Healthcare, Medical Devices | JD Supra Law News

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

Capital Infusion - May 2013: Deal Spotlight: Patton Boggs Advises on Innovative Health Care Transaction

by Adam Connatser, Jon Finger, Rani Hauth Guerra, J. Atwood Jeter, David McLean | Patton Boggs LLP on 5/13/2013

Patton Boggs recently advised Satori Capital, a Dallas-based private equity firm, on its acquisition of Longhorn Health Solutions, Inc. Longhorn is headquartered in Austin, Texas and is a leading direct-to-home provider of...more

An “App” a Day Will NOT Keep the FDA Away: The Rise of Mobile Medical Applications

by Nicholas Weiss | Sedgwick LLP on 4/26/2013

The number of mobile applications (apps) available to consumers on their iPhones, Androids, and iPads is astonishing. As of January 2013, there were more than 775,000 different apps available to iPhone and iPad users. It...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

Hernia Patients in Pain as Skin Procedure Fails [Video]

by Lawyers.com on 4/22/2013

Hernia patients have filed lawsuits against the manufacturers of AlloDerm, a product made from the skin tissue of cadavers. They claim once implanted, the AlloDerm stretches and fails, resulting in serious and painful...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

Focus on Health Care Firms in FCPA Investigations

by Doreen Edelman | Baker, Donelson, Bearman, Caldwell &... on 4/10/2013

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

Thoughts on Regulatory Constraints of Business Models

by Seth Mailhot | Sheppard Mullin Richter & Hampton LLP on 4/8/2013

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

Increased Government Scrutiny of Physician-Owned Device Distributorships

by Philip Lebowitz | Duane Morris LLP on 4/3/2013

On March 26, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) increased its scrutiny of and pressure on physician-owned entities (particularly medical device distributorships) by...more

Health Care Reform Update -- April 2, 2013

by Joseph P. Hammang, Alexander Hecht, Kevin M. Kappel, Tom Koutsoumpas, Jeremy Rabinovitz, Robert C. Skinner | Mintz Levin - Health Law on 4/3/2013

In This Issue: Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more

OIG Issues Special Fraud Alert on Physician-Owned Distributorships

by King & Spalding on 4/2/2013

On March 26, 2013, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert warning that OIG will view physician-owned distributorships (PODs) as “inherently suspect” under the Federal anti-kickback statute....more

OIG Calls PODs "Inherently Suspect"

by Julie Kass, William Mathias, Sanford Teplitzky | Ober|Kaler on 3/29/2013

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

Physician-Owned Device Companies: OIG Issues Further Guidance

by Anthony Ten Haagen | Holland & Knight LLP on 3/29/2013

The Office of the Inspector General for the United States Department of Health and Human Services (OIG) issued a Special Fraud Alert on March 26, 2013 (the "2013 POD alert"), that identifies physician-owned distributorships...more

AHRQ Releases Draft Report on Implantable Defibrillators and Prevention of Sudden Cardiac Death

by King & Spalding on 3/28/2013

On March 21, 2013, the Agency for Healthcare Research and Quality’s (AHRQ) Technology Assessment Program released a draft technology assessment report regarding implantable cardioverter-defibrillators (ICDs) and the evidence...more

Getting Ready For The Physician Payment ‘Sunshine’ Rule

by Kathleen Howard, Joel R. Levin, Charles Mulaney, Jerica L. Peters | Perkins Coie on 3/22/2013

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

Here Comes the Sun: What You Need to Know about the Sunshine Act and Its Implementing Rules

by Edward Buthusiem, Cheray Lynch Sieminski | Berkeley Research Group, LLC on 3/20/2013

After years of deliberation, the Center for Medicare & Medicaid Services (CMS) published its long-awaited regulations to implement the specific requirements of the Physician Payment Sunshine Act (Sunshine) on February 1,...more

ProPublica's "Dollars for Docs": Will The Physician Payments Sunshine Provisions Clear The Haze?

by Robert Radick | Morvillo Abramowitz Grand Iason & Anello P.C.... on 3/20/2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-delayed final rule that is intended to implement the Physician Payments Sunshine provisions that were included in the Patient...more

Defective Medical Products: The Meningitis Outbreak

by Thorsnes Bartolotta McGuire LLP on 3/20/2013

The Centers for Disease Control and Prevention (CDC) estimates healthcare-associated infections (HAI) afflict one in 20 admitted patients. According to the California Department of Public Health, HAIs account for 200,000...more

CMS Issues Rules On Physician Payments Sunshine Act

by Michael Volkov on 3/15/2013

People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

Understanding Pelvic Organ Prolapse

by Phillips Law Offices on 3/11/2013

Hundreds of women who received mesh to treat pelvic organ prolapse (POP) are suing manufacturers and physicians for injuries suffered as a result of the procedure. As the focus on damage caused by improper treatment...more

Final Sunshine Act Arrives: Now the Hard Part

by Michele L. Buenafe, Jonathan Havens, Kathleen McDermott, Rebecca Osowski, Albert Shay | Morgan Lewis on 3/8/2013

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

Physician Payment Sunshine Act Final Rule Released

by Thomas Donohoe, Lauren Groebe, Lindsay Kessler, Matthew Murer | Polsinelli on 3/7/2013

In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

The Sunshine Physician Payment Final Rule Overview and Analysis

by Nancy Bonifant, Elizabeth Carder-Thompson, Katie Pawlitz | Reed Smith on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule (Rule) to implement the “Sunshine” provisions of the Affordable...more

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Healthcare › Medical Devices

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

Capital Infusion - May 2013: Deal Spotlight: Patton Boggs Advises on Innovative Health Care Transaction

An “App” a Day Will NOT Keep the FDA Away: The Rise of Mobile Medical Applications

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

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

Hernia Patients in Pain as Skin Procedure Fails [Video]

OIG Special Fraud Alert on Physician-Owned Distributorships

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

Focus on Health Care Firms in FCPA Investigations

Thoughts on Regulatory Constraints of Business Models

Increased Government Scrutiny of Physician-Owned Device Distributorships

Health Care Reform Update -- April 2, 2013

OIG Issues Special Fraud Alert on Physician-Owned Distributorships

OIG Calls PODs "Inherently Suspect"

Physician-Owned Device Companies: OIG Issues Further Guidance

AHRQ Releases Draft Report on Implantable Defibrillators and Prevention of Sudden Cardiac Death

Getting Ready For The Physician Payment ‘Sunshine’ Rule

Here Comes the Sun: What You Need to Know about the Sunshine Act and Its Implementing Rules

ProPublica's "Dollars for Docs": Will The Physician Payments Sunshine Provisions Clear The Haze?

Defective Medical Products: The Meningitis Outbreak

CMS Issues Rules On Physician Payments Sunshine Act

Understanding Pelvic Organ Prolapse

Final Sunshine Act Arrives: Now the Hard Part

Physician Payment Sunshine Act Final Rule Released

The Sunshine Physician Payment Final Rule Overview and Analysis

Hernia Patients in Pain as Skin Procedure Fails [Video]

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