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MMJ International Holdings Moves to Join Federal Lawsuit Challenging CMS Hemp-CBD Medicare Pilot as Preliminary Injunction Hearing Approaches.<\/strong><\/i><\/p>\n<\/p><\/div>\n The lawsuit, filed in the U.S. District Court for the District of Columbia<\/strong>, challenges the Centers for Medicare & Medicaid Services’ (CMS) newly launched Substance Access Beneficiary Engagement Incentive (BEI)<\/strong> model. The case was originally brought by Smart Approaches to Marijuana and other plaintiffs, who argue the program was implemented without required rulemaking procedures and conflicts with longstanding federal drug-approval safeguards.<\/p>\n MMJ International Holdings and its subsidiaries MMJ BioPharma Labs<\/strong> and MMJ BioPharma Cultivation<\/strong> have moved to participate in the litigation to ensure that federally reimbursed cannabinoid access policies remain anchored to scientific validation through the U.S. Food and Drug Administration’s botanical drug pathway.<\/a><\/p>\n A Federal Policy Shift Without FDA Approval<\/strong><\/p>\n The BEI program, launched April 1 through the CMS Innovation Center, allows participating organizations to discuss and furnish hemp-derived cannabinoid products containing no more than 0.3% delta-9 THC<\/strong> for symptom-management purposes.<\/p>\n While CMS has stated the program does not constitute formal Medicare reimbursement coverage<\/strong>, critics argue the model creates a federally supported distribution pathway for products that have not undergone FDA drug approval.<\/p>\n “A federal pilot built on the 0.3% THC loophole is reshaping cannabinoid access policy – without FDA approval, without reimbursement transparency, and without advance market notice,” said Duane Boise<\/strong>, CEO of MMJ International Holdings. “Patients deserve clinically validated therapies, not experimental access models funded through federal healthcare infrastructure.”<\/p>\n Legal Questions at the Center of the Case<\/strong><\/p>\n The lawsuit raises three central federal law concerns:<\/strong><\/p>\n Whether CMS exceeded its authority under the Administrative Procedure Act<\/strong><\/p>\n<\/li>\n Whether the BEI conflicts with the Federal Food, Drug, and Cosmetic Act<\/strong><\/p>\n<\/li>\n Whether the Innovation Center can create access pathways for unapproved cannabinoid products prior to FDA drug validation<\/strong><\/p>\n<\/li>\n<\/ul>\n Although the court denied an emergency temporary restraining order on March 31, the litigation continues, with a preliminary injunction hearing scheduled for April 20, 2026<\/strong>.<\/p>\n Federal defendants have requested that the hearing be postponed.<\/p>\n Why MMJ International Holdings Is Participating<\/strong><\/p>\n MMJ International Holdings is currently developing standardized cannabinoid soft-gel capsule therapies under FDA Investigational New Drug (IND) authorization<\/strong> targeting Huntington’s disease and multiple sclerosis. The company has followed the federal pharmaceutical pathway for nearly a decade, including:<\/p>\n IND-authorized clinical research<\/strong><\/p>\n<\/li>\n Orphan Drug Designation for Huntington’s disease<\/strong><\/p>\n<\/li>\n DEA-licensed analytical laboratory infrastructure<\/strong><\/p>\n<\/li>\n Pharmaceutical-grade botanical formulation development<\/strong><\/p>\n<\/li>\n<\/ul>\n The company’s participation in the lawsuit reflects concerns that federal reimbursement-adjacent cannabinoid access programs could undermine the scientific framework required for drug safety and efficacy evaluation.<\/p>\n “When federal healthcare programs begin supporting cannabinoid products outside the FDA pathway, they risk creating a shadow approval system,” Boise added. “That is not how medicine in the United States is supposed to work.”<\/p>\n Innovation Model or Regulatory Shortcut?<\/strong><\/p>\n Supporters of the BEI model argue it expands structured patient access to hemp-derived wellness products for chronic conditions.<\/p>\n Opponents argue it creates a precedent allowing federally supported cannabinoid distribution before clinical validation standards are met<\/strong>.<\/p>\n MMJ International Holdings maintains that cannabinoid therapies intended for symptom treatment in serious neurological diseases should advance through the FDA’s botanical drug framework – the same pathway used for every other prescription medicine.<\/p>\n About MMJ International Holdings<\/strong><\/p>\n MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing pharmaceutical-grade cannabinoid therapies for Huntington’s disease and multiple sclerosis. Through its subsidiaries MMJ BioPharma Cultivation<\/strong> and MMJ BioPharma Labs<\/strong>, the company is advancing FDA-regulated botanical drug candidates designed to meet rigorous federal safety, quality, and efficacy standards.<\/p>\n Madison Hisey
\n WASHINGTON, April 11, 2026 (Newswire.com)
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\n <\/strong>MMJ International Holdings, Inc. (MMJIH), a leading developer of pharmaceutical-grade cannabinoid therapeutics for Huntington’s disease and Multiple Sclerosis, today confirmed that it has moved to join litigation challenging a new federal pilot program<\/strong> that permits discussion and furnishing of hemp-derived cannabinoid products to Medicare beneficiaries without FDA drug approval.<\/strong><\/a><\/p>\n\n
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MHisey@mmjih.com<\/a>
203-231-85832<\/p>\n