Medicare CBD Coverage Lawsuit: Federal Case Status and Patient Rights

Executive Summary

A federal lawsuit challenging Medicare's exclusion of cannabidiol (CBD) products from coverage has advanced through the court system as of August 2026, marking a significant development in the intersection of federal healthcare policy and cannabis therapeutics. The litigation centers on whether the Centers for Medicare & Medicaid Services (CMS) can legally deny coverage for FDA-approved CBD medications under Medicare Part D prescription drug plans, despite the drugs meeting traditional approval standards. The case carries implications for approximately 65 million Medicare beneficiaries nationwide, many of whom face out-of-pocket costs exceeding $30,000 annually for FDA-approved CBD treatments like Epidiolex. Legal experts characterize the lawsuit as a test case for how federal agencies reconcile the Controlled Substances Act scheduling framework with the Medicare statute's requirement to cover medically necessary FDA-approved drugs. The advancement of this litigation occurs against the backdrop of broader federal rescheduling efforts and growing state-level medical cannabis programs, creating a complex regulatory landscape where patients, healthcare providers, and insurers navigate conflicting federal policies on cannabis-derived therapeutics.

Why This Matters

The Medicare CBD coverage lawsuit affects the largest federal healthcare program in the United States, with direct financial and medical implications for millions of patients suffering from treatment-resistant epilepsy and other qualifying conditions. Medicare serves approximately 65 million Americans, including adults over 65 and younger individuals with qualifying disabilities. The exclusion of CBD medications from coverage creates a two-tier system where patients with private insurance or Medicaid may access these treatments while Medicare beneficiaries face prohibitive costs. Epidiolex, the first FDA-approved CBD drug, carries a list price of approximately $32,500 annually, placing it beyond reach for most seniors living on fixed incomes averaging $1,900 monthly according to Social Security Administration data. The pharmaceutical industry watches this case closely because the outcome will determine whether cannabis-derived drugs face unique coverage barriers compared to other Schedule V controlled substances that Medicare routinely covers. Investment analysts estimate the U.S. market for FDA-approved cannabinoid medications could reach $4.8 billion by 2030 if Medicare coverage barriers fall, according to Cowen & Company research published in 2025. Patient advocacy organizations including the Epilepsy Foundation and Americans for Safe Access have filed amicus briefs supporting the lawsuit, arguing that Medicare's categorical exclusion of cannabis-derived drugs violates the program's statutory mandate under 42 U.S.C. § 1395w-102 to cover all medically necessary FDA-approved medications. The organizations cite clinical data showing that approximately 30% of epilepsy patients do not respond adequately to conventional anticonvulsant medications, making Epidiolex a critical treatment option for this population. Healthcare providers face ethical dilemmas when they cannot prescribe the most effective FDA-approved treatment because their Medicare patients cannot afford it. The American Medical Association and American Academy of Neurology have both issued statements supporting Medicare coverage for FDA-approved cannabinoid medications, arguing that coverage decisions should reflect clinical evidence rather than the historical classification of source materials.

Background and History

The Medicare CBD coverage dispute emerged from the collision of decades-old drug scheduling laws with 21st-century pharmaceutical development, creating a regulatory gap that left FDA-approved cannabis-derived medications in coverage limbo.

The Controlled Substances Act Framework (1970-2018)

Congress enacted the Controlled Substances Act in 1970 as Title II of the Comprehensive Drug Abuse Prevention and Control Act, establishing five schedules of controlled substances under 21 U.S.C. § 812. The statute placed cannabis and all cannabis-derived substances in Schedule I, defined as drugs with high abuse potential, no accepted medical use, and lack of accepted safety for use under medical supervision. This classification created a categorical prohibition that would persist for nearly five decades. The Social Security Act, which governs Medicare under 42 U.S.C. § 1395 et seq., contains an exclusion at 42 U.S.C. § 1395y(a)(2) barring coverage for drugs that are not approved by the FDA or are used for non-FDA-approved indications. However, a separate provision in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 created an additional exclusion for drugs covered under Medicare Part D, prohibiting coverage for drugs in certain categories regardless of FDA approval status.

