The Hemp Brand's BEI Playbook
How hemp brands enter Medicare's first federal cannabinoid channel,
powered by TruCBN™




A new federal channel for hemp-derived cannabinoid products in Medicare has launched
The CMS Substance Access BEI Program went live on April 1, 2026, inside ACO REACH and the Enhancing Oncology Model — covering 125,000+ providers and roughly 1.7 million Traditional Medicare beneficiaries.¹
~46%
Sleep Difficulty
of adults 65–74 report sleep difficulty²
14.3M
Medicare in ACOs
beneficiaries already in ACOs, on a path to 100% of Traditional Medicare (~33M) by 2030³ ⁴
~32M
Risky Prescriptions
benzodiazepine and Z-drug prescriptions filled by Medicare patients 65+ each year — all on the AGS Beers list⁵
$625K
Per ACO / Year
in revenue at 10% adoption of the $500/year hemp BEI for a single, average-sized ACO. REACH alone has 73 ACOs.⁶
ACOs are submitting Implementation Plans to CMS detailing how they will incorporate hemp-derived cannabinoid products into patient care. Once approved, the ACO buys products at fair market value and provides them free to enrolled Medicare patients (capped at $500 per patient annually), in coordination with treating physicians through shared decision-making. The ACO absorbs the product cost but earns a share of any Medicare savings generated when those products improve outcomes and reduce downstream spending.

For the hemp industry, this is the first federally sanctioned pathway for non-pharmaceutical cannabinoids into the healthcare system — with the potential to reshape how sleep, pain, and anxiety are managed across the Medicare population.
Positioning for Success
This is a significant opportunity for hemp CPG brands, but the program's success will hinge on whether physicians are willing to recommend these products to their elderly patients. CMS has set the minimum bar for product acceptance — but that bar will not be enough to earn a physician recommendation.
What Physicians Must Do
Before recommending a product, physicians must conduct a documented shared decision-making conversation with each patient, covering risks, benefits, and drug interactions.⁷
A third-party COA does not give them what they need for that conversation. Medicare patients are older than most clinical trial participants, manage multiple chronic conditions, and often take several prescriptions with real interaction risk.
What Physicians Need to Know
  • How your product behaves in the elderly population
  • How it interacts with existing medications
  • Whether outcomes hold up outside of a controlled trial setting
  • Peer-reviewed clinical and real-world evidence to defend recommendations to colleagues
  • Documentation they can place in the patient's chart if questions arise later
TruCBN™ Meets the Needs of ACOs, Physicians, and Patients
As the only hemp ingredient on the market today that is clinically validated to improve sleep, TruCBN™ delivers on every level:
For ACOs
A clear financial impact analysis demonstrating measurable Medicare savings potential
For Physicians
Peer-reviewed efficacy and safety data to support confident, documented recommendations
For Patients
An effective sleep solution that won't impair cognition — safe for the elderly population
Your Guide to Getting Your Product Accepted
Below are the minimum requirements for the BEI Hemp Substance Access Implementation Plan, alongside the TruCBN™ material that satisfies each one.

While the minimum requirements may earn your product a consideration, convincing ACOs to adopt your product requires much more — including a compelling financial impact case.
Beyond the Basics: The Financial Impact Case for Sleep
ACOs earn 50% of any Medicare savings generated when these products improve outcomes and reduce downstream spending. To win with ACOs, you need a clear understanding of the financial impact your product offers.
The Hidden Cost of Poor Sleep
Poor sleep is one of the largest hidden cost drivers in the Medicare population. The current standard of care for older adults with sleep complaints is benzodiazepines and Z-drugs — both on the AGS Beers list and explicitly flagged to be avoided in this population because of:
  • Falls and fractures
  • Delirium
  • Cognitive impairment⁸
The Numbers That Matter to ACOs
$53B
Falls Cost Medicare
per year in fall-related healthcare spending⁹
$40K+
Hip Fracture
average first-year cost per hip fracture event⁹
Every sedative-hypnotic prescription written for a senior patient carries a probability of becoming an ED visit, a hospitalization, or a post-acute episode that lands directly on the ACO's books.

