News & Analysis as of

HRSA Healthcare Final Rules

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

Quarles & Brady LLP on

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Hogan Lovells

HRSA Releases Ceiling Price and CMP Final Rule

Hogan Lovells on

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

McDermott Will & Emery

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

McDermott Will & Emery on

On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more

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