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The past several months have seen several major developments in the world of 340B drug pricing. 340B Health President and CEO Maureen Testoni returns to the show to break down some of the most important recent 340B stories.

Landmark Federal Court Ruling on Patient Definition

In November, a federal court in South Carolina ruled against the Health Resources & Services Administration for an unpublished interpretation of 340B patient definition guidelines the agency had been using in audits of covered entities. Maureen explains the implications of this ruling, which could extend far beyond the long-running dispute between HRSA and community health center Genesis Healthcare.

HRSA Notice Officially Limits Use of 340B in New Hospital Clinics

HRSA also released a new notice in October clarifying that new hospital clinics cannot use 340B until they appear on a filed Medicare cost report and are registered – a process that could take up to nearly two years. Maureen describes a transition period for certain hospitals to come into compliance with the policy, continued advocacy for changes to the restrictions, and a new hospital lawsuit over the issue.

Repayments Coming for 340B Medicare Payment Cuts

Hospitals affected by unlawful Medicare payment cuts from 2018-2022 are set to receive direct lump-sum payments by early 2024 under a final rule the Centers for Medicare & Medicaid Services issued in November. Maureen goes over the repayments and discusses lingering concerns about how CMS is implementing the plan.

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Resources

1. Federal Court Issues Decision Against HRSA Limitation on “Patient”
2. HRSA Facing Hospital Lawsuit Over Child Site Eligibility Policy
3. Read 340B Health’s Analysis of the Medicare 340B Pay Cut Remedy
4. West Virginia Journal: A Health Care Policy We Can All Support
5. Zanesville Times Recorder: Drug Pricing Program Is Critical for Patient Care
6. Los Angeles Sentinel: Black Pharmacists Stand as Advocates in Support of 340B Access to Care
7. The Washington Informer: Holy Cross Health, Maryland, Laser-Focused on Achieving Health Equity Through 340B Drug Discounts