Physician Concerns Raise Questions About CMS Hemp CBD Program

The Centers for Medicare & Medicaid Services (CMS) is facing a significant challenge with its Substance Access Beneficiary Engagement Incentive (Substance Access BEI) program, according to a recent statement from MMJ International Holdings, Inc. (MMJ). The program, which allows participating organizations in certain Medicare Innovation Center models to provide qualifying hemp-derived cannabinoid products to eligible beneficiaries, has run into a critical issue: the role of the physician.

Dr. Paul Shields, Chief Medical Officer of Vantage Hemp, a company working with healthcare organizations around the CMS initiative, has highlighted the importance of standardized, reproducible products and controlled clinical trials. Shields, speaking in a recent healthcare-industry discussion, noted that while CMS can create the program and financial incentives, physicians remain responsible for determining the appropriateness of the use, reviewing medications and potential interactions, discussing risks and benefits, and following the patient.

Shields emphasized that the physician acts as the final clinical checkpoint between an unvalidated cannabinoid product and a Medicare patient. This role is crucial, as it underscores the need for evidence-based medicine. Shields stated, "Healthcare requires evidence. Current cannabinoid experience can be difficult to reproduce and standardize, and medicine needs reproducible, standardized products."

MMJ, which has spent over eight years and more than $10 million on developing its own defined soft-gelatin capsule containing 5 mg CBD and 2.5 mg THC, has built the pathway described by Shields. The company has pursued analytical characterization, chemical fingerprinting, pharmaceutical stability work, and two FDA Investigational New Drug programs. Despite these efforts, the path to widespread adoption remains challenging.

The issue is further complicated by ongoing litigation. In May 2026, U.S. District Judge Trevor N. McFadden dismissed a challenge brought by MMJ and its co-plaintiffs for lack of Article III standing. The court did not rule on the underlying Administrative Procedure Act claims or the statutory authority asserted for the initiative. MMJ has appealed the decision, and the case remains before the U.S. Court of Appeals for the D.C. Circuit.

CMS has deliberately carried the Substance Access BEI into a federal Medicare framework that will operate for a decade, starting January 1, 2027. This move raises questions about the program's long-term viability and the need for standardized, reproducible products. CMS places physicians in the position of evaluating appropriateness, medications, interactions, risks, and benefits, highlighting the critical role they play.

The European Food Safety Authority (EFSA) recently evaluated a Charlotte's Web, Inc. carbon-dioxide extract from Cannabis sativa L. submitted as a novel food. EFSA identified problems involving product characterization, stability information, and whether the material used in toxicology studies was sufficiently representative of the product under evaluation. EFSA ultimately concluded that safety under the proposed conditions of use could not be established from the evidence submitted.

This decision underscores the importance of reproducibility and standardized products. Shields, in his discussion, emphasized that "product composition matters. Dose matters. Manufacturing consistency matters. Stability matters. Otherwise, differences in the products themselves risk becoming another variable in the data the government is trying to interpret."

MMJ's CEO, Duane Boise, echoed Shields' sentiments, stating, "CMS can create an incentive, but it cannot create physician confidence in an unvalidated product.

The challenge for CMS is clear: while the program aims to provide access to cannabinoid products, the lack of standardized, reproducible products and controlled clinical trials remains a significant hurdle. The physician's role as the final clinical checkpoint underscores the need for evidence-based medicine and the importance of addressing these issues before the program's 10-year tenure begins.