For medtechs, overcoming the “valley of death” between FDA approval and coding, coverage, and payment for their innovations is a struggle. The proposed MCIT pathway could enable many start-ups to cross the valley more easily. Pricing remains a key unknown, but if the program is implemented, it could have far-reaching implications for innovators and their FDA Breakthrough devices. By David Lee and Stacey Zhang, Simon-Kucher & Partners.
Reimbursement has become the leading challenge facing medical device companies looking to get their new products on the market today, surpassing even regulatory issues as CMS remains an obstacle that has become harder to overcome than FDA. Receiving FDA clearance/approval is of little help if there is no reimbursement. That is why CMS’ newly-proposed Medicare Coverage for Innovative Technology (MCIT) program could be critical to the success of many new medical technologies. MCIT could potentially drive a new wave of medical technology innovation by granting Medicare beneficiaries access to the latest, most cutting-edge devices and bridging a gap that many medtech start-ups have previously failed to overcome.