MITA disappointed in proposed withdrawal of breakthrough coverage MCIT rule
September 17, 2021
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 – expressed disappointment with the announcement from the Centers for Medicare and Medicaid Services (CMS) to withdraw the proposed Medicare Coverage of Innovative Technology (MCIT) rule to create a new, accelerated Medicare coverage process for innovative products that the Food and Drug Administration (FDA) deems “breakthrough.”
“For all interested parties, patient safety is the foremost concern, but the repeal of MCIT is misguided,” said Patrick Hope, Executive Director, MITA. “This is a major setback for efforts to eliminate the lengthy and costly lag between FDA approval and Medicare coverage determination. As a result innovative technologies will not be available to Medicare beneficiaries sooner.”
The proposed policy would have provided provisional national Medicare coverage for four years for breakthrough-designated devices following FDA approval. After that time, CMS could reevaluate coverage of the device based on clinical and real-world evidence. The extended coverage period would allow manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population.
“The ‘Catch-22’ scenario many medical innovations are stuck in needs a solution. Right now, innovative devices are approved by the FDA but are not covered by Medicare until sufficient evidence has been collected. However, data collection is made more difficult by lack of coverage,” noted Hope. “Limiting access to only those who can afford to pay out-of-pocket for an FDA-approved diagnostic or therapy ultimately disadvantages millions of Medicare beneficiaries.”
“A solution to this issue is still very much needed, and we expect the Administration will reconsider MCIT or work to produce an equally expeditious alternative. Delays in coverage have held back medical innovation long enough.” Hope concluded.