Practical Advice for Medical Devices Firms | Page 11

www.clinipace.com Private carrier payment When a company is trying to obtain approval from managed care organizations, data must be submitted that includes peer-reviewed literature, assessments by specialty organizations, and endorsements from key opinion leaders. Unlike the Center for Medicare and Medicaid Services, private payers often consider cost of the device in their decision-making analysis. One of the most developed entities in the private payer evaluation process is the Blue Cross Blue Shield Technology Evaluation Center that uses the following five criteria for reimbursement approval: 1. The technology must have received final approval from the appropriate governmental bodies 2. Scientific evidence must permit conclusions concerning the technologies affect on health outcomes 3. The technology must improve the net health outcome 4. The technology must be as beneficial as any established alternatives 5. Improvement must be obtainable outside the investigational setting Page | 11 ©2012 Clinipace Worldwide, Inc. All rights reserved.