Cerulean Named as IRO in Consent Decree
Cerulean Associates LLC has been chosen as the independent review organization (IRO) for a major consent decree. The consent decree, between the US Department of Health and Human Services, the Office of Inspector General and the Wisconsin medical device firm Dr. Comfort, runs from March 2011 until May 2017.
Under the consent decree, Cerulean will perform regular quality systems management reviews to ensure that Dr. Comfort’s manufacturing processes and controls meet the rules and regulations associated with diabetic footwear medical devices. This review will help ensure compliance with the Medicare reimbursement rules and regulations.
“Our goal is to ensure Dr. Comfort’s compliance with HHS requirements,” said Cerulean’s Managing Director and Founder, John Avellanet. “And as with all of the firms we help, we want to make sure to strike a practical balance between compliance and cost. The key is to ensure all the terms of the corporate integrity agreement are met, and preferably in the least burdensome manner. This will help position Dr. Comfort products for success in the wider global marketplace and regulatory landscape.”
Much as with its other clients, Cerulean will rely upon a blend of qualitative and quantitative methods to assess compliance. The first step is to take a qualitative approach to analyze the manufacturing and reimbursement processes and controls. Such a review asks a simple question: Should the processes and controls, as written, work?
The next step is to take a quantitative approach, reviewing records and data that serve as proof that the processes and controls did, in fact, work as expected. This approach uses record sampling to provide a 95-99% degree of confidence that the processes and controls are working as intended.
Cerulean’s blended approach to auditing processes and reviewing compliance controls provides enough information, and enough confidence in the reliability of that information, to make reliable judgements at reasonable costs.
About Cerulean Associates LLC
Cerulean offers expert FDA quality systems and compliance analysis, remediation and improvement consulting. Emphasis is on cost-effective compliance for device and drug companies. Cerulean employs only highly experienced industry professionals and experts to consistently prevent and solve compliance challenges with practical solutions. Cerulean is the only compliance consultancy to offer guaranteed results.