Anti-Kickback Statute Stark Law

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

Healthcare Legal News: Volume 5, Number 3

RESPONDING TO SUBPOENAS AND OTHER REQUESTS FOR PERSONAL HEALTH INFORMATION: TAKE THEM AT FACE VALUE - Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from...more

Free Patient Parking May Trigger False Claims Act Violation

Who knew? When you park for free at your doctor’s office, you may be a pawn in a scheme to violate the Anti-Kickback Statute, the Stark Law, and the False Claims Act. It’s enough to make you sick....more

OIG Issues Two Favorable Advisory Opinions

OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

CMS Stark Proposals Allow “Holdover” Arrangements and Signature Window

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available below....more

Health Law Pulse - August 2015

The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a nonprofit health system (System) and a nonprofit psychiatric hospital (Center) regarding a proposal whereby the...more

CMS Proposes New Stark Exceptions: Timeshare Lease

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comment on what I consider the most significant new...more

Physician Compensation Arrangements Under The Microscope

On June 9, 2015, the United States Department of Health and Human Services Office of Inspector General (OIG) issued a Fraud Alert titled, "Physician Compensation Arrangements May Result in Significant Liability," focusing on...more

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

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