Affordable Care Act, Section 340B, Department of Health and Human Services (HHS)

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

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

Alston & Bird on 12/6/2022

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

The Courts and Healthcare Policy - August 2021

McGuireWoods Consulting on 8/10/2021

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

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

Foley Hoag LLP - Medicaid and the Law on 6/25/2021

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

Washington Healthcare Update - June 2021 #3

McGuireWoods Consulting on 6/22/2021

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

The Courts and Healthcare Policy - April 2021

McGuireWoods Consulting on 4/28/2021

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

Senate Finance Committee Holds Confirmation Hearing For Top Biden HHS Nominees

ArentFox Schiff on 4/16/2021

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

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

Foley & Lardner LLP on 4/16/2021

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

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

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

The Courts and Healthcare Policy

McGuireWoods Consulting on 2/2/2021

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

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

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

K&L Gates LLP on 12/14/2020

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

President Trump's Budget: Key Takeaways for Health Care

Baker Donelson on 3/18/2019

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

Washington Healthcare Update February 2019 #1

McGuireWoods Consulting on 2/5/2019

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

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

K&L Gates LLP on 1/31/2019

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

Window On Washington - Vol. 3, Issue 1

Clark Hill PLC on 1/3/2019

Outlook for This Week in the Nation's Capital - The 116th Congress. The 116th Congress, with 100 new members of the US House of Representatives (63 Democrats), convenes on Thursday, January 3, with Democrats returning to...more

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on 12/13/2018

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Patient Protection and Affordable Care Act (PPACA) › Section 340B › Department of Health and Human Services (HHS)