The proposed binding administrative dispute resolution process would be used when 340B program participants claim they have been overcharged for drugs purchased through the program. It would also be used to resolve claims by manufacturers that allege a 340B program participant has violated the prohibitions against duplicate discounts and diversion.
Instead of having a single decision-making official who reviews and resolves these claims, the proposed rule calls for an ADR panel to be established to review claims. This will ensure an “unbiased” and “fair” review of the claims, according to HRSA.
The proposed rule will be published in the Federal Register Aug. 12, and comments will be accepted through Oct. 11.
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