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HRSA Implements Administrative Dispute Resolution Process for 340B Program

On December 10, 2020, HRSA issued a final rule (the Final Rule) implementing the 340B Drug Pricing Program administrative dispute resolution (ADR) process–an overdue mandate from the Affordable Care Act. Under the Final...more

Reportedly Leaked White House Policy “Wish-List” Lists “Serious 340B Reform,” Demonstration of Value-Based Payments for Drugs and...

A While House policy “wish-list,” reportedly leaked on October 19 (Policy Document), identifies what appear to be the Trump Administration’s policy goals for various government programs, including Medicaid, the 340B Drug...more

HRSA Withdraws 340B Program “Mega Guidance” from OMB Review

On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the...more

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