Stark Law Anti-Kickback Statute Medicare

News & Analysis as of

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

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

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

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

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

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

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

Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

Electronic Health Records Donations: Proposed CMS And OIG Rules Revise Stark Exception And Anti-Kickback Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (‘‘CMS'') and the Office of the Inspector General of the Department of Health and Human Services (‘‘OIG'') published twin proposed rules that amend and extend...more

2013 Healthcare Fraud and Abuse Bootcamp Webinar Series, Part V: Compliance

Bill Mathias of Ober|Kaler's Health Law Group presented on compliance as a part of the 2013 Healthcare Fraud and Abuse Bootcamp Webinar Series sponsored by the American Health Lawyers Association. This webinar...more

HHS Extends Sunset Date for Stark Exception and Anti-Kickback Safe Harbor for EHR Donations

The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services issued proposed rules that would extend the sunset date for the Stark Law exception and the federal Anti-Kickback Statute safe...more

The Healthcare Industry And The Voluntary Disclosure Process

It is always important to consider how different parts of the government handle voluntary disclosures. The FCPA enforcement initiative has been largely the result of the voluntary disclosure process, and the government...more

OIG Advisory Opinion Sheds Light On Pay-For-Performance Relationships Between Hospitals And Physicians

On January 7, 2013, the HHS OIG released Advisory Opinion 12-22 concerning a rural hospital's (Hospital) proposal to pay a cardiology group (Group) a performance bonus for achieving certain patient service, quality and cost...more

The False Claims Act and Healthcare Providers: Key Results from 2012 and Likely Trends for 2013

From the perspective of False Claims Act (FCA) results, 2012 was a decidedly mixed year for healthcare providers. The bad news was quite bad—increased FCA scrutiny by the Department of Justice (DOJ) led to $3 billion of...more

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