"You cannot claim to follow science while bypassing the scientific process," said Duane Boise, CEO of MMJ International Holdings.
"Not all CBD is the same. Without FDA validation, you're not practicing medicine-you're experimenting on patients with inconsistent products."

WASHINGTON, D.C. / ACCESS Newswire / March 20, 2026 / In what may become one of the most controversial healthcare policy experiments in recent years, the Centers for Medicare & Medicaid Services (CMS) is preparing to launch a pilot program that would provide federal reimbursement for cannabidiol (CBD) products.

On its surface, the initiative is framed as compassionate, forward-thinking, and responsive to patient demand - particularly among seniors suffering from chronic pain.

But beneath the policy language lies a far more troubling question:

Is the federal government preparing to pay for products that have never met the scientific standards required of medicine in the United States?

A Direct Collision With FDA Drug Approval Standards

For decades, the United States has maintained a clear and uncompromising standard:

If a product is intended to diagnose, treat, or mitigate disease, it must go through the U.S. Food and Drug Administration (FDA) drug approval process.

That process - particularly for botanical drugs - requires:

• Defined composition

• Controlled manufacturing

• Pharmacokinetic data

• Clinical trials establishing safety and efficacy

It is the pathway followed by approved cannabinoid drugs such as Epidiolex and Marinol.

It is also the pathway followed - at great cost and over many years - by companies like MMJ International Holdings and its subsidiaries, including MMJ BioPharma Cultivation and MMJ BioPharma Labs, which have pursued FDA Investigational New Drug (IND) applications and clinical development under full federal oversight.

CMS is now proposing something entirely different.

"CBD" Is Not a Drug Category-It's a Label

The fundamental flaw in the CMS pilot is scientific:

Not all CBD is the same.

CBD products in the consumer marketplace vary dramatically in:

• Purity

• Bioavailability

• Manufacturing quality

• THC contamination levels

• Stability and dosing consistency

Two products labeled "CBD" may produce entirely different effects in the human body.

This variability is precisely why the FDA requires strict standardization before a product can be called medicine.

Yet CMS is moving toward reimbursing CBD products as if they are interchangeable.

They are not.

The THC Contradiction That Exposes the Problem

According to early reporting, CMS is considering allowing up to 3 milligrams of total THC per serving in eligible products.

That figure stands in direct conflict with a separate federal law redefining hemp, which limits THC to approximately 0.4 milligrams per container.

This is not a minor discrepancy-it is a sevenfold regulatory mismatch.

It raises a critical question:

If federal agencies cannot agree on what constitutes a legal cannabinoid product, how can one agency justify reimbursing it as a healthcare benefit?

Reimbursement Without Approval Creates "Shadow Medicine"

CMS maintains that this is only a pilot program and not a formal drug approval.

But in practice, reimbursement changes everything.

Once Medicare:

• Pays for a product

• Encourages physician recommendation

• Integrates it into care models

That product becomes, functionally, medicine.

And yet:

• It has not gone through FDA approval

• It lacks standardized dosing

• It may vary from batch to batch

This creates what critics are calling a "shadow medical system"-where products are used like drugs without being regulated as drugs.

A Two-Tier System: Science vs. Convenience

The implications are profound.

On one side:

• Pharmaceutical developers follow FDA rules

• Conduct clinical trials

• Spend years generating safety and efficacy data

On the other:

• Consumer CBD products enter federal reimbursement programs

• Without the same evidentiary standards

• Without the same regulatory burden

"You cannot claim to follow science while bypassing the scientific process," said Duane Boise, CEO of MMJ International Holdings.
"Not all CBD is the same. Without FDA validation, you're not practicing medicine - you're experimenting on patients with inconsistent products."

The Risk to Patients - and to the System

Supporters argue the pilot could expand access and generate real-world data.

But critics warn it could:

• Expose vulnerable populations to inconsistent formulations

• Undermine FDA drug standards

• Create liability risks for federal healthcare programs

• Distort the market away from validated therapies

Most concerning of all, it may signal that scientific rigor is optional when political momentum is strong enough.

At The End Of THE Day

CMS may call it a pilot program.

But to patients, physicians, and taxpayers, the stakes are far higher.

If the federal government begins paying for cannabinoid products that have not met FDA standards, it risks dismantling a system that has defined drug safety and efficacy for more than a century.

Because in medicine, one principle has always held:

Not all compounds are created equal - and not all products deserve to be treated as drugs.

Madison Hisey
MHisey@mmjih.com
203-231-85832

SOURCE: MMJ International Holdings