Anti-Kickback Statute

PODs Beware: OIG Releases Special Fraud Alert

by Matthew Murer | Polsinelli on 5/10/2013

The Office of the Inspector General (OIG) released a Special Fraud Alert on March 26, 2013 warning that physician-owned distributorships (PODs) are "inherently suspect" under the Anti-Kickback Statute (AKS). Generally...more

Law Enforcement In The Health Care Industry: What Do New Cases Against Novartis Tell Us?

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 5/9/2013

In recent years, pharmaceutical companies have faced criminal investigations and charges in regard to alleged off-label marketing of prescription drugs and kickbacks to doctors. For this reason, the filing last month of two...more

Capital Infusion: Private Equity Update - May 2013

by Sean Clancy, Adam Connatser, Lindsay Faine, Jon Finger, Rani Hauth Guerra, J. Atwood Jeter, Robert Johnston III, Amy Kaufman, David McLean, Ryan Mitchell, George Schutzer, Akash Sethi | Patton Boggs LLP on 5/8/2013

In This Issue: - DIGGING DEEPER: A Guide to Health Care Regulatory Due Diligence in Private Equity Deals 1 - Policy Spotlight: Affordable Care Act 6 - Case Spotlight: Best Practices in Down-Round Financings &...more

CMS and OIG Propose Changes to the Electronic Health Records Exception and Safe Harbor

by Thompson Coburn LLP on 4/25/2013

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

Hospital And Physician Compliance With Anti-Kickback And Stark Restrictions

by Michael Volkov on 4/24/2013

A bribe is a bribe. It is not as easy as it sounds. Not all payments of money or transfers of value are bribes. The FCPA tells us that. It is even more complicated when trying to navigate Anti-Kickback and Stark law...more

The Top 10 Things You Need To Know About The OIG’S Revised Self-Disclosure Protocol

by Laurence Freedman, Laura Laemmle-Weidenfeld | Patton Boggs LLP on 4/23/2013

On Wednesday, April 17, 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) released an updated Self-Disclosure Protocol (SDP) governing the process by which health care providers can...more

OIG Unveils Updated Self-Disclosure Protocol

by George Breen, Jason Christ, Anjali Downs, Jennifer Goodwin, David Matyas, Deepa Selvam, Carrie Valiant | Epstein Becker & Green, P.C. on 4/23/2013

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

OIG Special Fraud Alert Labels Physician-Owned Distributorships (PODs) as “Inherently Suspect”

by Dennis Diaz, Sarah S. Fallows | Davis Wright Tremaine LLP on 4/22/2013

The U.S. Department of Health & Human Services, Office of Inspector General (the “OIG”) issued a Special Fraud Alert (“Alert”) on March 26, underscoring its heightened focus on fraud and abuse risks posed by physician-owned...more

OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations

by Darby C. Allen, Donna S. Clark | BakerHostetler on 4/22/2013

In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic...more

OIG Updates Provider Self-Disclosure Protocol

by B. Scott McBride, Summer Swallow | BakerHostetler on 4/19/2013

On April 17, 2013, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a revised Provider Self-Disclosure Protocol (SDP) that clarifies the process for healthcare providers, suppliers...more

CMS and OIG Issue Proposed Rules Modifying the Stark Exception and Anti-Kickback Safe Harbor for Donation of EHR

by C. Frederick Geilfuss II, Shilpa Patel, Richard Rifenbark, Donald H. Romano | Foley & Lardner LLP on 4/19/2013

On April 10, 2013, the Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) each published proposed rules in the Federal Register...more

HHS Extends Sunset Date for Stark Exception and Anti-Kickback Safe Harbor for EHR Donations

by Daniel F. Gottlieb | McDermott Will & Emery on 4/19/2013

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

OIG Issues Updated Self-Disclosure Protocol

by Tom Crane, Nili Yolin | Mintz Levin - Health Law on 4/18/2013

The Department of Health and Human Services Office of Inspector General (“OIG”) has published an updated Provider Self-Disclosure Protocol (the “Updated SDP”) that offers health care providers guidance on how to disclose...more

HHS OIG Issues Revised Self-Disclosure Protocol

by Holly Barker, Albert Shay, Howard Young | Morgan Lewis on 4/18/2013

OIG touts substantial benefits of disclosing, provides greater detail for different types of disclosures, and captures 15 years of OIG Self-Disclosure Protocol experience....more

CMS, OIG Propose to Extend EHR Stark Exception and Anti-Kickback Safe Harbor

by King & Spalding on 4/16/2013

On April 10, 2013, CMS and the HHS Office of Inspector General (OIG) each published proposed rules to extend the sunset dates for the Stark exception and anti-kickback statute safe harbor permitting donations of EHR software...more

OIG Special Fraud Alert on Physician-Owned Distributorships

by James Henry, Kristen A. Larremore | Bradley Arant Boult Cummings LLP on 4/16/2013

On March 26, 2013, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled “Physician-Owned Entities.” The Alert is consistent with an ongoing theme of concern...more

OIG Issues Special Fraud Alert on Business Arrangements with Physician-Owned Entities

by Herschel Goldfield, Malcolm Harkins, III, Edward Kornreich, Elizabeth Mills, Ellen Moskowitz, Richard Zall | Proskauer Rose LLP on 4/15/2013

On March 26, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert (Fraud Alert) reiterating its long-standing concern that the opportunity for a referring physician to earn a profit by investing in a venture...more

OIG Proposes Amendments to the Electronic Health Records Safe Harbor

by Paul Koob, Dee Spagnuolo | Ballard Spahr LLP on 4/11/2013

The Office of the Inspector General (OIG) for the Department of Health and Human Services announced and solicited comments to proposed rule changes to the Electronic Health Records Safe Harbor (EHRSH) under the federal...more

CMS and OIG Propose Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

by Ropes & Gray LLP on 4/11/2013

On Wednesday, April 10, 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 proposed rules in the...more

Health Care Client Alert: OIG and CMS Propose Extensions and Modifications to Their EHR Anti-Kickback Safe Harbor & Physician...

by Sven Collins, Melodi Gates, Mimi Hu, Stephen Nash, Michi Tsuda | Patton Boggs LLP on 4/10/2013

On Monday April 8, 2013, the Department of Health and Human Services Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) released closely aligned proposed rules to extend their parallel...more

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