Memorandum Opinion Granting the 30 Motion to Dismiss, and Denying as Moot Plaintiffs' 27 Emergency Motion for a Preliminary Injunction, Motion to Stay. See Attached Opinion for Details. Signed by Judge Trevor N. McFadden on 5/22/2026. (lctnm1)

MARIJUANA, et al.,

Plaintiffs, v.

ROBERT F. KENNEDY, JR., Secretary of Health and Human Services, et al.,

Defendants. Case No. 1:26-cv-1081 (TNM) MEMORANDUM OPINION

In a founding era exchange about agricultural affairs, Gouverneur Morris commented to Thomas Jefferson that hemp “is of Necessity to the Commerce and Marine in other Words to the Wealth and Protection of the Country.” Enclosure: Notes respecting Tobacco (March 16, 1791), in 19 Papers of Thomas Jefferson 576–578 (Boyd ed. 1974). Though the cannabidiol product known as “hemp” no longer forms part of the backbone of American commerce, its role in American medicine has grown large enough to prompt regulatory action.

This case concerns recent developments on that front. In April 2026, the Center for Medicare and Medicaid Innovation (“CMMI”) implemented a new, optional pathway for qualifying Medicare providers to furnish qualifying beneficiaries with hemp. That decision drove many challengers—spanning from patients and providers to several organizations to pharmaceutical companies—to this Court. They seek a preliminary injunction to put the new pathway on hold. In support, Plaintiffs mount a series of claims under the Administrative Procedure Act (“APA”) and the Constitution, arguing that the pathway conflicts with federal law and that CMMI failed to follow required procedures in creating it.

But the Court need not address those question to resolve this dispute. Plaintiffs, though numerous, have not established standing to bring this case. Each claims an injury too abstract or too remote to open the courtroom doors. The Court will thus grant Defendants’ motion to dismiss and deny Plaintiffs’ motion for a preliminary injunction as moot.

I.

For more than a decade, the federal government has been in the business of testing new ways to serve Medicare beneficiaries. It began that effort in 2010 when Congress, through § 1115A of the Social Security Act, established CMMI within the Centers for Medicare & Medicaid Services (“CMS”). See 42 U.S.C. § 1315a. As § 1115A instructs, CMMI tests “innovative payment and service delivery models” that aim to “reduce program expenditures . . . while preserving or enhancing the quality of care” for Medicare and Medicaid beneficiaries. See id.

In creating CMMI, Congress delegated authority to the Secretary of Health and Human Services (“HHS”) to design and implement these payment models. See id. The Secretary may select models, determine their elements and parameters, set their scope and duration, and choose their participants. Id. § 1315a(b). CMMI has tested numerous payment models since its creation. Fishman Decl. ¶ 5, ECF No. 30-2. Many models or components of them—like those at issue—are voluntary. Id. Eligible healthcare providers can choose to opt into them by signing a participation agreement with CMS. Id.; Am. Compl. ¶ 81, ECF No. 25. These participation agreements define model requirements including quality benchmarks, spending targets, reporting obligations, beneficiary engagement incentives, payment methodologies, and other conditions. Fishman Decl. ¶ 5; see Am. Compl. ¶ 83. Over its sixteen-year existence, CMMI has never conducted a notice-and-comment rulemaking for a voluntary model component. Fishman Decl. ¶ 5; see Hr’g Tr. at 13:23–14:25.

In March 2026, CMS announced a new voluntary model component to participants in three existing CMMI models. This component, called the Substance Access Beneficiary Engagement Incentive (“BEI”) allows providers who opt in to consult with eligible patients about the possible use of certain hemp products to address their health needs. Am. Compl. ¶ 83; Fishman Decl. ¶ 8. If appropriate, those healthcare providers may furnish beneficiaries with up to $500 of hemp products annually. Am. Compl. ¶ 83.

