How access works
Reviewed by executive management. September 16, 2026. Scientific review pending.
The Substance Access Beneficiary Engagement Incentive is an optional feature of three CMS Innovation Center models. An approved model participant that elects the incentive may consult with eligible patients about certain hemp products and, subject to CMS requirements and safeguards, furnish an eligible product directly. This is not Medicare coverage or reimbursement for the product.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
Who can offer it
The incentive is available to approved participants in:Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
- The ACO REACH Model and Enhancing Oncology Model from April 1, 2026
- The Long-term Enhanced ACO Design Model from January 1, 2027
A participant may offer the incentive only after electing it for the applicable performance period, submitting and maintaining a CMS-required Implementation Plan, and receiving CMS approval.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
Who can receive it
Only patients currently aligned with an approved participating organization that has elected the incentive may receive it. Additional requirements appear in the applicable model documents and the organization’s CMS-approved Implementation Plan.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
CMS says the general criteria include being 18 or older, not meeting the model’s frailty exclusion, not having a specified disqualifying condition, and not being pregnant or breastfeeding.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
The participating organization applies these criteria. Micelle Therapeutics does not determine whether a patient is eligible.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
What the physician must do
A physician must determine that use is appropriate and document shared decision-making. At a minimum, that includes discussing:Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
- Potential benefits and risks
- The patient’s goals and preferences
- Current medicines and possible interactions
- A plan for follow-up
Any eligible product must be furnished directly by a qualified physician affiliated with the participating organization.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
What it costs
The participating organization is responsible for procurement and operations. Medicare does not pay the organization for the product.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
CMS permits a participant to furnish up to $500 in product value per eligible patient per year. The $500 figure is an annual ceiling, not a guaranteed allowance, cash payment, reimbursement or product price.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
Patients should not be asked to submit a Medicare claim or to buy a product at retail and submit a receipt under this incentive.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
What an eligible product is
Under CMS’s current definition, an eligible product must be a federally legal hemp-derived product containing no more than 0.3 percent delta-9 THC on a dry-weight basis. It must also comply with applicable state and local laws.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
The product cannot be inhaled. An orally administered product cannot contain more than 3 milligrams per serving of specified tetrahydrocannabinols, including delta-8 THC, delta-10 THC and THCA. It cannot contain cannabinoids that are not naturally produced, or capable of being produced, by the cannabis plant during cultivation.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
CMS also requires products to come from a legally compliant source and to undergo third-party testing for potency, contaminants and microbial hazards, with negative results for contaminants and microbial hazards.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
Federal law is changing
Federal hemp law is changing in stages. From November 12, 2026, products containing cannabinoids that the cannabis plant cannot naturally produce are excluded from the federal definition of hemp. Further changes follow in December 2026, moving the definition to a combined total cannabinoid standard measured per container and potentially covering additional cannabinoids specified by statute or determined by federal authorities. We will state the exact thresholds and effective date here once they are confirmed against the enacted text. CMS says it will adjust its definition when applicable legal limits change.Source: Public Law 119-37, Section 781; CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
What this incentive is not
This incentive is not Medicare coverage or reimbursement for a hemp product. Medicare does not pay the participating organization for the product.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
CMS approval of an organization’s Implementation Plan does not make a product an FDA-approved treatment. Participating organizations also may not market the incentive or product availability to influence whether a patient selects or remains aligned with them.Source: CMS: Substance Access Beneficiary Engagement Incentive; FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). Last checked: .
If you believe your care organization participates, ask your care team. Micelle Therapeutics cannot determine whether you are eligible.Source: CMS: Substance Access Beneficiary Engagement Incentive. Last checked: .
Primary sources: CMS, “Substance Access Beneficiary Engagement Incentive”; FDA CBD regulatory information; and Public Law 119-37 §781. Last checked September 16, 2026.Source: CMS: Substance Access Beneficiary Engagement Incentive; FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD); Public Law 119-37, Section 781. Last checked: .