e are comfortable with what we know and uncertain with what we don't know, and this is especially true for the government agencies that determine reimbursement for new medical technologies. While they know that we need innovative medical devices and mHealth to improve the quality and cost of health care, being "innovative" can mean "uncertain," in regards to the challenge of trying to demonstrate Value or Reasonable and Necessary usage. The result is a gap between innovation and profitable reward for that innovation.
To close this gap, medical device and mHealth companies need to develop strategies to eliminate the possibility of this gap during their initial stages of design and planning, as it is no longer sufficient to wait until after FDA approval.
Yet putting one's arms around the coverage maze, and the contra position between regulatory approval for Safe & Effective and reimbursement for Reasonable & Necessary (CMS), while still retaining Value for private sector, requires understanding the complex processes.
- Hurdle #1 – "coverage," which requires knowing which of the tens of thousands of reimbursement policies apply to your device
- Hurdle #2 – identifying the right procedure code(s), and if one is not the best fit, working with the AMA to adapt or create a new code.
- Hurdle #3 – setting the payment for the new usage of the code(s)
Just because something is Safe & Effective does not mean it can be proved to have Value or be Reasonable and Necessary. Safe & Effective is demonstrated in controlled clinical trials, where patients are excluded due to co-morbidities or the wrong stages of their condition to create homogenous study arms. This ideal setting enables a device to demonstrate specific safety and effectiveness questions. Yet in the "real-world," patients have co-morbidities and varying stages of a disease. Reimbursement organizations need to understand how the device performs under these conditions in order to jump the three hurdles for profitable reimbursement.
Innovators often do not have time to dig through policies to determine which apply to them and how best to traverse the three hurdles. Innovator's options are limited: either take the time to 'do it yourself' or hire consultants, which are expensive. The cost associated with either approach becomes a major barrier to innovative ideas becoming reality. Tools are needed to enable innovators to innovate and successfully traverse through reimbursement planning.
Today the medical device industry faces the same challenge that taxpayers faced before tools like TurboTax and TaxCut automated similar interactions with government agencies. The task is overwhelming, time-consuming and fraught with error.
Being an FDA Entrepreneur in Residence has given me keen insight into this challenge. The company I have started is dedicated to offering tools such as ClearRoadmap'sSM Reimbursement Eligibility Assessment. These tools are designed to help innovators be proactive, helping companies be prepared for the future from the start.
To help innovators better understand these challenges, I will be conducting a series of free Webinars in December to explore Medical Device regulation and reimbursement issues. For more information on these webinars, please send an email expressing your interest to info@ClearRoadmap.com.
-- Vizma Carver, Founder and CEO, Carver Global Health Group