March 28, 2023

Volume XIII, Number 87


March 27, 2023

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340B Covered Entities May See Access Changes to Contrast Media, Radiopharmaceuticals and Other Products

340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023 is a new law requiring the US Food and Drug Administration (FDA) to treat all contrast media, radiopharmaceuticals and over-the-counter (OTC) monograph drugs as “drugs.” As a result, certain products—notably some contrast media—that were previously classified as “devices” by the FDA will now be considered “drugs.”

This means that some products that were not previously available at 340B prices may now be. 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. In the interim, there could be challenges in obtaining some of the products previously marketed as “devices.”

340B covered entities should review their current purchasing process for contrast media, radiopharmaceuticals and OTC monograph drugs that are not available through 340B accounts to determine which products may soon have 340B prices available. Additionally, 340B covered entities should review their policies and procedures and make any updates that may be necessary because of this new law and note future changes in 340B eligibility for affected products.

© 2023 McDermott Will & EmeryNational Law Review, Volume XIII, Number 33

About this Author

Emily J. Cook, McDermott Will Emery Law Firm, Health Care Attorney

Emily J. Cook is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Los Angeles office.  She focuses her practice on Medicare provider certification, reimbursement and regulatory compliance.

Anisa Mohanty, McDermott Law Firm, Health Care Attorney

Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Anisa also assists clients with US Food and Drug Administration (FDA) engagement strategies and responding to FDA administrative and enforcement actions.