (2010) (citation omitted).
Even assuming that the Government forfeited the
argument, that answers only what the Government may press,

32

not what we may consider. The Supreme Court has expressly
instructed that, even when ripeness presents “only prudential
concerns,” a court may consider the issue on its “own motion.”
Nat’l Park Hosp. Ass’n v. Dep’t of Interior, 538 U.S. 803, 808
(2003). A party’s forfeiture and a court’s jurisdiction pose
different questions. Whatever argument the Government may
have abandoned, we remain free to ask whether Teva’s claim
is ripe. So we do.
2.
Prudential ripeness turns on “the fitness of the issues for
judicial decision and the hardship to the parties of withholding
court consideration.” Crowley Gov’t Servs., Inc. v. GSA, 143
F.4th 518, 531 n.6 (D.C. Cir. 2025) (internal quotation marks
omitted). Teva satisfies both factors.
A claim is fit for review when it presents a purely legal
question, requires no further factual development, and
challenges sufficiently final agency action. See Energy Future
Coal. v. EPA, 793 F.3d 141, 146 (D.C. Cir. 2015) (Kavanaugh,
J.). Teva’s claim checks each box.
First, Teva’s claim presents a pure question of law. Teva
contends that CMS exceeded its statutory authority by adding
a “bona fide” marketing requirement that the IRA does not
contain. Whether CMS exceeded its statutory authority by
imposing that requirement presents a “question of law, and
only a question of law.” Marshall Cnty. Health Care Auth. v.
Shalala, 988 F.2d 1221, 1226 (D.C. Cir. 1993).
Second, no further factual development would aid that
inquiry. The parties represented as much in the district court.
We do not consider whether some particular generic will
eventually satisfy CMS’s standard but whether CMS may
lawfully impose that standard at all. The district court itself

33

recognized that Teva brings “a facial challenge to set aside
CMS’s guidance.” J.A. 180. We have “often observed” that a
purely legal claim challenging an agency rule in this manner is
presumptively fit for review. Nat’l Ass’n of Home Builders v.
U.S. Army Corps of Eng’rs, 417 F.3d 1272, 1282 (D.C. Cir.
2005) (internal quotation marks omitted).
Third, the Guidance is final agency action. When an
agency announces that a policy “governs and will continue to
govern its decisions,” the policy is final enough for ripeness
purposes. Better Gov’t Ass’n v. Dep’t of State, 780 F.2d 86, 93
(D.C. Cir. 1986) (emphasis omitted). CMS has published the
standard it intends to apply when deciding whether a generic is
marketed and whether the corresponding brand-name drug
should remain in the Negotiation Program. And when a suit
presents the purely legal question whether final agency action
violates a statute, “it is unnecessary to wait for [the agency’s]
legal conclusion to be applied in order to determine its
legality.” Energy Future Coal., 793 F.3d at 146 (citation and
internal quotation marks omitted). That settles fitness.
However, because the district court rested its contrary
conclusion on several factual premises, we address those too.
The district court believed that FDA had not approved Teva’s
relevant generics. Yet in the district court, Teva’s declarant
stated under oath that “FDA has approved” Teva’s generic
Xtandi capsules. J.A. 155. On appeal, Teva also identifies its
other generics that have received final or tentative approval.
The district court also believed the 2027 Guidance would
not apply to Teva’s generics. But those generics correspond to
innovator drugs selected for the 2027 initial price applicability
year. The 2027 Guidance therefore governs whether those
drugs will later be deselected. See 2027 Guidance at 131, 279.
Nor did the record leave launch dates to speculation. Teva’s

