News & Analysis as of

Pharmacies Pharmaceutical Industry Anti-Kickback Statute

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

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On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

McDermott Will & Emery

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

Akerman LLP - Health Law Rx

When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

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Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

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Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Harris Beach PLLC

HHS Office of Inspector General November 2023 Enforcement Activity

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...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 Q2 2023

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There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023.  Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

Bass, Berry & Sims PLC

Lead Generation Prosecution Reminds Pharmacies of Higher Risk Arrangements

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In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

Robinson+Cole Health Law Diagnosis

Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more

Robinson & Cole LLP

Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act

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On October 14, 2021, the Massachusetts Attorney General (MA AG) announced a $25 million settlement with South Bay Mental Health Center, Inc.’s (SBMHC) private equity owner and two former executives for allegedly causing false...more

Holland & Knight LLP

Healthcare Law Update: October 2021

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Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

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The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

Rivkin Radler LLP

NYC Pharmacy Owner Charged With Healthcare Fraud

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The owner of Brooklyn Chemists in Gravesend, Brooklyn and Lucky Care Pharmacy in Flushing, Queens was recently indicted on charges of conspiracy to commit health care fraud, conspiracy to defraud the United States by paying...more

Patterson Belknap Webb & Tyler LLP

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

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

Farrell Fritz, P.C.

Compound Pharmacies Enter False Claims Act And Anti-Kickback Statute Settlement

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Compound prescription drugs have increasingly become a target for DOJ health fraud enforcement activities. ...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Annual Review 2019

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Bass, Berry & Sims is pleased to announce the release of the 2019 edition of its Healthcare Fraud & Abuse Annual Review. Compiled by the firm’s Healthcare Fraud Task Force, the Review is an in-depth and comprehensive analysis...more

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

King & Spalding

HHS Issues Proposed Rule to Update Anti-Kickback Statute Safe Harbors – What Does it Mean for Life Sciences Companies?

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HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers - In today’s Federal Register, the...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

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In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more

Foley & Lardner LLP

Drug Pricing: White House Announces Withdrawal of Proposed Changes to Anti-Kickback Safe Harbors

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On July 11, 2019, the Trump administration announced it would withdraw a proposed rule that would eliminate the Anti-Kickback Statute (AKS) safe harbor that protected rebates made from pharmaceutical manufacturers to pharmacy...more

Arnall Golden Gregory LLP

HUBs: The Good, The Bad, The Balance

Lately, we have answered more and more questions from pharmaceutical clients on hubs and specialty pharmacies, and associated compliance risks. In this Bulletin, we will summarize, at a very high level, the nature of hubs and...more

Jackson Walker

Opioids, Healthcare Enforcement, and Increased Scrutiny of Corporate Conduct for Criminal Prosecution

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The national opioid epidemic is almost unprecedented in every conceivable way—its catastrophic death toll, its broad effect on a wide swath of this country’s population, its rapid escalation (which is alleged to have been...more

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