HRSA Releases Details and FAQs About New 340B Dispute Resolution System

The U.S. Health Resources and Services Administration (HRSA) Tuesday afternoon posted a new webpage describing the steps health care providers and drug manufacturers must follow to invoke the 340B program’s new administrative dispute resolution (ADR) process. It simultaneously posted 11 FAQs about the process.

Today, Jan. 13, is the first day providers and manufacturers can file claims under the ADR process. One or more petitions are expected to be filed today. HRSA announced on its home page and in email messages to stakeholders that the new ADR webpage was live.

HRSA said, in general, the ADR process will have 10 steps:

1. A petitioner emails HRSA at 340BADR@hrsa.gov with a request to file a petition through the ADR process.
2. HRSA responds with specific instructions on accessing a secure email and file transfer system in order to file the petition.
3. Once the petition, including any supporting documentation, is received, HRSA reviews the petition for completeness and will notify the petitioner of whether the petition will move forward to the ADR Panel for review.
4. If HRSA deems the petition complete, ADR Panel members are selected from the 340B ADR Board and are convened to begin their review of the petition.
5. The petitioner (or initiating party) must provide a copy of their petition with any attachments to the General Counsel or other senior official of the opposing party at its principal place of business by certified mail, return receipt requested, within three days of filing the claim.
6. The opposing party (or respondent) will have an opportunity to respond to the petition.
7. HRSA will provide both the petitioner and the opposing party access to a secure email and file transfer system upload any relevant documents related to the petition.
8. The ADR Panel will review the petition, the opposing party’s response, and all supporting documentation or other information from the parties. 
9. Following its review of all of the evidence, the ADR Panel will make a final agency decision that will be sent to the parties and HRSA. 
10.  HRSA then will take enforcement actions or apply sanctions as appropriate, including referral to the HHS Office of Inspector General for its consideration of civil monetary penalties, as appropriate.

HRSA also posted 11 FAQs about the process.

Tom Mirga

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