The federal court ruled on Monday that hemp-derived products could be initially used as part of Medicare pilot programs pending the resolution of an anti-marijuana group’s lawsuit seeking to stop this policy.
The decision clears the way for the initiative, under the Centers for Medicare & Medicaid Services (CMS), to launch as the legal challenge moves forward.
The court denied the emergency request of the plaintiffs who wanted to stop the programme before it started. However, the case is still active and the process could continue for several months.
The narrow federal path, which allows non-intoxicating CBD-derived products to be used in certain CMS pilots is also being contested by drug developers. CBD producers are likely to be the most interested in the ruling, as they could potentially benefit the most from the CMS program.
‘Regulatory arbitrage’
Duane B. Boise is the CEO of MMJ International Holdings in Washington, D.C., which develops cannabinoid based drugs. By creating a funding channel for hemp retail while locking the door to the pharmaceutical industry, the government signals that shortcuts make more money than science.
Boise stated that the federal government has created two parallel systems. One requires years of clinical testing and regulatory reviews, while another allows consumer hemp products to be used in care settings via CMS-backed models.
While the network of anticannabi organizations that brought the suit claim the policy undermines the U.S. Food and Drug Administration drug approval system while others criticize it for being a risk to public health and an abuse of federal power.
Smart Approaches to Marijuana (Smart Approaches to Marijuana), the plaintiff’s organization, called CMS initiative anti-science and likely violative of federal laws, warning that the program will “seriously damage public health.”
The scope of the project is important
Officials from the federal government say that critics mischaracterize the program. They emphasize that it only applies to a limited number of pilots and is not a direct Medicare reimbursement.
In filings with the court, the government also claimed that opponents were confusing hemp and marijuana. They ignored the legal distinction created by the 2018 Farm Bill that removed hemp from the controlled substance list. The government also disputed claims that hemp was causing commercial damage, claiming some plaintiffs were attempting to claim damages in markets where they had not yet established themselves.