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Mayer Brown

Supreme Court Holds That to State a Claim for Inducing Patent Infringement, the Complaint Must Plausibly Allege That the Defendant...

Mayer Brown on

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 - Introduction - Yesterday, the Supreme Court held in a unanimous 9-0 decision that induced patent infringement requires active steps to encourage...more

Polsinelli

The Work Behind the Work Requirement: CMS Imposes Sweeping Medicaid Community Engagement Rule

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Key Takeaways - On June 1, CMS released an interim final rule implementing the new Medicaid community engagement requirement (i.e., work requirement) as a condition of Medicaid eligibility for adults aged 19-64 with access to...more

Sheppard

OHCA Releases Proposed Emergency Regulations Implementing AB 1415 Reporting Requirements for Private Equity (PE) and Management...

Sheppard on

Since Governor Newsom signed AB 1415 into law last October, stakeholders have been awaiting the release of draft regulations from California’s Office of Health Care Affordability (“OHCA”) to clarify the statute’s notice and...more

Jones Day

DOJ Announces Accelerated Review and Enhanced Enforcement in Benefits Fraud Matters

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Following a trend among federal agencies to crack down on alleged fraud in taxpayer-funded federal programs, the Department of Justice ("DOJ") Civil Division announced reforms that aim to leverage a whole-of-government...more

Polsinelli

Supreme Court Hands Generics a Unanimous Win on Skinny Labels in Hikma v. Amarin

Polsinelli on

A unanimous Supreme Court reversed the Federal Circuit and held that Amarin did not plausibly allege that Hikma’s skinny label and marketing actively induced infringement of Vascepa’s cardiovascular-use patents — a decisive...more

Vorys, Sater, Seymour and Pease LLP

Immediate Suspension of Payments for Ohio Medicaid Home Health and Waiver Services

As part of a coordinated national and state effort to address alleged Medicaid fraud in Ohio, the Ohio Department of Medicaid (ODM) has immediately suspended payments for Ohio Medicaid home health and waiver services provided...more

McDermott+

CMS drops interim final rule implementing Medicaid work requirements

McDermott+ on

As noted in last week’s Regs & Eggs blog post, the Centers for Medicare & Medicaid Services (CMS) is in the process of laying out a feast of Medicaid regs....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | April 2026 Recap

This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2026, including recent enforcement actions involving the False Claims Act (FCA), two favorable Office of...more

Goldberg Segalla

Lowering the Limits: New York’s Push for Stricter Lead Dust Standards

Goldberg Segalla on

Between 2025 and 2026, several proposed changes to New York’s lead regulations have emerged at both the state and city levels. One of the most significant is Bill S122A, introduced last year, which directs the New York State...more

BakerHostetler

[Podcast] The Cloakroom with Peter Roskam: 37th Annual Legislative Seminar – Congresswoman Erin Houchin, R-IN

BakerHostetler on

Former Congressman Peter Roskam, who leads BakerHostetler’s Federal Policy team, provides listeners with a front-row seat to the most important policy and political debates in Congress. In this episode of “The Cloakroom with...more

Dinsmore & Shohl LLP

Ohio Med Spa Nurses Increasingly Punished for Practicing Beyond the Scope of Their License

Dinsmore & Shohl LLP on

Key Takeaways: Ohio Boards are increasing enforcement against nurses involved in IV therapy and aesthetic injections....more

McGuireWoods LLP

Supreme Court Unanimously Rules Against Induced Infringement Claims Based on Routine Generic Drug Marketing

McGuireWoods LLP on

On June 4, 2026, the U.S. Supreme Court held in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, that routine generic drug marketing activities, including skinny labels, standard therapeutic equivalence...more

Goodwin

Boan Biotech Submits BLA to FDA for Two Denosumab Biosimilars

Goodwin on

On May 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and BA1102 (denosumab; injection 120 mg),...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Sagemount Invests in LSPedia

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Bregal Sagemount has made a strategic growth investment in LSPedia, according to a news release. LSPedia, founded in 2013 and with its U.S. headquarters in Farmington Hills, Michigan, is a provider of compliance,...more

Harris Beach Murtha

Five Reasons Why a Power of Attorney May Fail in Medicaid Planning (Especially in New York)

Harris Beach Murtha on

Many families believe they are 'covered' once a Power of Attorney (POA) is executed. It is one of the most practical documents in any estate plan, allowing a trusted person to step in and manage finances when you cannot....more

King & Spalding

Department of Justice Announces FCA Settlement with Psychiatric Hospital Operator

King & Spalding on

On May 27, 2026, the Department of Justice (DOJ) announced a False Claims Act settlement with psychiatric hospital operator Oglethorpe Inc. (Oglethorpe) and three executives resolving allegations that they violated the False...more

Mintz - Intellectual Property Viewpoints

Supreme Court Clarifies Standard for Induced Infringement in Hikma v. Amarin

In a unanimous decision handed down today, the Supreme Court delivered a tactical victory for Hikma, and a measure of guidance for other generic manufacturers. In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No....more

Proskauer Rose LLP

Supreme Court Reverses Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.: A Unanimous Decision for “Skinny...

Proskauer Rose LLP on

Today, the U.S. Supreme Court issued its decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, unanimously reversing the Federal Circuit and holding that Amarin failed to state a claim “more than a...more

Epstein Becker & Green

DOJ Civil Division Announces Accelerated Review of FCA Whistleblower Complaints Involving Federally Funded, State-Administered...

On May 27, 2026, DOJ’s Civil Division announced (“Announcement”) new efforts included in the Shumate Memo to accelerate the review of FCA whistleblower complaints alleging fraud against federally funded, state-administered...more

Foley Hoag LLP

CMS Issues Interim Final Rule Imposing Medicaid Work Requirements for Expansion Populations

Foley Hoag LLP on

Key Takeaways: New mandatory work requirements take effect July 31, 2026. CMS has published an Interim Final Rule implementing the requirement in H.R. 1 that certain Medicaid beneficiaries who live in states that expanded...more

Holland & Knight LLP

New York's FY 2026-27 Enacted Budget: Healthcare Regulatory Proposals Fail to Advance

Holland & Knight LLP on

In January 2026, Holland & Knight's Healthcare Blog summarized several notable healthcare-related proposals in New York Gov. Kathy Hochul's fiscal year (FY) 2026-27 Executive Budget. These included expanded oversight of...more

Polsinelli

Congress Considers Expanded Schedule H Reporting Requirements for Tax-Exempt Hospitals

Polsinelli on

Key Takeaways: Congress is considering expanded Schedule H reporting requirements for certain tax-exempt hospital organizations required to file Form 990 to require more detail on community benefit, charity care, 340B...more

Cozen O'Connor

Massachusetts AG Accuses UnitedHealthcare of Inflating Medicaid Reimbursements

Cozen O'Connor on

Massachusetts AG Andrea Joy Campbell sued UnitedHealthcare Insurance Company, d/b/a UnitedHealthcare Community Plans of Massachusetts, asserting Massachusetts False Claims Act, unjust enrichment, and breach of contract claims...more

Rivkin Radler LLP

HHS Finalizes Major Reforms to IDR Process under NSA

Rivkin Radler LLP on

On May 28, the U.S. Department of Health and Human Services (HHS) finalized regulations intended to make the Independent Dispute Resolution (IDR) process under the No Surprises Act (NSA) more efficient and transparent in...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Key Takeaways: Patenting Personalized Medicine: One Size Does Not Fit All

Personalized medicine continues to reshape life sciences innovation, but it also introduces unique challenges in today’s evolving legal landscape....more

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