News & Analysis as of

Food and Drug Administration (FDA) Section 340B Patient Protection and Affordable Care Act (PPACA)

Holland & Knight LLP

Holland & Knight Health Dose: July 8, 2025

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With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more

Alston & Bird

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

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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

McGuireWoods Consulting

Washington Healthcare Update - June 2021 #3

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

McGuireWoods Consulting

The Courts and Healthcare Policy

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

McGuireWoods Consulting

Courts and Healthcare Policy in 2020

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

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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

This Week: Happy New Year! The 116th Congress begins and healthcare issues are part of the "buzz" of day one. Part of the government is still closed. ...more

McGuireWoods Consulting

Washington Healthcare Update

This Week: Congress focuses on organizing for the next Congress and the continuing resolution; previews of drug pricing legislation for the next Congress; CMS issues controversial guidance concerning how states can use...more

McGuireWoods Consulting

Washington Healthcare Update

McGuireWoods Consulting on

Administration - Trump Administration Announces HRA Regulatory Proposal to Prevent Adverse Selection - The Trump administration announced a regulatory proposal to permit employees to go to the individual market to...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 #4

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Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 pt 2

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Foley & Lardner LLP

Health Care Policy Newsletter - May 2018 pt 2

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly Health Care Newsletter” in which we compile the latest health care policy news and legislation.*Please note that we...more

Foley & Lardner LLP

Health Care Policy Newsletter

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more

BakerHostetler

Capitol Hill Healthcare Update

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Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable? Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’...more

BakerHostetler

Capitol Hill Healthcare Update

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With only 10 legislative days before Senate Republicans’ self-imposed deadline, GOP lawmakers face growing obstacles in their quest to vote on replacing the Affordable Care Act (ACA) before the beginning of their scheduled...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Senate Republicans return to Washington this week after a 10-day recess facing a key inflection point in their effort to repeal and replace the Affordable Care Act (ACA) as GOP leaders will outline policy options they hope...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

Mintz - ML Strategies

Health Care Update - October 2015

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Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

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In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

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Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Troutman Pepper

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

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HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

McDermott Will & Emery

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

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On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Mintz - ML Strategies

Health Care Update - March 2015 #2

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In This Issue: - Senate HELP Begins Innovation for Healthier Americans Hearings - 340B Hearing Postponed; Written Testimonies Shed Light on Agenda - Implementation of the Affordable Care Act -...more

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