News & Analysis as of November 15, 2024

Health Insurance

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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 | September 2024 Recap

McDermott Will & Emery on 10/25/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

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

The Volkov Law Group on 10/23/2024

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

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

Bass, Berry & Sims PLC on 9/19/2024

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

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

Foley & Lardner LLP on 8/29/2024

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

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

Robinson+Cole Health Law Diagnosis on 7/2/2024

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

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

Bass, Berry & Sims PLC on 6/28/2024

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

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

Nelson Mullins Riley & Scarborough LLP on 5/28/2024

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

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

Akerman LLP - Health Law Rx on 5/23/2024

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

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

Dentons on 3/4/2024

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

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

Epstein Becker & Green on 8/14/2023

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

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

Akerman LLP - Health Law Rx on 8/10/2023

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

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

Carlton Fields on 6/5/2023

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

False Claims Act 2022 in Review

Akerman LLP on 4/18/2023

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

DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

Polsinelli on 4/17/2023

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

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

Bodman on 4/11/2023

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

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

Mintz - Health Care Viewpoints on 4/6/2023

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

The Trebling Effect of (Some) False Claims Act Trials

Akerman LLP - Health Law Rx on 3/30/2023

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

Modernizing Medicine Settles False Claims Act Violations for $45 Million

The Volkov Law Group on 11/16/2022

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

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

Robinson+Cole Health Law Diagnosis on 10/26/2022

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

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

Jones Day on 2/23/2022

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

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on 1/13/2017

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

The AHA’s Letter to Santa Claus

Akerman LLP - Health Law Rx on 1/10/2017

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

Justice Department Charges Pharma President with Kickback Conspiracy

The Volkov Law Group on 11/4/2015

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

Millennium Health to Pay $256 million in False Claims Act Settlement

Polsinelli on 11/3/2015

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

OIG Issues Advisory Opinion Regarding Pharmaceutical Manufacturers’ Program to Provide Free Limited Drugs to Beneficiaries When...

King & Spalding on 8/25/2015

On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more

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