CMS definition and requirements
Primary-source requirements for participants, with Micelle evidence and interpretation clearly bounded.
Primary source crosswalk
CMS requirements and the Micelle response.
CMS defines its incentive and approves participant plans. Micelle is a potential supplier, not a model participant or approving authority. A planned federal THC target alone does not establish compliance or eligibility.
| Requirement | CMS source requirement | Responsible party | Micelle response or gap | Evidence status |
|---|---|---|---|---|
| Participating model and election | Eligible ACO REACH and Enhancing Oncology Model (EOM) participants may begin offering the BEI April 1, 2026; it becomes available to eligible LEAD participants January 1, 2027. The participant must elect it for the applicable period. | Organization | Micelle provides product information for consideration, not model participation or CMS election. | Verified against CMS page, October 1, 2026 |
| CMS Implementation Plan | A participant submits and maintains a plan naming product and dosing, distribution amount/frequency, beneficiary eligibility, safeguards and oversight; CMS approval is required. | Organization / CMS | Access framework and template structure available. No organization-specific plan or CMS approval is represented. | Planned approach |
| Product definition and law | CMS limits eligible products to federally legal hemp-derived products with no more than 0.3% delta-9 THC. It excludes inhalables; orally administered products above 3 mg tetrahydrocannabinols per serving (including delta-8, delta-10 and THCA); and products containing cannabinoids not naturally produced or capable of being produced by or in the cannabis plant during cultivation. State and local law also applies; CMS says its definition will adjust to legal changes. | Organization evaluates; supplier provides evidence | Planned isolate softgel and controlled testing structure. Final composition and genuine lot evidence pending; the planned <0.4 mg/container target alone proves neither compliance nor CMS eligibility. | Evidence pending |
| Product quality and testing | Applicable production, quality and safety law; legally compliant source and high-quality farm. Third-party testing must measure cannabinoid potency accurately, separately from contaminant and microbial-hazard testing with negative results. | Organization procurement / supplier evidence | Ingredient evidence-status records A and B explain which source certificates are missing, and a blank finished-product certificate format model is available. Actual controlled certificates, independent finished-product results and laboratory engagement remain pending. | Evidence pending |
| Beneficiary and physician decision | Participant applies beneficiary criteria. A physician determines appropriateness and documents risks, benefits, goals, preferences, medication review and follow-up. | Participating organization and affiliated physician | Patient discussion guide available for review; no individual eligibility decision or medical advice on this website. | Planned approach |
| Procurement and direct supply | Participant controls procurement, contracting, storage, inventory and distribution; a qualified affiliated physician furnishes product directly. No retail receipt reimbursement. | Participating organization | Planned handling and lot-record model; no released supply service or contract terms are published. | Evidence pending |
| Cost and contracting | Up to $500 per eligible beneficiary per year, subject to safeguards; Medicare does not pay for the product. No inducement or manufacturer selection remuneration; fair-market-value and referral restrictions apply. | Participating organization | No Micelle price, valuation method, coverage or contract is asserted. The $500 limit is not a published Micelle price or a reimbursement claim. | Evidence pending |
| Reporting and integrity | Required quarterly reports, supplemental information on request, participant oversight and program-integrity safeguards. | Participating organization | Synthetic example CSV illustrates a possible de-identified record shape only. Not a CMS submission or approved reporting format. | Planned approach |
Primary source: CMS Substance Access BEI requirements . Retrieved October 1, 2026. Product interpretation requiring independent legal review remains pending.
Next step: Request a briefing for your organization's review. Do not send patient information.