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

CMS Self-referral Disclosure Protocol: 2013 Update and Summary of Settlements

The CMS Self-referral Disclosure Protocol – Background - Under delegated authority, the Centers for Medicare and Medicaid Services (CMS) released its Self-Referral Disclosure Protocol (SRDP) on September 23, 2010, with...more

New Rules Amend Regulatory Exceptions For Donation Of Electronic Health Records Items And Services

On December 27, 2013, the Department of Health and Human Services published two final rules, one amending the Office of Inspector General’s (OIG) Anti-Kickback safe harbor related to electronic health records (EHR) items and...more

CMS And OIG Release Final Rules Extending Stark Law Exception And Anti-Kickback Statute Safe Harbor For Donations Of Electronic...

In 2006, the Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General of the Department of Health and Human Services (the "OIG") published final rules providing for an exception to the Stark Law...more

Health Reform + Related Health Policy News - December 2013

In This Issue: - Top News ..CMS Releases Payment Rules for the Medicare Physician Fee Schedule, Hospital Outpatient Prospective Payment System, Renal Dialysis and Home Health ..President Signs the Drug Quality...more

Bonuses for Physician Employees: Lessons Learned from the Halifax Hospital Case

This week, a federal district court in Florida concluded that a hospital violated Stark as a matter of law by entering into employment agreements with physicians that included bonus compensation that was not based exclusively...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

Hospitals And Compliance

Hospitals are being squeezed on many fronts – government reimbursement for medical services are declining, government regulatory requirements are increasing, and the prospects for improvement are dwindling. Medicare and...more

Lawsuit Based on Kickback, Stark Law Violations Sustained; Civil Suit Offers Additional Option to Counter Competitor's Illegal...

Hospitals, laboratories, and other health care providers that rely on referrals from other health professionals may encounter situations where competitors have entered into arrangements with physicians or other referral...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

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

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

Court Sides With CMS Stark Regulations on Physician-Owned Under Arrangement Service Providers

On May 24, the U.S. District Court for the District of Columbia in Council for Urological Interests v. Sebelius1 (‘‘CUI’’) sided with the Centers for Medicare & Medicaid Services in a lawsuit brought by a group of urologists...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

Federal District Court Upholds Stark Regulation Ban on Physician-Owned Under Arrangement Service Providers

On May 24 the District Court for the District of Columbia rejected an appeal brought by a group of urologists (“CUI”) seeking to overturn regulations promulgated in 2008 by the Centers for Medicare & Medicaid Services (“CMS”)...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

A “Stark” Result for South Carolina Hospital: Stark Law Violations May Cost Up to $357 Million in Penalties

After a four-week retrial, a federal jury concluded on May 8, 2013 that Tuomey Healthcare System (Tuomey) violated both the Stark Law and the False Claims Act (FCA). The jury determined that Tuomey violated the Stark Law by...more

Groundhog Day for Tuomey: Jury Finds Hospital Violated Stark Law and False Claims Act

On May 8, 2013, a jury in the Columbia Division of the U.S. District Court for the District of South Carolina returned a verdict finding that Tuomey Healthcare Systems, Inc. (Tuomey) violated the Stark Law and the federal...more

Jury Ruled in Tuomey Healthcare Retrial that the Hospital Violated the Stark Law and False Claims Act

On May 8, 2013, a jury concluded that Tuomey Healthcare System, Inc. (Tuomey), a community hospital in Sumter, S.C., violated the Stark law for allegedly improper compensation arrangements in 2005 between the hospital and 19...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

Recent CMS Guidance Partially Lifts Veil on Stark Self-referral Disclosure Protocol

In 2012, the Centers for Medicare and Medicaid (CMS) issued much-anticipated guidance on the Self-Referral Disclosure Protocol (SRDP) through its publication of thirteen settlements and its statutorily-mandated “Report to...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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