Anti-Kickback Statute

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 -
News & Analysis as of

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Third Circuit Affirms Summary Judgment Of Captive Reinsurance Dispute As Being Time-Barred

In early January, the Third Circuit Court of Appeals affirmed summary judgment of a putative class action dispute regarding private mortgage insurance and captive reinsurance of the same by M&T. We previously blogged about...more

Aetna Wins $37.5 Million for Overbilling Scheme

It’s easy to fall into the habit of regarding self-referrals and kickbacks as strictly a matter of federal law, governed only by the federal Stark Law and Anti-Kickback Statute. But an April 13 verdict in California provides...more

Yet Again, OIG Approves Medigap Policy Contracts with Preferred Hospital Network

On March 11, 2016, the U.S. Department of Health & Human Service, Office of the Inspector General (OIG) issued an advisory opinion approving the use of a preferred hospital network as part of Medicare Supplemental Health...more

Red Notice Newsletter - March 2016

ANTICORRUPTION DEVELOPMENTS – Olympus to Pay $646 Million for Anti­Kickback and FCPA Violations - Early this month, Olympus Corp. of the Americas (OCA) settled government investigations related to violations of the...more

Joint Enforcement of the Anti-Kickback Statute and the Foreign Corrupt Practices Act

On March 1, 2016, the Department of Justice (“DOJ”) announced that Olympus Corporation of the Americas (“Olympus”) entered into two deferred prosecution agreements with DOJ, under which Olympus will pay a total of $646...more

Kickbacks and Commercial Bribery: Another Touchstone to Consider

The latest indictment confirms that fraud and abuse analysis is about more than just the federal and state healthcare anti-kickback statutes. The U.S. Attorney for the Northern District of New Jersey has just charged the 26th...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

AGG Food and Drug Newsletter - March 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

OIG rules hospital's offer of free transportation, lodging doesn't violate anti-kickback statute

The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by an academic medical center that offers free transportation and lodging to...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

OIG Approves Free Transportation and Lodging for Certain, Low-Income Pregnant Women - Advisory Opinion 16-02

On March 1, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 16-02 [PDF], approving an academic medical center's (AMC's) provision of free transportation and lodging...more

Compliance Lessons from the Olympus Corporate Integrity Agreement – Part I

The recent Olympus Corporation and related entities (collectively ‘Olympus’) enforcement action demonstrated a company seemingly dedicated to lying, cheating and stealing its way across the globe in search of almighty dollar....more

Anti-Kickback Enforcement – Steady and Aggressive

When commentators criticize the FCPA for its broad coverage of international business operations, these same commentators would have real trouble with the US Anti-Kickback statute. Talk about broad coverage and then...more

The Olympus Debacle: Why Internal Whistleblowing is a Good Thing for Compliance

The U.S. Department of Justice announced last week that Olympus Corporation of the Americas (OCA) agreed to pay $646 million to resolve three cases relating to its longstanding practice to bribe doctors and hospitals in the...more

Olympus Settles FCPA Charges with DOJ

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

Sixth Circuit Strikes a Blow to the Government's False Claims Act Damages Theory

The Sixth Circuit’s recent decision in United States ex rel. Wall v. Circle C. Construction, No. 14-6150, 2016 WL 423750 (6th Cir. Feb. 4, 2016), strikes a blow against the government’s False Claims Act (FCA) theory that, in...more

CMS Finalizes Overpayment Reporting Rule, Intensifying Need for Proper Compliance Programs

The Centers for Medicare & Medicaid Services (CMS) published a Final Rule on February 12, 2016 requiring providers and suppliers receiving funds under the Medicare program to self-identify, report and return overpayments...more

OIG Approves Charitable Program Providing Financial Assistance for MRIs in Advisory Opinion 15-14

On November 13, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-14. The Arrangement at issue is a charitable program designed to assist financially needy...more

OIG Approves Hospital-provided Transcription Services Arrangement in Advisory Opinion 15-15

The Office of Inspector General (OIG) recently issued Advisory Opinion 15-15 and concluded that an arrangement under which a hospital proposed to provide transcription services to a radiology practice in exchange for fair...more

The 60-Day Rule: CMS Issues Final Rule on Reporting & Return of Overpayments

On February 12, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a Final Rule regarding the so-called “60-day rule”: the obligation of providers and suppliers to report and return...more

OIG Approves Another Patient Assistance Program in Advisory Opinion 15-16

On December 28, 2015, the Office of Inspector General (OIG) approved another patient assistance program in Advisory Opinion 15-16. The OIG analyzed contributions to a private charitable organization under the anti-kickback...more

Alert: 340B Self-Audits: The Best Defense Is A Good Defense

Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who...more

Charity's Patient Assistance Program Passes OIG Muster in Advisory Opinion 15-17

On December 28, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued OIG Advisory Opinion 15-17, approving a charity’s proposal to unveil a new patient assistance program dedicated to...more

OIG Issues (Another) Favorable Advisory Opinion Regarding Medigap/Preferred Hospital Network Arrangement in Advisory Opinion 16-01

On January 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 16-01, approving yet another insurer’s proposed contract with a preferred hospital network. The...more

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