News & Analysis as of

Pharmacies Drug Pricing Civil Monetary Penalty

ArentFox Schiff

The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow

ArentFox Schiff on

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

Bass, Berry & Sims PLC on

On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

Hogan Lovells

2020 final price reporting developments: stimulus legislation, 340B contract pharmacy Advisory Opinion

Hogan Lovells on

As we begin the new year, we wanted to highlight two final developments from December 2020: First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

K&L Gates LLP

340B Update: Trump Administration Withdraws Omnibus Guidance, Delays Final Rule on 340B Drug Pricing and CMPs

K&L Gates LLP on

The new administration has had an immediate impact on the federal 340B Drug Discount Program (“340B Program”) with two significant developments in the first days since President Trump took office: (1) the withdrawal of the...more

Polsinelli

340B Program Change on the Horizon? OMB Completes Review of the 340B Omnibus Guidance

Polsinelli on

Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more

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