MITA Comments on CMS Proposed Rescission of MCIT Program

Oct 19, 2021, 09:30 AM

Washington, D.C – The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – in a comment letter to  Centers for Medicare & Medicaid Services (CMS), expressed disappointment with the Agency’s proposal to withdraw the previously finalized Medicare Coverage of Innovative Technology (MCIT) rule and urged CMS to work with industry, healthcare providers, patients, and others to improve and expedite the path from U.S. Food & Drug Administration (FDA) marketing authorization to CMS coverage.

“Medical technology developers need to have access to expedient, transparent, and predictable pathways to bring innovative products to Medicare beneficiaries,” the letter noted. It continued by highlighting MITA  comments requesting that the MCIT program be expanded beyond just “Breakthrough” technologies, given that not all innovative products earn this designation.

In January 2021, CMS published a final rule called The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ (MCIT/R&N). The MCIT program would have granted expedited Medicare coverage for up to four years for any FDA-designated “Breakthrough” device once the device received marketing authorization.

The full MITA comments are available here.

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MITA is the collective voice of manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging innovations. These products include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. MITA Member company technologies are an important part of our nation’s healthcare infrastructure and are essential for the screening, diagnosis, staging, managing and effectively treating patients with cancer, heart disease, neurological degeneration, and numerous other medical conditions.