News & Analysis as of September 17, 2024

Department of Health and Human Services (HHS)

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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 +

340B Program Administrative Dispute Resolution Final Rule: Key Takeaways

Mintz - Health Care Viewpoints on 5/17/2024

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

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

ArentFox Schiff on 5/15/2024

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

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

HRSA Proposes Changes to ADR Procedures for 340B Disputes

King & Spalding on 12/9/2022

On November 29, 2022, the Health Resources and Services Administration (HRSA) issued a proposed rule (Proposed Rule) to revise the alternative dispute resolution (ADR) procedures for disputes arising under the 340B drug...more

HHS Issues Interim Final Rule Implementing Certain Provisions of the No Surprises Act

Holland & Knight LLP on 7/6/2021

The U.S. Departments of Health and Human Services (HHS), Labor and Treasury, along with the Office of Personnel Management, on July 1, 2021, issued a much-anticipated Interim Final Rule with Comment Period (IFC) –...more

Federal Guidance On Balance Billing: The No Surprises Act And Its Interim Final Rule: Part I

Husch Blackwell LLP on 7/6/2021

On July 1, 2021, the Office of Personnel Management (“OPM”), the Internal Revenue Service (“IRS”), the Department of Treasury (“Treasury”), the Employee Benefits Security Administration (“EBSA”), the Department of Labor...more

Federal Judge Blocks Implementation of 340B ADR Final Rule

King & Spalding on 3/24/2021

On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would...more

HRSA Implements Administrative Dispute Resolution Process for 340B Program

King & Spalding on 12/21/2020

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

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

McDermott Will & Emery on 8/17/2016

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

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Patient Protection and Affordable Care Act (PPACA) › Dispute Resolution › Department of Health and Human Services (HHS)

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