Hemp in Medicare: The BEI Playbook
How to enter Medicare's first federal cannabinoid channel with clinical evidence + safety data, powered by TruCBN™
A new channel for hemp-derived cannabinoid products in Medicare has launched
The CMS Substance Access BEI Program went live April 1, 2026, inside ACO REACH and the Enhancing Oncology Model — two models that together cover 125,000+ providers and roughly 1.7M Traditional Medicare beneficiaries. ¹ ²
Sleep Difficulty
of adults 65–74 report sleep difficulty³
Medicare Beneficiaries in ACOs
14.3M Medicare beneficiaries already in ACOs, with continued CMS direction to expand accountable care.²
High Risk Prescriptions
benzodiazepine and Z-drug prescriptions filled by Medicare patients 65+ each year — all on the AGS Beers list⁴
Per ACO / Year
Potential revenue modeled at 10% adoption of the $500/year hemp BEI for an average ACO. REACH alone has 74 ACOs.¹ ²
How it Works
ACOs submit Implementation Plans to CMS detailing how they will incorporate hemp-derived cannabinoid products into patient care. Once approved, the ACO procures products at fair market value and supplies them to its affiliated physicians, who furnish them directly to enrolled Medicare patients (capped at $500 per patient annually) as part of a clinician-led care plan built around shared decision-making. The ACO fronts the product cost but earns a share of any Medicare savings generated when those products improve outcomes and reduce downstream spending.
Product Acceptance Guide
Below are the minimum requirements for the BEI Hemp Substance Access Implementation Plan, alongside the TruCBN™ material that satisfies each one.
TruCBN™ Meets the Needs of ACOs, Physicians, and Patients
TruCBN™ is the only hemp-derived ingredient on the market today with published peer-reviewed clinical evidence for sleep and safety, which matters because adoption inside the BEI program does not come from a single decision. It comes from three: the ACO needs to approve the product, the physician needs to recommend it, and the patient needs to trust it. TruCBN™ gives your brand what it takes to clear all three.
For ACOs
TruCBN™ gives ACO medical directors a defensible cost-of-care argument for sleep. Peer-reviewed clinical and real-world evidence support meaningful sleep improvement in a non-impairing format, which addresses patient complaints while reducing downstream cost categories that drive ACO losses. For an ACO operating on shared savings, that creates a credible path to reducing total cost of care across the Medicare panel.
For Physicians
TruCBN™ gives physicians the documentation they need to lead a defensible shared decision-making conversation. The package covers the core areas that conversation has to address: how the product is expected to help the patient, what potential side effects to watch for, and what guidance to provide on drug interactions. That gives physicians the confidence to recommend, defend, and document the choice.
For Patients
What older patients want from a sleep solution is straightforward: fall asleep, stay asleep, wake up clear-headed, and not worry that what they are taking will become a habit or interfere with their other medications. TruCBN™ delivers on every one of those needs. When the recommendation comes from their physician, patients can trust the product because the science behind it earned the physician's trust first.
ACOs — The Financial Impact Case for Sleep
ACOs share in any Medicare savings they generate when outcomes improve and downstream spending drops. Because poor sleep directly contributes to many of the most expensive cost categories in the elderly Medicare population, it is one of the easiest places to build a quantifiable savings model.
The Sleep Cost Cascade
The current standard of care — benzodiazepines and Z-drugs — can work against an ACO's desired outcomes. Both types of drugs sit on the AGS Beers list with explicit recommendations to avoid them in older adults⁵, yet together they account for roughly 32 million prescriptions a year for Medicare patients 65 and over⁴. Each one of those prescriptions creates a potential liability for an ACO.
Average cost per event: $48,000+ for a single hip fracture⁶, $30,000+ for a delirium episode⁷, and $25,000+ for a fall-related hospitalization⁸.
What TruCBN™ Brings to An ACO
Sleep Without Impairment
A hemp-derived sleep ingredient with published clinical evidence of meaningful sleep improvement and no measured cognitive impairment.
Improved Cognition
Replacing benzodiazepines and Z-drugs with a non-impairing alternative supports clearer cognition across the patient population.
Reduced Medicare Spending
Better sleep means fewer falls, fewer ER visits, and fewer hospital stays. Each one reduces Medicare spending, and ACOs share in what gets saved.
Physicians & Patients —Positioning for Success
Physicians operate inside the framework of evidence-based medicine. Every recommendation they put in a patient's chart has to be defensible to the patient asking questions and to other providers reviewing the file. Published, peer-reviewed evidence gives them that defensibility. Without it, a recommendation sits outside the standard of care, and most physicians won't take that risk for an elderly Medicare patient on multiple medications.
TruCBN™ gives physicians the evidence to lead a documented shared decision-making conversation with confidence:
Product performance in adults with sleep difficulties
Peer-reviewed clinical evidence to inform recommendations
On-going real-world evidence on quality of life
Safety, toxicology and drug interaction data to reference
Built for Commercialization, Not Just Supply
TruCBN™ is a clinically validated, regulatory-ready CBN ingredient with the evidence, safety data, and quality documentation needed to support a differentiated sleep product line.
