Preparing for the Possible Reclassification of Marijuana: Potential Impacts on Pharmacy Benefits

The reclassification of marijuana from Schedule I to Schedule III could bring significant changes to the pharmacy benefits landscape. Read how plans can prepare.

The Department of Justice (DOJ) is investigating the classification of marijuana, with the possibility of moving it from Schedule I to Schedule III of the Controlled Substances Act (CSA). This shift is in line with the Department of Health and Human Services’ (HHS) view that marijuana has legitimate medical applications and a lower potential for abuse compared to other Schedule I and II substances.1

The reclassification of marijuana from Schedule I to Schedule III could bring significant changes to the pharmacy benefits landscape. Coupled with the Medical Marijuana and Cannabidiol Research Expansion Act, which was approved in December 2022, payers must understand and prepare for these potential impacts.

Background

Marijuana has been classified as a Schedule I substance since the enactment of the CSA in 1970. Other drugs in this class include heroin, LSD, and ecstasy. Marijuana contains Δ9-THC—also known as dronabinol—which has been found to produce rewarding effects consistent with long-term nonmedical use and abuse. The Food and Drug Administration (FDA) has approved two drug products containing dronabinol: Marinol (Schedule III, 1985) and Syndros (Schedule II, 2016), for specific medical uses.2

In late 2022, the Medical Marijuana and Cannabidiol Research Expansion Act was approved, opening the doors for extensive research on marijuana and cannabidiol, potentially leading to rapid advancements in marijuana-based therapies.3 This is significant, as one of the requirements under the CSA for determining a drug’s schedule is whether the drug has a “currently accepted medical use” (CAMU) in the U.S. The other factors are (1) potential for abuse and (2) safety while under medical supervision or psychological or physical dependence that could result from abuse of the drug.4

Drugs in schedule II include cocaine, methamphetamine, methadone, oxycodone and fentanyl and are considered less abusive than schedule I drugs. Those drugs managed under schedule III, which is the category proposed for marijuana, include products containing less than 90 milligrams of codeine per dosage unit, ketamine and anabolic steroids. Schedule III drugs have an accepted medical use and are prescribed as medication.5 If approved, marijuana would be regulated similarly to other Schedule III drugs, with specific controls and additional regulations as needed to meet U.S. treaty obligations. However, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to applicable criminal charges under the CSA.

Currently, 38 States and the District of Columbia have enacted laws allowing individuals to use marijuana under certain circumstances for medical purposes.6 This creates a complex landscape where outside of Federal and State-sanctioned medical use of marijuana, individuals are using marijuana on their own initiative for medical, as well as nonmedical, purposes. However, as a schedule I drug, marijuana is illegal under U.S. federal law. If reclassified to schedule III, it would still be federally illegal, but in a class with prescription drugs that have a lower potential for abuse and have accepted medical application. Additionally, it would apply only to marijuana as the plant and derivatives of the plant, and synthetic THC would remain in schedule I.7

In addition, marijuana would remain subject to applicable provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). For example, under the FDCA, a drug containing a substance within the CSA’s definition of “marijuana” would need FDA approval to be lawfully “introduce[d] or deliver[ed] for introduction into interstate commerce,” unless an investigational new drug (IND) is in effect for that drug. To date, although there have been INDs for drugs containing a substance within the CSA’s definition of “marijuana,” no such drugs have been approved by FDA.8

Although no professional medical organization currently recommends use of marijuana, HHS concluded after reviewing several studies that there was some credible scientific support that marijuana could be used to effectively treat pain, anorexia, and nausea and vomiting and that using medical marijuana to treat these conditions did not pose “unacceptably high safety risks.”9

