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340B Audit ‘Protections’ Needed Prior To Dispute Resolution Final Rule, Lilly Tells OMB

 
• By Cathy Kelly

Lilly wants White House Office of Management and Budget to delay final rule until there are regulatory controls against duplicate and diverted discounts. OMB has also held three meetings over past few months with organizations representing 340B providers.

More Evidence That Legislative Clarity Is Needed For 340B Program • Source: Shutterstock

A final rule revising the 340B administrative dispute resolution process should not be released until federal regulators issue guidance or regulations affirming manufacturer protections against providing duplicate 340B and Medicaid discounts on the same drug and providing discounts on drugs diverted to ineligible patients, Eli Lilly and Company urged the White House Office of Management and Budget during a 22 January meeting.

Manufacturers are granted the right to audit 340B hospitals and other providers by law and audits are to be conducted...

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