Medical Hashish in Pennsylvania – Since It’s Authorized, It’s Reimbursable, FDA Regulatory Standing However

We usually maintain our distance from medical hashish/marijuana.  We’re not a type of blogs.  But when authorized holdings of curiosity to us occurs to contain hashish, we’ll remark.  Thus, we convey you Schmidt v. Schmidt, Kirifides & Rassias, PC, ___ A.3d ___, 2023 WL 7502499 (Pa. Commw. Nov. 14, 2023), holding that the price of authorized, physician-prescribed medical marijuana is professional medical expense reimbursable by way of the Pennsylvania Employee’s Compensation system, however such merchandise’ full lack of FDA approval.

The claimant had switched to a kind of prescription medical marijuana (cannabinoid (“CBD”) oil) and away from the opioid medicine he had beforehand been taking for a work-related harm.  Id. at *1-2.  Nonetheless, the employer “refused to reimburse Claimant’s out-of-pocket CBD oil bills on the premise that CBD oil will not be a pharmaceutical drug.”  Id. at *2.  The executive regulation choose discovered that this therapy with medical marijuana was medically applicable, and the truth that it was obtainable over-the-counter didn’t exclude it from protection.  Id. at *3-4.

Nonetheless, the board that oversees Pennsylvania’s employees’ compensation program reversed, holding that FDA warning letters regarding this product precluded reimbursement:

Primarily based on the said place and up to date actions of the FDA, an insurer or employer can’t be required to pay for hashish or cannabis-derived merchandise . . . .  Subsequently, Employer’s failure to reimburse Claimant . . . will not be a violation of the Act. . . .  Discovering a violation right here is concomitant to forcing an employer to violate federal regulation.

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

On additional attraction, the Pennsylvania Commonwealth Court docket (an intermediate appellate courtroom with jurisdiction over, inter alia, administrative appeals) reversed.  That the medicine was bought OTC didn’t matter.  Reasonably,  the “Claimant want solely present that CBD oil is a drugs or provide.”  Id. at *12 (quotation omitted).  These phrases weren’t restricted to prescription-only merchandise:

[T]he time period “medical provides” is outlined as “[a]ny merchandise that’s important for treating sickness or harm.”  Right here, [claimant’s physician] prescribed CBD oil to Claimant to deal with his ache.  The CBD oil has benefitted Claimant’s well-being by decreasing his ache, eliminating his want to extend using extremely addictive opioid drugs, and forestalling costly and dangerous surgical procedure. Accordingly, CBD oil matches throughout the definitions of “medicines” and “provides.”

Schmidt, 2023 WL 7502499, at *14 (citations and footnote omitted).  Additional, decision of points like OTC standing was throughout the scope of unbiased “utilization evaluate” (“UR”)  − a statutory “treatment” that the employer had failed to hunt.  Id. at *15.  Lastly, given the Employee’s Compensation Act’s “humanitarian targets,” if the act was to be construed to bar reimbursement of OTC merchandise, that will require legislative motion.  Id. at *20.

FDA non-approval of medical marijuana likewise made no distinction.  “FDA approval of a therapy will not be a requirement beneath the Act.”  Id. at *21  “[W]hether a therapy is FDA authorised for a selected function must be raised throughout the framework of the  UR course of.”  Id. at *15.  Having legalized medical marijuana, Pennsylvania was beneath no obligation to comply with FDA limitations on what was medically reimbursable.  “[T]hat some companies advertising CBD merchandise might violate federal regulation . . . doesn’t make Claimant’s use or Employer’s reimbursement for CBD oil unlawful.”  Id. at *17.  Nor did marijuana’s continued illegality beneath federal regulation make employer reimbursement someway “unlawful.”  All of the employer was required to do was pay cash for medical therapy discovered “affordable and needed” beneath Pennsylvania’s employees’ compensation scheme:

Because the employer will not be prescribing marijuana, however fairly reimbursing the claimant for his lawful use thereof, the employer will not be in violation of federal regulation. . . .  As a result of the employer wouldn’t be in violation of federal regulation by reimbursing the claimant for his lawful medical marijuana use, and the [administrative judge] concluded that the medical marijuana use was causally associated to the work harm, the employer is required to reimburse the claimant for his out-of-pocket prices beneath the [Workers’ Compensation] Act.

Schmidt, 2023 WL 7502499, at *18 (citations and citation marks omitted).  FDA non-approval didn’t matter the place a hashish product “is lawfully bought over-the-counter in Pennsylvania and all around the United States.”  Id. (quotation and citation marks omitted).

We’ve said quite a few instances that state regulation, not FDA regulatory standing, governs the legality of off-label use.  Schmidt is attention-grabbing to us as a result of it goes one step past – medical marijuana, together with CBD oil, has no FDA approval for any use.  With nicely over half the states having legalized medical use of hashish, persevering with federal inaction on this challenge dangers the FDA being left behind.