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

CMS and the OIG Extend Protections for Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) each published, in the Federal Register, a final rule that amends regulations under the Anti-Kickback...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

Federal Government Extends Donated EHR Technology Protections under Stark and AKS through 2021

Some of the most important protections under the federal Stark Law (“Stark”) and the federal Anti-Kickback Statute (“AKS”) have been those that permit hospitals and other organizations to donate electronic health records...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

CMS and OIG Issue Final Rules Extending EHR Stark Law Exception and AKS Safeharbor to December 31, 2021

On December 27, 2013, CMS published a final rule in the Federal Register revising the previously enacted exception to the Stark law that permits certain arrangements involving the donation of electronic health records (EHR)...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 & OIG Final Rules Extend And Amend Protection For EHR Donations

Ordinarily, the donation of Electronic Health Record (EHR) technology, services or training to a provider would raise fraud and abuse concerns and potentially implicate the Stark law and Anti-kickback Statute. In order to...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

2013 – The Health Law Year in Review

As 2013 draws to a close, we are pleased to look back on the year that was and highlight some of the key developments in the ever-changing field of health law. While a great deal of attention was focused on the implementation...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

Update: New Reporting Requirements Deadline for Physician-Owned Hospitals Extended to March 1

The Centers for Medicare & Medicaid Services (CMS) has extended the deadline for physician-owned hospitals seeking to avail themselves of the “whole hospital” exception or “rural provider” exception to the Stark Law to report...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

CMS Issues FAQs Regarding Self-Referral Disclosure Protocol

CMS has released its responses to eight frequently asked questions [PDF] regarding its Self-Referral Disclosure Protocol (SRDP). The questions fall into three categories, listed below, and respond to issues that are often...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

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

Court Rejects Urologists’ Appeal to Overturn Regulatory Changes to Stark Law

The Stark Law regulations are not without controversy, as an unsuccessful appeal by a group of urologists brought against the Centers for Medicare & Medicaid Services (CMS) illustrates. The Council for Urological Interests, a...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

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