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

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

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Another Day, Another Whistleblower Retaliation Suit

A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today....more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

Whose Turn To Pay? New OIG Opinion Provides Clarity Regarding Payment of Radiology Transcription Fees

A new OIG opinion clarifies that providers are free to determine who will pay the transcription fees when separate parties perform the professional and technical components of a radiology exam. ...more

District Court Dismisses Government’s False Claims Act Complaint for Failure to Allege Actual False Claims with Particularity

On January 7, 2016 the United States District Court for the Middle District of Florida took the rare step of dismissing (with leave to amend) the government’s Complaint in Intervention in a False Claims Act Case. This case...more

Solicitation of New Safe Harbors and Special Fraud Alerts

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently announced its annual solicitation of proposals and recommendations for developing new, and modifying existing, safe harbor provisions...more

Health Law Pulse - January 2016

CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN FEE SCHEDULE - The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more

Record Mega-Settlements May Attract More Whistleblowers

September was a record-setting month for the United States Department of Justice, which entered into major health care fraud settlements with two large Floridabased hospital systems. The settlements were made in the face of...more

Federal Spotlight Continues to Shine on Physician-Owned Distributorships

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business...more

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

HHS OIG Invites Suggestions for New Fraud Alerts, Anti-Kickback Safe Harbors

On December 23, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its annual notice soliciting recommendations for new or modified, safe harbor provisions under the...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: December 2015

Trends & Analysis - We have identified 24 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of the 24 cases, five were filed within the past year, seven were filed in 2014, three...more

False Claims Act: 2015 Year in Review

This year continued the trend of aggressive False Claims Act (FCA) enforcement by the Department of Justice (DOJ) and high volumes of qui tam lawsuits brought by whistleblowers. In fiscal year 2015, the DOJ marked the fourth...more

OIG Tightens Requirements of Prior Favorable Advisory Opinion on Charity Patient Assistance Program for Cancer Drugs

On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

OIG Issues Fall 2015 Semiannual Report to Congress

The HHS Office of Inspector General (OIG) has issued its Semiannual Report to Congress covering April 1 – September 30, 2015. The report summarizes significant OIG audits, investigations, and enforcement activities during...more

[Webinar] 2016 OIG Work Plan: Focus on Compliance - Dec. 10th, 12:00pm ET

This webinar will include an overview of OIG’s new and ongoing areas of focus related to hospitals and physicians. The focus of the discussion will be the practical impact of these key enforcement priorities on planning and...more

OIG Authorizes Arrangement to Pay for MRI Services

On November 20, 2015, OIG issued a favorable advisory opinion, Advisory Opinion No. 15-14, regarding a charitable organization’s arrangement to pay for magnetic resonance imaging (MRI) services for patients afflicted with a...more

DOJ and OIG Launch Wave of Aggressive Prosecutions Targeting Entities and Individuals for Illegal Health Care Marketing Practices

In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more

[Webinar] The Impact of the Finalized Modifications to the Stark Law - Nov. 19th, 12:00pm EDT

Please join LeClairRyan for this 30 minute online event providing an overview of the recently finalized changes to the physician self-referral regulations issued by the Centers for Medicare & Medicaid Services (CMS)....more

OIG Policy Statement Outlines Conditions Under Which Hospitals May Waive Beneficiary Copayments for Outpatient Self-Administered...

The OIG has issued a policy statement clarifying the conditions under which hospitals may discount or waive Medicare beneficiary copayment amounts for self-administered drugs (SADs) received in outpatient settings without...more

CMS Issues Final Rule for Waivers in Connection With the Shared Savings Program

On October 29, 2015, CMS issued its Final Rule setting forth waivers of the application of the physician self-referral law (the Stark law), the Federal anti-kickback statute (AKS), and the civil monetary penalties (CMP) law...more

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