The Centers for Medicare and Medicaid Services (CMS) will soon launch a pilot program Cover the costs of CBD products under certain federal health insurance plans for eligible patients. But the newly announced details of the effort indicate the policy could conflict with a separate law redefining hemp in a way that severely limits the amount of THC allowed.
CMS Administrator Mehmet Oz previously described the CBD coverage plan he is implementing in response to an executive order signed by President Donald Trump in December, which also directs the finalization of a federal rule to reorganize marijuana, saying the plan’s CBD components could be rolled out in April.
But as the agency prepares to offer cannabidiol coverage as part of the pilot program, it has set an initial limit of 3 milligrams of total THC (including delta-8, delta-9 and delta-10 THC, for example) per serving, first as Cannabis Wire. notify—that’s more than seven times the THC limit for hemp-derived cannabinoid products, as defined in the spending bill Trump signed last year.
The cannabis section of that agriculture-based spending bill limits total THC content to 0.4 milligrams per container. And that law, which takes effect in November, will effectively wipe out the market for edible cannabinoids, industry insiders say.
A CMS spokesperson told Cannabis Wire that the agency will “adjust its definition as required by law,” without clarifying how it arrived at the 3-milligram THC limit in the first place.
Bipartisan lawmakers and hemp industry advocates have it He pushed to delay the implementation of new hemp THC restrictions Trump signed it, but these efforts have not gained traction. An amendment on the matter was not accepted in the last House Committee’s markup of a new Farm Bill.
Marijuana Moment reached out to CMS to ask more about the THC policy dispute, but a representative was not immediately available.
The planned pilot program “specifically excludes respirable products,” the spokeswoman also said. And available “orally administered” CBD products would be subject to “state and local laws,” though that raises other questions given the complex patchwork of state-level hemp and cannabinoid policies.
In any case, the newly announced details about the yet-to-be-released rules for the pilot program come weeks after an executive at a hemp company working with CMS said the agency already has them. ended federal health insurance plans for cannabidiol.
“This pilot will help (the Food and Drug Administration, or FDA) move from uncertainty to a practical framework with clear dosing, risk reduction and clear manufacturing label expectations that end up rewarding responsible companies and ultimately protecting and serving the consumer,” said Jared Stanley, founder of cannabis company Charlotte’s Web.
“In terms of the population, it’s important to note in the memo that this is starting in a pilot, but it’s expected to expand beyond the pilot,” he said. “So that’s multiple signs that we’re hoping to see. And we’re very excited. It has amazing potential.”
Relatedly, a CMS spokesperson told Cannabis Wire that while he could not provide exact numbers on the number of patients who will be participating in the pilot program, those details will be released as they become available, and the agency will generally provide updates on the rollout “in the coming weeks.”
When asked about the state of CBD regulation last month, CMS directed Marijuana Moment to a website that describes the integration of hemp into a Beneficiary Engagement Incentive (BEI) program under the agency’s long-term ACO Enhanced Design (LEAD) Model.
“Substance Access BEI allows model participants to consult with their patients about the use of eligible hemp products,” the CMS page states. “Implementation of this BEI and any related distribution would be funded entirely at the participant’s expense; CMS would not cover the cost of these products. Additionally, CMS would have strict program integrity safeguards to ensure that these incentives do not result in program or patient abuse.”
“Substance access is only available to participants in states where BOTH eligible hemp products are considered legal,” it says.
While the broader rules for the CBD Medicare pilot program have not yet been released, the CMS website briefly outlines how it navigates hemp-related issues within the regulatory framework. LEADhas Accountability Accountable Organization (ACO) and Improving Oncology Modeling (EOM).
Oz, the CMS administrator, explained in December that the policy change “will make millions of Americans on Medicare eligible to receive CBD in April of next year, and for free, if their doctors recommend it.”
He added that the Medicare Advantage insurers contacted by CMS “also approve the use of CBD for the 34 million Americans they cover.”
One outstanding question is about coverage eligibility. As the administrator described in December, it would affect those 65 and older who are eligible for Medicare, but the exact conditions were not specified. There were repeated mentions of chronic pain, particularly in relation to cancer, but the CBD eligibility criteria may include additional conditions.
At the signing ceremony, Oz paid tribute to Howard Kessler, founder of The Commonwealth Project, who joined him. Trump shared a video about the benefits of cannabidiol for the elderly Truth Social last year and apparently pressured the president to reform to expand access to cannabis.
While CMS issued a previous final rule this past April specifically stipulating that marijuana, as well as CBD derived from federal law hemp, are ineligible For coverage of the Medicare Advantage program and other services, the agency is revising that policy.
CMS already announced some changes as part of a rulemaking process filed late last year, It affects “marketing and communications, drug coverage, enrollment processes, special needs plans and other programming areas.” for the insurance programs it oversees. One of these changes concerned the coverage of cannabidiol.
The proposed rule would change the regulations, which currently say that “cannabis products” cannot be covered. The policy would “prevent coverage of cannabis products that are illegal under applicable state or federal law, including the Food, Drug, and Cosmetic Act.” Because hemp and its derivatives like CBD are federally legal, the change suggests that patients in states where these products are legal can make valid insurance claims to pay for alternative treatment options, as long as the product is federally legal.
Meanwhile, following the White House’s announcement in December, Oz spoke to NewsNation about the policy change, responding to a question about the Trump administration’s aggressive efforts to stem the flow of other illegal drugs, particularly fentanyl, as the broad decision to re-regulate marijuana.
“We think they go hand in hand,” he said. “This is really research, specifically CBD, hemp-derived endocannabinoids (sic) – that Americans deserve to use them,” he said. “It’s hard to do some of that work, especially with medical marijuana. And this is not about legalizing marijuana.”
“There is no legalization language at all,” he added. “It’s a reprogramming of this product class to make it easier to research.”
The idea that marijuana, as currently defined as a Schedule I drug, has no medical value is “significantly wrong for marijuana,” he said, noting that the Food and Drug Administration (FDA) has approved some cannabis-based drugs for conditions like epilepsy that “work quite well.”
“It’s just a wrong place to put that belief that Schedule I should be,” he said. “Schedule III seemed to make sense to the president. He argued that it allows us to do research more easily.”
“We’re finding a way to make some of these products available to Medicare beneficiaries. And so within Medicare, we have the ability, for the first time, and today we’re making good on this promise to the president, to allow doctors to recommend hemp-derived CBD for, for example, cancer patients who are in a lot of pain.”
The administrator said surveys show that most seniors who take CBD for pain management find it beneficial, and the White House wants to “make it easier for patients to access it” and allow them to access the cannabinoid “at no charge” through the federal health insurance program.
Meanwhile, Oz took a different tone when he warned that last month “there will be consequences” as more Americans choose marijuana over alcohol– Including problems caused by “high dose hemp and CBD”.
In the background, the US Department of Health and Human Services (HHS) and the FDA has recently presented a proposed regulation on CBD enforcement and compliance With the White House Office of Management and Budget (OMB) and the Office of Information and Regulatory Affairs (OIRA). There has been speculation that the rule may be related to the CMS pilot program, but this has not been confirmed. And the proposal may be tied to Congress’s mandate for the FDA to produce a list of known cannabinoids ahead of the federal redefinition of hemp.
user photo Nanny Kimzy.