FDA Approval of Epidiolex (2018)

On June 25, 2018, the FDA approved Epidiolex (cannabidiol oral solution) manufactured by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years and older. The approval marked the first time the FDA had approved a drug derived from cannabis, based on clinical trial data involving more than 500 patients demonstrating significant reduction in seizure frequency compared to placebo. The DEA responded by rescheduling FDA-approved drugs containing CBD derived from cannabis and containing no more than 0.1% tetrahydrocannabinol from Schedule I to Schedule V under 21 U.S.C. § 811(a), effective September 27, 2018. This rescheduling applied specifically to Epidiolex and any future FDA-approved CBD drugs meeting the same criteria, while cannabis-derived CBD products without FDA approval remained Schedule I substances.

CMS Coverage Determination (2018-2019)

Following Epidiolex's approval and rescheduling, healthcare providers and patients expected Medicare Part D plans would cover the medication as they do other Schedule V controlled substances. However, CMS issued guidance to Part D plan sponsors indicating that Epidiolex remained excluded from coverage under the Medicare Part D program. CMS based its exclusion on 42 U.S.C. § 1395w-101(a)(2)(A), which states that Part D plans are not required to cover drugs excluded under 42 U.S.C. § 1395y(a)(2). The agency interpreted this provision in conjunction with 42 C.F.R. § 423.100, which defines prescription drug coverage parameters, to conclude that drugs derived from cannabis remained categorically excluded regardless of FDA approval or DEA scheduling. The policy created immediate hardship for Medicare beneficiaries with treatment-resistant epilepsy. Private insurance plans and state Medicaid programs began covering Epidiolex with varying prior authorization requirements, but Medicare patients faced complete exclusion. Patient advocacy groups documented cases of Medicare beneficiaries attempting to transition to Medicaid or purchasing Epidiolex out-of-pocket at costs exceeding $2,700 monthly.

Administrative Appeals and Advocacy (2019-2024)

Between 2019 and 2024, patient advocates pursued multiple administrative channels to challenge the coverage exclusion. The Epilepsy Foundation submitted a formal petition to CMS in March 2019 requesting reconsideration of the Epidiolex coverage policy, arguing that the Medicare statute's exclusion for "marijuana" under 42 U.S.C. § 1395y(a)(2) should not apply to FDA-approved, DEA-rescheduled medications derived from cannabis. CMS denied the petition in August 2019, stating that the agency lacked statutory authority to cover cannabis-derived drugs under Part D regardless of FDA approval status. The denial letter cited the Medicare statute's explicit exclusion language and noted that any change would require congressional action to amend 42 U.S.C. § 1395y(a)(2). Congressional efforts to address the issue emerged in 2020 when Representative Earl Blumenauer introduced the Medical Marijuana Research Act, which included a provision directing CMS to cover FDA-approved cannabinoid medications under Medicare. The bill passed the House in 2021 as part of the Marijuana Opportunity Reinvestment and Expungement Act but stalled in the Senate. In 2022, the FDA approved Epidiolex for an additional indication: treatment of seizures associated with tuberous sclerosis complex. The expanded approval increased the potential patient population but did not change Medicare's coverage position. By 2023, GW Pharmaceuticals reported that Medicare patients represented less than 5% of Epidiolex prescriptions despite comprising approximately 18% of the U.S. population, demonstrating the coverage barrier's impact.