TruCBN™ changes the math. Non-intoxicating, with no next-day cognitive impairment profile and no association with the fall risk that defines the existing standard of care — that is the cost-of-care case the medical director needs to see, and it is the case TruCBN™ is already prepared to make.
Fully Prepared, From Day One
TruCBN™ is the most clinically validated, regulatory-ready CBN ingredient on the market. Below is the full stack of evidence and documentation already produced to support physicians, medical directors, and ACO leadership making decisions about which products to bring into their Implementation Plans.
Published RCT
1,020-participant, double-blind, placebo-controlled study across three dose levels¹⁰
GLP Toxicology
Full GLP toxicology and genotoxicity package
Real-World Evidence
164-participant, 29-day real-world evidence study
Regulatory Filings
Self-Affirmed GRAS and NDI filings in progress
Certified Manufacturing
cGMP, ISO 9001, and NSF certified facility
CMC Documentation
Comprehensive CMC documentation package
Product Profile
THC-free, non-hormonal, non-habit-forming

The value doesn't stop with the BEI. The same evidence that gets a physician to recommend TruCBN™ to a Medicare patient also stands up in a retail buyer meeting, on a product page, and in front of any customer asking what makes this CBN different.
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.¹¹
1
April 1, 2026
BEI Program launches inside ACO REACH and Enhancing Oncology Model. FDA issues first enforcement discretion for hemp-derived CBD in Medicare.¹³
2
January 1, 2027
ACO LEAD launches, replacing REACH. Expands eligibility to dually eligible, homebound, and underserved populations. Runs through December 31, 2036.
3
2030
CMS goal: 100% of Traditional Medicare beneficiaries (~33 million people) in an accountable care relationship. Every one a potential BEI patient.³ ⁴
4
2036
Brands that earn physician recommendations early will define the cannabinoid category through the next decade of LEAD program operation.
The December 2025 executive order behind the BEI directs federal agencies to "develop research methods and models utilizing real-world evidence to improve access to hemp-derived cannabinoid products"¹² — the federal channel hemp brands have spent years asking for. TruCBN™'s in-progress GRAS and NDI work is built precisely for this regulatory precedent.

Pick TruCBN™ once and you're positioned for both — the BEI today, and the broader supplement market right behind it.
Move First
The brands that build BEI-ready products soon will be the ones physicians recommend in 2027 and beyond. Choose how you want to get there:

Build it yourself
Purified Bulk CBN 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 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 your company:
Get in Touch

Thank you,
Micah Hogan
Chief Growth Officer, FloraWorks
micah@flora-works.com
References & Disclosures
  1. CMS / Vicente, Substance Access BEI Program FAQ (Feb 2026) — 74 ACO REACH ACOs + 28 EOM oncology practices = 102 organizations, 125,000+ providers, ~1.7M Traditional Medicare beneficiaries in 2026. https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive
  1. 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
  1. CMS, 2026 Medicare Accountable Care Organization Initiatives Participation Highlights — 14.3M Medicare beneficiaries in an ACO as of January 2026, up 4.4% YoY. https://www.cms.gov/newsroom/fact-sheets/2026-medicare-accountable-care-organization-initiatives-participation-highlights
  1. CMS stated goal: 100% of Traditional Medicare beneficiaries in accountable care relationships by 2030 (referenced in CMS 2026 ACO Participation Highlights and Innovation Center strategy materials). 2030 Traditional Medicare population estimated at 33M, derived from CBO/Trustees total Medicare projection (77–78M by 2030/2031) minus projected MA share (~57% per CBO). https://www.cbo.gov/publication/60383
  1. 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
  1. CMS Innovation Center, Substance Access Beneficiary Engagement Incentive (program page) — establishes the $500/beneficiary/year cap and the participating-ACO structure used in this calculation. https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive
  1. CMS Substance Access BEI requirements — physician-supervised shared decision-making, medication review, follow-up. https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive
  1. American Geriatrics Society 2023 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults — benzodiazepines and Z-drugs explicitly to be avoided.
  1. Haddad YK, et al. Healthcare spending for non-fatal falls among older adults, USA, 2024 — total ~$80B in healthcare spending from non-fatal falls, $53.3B Medicare (2020 data). https://pmc.ncbi.nlm.nih.gov/articles/PMC11445707/ Hip fracture first-year costs: CDC, Cost of Older Adult Falls.
  1. 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
  1. 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
  1. Executive Order, Increasing Medical Marijuana And Cannabidiol Research, December 18, 2025.
  1. FDA, Enforcement Discretion for Orally Administered Hemp-Derived Cannabidiol Products Provided Through Medicare Programs, announced April 1, 2026 by Commissioner Martin Makary. Discretion applies to products that (1) are manufactured, marketed, and labeled consistent with the dietary supplement framework; (2) are not contaminated; (3) are not packaged or marketed for children; and (4) are provided to beneficiaries through a Medicare program under physician direction. https://www.fda.gov/media/191782/download

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.