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We generally keep our distance from medical cannabis/marijuana.  We’re not one of those blogs.  But if legal holdings of interest to us happens to involve cannabis, we will comment.  Thus, we bring you Schmidt v. Schmidt, Kirifides & Rassias, PC, ___ A.3d ___, 2023 WL 7502499 (Pa. Commw. Nov. 14, 2023), holding that the cost of legal, physician-prescribed medical marijuana is legitimate medical expense reimbursable through the Pennsylvania Worker’s Compensation system, notwithstanding such products’ complete lack of FDA approval.

The claimant had switched to a type of prescription medical marijuana (cannabinoid (“CBD”) oil) and away from the opioid drugs he had previously been taking for a work-related injury.  Id. at *1-2.  However, the employer “refused to reimburse Claimant’s out-of-pocket CBD oil expenses on the basis that CBD oil is not a pharmaceutical drug.”  Id. at *2.  The administrative law judge found that this treatment with medical marijuana was medically appropriate, and the fact that it was available over-the-counter did not exclude it from coverage.  Id. at *3-4.

However, the board that oversees Pennsylvania’s workers’ compensation program reversed, holding that FDA warning letters concerning this product precluded reimbursement:

Based on the stated position and recent actions of the FDA, an insurer or employer cannot be required to pay for cannabis or cannabis-derived products . . . .  Therefore, Employer’s failure to reimburse Claimant . . . is not a violation of the Act. . . .  Finding a violation here is concomitant to compelling an employer to violate federal law.

Schmidt, 2023 WL 7502499, at *5 (citation and quotation marks omitted).

On further appeal, the Pennsylvania Commonwealth Court (an intermediate appellate court with jurisdiction over, inter alia, administrative appeals) reversed.  That the medication was purchased OTC did not matter.  Rather,  the “Claimant need only show that CBD oil is a medicine or supply.”  Id. at *12 (citation omitted).  These terms were not limited to prescription-only products:

[T]he term “medical supplies” is defined as “[a]ny item that is essential for treating illness or injury.”  Here, [claimant’s physician] prescribed CBD oil to Claimant to treat his pain.  The CBD oil has benefitted Claimant’s well-being by reducing his pain, eliminating his need to increase the use of highly addictive opioid medications, and forestalling expensive and risky surgery. Accordingly, CBD oil fits within the definitions of “medicines” and “supplies.”

Schmidt, 2023 WL 7502499, at *14 (citations and footnote omitted).  Further, resolution of issues like OTC status was within the scope of independent “utilization review” (“UR”)  − a statutory “remedy” that the employer had failed to seek.  Id. at *15.  Finally, given the Worker’s Compensation Act’s “humanitarian objectives,” if the act was to be construed to bar reimbursement of OTC products, that would require legislative action.  Id. at *20.

FDA non-approval of medical marijuana likewise made no difference.  “FDA approval of a treatment is not a requirement under the Act.”  Id. at *21  “[W]hether a treatment is FDA approved for a particular purpose should be raised within the framework of the  UR process.”  Id. at *15.  Having legalized medical marijuana, Pennsylvania was under no obligation to follow FDA limitations on what was medically reimbursable.  “[T]hat some firms marketing CBD products may violate federal law . . . does not make Claimant’s use or Employer’s reimbursement for CBD oil illegal.”  Id. at *17.  Nor did marijuana’s continued illegality under federal law make employer reimbursement somehow “illegal.”  All the employer was required to do was pay money for medical treatment found “reasonable and necessary” under Pennsylvania’s workers’ compensation scheme:

Since the employer is not prescribing marijuana, but rather reimbursing the claimant for his lawful use thereof, the employer is not in violation of federal law. . . .  Because the employer would not be in violation of federal law by reimbursing the claimant for his lawful medical marijuana use, and the [administrative judge] concluded that the medical marijuana use was causally related to the work injury, the employer is required to reimburse the claimant for his out-of-pocket costs under the [Workers’ Compensation] Act.

Schmidt, 2023 WL 7502499, at *18 (citations and quotation marks omitted).  FDA non-approval did not matter where a cannabis product “is lawfully sold over the counter in Pennsylvania and all over the United States.”  Id. (citation and quotation marks omitted).

We’ve stated numerous times that state law, not FDA regulatory status, governs the legality of off-label use.  Schmidt is interesting to us because it goes one step beyond – medical marijuana, including CBD oil, has no FDA approval for any use.  With well over half the states having legalized medical use of cannabis, continuing federal inaction on this issue risks the FDA being left behind.