The U.S. government is fighting a lawsuit that seeks to block implementation of a Medicare program that would cover the cost of CBD products for seniors, all while the government continues to steadily move toward a November hemp-THC ban.
Smart Approaches to Marijuana leads a coalition of cannabis prohibitionist groups fighting the Centers for Medicare and Medicaid Services’ (CMS) new program in federal court. The case’s first major hearing is set for May 1.
“CMS’s action represents an unprecedented and unlawful assertion of binding decision-making authority that will profoundly affect the health of elderly Americans,” said the 41-page complaint filed March 30 in the U.S. District Court of D.C. “CMS took this action without the guardrails imposed by the administrative process, without any reasoned explanation, in conflict with the agency’s own recent APA compliant determination, and without statutory authority. “
The hearing was originally scheduled for April 20, but it was pushed back by U.S. District Judge Trevor McFadden after he denied a motion for a restraining order from the plaintiffs and an attempt to dismiss the case by the federal government.
Seniors could get $500 for CBD products
The new program covers up to $500 for CBD products for seniors on Medicare. It was announced on Dec. 18, 2025, along with President Donald Trump’s executive order calling for the rescheduling of cannabis. The new Medicare CBD program started April 1, but it applies only to seniors participating in CMS Innovative Center models.
“This new CMS initiative gives providers in certain models another tool – with necessary safeguards – to support their patients’ needs through consultation about whether possible use of hemp products could help improve symptoms,” CMS Innovation Center Director Abe Sutton said in an April 1 statement.
Two days before the CMS pilot program was set to begin, Smart Approaches to Marijuana, along with nine other prohibitionist organizations sued the U.S. Department of Health and Human Services in federal court.
One of the major legal challenges for the plaintiffs is showing how they would be directly impacted by the program, which is legally required to justify their lawsuit. The original complaint also included a single Medicare recipient as a plaintiff, David Evans. But given his history of speaking out about CBD himself, McFadden suggested, in denying a motion for an injunction from the plaintiffs, there was little harm that the program would do to Evans, when he was not planning to take part in it.
The plaintiffs filed an amended complaint on April 13, adding two new parties to their side of the litigation, including MMJ International Holdings, a pharmaceutical company specializing in developing cannabis-derived products that are FDA-approved, and Dr. Kenneth Finn, an outspoken prohibitionist.
“Not only is it a federal handout to Big Tobacco, its risks go far beyond the danger of normalizing drugs. Dr. Finn and other physicians would face unprecedented risks as practitioners under this program. MMJ would face an unfair regulatory burden for trying to do business the right way,” said SAM CEO Kevin Sabet in an emailed statement announcing the amended complaint.
FDA won’t enforce CBD law
Legal battles aside, the Food and Drug Administration has said it would not get in the way of the new Medicare program. Food and Drug Commissioner Martin Makary issued an April 1 memo stating that the FDA would not interfere with CMS’ coverage of CBD products for Medicare patients.
Specifically, the FDA said that it does not intend to enforce sections 502(f)(1) or 505 of the Federal Food, Drug, and Cosmetic Act with respect to an orally administered, hemp-derived CBD product solely on the basis that it contains CBD. It will require that the product is properly manufactured, packaged and labeled as a dietary supplement, is not contaminated, is not packaged or marketed in a way that attracts the attention of children, and is provided as a medical or service item as per Title XVIII under direction of the patient’s treating physician.
However, attorney Vince Sliwoski, in an April 3 response to the memo, said the FDA hasn’t been enforcing the law anyway.
“But the agency is mostly just talk. Its efforts have been limited to sending (and bragging on) sporadic warning letters to select CBD sellers, who make the wildest health claims. All the while, the U.S. hemp cannabinoids market has blossomed into a $20 billion behemoth, with scrupulous and unscrupulous parties selling their wares in a regulatory vacuum,” Sliwoski wrote.
While uncertainty persists within the legal hemp market, Kentucky-based hemp company Cornbread Hemp recently announced it has been selected to be a partner in the government’s program.
“While our industry faces real uncertainty, including a potential federal hemp ban this November, we’re also seeing clear signals that the perception of hemp is shifting,” wrote Cornbread Chief Marketing Officer Jon Katz in a Linkedin post announcing the partnership. “Providers are leaning in. Patients are opening up. Institutions are starting to take this seriously. This pilot is more than distribution. It’s validation.”
