A coalition of anti-marijuana organizations is suing the Trump administration over a novel initiative set to launch this week to widen the availability of CBD and THC for certain patients by covering hemp-derived products under select federal health insurance programs.
Smart Approaches to Marijuana (SAM) and nine other drug prevention groups on Monday filed a lawsuit in the U.S. District Court for the District of Columbia, challenging the legality of the cannabis program—which is being facilitated by the Centers for Medicare & Medicaid Services (CMS)—and seeking a temporary restraining order to immediately halt the process.
The filing names CMS Administrator Mehmet Oz and U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. as defendants in the lawsuit. The lawsuit comes as CMS is set to start covering CBD and THC products as a Substance Access Beneficiary Engagement Incentive (BEI) beginning on Wednesday.
Under the BEI, patients enrolled in specific federal health insurance programs could have up to $500 worth of hemp-derived products covered each year. The CBD-focused plan will also allow a certain amount of THC in products, but the agency said earlier this month the rules are subject to change if federal hemp policy changes, as is currently expected under a law set to take effect later this year.
SAM and the other organizations—including the Cannabis Impact Prevention Coalition, Drug Free American Foundation and Save Our Society From Drugs—made several arguments in support of legal intervention to prevent the cannabidiol BEI from moving forward. Much of the complaint focuses on alleged violations of administrative rules to provide the treatment, which they point out has not received Food and Drug Administration (FDA) approval.
CMS didn’t publish a notice of proposed rulemaking for the cannabis BEI that would have afforded the public with a comment period to weigh in, and the agency’s initiative runs counter to a separate final rule it issued last year that “declared cannabis products ineligible for supplemental Medicare coverage for chronically ill patients,” the prohibitionist plaintiffs said.
Beyond those alleged violations of the Administrative Procedure Act (APA), the groups noted that CMS described a BEI for CBD containing a maximum THC concentration that exceeds what would constitute federally legal hemp under a policy that’s set to be implemented in November.
The filing says the program would additionally violate the Social Security Act (SSA), which “does not allow CMS to sanction the possession and use of illegal and dangerous Schedule I substances by Medicare patients without clear congressional authorization.”
“CMS’s action represents an unprecedented and unlawful assertion of binding decision-making authority that will profoundly affect the health of elderly Americans,” SAM and the other organizations said in their complaint. “CMS took this action without the guardrails imposed by the administrative process, without any reasoned explanation, in conflict with the agency’s own recent APA-compliant determination, and without statutory authority.”
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