Stark Law Dept. of Health and Human Services

News & Analysis as of

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

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

DC Circuit calls into question legality of Stark Law ban on per-click equipment leases

On June 12, 2015, the US Court of Appeals for the District of Columbia Circuit issued a lengthy decision calling into question the regulatory prohibition on per-click equipment leases under the federal physician self-referral...more

Paperwork Burden Eased in CMS Voluntary Self-Referral Disclosure Protocol Filings

In late December 2014, CMS made a small change to its voluntary Self-Referral Disclosure Protocol (SRDP) to help reduce some of the paperwork burden associated with filing under the SRDP. Section 6409 of the Affordable...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

News from the Health Law Gurus™

Chinese Hackers Infiltrate Health System Network Affecting 4.5 Million Individuals – Community Health Systems, Inc. (“CHS”) reported this week that the information of approximately 4.5 million individuals has been affected by...more

Anti Kickback and Stark Law Enforcement and Compliance Issues [Video]

The Department of Justice and the Health and Human Services-Office of Inspector General have aggressively been enforcing anti-kickback (AKS) and Stark laws. DOJ and HHS-OIG have combined these prohibitions with The False...more

HHS Heat Initiative Continues Fraud Crackdown

A number of recent cases demonstrate Health and Human Services’ (“HHS”) Health Care Fraud Prevention and Enforcement Action Team’s (“HEAT”) continued success in cracking down on healthcare provider fraud. Since 2009, the...more

Healthcare Law: What Every Provider Should Know

Healthcare is an incredibly broad, diverse and dynamic industry. Because of the breadth in the field, providers are surrounded by a wide array of legal issues relating to: employment contracts, taxes, business structure,...more

Halifax Pays $85 Million to Resolve Improper Physician Compensation Arrangement Claims Brought by Employee-Whistleblower

Since January 2009, the DOJ has recovered more than $13.4 billion through False Claims Act cases involving fraud against federal health care programs, and last month, Halifax Hospital Medical Center and Halifax Staffing, Inc....more

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

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