The Health Resource Services Administration has issued a proposed rule that would create a dispute resolution process for those providers who contend they may have been overcharged for drug purchases made through the 340B program, or by drug manufacturers who have claimed program participants have diverted drugs to ineligible patients.
The HRSA proposal was posted on the Federal Register last week. The agency is currently seeking comments through the first part of October.
Currently, any disputes between manufacturers and 340B participants are settled between the two parties. “The...process as proposed in this rule is not intended to replace these good faith efforts, but should be considered as a last resort in the event good faith efforts to resolve disputes have not been successful,” the proposal said.
The 340B program has helped safety-net providers obtain medication at steep discounts. But both the drug companies and providers have come under scrutiny in recent years. The drug companies have been criticized for dramatically raising prices, while some 340B providers have come under fire for reselling some of their discounted drugs to insured patients at a big profit.
Under the proposal, an alternative dispute resolution panel will facilitate the review and resolution of claims within a reasonable time period. The panel will include three members, chosen from a roster of eligible individuals alternating from claim to claim, and one ex-officio, non-voting member chosen from the staff of the Office of Pharmacy Affairs. The proposed roster of eligible individuals will be comprised of federal employees (e.g., employees of CMS or the U.S. Department of Veterans Affairs) with "demonstrated expertise or familiarity with the 340B program.” the proposal said.
The panel would only rule on individual claims. Decisions would be based on majority votes. Any dispute would have to be brought within three years of its origin, according to the proposed rule.
- read the HRSA proposed rule (.pdf)