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Belgium: Beware Of The Barking Privacy Watchdog, She’s Biting

The quietness in the privacy landscape in Belgium is about to drastically change. Reason for the change of pace are the recent major data breaches that were published by the media. The Privacy Commission announced it will...more

Insight and Input on ONC’s Proposed Roadmap for EHR Technology: ONC Issues Proposed 2015 Edition of Meaningful Use EHR...

On Feb. 21, the Office of the National Coordinator for Health Information Technology (“ONC”) released a proposed rule for voluntary 2015 Edition EHR certification criteria for the Medicare and Medicaid meaningful use...more

Unique Data Breach Settlement – A Sign Of Things To Come?

A judge in the United States District Court for the Southern District of Florida has approved a $3 million data breach class action settlement agreement between AvMed, Inc. and plaintiffs. The settlement arises out of a...more

HHS Extends Patient Access To Laboratories

On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance...more

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

Taking Precautions Against Medical Identity Theft

We recently reported that the number of cyber events involving the healthcare industry is expected to rise in 2014. The reliance on electronic medical records and the use of insurance exchanges increase efficiency but...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

Health Update -- Dec 19, 2013

The Debate over Specialty Pharmaceuticals: Is the Promise Worth the Price? - ..What’s the Issue? - Specialty pharmaceuticals are a rapidly growing share of total drug expenditures by public and private health...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

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

Health Care Reform Update -- November 25, 2013

In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from...more

OIG Advisory Opinion 13-15 - Anesthesiologists: Chickens or Eggs?

It is often said that advisory opinions are requested from the U.S. Office of Inspector General (OIG) when one wants a very safe deal blessed or when one wants to dissuade a competitor or counter-party from entering into or...more

The Anti-Kickback Statute And The Affordable Care Act: A Law Enforcement Tool Suddenly Goes Missing

With the aggressive pursuit of cases against the pharmaceutical and device industries (including the recent $2.2 billion settlement with Johnson & Johnson), the implementation of Medicare Fraud Strike Forces in major cities...more

Health Care Reform Update -- November 12, 2013

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

Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

Lessons from Frankenstein: Don't Create a Whistleblower

Given the publicity generated by large settlements paid to whistleblowers, many individuals are regularly on the prowl for a qui tam lawsuit that will yield a large bounty. These eager whistleblowers may be likely to pursue a...more

OIG Report Concludes that Physician-owned Distributors Increase Utilization

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

Medicare Part D Savings from Preferred Pharmacy Networks

The Pharmaceutical Care Management Association recently engaged Milliman, an actuarial and consulting firm, to analyze the impact of preferred pharmacy networks on Medicare Part D spending. The results of Milliman’s study...more

"Meaningful" Errors Require Hospital System To Refund $31M

In what is reported to be the largest repayment to date involving "meaningful use" incentive payments, Naples, Florida-based Health Management Associates, Inc. ("HMA"), with 71 inpatient facilities in 15 states, including...more

CMS Declares Third Party Payment of QHP Premiums Not OK

On the heels of HHS’s recent announcement that qualified health plans (QHPs) purchased through the Affordable Care Act (ACA) insurance exchanges are not “federal health care programs” for purposes of the federal anti-kickback...more

Second Circuit Affirms Dismissal of Qui Tam Case Based on Attorney’s Use of Confidential Information

The US Court of Appeals for the Second Circuit recently affirmed the decision of the District Court for the Southern District of New York to disqualify Fair Laboratory Practices Associates (FLPA) from its qui tam suit against...more

Health Alert (Australia) - 4 November 2013

In This Issue: - Judgments - Legislation - Reports - Excerpt from Reports: Australia. Department of Health & Ageing - ..1 November 2013 - GPs can now order subsidised magnetic resonance...more

Health Reform + Related Health Policy News - October 2013 - Issue 3

In This Issue: - Top News ..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law ..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues ..Kaiser Study...more

New OIG Report Examines Cost-Effectiveness of Physician-Owned Spinal Device Distributorships

On Thursday, October 24, the HHS Office of Inspector General (OIG) released a report responding to a request from members of the Senate Finance Committee to determine the extent to which physician-owned distributorships...more

District Court Dismisses Whistleblower’s Medicaid Fraud Allegations Against Quest and LabCorp

The U.S. District Court for the Eastern District of Virginia granted Quest Diagnostics Inc.’s (Quest’s) Motion to Dismiss a whistleblower lawsuit under the Virginia Fraud Against Taxpayers Act and the federal False Claims Act...more

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