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Patient Protection and Affordable Care Act (PPACA) › Section 340B

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

Mintz - Health Care Viewpoints on

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

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

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

King & Spalding on

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

Alston & Bird

Health Care Week in Review: HHS Issued Proposed Rules and a Request for Information

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2022 #2

Latham & Watkins LLP on

Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more

McGuireWoods Consulting

The Courts and Healthcare Policy - August 2021

McGuireWoods Consulting on

The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

Foley Hoag LLP - Medicaid and the Law

Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion

Foley Hoag LLP - Medicaid and the Law on

Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.  Given the link between the Medicaid drug rebate...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021 #2

Latham & Watkins LLP on

Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...more

McGuireWoods Consulting

Washington Healthcare Update - June 2021 #3

McGuireWoods Consulting on

This week in Washington: Supreme Court dismisses challenge to the Affordable Care Act....more

McGuireWoods Consulting

The Courts and Healthcare Policy - April 2021

McGuireWoods Consulting on

2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

ArentFox Schiff

Senate Finance Committee Holds Confirmation Hearing For Top Biden HHS Nominees

ArentFox Schiff on

Deputy Secretary and CMS Administrator Picks Would Fill Two Critical Policy Positions - On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated...more

Foley & Lardner LLP

Relevant Highlights: Hearing to Consider the Nomination of Chiquita Brooks-LaSure to be Administrator for the Centers for Medicare...

Foley & Lardner LLP on

This morning, the United States Senate Committee on Finance questioned Pres. Biden’s nominee, Chiquita Brooks-LaSure, for Administrator for Centers for Medicare and Medicaid Services (CMS), as well as Andrea Palm, the nominee...more

K&L Gates LLP

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

K&L Gates LLP on

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

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

King & Spalding on

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

McGuireWoods Consulting

The Courts and Healthcare Policy

McGuireWoods Consulting on

2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

King & Spalding

HRSA Implements Administrative Dispute Resolution Process for 340B Program

King & Spalding on

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

McDermott Will & Emery

HRSA Releases Final Rule Establishing Dispute Resolution Process for the 340B Program

McDermott Will & Emery on

On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes...more

K&L Gates LLP

HRSA Publishes Long-Awaited (and Long-Overdue) 340B Program Alternative Dispute Resolution Process Final Rule

K&L Gates LLP on

On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative...more

Polsinelli

The Fate of the Trump Administration’s Controversial Most Favored Nation Drug Pricing Model Is Unclear Given Mounting Legal...

Polsinelli on

On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive...more

McGuireWoods Consulting

Courts and Healthcare Policy in 2020

McGuireWoods Consulting on

2019 saw court hearings of a number of cases related to the Affordable Care Act (ACA). Several other Trump administration policies were also challenged, including Medicare payment policies, price transparency, how the...more

Baker Donelson

President Trump's Budget: Key Takeaways for Health Care

Baker Donelson on

President Trump's fiscal year 2020 (FY20) budget proposal for the Department of Health and Human Services (HHS) reflects the Trump Administration's priorities to repeal and replace the Affordable Care Act (ACA), implement...more

McGuireWoods Consulting

Washington Healthcare Update February 2019 #1

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Coming Week’s Highlights: State of the Union scheduled for Feb. 5; House committees continue discussion on pre-existing conditions....more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

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