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

The Physician’s Self-Referral Law – Are Changes Finally Coming?

The Physician Self-Referral Law, also known as the Stark law, prohibits a physician from referring federal health care program patients for “designated health services” to an entity in which the physician (or an immediate...more

Check Up on Healthcare Fraud Prosecutions

Chief compliance officers face an overwhelming level of risk in the healthcare sector. I do not mean to belittle the risks of corruption, AML, sanctions and other risks typically associated with global companies. Healthcare...more

Hospital/Physician Leases Compliance Checklist

LEGAL REQUIREMENTS: A "no" answer to any of the following questions may mean your lease is out of compliance with applicable laws. Is the lease in writing? Is the lease signed by both parties? Does it...more

Are Changes to the Stark Law on the Way?

Congress has acknowledged that the Stark law is standing in the way of the healthcare industry's transition to alternative, value-based payment models, and in turn, meaningful reform may soon be on the horizon. Last...more

[Webinar] Healthcare Real Estate: Navigating Stark Law and the Anti-Kickback Statute in Real Estate Leasing - July 20th, 12:00pm...

When healthcare providers are involved in real estate leasing, they bring with them a host of laws and regulations that may be unfamiliar to professionals accustomed to handling traditional real estate leasing....more

Senate Finance Committee Examines Repeal of the Stark Law

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...more

Free Transportation Gets Another Nod from OIG

On March 1, 2016, the Department of Health and Human Services Office of Inspector General once again issued a favorable advisory opinion for the provision of free transportation by a healthcare facility. In this instance, an...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

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

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

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

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

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

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

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

[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

[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

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

Advisory Opinion: Free van shuttle services to medical facilities

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle...more

Limited Modifications in Final ACO Fraud and Abuse Waivers Most Notably Include Cut of Gainsharing CMP Waiver

Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more

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