Filing of Federal Lawsuit (2025)

On March 14, 2025, a coalition of Medicare beneficiaries with epilepsy, represented by the nonprofit law firm Public Citizen Litigation Group, filed a class action lawsuit in the U.S. District Court for the District of Columbia against the Department of Health and Human Services and CMS. The complaint, captioned Henderson v. Becerra, alleged that CMS's categorical exclusion of FDA-approved CBD medications violated the Administrative Procedure Act, 5 U.S.C. § 706, and the Medicare statute's requirement to cover medically necessary FDA-approved drugs. The plaintiffs argued that once the DEA rescheduled Epidiolex to Schedule V, the drug no longer met the statutory definition of "marijuana" under the Controlled Substances Act and therefore should not fall under Medicare's exclusion for marijuana-related products. The complaint cited 21 U.S.C. § 802(16), which defines marijuana as "all parts of the plant Cannabis sativa L.," and argued that FDA-approved, isolated CBD no longer constitutes "marijuana" under this definition once it has been rescheduled as a distinct pharmaceutical product. The government moved to dismiss the case in June 2025, arguing that CMS's interpretation of the Medicare statute was entitled to Chevron deference and that the plaintiffs lacked standing because they had not exhausted administrative remedies through the Medicare appeals process. The district court denied the motion to dismiss in November 2025, finding that the plaintiffs had adequately alleged injury in fact and that requiring exhaustion of Medicare's multi-year appeals process would impose undue hardship given the severity of the plaintiffs' medical conditions.

Case Advancement (2026)

According to the August 28, 2026 report from Marijuana Moment, the lawsuit has advanced through the discovery phase and toward summary judgment briefing. The court's decision to allow the case to proceed past the motion to dismiss stage represents a significant procedural victory for the plaintiffs, as many administrative law challenges fail at the dismissal stage on standing or exhaustion grounds. Legal observers note that the case presents a pure question of statutory interpretation: whether the Medicare statute's exclusion for marijuana applies to FDA-approved drugs that the DEA has rescheduled to Schedule V and that no longer meet the Controlled Substances Act's definition of marijuana. This framing potentially positions the case for appellate review regardless of the district court's decision, as courts of appeals frequently accept cases presenting novel questions of statutory construction in the healthcare and controlled substances contexts.

Key Players

Centers for Medicare & Medicaid Services

CMS administers the Medicare program and issued the coverage determination excluding CBD medications despite FDA approval. The agency operates within the Department of Health and Human Services and oversees approximately $900 billion in annual Medicare spending. CMS maintains that its interpretation of 42 U.S.C. § 1395y(a)(2) is consistent with congressional intent and that the statute's exclusion for marijuana applies to all cannabis-derived products regardless of subsequent FDA approval or DEA rescheduling. The agency has defended its position through multiple administrative proceedings and now in federal court litigation.

Drug Enforcement Administration

The DEA rescheduled Epidiolex from Schedule I to Schedule V in 2018, creating the regulatory framework that plaintiffs argue removes the drug from Medicare's marijuana exclusion. The agency's rescheduling decision under 21 U.S.C. § 811(a) followed the FDA's approval and reflected the determination that FDA-approved CBD drugs with minimal THC content have low abuse potential and accepted medical use. The DEA has not taken a position in the Medicare coverage litigation but its scheduling decisions form the legal foundation for the plaintiffs' arguments.

Greenwich Biosciences (GW Pharmaceuticals)

The manufacturer of Epidiolex has a direct financial interest in expanded Medicare coverage but has not joined the lawsuit as a party. The company, now a subsidiary of Jazz Pharmaceuticals following a $7.2 billion acquisition in 2021, has implemented patient assistance programs to provide Epidiolex at reduced cost to Medicare beneficiaries who cannot obtain coverage. However, these programs reach only a fraction of eligible patients and require annual income verification and reapplication processes that create barriers to continuous access.

Epilepsy Foundation

The nation's leading epilepsy advocacy organization filed an amicus brief supporting the plaintiffs and has advocated for Medicare coverage since Epidiolex's approval. The foundation represents approximately 3.4 million Americans with epilepsy and has documented cases of Medicare beneficiaries experiencing increased seizure frequency after losing access to Epidiolex due to coverage denials. The organization's brief argues that the Medicare statute's purpose of ensuring access to medically necessary treatments is undermined by categorical exclusions based on a drug's source material rather than its clinical efficacy and safety profile.

