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

Another Medigap/Preferred Hospital Network Arrangement Approved by OIG in Advisory Opinion 16-05

On May 3, 2016, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued another favorable advisory opinion, No. 16-05 [PDF], regarding an agreement between a Medicare Supplemental Health...more

Legal Issues Associated with Multi-Provider Alternative Payment Model

Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...more

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

OIG Issues Favorable Advisory Opinion Regarding Proposed Ownership Structure of Group Purchasing Organization

On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more

Physician-Owned Distributor (POD) Update

For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors ("PODs"). From the Department of Health and Human Services Office of Inspector General’s ("OIG") issuance...more

Senate Finance Report Puts another Nail in the POD Coffin

On May 10, 2016, the Senate Finance Committee Majority Staff released a long-awaited report entitled “Physician Owned Distributorships: An Update on Key Issues and Areas of Congressional Concern” (Report). The Report follows...more

Senate Finance Committee Updates Report on Physician-Owned Distributorships

The report finds that PODs increase overutilization, lack transparency, and increase the risk of patient harm and warns that hospitals must combat the growing threat of PODs. On May 10, the US Senate Committee on Finance...more

OIG Approves Another Medigap/Preferred Hospital Network in Advisory Opinion 16-04

On April 18th, the OIG issued a new favorable Advisory Opinion, No. 16–04, regarding an agreement between a Medigap insurer and preferred hospital network. The opinion tracked other, similar opinions in favorably addressing...more

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

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

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