Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
Among the critical components of life sciences compliance, speaker programs and healthcare professional (HCP) meals are two high-risk areas subject to regulatory scrutiny and governed by various applicable laws. These initiatives are designed by life sciences companies to educate medical professionals about the development of new drugs and devices, ensuring they are well informed about […]
The Sunshine Act, a provision of the Affordable Care Act, requires life sciences organizations to report payments and other transfers of value to the Centers for Medicare and Medicaid Services (CMS). This information is then made publicly accessible on CMS’s website. The reporting process involves preparing aggregate spend reports according to a CMS-preferred format and […]
As the deadline for CMS Open Payments reports submission draws close, we ought to share 4 of the common mistakes that happen during Federal Sunshine Act reporting. And how you should be avoiding them. Before we begin, let’s keep in mind that two types of errors could potentially come with spend transparency: Technical errors Compliance […]
About three weeks ago, on November 15th, the compliance industry had another “Oh God, not again!!!” moment. Because CMS had issued changes in the scope of the Open Payments program. For the compliance professionals already struggling with data collection and compilation following the first set of changes issued in August 2019, these latest changes in […]
In case you missed it, OIG recently published a report on its review of Open Payments data published by CMS. A key objective of this review was to “assess whether data published on the Open Payments website were missing data elements, were inaccurate, or were inconsistent.” OIG only reviewed the data published by CMS for […]
This blog carries on from our previous blog (Compliance Professionals, Are Your Findings Statistically Significant?) on the difference between correlation and causality. Causality is established when the following three conditions are met: a) Temporal Association: For Event A to cause Event B, B must follow A. You cannot establish causality if two events are occurring […]
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