Centers for Medicare & Medicaid Services Releases New Details on CBD Pilot Program, Starting April 1
- The Centers for Medicare and Medicaid Services (CMS) will launch a pilot program starting April 1 allowing certain Medicare beneficiaries to receive up to $500 per year in eligible hemp-derived products through participating organizations, though Medicare will not cover the cost directly.
- Eligible hemp products must be federally legal, containing no more than 0.3% delta-9 THC, and orally administered products may have up to 3 mg of certain tetrahydrocannabinols; inhalable products and synthetic cannabinoids are excluded.
- Qualification for the program requires beneficiaries to be at least 18, aligned with participating organizations, free of disqualifying conditions, not pregnant or breastfeeding, and approved by a physician after a documented shared decision-making process.
- Strict quality and safety requirements mandate products comply with federal, state, and local laws, come from legal sources, and pass third-party testing, with participating organizations managing procurement and distribution without directing beneficiaries to retail purchases.
The Centers for Medicare and Medicaid Services has posted new details about its forthcoming hemp products pilot, confirming that certain Medicare beneficiaries may receive eligible hemp-derived products through participating organizations beginning April 1. The updated information provides a clearer picture of how the Substance Access Beneficiary Engagement Incentive, or BEI, will work. According to CMS, the optional program will allow participants in certain Innovation Center models to consult with eligible beneficiaries about the possible use of hemp products to improve symptom control. Participating organizations may furnish up to $500 per year in eligible hemp products for each beneficiary, although Medicare itself will not pay for the products and beneficiaries are not supposed to submit a Medicare claim for them.
The new guidance also confirms that eligible hemp products will be limited to federally legal hemp-derived products containing no more than 0.3% delta-9 THC. In addition, CMS says orally administered products may contain no more than 3 milligrams per serving of tetrahydrocannabinols such as delta-8-tetrahydrocannabinol, delta-10-tetrahydrocannabinol and tetrahydrocannabinolic acid. Inhalable products are excluded, as are cannabinoids that are not naturally produced, or capable of being produced, by the marijuana plant during cultivation.
CMS also added new details on who may qualify. Only beneficiaries aligned to participating organizations that elect to offer the BEI may receive it. To qualify, a beneficiary generally must be at least 18, cannot meet the model’s frailty exclusion, cannot have certain disqualifying conditions and cannot be pregnant or breastfeeding. A physician must determine that use is appropriate and document a shared decision-making process that includes a discussion of benefits and risks, the beneficiary’s goals and preferences, and a review of current medications and potential interactions.
The agency also outlined new quality and safety requirements. Products must comply with federal, state and local production, quality and safety laws, come from a legally compliant source consistent with 2018 Farm Bill hemp requirements, and be tested by a third party for potency, contaminants and microbial hazards with negative results.
The updated page further says participating organizations are responsible for procurement, ordering, storage, inventory controls and distribution workflows. Eligible products must be provided directly by a qualified physician affiliated with the participant organization, and participants cannot tell beneficiaries to buy retail products and seek reimbursement.
The update adds significantly more structure to a pilot that until now had been short on specifics, including clearer guardrails on eligibility, THC content, sourcing and product safety.