Managed Care Outlook 2025

Legal and regulatory challenges - chess pieces icon

Read time: 4 minutes

Despite a challenging legal landscape, cannabis and psychedelics have emerged as potentially legitimate treatment options in the U.S. This article explores how that happened and what it means for managed care companies.

Legal landscape

The U.S. regulates controlled substances through the Controlled Substances Act (CSA) and the Food and Drug Administration (FDA). The CSA allocates drugs in five schedules based on their medical use, potential for abuse, and safety and risk of dependence. Schedule I drugs include heroin, cannabis, psilocybin and MDMA. According to the CSA, these drugs have no currently accepted medical use and a high potential for abuse.Studies predict that if medical cannabis were legalized at the federal level, U.S. health care expenditures would decrease by $29 billion annually

Any drug listed on Schedules II through V is eligible for FDA approval. The FDA reviews clinical trials and peer-reviewed studies to determine the safety and efficacy of a substance for a particular purpose. Once approved by the FDA, the drug may be manufactured and distributed in interstate commerce. Although FDA approval is limited to particular dosages, forms and/or indications, providers may still prescribe FDA-approved drugs “off-label” in a manner that has not been approved by the FDA.

Schedule I substances face many hurdles to accepted use in treatment, including research and funding restrictions and limitations on substance access and supply. Consequently, Schedule I drugs tend to stay on Schedule I indefinitely.

Key takeaways
  • Schedule I controlled substances face significant hurdles to accepted use in treatment in the U.S.
  • Through state led initiatives, private innovation and direct appeals to the federal government, cannabis and psychedelics are increasingly seen as a potential treatment for various medical conditions
  • While managed care companies face little risk refusing coverage for Schedule I drugs, they should continue to monitor the landscape to understand their coverage obligations
Download full report
Download full report
Download