Health care providers in the coming months may get previously unavailable access to 340B pricing on contrast agents, radiopharmaceuticals, and so-called “OTC monograph” drugs thanks to language tucked into the massive fiscal year 2023 federal spending bill signed into law Dec. 29.
McDermott Will & Emery attorneys Emily Cook and Anisa Mohanty brought the provision to light in a Feb. 2 blog post.
Cook and Mohanty note that language buried in the Consolidated Appropriations Act of 2023 declares contrast agents, radiopharmaceuticals, and certain over-the-counter products to be “drugs” under the Food, Drug, and Cosmetics Act.
“This means that some products that were not previously available at 340B prices may now be,” Cook and Mohanty said. “Specifically, products that were excluded from the 340B definition of ‘covered outpatient drug’ because they did not go through the FDA drug approval process may eventually obtain drug approval and therefore qualify for 340B pricing. Further, going forward, new contrast media, radiopharmaceuticals and OTC monograph drugs will also be considered ‘drugs’ and may meet the definition of ‘covered outpatient drug’ for 340B pricing purposes. We expect the FDA to release guidance on the implementation of this new law.”
Treatment of contrast media for 340B purposes has long been a gray area. Some manufacturers reportedly have offered 340B pricing on the product. Some covered entities reportedly have interpreted the definition of covered outpatient drug to include the products.