Teva Pharmaceuticals USA, Inc. v. Robert F. Kennedy, Jr.

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.  2 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.  3 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  4 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  5 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).  6 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  7 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  8 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,  9 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.  10 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  11 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.  12 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.  13 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.  14 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.  15 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