News & Analysis as of

Reimbursements Prescription Drugs

Mitchell, Williams, Selig, Gates & Woodyard,...

2025 Arkansas Insurance Legislation Summary: Health

This is the third article in a series of summaries of insurance legislation from the 95th Arkansas General Assembly....more

DLA Piper

New Federal Initiatives Signal Digital Health Access as a Key Priority

DLA Piper on

Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

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On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

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On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more

Bressler, Amery & Ross, P.C.

The New Jersey Department of Banking & Insurance Issues Two Health-Related Insurance Bulletins Announcing Changes to the Law,...

On December 31, 2024, the New Jersey Department of Banking & Insurance (“Department”) issued two Bulletins, announcing changes to the law, effective January 1, 2025. Both Bulletins addressed health insurance. Bulletin, No....more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Smart & Biggar

CDA–AMC (formerly CADTH) announces several pilot projects, including Target Zero initiative

Smart & Biggar on

CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more

Wiley Rein LLP

Proposed State and Federal PBM Legislation: Is There Reason for Action Now?

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Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more

Farrell Fritz, P.C.

Second Circuit Defines “Willfulness” Standard Under Anti-Kickback Statute

Farrell Fritz, P.C. on

Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS). False Claims Act relator Adam Hart alleged that...more

Marshall Dennehey

Commonwealth Court Holds That an Employer’s Failure to Reimburse a Claimant for Out-of-pocket Payments for CBD Oil is in Violation...

Marshall Dennehey on

Schmidt v. Schmidt, Kirifides & Rassias, Pa. C. (WCAB); No: 1039 C.D. 2021; filed Nov. 14, 2023; Judge Covey - In this case, the claimant, an attorney, sustained a work injury on April 14, 2017, while loading files into a...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

A&O Shearman

UK CMA issues 'prioritisation statement' to allay competition law fears that prevent combination therapies reaching NHS

A&O Shearman on

The UK Competition and Markets Authority (CMA) has taken the unusual step of issuing a prioritisation statement on cooperation between competitors to make combination therapies available to the NHS. The CMA worked closely...more

Smart & Biggar

CADTH time-limited recommendation category to enhance earlier access to promising new drugs

Smart & Biggar on

On September 28, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) introduced the time-limited reimbursement recommendation category, which aims to provide early access to promising new drugs that target...more

Arnall Golden Gregory LLP

The Government Cannot Cut Corners: Appellate Courts Reverse Sentences in Three Recent Cases Because the Government Did Not...

Three appellate courts recently reversed sentences because the government did not adequately present evidence to support the alleged loss calculation underlying the court’s determination of the sentencing guidelines range. In...more

Tarter Krinsky & Drogin LLP

New Jersey Passes Landmark Law to Limit Pharmacy Benefit Managers

New Jersey has passed a landmark law limiting the power of pharmacy benefit managers (PBMs). On Monday, July 10, 2023, Governor Phil Murphy signed the law, requiring PBMs to disclose their negotiated reimbursement rates for...more

Ballard Spahr LLP

Supreme Court’s SuperValu Decision: a Game-Changer for Assessing FCA Violations

Ballard Spahr LLP on

Summary - On June 1, 2023, the Supreme Court issued a landmark decision in False Claims Act cases. In United States ex rel. Schutte v. SuperValu Inc., it unanimously held that liability under the False Claims Act depends...more

ArentFox Schiff

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

ArentFox Schiff on

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

Davis Wright Tremaine LLP

Supreme Court Clarifies FCA Scienter Standard – Overturns 7th Circuit Decision

Ruling in case involving national retail pharmacies rejects the “objective reasonableness” standard for the False Claims Act - On June 1, 2023, the U.S. Supreme Court unanimously vacated the 7th Circuit's decision in U.S....more

WilmerHale

High Court Hears Important Case on False Claims Act’s Scienter

WilmerHale on

On April 18, the Supreme Court heard oral argument and what has been billed as the most important False Claims Act (FCA) case in a decade. Since the FCA was enacted in the Civil War era, it has been the primary tool for the...more

Foley & Lardner LLP

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

Foley & Lardner LLP on

On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

Rivkin Radler LLP

Fraud Week: Garden State Fraud Roundup; Much Compounding

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Here’s a selection of recent healthcare frauds from New Jersey. On April 17, John Sher of Margate was sentenced to 37 months in prison and ordered to pay $2.77 million in restitution and $327,987 in forfeiture for defrauding...more

American Conference Institute (ACI)

[Event] 21st Annual Rx Drug Pricing Boot Camp - May 4th - 5th, New York City, NY

The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more

McDermott Will & Schulte

ERISA Preemption Developments in Managed Care

For plans governed by the Employee Retirement Income Security Act of 1974, 29 U.S.C. §§ 1001-1461 (ERISA), the doctrine of federal ERISA preemption over state statutes, regulations or administrative schemes has been a central...more

King & Spalding

Supreme Court Ruling in AHA v. Becerra May Affect 340B Hospitals' Reimbursement Rights Against Medicare Advantage Plans

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Hospitals that participate in the 340B program may be entitled to additional monies from Medicare Advantage plans in the wake of the Supreme Court’s decision in AHA v. Becerra. In AHA v. Becerra, a unanimous Supreme Court...more

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