February 6, 2023

Volume XIII, Number 37

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February 03, 2023

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New 340B Dispute Resolution Process: Will It Level the Playing Field?

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA's use of the administrative rulemaking process is a rare occasion given its perceived limited rulemaking authority granted by Congress. It is critical that stakeholders review HRSA's proposal to consider how it would impact current and future 340B-related disputes, and to determine if the proposed rule goes far enough to level the 340B pricing playing field.

The proposed ADR rule implements a law which requires the Secretary of Health and Human Services (HHS) to establish and implement a binding ADR process for certain disputes arising under the 340B program. When finalized, this proposed rule appears to replace the 340B Program's guidelines on the informal—and seldom used—dispute resolution process. We encourage covered entities, manufacturers and other stakeholders to carefully review the ADR proposal and submit comments on or before October 11, 2016.

The following are key highlights from HRSA's proposal:

  • The ADR process is limited to three subject matters,

  • Decisions of the 340B ADR Panel would be binding,

  • Covered entities may have the right to file civil actions challenging ADR decisions

  • HRSA proposed a 3-year time bar

  • Multiple covered entities may consolidate claims

  • Covered entities may obtain additional information from manufacturers via the ADR process

  • Comments are due on or before October 11, 2016

ADR Panel Composition and Purpose

The rule proposes to create a decision-making body, referred to as the 340B ADR Panel, to resolve claims between covered entities and manufacturers regarding overcharges, diversion, and duplicate discounts.

Initiating the ADR Process

The party filing the claim must include documentation sufficient to support its claim. It is unclear in the proposed rule what burden must be met by the filing party in order to proceed to the ADR process.

Consolidation of Claims and Data Requests

Pursuant to statutory requirements, the proposed rule permits the consolidation of multiple claims against the same entity brought by covered entities or manufacturers.

3-Year Time Limitation

The rule proposes a claim filing deadline of three years from the date of the sale or payment at issue. This timeframe is meant to be consistent with the record retention expectations for the 340B program.

Agency Decision-Making Process

Once the 340B ADR Panel has reviewed the claim and all supporting documentation provided by all parties involved, it will prepare a draft agency decision letter detailing the Panel's findings and conclusions regarding the alleged violation(s).

HRSA Seeks Comments

HRSA is soliciting comments...

© Polsinelli PC, Polsinelli LLP in CaliforniaNational Law Review, Volume VI, Number 242

About this Author

Mary Beth Blake, Polsinelli, physician groups attorney, hospice organizations lawyer
Senior Partner

Mary Beth Blake is a creative problem solver who works with health systems, hospitals, physician groups, hospice organizations, and dental groups. She is an active participant with clients as they plan for the future and update their operations and policies to comply with the ever changing health care environment or respond to regulatory issues and requirements. 

Mary Beth's experience as in-house counsel for a large medical school and teaching hospital forms the basis of her understanding and knowledge of various parts of the health care...

Lauren Z. Groebe, Polsinelli, HIPAA Compliance Attorney, Health Care Provider Lawyer

Lauren Groebe tackles client’s issues with a high level of commitment and enthusiasm every time. She brings a passion for the practice of health care law and a genuine interest in its business and compliance components.

With a master’s degree in health administration and a Health Law Certificate from St. Louis University, Lauren understands the numerous changes and ongoing issues facing health care providers from a variety of perspectives. Lauren works with clients on operational, compliance, and regulatory issues with a focus on the 340B...

Travis F. Jackson, Polsinelli, Hospital Organization Lawyer, Transactional Matters Attorney

Travis Jackson identifies practical options to address the challenging issues facing hospitals and nonprofit organizations in today’s rapidly changing environment. He assists clients with a variety of tax and transactional matters that satisfy their business objectives while also furthering their missions. He has counseled health systems and hospitals in:  

  • Pursuing mergers and acquisitions that enable hospitals to develop the economies of scale necessary to succeed under federal health reform and ensure the continuity of care in their...


Emily Shaw approaches problems with diligence, creativity, and enthusiasm. She combines her passion for health care law with her commitment to each client’s individual business needs to identify legal options to help them overcome challenges within their organizations, as well as within the industry. She assists a broad range of health care organizations with complex transactional and regulatory matters. Prior to joining the firm, Emily gained health care administrative experience through an internship with a large non-profit hospital.

Emily is committed to...

Kyle A. Vasquez, Polsinelli, Compliance Support Lawyer, Health Care Reform Attorney

Kyle Vasquez provides pragmatic legal and compliance support to a wide range of health care clients. He utilizes his background in health law and his prior experience as a health care consultant to develop creative approaches that address the unique challenges that health care providers face. Kyle works collaboratively with health care stakeholders to assist in identifying forward-thinking models that meet their financial and operational needs. Kyle represents a broad set of health care entities including multi-hospital health systems, community hospitals, FQHCs,...