News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) Covered Entities Dispute Resolution

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 +
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 subsidies to reduce the number of uninsured citizens. less -
Mintz - Health Care Viewpoints

340B Program Administrative Dispute Resolution Final Rule: Key Takeaways

On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

ArentFox Schiff

Health Resources and Services Administration Enjoined from Implementing the 340B Dispute Resolution Rule

ArentFox Schiff on

US District Court for Southern District of Indiana granted plaintiffs Eli Lilly and Company and Lilly USA a preliminary injunction barring HRSA from implementing the final Administrative Dispute Resolution rule that was to...more

Foley & Lardner LLP

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Foley & Lardner LLP on

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

McDermott Will & Emery

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

McDermott Will & Emery on

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

Foley Hoag LLP

DC District Court Strikes Down 340B Orphan Drug Rule

Foley Hoag LLP on

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

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