News & Analysis as of

Dispute Resolution Patient Protection and Affordable Care Act (PPACA)

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

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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

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

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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

King & Spalding

HRSA Proposes Changes to ADR Procedures for 340B Disputes

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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

Holland & Knight LLP

Holland & Knight Health Dose: December 6, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: -...more

Holland & Knight LLP

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

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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

Husch Blackwell LLP

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

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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

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

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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

ArentFox Schiff

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

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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

King & Spalding

HRSA Implements Administrative Dispute Resolution Process for 340B Program

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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

Pullman & Comley, LLC

Health Law From the Courts: Review of 2019 Connecticut Case Law

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Our annual survey of health law cases for 2019 includes a number of notable decisions affecting the practice of medicine and the delivery of other health care services in Connecticut.  These include the Connecticut Supreme...more

Manatt, Phelps & Phillips, LLP

Health Update - October 2016

Defining and Resolving the Provider Data Dilemma - Editor’s Note: Provider data drives the most fundamental processes in the healthcare system. Inaccurate provider data puts patient care and billions of dollars at risk....more

Foley & Lardner LLP

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

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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

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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

Constangy, Brooks, Smith & Prophete, LLP

15 For ’15: Employment And Labor Resolutions For The New Year

While the year is still young, here are 15 New Year’s resolutions that employers may want to make: 1. Make sure your “independent contractors” are really independent contractors. ”Independent contractors” are under...more

Foley Hoag LLP

DC District Court Strikes Down 340B Orphan Drug Rule

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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

Epstein Becker & Green

Take 5 Newsletter: An Employer's "Top 5" Action Items for 2014

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It's December, and human resources professionals and law departments are reflecting on the issues addressed in 2013 and giving thanks for incident-free holiday parties. But the big question is this: What issues should get...more

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