CLSA Working to Submit Comments to CMS on Medicare Coverage of Innovative Technology (MCIT) Proposed Rule

In September, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule (CMS-3372-P) entitled “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’”.  The proposed rule would create a program for automatic CMS coverage – for 4 years – for medical technologies (including devices and some diagnostic tests) that receive Food and Drug Administration (FDA) breakthrough technologies program designation and subsequent market authorization through their Expedited Review Approval Process.

The FDA breakthrough designation is only awarded to products that meet two criteria: 1) provides an effective treatment or diagnosis of life-threatening or debilitating diseases or conditions; and 2) either has no alternative on the marker; offers significant advantages over existing alternatives; or the product being available is in the best interest of patients.  Despite FDA recognition that breakthrough products should be made available to patients as soon as possible, many medical technologies and diagnostics that receive the breakthrough designation via the FDA experience a considerable delay in receiving coverage decisions from CMS, preventing patients from accessing the product for up to three years.  The MCIT proposed rule seeks to address this problem by allowing temporary coverage of eligible products immediately upon approval by FDA.

CLSA has long advocated – both via legislation and regulation – for efficient regulatory processes at the FDA for breakthrough medical technologies to be coupled with timely and appropriate coverage and payment determinations at CMS to avoid the “valley of death” for innovative products.  In an effort to continue that advocacy, CLSA has convened a working group of interested members to ensure that our comment letter is reflective of our members’ feedback, questions, and concerns.  Final comments in response to the proposed rule are due on November 2nd.

For more information about the MCIT proposed rule and CLSA’s comment letter, please contact Dani Mitchell (, CLSA’s Manager of Federal Government Relations and Programs.