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Anti-Kickback Statute Trump Administration

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... more +
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 -
Arnall Golden Gregory LLP

Government Investigations Team Insights - May 2025

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more

ArentFox Schiff

Investigations Newsletter: DOJ Plans to Use the FCA to Attack DEI Initiatives

ArentFox Schiff on

DOJ Plans to Use the FCA to Attack DEI Initiatives - On May 19, the US Department of Justice (DOJ) announced a novel use of the False Claims Act (FCA) to enforce Trump Administration policies against antisemitism, gender...more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Wiley Rein LLP

As Health Care Enforcement Surges, Buckle Up for a Bumpy Ride

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As the saying goes, the more things change, the more they stay the same – and the world of health care fraud enforcement is no exception. Recent years have seen a wave of novel technologies, emerging threats to our nation’s...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | February 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2025, including long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability Act...more

King & Spalding

Recent Decisions and DOJ Policy Announcements Signal Key Changes to FCA Enforcement and Litigation Environment

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Recent legal and political False Claims Act (“FCA”) developments signal a potentially turbulent time for the defense of investigations and lawsuits brought under the FCA...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Lowenstein Sandler LLP

In Trump’s Second Term, Healthcare Enforcement May Remain Business as Usual

Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more

White & Case LLP

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

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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

Davis Wright Tremaine LLP

New Sprint Regulations Encourage Investment in EHR and Cybersecurity Technology

On December 2, 2020, under the Trump Administration's "Regulatory Sprint to Coordinated Care" initiative, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final...more

K&L Gates LLP

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

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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

Foley Hoag LLP

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

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On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more

Mintz - Health Care Viewpoints

HHS Issues Controversial Drug Rebate Reform Final Rule

Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...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

Akin Gump Strauss Hauer & Feld LLP

Friday Evening Health Care Regulatory Blitz!

Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants. On the drug pricing front, the...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

Seyfarth Shaw LLP

President Trump Orders HHS to Rescind Discount Safe Harbor for PBMs, but Questions Remain

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Prescription drug prices are one of the biggest drivers of rising health care costs. To address this issue, the Trump administration issued its Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to...more

Faegre Drinker Biddle & Reath LLP

Executive Order Revives HHS Proposed Rule on Prescription Drug Rebates

On July 24, 2020, President Trump signed four Executive Orders related to drug pricing that direct the Secretary of Health and Human Services (HHS) to take a number of actions aimed at lowering prescription drug prices. These...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

Bricker Graydon LLP

Wide-ranging executive orders regarding pharmaceutical pricing and availability

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President Trump signed four executive orders on July 24, 2020, that appear to push forward the administration’s efforts to lower prescription drug costs and pass the savings on to consumers. ...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

K&L Gates LLP

President Trump Signs Drug Pricing Executive Orders Reinforcing the Administration's Priorities

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On July 24, 2020, President Trump issued four executive orders aimed at lowering drug prices. The executive orders direct the Secretary of the Department of Health and Human Services (HHS) to: Increase access to insulin and...more

Mintz - Health Care Viewpoints

Trump Administration Releases Series of Executive Orders on Drug Pricing

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more

Mintz - Health Care Viewpoints

CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more

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