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Medicare Anti-Kickback Statute Drug Pricing

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...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

The Volkov Law Group

Teva Pharmaceuticals Pays $450 Million to Resolve Anti-Kickback and False Claims Act Violations

The Volkov Law Group on

Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

Goodwin

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

Goodwin on

​​​​​​​As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more

Warner Norcross + Judd

Supreme Court Removes Some Defenses to False Claims Act Liability for Government Contractors and Health Care Providers

Government contractors, health care providers and many other parties who submit claims for payment to the federal government are subject to liability under the False Claims Act (FCA). This month, the U.S. Supreme Court issued...more

MoFo Life Sciences

Supreme Court Denies Review Of Cost Sharing Assistance Program

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The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more

ArentFox Schiff

Investigations Newsletter: OIG Warns That Proposed Drug Discounts May Warrant Sanctions

ArentFox Schiff on

OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

Mintz - Health Care Viewpoints

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more

McDermott Will & Schulte

Recent Litigation Shines Spotlight on Hospital and Physician Group Transactions

The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more

Foley Hoag LLP - Medicaid and the Law

A Deeper Dive into CMS’ Multiple Best Prices Policy

As my colleague Tom wrote about in a recent post, the Centers for Medicare & Medicaid Services (CMS) has finally responded to a growing chorus of stakeholders that government price reporting requirements, particularly...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

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The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

K&L Gates LLP

Trump Administration Issues Flurry of Last Minute Healthcare Regulations: What Will the Incoming Administration Do Next?

K&L Gates LLP on

On 20 November 2020, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General finalized several rules from President Trump’s health care agenda...more

King & Spalding

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

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On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more

Rivkin Radler LLP

Gilead Reaches $97 Million FCA/AKS Settlement

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On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of...more

White & Case LLP

President Trump's Most Favored Nation Policy for Medicare Drug Costs Unlikely to Bring Near Term Changes

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On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...more

White & Case LLP

Uncertainty on Drug Pricing Remains Following Trump Administration Executive Orders

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On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth.  The Orders represent the Trump Administration's latest effort to implement previously outlined...more

Sheppard Mullin Richter & Hampton LLP

A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that...

On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the...more

King & Spalding

New Risks, New Rewards, New Exposure

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Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

McGuireWoods Consulting

Washington Healthcare Update - November 2019 #2

McGuireWoods Consulting on

This week in Washington: House returns from recess and has scheduled hearing on caring for aging Americans; Senate to hold hearing on rising electronic cigarette use among youth and will hold a confirmation hearing for Dr....more

McGuireWoods Consulting

Washington Healthcare Update - October 2019 #4

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This week in Washington: Senate to hold a hearing on eligibility requirements under the Medicaid program, as well as a hearing to review a number of healthcare bills, including OTC drug safety, innovation and reform....more

McGuireWoods Consulting

Washington Healthcare Update - October 2019 #3

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This week in Washington: House to hold a markup of five healthcare bills, as well as a hearing to seek clarity on the Trump administration's health care policy choices; Senate to discuss solutions to the substance misuse...more

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