"While only a small number of devices have received breakthrough marketing authorization by the FDA, there are many other promising innovative devices that may not meet the stringent definitions for a breakthrough," added Foley. "We urge CMS to expand the criteria for acceptance to the MCIT program to include more universal coverage of noninvasive medical devices including focused ultrasound that may be strongly preferred by patients as compared to more invasive alternatives."
MITA also recommended that CMS update the definition of the "reasonable and necessary" criteria under which the agency determines whether or not to cover a product or service. In the proposed rule, CMS proposes to create a separate basis under which an item or service would be considered "appropriate" based on commercial health insurers' coverage policies. Pointing out that private payer coverage policies can vary widely regarding the medical technologies and populations they cover, MITA urged the agency to develop coverage policies based on transparent and high-quality data sources and evaluation methods. As the letter notes, "there may not in all cases be a simple crosswalk between these [commercial insurers'] policies and a unitary CMS coverage determination."
About MITA
The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology.
About The Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of this noninvasive technology. The Foundation works to clear the path to global adoption by organizing and funding research, fostering collaboration, and building awareness among patients and professionals. The Foundation is the largest nongovernmental source of funding for focused ultrasound research.
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