The Company Nobody Knows That Just Handed Prohibitionists the Keys to Block Medicare Cannabis Access

On March 31, 2026, a federal judge in Washington, D.C. all but told Smart Approaches to Marijuana that their lawsuit to block Medicare's new hemp CBD pilot program was going to die. The problem was standing — SAM is an advocacy group, not a business competitor. They hadn't been harmed. They just didn't like the policy.

Eight days later, a company called MMJ International Holdings filed a motion to join the case. Most people in the cannabis space had never heard of them. The government didn't oppose their entry. And just like that, a lawsuit that was circling the drain had the one thing it needed to survive: a plaintiff that could claim real economic injury.

On May 1, the judge heard oral arguments. Courtroom observers noted that he emphasized four separate times that his ruling must withstand appellate review — language widely interpreted as signaling he's looking for a procedural path to keep the case alive. A ruling is expected soon.

If this case survives, MMJ International Holdings is the reason. And the 65 million Americans enrolled in Medicare who might have benefited from the pilot program should know who they are and why they did it.

What the Pilot Actually Does

The CMS Substance Access Beneficiary Engagement Incentive — the program being challenged — launched April 1 under CMS Administrator Dr. Mehmet Oz. It allows Medicare providers participating in certain Innovation Center models to furnish hemp-derived CBD products to eligible beneficiaries, with up to $500 per patient per year in coverage. The products must contain no more than 0.3% delta-9 THC by dry weight and no more than 3 milligrams of total THC per serving. Providers front the cost themselves. If the intervention reduces downstream healthcare claims, the provider and CMS share the savings. If it doesn't, the provider absorbs the loss.

This isn't Medicare writing blank checks for gas station gummies. It's a structured pilot with physician oversight, documented shared decision-making, quarterly reporting requirements, and outcome data collection. CMS has said publicly that if the pilot shows promise, they'll expand access. If it doesn't, they won't.

The pilot exists because millions of seniors are already using CBD products — spending their own money, with no clinical guidance, no dosing oversight, and no data being collected on outcomes. The BEI puts a doctor in the room and turns anecdotal usage into measurable evidence.

What SAM Wanted

SAM filed suit on March 30, the day before launch, seeking an emergency temporary restraining order and a permanent injunction to kill the program entirely. Their argument: CMS bypassed notice-and-comment rulemaking required under the Administrative Procedure Act, exceeded its statutory authority, and violated the Federal Food, Drug, and Cosmetic Act by creating a federal reimbursement pathway for products that haven't gone through FDA approval.

SAM's CEO Kevin Sabet framed the lawsuit as procedural, not ideological. But SAM is an organization whose entire mission is opposing cannabis normalization. They have fought legalization, decriminalization, and medical access at every level of government for over a decade. This is what they do.

The problem was that the judge wasn't buying their standing argument. At the March 31 hearing, he denied the emergency restraining order and — according to the government's subsequent briefing — raised pointed questions about whether SAM and the other advocacy group plaintiffs could demonstrate the kind of concrete, particularized injury required to maintain the lawsuit. Being philosophically opposed to a policy isn't standing. Being an advocacy group that dislikes the direction of regulation isn't standing.

The case was on life support.

Enter MMJ International Holdings

MMJ International Holdings is a privately held company founded in 2015 by Duane Boise, based in Westerly, Rhode Island, with operations in Jamaica. They describe themselves as a clinical-stage biopharmaceutical company developing plant-derived cannabinoid therapeutics through the FDA's botanical drug development pathway.

Here's what they have: two Investigational New Drug applications accepted by the FDA (MMJ-001 for multiple sclerosis spasticity, MMJ-002 for Huntington's disease chorea). An FDA Orphan Drug Designation for the Huntington's program, granted in 2019. A DEA Schedule I Analytical Laboratory registration. A 2020 DEA-authorized importation of THC extracts from Jamaica to the US — described as a first. A joint development agreement with the Saint Regis Mohawk Tribe to build a 500,000 square foot cultivation facility on tribal land in Akwesasne, New York. A Chief Medical Officer, Dr. Terry Plasse, who developed dronabinol (Marinol), the only FDA-approved THC-based drug.

Here's what they don't have: a DEA Schedule I Bulk Manufacturer license to grow cannabis in the United States. They applied in 2016 when the DEA opened applications. They're still waiting. The DEA licensed eight other companies in 2021-2022. According to MMJ's own public statements, seven of those eight are now bankrupt, inactive, or non-operational. MMJ — the company with the orphan drug designation and active FDA trials — was left out. They sued the DEA in September 2024 over this.

They also don't have a commercially available product. No completed clinical trials. No revenue that anyone outside the company can verify, because as a private company, they file no public financial disclosures. The federal government itself noted in court filings that MMJ's claimed injuries are "speculative and tied to products that remain years away from commercialization."

MMJ has been issuing press releases saying they're about to begin clinical trials for roughly six years.

