WASHINGTON, D.C. – Today, the Advanced Medical Technology Association (AdvaMed) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on its proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule. In the letter, AdvaMed, which represents more than 400 medical device companies, urged CMS to ensure patients have expedited access to innovative life-saving and life-enhancing medical devices and diagnostics.
“The implementation of the MCIT rule would give doctors and patients access to FDA-approved breakthrough medical technologies that are transformational. We are disappointed in the recent proposal to repeal this rule, but AdvaMed is committed to working with CMS on a pathway forward that prioritizes patients and puts evidence development at the center of the process. Coverage of breakthrough innovations in medical technology that improve care for patients are both reasonable and necessary for those who are suffering. It remains critically important to have a predictable and transparent pathway that ensures these innovations get to patients in need. We urge CMS not to repeal the MCIT final rule and instead work with us and our members to achieve our mutually shared goal of timely access of new innovations in health care diagnosis and treatment to patients.”
Under the rule CMS has proposed to repeal, 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. While AdvaMed is disappointed in CMS’ proposal to repeal the MCIT final rule, we are committed to working with the Agency to find a workable path forward so that Medicare patients with serious or debilitating illness will have access to breakthrough technologies where existing alternatives are limited or do not exist.
About AdvaMed
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.
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