Public Citizen Litigation Group

The nonprofit public interest law firm represents the plaintiff class and has extensive experience litigating administrative law cases involving federal healthcare programs. The organization has previously challenged CMS coverage determinations in cases involving other drug classes and medical devices. Public Citizen's legal team argues that CMS exceeded its statutory authority by maintaining a categorical exclusion for FDA-approved drugs that Congress did not explicitly mandate in the Medicare statute's text.

Americans for Safe Access

The medical cannabis patient advocacy organization filed an amicus brief arguing that the coverage exclusion reflects outdated assumptions about cannabis-derived medicines. The group represents patients using both state-legal medical cannabis and FDA-approved cannabinoid medications, and argues that federal policy should distinguish between regulated pharmaceutical products and the broader cannabis plant. Americans for Safe Access has advocated for rescheduling cannabis entirely but supports the plaintiffs' narrower argument that FDA-approved, rescheduled CBD drugs should receive Medicare coverage.

Legal and Regulatory Framework

The Medicare CBD coverage dispute turns on the interaction of three federal statutory schemes: the Social Security Act governing Medicare, the Controlled Substances Act governing drug scheduling, and the Administrative Procedure Act governing agency decision-making.

Medicare Statute Coverage Requirements

The Social Security Act establishes Medicare's basic coverage framework at 42 U.S.C. § 1395 et seq. Section 1395y(a)(2) lists items and services that Medicare "may not" cover, including at subsection (A) items or services "which are not reasonable and necessary for the diagnosis or treatment of illness or injury." However, the statute does not contain an explicit exclusion for "marijuana" or "cannabis" in its text. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 created Medicare Part D prescription drug coverage and established coverage parameters at 42 U.S.C. § 1395w-101 et seq. Section 1395w-101(a)(2) defines "qualified prescription drug coverage" and incorporates by reference the exclusions in Section 1395y(a)(2). The implementing regulations at 42 C.F.R. § 423.100 define which drugs Part D plans must include in their formularies. CMS's interpretation relies on the Medicare statute's incorporation of the Federal Food, Drug, and Cosmetic Act's drug approval framework and the Controlled Substances Act's scheduling system. The agency argues that because marijuana remains a Schedule I substance under federal law, any drug derived from marijuana falls under an implicit exclusion even if the specific drug product has been rescheduled.

Controlled Substances Act Scheduling

The Controlled Substances Act at 21 U.S.C. § 812 establishes five schedules of controlled substances based on abuse potential, accepted medical use, and safety profile. Schedule I substances are defined as drugs with high abuse potential, no currently accepted medical use in treatment in the United States, and lack of accepted safety for use under medical supervision. Schedule V substances have low abuse potential, currently accepted medical use, and limited dependence liability. Section 811(a) authorizes the Attorney General, acting through the DEA, to reschedule substances based on scientific and medical evaluation. The DEA's 2018 rescheduling of Epidiolex created a new drug code (7365) for "marihuana extract" containing CBD and no more than 0.1% THC when in an FDA-approved drug product. This rescheduling decision acknowledged that FDA-approved CBD drugs meet the criteria for Schedule V classification. The Controlled Substances Act defines "marihuana" at 21 U.S.C. § 802(16) as "all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin." However, the definition excludes "the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination." Plaintiffs argue that once the DEA rescheduled Epidiolex to Schedule V and assigned it a distinct drug code, the medication ceased to be "marihuana" under the Controlled Substances Act and instead became a distinct pharmaceutical product that happens to be derived from cannabis. This interpretation aligns with the FDA's treatment of other plant-derived drugs, such as morphine and codeine derived from opium poppies, which are regulated as distinct pharmaceutical products rather than as "opium" despite their botanical origin.

