Stark Law Dept. of Health and Human Services

News & Analysis as of

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 finalizes significant Stark Law rulemaking

In July of this year, the US Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the regulations implementing the federal physician self referral law...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

Corporate Investigations & White Collar Defense - October 2015

"Wherefore Art Thou Due Process?" Part III - Why it matters: It is time for another installment in our continuing "Wherefore Art Thou Due Process?" coverage into the ongoing constitutional challenges to the SEC's...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

Corridors September 2015 - News for North Carolina Hospitals

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Also In The News - Health Headlines - August 2015 #4

President Obama Signs Outpatient Status Notification Bill On August 6, 2015, President Obama signed the Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act. This legislation requires hospitals...more

The “Cross-Your-Fingers-And-Hope-It-Goes-Away” School of Statutory Interpretation”: Recent D.C. Circuit Opinion Orders HHS To...

On June 12, 2015, the U.S. Court of Appeals for the District of Columbia (the “Court”) issued an opinion questioning the Department of Health & Human Services’ (“HHS”) interpretation of congressional intent when it...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

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

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