34

declarant explained that its generic Xtandi capsule is expected
to launch shortly before August 13, 2027. And for Ofev, the
record identifies no meaningful barrier to entry arising from the
single, limited extension of exclusivity.
That leaves hardship. Precedent requires us to consider it,
even when the dispute is purely legal. See Sidak v. U.S. Int’l
Trade Comm’n, 174 F.4th 151, 157 & n.5 (D.C. Cir. 2026). But
once fitness is established, a litigant need not demonstrate
individualized hardship unless some “institutional interests”
favor postponing review. Id. at 157 (quoting Sabre, Inc. v.
Dep’t of Transp., 429 F.3d 1113, 1120 (D.C. Cir. 2005)).
No such interest appears here. CMS is not reconsidering
its interpretation and no unfinished agency proceeding
promises to sharpen the interpretative question. Meanwhile,
Teva must plan its generic launches under a standard that CMS
says already governs whether the corresponding innovator
drugs will remain in the Negotiation Program.
Teva’s challenge to CMS’s “bona fide” marketing
requirement is therefore ripe. We do not, however, decide its
merits. The district court never addressed whether CMS’s
standard comports with the IRA, and we leave that question for
it to consider in the first instance. We are, after all, “a court of
review, not of first view.” Capitol Servs. Mgmt., Inc. v. Vesta
Corp., 933 F.3d 784, 789 (D.C. Cir. 2019) (internal quotation
marks omitted). We therefore reverse the district court’s
judgment as to this claim and remand for further proceedings.
C.
Turning next to whether the Negotiation Program violates
the Fifth Amendment’s Due Process Clause, we conclude that
it does not.

35

1.
Before delving into the merits of this issue, we address one
more jurisdictional question: Does 42 U.S.C. § 1320f-7(2)
preclude Teva’s constitutional claim? The Government is
silent on the issue. Still, we have an independent obligation to
decide it. See Stabil LLC v. Russian Fed’n, 167 F.4th 506, 525
(D.C. Cir. 2026) (explaining that arguments against subject
matter jurisdiction cannot be forfeited or waived). We
therefore address that issue briefly.
We begin with a settled rule. “[W]here Congress intends
to preclude judicial review of constitutional claims its intent to
do so must be clear.” Webster v. Doe, 486 U.S. 592, 603
(1988). The reason for demanding clarity is not hard to see.
Reading a statute to deny every judicial forum for a colorable
constitutional claim would itself raise a “serious constitutional
question.” Id. (internal quotation marks omitted). So we
require a “heightened showing,” id., and find constitutional
claims precluded “only if the evidence of congressional intent
to preclude is ‘clear and convincing,’” McBryde v. Comm. to
Rev. Cir. Council Conduct & Disability Orders of the Jud.
Conf. of the U.S., 264 F.3d 52, 59 (D.C. Cir. 2001) (collecting
cases).
Consider our recent decision in Doe v. Blanche, 172 F.4th
901 (D.C. Cir. 2026). The statute there provided that,
“[n]otwithstanding any other provision of law, a designation of
a place of imprisonment under this subsection is not reviewable
by any court.” Id. at 912 (quoting 18 U.S.C. § 3621(b)). We
held that categorical language alone could not foreclose
constitutional review. Even “broad and seemingly
comprehensive statutory language” did not by itself “supply[]
the necessary clarity to bar as applied constitutional claims.”
Id. (alteration in original) (quoting McBryde, 264 F.3d at 59).

36

We required some further indication that Congress meant to
reach constitutional claims. Finding none, we proceeded to the
Eighth Amendment claim. Id. at 912–13.
Now compare the IRA. Section 1320f-7(2) does not
mention anything about constitutional claims. Nor does the
Government identify anything else in the statute showing that
Congress meant to foreclose them. So if the broader language
in Doe could not alone satisfy McBryde, the language before
us cannot do so without some further evidence of preclusive
intent. None appears.
Garland v. Aleman Gonzalez, 596 U.S. 543 (2022) colors
that understanding. The Supreme Court there rejected a
reading of 8 U.S.C. § 1252(f)(1) that would have left the
provision operating mainly against constitutional claims. See
id. at 553–54. That result struck the Court as “most unusual.”
Id. at 554. If Congress had wished to “target just constitutional
claims,” the Court reasoned, it “could have surely made the
point more directly.” Id. Congress made no such point in
§ 1320f-7(2).
We therefore hold that we have jurisdiction to consider
Teva’s due process claim.
2.
Teva argues that the IRA’s “price-control program impairs
Teva’s protected interests in both its generics licenses and
innovator products without providing the constitutional
protections” it is due. Appellant’s Br. 49. We reject that claim
because Teva identifies no protected property interest.
The Due Process Clause protects against the deprivation
“of life, liberty, or property, without due process of law.” U.S.
Const. amend. V. To state a claim for government deprivation

