Whether the Medicare Drug Price Negotiation Program's compulsory participation and price-setting mechanism constitutes an unconstitutional taking or compelled speech in violation of the Fifth and First Amendments

No question identified. : “maximum fair price” for a defined set of prescription drugs and requires manufacturers to provide “access” to the drugs at that price. See 42 U.S.C. §§ 1320f— 1320f-4. But Congress knew that top-down government price setting was politically unpopular and thus characterized the Program as involving negotiations between CMS and manufacturers. Under the Program, a manufacturer must not only grant Medicare beneficiaries access to a covered drug on CMS’s terms, but also sign documents attesting that it “negotiate[d]” and “agree[s]” to the “maximum fair price” prescribed by CMS. 42 U.S.C. § 1320f-2(a). Failure to sign these “agreements” subjects the manufacturer to a 1900% excise tax penalty (amounting to billions of dollars per year in Boehringer’s case); failure to provide access to the drug according to the “agreements” results in millions of dollars in additional penalties per day. See 26 U.S.C. § 5000D; 42 U.S.C. § 1320f-6(a); Marsh Decl. § 16, Boehringer Ingelheim Pharm, Inc. v. HHS, No. 24-2092, ECF 47, at 89 (2d Cir. Nov. 4, 2024). A manufacturer cannot avoid the Program or its penalties unless it withdraws all its drugs (not just the selected drug) from both Medicare and Medicaid, which collectively make up nearly half the U.S. drug market. In short, Congress created a program designed to compel one outcome: compliance. As Judge Hardiman recently observed in a related case, Congress had several constitutionally permissible options at its disposal to reduce Medicare spending on prescription drugs. “Instead of” exercising those options, however, Congress “made [manufacturers] an offer they couldn’t refuse,” thus “compel[ling] manufacturers to subject themselves to prices set by CMS” and “misrepresent that they agreed to such prices.” Bristol Myers Squibb Co. v. Sec’y of HHS, 2025 WL 2537005, *25, *33 (3d Cir. Sept. 4, 2025) (dissenting opinion, cleaned up) (“BMS”). 2. Boehringer’s Jardiance® was among the first group of drugs selected for the Program. App. 21a. Jardiance® is widely prescribed to reduce the risk of cardiovascular death, lower blood sugar in adults with type 2 diabetes, and prevent chronic kidney disease from worsening. It is one of many innovative lifesaving and life-improving treatments that Boehringer and its affiliates have spent years of effort and billions of dollars to develop, benefitting millions of patients worldwide. When CMS selected Jardiance® for the Program, Boehringer had no choice but to comply: the excise tax liability for failing to participate in the Program would have been hundreds of millions of dollars per week initially, quickly increasing to billions per week; and withdrawing Boehringer’s entire portfolio (more than 20 drugs) from Medicare and Medicaid would have eliminated more than half the company’s net domestic sales, depriving Boehringer of the ability to continue developing innovative medicines. See Marsh Decl., supra, {{ 7, 17-19. Boehringer thus made the only viable choice and signed (under protest) an agreement drafted by CMS, purportedly expressing Boehringer’s assent to participate in “negotiation[s]” with the agency. Id. 4] 11-14; App. 21a. Once that “negotiation” process was complete, Boehringer signed (again, under protest) an addendum drafted by CMS expressing “agreement” that the price set by CMS—a 66% reduction below market value!—was the “maximum fair 1 See CMS, Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026 (Aug. 15, 2024), see also 42 U.S.C. § 1320f-2. price” for Jardiance®. App. 22a. Boehringer’s obligation to provide “access” to Jardiance® on those terms begins on January 1, 2026, and will remain in effect until the drug is subject to generic competition. See 42 U.S.C. §§ 1320f(b)(1), 1320f-2(b). 3. In parallel, Boehringer sought redress from the courts, alleging, among other things, that the Program—whether directly or as an unconstitutional condition on Medicare and Medicaid parti