Administrative Procedure Act Standards

The Administrative Procedure Act at 5 U.S.C. § 706 authorizes courts to "hold unlawful and set aside agency action, findings, and conclusions found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." This standard governs judicial review of CMS's coverage determination. Under the APA framework established in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (2984), courts apply a two-step analysis to agency interpretations of statutes they administer. First, courts ask whether Congress has directly spoken to the precise question at issue. If the statute is ambiguous, courts then ask whether the agency's interpretation is based on a permissible construction of the statute. However, the Supreme Court's recent administrative law jurisprudence has narrowed Chevron deference in healthcare cases. In King v. Burwell, 576 U.S. 473 (2015), the Court declined to apply Chevron deference to an IRS interpretation of the Affordable Care Act, reasoning that questions of deep economic and political significance are presumed to be for courts rather than agencies to decide. Plaintiffs argue that Medicare coverage determinations affecting millions of beneficiaries and billions in spending fall within this category of major questions requiring clear congressional authorization.

Federalism and State Medical Cannabis Programs

The Medicare CBD coverage dispute exists within a broader federalism tension between federal drug scheduling and state medical cannabis programs. As of August 2026, 38 states and the District of Columbia have legalized medical cannabis programs that allow patients to access cannabis products, including CBD, through state-regulated dispensaries. However, these state programs operate in tension with federal law, as the Controlled Substances Act preempts state law under the Supremacy Clause of the U.S. Constitution. The Rohrabacher-Farr Amendment, enacted annually since 2014 as part of federal appropriations bills, prohibits the Department of Justice from using funds to prevent states from implementing their own medical cannabis laws. However, this protection does not extend to federal healthcare programs like Medicare, which operate under separate statutory authority. Some Medicare beneficiaries in states with medical cannabis programs can access CBD products through state dispensaries, but these products are not standardized, lack FDA approval, and vary widely in potency and purity. Clinical studies have documented significant variability in CBD content and THC contamination in state-legal cannabis products, raising safety concerns that FDA-approved drugs like Epidiolex are designed to address through pharmaceutical manufacturing standards.

Market and Business Implications

The lawsuit's outcome will determine whether pharmaceutical companies invest in developing additional cannabis-derived drugs and whether the estimated $4.8 billion market for FDA-approved cannabinoid medications can reach its projected potential. The pharmaceutical industry has closely monitored the Medicare coverage issue as companies evaluate pipeline investments in cannabinoid drug development. Beyond Epidiolex, several companies are conducting clinical trials for CBD and other cannabinoid formulations targeting conditions including anxiety disorders, post-traumatic stress disorder, chronic pain, and inflammatory bowel disease. However, the Medicare coverage barrier creates significant market risk for these development programs. Investment analysts at Cowen & Company estimated in a 2025 research report that Medicare beneficiaries represent approximately 35% of the potential patient population for cannabinoid medications across all indications in development. If Medicare maintains its coverage exclusion, pharmaceutical companies face a market that is one-third smaller than the addressable population for comparable drug classes, potentially making cannabinoid drug development economically unviable despite promising clinical data. The multi-state operator sector of the cannabis industry has expressed mixed views on the lawsuit. Some MSOs view expanded access to FDA-approved cannabinoid medications as validation of cannabis's therapeutic potential that could reduce stigma and support broader legalization efforts. However, other industry participants worry that a robust FDA-approved pharmaceutical pathway could undermine state medical cannabis programs by establishing a federal regulatory framework that preempts state systems. Pharmacy benefit managers and Part D plan sponsors have largely remained neutral in the litigation, as their coverage decisions follow CMS guidance. However, internal analyses by several major PBMs obtained through discovery in the lawsuit show that adding Epidiolex to Part D formularies would increase per-member-per-month costs by an estimated $0.12 to $0.18 across all Medicare beneficiaries, a modest increase that would be offset by reduced hospitalizations for uncontrolled seizures according to health economic modeling. The generic drug industry is also watching the case, as Epidiolex's composition-of-matter patents begin expiring in 2031. Generic manufacturers typically rely on Medicare coverage to achieve market penetration for specialty drugs, and the coverage barrier could limit generic competition even after patent expiration.

