340B Drug Pricing Program

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Cornerstone Research professionals and experts have experience analyzing the 340B drug pricing program and its role in the pharmaceutical industry.

Our experts have examined this program in litigation and published research and have testified about it before Congress and other regulatory bodies. Their work has analyzed the implications of the 340B program and its impact on consumers, healthcare providers, insurance companies, and pharmaceutical manufacturers.

Our litigation experience includes analysis of:

  • Expansion of covered entities and contract pharmacy participation in the 340B program over time
  • Benefits and costs of the 340B program for various stakeholders
  • Contract pharmacy arrangements, third-party administrator agreements, and fee structures
  • 340B claim identification in rebate, patient diversion, and duplicate discount disputes
  • Alleged patient steering to institutional or contract pharmacies

Featured Insights

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program
Headshot of Sayeh Nikpay An interview by Cornerstone Research with Sayeh Nikpay

We interview Professor Sayeh Nikpay of the School of Public Health, University of Minnesota, who shares her insights into the 340B program, its role in the healthcare safety net, implementation challenges, and related legal matters.

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Pharma Law USA
Headshot of Benjamin Fuller Panel with Benjamin Fuller

Benjamin Fuller spoke on a panel titled “Navigating 340B Drug Program Litigation.” Panelists discussed the current state of 340B litigation, including related challenges and complexities, as well with potential ways to enhance the program.

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Recent court ruling could increase the size and administrative complexity of the 340B program
Headshot of Sayeh Nikpay
Headshot of JP Bruno
An article published in Health Affairs Scholar by Sayeh Nikpay and J.P. Bruno

The 340B program allows certain hospitals and clinics to use outpatient drugs purchased at substantial discounts on insured patients, generating profits to fund care. The size of these profits depends on the number of prescriptions filled by participating hospital or clinics’ insured patients that also meet the Health Resources and Services Agency’s definition of an eligible patient. A recent court case has challenged the Agency’s longstanding definition of a patient, resulting in new definition that could significantly expand the size of the program and create conflicts when an insured patient satisfies the new definition for more than one hospital or clinic participating in the program. In this paper, we use Medicare Part D data from 2018 to simulate the proportion of prescription drug fills eligible for 340B discounts and total program spending under both existing and new definitions. We found that the new definition could increase the share of 340B-eligible fills in Medicare Part D by 25%, from 12% of fills to 16%, and that the share of fills subject to a conflict could double, from 1% of fills to 1%-2%. Our results suggest that the new definition could increase covered entities’ 340B profits by roughly a third.

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The annual conference of the American Society of Health Economists

Sayeh Nikpay and J.P. Bruno presented on the 340B drug pricing program

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Headshot of Sayeh Nikpay Sayeh Nikpay chaired and spoke on several panels at ASHEcon 2024, a conference that provides a platform for sharing findings, methods, and insights in health economics and related topics. The panels on which she discussed 340B-related topics include:

  • “Net Spending and Sources of Growth in the 340B Drug Pricing Program”
  • “Exploring the Rapid Growth of 340B Contract Pharmacies Among STD and HIV Clinics in the U.S. Safety Net”
  • “Only One Can Win – Medicaid Drug Rebates and 340B Discounts”
  • “Estimated Impact of New 340B Patient Definitions on the Size of the 340B Program in Medicare”
  • “Impact of 340B Exposure on Treatment Cost of Medicare Patients with Cancer”
Headshot of JP Bruno J.P. Bruno also authored research that was presented at several sessions, including:

  • “How Leaky Is the Bucket? Network Effects of 340B Contract Pharmacies”
  • “Does 340B Status Affect Pharmacy Demand? Evidence from Medicare Part D Plans”
  • “Estimated Impact of New 340B Patient Definitions on the Size of the 340B Program in Medicare”

Featured Experts and Professionals

J.P. Bruno
  • Location icon Chicago
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J.P. Bruno

Manager

Alice Chen

Alice Chen

Associate Professor,
Sol Price School of Public Policy;
Senior Fellow,
Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California

Gautam Gowrisankaran

Gautam Gowrisankaran

Professor of Economics,
Columbia University;
Senior Advisor, Cornerstone Research

Benjamin H. Fuller
  • Location icon Boston
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Benjamin H. Fuller

Principal

Zoya Marriott
  • Location icon Boston
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Zoya Marriott

Vice President

Sayeh Nikpay

Sayeh Nikpay

Associate Professor, Division of Health Policy & Management,
School of Public Health,
University of Minnesota

Maria Salgado
  • Location icon San Francisco
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Maria Salgado

Vice President

Erin Trish

Erin Trish

Associate Professor,
Department of Pharmaceutical and Health Economics,
Mann School of Pharmacy and Pharmaceutical Sciences,
Co-Director, Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California