Possible Implications for Pharmacy Benefits

  • Enhanced Access to Medical Marijuana: With marijuana recognized for its medical uses, there could be an increase in demand for medical marijuana prescriptions. However, as mentioned previously, the FDA has not approved a New Drug Application (“NDA”) for a drug product containing botanical marijuana for any therapeutic indication. Thus, the only way an individual can use marijuana on the basis of medical advice through legitimate channels under Federal law is by participating in research under an IND application.
  • Effect on Patient Health: While medical marijuana has its benefits, smoking marijuana can cause lung damage. According to the CDC, marijuana has similar toxins and carcinogens as tobacco, putting users at risk for lung and respiratory diseases. Additionally, it can be addictive, and can affect memory, learning, decision making and coordination, leading to safety issues. Cannabis can also cause an increase in heart rate and blood pressure, as well as an increased risk of stroke, heart disease, and other vascular diseases. More research is needed to weigh the health benefits versus the risks of marijuana-based therapies.10
  • Regulatory Compliance Adjustments: Reclassification would impose Schedule III regulatory controls, including stringent record-keeping and reporting requirements. Payers must ensure compliance with these new regulations, which could necessitate changes to internal processes and systems. Additionally, staying informed about any specific marijuana-related controls or additional requirements is vital for maintaining compliance.
  • Accelerated Research and Innovative Therapies: The Medical Marijuana and Cannabidiol Research Expansion Act could expand treatment options for various medical conditions and offer new opportunities for payers to incorporate innovative treatments into benefit plans. Reclassification could spur pharmaceutical companies to invest in developing new cannabis-based medications, increasing competition and innovation in the market. Payers should stay abreast of emerging therapies and be prepared to evaluate their efficacy and cost-effectiveness for inclusion in benefit plans. This proactive approach can help in offering cutting-edge treatments to members.
  • Potential for Coverage Changes: While medical marijuana is currently not covered by pharmacy benefits, the potential reclassification could pave the way for marijuana-based medications to receive FDA approval. If so, payers would need to consider inclusion in formularies, and the financial implications. Payers should stay vigilant and consider the potential for policy changes that might incorporate medical marijuana into coverage plans. Engaging in discussions with regulatory bodies and staying updated on research developments will be crucial for anticipating and adapting to these changes.
  • Impact on Existing Therapies: Cannabis could be considered as an alternative or adjunct to opioid therapies for pain management, potentially impacting opioid prescription rates. However, potential drug interactions would need to be considered to ensure patient safety.
  • Provider and Patient Education: With the legalization of medical marijuana spreading throughout the U.S. despite being illegal federally, many patients and providers may believe that the reclassification makes marijuana legal. They may also believe that if they receive a prescription for medical marijuana from a doctor, that it is a covered benefit. It may be necessary to educate providers and patients that your plan only covers FDA-approved medications. However, patients should be informed about the potential benefits, risks, side effects, and potential interactions with other medications of marijuana-based therapies. Effective communication strategies will be key to managing this topic.
  • Legal and Operational Considerations: Despite reclassification, marijuana will still be subject to strict legal controls. Payers must navigate the complexities of state and federal regulations, ensuring that their policies align with the latest legal requirements. Operational adjustments, such as updating coverage criteria and claims processing protocols, will be necessary to accommodate the new landscape.

Preparing for Change

The DOJ is currently seeking public comments on the proposed reclassification. Payers should actively participate in this dialogue and prepare for the potential changes. By staying informed and proactive, payers can effectively manage the transition and continue to provide high-quality, compliant, and cost-effective pharmacy benefits.

SlateRx aims to equip you with the knowledge and insights needed to navigate the evolving regulatory environment and its impact on pharmacy benefits. Stay informed, stay prepared, and ensure your organization is ready for the future of medical marijuana coverage and the advancements in marijuana and cannabidiol research.


SOURCES

  1. Department of Justice (2024). Press release: Justice Department submits proposed regulation to reschedule marijuana. Accessed from: https://www.justice.gov/opa/pr/justice-department-submits-proposed-regulation-reschedule-marijuana
  2. Department of Justice (2024). Notice of proposed rulemaking. Accessed from: https://www.dea.gov/sites/default/files/2024-05/Scheduling%20NPRM%20508.pdf
  3. Sabaghi, D. (2022). Biden signs medical marijuana research bill. Forbes.com. Accessed from: https://www.forbes.com/sites/dariosabaghi/2022/12/03/biden-signs-medical-marijuana-research-bill/?sh=2e0e67877c69
  4. Department of Justice (2024). Notice of proposed rulemaking.
  5. IBID
  6. State Medical Cannabis Laws. 2023. National Conference of State Legislatures. Accessed from: https://www.ncsl.org/health/state-medical-cannabis-laws
  7. Awam, Omer (2024). The U.S. Government plans to reclassify marijuana from a schedule I to Schedule II drug: Here are the concerns. Forbes.com accessed from: https://www.forbes.com/sites/omerawan/2024/05/12/the-us-federal-government-plans-to-reclassify-marijuana-from-a-schedule-i-to-schedule-iii-drug-here-are-the-concerns/?sh=78722ba13f07
  8. Department of Justice (2024). Notice of proposed rulemaking.
  9. Department of Justice (2024). Questions related to the potential rescheduling of marijuana. Justice.gov. Accessed from: https://www.justice.gov/olc/media/1352141/dl?inline
  10. CDC. (2024). Cannabis and Public Health. CDC.gov. Accessed from: https://www.cdc.gov/cannabis/health-effects/lung-health.html?CDC_AAref_Val=https://www.cdc.gov/marijuana/health-effects/lung-health.html