340B Administrative Dispute Resolution (ADR)

Stakeholders can begin submitting claims once the 340B Administrative Dispute Resolution (ADR) final rule (89 FR 28643, April 19, 2024) becomes effective on June 18, 2024. Detailed information on the submission process can be found on this webpage. Any additional questions can be sent to 340BADR@hrsa.gov.

The 340B ADR Panel will consist of individuals from a 340B ADR Roster comprised of OPA staff with subject matter expertise of the 340B Program. The OPA Director, or designee, will select at least three members for each 340B ADR Panel. Prior to appointment to the 340B ADR Roster, OPA staff will be screened for conflicts of interests by the OPA Director and government ethics officials. All individuals on the 340B Panel will also undergo additional screening conducted by HRSA prior to reviewing a specific claim.

To be considered eligible for Secretarial appointment to the 340B ADR Roster, the OPA staff members must annually file and submit an Office of Government Ethics (OGE) Form 450 through the HHS Electronic Financial Disclosure System (EFDS). This form will also be certified by an Ethics Specialist in HRSA’s Office of Operations.

Prior to selection for an ADR Panel assignment, the OPA Director or designee, will evaluate if a prospective Panel member has any potential conflicts, including financial interest conflicts, current or former business relationships or other involvement with parties involved in the claim.

Additionally, the OPA Director or designee will perform screening to ensure that a 340B ADR Panel member was not directly involved in a decision concerning the specific issue of the ADR claim as it relates to the specific covered entity or manufacturer involved, including previous 340B ADR Panel decisions.

The Secretary may remove any individual from the 340B ADR Roster for any reason, including from any 340B ADR Panel to which the individual has already been assigned. To the extent that any significant conflict issue is raised after appointment, the OPA Director or the Secretary have the discretion to remove a 340B ADR Panel member.

In accordance with the 340B ADR final rule (89 FR 28643, April 19, 2024), claims may be submitted by:

• Covered entities that may have been overcharged for covered outpatient drugs purchased from manufacturers
• Manufacturers of 340B drugs, after the manufacturer has conducted an audit of the covered entity, when covered entities may have violated the prohibitions against duplicate discounts or diversion

In addition, the petition must be submitted within three years of the date of the alleged violation. Stakeholders must also submit documentation of any prior good faith efforts to resolve the dispute at issue.

There is no monetary threshold that must be satisfied for a claim to proceed to the 340B ADR Panel review. However, covered entities and manufacturers should carefully evaluate whether the ADR process is appropriate for minor or de minimis claims given the investment of time and resources required of the parties involved.

Covered entities and manufacturers must attempt to resolve issues in good faith prior to initiating a formal ADR process, which should be used as a last resort. Covered entities and manufacturers should carefully evaluate whether the ADR process is appropriate given the investment of the time and resources required of the parties involved.

When submitting a claim, stakeholders must include any documentation of prior good faith efforts, along with documentation including invoices, audit reports, policy statements, or correspondence, to substantiate the claim filed by the petitioner.

Stakeholders should email the following information to 340BADR@hrsa.gov to begin the 340B ADR process:

• Petitioner Organization Name, 340B ID or Labeler Code
• Petitioner Point of Contact Name, Email Address and Phone number
• The opposing party’s 340B ID or Labeler Code
• A brief (1-2 sentence) description of the reason the petition is being filed

The 340B ADR Panel’s decision letter will be completed within one year of receiving a complete claim for review. Depending on the complexity of the issue, issuance of the ADR Panels decision letter may occur after this date.

The 340B ADR Panel will review the claim, the opposing party’s response, and supporting documentation or other information from the parties. The 340B ADR Panel will follow the 340B statue, regulations, and all policies governing the 340B Program when reviewing and evaluating ADR claims. Following its review of all evidence, the 340B ADR Panel will issue a decision that will be sent to the parties and HRSA.

Within 30 business days of the 340B ADR Panel decision, manufacturers or covered entities may initiate a reconsideration request. If neither party submits a reconsideration request, then based on the final decision the OPA Director will determine any necessary corrective action or whether to take enforcement action, including referral to the HHS Office of Inspector General for its consideration of civil monetary penalties, as appropriate.

Yes. Covered entities must be members of the organization or association filing a claim on their behalf. All claims must allege violations by the same manufacturer and for the same drug(s). Organizations or associations must submit a joint claim attestation letter that they have confirmed that all the individual covered entities have agreed to be part of the ADR claim.

Joint claims are permitted for covered entities if certain criteria are met. Multiple covered entities, or their membership organizations or associations, can file together against a single manufacturer for the same drug(s) (a joint claim), but each must submit all documentation required to file a claim (e.g., invoice, 340B ceiling price, attempts to purchase at 340B). A joint claim attestation letter that confirms each covered entity has agreed to be part of the ADR claim must also be submitted.

Multiple manufacturers can file together against a single covered entity (a consolidated claim) if each manufacturer could individually file a claim against the covered entity, consents to the consolidated claim, meets the requirements for filing a claim, and the 340B ADR Panel determines that such consolidation is appropriate and consistent with the goals of fairness and economy of resources.

Consolidated claims filed on behalf of manufacturers by associations or organizations representing their interests are not permitted.