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Manufacturers Reimbursements

Blank Rome LLP

CMS Proposes New Rules for Calculating Average Sales Price for Medicare Part B Drug Reimbursement

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The Centers for Medicare & Medicaid Services (“CMS”) released the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) proposed rule on July 16, 2025. (See...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

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Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

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Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Nelson Mullins Riley & Scarborough LLP

New Jersey Poised to Adopt Unique Warranty Time Multiplier: Latest Development In Statutory Warranty Reimbursement Requirements

New Jersey appears poised to adopt a unique “average retail labor time allowance” multiplier to the compensation OEMs must pay dealers for warranty service, after both houses of that state’s Legislature voted on June 30, 2025...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

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

Flaster Greenberg PC

Dealer Alert: What New York’s New Warranty Reimbursement Law Means for Dealers in PA & NJ

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New York recently joined a small but growing number of states when it enacted a new law requiring automobile manufacturers to pay dealers for warranty work using “reasonable” time allowances from standard labor time guides....more

ArentFox Schiff

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

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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

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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

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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

King & Spalding

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

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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

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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

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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

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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

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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

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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...

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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

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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

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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

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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

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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

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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

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