MMJ International Holdings Seeks Federal Preliminary Injunction May 1 to Halt CMS Hemp-CBD Medicare Pilot

"MMJ followed the federal FDA pathway because patients deserve medicines supported by standardized dosing, controlled manufacturing, and clinical validation-not reimbursement-adjacent access to products that have never been tested through the drug-approval process. The Court's May 1 hearing is an important step toward protecting the integrity of evidence-based cannabinoid medicine in the United States" stated Duane Boise, CEO MMJ International Holdings.

WASHINGTON, D.C. / ACCESS Newswire / April 16, 2026 / MMJ International Holdings, Inc. today confirmed it has joined federal litigation challenging the Centers for Medicare & Medicaid Services' ("CMS") Substance Access Beneficiary Engagement Incentive (BEI) program and is seeking a preliminary injunction and stay of agency action ahead of a scheduled May 1, 2026 federal court hearing in the United States District Court for the District of Columbia.

MMJ International Holdings and its subsidiaries MMJ BioPharma Labs, Inc. and MMJ BioPharma Cultivation, Inc. joined the case to ensure that cannabinoid therapies intended for treatment of serious neurological disease remain anchored to the FDA botanical drug development pathway, the same regulatory framework required for all prescription medicines in the United States.

The lawsuit was originally filed by Smart Approaches to Marijuana and other plaintiffs challenging the legality of CMS's rollout of the BEI model without notice-and-comment rule making under the Administrative Procedure Act.

Federal Court to Consider Whether CMS Lawfully Implemented the BEI Program

The BEI program, launched April 1 through the CMS Innovation Center, allows participating healthcare organizations to discuss and furnish hemp-derived cannabinoid products containing no more than 0.3% delta-9 THC to Medicare beneficiaries for symptom-management purposes.

Although CMS states the program does not constitute formal Medicare reimbursement coverage, plaintiffs argue the initiative creates a federally supported clinical distribution pathway for non-FDA-approved cannabinoid products without the procedural safeguards normally required for changes affecting federal healthcare programs.

The May 1 hearing will determine whether the Court should temporarily halt implementation of the BEI program while the legality of the policy is reviewed.

Protecting the FDA Cannabinoid Drug Development Framework

MMJ International Holdings, Inc. is developing standardized cannabinoid soft-gel capsule therapies under FDA Investigational New Drug (IND) authorization targeting:

• Huntington's disease

• Multiple Sclerosis

The company's regulatory program includes:

• FDA IND-authorized development

• Orphan Drug Designation for Huntington's disease

• DEA Schedule I analytical laboratory registration

• pharmaceutical-grade botanical formulation development

• collaboration with Pharma Solutions company on final-dose capsule manufacturing

MMJ states the BEI model risks weakening the regulatory distinction between validated pharmaceutical cannabinoid medicines and non-approved cannabinoid products introduced into Medicare-linked clinical environments.

Company Statement on the Federal Policy Shift

"A federally supported cannabinoid access pathway operating outside the FDA drug approval process raises serious scientific, regulatory, and investment-framework concerns," said Duane Boise, CEO of MMJ International Holdings.

"Patients deserve therapies supported by standardized dosing, controlled manufacturing, and clinical validation. The preliminary injunction hearing on May 1 is an important step toward ensuring that federal healthcare policy remains aligned with evidence-based medicine."

Key Legal Questions Before the Court

The litigation asks the Court to determine whether CMS:

• violated the Administrative Procedure Act by implementing BEI without notice-and-comment rulemaking

• created a federal clinical access pathway inconsistent with longstanding FDA drug-approval safeguards

• exceeded its authority under the CMS Innovation Center demonstration-model framework

• altered reimbursement-adjacent cannabinoid access policy without transparency or coordination with federal drug-approval standards

Plaintiffs also argue the program affects companies actively pursuing FDA-regulated cannabinoid therapies by weakening the expected regulatory differentiation between approved medicines and non-approved cannabinoid products.

Why MMJ International Holdings Entered the Case

Over the past decade, MMJ has invested a significant amount of money in advancing cannabinoid therapies through the federal FDA-DEA regulatory pathway rather than state cannabis markets.

The company states that introduction of a Medicare-linked cannabinoid access model outside that pathway risks:

• reducing incentives for controlled neurological-disease trials

• weakening investor confidence in pharmaceutical cannabinoid development

• complicating clinical-trial recruitment assumptions

• blurring distinctions between standardized medicines and non-approved cannabinoid exposure

MMJ's motion seeks to preserve the longstanding federal principle that therapies intended to treat disease advance through FDA clinical validation before entering federally supported healthcare distribution frameworks.

Upcoming Federal Hearing

The Court is scheduled to hear arguments on May 1, 2026 regarding plaintiffs' request for a preliminary injunction and stay of agency action pending judicial review of the BEI program.

MMJ International Holdings expects the hearing to address whether the program should remain in effect while the Court evaluates whether CMS acted lawfully in creating the initiative.

About MMJ International Holdings

MMJ International Holdings, Inc. is a U.S.-based life sciences company developing pharmaceutical-grade cannabinoid therapeutics under FDA botanical drug guidance for Huntington's disease and multiple sclerosis. Through its subsidiaries, the company operates an integrated regulatory platform supporting cultivation, analytical characterization, and clinical-trial preparation consistent with federal drug-development standards.

Madison Hisey
MHisey@mmjih.com
203-231-8583

SOURCE: MMJ International Holdings