News & Analysis as of

Appeals Drug Pricing

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

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On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Bass, Berry & Sims PLC

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

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On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more

ArentFox Schiff

Investigations Newsletter: Supreme Court Again Tightens FCA Intent, But Tricky Questions Linger

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The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more

Foley & Lardner LLP

The Future of the 340B Program: 2023 Key Decisions

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Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more

McDermott Will & Emery

This Week in 340B: January 2023 #5

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Bass, Berry & Sims PLC

Third Circuit Ruling Allows Restrictions on 340B Contract Pharmacies

On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more

Foley Hoag LLP

United States Court of Appeals for the Third Circuit Holds That Drug Manufacturers Are Not Required to Contract with Unlimited...

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On January 30, 2023, the United States Court of Appeals for the Third Circuit issued its decision in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, enjoining the United States Department of...more

McDermott Will & Emery

Court Rules in Favor of Manufacturers in 340B Contract Pharmacy Case

Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...more

King & Spalding

Supreme Court to Determine Whether False Claims Act Requires Objective Scienter Standard

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Last week, the Supreme Court granted review to clarify the scienter requirement in False Claim Act (31 U.S.C. §§ 3729 et seq.) (FCA) cases. This significant decision will affect the scope of FCA liability by addressing what...more

Foley Hoag LLP

American Hospital Association et al. v. Becerra et al.: Supreme Court Rejects CMS Policy to Adjust Medicare Part B Payments for...

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Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more

Smart & Biggar

Confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations declared invalid by...

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On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more

Bradley Arant Boult Cummings LLP

2 Recent Decisions Highlight Ambiguity As FCA Defense | Insights & Events

The past year has seen substantial activity by the federal courts in guarding against government overreach in False Claims Act cases. One of the principal areas courts have focused on is the FCA's knowledge requirement —...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

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On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

McDermott Will & Emery

July Surprise - Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more

McDermott Will & Emery

International News: Healthcare - Spotlight on the Industry - May 2021

Sovereign Wealth Fund Investment in the Global Healthcare Industry - Sovereign Wealth Funds (SWF) seek out investments that are resilient, conducive to their aims and objectives, and reasonably free from market...more

McDermott Will & Emery

Fourth Circuit Breathes New Life into Monopolization Suit

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The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration...more

Dorsey & Whitney LLP

The Supreme Court - December 10, 2020

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Rutledge v. Pharmaceutical Care Management Assn., No. 18-540: Arkansas’ Act 900 regulates the price at which pharmacy benefit managers (“PBMs”) reimburse pharmacies for the cost of drugs covered by prescription-drug plans....more

Sheppard Mullin Richter & Hampton LLP

The U.S. Court of Appeals Denies Rehearing on Cuts to 340B Drug Pricing Program

In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19,...more

Baker Donelson

Federal Appeals Court Upholds Payment Reduction to 340B Hospitals

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On July 31, 2020, the D.C. Circuit Court of Appeals issued a decision reversing a lower court decision and upholding Medicare payment cuts to certain hospitals participating in the 340B drug pricing program that have been in...more

K&L Gates LLP

340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

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In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

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Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

Rivkin Radler LLP

Drug Price Disclosure Rule Rejected Again

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On June 16, the U.S. Court of Appeals for the District of Columbia Circuit upheld a ruling from a year ago that struck down a federal regulation requiring pharmaceutical companies to disclose wholesale prices of prescription...more

White & Case LLP

Court of Appeal broadly upholds the CAT's judgment in Phenytoin and clarifies "excessive pricing" test - Authorities can't stick...

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On 10 March 2020 the Court of Appeal upheld the Competition Appeal Tribunal's (CAT) quashing of the Competition and Markets Authority's (CMA) decision that Pfizer and Flynn Pharma (Flynn) had abused their dominant positions...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

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In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more

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