A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals. On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. For the purposes of assessing the annual opiate product registration fee, a “unit” means “the individual dosage form of the particular drug product that is prescribed to the patient. One unit equals one tablet, capsule, patch, syringe, milliliter, or gram.” Minn. Stat. § 151.066, Subd. 3(f).
The amendment proposed by HF33 would exempt “any injectable opiate product distributed to a hospital or hospital pharmacy” from the determination of the opiate product registration fee. Manufacturers would still be required to report sales of these products to the Board of Pharmacy, but they would not be factored into the determination of the opiate product registration fee. If a manufacturer already paid its annual opiate product registration fee, which was due June 1, 2021, and said manufacturer would not have been required to pay the fee based on the proposed exemption for injectable opiates distributed to a hospital or hospital pharmacy, then the Board of Pharmacy would refund the fee to the manufacturer.
The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021. If HF33 is signed by Minnesota Governor Tim Waltz, the opiate registration fee reduction would be effective the day following final enactment.
We speculate that this amendment is intended to ensure that the significant product registration fees would not cause potential shortages of certain opiate injectables for hospitals. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers. As it currently stands, no products are excluded from Minnesota’s determination of the opiate product registration fee. However, we note that the Maine opioid medication product registration fee, which uses a very similar statutory framework, excludes units of opioid medications prescribed for the “purpose of medication-assisted treatment of substance use disorder.”