37

of property without due process of law, a plaintiff must possess
a protected interest that triggers the Fifth Amendment’s due
process protections. See Am. Mfrs. Mut. Ins. Co. v. Sullivan,
526 U.S. 40, 59 (1999). It is well established that a property
interest arises from an independent source, such as state or
federal law. See Bd. of Regents v. Roth, 408 U.S. 564, 577
(1972). One “clearly must have more than an abstract need or
desire for it” and “more than a unilateral expectation of it.” Id.
“When a person has voluntarily relinquished [a] claim to
property,” the concerns served by procedural due process
“disappear.” United States v. 8 Gilcrease Lane, Quincy, Fla.
32351, 638 F.3d 297, 300 (D.C. Cir. 2011). Without a
protected property or liberty interest, “one has no entitlement
to procedural due process.” Sargeant v. Dixon, 130 F.3d 1067,
1070 (D.C. Cir. 1997); see also Muwekma Ohlone Tribe v.
Salazar, 708 F.3d 209, 219 (D.C. Cir. 2013) (characterizing 8
Gilcrease Lane as holding that an individual “no longer
possesses [a] due process right to challenge seizure of property
that is voluntarily forfeited” (internal quotation marks
omitted)).
In light of those principles, Teva invokes three sources of
law for its protected property interest: (a) course of dealing; (b)
common law; and (c) patents. Yet none supplied Teva with the
protected property interest it needed to prevail on this claim.
a.
Teva first invokes its course of dealing with Medicare. It
argues that the Negotiation Program interferes with its existing
contracts to sell generic drugs and thus impairs a protected
property interest. But those contracts do not obligate the
Government to keep reimbursing drug purchases on the same
terms.

38

“Congress has broad power under the Spending Clause of
the Constitution to set the terms on which it disburses federal
funds.” Cummings v. Premier Rehab Keller, PLLC, 596 U.S.
212, 216 (2022). The Government may therefore “determine
those with whom it will deal” and “fix the terms and
conditions” of its purchases. Perkins v. Lukens Steel Co., 310
U.S. 113, 127 (1940). Put simply, no one “has a ‘right’ to sell
to the government that which the government does not wish to
buy.” Coyne-Delany Co. v. Cap. Dev. Bd. of State of Ill., 616
F.2d 341, 342 (7th Cir. 1980) (per curiam).
The Second and Third Circuits have applied that rule to the
Negotiation Program. The Third Circuit held that a
manufacturer has “no protected property interest” in selling
drugs at a price above what Medicare will pay when
reimbursing the purchase. AstraZeneca Pharms. LP v. Sec’y
U.S. Dep’t of Health & Hum. Servs., 137 F.4th 116, 125–26 (3d
Cir. 2025). The Second Circuit likewise held that a
manufacturer’s voluntary participation in the Program creates
no protected property interest in its preferred reimbursement
terms. See Boehringer Ingelheim Pharms., Inc. v. U.S. Dep’t
of Health & Hum. Servs., 150 F.4th 76, 94 (2d Cir. 2025).
Teva’s prior dealings with Medicare do not change the
analysis. A protected property interest requires a legitimate
“claim of entitlement” to continued benefits, not merely an
expectation built on past practice. See Roth, 408 U.S. at 577.
Medicare’s past reimbursement of Teva’s customers, including
Part D sponsors, did not promise reimbursement forever or
freeze the governing terms in place. Past business is not an
entitlement to future business. Teva’s course of dealing
therefore creates no protected property interest.

