If you don’t plan where you are going, you’ll never get there. Once you have conducted a comprehensive reimbursement landscape assessment from the beginning and not before launch, it is critical to develop a reimbursement roadmap. This document is a visual, month-by-month plan for action for both the financial and operational aspects of the business with realistic benchmarks, milestones and timelines needed to eventually secure coding, coverage and payment by insurers, with the emphasis on the word “action”. It is not a one-time thing. It needs to be revised and updated as your medical device travels through the roadmap. The key to successfully working this plan is to keep it front and center such that it drives your company’s daily activities. A well-conceived plan should be created early in the device’s development to help you gain clarity on what reimbursement initiatives need to be completed and when. It is also important to recognize that reimbursement-related actions vary as a product moves through various stages of development. Be prepared for investors and financial lenders to ask hard questions about whether you have a path to reimbursement for your device.
This also is the time to establish the design of your clinical trial(s) according to the stage of where your medical device is in its reimbursement cycle. The value of conducting clinical studies, of gathering data, of providing scientific evidence cannot be underestimated. Data is king!!! Upon application for FDA approval, you should include clinical trials, protocols, results, and reports, allowing the FDA to verify the rigorousness of your testing. The FDA accepts clinical trials showing safety and effectiveness using a
placebo or a sham procedure, but insurers want to see how your medical device and/or its associated procedure compares with the best available therapy or with the current standard of care. Your data must show that your device, above all others, is the one that’s best both for the patient and cost-savings. In addition, a manufacturer may be able to use such data to charge a higher price as the clinical evidence shows that the use of their device can offset costs.
Hope this helps,
Alan Schwartz, mdi Consultants, Inc
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