The panel’s decisions will be final unless overturned by a court.

Aug. 15—A long-anticipated dispute resolution panel for the 340B drug pricing program took a step toward becoming reality when the Health Resources and Services Administration (HRSA) recently outlined its structure.

Under a HRSA proposed rule that would implement the Affordable Care Act requirement that a binding administrative dispute resolution (ADR) process for the 340B program be instituted, providers can file challenges if they believe they were overcharged for drugs purchased through the program.

The proposed process also would be available to drug manufacturers.

Here are some key components of the proposed ADR panel:

  1. The 340B ADR process is not intended to be a trial-like proceeding governed by formal review of evidence and procedure. Rather, it is an administrative process.
  2. The ADR process should be considered a last resort to be used after good-faith efforts to resolve disputes are unsuccessful.
  3. The ADR panel will be comprised of federal employees who are familiar with the 340B program.
  4. Claims must be filed within three years of the date of sale or payment.
  5. Required documents will include a 340B purchasing account invoice that shows the purchase price by national drug code, minus any taxes or fees.
  6. While a ceiling-price tracking system is being developed, HRSA will provide ceiling-price data to claimants.
  7. Consolidated claims by an organization or association must assert overcharging by the same manufacturer for the same drug.
  8. Regulations will establish procedures for claimants to discover or obtain information from manufacturers that is relevant to an overcharge claim.
  9. A draft version of an agency decision letter will be sent to all parties and will include the panel’s findings and conclusions regarding the alleged violation.
  10. After allowing time for responses, a final agency decision letter will be sent to all parties in the dispute.
  11. HRSA will take enforcement action or apply sanctions, as appropriate.
  12. The decision is final unless invalidated by a court order.

Rich Daly is a senior writer/editor in HFMA’s Washington, D.C. office. Follow Rich on Twitter: @rdalyhealthcare

Publication Date: Monday, August 15, 2016