News & Analysis as of

Program Integrity Priorities Revealed in FY 2015 HHS Budget

On March 14, 2014, President Obama unveiled his Administration’s proposed fiscal year 2015 budget for the Department of Health and Human Services (HHS). In total, the Administration is seeking $77.1 billion to fund HHS in FY...more

Halifax Settles Stark Damages for $85 Million

Halifax Hospital Medical Center and Halifax Staffing, Inc. (collectively, “Halifax”) have agreed to pay $85 million to settle allegations that Halifax compensated a group of physicians in a manner not permitted by the Stark...more

CMS and OIG Issue Final Regulations to Extend the Stark Exception and Anti-Kickback Statute Safe Harbor for EHR Donations

On December 27, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and...more

CMS and OIG Finalize Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

On Friday, December 27, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) of the Department of Health and Human Services published complementary final rules in the...more

EHR Donation Exception and Safe Harbor Modified and Extended through 2021

On December 27, 2013, the Centers for Medicare & Medicaid Services and the Office of the Inspector General, both of the Department of Health and Human Services, issued closely coordinated rules (“Final Rules”) extending the...more

Final EHR Donation Rules Issued in Time for the New Year

On December 27, 2013, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules revising the Stark exception (42 CFR...more

The Long Sunset: EHR Donations May Continue Until 2021 (With a Few Changes)

Under long-awaited final rules recently published by the federal government, hospitals and other “protected donors” may continue to “donate” interoperable electronic health record items and services without incurring...more

Health Reform + Related Health Policy News - October 2013

In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small...more

Bill Introduced to Curtail the Stark Law's In-Office Ancillary Services Exception

On August 1, Rep. Jackie Speier (D-CA) introduced H.R. 2914, the Promoting Integrity in Medicare Act. The legislation would provide that the Stark Law's in-office ancillary services (IOAS) exception is not available for...more

New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...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

Healthcare Providers And Self-Disclosure Of Violations

The healthcare industry has a long history of innovative compliance policies and strategies. ...more

Intermountain Healthcare Settlement – Dangers Of Hospital Agreements With Physicians

Hospitals continue to be under the Department of Justice-HHS/Office of Inspector General microscope. DOJ-OIG is a potent combination and carry with them the threat of criminal prosecution, civil false claims enforcement and...more

CMS and OIG Propose Changes to the Electronic Health Records Exception and Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of Inspector General (“OIG”) published parallel proposed rules revising, respectively, the Stark...more

The Top 10 Things You Need To Know About The OIG’S Revised Self-Disclosure Protocol

On Wednesday, April 17, 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) released an updated Self-Disclosure Protocol (SDP) governing the process by which health care providers can...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

HHS OIG Issues Revised Self-Disclosure Protocol

OIG touts substantial benefits of disclosing, provides greater detail for different types of disclosures, and captures 15 years of OIG Self-Disclosure Protocol experience....more

CMS, OIG Propose to Extend EHR Stark Exception and Anti-Kickback Safe Harbor

On April 10, 2013, CMS and the HHS Office of Inspector General (OIG) each published proposed rules to extend the sunset dates for the Stark exception and anti-kickback statute safe harbor permitting donations of EHR software...more

$25.5 Million Settlement Agreement Reached Between Intermountain Health Care, Inc. and the United States Based on Self Disclosure...

On April 3, 2013, the Department of Justice (DOJ) and Intermountain Health Care, Inc. (Intermountain) entered into a settlement agreement resolving Intermountain’s potential liability under the Stark Law and False Claims Act....more

CMS and OIG Propose Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

On Wednesday, April 10, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) of the Department of Health and Human Services published complementary proposed rules in the...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

Stark Exception For ESRD Not Recognized In Florida

On January 10, 2013, the U.S. Court of Appeals for the Eleventh Circuit ruled in Fresenius Medical Care Holdings, Inc. v. Tucker, that an arrangement can violate Section 456.053 of the Florida Statutes, also known as...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

A Message From Donna Clark And Darby Allen On The A To Zs Of Stark Law Compliance

Healthcare providers, particularly physicians and hospitals, regularly engage in business arrangements that may implicate the federal self-referral law, known as the Stark Law. Recent changes to the Stark Law, including...more

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