CMS's Hemp CBD Program Has A Physician Problem - MMJ Appeal Pending

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In a recent interview Vantage Hemp's Chief Medical Officer says healthcare needs standardized, reproducible products and controlled clinical trials - as CMS carries its cannabinoid initiative into the 10-year LEAD Medicare model

WASHINGTON, D.C. / ACCESS Newswire / September 12, 2026 / MMJ International Holdings, Inc., together with MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc. (collectively, "MMJ"), says the federal government's cannabinoid experiment on seniors is confronting a basic problem that policy cannot solve:

Physicians still have to decide what they are willing to give their patients.

The Centers for Medicare & Medicaid Services created the Substance Access Beneficiary Engagement Incentive, or Substance Access BEI , allowing participating organizations in certain Medicare Innovation Center models to furnish qualifying hemp derived cannabinoid products to eligible beneficiaries for possible symptom control.

CMS can create the program. It can create financial incentives. But under the program, physicians remain responsible for determining whether use is appropriate, reviewing medications and potential interactions, discussing risks and benefits, and following the patient. CMS Substance Access BEI

That makes the physician the final clinical checkpoint between an unvalidated cannabinoid product and a Medicare patient.

And a physician working inside the cannabinoid industry is now describing why that matters.

Vantage Hemp's Chief Medical Officer: Healthcare Requires Evidence

Dr. Paul Shields, DO, serves as Chief Medical Officer of Vantage Hemp , a cannabinoid company working with healthcare organizations around the CMS initiative. Vantage Hemp

In a recent healthcare-industry discussion reviewed by MMJ, Shields said he knew organizations involved with the BEI but was not aware of one that had operationalized the program.

He then described what he believes the easier healthcare pathway ultimately looks like: a defined product moving through conventional medical infrastructure - physician prescription, pharmacy dispensing and insurance reimbursement.

More importantly, Shields questioned whether the pilot structure is the right mechanism for generating credible medical evidence. He discussed pharmaceutical companies conducting double-blind clinical trials to determine concentration and efficacy .

His larger point was unmistakable: healthcare requires evidence. Current cannabinoid experience can be difficult to reproduce and standardize, and medicine needs reproducible, standardized products .

That is not criticism from an opponent of cannabinoid medicine.

It is the Chief Medical Officer of a cannabinoid manufacturer describing what healthcare requires for broader medical adoption.

Is Physician Adoption the Program's Real Bottleneck?

CMS announced the Substance Access BEI in April 2026 and said five ACOs had submitted implementation plans. CMS Substance Access BEI announcement

But authorization is not adoption.

A physician treating a Medicare beneficiary still confronts questions no government incentive can answer:

What exactly is in the product? Is one batch meaningfully comparable to another? Is the dose reproducible? What happens during storage? What are the drug interactions? And what clinical evidence supports using that product for this patient's symptoms?

CMS itself recognizes the importance of these questions by requiring physician involvement, medication review, risk-benefit discussion and follow-up.

That may help explain why policy enthusiasm has not automatically translated into implementation.

Doctors are not simply another distribution channel. They are the last clinical line of defense.

What Does "Unvalidated" Mean?

"Unvalidated" does not mean a product has been proven unsafe.

It means important questions may not have been answered through the evidentiary process normally required for an FDA-approved drug.

For a cannabinoid product, those questions can include chemical characterization, batch consistency, potency, impurities, degradation products, stability, representative toxicology, drug interactions, reproducible dosing and controlled evidence of safety and efficacy for an intended medical use.

CMS does impose product safeguards, including third-party potency and contaminant testing.

Those protections matter.

But potency testing is not FDA drug approval.

A certificate of analysis does not establish clinical efficacy. Contaminant testing does not establish long-term stability. And neither establishes that toxicology or clinical evidence applies to the precise formulation being furnished to a patient.

Europe Just Denied Charlotte's Web

The European Food Safety Authority recently evaluated a Charlotte's Web, Inc. carbon-dioxide extract from Cannabis sativa L. submitted as a novel food.

EFSA identified problems involving product characterization, stability information and whether the material used in toxicology studies was sufficiently representative of the product under evaluation. EFSA ultimately concluded that safety under the proposed conditions of use could not be established from the evidence submitted. EFSA Charlotte's Web safety assessment

That does not mean EFSA determined Charlotte's Web products are unsafe.

It demonstrates something more important scientifically:

If the material studied is not sufficiently representative of the product being evaluated, the evidence may not answer the safety question physicians and regulators need answered.

That is why reproducibility matters.

CMS Is Carrying the Initiative Into a 10-Year Medicare Model

Despite the implementation questions surrounding the current initiative, CMS has already made the Substance Access BEI available within its new Long-term Enhanced ACO Design, or LEAD, Model .

LEAD begins January 1, 2027 and runs through December 31, 2036. CMS describes it as a 10-year voluntary accountable-care model with the longest performance period the Innovation Center has ever tested. CMS LEAD Model

The cannabinoid incentive itself remains optional. CMS is not requiring every LEAD participant to furnish hemp products for ten years.

