Federal Appeals Court Sets Briefing Schedule in Challenge to Centers for Medicare & Medicaid Services Hemp Program

A federal appeals court has established a briefing schedule in a lawsuit challenging a Centers for Medicare & Medicaid Services (CMS) program that allows certain health care providers to furnish eligible patients with hemp-derived cannabinoid products.

The U.S. Court of Appeals for the D.C. Circuit is considering Smart Approaches to Marijuana v. Kennedy, an appeal filed after a federal district judge dismissed the challenge in May for lack of standing. The opening brief is due October 5, followed by the federal government’s brief on November 4, with briefing scheduled to conclude December 16.

The case centers on CMS’ Substance Access Beneficiary Engagement Incentive, an optional program launched April 1 that allows organizations participating in certain CMS Innovation Center models to consult with eligible patients about using qualifying hemp products for symptom control. Participating providers may furnish patients with up to $500 worth of eligible hemp products annually. Medicare does not reimburse providers for the products.

Qualifying products must be federally legal hemp and generally contain no more than 0.3% delta-9 THC. Inhalable products are excluded, as are orally consumed products containing more than 3 milligrams of total tetrahydrocannabinols per serving. Products must also meet applicable state and local laws and undergo third-party testing for potency and contaminants.

Smart Approaches to Marijuana, MMJ International Holdings and several other plaintiffs sued the Department of Health and Human Services, CMS, HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz shortly before the program took effect. The plaintiffs alleged, among other claims, that CMS exceeded its statutory authority and failed to follow required administrative procedures.

U.S. District Judge Trevor McFadden dismissed the lawsuit on May 22 without reaching those underlying claims, finding that the plaintiffs had failed to establish the Article III standing necessary to pursue the case. McFadden said the alleged injuries were “too abstract or too remote” to establish jurisdiction.

The plaintiffs appealed on June 8, sending the dispute to the D.C. Circuit.

The appeal will initially focus on whether the challengers have standing to bring their claims. A reversal could reopen the door for judicial review of the legality of the hemp program itself.