Why They Joined — And What It Really Means

MMJ moved to intervene on April 7, less than 48 hours before the government's opposition brief was due, and nine days after the judge questioned whether the existing plaintiffs had standing.

The government's briefing was blunt about the timing. They argued that MMJ had been publicly criticizing the BEI since early March and was aware of the lawsuit no later than March 31, when the company issued a press release linking directly to the complaint. Yet they waited until the standing question arose to seek intervention.

MMJ's stated position sounds reasonable on the surface: cannabinoid products entering federal healthcare should go through the same FDA botanical drug approval pathway that pharmaceutical developers are required to follow. Science before reimbursement. Their CEO Duane Boise has been quotable and prolific, offering lines like "a soft-gel is a medicine; a gummy is a snack."

But step back and look at the incentive structure.

MMJ's entire business model depends on the FDA botanical drug pathway being the exclusive route for cannabinoids to enter federal healthcare. They have spent a decade and, by their own account, millions of dollars navigating that pathway. If the CMS pilot succeeds — if Medicare starts covering retail CBD products through a streamlined BEI program — then MMJ's decade of IND applications, orphan designations, and DEA battles becomes a competitive disadvantage. They did the expensive thing that the government just told everyone else they could skip.

Blocking the pilot isn't about patient safety for MMJ. It's about protecting their moat.

And they're the only plaintiff in this case who can provide the standing SAM needs to keep it alive. SAM is an anti-cannabis advocacy group that can't demonstrate economic harm. MMJ is a company that can point to years of investment in a competing FDA pathway and argue that the BEI devalues that investment. Without MMJ's standing, the case likely dies on procedural grounds. With MMJ, it has a real chance of proceeding — potentially becoming the first federal court challenge to successfully block a CMS Innovation Center model component.

The alliance is nakedly transactional. SAM gets the legal standing it couldn't generate on its own. MMJ gets the prohibitionist legal infrastructure — including constitutional attorney Ilya Shapiro and nationally recognized pain specialist Kenneth Finn, M.D. — that it couldn't build alone. SAM's goal is to block cannabis access, period. MMJ's goal is to ensure that all cannabis access flows through the FDA pathway that only they are pursuing.

The people who lose are the seniors who could have benefited from the pilot.

The Uncomfortable Questions

If MMJ's argument is that science must precede reimbursement, then where is the science? After ten years of operation, two IND applications, an orphan drug designation, and a CMO who literally developed the only FDA-approved THC drug in history — where are the clinical trial results? Where is the data? Where is the soft-gel capsule that Boise says is a medicine and not a snack?

The answer, MMJ would say, is the DEA. And there's real truth to that. The DEA's multi-year stonewalling of legitimate cannabis research applications is well-documented and indefensible. MMJ has been caught in a genuine Catch-22: the FDA tells them to develop drugs, the DEA refuses to let them grow the plants they need to develop those drugs.

But that Catch-22 cuts both ways. If the federal regulatory system is so broken that a company with FDA designations can't get a DEA cultivation license after seven years, then insisting that every other cannabinoid product must complete that same broken process before reaching patients isn't a principled stand — it's pulling up the ladder behind you when you haven't even reached the top.

Millions of Medicare beneficiaries manage chronic pain with CBD products they buy at retail, with no physician oversight, no dosing guidance, and no outcome tracking. The BEI pilot was an attempt to bring that existing behavior into a clinical framework. Imperfect? Absolutely. Better than the status quo of zero oversight? Almost certainly.

MMJ's position is that the perfect — FDA-approved, clinically validated, pharmaceutically standardized botanical drugs — should be the enemy of the good. Meanwhile, the perfect doesn't exist and may not exist for years.

Where This Goes

The judge heard oral arguments on May 1. A ruling is expected soon. If the case proceeds, it could set precedent for how far CMS Innovation Center authority extends — and whether federal agencies can create cannabinoid access pathways outside of traditional FDA drug approval. If it's dismissed, the pilot continues and CMS collects the outcome data that might eventually make the scientific case MMJ says it wants.

There's an additional wrinkle: the November 12, 2026 implementation of the 2026 Agriculture Appropriations Act, which would cap hemp products at 0.4 milligrams of total THC per container — effectively banning most CBD products currently on the market. If that takes effect without congressional intervention, the pilot becomes moot anyway.

But the principle being contested here will outlast any single pilot program. The question at the center of this case is whether the federal government can integrate cannabinoid products into healthcare before the FDA's traditional drug approval process catches up to where patients already are. MMJ says no. The 65 million Americans on Medicare who are already using these products without any clinical support might disagree.

What's clear is that this case would not exist in its current form without MMJ International Holdings. A company that most cannabis investors, advocates, and policy watchers had never heard of until last month may end up shaping federal cannabinoid healthcare policy for years to come — not by bringing a product to market, but by ensuring nobody else can either.

Disclosure: The author has interests in the cannabis sector. This article is commentary and analysis, not legal or investment advice.