News & Analysis as of

Reimbursements Prescription Drugs

Smart & Biggar

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

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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

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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

Rivkin Radler LLP on

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

Kohn, Kohn & Colapinto LLP

The Government’s Ability to Combat Fraud is on the Line in False Claims Act Supreme Court Case

Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...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 & Emery

ERISA Preemption Developments in Managed Care

McDermott Will & Emery on

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

King & Spalding

Court Rules on Retrospective Relief for 340B Hospitals Without Vacating CMS’s Rules

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On January 10, 2023, Judge Contreras of the United States District Court for the District of Columbia ruled that CMS’s 340B drug reimbursement rates dating back to January 1, 2018, were unlawful and underpaid affected...more

Smart & Biggar

Innovative Medicines Canada proposes framework for innovative agreements for drug reimbursement

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Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the form of a first dollar...more

Polsinelli

340B Hospital Reimbursement Update – Underpayments and the Need to Act Now

Polsinelli on

It has certainly been a year of ups and downs for 340B hospitals. While litigation continues in the manufacturer 340B price restriction space, and 340B hospitals continue to experience financial, legal and operational...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions

On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] Understanding the 340B Program: A Guide to the Newest Developments - November 9th, 3:00 pm - 4:00 pm ET

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The 340B discount program—which requires manufacturers to provide outpatient drugs to...more

Greenbaum, Rowe, Smith & Davis LLP

U.S. District Court Judge Vacates Unlawful Drug Reimbursement Rate For 340B Hospitals for Remainder of 2022

As we reported previously in this post on our Healthcare Perspectives blog, the U.S. Supreme Court earlier this summer held that the federal government improperly lowered drug reimbursement payments to certain 340B hospitals...more

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