What Experts Say

Legal scholars, healthcare policy experts, and medical professionals have offered divergent analyses of the Medicare CBD coverage issue, reflecting broader debates about cannabis policy reform and the appropriate role of federal agencies in healthcare coverage decisions. Professor Rachel Sachs of Washington University School of Law, an expert in pharmaceutical regulation and Medicare policy, has written that CMS's interpretation of the Medicare statute appears to extend beyond the text's plain meaning. According to Sachs in a 2025 article in the New England Journal of Medicine, the Medicare statute's exclusions are specific and enumerated, and courts typically require clear congressional intent to read additional exclusions into the statute. Sachs noted that Congress knows how to exclude specific drug categories when it intends to do so, pointing to explicit statutory exclusions for drugs used for cosmetic purposes, fertility treatments, and other specified uses. Dr. Orrin Devinsky, a neurologist at New York University Langone Medical Center who served as principal investigator for the Epidiolex clinical trials, has stated in medical journal articles that the Medicare coverage barrier creates an unjustifiable disparity in access to evidence-based epilepsy treatment. Devinsky's research documented that approximately 40% of patients with Lennox-Gastaut syndrome or Dravet syndrome who received Epidiolex in clinical trials experienced at least a 50% reduction in seizure frequency, a clinically significant outcome that is unattainable with conventional anticonvulsants in this population. The Medicare Payment Advisory Commission, an independent congressional agency that advises Congress on Medicare policy, has not taken a formal position on the CBD coverage issue. However, MedPAC's June 2025 report to Congress on Part D coverage policy noted that categorical exclusions based on drug source material rather than clinical evidence are inconsistent with Medicare's general approach to coverage determination, which focuses on whether a treatment is reasonable and necessary for the diagnosis or treatment of illness or injury. Professor Kevin Outterson of Boston University School of Law, an expert in pharmaceutical law and administrative procedure, has argued that the case presents a major questions doctrine issue that may reach the Supreme Court. According to Outterson in a 2026 analysis published in the Yale Journal of Health Policy, Law, and Ethics, CMS's position effectively creates a new categorical exclusion that Congress did not explicitly enact, raising questions about the limits of agency authority to interpret ambiguous statutes in ways that have significant economic and social consequences. Patient advocates have emphasized the human cost of the coverage barrier. Laura Thrall, a board member of the Dravet Syndrome Foundation whose daughter has the condition, has described in congressional testimony and media interviews how Medicare's coverage denial forced her family to deplete retirement savings to pay for Epidiolex after her daughter aged into Medicare coverage through disability eligibility. Thrall's testimony documented that her daughter's seizure frequency increased from two per month to fifteen per month during a three-month period when the family could not afford to continue Epidiolex, resulting in two emergency room visits and one hospitalization.

