WASHINGTON, DC / ACCESS Newswire / April 29, 2026 / Somewhere in America right now, a Medicare patient over 65 - perhaps managing cancer, perhaps on blood thinners, perhaps already navigating a complex medication regimen - may be offered a hemp-derived cannabinoid product through their federally sponsored health program. Not because a doctor prescribed it after a clinical evaluation. Not because the FDA approved it. Not because a single randomized controlled trial has demonstrated it is safe or effective for that patient's condition. But because CMS decided, quietly and without public input, to make it available anyway.
This is the Substance Access Beneficiary Engagement Incentive - the BEI - a program component tucked inside CMS's Center for Medicare and Medicaid Innovation that authorizes participating Medicare ACOs to distribute hemp-derived cannabinoid products, including those containing delta-9 THC, to enrolled beneficiaries. The agency calls it an "innovative payment and service delivery model." Critics call it an uncontrolled experiment on the nation's most medically vulnerable population.
"No clinical trial. No FDA approval. No public comment period. Just a federal program handing psychoactive products to elderly cancer patients."
THE CORE OF THE LEGAL CHALLENGE
The program did not go through notice-and-comment rulemaking. The public was not invited to weigh in. Physicians outside participating models were not consulted. Patient advocacy organizations were not notified. CMS simply announced it - and when challengers sued, the government's lawyers filed a reply brief this week arguing, with apparent confidence, that none of that was legally required.
WHAT THE BEI ACTUALLY DOES
▸Authorizes distribution of hemp-derived cannabinoid products, including THC-containing items, to Medicare beneficiaries enrolled in ACO REACH and Enhancing Oncology Model programs
▸Requires no FDA approval, no clinical trial data, and no physician prescription for the specific products distributed
▸Was implemented with no public notice-and-comment period
▸Targets patient populations including elderly cancer patients - among the most medically complex and medication-sensitive in the country
▸Operates under a statutory preclusion provision that, the government argues, bars any judicial review of its design
THE PATIENTS
Medicare beneficiaries are not a general population. They are overwhelmingly over 65, disproportionately managing multiple chronic conditions, and frequently on polypharmacy regimens where drug interactions carry serious risk. The Enhancing Oncology Model, one of the two programs through which the BEI operates, serves cancer patients - individuals whose bodies are already under significant physiological stress and whose treatment protocols are among the most precisely calibrated in medicine.
For this population, the introduction of any new substance carries heightened risk. Cannabinoids are known to interact with common medications including blood thinners, chemotherapy agents, and immunosuppressants. The FDA has approved exactly one cannabinoid-based drug - Epidiolex, for specific forms of pediatric epilepsy - after years of clinical trials. The consumer hemp products distributed under the BEI have undergone no such scrutiny. They are, in the most precise regulatory sense, unvalidated for the populations receiving them.
THE PROCESS - OR THE ABSENCE OF ONE
Federal agencies introducing new healthcare interventions for Medicare beneficiaries are generally expected to do so through notice-and-comment rulemaking - a process that invites public scrutiny, allows medical experts to weigh in, and creates a record that courts can review. CMS bypassed this entirely, relying on a provision of the Social Security Act that grants CMMI broad authority to test "innovative" payment and delivery models and a separate statutory exemption for matters "relating to benefits."
The government's legal argument, stated plainly, is this: because the BEI operates inside a Medicare payment model, it is exempt from ordinary procedural requirements, and because Section 1115A strips courts of review authority over model design decisions, no one can challenge it in court regardless. The agency can introduce any product it chooses, to any patient population it chooses, and the public has no formal mechanism to object.
"The check is congressional oversight, not judicial review." The government said this out loud, in a brief, about a program affecting cancer patients."
DEFENDANTS' REPLY BRIEF, CIVIL ACTION NO. 26-1081
In its reply brief filed Wednesday the government lawyers made this argument explicitly: "The check is congressional oversight, not judicial review." They argued that Congress, not courts, is the appropriate body to police CMS's innovation authority. Left unsaid is how a Medicare cancer patient is supposed to navigate that oversight structure when her oncology practice begins offering her hemp gummies as part of a federal wellness initiative she never heard of and never consented to in any meaningful regulatory sense.
THE GOVERNMENT'S RESPONSE
To its credit or discredit, the government's brief makes several inaccurate points.
The products distributed under the BEI are hemp-derived and fall below the 0.3% THC concentration threshold established by the 2018 Farm Bill, meaning they are not federally controlled substances., however the products are not validated.
The program is voluntary - no ACO is required to participate, and no patient is compelled to accept any product. And CMS has committed to updating its definitions as the law evolves, including when the Appropriations Act's stricter dosing thresholds take effect in November 2026.
But legal accuracy is not the same as patient safety. A product can be lawful under the Farm Bill and still carry meaningful clinical risk for an elderly cancer patient on chemotherapy. Voluntary participation at the ACO level does not translate to meaningful informed consent at the patient level. And the commitment to future regulatory compliance does not retroactively validate the decision to launch the program without the expert public scrutiny that notice-and-comment is designed to provide.
QUESTIONS THE GOVERNMENT'S BRIEF DOES NOT ANSWER
▸What clinical evidence supports the safety of these products for elderly cancer patients specifically?
▸What drug interaction screening, if any, is required before a product is distributed to a beneficiary on a complex medication regimen?
▸What informed consent process exists at the patient level?
▸Who bears liability if a patient suffers an adverse event attributable to a BEI product?
▸What outcomes data will CMS collect, and when will it be reviewed?
THE PRECEDENT
Perhaps the most consequential aspect of this case is not the BEI itself but what the government's legal theory would permit going forward. If CMS can distribute consumer hemp products to Medicare cancer patients without notice-and-comment and without judicial review, the logical boundaries of that authority are difficult to identify. The government's brief acknowledges Section 1115A has limits - but those limits, it argues, are enforced by Congress, not courts.
That is a remarkable position. It means that for every future model component CMS chooses to introduce - whatever the product, whatever the patient population - the public's recourse is to call their congressman. For a 72-year-old cancer patient in rural Arizona whose oncology ACO has just added an unvalidated cannabinoid product to her care pathway, that is not a remedy. It is an abstraction.
The district court will decide whether this case survives dismissal. The standing questions are real, the legal arguments are complex, and the government may not prevail. But the legal outcome and the policy question are separate things. Whatever the court decides, the question of whether CMS should be introducing unvalidated consumer products into Medicare without public input - for patients who have no meaningful way to object - deserves a straight answer. The government's reply brief does not provide one.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire
