On Oct. 11, CHA in coordination with the 340B Coalition, submitted comments to the Health Resources and Services Administration (HRSA) on the proposed Administrative Dispute Resolution (ADR) process rule. The overall purpose of the ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers; and (2) claims by manufacturers, that after a manufacturer has conducted an audit, a covered entity violated the prohibition on diversion to ineligible patients or duplicate discounts.
Highlights from the coalition letter include:
- the request for established deadlines and a process to ask for an extension
- suggestions around the composition of the ADR panel
- the need to define an “alleged violation”
- language urging HRSA to launch their 340B ceiling price database
- comments supporting the limiting of manufacturer claims to alleged diversion or duplicate discounts