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False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback...more

A Whistleblower Hotline can protect against medical identity theft

Last year, medical identity theft affected nearly two million Americans - 32% more than the year before. This is a staggering number! And considering that today, medical identity theft accounts for 43% of all identity theft...more

Health Care Reform Implementation Update

The Affordable Care Act (ACA) received a great deal of attention this past week in Washington. The House held numerous hearings on implementation issues, including oversight of access to care for ACA enrollees and improper...more

Minnesota Federal District Court Explores Application of Corporate Practice of Medicine Doctrine to MRI Scans

On March 25, 2014, in State Farm Mutual Automobile Insurance Company v. Mobile Diagnostic Imaging, Inc., the U.S. District Court for the District of Minnesota held that a corporation not owned or controlled by physicians does...more

CMS's Final Exchange and Insurance Market Standards Impact Qualified Health Plan Filings for 2015 and Beyond

On May 16, 2014, the Centers for Medicare & Medicaid Services ("CMS") released a final rule titled "Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond" ("Final Rule")...more

First Circuit Affirms Dismissal of FCA Complaint Based on First-to-File Bar

The First Circuit recently affirmed the dismissal of United States ex rel. Wilson v. Bristol-Myers Squibb, Inc. under the False Claims Act’s (“FCA”) “first-to-file” provision, which prohibits any person “other than the...more

So, Are You Really Compliant With HIPAA?

As covered entities under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), healthcare providers are intimately familiar with the strict privacy and security requirements imposed on them by HIPAA and...more

Employment Law

California Employers Face Rise In PAGA Suits - Why it matters: California employers are facing a proliferation of suits filed under the State’s Private Attorney General Act (PAGA): new data reveals that the number of...more

HHS announces new risk assessment tool for HIPAA security compliance

Recently, the Department of Health and Human Services released an interactive security risk assessment tool intended to assist employers who sponsor self-insured group health plans in complying with their HIPAA security rule...more

Minimum Necessary and the Breach Standard

When the new HITECH rules came out OCR specifically said, “...uses or disclosures that impermissibly involve more than the minimum necessary information...may qualify as breaches.” But what exactly is the minimum necessary...more

Health Update

Ten Years In: Charting the Progress of Health Information Exchange in the U.S. - HITECH: Federal Dollars Spur Adoption and Use: The modern era of HIE-related public policy began in May 2004 with the appointment...more

Take 5 Newsletter: 5 Employment Law Considerations in "The Cloud"

What is "the cloud," and what on Earth (pun intended) does cloud computing have to do with employment law? While many definitions abound, cloud computing at its core is a form of remote electronic data storage,...more

Health Update -- Nov 26, 2013

10 Megatrends Shaping Healthcare’s Next 10 Years - The American healthcare system is undergoing massive change. From transformational policies to disruptive technologies to groundbreaking medical advances, powerful...more

The HIPAA Gap Between Employers And Employees

“…HIPAA does not create a duty on the part of employers to protect employees from computer-virus related injuries” This quote, from the Farr v. St. Francis Hosp. & Health Centers case in the Southern District of Indiana,...more

Hodgson Russ Helps Clients in Largest-Ever False Claims Act Settlement In Risperdal Lawsuits Against Johnson & Johnson

The Justice Department announced that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug...more

Second Circuit: in-house counsel may not seek to profit as whistleblowers against former employers

The United States Court of Appeals for the Second Circuit has issued an important ruling restricting in-house counsel from acting as whistleblowers in litigation against their current or former employers. ...more

HHS Office of Civil Rights Releases Several Model Notices of Privacy Practices

The HHS Office of Civil Rights (OCR) recently released several versions of a model Notice of Privacy Practices (NPP) for use by covered entity health plans and health care providers. The notices have been written specifically...more

Ready For HITECH Changes On September 23, 2013? Find Out With This Compliance Checklist For Employer-Sponsored Health Plans

The final regulations implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act were issued in January and compliance is required by September 23, 2013. The final regulations require covered...more

New HIPAA Deadline Around the Corner: Be Prepared!

Don’t look now, but another HIPAA deadline is just around the corner. As we noted last month, the deadline is looming for employer-sponsored health benefit plans to come into compliance with U.S. Department of Health...more

3 Weeks Left: Is Your Business Ready for HIPAA Compliance?

The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of...more

Paying for Family Vacations With NIH Funds Triggers FCA Lawsuit and Settlement

Northwestern University will pay $2.93 million to settle a federal False Claims Act (FCA) lawsuit brought by a former employee who alleged Northwestern allowed a researcher to submit false claims under certain cancer research...more

Does District Court Dismissal of Declined Qui Tam Threaten Future DOJ False Claims Enforcement?

The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more

The Road Map to HIPAA Compliance: What Your Nonprofit Needs to Know

In this presentation: - Overview of HIPAA - Privacy Rule - Notice of Breach - Security Rule - Business Associates & Business Associate Agreements - Notice of Privacy...more

Healthcare Update, No. 3, August 2013: Protect Your Key Information – And Your Key Relationships

Decades ago, it was reasonable to imagine that one could work for the same company from the start of one’s career to the end. Think about the world portrayed in Mad Men. Don Draper has mostly worked with the same fictional...more

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more

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