Articles and Blogs

On Thursday, April 18, 2024, the Department of Health and Human Services (“HHS”) published a Final Rule implementing 340B Program Administrative Dispute Resolution Regulations (“ADR Rule”), which can be found here. The ADR Rule is set to be published on April 19, 2024, and will go into effect 60 days after the publication date... READ MORE

The Centers for Medicare & Medicaid Services (“CMS”) just released its Proposed Rule for repaying hospitals that were affected by the 340B OPPS payment cuts from 2018 through 2022. CMS has proposed that 340B hospitals will receive a one-time lump sum payment at the end of 2023 or beginning of 2024. Each hospital’s payment... READ MORE

Last week, the D.C. Circuit Court of Appeals (the “Court”) reinstated a rule cutting reimbursement rates for drugs purchased at a substantial discount under Section 340B of the Public Health Service Act (the “340B Program”) that had previously been ruled unenforceable by the District Court. In American Hospital Association v. Azar,[1] the Court held... READ MORE

On July 24, 2020, President Trump announced four Executive Orders (“Executive Orders”) characterized as focusing on lowering drug prices via various mechanisms. These Executive Orders, described in more detail below, include: (1) Executive Order on Access to Affordable Life-saving Medications; (2) Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; (3)... READ MORE

Based on recent interactions Hall Render has had with HRSA Office of Pharmacy Affairs (“OPA”) representatives, hospitals participating in the 340B drug discount program as covered entities (“Covered Entities”) may now be able to consider patients 340B-eligible in new locations of the hospital outside of the four walls of the hospital building even if... READ MORE

In a March 20, 2020 letter to HHS Secretary Azar, 340B Health, a membership organization consisting of more than 1,400 nonprofit hospitals in the 340B drug pricing program, advised the Secretary that its member hospitals fear the COVID-19 public health emergency could have a “material impact” on hospital admissions and payor mix, which, in... READ MORE

On March 23, 2020, the Health Resources & Services Administration (“HRSA”) launched a new webpage providing COVID-19 information related to the 340B drug discount program (“340B Program”), including responses to frequently asked questions related to COVID-19. HRSA’s COVID-19 Resources webpage is available here. In response to the COVID-19 pandemic, hospitals and other 340B Program... READ MORE

Saturday, March 21 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website.​ Congressional Outlook After 12 hours of negotiation on Friday, Republicans and Democrats... READ MORE

On January 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an Informational Bulletin titled “Best Practices for Avoiding 340B Duplicate Discounts in Medicaid” (“Bulletin”). The Bulletin outlines best practices that CMS encourages state Medicaid agencies to consider to avoid the situation where a manufacturer provides both a Medicaid drug rebate and... READ MORE

This week, CMS released the 2020 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center Payment System Proposed Rule (“Proposed Rule”). Among a host of other items, CMS announced its intent to continue paying Average Sales Price (“ASP”) minus 22.5 percent for most drugs acquired under the 340B drug discount program (“340B... READ MORE