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PHRMA Section 340B

Mintz - Health Care Viewpoints

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more

ArentFox Schiff

The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow

ArentFox Schiff on

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Learning From Experience: Medicare Drug Price Negotiation Program Updates

Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more

ArentFox Schiff

The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court

ArentFox Schiff on

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

Baker Donelson

Lawmakers Call on HHS to Stop Drug Companies from Denying 340B Drug Pricing

Baker Donelson on

Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...more

Mintz - Health Care Viewpoints

The Uncertain State of the 340B Program: Where Are We Now?

In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the...more

K&L Gates LLP

What a Trump Administration Could Mean for the 340B Drug Program

K&L Gates LLP on

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

Manatt, Phelps & Phillips, LLP

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

Arnall Golden Gregory LLP

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...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...

K&L Gates LLP on

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

BakerHostetler on

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

Mintz - Health Care Viewpoints

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Foley & Lardner LLP on

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

Polsinelli

Orphan Drug Ruling Disrupts the 340B Program

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On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

King & Spalding

Victory for Pharmaceutical Manufacturers Challenging HHS’s Interpretive Rule Covering Orphan Drugs Under 340B Program

King & Spalding on

On October 14, 2015, the United States District Court for the District of Columbia struck down an interpretive rule from HHS that limited the prices pharmaceutical manufacturers could charge for orphan drugs sold to certain...more

King & Spalding

Congress Holds Hearing on 340B Program

King & Spalding on

The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more

McDermott Will & Emery

New Challenge to 340B Rule Regarding Orphan Drugs

McDermott Will & Emery on

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

Cooley LLP

Blog: Phrma Challenges HRSA Interpretative Rule On Orphan Drugs In The 340B Drug Discount Program

Cooley LLP on

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive...more

Mintz - Health Care Viewpoints

The Increasingly Murky World of 340B: What’s Next?

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more

King & Spalding

D.C. District Court Rules Drug Manufacturer Group Must File New Lawsuit To Challenge HHS Interpretive Rule on 340B Orphan Drug...

King & Spalding on

On August 27, 2014, the United States District Court for the District of Columbia rejected Plaintiff Pharmaceutical Research and Manufacturers of America’s (PhRMA) request to invalidate HHS’s recent interpretive rule...more

Foley & Lardner LLP

340B Drug Pricing Program Interpretative Rule Survives (for Now)

Foley & Lardner LLP on

A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance...more

Polsinelli

Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program

Polsinelli on

Polsinelli Podcast Explores Upcoming Webinar Covered entities and drug manufacturers expected the Health Resources and Services Administration (HRSA) to issue its much anticipated mega-reg for the 340B Program in June....more

Faegre Drinker Biddle & Reath LLP

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

BakerHostetler

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

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On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

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