MMJ International Holdings Sues to Block CMS CBD Medicare Pilot

Lawsuit Alleges Federal Agency Overstepped Authority in Launching Cannabinoid Access Program

Apr. 13, 2026 at 4:08pm

Got story updates? Submit your updates here. ›

A ghostly, translucent X-ray photograph revealing the complex inner structures of a human brain, with glowing neural pathways and anatomical details conceptually representing the regulatory framework for cannabinoid therapies.An X-ray view of the intricate regulatory landscape governing cannabinoid therapies, as a federal lawsuit challenges an agency's attempt to bypass established approval processes.Washington Today

MMJ International Holdings, a pharmaceutical company developing cannabinoid therapies, has filed a federal lawsuit challenging the Centers for Medicare & Medicaid Services' (CMS) newly launched Substance Access Beneficiary Engagement Incentive (BEI) program. The lawsuit alleges CMS created a federally supported cannabinoid access pathway for Medicare beneficiaries without required rulemaking, public notice, or FDA clinical validation standards, raising concerns over regulatory overreach and patient safety.

Why it matters

The case exposes tensions between companies pursuing FDA-approved cannabinoid drugs and federal agencies attempting to expand patient access to hemp-derived CBD products outside the traditional drug approval process. MMJ argues the BEI program undermines incentives for pharmaceutical development by allowing non-approved cannabinoid products to reach Medicare beneficiaries without scientific safeguards.

The details

The lawsuit alleges CMS implemented the BEI program without the notice-and-comment rulemaking required under the Administrative Procedure Act, despite the program's clear policy consequences for national cannabinoid access and reimbursement. The complaint also notes CMS's own prior rulemaking had stated cannabis products were ineligible for Medicare coverage, making the BEI a direct reversal of federal policy without explanation. Plaintiffs argue the program effectively authorizes distribution of hemp-derived THC-containing products to seniors without FDA approval, clinical trial evidence, or public safety analysis tailored to elderly populations.

  • CMS launched the BEI program in April 2025.
  • MMJ International Holdings filed the federal lawsuit in April 2026.

The players

MMJ International Holdings, Inc.

A U.S.-based pharmaceutical company developing cannabinoid therapies for Huntington's disease and multiple sclerosis through the FDA botanical drug pathway.

Centers for Medicare & Medicaid Services (CMS)

The federal agency that oversees the Medicare and Medicaid programs and launched the Substance Access Beneficiary Engagement Incentive (BEI) program to allow participating healthcare organizations to discuss and furnish hemp-derived cannabinoid products to Medicare beneficiaries.

Duane Boise

The CEO of MMJ International Holdings.

Got photos? Submit your photos here. ›

What they’re saying

“This program creates a fast lane for retail-grade cannabinoid access while companies pursuing FDA approval continue to follow the law. That is not healthcare policy. That is regulatory improvisation.”

— Duane Boise, CEO, MMJ International Holdings

“CMS is treating America's seniors like laboratory subjects in a nationwide cannabinoid access experiment.”

— Duane Boise, CEO, MMJ International Holdings

“This case is about whether agencies can change national drug-access policy without transparency, without science, and without Congress.”

— Duane Boise, CEO, MMJ International Holdings

What’s next

The federal court has scheduled expedited briefing and a preliminary injunction hearing to determine whether CMS exceeded its statutory authority when launching the BEI model. If granted, the injunction would pause the federal pilot program and reaffirm that cannabinoid therapies entering Medicare policy must first meet FDA clinical validation standards.

The takeaway

This case highlights the ongoing tension between federal agencies seeking to expand patient access to cannabinoid products and pharmaceutical companies pursuing FDA-approved therapies through the rigorous drug development process. The outcome could have significant implications for the future of cannabinoid regulation and reimbursement in the United States.