News & Analysis as of

Health Insurance Anti-Kickback Statute

The Volkov Law Group

Oak Street Health Pays $60 Million to Resolve False Claims Act Violations

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Federal whistleblowers have been exposing health care fraud for years.  The False Claims Act (“FCA”) contains robust whistleblower provisions and protections that reward whistleblowers with financial payouts. The process for...more

Bass, Berry & Sims PLC

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

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On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

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Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Summer 2024 False Claims Act Newsletter

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Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

Robinson+Cole Health Law Diagnosis

DOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse Schemes

On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care...more

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

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On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

Nelson Mullins Riley & Scarborough LLP

Using A Value-Based Enterprise to Integrate Specialists and Primary Care: Taking Value-Based Care to the Next Level

Meaningful progress has been made in value-based care, but the documented advances in reducing costs and improving patient outcomes have taken place predominately in the primary care sector. Significantly less headway has...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

Dorsey & Whitney LLP

Healthcare Fraud: A World Beyond the Anti-Kickback Statute

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Americans spend more than $3 trillion per-year on healthcare-related expenses. Of that, the National Health Care Anti-Fraud Association estimates that between $60-250 billion is lost to fraud every year....more

Arnall Golden Gregory LLP

OIG Approves Arrangement Incentivizing Medigap Policyholders to Seek Treatment From PHO Network Hospitals

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-01 (the “Opinion”), to a Medicare Supplemental Health Insurance...more

Dentons

DOJ Reports Record False Claims Act Settlements & Judgments in FY 2023

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Fiscal year 2023 saw record recoveries and the highest number of settlements and judgments ever under the Federal False Claims Act. According to a new report released by the United States Department of Justice (“DOJ”), the...more

Epstein Becker & Green

Physicians Beware! Groups Providing DME, Prosthetic Devices, and Other Medical Supplies to Their Medicare Patients Risk Violating...

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When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal...more

Akerman LLP - Health Law Rx

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more

Carlton Fields

7th Cir. Holds Insurance Coverage Applies to Settlement Payments for Alleged Anti-Kickback and False Claims Act Violations

Carlton Fields on

On May 3, 2023, the Seventh Circuit Court of Appeals, in Astellas US Holding Inc. v. Federal Insurance Co., held that a liability insurer was required to contribute its limits toward its insured’s payment to settle potential...more

Akerman LLP

False Claims Act 2022 in Review

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The U.S. government continued to earn its longstanding reputation for its vigorous enforcement of the False Claims Act (FCA) in 2022, either directly or through relator proxies. The Department of Justice (DOJ) recorded the...more

Polsinelli

DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

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Signaling its continued scrutiny of the laboratory industry, the Department of Justice (DOJ) entered into a settlement agreement with Texas lab Genotox Laboratories Ltd. last month related to compensation Genotox paid to...more

Bodman

One Month Until May 11, 2023 – the Expiration Date for the COVID-19 Public Health Emergency

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The Secretary of the U.S. Department of Health and Human Services (HHS) first declared the existence of a public health emergency (PHE) on January 31, 2020. The PHE allowed HHS to implement a number of regulatory waivers and...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

Akerman LLP - Health Law Rx

The Trebling Effect of (Some) False Claims Act Trials

There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business...more

Akin Gump Strauss Hauer & Feld LLP

Updates in Co-Pay Assistance and Accumulators Litigation

Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more

The Volkov Law Group

Modernizing Medicine Settles False Claims Act Violations for $45 Million

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The Justice Department continues to pile up healthcare enforcement actions — false claims, anti-kickback, and fraud.  DOJ is on its way to a record year....more

Robinson+Cole Health Law Diagnosis

Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million

On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions

On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more

Mintz - Health Care Viewpoints

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more

Jones Day

DOJ Announces Second-Largest Annual Total Recoveries in False Claims Act History

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DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. - The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more

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