News & Analysis as of September 17, 2024

Manufacturers

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The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on 4/24/2024

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

340B Update: Federal Court Halts 340B Administrative Dispute Resolution Rule

K&L Gates LLP on 3/30/2021

Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...more

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

Polsinelli on 1/25/2017

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

K&L Gates LLP on 1/19/2017

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more

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