News & Analysis as of September 21, 2024

Anti-Kickback Statute › Drug Pricing

+ Follow

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

McDermott Will & Emery on 8/1/2024

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

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

Goodwin on 4/22/2024

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

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

Warner Norcross + Judd on 6/9/2023

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

Investigations Newsletter: Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback...

ArentFox Schiff on 5/8/2023

Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback Litigation - During a recent interview commemorating the 50th anniversary of the enactment of the Anti-Kickback Statute, two...more

Pharmaceutical Suppliers Beware: Expect Increased Scrutiny of Average Wholesale Pricing Methodology and Marketing “The Spread”

McGuireWoods LLP on 4/25/2023

A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and...more

Supreme Court Denies Review Of Cost Sharing Assistance Program

MoFo Life Sciences on 2/8/2023

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

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Sheppard Mullin Richter & Hampton LLP on 11/22/2022

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

Sheppard Mullin Richter & Hampton LLP on 10/13/2022

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more

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

ArentFox Schiff on 10/10/2022

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

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

McDermott Will & Emery on 9/1/2022

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

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

Mintz - Health Care Viewpoints on 8/10/2022

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

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

McDermott Will & Emery on 5/27/2022

This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Recent Litigation Shines Spotlight on Hospital and Physician Group Transactions

McDermott Will & Emery on 4/19/2022

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

Investigations Newsletter: DOJ Continues To Prosecute PPP Fraud

ArentFox Schiff on 3/7/2022

DOJ Continues To Prosecute PPP Fraud - Earlier this week, Ana Soto of Newark, Delaware pled guilty to fraudulently obtaining and spending money received through Paycheck Protection Program (“PPP”) loans. Between March...more

HHS Office of Inspector General Issues Important Update to Self-Disclosure Protocol

Snell & Wilmer on 11/12/2021

For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

Goodwin on 10/4/2021

In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

King & Spalding on 2/4/2021

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

AGG Food & Drug Newsletter - January 2021

Arnall Golden Gregory LLP on 1/26/2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

A Deeper Dive into CMS’ Multiple Best Prices Policy

Foley Hoag LLP - Medicaid and the Law on 1/15/2021

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

Pharmaceutical Companies Beware: New Final Rule Changes Existing Anti-Kickback Statute Discount Safe Harbor Provisions

Arnall Golden Gregory LLP on 1/13/2021

In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription...more

Does HHS’s Elimination of the Safe Harbor for Manufacturer Rebates Leave Manufacturers with Increased Antitrust Risk?

Patterson Belknap Webb & Tyler LLP on 12/15/2020

On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...more

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

Holland & Knight LLP on 12/8/2020

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

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

White & Case LLP on 12/4/2020

The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

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

Sheppard Mullin Richter & Hampton LLP on 12/3/2020

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

OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts...

K&L Gates LLP on 12/3/2020

On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more

102 Results

View per page

Page: of 5

Anti-Kickback Statute › Drug Pricing

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