39

b.
Teva turns next to the common law. The Negotiation
Program, it says, “impairs” its “‘treasured’ common-law right
to sell its products at market prices free from arbitrary and
undisclosed governmental constraints.” Appellant’s Br. 50
(citing Cedar Point Nursery v. Hassid, 594 U.S. 139, 149
(2021); Old Dearborn Distrib. Co. v. Seagram-Distillers
Corp., 299 U.S. 183, 192 (1936)). That argument fares no
better than the last.
Start with Cedar Point Nursery. That case involved a state
regulation requiring agricultural employers to admit union
organizers onto their property for up to three hours a day, 120
days a year. 594 U.S. at 149. The Court treated the regulation
as a physical taking because it invaded “the right to exclude,”
a right of “central importance to property ownership.” Id. at
149–50. This case involves no invasion, occupation, or right
to exclude. And Cedar Point Nursery says nothing about a
manufacturer’s asserted right to name its price while accepting
federal reimbursement.
The difference runs deeper still. Cedar Point Nursery
involved regulation imposed by law. Spending Clause
programs rest on a bargain. “Unlike ordinary legislation,
which imposes congressional policy on regulated parties
involuntarily, Spending Clause legislation operates based on
consent: in return for federal funds, the recipients agree to
comply with federally imposed conditions.” Cummings, 596
U.S. at 219 (citation modified). The Negotiation Program does
not seize Teva’s drugs or force Teva to sell them because it
only offers federal reimbursement on negotiated terms. Teva
may accept federal funds and their conditions, or it may decline
both.

40

Old Dearborn comes closer in vocabulary but not in
governing law. There, the Court described “the right of the
owner of property to fix the price at which he will sell” in the
broader marketplace. Old Dearborn, 299 U.S. at 192. That
principle is not implicated here because “the Negotiation
Program only sets prices for drugs that [the Government] pays
for when it reimburses sponsors.” AstraZeneca, 137 F.4th at
126 (emphasis omitted).
Teva’s argument also overlooks the voluntary character of
Medicare participation. Because “participation in the Medicare
[and Medicaid spending] program[s] is wholly voluntary,”
“any obligations” imposed by the Negotiation Program “are as
freely accepted as the benefits.” Baptist Hosp. E. v. Sec’y of
Health & Hum. Servs., 802 F.2d 860, 869–70 (6th Cir. 1986).
To be sure, the Government’s size may make the choice an
economically weighty one, but size is not compulsion.
“Economic factors may have a strong influence on a
company’s choice to do business with the government, but a
company that chooses to do so still acts voluntarily.” Bristol
Myers Squibb Co. v. Sec’y U.S. Dep’t of Health & Hum. Servs.,
155 F.4th 245, 257 (3d Cir. 2025). And because that choice
remains voluntary, “participation in the federal Medicare
reimbursement program is not a property interest” protected by
the Due Process Clause. Shah v. Azar, 920 F.3d 987, 998 (5th
Cir. 2019).
Teva responds that the “Program controls the price at
which [it] may sell to Medicare-eligible individuals, providers,
and dispensers in completely private transactions.”
Appellant’s Br. 55. It offers a more vivid version of the same
point: “[W]hen your grandmother buys AUSTEDO XR, she is
the purchaser; she does not act as an ‘agent’ or ‘private
intermediar[y] of the federal government.’” Id.