But CMS has deliberately carried the Substance Access BEI into a federal Medicare framework designed to operate for a decade.

That raises a legitimate question:

Why institutionalize the pathway before demonstrating that it can generate the standardized, reproducible and clinically interpretable evidence physicians say they need?

The Government Says the Evidence Should Inform Standards of Care

The issue becomes even more significant under Executive Order 14370.

The order directs HHS, FDA, CMS and NIH to develop research methods and models using real-world evidence to improve access to hemp-derived cannabinoid products "in accordance with Federal law and to inform standards of care." Executive Order 14370 - Increasing Medical Marijuana and Cannabidiol Research

If the objective is to generate evidence capable of informing standards of care, researchers need to know what intervention patients actually received.

Product composition matters.

Dose matters.

Manufacturing consistency matters.

Stability matters.

Otherwise, differences in the products themselves risk becoming another variable in the data the government is trying to interpret.

MMJ Built the Pathway Physicians Are Now Describing

MMJ chose the federal pharmaceutical pathway.

The company developed a defined soft-gelatin capsule containing 5 mg CBD and 2.5 mg THC , and approximately 50,000 finished capsules were manufactured with Catalent Pharma Solutions in May 2022 .

MMJ has pursued analytical characterization, chemical fingerprinting, pharmaceutical stability work, CMC controls, two FDA Investigational New Drug programs and an FDA Orphan Drug Designation.

MMJ's investigational drug candidates are not FDA approved , and MMJ does not claim they have been demonstrated safe or effective.

That is precisely the distinction.

MMJ has spent more than eight years and more than $10 million attempting to establish those propositions through the federal drug-development process before asking physicians to prescribe its medicine.

The healthcare discussion is now describing essentially the same destination: standardized product, reproducibility, controlled clinical trials, prescriptions, pharmacies and conventional healthcare infrastructure.

That is drug development.

Judge McFadden Never Decided Whether the CMS Program Was Lawful

These questions are also the subject of continuing federal litigation.

On May 22, 2026, U.S. District Judge Trevor N. McFadden dismissed the challenge brought by MMJ and its co-plaintiffs for lack of Article III standing.

The court did not hold that the CMS program was lawful.

It did not decide the underlying Administrative Procedure Act claims or resolve whether CMS possessed the statutory authority asserted for the initiative.

MMJ and its co-plaintiffs appealed.

The case remains before the U.S. Court of Appeals for the D.C. Circuit, where the appellate court will determine whether the plaintiffs should have been permitted through the courthouse door to litigate their underlying claims.

The Government Cannot Have It Both Ways

CMS says the program is not Medicare drug coverage.

FDA has not approved the participating hemp products as drugs.

The Executive Order says the research should help inform standards of care.

CMS places physicians in the position of evaluating appropriateness, medications, interactions, risks and benefits.

A cannabinoid manufacturer's own Chief Medical Officer says healthcare requires standardized, reproducible products and controlled evidence.

And EFSA has demonstrated why product characterization, representative test material, stability and toxicology matter.

Yet CMS is carrying the cannabinoid incentive into a Medicare model extending through 2036.

"CMS can create an incentive, but it cannot create physician confidence in an unvalidated product," said Duane Boise, CEO of MMJ International Holdings. "The physician is the last clinical checkpoint between that product and a Medicare patient. Dr. Shields is describing what MMJ has spent more than eight years building toward: standardized formulation, reproducible chemistry, controlled manufacturing and clinical trials. The medical community isn't asking Washington for more marketing. It is asking for evidence."

Boise added:

"If the government wants real-world evidence capable of informing standards of care, it first has to know what patients are receiving. A hemp definition is not validation. A potency test is not validation. Schedule III is not validation. Medicine ultimately has to stand on reproducible science."

The Physician May Be Washington's Final Reality Check

The federal government can create access.

It can create incentives.

It can change scheduling policy.

It can establish a 10-year Medicare model.

But it cannot eliminate a physician's responsibility to make a defensible clinical judgment for an individual patient.

And that may ultimately explain why physicians - rather than Washington - become the final line of defense between cannabinoid policy and cannabinoid medicine.

CONTACT:

Madison Hisey

[email protected]

203-231-8583

Cautionary Statement

MMJ's cannabinoid drug candidates are investigational and have not been approved by FDA. Nothing in this release establishes their safety or efficacy. EFSA's findings concern the specific Charlotte's Web novel-food application and evidence submitted in that proceeding and should not be interpreted as establishing that all hemp or CBD products are unsafe. CMS requires product-quality safeguards and physician oversight under the Substance Access BEI, participation is voluntary, and Medicare does not reimburse the hemp products themselves. MMJ's federal appeal remains pending, and no court has ruled that the Substance Access BEI is unlawful.

SOURCE: MMJ International Holdings