AdvaMed® Statement on The Repeal of MCIT
WASHINGTON, D.C. – 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Under the now-repealed MCIT rule, Medicare would have provided immediate national coverage for four years for any new device or diagnostic designated as a “breakthrough” technology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 AdvaMed®’s 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.