A law unrelated to CMMI model mechanics lets the agency treat hemp this way. Hemp, after all, is a marijuana derivative. And marijuana is a Schedule I substance that is generally illegal under federal law. 21 U.S.C. § 812(c)(10).1 But the Agriculture Improvement Act of 2018 (“2018 Farm Bill”) drew a statutory line between hemp and marijuana. Congress defined “hemp” as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,” with “a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” 7 U.S.C. § 1639o(1). At the same time, it amended the Controlled Substances Act to exclude hemp from the definition of “marihuana.” See Agriculture Improvement Act of 2018, Pub. L. No. 115-334, § 12619, 132 Stat. 4490, 5018. Put together, these features mean that hemp is not a 1 Recent initiatives have carved out exceptions to marijuana’s Schedule I status. See Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana From Schedule I to Schedule III, 81 Fed. Reg. 22714 (April 28, 2026) (to be codified at 21 C.F.R. pts. 1300, 1301, 1308, and 1312) (placing certain FDA-approved products containing marijuana in Schedule III). While marijuana otherwise remains a Schedule I substance, initiatives to more broadly reschedule it are under way. See Schedules of Controlled Substances: Rescheduling of Marijuana, 91 Fed. Reg. 22777 (April 28, 2026). Schedule I controlled substance and is not illegal under federal law. See DeLorean 88 LLC v. District of Columbia, 806 F. Supp. 3d 49, 54–55 (D.D.C. 2025).

This statutory and regulatory background sets the scene for this dispute. Plaintiffs include one patient, one physician, eleven organizations, and a pharmaceutical company and its subsidiaries. Am. Compl. ¶¶ 6-21. All oppose the BEI for many reasons. The Court briefly describes each Plaintiff below.

Individual Plaintiffs. The first individual Plaintiff is David Evans, a 78-year-old Medicare beneficiary who receives care from Hopscotch Primary Care, which participates in a CMMI model eligible for the BEI (though it has not opted into the BEI). Evans Decl. ¶¶ 4, 6, ECF No. 28-6. Evans is “opposed to expanded access to cannabis and hemp-derived products” and does “not want such products provided by or through [his] Medicare provider.” Id. ¶ 7.

Next is physician Dr. Kenneth Finn, who practices pain medicine in Arizona. Finn Decl. ¶ 3 ECF No. 28-7. While he does not claim to participate in any CMMI model that could opt into the BEI, he fears he will be asked to participate in the BEI, and he expects the BEI to result in increased emergency room visits and more malpractice liability. Id. ¶¶ 17–19.

Organizational Plaintiffs. Turning to the eleven organizational Plaintiffs, each stands on similar footing. None participates in the BEI or has members that do. See generally Am. Compl. ¶¶ 6–16. Rather, each claims the BEI impeded their programming. Because these Plaintiffs’ operations differ, a description of each is in order.

Many organizational Plaintiffs work in the drug-education and safety realm. Smart Approaches for Marijuana (“SAM”), for instance, does “education and advocacy regarding the public health and safety impact of marijuana and cannabis policy.” Niforatos Dec. ¶ 5, ECF No. 28-1. To support its mission, SAM runs “public health education campaigns” and “research and policy analysis programs.” Id. ¶ 6.

Cannabis Industry Victims Educating Litigators (“CIVEL”) has a similar purpose. Am. Compl. ¶ 7. It educates “legal professionals and the public about the harms caused by the cannabis industry.” Id. CIVEL does so through “legal education seminars, victim assistance programs, and community outreach.” Id.

Americans Against Legalizing Marijuana (“AALM”) is likewise “dedicated to providing information on the harms of marijuana to individuals and our country,” id. ¶ 8, and it likewise runs “education programs” and “public awareness campaigns,” and supports doctors and lawyers in these fields, id.

North Carolinians Against Legalizing Marijuana (“NCALM”) opposes the “legalization of medical hemp-derived” products. Id. ¶ 9. Its activity includes “legislative advocacy, public education campaigns, and policy analysis regarding the risks of marijuana.” Id.

Cannabis Industry Victims Seeking Justice (“CIVSJ”) seeks to hold “the marijuana industry legally accountable to its victims and to provide advocacy services to the many victims of the cannabis industry.” Id. ¶ 11. It runs “victim advocacy” programs, “legal accountability initiatives, and public education” programs to do so. Id.

Cannabis Impact Prevention Coalition, LLC (“CIPC”) strives to “prevent the negative social, health, public safety, and environmental impacts of marijuana.” Am. Compl. ¶ 10. CIPC also operates “public education, community outreach, and policy advocacy” programs to further its mission. Id.

Drug Free America Foundation (“DFAF”) is a “drug prevention and policy organization” that seeks to “prevent drug use and promote sustained recovery.” Ronshausen Decl. ¶ 5, ECF