News & Analysis as of

Recent Changes to Stark Law's Whole Hospital Exception

The federal physician self-referral law, or Stark Law, provides a number of exceptions to the law's prohibition of physician referrals of designated health services to an entity in which the physician has an ownership or...more

CMS Grants First Waiver of Stark Law Expansion Restrictions—Are More Ahead?

Are changes to the landscape of physician hospital ownership ahead? The Affordable Care Act amended the federal Stark Law to eliminate the “whole hospital exception” that permitted self-referrals provided the referring...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

SRDP No Longer New Wine

More than four years after the Centers for Medicare & Medicaid Services' (CMS) issuance of the Stark Self-Referral Disclosure Protocol (SRDP), it's time to assess the results. The SRDP was designed by Congress to resolve...more

Texas Hospital Qualifies for Exception to Limitation on Exception to Elimination of Exception to Stark Law

Lake Pointe Medical Center has become the first hospital in America to qualify for (i) an exception to (ii) the limitation on the (iii) grandfather exception to the (iv) elimination of the (v) whole-hospital exception to the...more

Health Care Reform Implementation Update

The Centers for Medicare and Medicaid Services (CMS) began sending reminders last week that open enrollment begins on November 15; CMS’s Marketplace CEO, Kevin Counihan, said that end-to-end testing of HealthCare.gov was...more

CMS and OIG Extend Interim Final Rule Regarding Waivers of Fraud and Abuse Laws For ACOs

On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Health Update - Jun 2014

Removing Regulatory Barriers to Accelerate EHR Adoption - Recognizing the potential long-term value of EHRs for improving care and reducing costs, many hospitals considered offering physicians financial support to...more

The Deadline for Submitting Comments Regarding the Self-Referral Disclosure Protocol Is Fast Approaching

On May 2, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published a request for comments relating to the Self-Referral Disclosure Protocol (“SRDP”). The SRDP is a voluntary self-disclosure instrument that...more

Comments Due for New Expedited Review Process for CMS's Voluntary Self-Referral Disclosure Protocol (SRDP)

The creation of the SRDP through the Affordable Care Act as a mechanism to resolve potential Stark violations was welcomed by the industry. However, since enactment of the regulations implementing the SRDP in 2010, the volume...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

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

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