Archives: Fraud and Abuse

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Industry Guidance on Unapproved or Off-Label Information Provides Insight Into Issues Under FDA Review

As we recently reported, in the wake of court rulings and settlements addressing the First Amendment in the context of providing truthful, non-misleading speech, including about unapproved (or, “off-label”) use of approved or cleared medical products, on September 1, 2016, the FDA issued a notice that it will hold a public hearing on November 9 and … Continue Reading

Reimbursement Considerations in Rare False Claims Act Jury Trial Addressing Off-Label Issues

On April 7, 2016, a Texas jury found by a 10-1 verdict that Abbott Laboratories did not violate the False Claims Act (FCA) in its marketing of biliary stents used off-label for non-coronary vascular stenting procedures.  The verdict—significant in its up to $1 billion exposure in damages—was the culmination of a decade of litigation before … Continue Reading

Sunshine Act Data Collection to Begin August 1

Medical device manufacturers are just days away from being required to track and report financial arrangements with health care providers, as required by the Physician Payment Sunshine Act (the “Sunshine Act”).  (Read the final rule.)  Beginning August 1, 2013, most device manufacturers will be required to annually collect data regarding payments and transfers of value … Continue Reading

CMS Posts Responses to FAQs on Sunshine Act Compliance

With the Sunshine Act’s August 1 compliance date for data collection rapidly approaching, the Centers for Medicare and Medicaid Services (CMS) has set up a page of frequently asked questions (FAQs) on its Open Payments website.  CMS appears to be adding FAQs on a rolling basis, with the most recent round of updates loaded in … Continue Reading

CMS Issues Sunshine Act Final Rule and Requires Data Collection for 2013

On February 8, 2013, the Centers for Medicare and Medicaid Services (CMS) published its much-anticipated final rule implementing Section 6002 the Patient Protection and Affordable Care Act, known as the Sunshine Act.  The Sunshine Act requires applicable manufacturers to collect and report to CMS data on payments and transfers of value made to physicians and … Continue Reading
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