Published works by Brenda Maloney Shafer

Published works

• 340B Program Alert: Federal Court Ruling Vacates HRSA Notice Related to Child Site Registration Requirements

  To Be or Not to 340B Blog · March 5, 2026

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• 340B Program Alert: Despite Recent Setbacks, HRSA Continues to Advance Potential 340B Rebate Model Pilot

  To Be or Not to 340B Blog · February 17, 2026

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• 340B Program Alert: Federal District Court Pauses Scheduled Implementation of Rebate Pilot Program

  To Be or Not to 340B Blog · January 6, 2026

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• 340B Program Alert: HRSA Approves Manufacturer Rebate Models for Pilot Program Participation

  To Be or Not to 340B Blog · November 4, 2025

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• Manufacturer Rebate Models: The Next 340B Program Battleground

  To Be or Not to 340B Blog · August 4, 2025

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• The 340B Program in 2024: A Tumultuous Year in Review

  To Be or Not to 340B Blog · December 30, 2024

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• HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

  To Be or Not to 340B Blog · May 2, 2024

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• 340B Developments in 2024 – Litigation and Legislation

  To Be or Not to 340B Blog · March 15, 2024

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• District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

  To Be or Not to 340B Blog · November 8, 2023

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• HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

  To Be or Not to 340B Blog · October 30, 2023

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• CMS Proposal to Make One-Time $9 Billion Lump Sum Payment to 340B-Covered Entity Hospitals

  To Be or Not to 340B Blog · July 17, 2023

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• Continuing Changes in the 340B Space: New Restrictions and Shifting Alliances

  To Be or Not to 340B Blog · April 13, 2023

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• The Current State of 340B and What to Expect in 2023

  To Be or Not to 340B Blog · February 8, 2023

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• Brenda Shafer, Michael French and Richard Davis Author <em>Law360</em> Article on Questions Related to Section 340B Drug Pricing

  To Be or Not to 340B Blog · December 15, 2022

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• 340B Program Changes on the Horizon? Start Planning Now for Potentially Seismic Impact of Upcoming Genesis Decision

  To Be or Not to 340B Blog · October 10, 2022

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• UPDATE: U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

  To Be or Not to 340B Blog · July 18, 2022

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• Supreme Court Decision Maintains Status Quo for Disproportionate Share Percentage Calculation: What Does It Mean for the 340B Program?

  To Be or Not to 340B Blog · June 24, 2022

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• Federal Spending Bill Offers Re-Enrollment Path for Some Hospitals

  To Be or Not to 340B Blog · March 22, 2022

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• The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback

  To Be or Not to 340B Blog · January 5, 2021

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• Notice to Covered Entities: Manufacturer Seeking 340B Claims Data

  To Be or Not to 340B Blog · July 10, 2020

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• CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020

  To Be or Not to 340B Blog · April 30, 2020

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• HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

  To Be or Not to 340B Blog · March 23, 2020

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• GAO Report Suggests Increased Oversight of 340B Program

  To Be or Not to 340B Blog · February 3, 2020

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• New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing

  To Be or Not to 340B Blog · September 18, 2019

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• Interesting 340B Takeaways from 2020 OPPS Proposed Rule

  To Be or Not to 340B Blog · August 6, 2019

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