For years, patients have turned to cannabinoid products like CBD to manage chronic conditions, often without guidance from their healthcare providers or support from federal systems.

 

That may finally be changing.

 

Following a recent executive action and announcements from the Centers for Medicare & Medicaid Services (CMS), a new pilot initiative is emerging that could expand access to cannabinoid therapies for millions of Americans, particularly those enrolled in Medicare.

 

As shared in a recent webinar between Realm of Caring and Americans for Safe Access, this moment represents more than just a policy shift. It signals a growing recognition that patients are already using these products and that it’s time for healthcare systems to catch up with science and real-world use.

 

Evidence: What We Know About the CMS CBD Pilot & Policy Updates

 

At the center of this effort is the Center for Medicare and Medicaid Innovation (CMMI), which is responsible for testing new healthcare delivery and payment models that aim to:

 

• Improve patient care
• Reduce overall healthcare costs
• Support more coordinated, patient-centered treatment approaches

 

During a recent press conference, Dr. Mehmet Oz emphasized that many Medicare beneficiaries are already using CBD to manage conditions like chronic pain and cancer-related symptoms, often without clinical oversight. He cited data suggesting that 6 in 10 users report improvements in pain, reinforcing the need for structured, evidence-generating programs.

 

The pilot, which is expected to roll out as early as 2026, will allow certain healthcare providers to recommend CBD products to Medicare patients, with the goal of collecting outcomes data that could inform broader coverage decisions in the future.

 

However, this is not a blanket Medicare benefit.

 

Instead, the program will operate through Accountable Care Organizations (ACOs), which are groups of providers who coordinate care and are incentivized to improve outcomes while reducing costs.

 

Where Hemp Products Fit In: The Substance Access BEI

 

A key component of this pilot is the Substance Access Beneficiary Engagement Incentive (BEI). This is a model designed to support structured, physician-guided conversations and potential integration of hemp-derived cannabinoid products into patient care.

 

This model allows participating providers to:

 

• Consult with patients about eligible hemp-derived products
• Integrate these products into care plans when appropriate
• Track outcomes and report findings to CMS

 

Who is eligible?

 

Eligibility for the Substance Access BEI is limited to beneficiaries aligned with participating organizations in models such as ACO REACH, the Enhancing Oncology Model (EOM), or the upcoming LEAD Model.

 

While full criteria are defined at the model level, general eligibility includes:

 

• Adults aged 18 and older
• Individuals who do not meet frailty exclusion criteria
• Those without specified disqualifying conditions (as defined by each model to reduce patient safety risks)
• Individuals who are not pregnant or breastfeeding

 

In addition, participation requires active physician oversight. Providers must determine that cannabinoid use is appropriate and document a shared decision-making process, including:

 

• A discussion of potential benefits and risks
• The patient’s goals and preferences
• A review of current medications and possible interactions
• A plan for follow-up and monitoring

 

What qualifies as an “eligible hemp product”?

 

CMS has begun to define clear parameters for what products may be included in this pilot. Eligible hemp products must:

 

• Be federally legal hemp-derived products containing no more than 0.3% delta-9 THC
• Be orally administered (inhalable products are explicitly excluded)
• Contain no more than 3 mg of total THC per serving, including compounds such as delta-8 THC, delta-10 THC, and THCA
• Contain only cannabinoids that are naturally produced by the cannabis plant (excluding synthetic or chemically altered cannabinoids)

 

In addition:

 

• Products must comply with state and local laws
• The definition aligns with the 2018 Farm Bill and does not override the Controlled Substances Act or authorize Schedule I substances
• CMS may update these definitions if federal law evolves (for example, through appropriations changes impacting hemp regulation)

 

Important considerations:

 

• CMS will not cover the cost of these products
• Participating providers or organizations must fund access
• Strict safeguards will be in place to ensure patient safety and prevent misuse

 

Limitations: Who Is Still Left Out and Why Advocacy Matters Now

 

While the CMS pilot marks meaningful progress, it also highlights just how many patients remain without access.

 

This initiative is limited in scope, both in who qualifies and what products are eligible.

 

Many individuals will still be left out, including:

 

• Pediatric patients, who are often among the most studied and in-need populations for cannabinoid therapies
• Medicaid beneficiaries, who are not included in these Medicare-focused models
• Adults under 65 who do not qualify through disability or other Medicare pathways
• Individuals receiving care in hospice, assisted living, or long-term care settings, where institutional policies and federal law still create barriers

 

At the same time, product eligibility under the pilot is narrowly defined. While this ensures safety and compliance, it may not fully reflect the real-world cannabinoid products that patients are currently using and reporting benefit from.

 

This tension comes at a critical moment.

 

Federal lawmakers are actively considering updates to hemp regulations through the upcoming Farm Bill and appropriations language, which could significantly reshape what products are legally available in the United States. These decisions will directly impact not only consumer access, but also the types of products that can be studied, recommended by providers, and integrated into future healthcare models.

 

Without thoughtful policy, there is a real risk of:

 

• Further limiting access to safe, regulated hemp-derived products
• Disrupting continuity for patients who rely on these therapies
• Slowing the progress of real-world evidence generation

 

At Realm of Caring, this is why initiatives like Save Hemp are so critical.

 

We believe that patients, providers, and researchers must have access to quality-controlled, transparently manufactured cannabinoid products that reflect how these therapies are actually being used in everyday life.

 

Why This Matters: ACOs, Aging, and Whole-Person Care

 

ACOs play a critical role in this model because they are designed to:

 

• Address both medical and social determinants of health
• Reduce unnecessary hospitalizations and ER visits
• Optimize medication use (including “de-prescribing”)

 

This is particularly important for older adults, who often take multiple medications daily. Cannabinoid therapies may offer an opportunity to complement, or in some cases reduce, pharmaceutical burden, but this must be studied carefully and responsibly.

 

Programs like ACO REACH (currently operating nationwide) and the upcoming LEAD Model (launching in 2027) are helping expand access to coordinated care, including for rural and underserved populations.

 

Practical Integration: What This Means for Key Stakeholders

 

For Patients

 

• Stay informed and ask your providers about participation in ACO models
• Consider enrolling in observational research, like Realm of Caring’s CBD & Aging Study
• Advocate for access within your care networks

 

For Providers & ACOs

 

• Evaluate participation in the Substance Access BEI
• Develop research protocols and submit them to CMS for approval
• Identify compliant, high-quality product partners

 

For Product Manufacturers

 

• Ensure products meet anticipated federal standards (GMP, testing, traceability)
• Prepare for consistent supply to support pilot programs
• Build partnerships with ACOs willing to fund and study product use

 

The Role of Research: Why Participation Is Critical

 

This pilot is not just about access, it’s about data.

 

Under the Affordable Care Act, successful demonstration models can be expanded nationally if they show:

 

• Improved health outcomes
• Maintained or reduced costs

 

That means participation from patients, providers, and industry is essential.

 

At Realm of Caring, our research initiatives, including the CBD & Aging Study, are designed to complement these efforts by capturing real-world data on how cannabinoid use impacts health over time.