41

One’s grandmother may stand at the pharmacy counter.
But when Medicare Part B or D helps pay the bill, the federal
government is no stranger to the sale. The Negotiation
Program also does not regulate every sale of Teva’s drugs
because it governs only those transactions funded through
Medicare. And “[t]hese are not private market transactions,
regardless of the private hands through which CMS’s funds
pass.” AstraZeneca, 137 F.4th at 126.
Teva’s argument concerning retroactive conditions falls
flat. The Negotiation Program is prospective because it does
not reopen completed transactions, recoup prior
reimbursements, or attach new consequences to past sales. It
sets the terms governing future Medicare-funded purchases.
Teva remains free to withdraw from the program rather than
accept those terms.
Neither National Federation of Independent Business v.
Sebelius, 567 U.S. 519 (2012), nor Bowles v. Willingham, 321
U.S. 503 (1944), rescues Teva’s argument. NFIB concerned
Congress’s effort to condition a state’s existing Medicaid
funding on its acceptance of a substantial program expansion.
See 567 U.S. at 575–85. The Court’s analysis rested on
federalism. Limiting Congress’s spending power was “critical
to ensuring that Spending Clause legislation does not
undermine the status of the States as independent sovereigns.”
Id. at 577. And the threatened loss of more than ten percent of
a state’s budget amounted to “economic dragooning that le[ft]
the States with no real option but to acquiesce.” Id. at 582.
Those concerns do not carry over to private businesses. That
is because the “Tenth Amendment concerns are simply not
present . . . where the federal government contracts with
private parties, rather than dealing with separate sovereigns.”
Bristol Myers Squibb, 155 F.4th at 259–60. Teva is a
corporation, not a sovereign. The Negotiation Program

42

therefore requires Teva to make a business choice, not to
govern.
Bowles is farther afield still. There, the Court upheld
wartime rent controls, observing that “there would be no
constitutional objection if Congress as a war emergency
measure had itself fixed the maximum rents.” 321 U.S. at 517.
Congress was responding to “conditions created by activities
resulting from a great war effort” and regulating prices
throughout the private housing market. Id. at 519. The
Negotiation Program instead sets the terms on which Medicare
funds drug purchases. For “the purpose of keeping its own
house in order,” the Government may “lay down guide posts
by which its agents are to proceed in the procurement of
supplies.” Perkins, 310 U.S. at 127. A statute doing “no more
than instruct its agents who were selected and granted final
authority to fix the terms and conditions under which the
Government will permit goods to be sold to it” is not “an
exercise by Congress of regulatory power over private
business.” Id. at 128–29.
So too here. The Negotiation Program sets the terms on
which Medicare funds may purchase selected drugs. Teva may
reject those terms and forgo the funds. What it may not do is
accept federal reimbursement while insisting on a price of its
own choosing. And unlike in Bowles, the Government here
“act[s] as [a] proprietor,” not a regulator, which invokes “a
crucial difference, with respect to constitutional analysis.”
Engquist v. Or. Dep’t of Agric., 553 U.S. 591, 598 (2008).
Given the distinct constitutional underpinnings present in NFIB
and Bowles, neither case supports Teva’s argument. In short,
Teva “suffers no deprivation of its property interests by
voluntarily submitting to a price-regulated government
program.” Boehringer, 150 F.4th at 94.

43

c.
Teva’s patent argument runs into a more basic problem. A
patent grants its holder “the right to exclude others from
making, using, offering for sale, or selling” the patented
invention. 35 U.S.C. § 154(a)(1). But, as the Federal Circuit
has explained, “federal patent laws do not create any
affirmative right to make, use, or sell anything.” Biotechnology
Indus. Org. v. District of Columbia, 496 F.3d 1362, 1372 (Fed.
Cir. 2007) (quotation marks omitted).
The Negotiation Program leaves Teva’s right to exclude
untouched. It neither cancels Teva’s patents nor licenses others
to use them. Instead, it sets the price available when Medicare
pays for Teva’s drugs. And “where federal patent laws do not
confer a right to sell at all, they do not confer a right to sell at a
particular price.” AstraZeneca, 137 F.4th at 125. Because
Teva identifies no patent right that the Negotiation Program
impairs, its patents cannot support a due process claim. See id.
Therefore, we hold that the Negotiation Program does not
violate the Fifth Amendment’s Due Process Clause.
* * * * *
For the foregoing reasons, we affirm in part and reverse in
part the district court’s grant of summary judgment and remand
Teva’s challenge to CMS’s “bona fide” marketing requirement
for the district court to consider in the first instance.
So ordered.