Stark Law Anti-Kickback Statute

News & Analysis as of

[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

CMS and OIG Issue Final ACO Waivers

On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

CMS/OIG Finalize Fraud Authority Waivers for Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program...

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized a rule designed to “remove legal and regulatory barriers that can impede care coordination in furtherance of the...more

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

Suing the Hand that Feeds You

Jeffrey Jacobs alleges that Idaho’s Pocatello Hospital violated the False Claims Act because of physician recruitment contracts that were overly generous to his practice group. Jeff should know because he was recruited under...more

Removing the Barriers to Coordinated Care: the Stark Law

August 10, 2015 was the 22nd anniversary of the expansion of the Medicare self-referral prohibition to include 10 “designated health services” in addition to clinical laboratory tests. This law is the so-called Stark Law....more

Giving Your Physician Agreements a Check-Up

On June 9, 2015, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a fraud alert regarding physician compensation relationships and potential liability for illegal kickbacks under the...more

Two More Hospitals Qualify for Exception to Exception to Grandfather Exception to Elimination of Whole Hospital Exception to Stark...

The Stark Law generally prohibits physicians from referring Medicare and Medicaid patients to facilities in which they have an ownership interest. There used to be a “whole hospital exception” excluding entire hospitals (as...more

Broward Health Wins Most-Illegal-Physician-Comp

Okay, there’s not really a Most-Illegal-Physician-Compensation Prize. But if there were, Florida’s North Broward Hospital District would have won in a walk. That’s why the district has agreed to pay the government $69.5...more

Pain Clinic Raids: Blocking and Tackling Drills for Physician Practices

Every day, medical providers are asked to serve a population that largely expects their healthcare to be free, and that everything they want is covered by insurance or government. Providers want to serve these wants and...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Alert: Key Regulatory Considerations for Digital Health Companies

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

On July 9, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that seeks to implement a mandatory episode-based payment model for lower extremity joint replacement (and reattachment) care in...more

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

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