Published RCT
1,020-participant, double-blind, placebo-controlled study across three dose levels⁹
GLP Toxicology
Full GLP toxicology and genotoxicity package
Real-World Evidence
164-participant, 29-day consumer use study supporting product experience
Regulatory Ready
Self-Affirmed GRAS and NDI filings in progress
Certified Manufacturing
cGMP, ISO 9001, and NSF certified facility
CMC-Backed Standardization
Documented specifications, analytical methods, and manufacturing controls
Clinical Use Guidance
Metabolism review, drug interaction, and dosing context from clinical and toxicology studies
Product Profile
THC-free, non-hormonal, non-habit-forming
Future Growth with TruCBN™
The BEI is the start of a decade-long expansion of cannabinoid access in Medicare. ACO REACH sunsets at the end of 2026 and rolls into ACO LEAD on January 1, 2027 — a 10-year program built to absorb current REACH participants and expand into dually eligible, homebound, and underserved populations.¹⁰
April 1, 2026
BEI Program launches inside ACO REACH and Enhancing Oncology Model.
January 1, 2027
ACO LEAD launches, replacing REACH. Expands eligibility to dually eligible, homebound, and underserved populations. Runs through December 31, 2036.
2030
CMS Innovation Center direction: expand accountable care to nearly all Traditional Medicare beneficiaries by 2030. Every one a potential BEI patient.¹¹
2036
Brands that earn physician recommendations early will define the cannabinoid category through the next decade of LEAD program operation.
Take Action Now
The brands that build BEI-ready products now will be the ones physicians recommend in 2027 and beyond. Choose how you want to get there:
Build it yourself
Purified Bulk TruCBN™ for your own formulations. Shipped with the full clinical, safety, and compliance documentation your team needs for ACO conversations.
Ship it under your brand
White label 50 mg TruCBN™ softgels: the exact format and dose from the published RCT, manufactured under FloraWorks' cGMP and shipped under your brand. The fastest path to a BEI-ready product.
Reach out and we'll walk you through whichever path makes sense for you and your company:
Thank you,
Micah Hogan
Chief Growth Officer, FloraWorks
micah@flora-works.com
References & Disclosures
- CMS, CMS Marks Milestone in Expanding Patient-Centered Innovation with Substance Access Beneficiary Engagement Incentive, press release, April 1, 2026. https://www.cms.gov/newsroom/press-releases/cms-marks-milestone-expanding-patient-centered-innovation-substance-access-beneficiary-engagement
- CMS, "2026 Medicare Accountable Care Organization Initiatives Participation Highlights," fact sheet, January 2026. https://www.cms.gov/newsroom/fact-sheets/2026-medicare-accountable-care-organization-initiatives-participation-highlights
- National Sleep Foundation, Sleep in America Poll (cited in NIH/PMC, Sleep in the Aging Population): 46% of community-dwelling adults aged 65–74 report insomnia symptoms; 40–50% of adults 60+ have difficulty sleeping. https://pmc.ncbi.nlm.nih.gov/articles/PMC5300306/ — Diagnosis rate (5–12% of cases captured in primary care): Pujol Salud J, et al. Primary Care Records and Population Prevalence of Chronic Insomnia: Do They Match? Healthcare, 2025. https://www.preprints.org/manuscript/202509.2506/download/final_file
- Borrelli E, et al. Assessing the prevalence of Beers medication utilization in the Medicare Part D population in 2020. Journal of the American Geriatrics Society, 2024. 25,949,994 benzodiazepine + 6,204,909 Z-drug prescriptions filled by Medicare beneficiaries 65+ in 2020. https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.18943
- By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society, 2023. (Benzodiazepines and non-benzodiazepine "Z-drug" hypnotics listed in the "Avoid" category for older adults due to increased risk of cognitive impairment, delirium, falls, fractures, and motor vehicle crashes.) https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.18372
- Williams SA, Daigle SG, Weiss R, et al. Economic Burden of Osteoporosis-Related Fractures in the US Medicare Population. Annals of Pharmacotherapy, 2021. https://pubmed.ncbi.nlm.nih.gov/33148010/
- Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-Year Health Care Costs Associated with Delirium in the Elderly Population. Archives of Internal Medicine, 2008;168(1):27-32. Delirium adds approximately $30,000–$60,000 in excess healthcare costs per case in older adults; benzodiazepine and Z-drug use is a known precipitant. https://pubmed.ncbi.nlm.nih.gov/18195192/
- Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. Journal of the American Geriatrics Society, 2018;66(4):693-698. Hospitalized falls in adults 65+ averaged ~$25,000–$30,000 in direct medical costs; the majority of these costs were borne by Medicare. https://pubmed.ncbi.nlm.nih.gov/29446432/
- Pharmaceuticals 2024, 17(8): 977 — TruCBN™ RCT (1,020 participants, double-blind, placebo-controlled, 25/50/100 mg). https://www.mdpi.com/1424-8247/17/8/977
- CMS, Long-term Enhanced ACO Design (LEAD) Model — launches January 1, 2027 and runs through December 31, 2036; replaces ACO REACH; LEAD is expected to be the main option for risk-bearing ACOs in FFS Medicare through 2036. Applications for the first performance year close May 17, 2026. https://www.cms.gov/priorities/innovation/innovation-models/lead
- CMS Innovation Center, "Innovation Center Strategy Refresh," whitepaper, October 2021. (Stated goal: 100% of Traditional Medicare beneficiaries in an accountable care relationship by 2030.) https://www.cms.gov/priorities/innovation/strategic-direction-whitepaper