Today, the Advanced Medical Technology Association (AdvaMed) released the following statement from President and CEO Scott Whitaker regarding the Centers for Medicare and Medicaid Services (CMS) recission of the Medicare Coverage for Innovative Technologies (MCIT) final rule:
The MCIT rule was truly transformational for Medicare patients and doctors looking for life-saving and life-enhancing breakthrough medical technology to diagnose and treat diseases. We are disappointed in the decision made today to repeal that rule without an established pathway to quickly get these FDA-approved devices to seniors who need them most. We are committed to working with CMS and lawmakers on both sides of the aisle to find a way forward to achieve our mutually shared goal of improving access to new innovations in medical technology for patients.
Under the now-repealed MCIT rule, Medicare would have provided immediate national coverage for four years for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA. During that four-year coverage period, manufacturers could continue to provide the additional data needed to maintain coverage after the four-year coverage period expired.
Last month, AdvaMed submitted comments to CMS urging the agency to not repeal the rule and work to ensure patients have expedited access to innovative, life-saving medical devices and diagnostics. Read AdvaMeds full comments to CMS on the proposed MCIT repeal here.
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AdvaMed member companies produce the medical devices, diagnostic products and digital health technologies that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.