The Trump administration has announced a new initiative that would allow participants in certain alternative payment models to offer hemp-based products to patients when it aligns with clinical guidance.
The new Substance Access Beneficiary Engagement Incentive (BEI) was unveiled on April 1 by the Centers for Medicare & Medicaid Services. The agency said it would be available to providers participating in the ACO REACH model as well as the Enhancing Oncology Model, and will be allowed under the eventual Long-Term Enhanced ACO Design (LEAD) Model beginning next year.
CMS said in the announcement that participating organizations approved under the BEI can offer hemp-derived products valued at up to $500 per beneficiary per year within the model's guidelines and safeguards, and subject to clinical guidance.
Legal products under the model must not exceed 0.3% delta-9 THC, and the program excludes inhalable products, any products where more than 3 mg per serving of tetrahydrocannabinols are ingested orally or any cannabinoids not derived naturally from cannabis plants, CMS said.
These guidelines, the agency said, are in line with existing laws and do not override the Controlled Substances Act.
CMS said that the BEI aligns with its broader goals to promote innovative and patient-centered care, and also tracks with an executive order issued by President Donald Trump in December to pursue research and innovation around hemp-derived products.
“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 the announcement.
CMS emphasized that the demonstration does not equate to a coverage change across Medicare broadly, and that participants will not be reimbursed for these products. The agency said it will track outcomes and implementation as it looks to identify new avenues for cost-effective and appropriate care.
Participants are also responsible for procuring any products offered through the program, CMS said.
For the current period, five ACO REACH accountable care organizations will participate, with additional organizations able to join over time.
“CMS is committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight,” said CMS Administrator Mehmet Oz, M.D., in the press release. “Under the President’s leadership, we’re expanding the tools available to improve patients’ health while generating important insights into how providers can use these tools safely and effectively in real-world care settings.”