William von Oehsen and Mark Ogunsusi presented at the Developments in Pharmacy Law Seminar hosted by the American Society for Pharmacy Law this November 3rd to 6th. Their presentation, Navigating Manufacturer Actions to Restrict 340B Drug Access at Contract Pharmacies: Critical Policies, Arguments, and Expectations, delved into the details related to the history and purpose the 340B Program with respect to contract pharmacy distribution models. Enacted in 1992, Section 340B of the Public Health Service Act entitles certain safety-net health care providers to purchase from manufacturers outpatient drugs at a deeply discounted ceiling price defined by the 340B statute. Drug manufacturers agree to provide the 340B discount in exchange for their drugs being reimbursed under the Medicaid and Medicare Part B programs – two critical markets for most manufacturers. For nearly three decades, the safety net hospitals and clinics participating in the 340B program – referred to as “covered entities” in the statute — have dispensed their 340B drugs through independent pharmacies operating under contract with covered entities. These contract pharmacy arrangements allow covered entities to extend the reach of their 340B pharmacy programs to more patients and are especially important for hospitals and clinics that lack in-house pharmacies. Additionally, the presentation discussed federal and state bills aimed at curbing the manufacturers’ restrictive policies and key predictions for the future of 340B contract pharmacy arrangements.
Click here to learn more and see the agenda. Additionally, click here to listen to the American Society for Pharmacy Law Podcast episode with William von Oehsen and Mark Ogunsusi on the topic.