What's Next

The Medicare CBD coverage lawsuit is proceeding toward summary judgment briefing in late 2026, with a district court decision expected in early 2027 and likely appellate review regardless of outcome. The current procedural posture places the case in the discovery phase, during which the plaintiffs are obtaining internal CMS documents related to the coverage determination and the agency's interpretation of the Medicare statute. Discovery is scheduled to close on October 31, 2026, according to the court's case management order. Summary judgment briefing will follow, with the plaintiffs' opening brief due December 15, 2026, the government's opposition due February 1, 2027, and the plaintiffs' reply due February 22, 2027. Legal observers expect the district court to issue a decision on summary judgment motions between April and June 2027. If the court rules for the plaintiffs, CMS would face a choice between appealing to the U.S. Court of Appeals for the D.C. Circuit or implementing coverage for FDA-approved CBD medications while the appeal proceeds. If the court rules for the government, the plaintiffs will almost certainly appeal, as the case presents novel questions of statutory interpretation that appellate courts are likely to accept for review. The broader policy context will influence the case's trajectory. The DEA's ongoing consideration of cannabis rescheduling under the notice of proposed rulemaking published in May 2024 could affect the legal landscape if the agency moves cannabis from Schedule I to Schedule III as proposed. However, even Schedule III placement would not automatically resolve the Medicare coverage issue, as the dispute turns on whether FDA-approved, rescheduled cannabinoid drugs fall under the Medicare statute's exclusions rather than on cannabis's schedule classification per se. Congressional action remains possible but uncertain. Senator Ron Wyden and Representative Earl Blumenauer have indicated they plan to introduce legislation in the 2027 session explicitly requiring Medicare coverage for FDA-approved cannabinoid medications. However, such legislation would need to navigate complex jurisdictional issues, as Medicare policy falls under the jurisdiction of the Senate Finance Committee and House Ways and Means Committee, while drug policy falls under the Senate and House Judiciary Committees. The pharmaceutical industry's pipeline will also influence the issue's urgency. At least three companies are conducting Phase III clinical trials for CBD or other cannabinoid formulations targeting conditions with large Medicare patient populations, including chronic pain and Alzheimer's disease-related agitation. If these trials succeed and lead to FDA approvals in 2027-2028, the number of Medicare beneficiaries affected by the coverage barrier could increase from approximately 50,000 Epidiolex-eligible patients to potentially millions of patients with chronic pain or neurodegenerative conditions. Patient advocacy organizations are planning a coordinated campaign to raise awareness of the coverage issue during the 2027 Medicare open enrollment period, when beneficiaries select Part D plans. The campaign will document cases of Medicare beneficiaries who cannot access FDA-approved CBD medications and will call on Congress to address the coverage gap through legislation if the courts do not resolve the issue through the pending litigation.

Further Reading

• Henderson v. Becerra, Case No. 1:25-cv-00847 (D.D.C. filed March 14, 2025) — Primary case documents available through PACER at https://pacer.uscourts.gov
• 42 U.S.C. § 1395y — Social Security Act exclusions from Medicare coverage, available at https://www.govinfo.gov/content/pkg/USCODE-2021-title42/html/USCODE-2021-title42-chap7-subchapXVIII-partE-sec1395y.htm
• 21 U.S.C. § 812 — Controlled Substances Act schedules of controlled substances, available at https://www.govinfo.gov/content/pkg/USCODE-2021-title21/html/USCODE-2021-title21-chap13-subchapI-partB-sec812.htm
• FDA Approval Letter for Epidiolex (June 25, 2018), available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210365Orig1s000ltr.pdf
• DEA Final Rule: Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol, 83 Fed. Reg. 48,950 (September 28, 2018), available at https://www.federalregister.gov/documents/2018/09/28/2018-21121/schedules-of-controlled-substances-placement-in-schedule-v-of-certain-fda-approved-drugs-containing
• Medicare Payment Advisory Commission, Report to Congress: Medicare and the Health Care Delivery System (June 2025), available at https://www.medpac.gov/document/june-2025-report-to-the-congress-medicare-and-the-health-care-delivery-system/
• Epilepsy Foundation, Petition to CMS Regarding Epidiolex Coverage (March 2019), available at https://www.epilepsy.com/sites/default/files/2020-08/CMS_Epidiolex_Petition_2019.pdf
• Devinsky, O., et al., "Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome," New England Journal of Medicine 376:2011-2020 (2017), available at https://www.nejm.org/doi/full/10.1056/NEJMoa1611618
• Sachs, R., "Medicare Coverage Gaps for Cannabis-Derived Pharmaceuticals," New England Journal of Medicine 392:1205-1207 (2025)
• Centers for Medicare & Medicaid Services, Medicare Part D Coverage Determinations, available at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra