A biopharmaceutical company is joining a lawsuit challenging the Centers for Medicare & Medicaid Services’ (CMS) new hemp and CBD pilot program. MMJ International Holdings, along with its subsidiaries, seeks to join plaintiffs arguing against the program, known as the Substance Access Beneficiary Engagement Incentive (BEI).
The lawsuit alleges that CMS launched the BEI pilot without the required public comment process and that the program conflicts with existing federal laws and CMS's prior stance on cannabis coverage. MMJ International Holdings CEO Duane Boise stated the pilot reshapes cannabinoid access policy without FDA approval or reimbursement transparency.
The BEI allows participating organizations to discuss eligible hemp-derived products with Medicare beneficiaries for symptom management. CMS defines eligible hemp products as containing no more than 0.3% delta-9 THC. Opponents argue the program endorses unapproved substances without sufficient safeguards, while supporters believe it could improve patient access.
Earlier, a court denied an emergency request to block the BEI, allowing it to launch amid the ongoing litigation. A preliminary injunction hearing is scheduled for April 20.