News & Analysis as of

Reimbursements Manufacturers

ArentFox Schiff

Investigations Newsletter: Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations

ArentFox Schiff on

Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations - On September 6, the US Attorney’s Office for the District of Maryland announced that THD America, Inc., and its parent company, THD SpA of Italy,...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2022

Bass, Berry & Sims PLC on

The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...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

King & Spalding

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

King & Spalding on

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical...

On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more

Foley & Lardner LLP

States Impose New Requirements for Dealer Warranty Reimbursement

Foley & Lardner LLP on

State legislatures across the country spent the first half of 2021 enacting laws that include several changes to warranty reimbursement obligations owed by suppliers to authorized dealers. Four states have new warranty...more

Seyfarth Shaw LLP

States Adopt Changes To Warranty Reimbursement Laws In First Half of 2021

Seyfarth Shaw LLP on

State legislatures were busy in the first half of 2021, with no fewer than six (and likely seven) states adopting changes to statutory obligations imposed on manufacturers with respect to reimbursing dealers for performing...more

Baker Donelson

Medicare Issues Interim Final Rule to Lower Payments to Hospitals and Physicians for Certain Drugs Starting January 1, 2021

Baker Donelson on

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) to implement a payment model that will significantly reduce Medicare reimbursement rates for...more

Seyfarth Shaw LLP

New York DMV Appeals Board Affirms Decision Rejecting Excessive Warranty Reimbursement Rate Demanded By Dealer

Seyfarth Shaw LLP on

The dealer statutes of many states require automobile manufacturers to reimburse dealers for parts and labor used in warranty repairs at the “average” retail rates charged by dealers for customer pay repairs. ...more

Seyfarth Shaw LLP

California Adopts Major Changes to Warranty Reimbursement Requirements Effective January 1, 2020

Seyfarth Shaw LLP on

On October 12, 2019, California governor Gavin Newsom signed into law Assembly Bill 179 (A.B. 179), a bill that will make significant changes to the warranty reimbursement provisions of the California Vehicle Code effective...more

Seyfarth Shaw LLP

Ohio Federal Judge Crafts An Unprecedented Class Action Mechanism To Bring Relief To Counties And Cities Struggling To Address...

Seyfarth Shaw LLP on

Seyfarth Synopsis: In complex class actions, courts have looked to Rule 23 to authorize class actions either for trial, or for approval of a previously negotiated settlement. Now as thousands of public entities nationwide...more

Perkins Coie

Belated Government Dismissal of False Claims Act Cases: DOJ Maneuvering in Post-Escobar and Granston Memo Era

Perkins Coie on

The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more

Bass, Berry & Sims PLC

DOJ Informs Supreme Court that It Will Dismiss FCA Case if Remanded to District Court

Bass, Berry & Sims PLC on

On November 30, 2018, the Solicitor General of the United States filed an amicus curiae brief in the closely watched False Claims Act (FCA) lawsuit, Gilead Sciences Inc. v. U.S. ex rel. Campie. In what appears to be an...more

Bass, Berry & Sims PLC

Fifth Circuit Relies on Escobar in Vacating $663 Million FCA Judgment

Bass, Berry & Sims PLC on

The U.S. Court of Appeals for the Fifth Circuit vacated a $663 million judgment, concluding that the Supreme Court’s opinion in Escobar doomed the plaintiff’s FCA claims on the issue of materiality....more

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

Foley & Lardner LLP on

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Williams Mullen

Southeast State & Local Tax: Important Developments - September/October 2014

Williams Mullen on

The Williams Mullen Southeast State and Local Tax (SESALT) team is pleased to provide you with a comprehensive recap of important tax developments around the Southeast. VIRGINIA - INDIVIDUAL INCOME TAX - ...more

Manatt, Phelps & Phillips, LLP

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

19 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide