Stark Law Anti-Kickback Statute

News & Analysis as of

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

Beware of Nurses Bearing Gifts

Alisia and David blew the whistle on their former employer, Nurses’ Registry & Home Health, for sending gift baskets and ticket events to doctors who referred patients to the home health operation. Their qui tam suit alleged...more

Stark Regulations: Technical Revisions

The proposed Physician Fee Schedule for CY 2016 includes multiple technical revisions to the regulations implementing the Stark law. These revisions appear to be designed to provide greater clarity and flexibility with...more

Mintz Levin Health Care Qui Tam Update - July 2015

Trends & Analysis - ..We have identified 36 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of these cases, eight were filed within the last year. A number...more

Tuomey’s Appeal of $237M False Claims Act Judgment Denied by the Fourth Circuit

In This Issue: - Background - Tuomey’s Second Appeal to the Fourth Circuit - The Trial Court’s Grant of a New Trial - Tuomey’s Request for Judgement as a Matter of Law on the Stark Law and FCA...more

Healthcare Law Update

Governing boards of health care organizations can greatly benefit from reading a recently released educational document that presents practical tips for board members responsible for overseeing their organizations’ compliance...more

Recent DOJ and OIG Actions Show Growing Federal Scrutiny of Physician Financial Arrangements

Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial...more

OIG Fraud Alert Cautions Against Sham Medical Director Arrangements

The HHS OIG recently issued a brief fraud alert (Fraud Alert) reminding physicians that inappropriate compensation arrangements may lead to enforcement actions under the federal anti-kickback statute and Civil Monetary...more

OIG Fraud Alert Targets Physician Compensation Arrangements

It bears repeating so much that even the Office of Inspector General of the Department of Health and Human Services just issued a Fraud Alert on it – physician compensation arrangements are fraught with potential violations...more

Physician Estopped From Alleging FCA Violations in Contract He Previously Approved

Cooper v. Pottstown Hospital is another case where a dissatisfied party is attempting to use the federal Anti-Kickback Statute or the Stark Law in litigation arising out of the contracts to which they were willing parties at...more

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

Trends & Analysis - ..We have identified 67 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of those cases, 29 were filed before January 1, 2014, with seven...more

ABA Antitrust Spring Meeting Highlight: “Antitrust & Health Care: Square Peg in a Round Hole?”

In this month’s American Bar Association (ABA) Section of Antitrust Law Spring Meeting, the program “Antitrust & Health Care: Square Peg in a Round Hole?” featured debate and discussion about antitrust law treatment of health...more

Anti-Kickback and Stark Law: Pitfalls and Problems

When you think your life is tough in the FCPA compliance arena, just remember you could be head of compliance for a pharmaceutical company or hospital responsible for domestic anti-kickback and Stark law compliance....more

2014 – The Health Law Year in Review

Each year brings significant changes and challenges in the laws governing the health care industry, and 2014 proved to be no exception. What the year may have lacked in the high drama that accompanies comprehensive health...more

ACO Fraud and Abuse Waivers Extended Through November 2, 2015

On October 17, 2014 the Centers for Medicare and Medicaid (CMS) and Office of Inspector General (OIG) within the Department of Health and Human Services published a continuation notice in the Federal Register extending the...more

Uncertain Privilege: Implied Waiver of the Attorney-Client Privilege in False Claims Act Litigation

In a pending False Claims Act (“FCA”) case stemming from alleged violations of the physician self-referral law (the “Stark Law”), 42 U.S.C. § 1395nn, and the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. §1320a-7b, the...more

Health Care Reform Implementation Update

The Centers for Medicare and Medicaid Services (CMS) began sending reminders last week that open enrollment begins on November 15; CMS’s Marketplace CEO, Kevin Counihan, said that end-to-end testing of HealthCare.gov was...more

Words can come back to haunt you: Boilerplate pleading could lead to inadvertent waiver of attorney-client privilege

Recently, a federal district court in Georgia ruled that a defendant waived the attorney-client privilege in communications with counsel about the lawfulness of its conduct under the False Claims Act simply by pleading good...more

CMS and OIG Extend Interim Final Rule Regarding Waivers of Fraud and Abuse Laws For ACOs

On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability...more

Provider Waives Attorney-Client Privilege in Qui Tam Case by Asserting Compliance with Law

A federal district court recently rejected a health care provider’s claim of attorney-client privilege and ordered the provider to produce written communications with its lawyers regarding the provider’s compliance with the...more

HealthCare Fraud and Courtesies: What to Know Before Waiving a Copayment

Many healthcare facilities and physicians waive the insurance copayment for physicians and their families (known as professional courtesy) or other patients. Yet, despite how prevalent the practice is and the limited...more

Another Court Weighs in on Rule 9(b)’s Requirements Under the False Claims Act

A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated...more

Summer Fraud and Abuse Roundup

The federal government was busy over the summer when it came to decisions and settlements under the Stark Law, anti-kickback law and federal False Claims Act. This article revisits recent developments with respect to...more

Commercial Real Estate Markets Benefit from Healthcare Industry Growth

The slowly recovering economy has presented challenges for most businesses over the past several years, and commercial landlords are no exception. The recent recession resulted in higher vacancy rates and downward pressure...more

What’s Scarier than a Compliance Officer Turned Whistleblower? A Whole Association of Them

In U.S. ex rel. Corporate Compliance Assocs. v. N.Y. Society for the Relief of the Ruptured & Crippled the court ruled that the whistleblower failed to meet the False Claims Act’s requirement that allegations be described...more

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