Compliance Essentials: Data-Driven HCP Engagements
July 5, 2024
Stay informed with expert insights, trends, and best practices in life sciences compliance.
The Department of Justice announced on February 3, 2017, that penalties for the False Claims Act (FCA) will be increasing once again, effective immediately. The minimum per-claim penalty will increase from $10, 781 to $10,957 as a pursuant to the 2015 budget bill that calls for annual re-indexing of FCA penalties for inflation. On the […]
The Open Payments system is now available for applicable manufacturers and group purchasing organizations (GPOs) to: – Register – Recertify their registration from the previous year – Submit data for the Program Year 2016 – Submit corrected data from previous Program Years (if required) Now that the system is available, all applicable manufacturers and GPOs […]
The dialogue supporting data mining of sources such as CMS, the Company’s commercial data, EU compliance data, clinical data, Medicaid, Medicare Part B, and Part C strongly implies that a robust risk-focused future lies ahead for compliance professionals. How prepared they are to respond to such a future may be measured by their vision of […]
With Republican lawmakers pushing to repeal the Affordable Care Act, there is rising fear amidst researchers, media, and the public that the section of the law that created the Open Payments program, namely the Sunshine Act, will face the chopping block. For the record, the enactment of the Open Payments program has shed light on […]
The government of Belgium enacted new legislation governing transparency reporting on December 27, 2016. The new legislation is known as The Sunshine Act. The law now deems it necessary for pharma manufacturers, retailers, medical device manufacturers, and even importers and distributors to disclose information about their interactions with HCPs and HCOs. This information has to […]
Shire Pharmaceuticals, an Ireland-based global specialty biopharmaceutical company, has agreed to pay $350 million to settle allegations of paying kickbacks. It was alleged that the company bribed physicians and clinics to lure them into using its diabetic ulcer treatment. As stated by A. Lee Bentley, the U.S. Attorney General for the Middle District of Florida, […]
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