Washington, D.C. – The Medical Imaging & Technology Alliance (MITA), the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators, and product developers, reaffirmed its support for the Medicare Coverage of Innovative Technology (MCIT) program in a letter to the Centers for Medicare and Medicaid Services (CMS) Acting Administrator Liz Richter. CMS had delayed implementation of the MCIT program until May 15, 2021. In the letter, MITA also reiterated its original recommendations for the MCIT coverage pathway outlined in a comment letter submitted last year.
Under the rule finalized by CMS in January 2021, the MCIT program would expedite beneficiary access to innovative medical devices with Food and Drug Administration (FDA) “breakthrough” designation. The rule also updated the definition of the “reasonable and necessary” criteria under which CMS determines whether or not to cover a product or service.
“In our original letter, MITA argued that the MCIT program, as proposed, would approximate an ideal pathway for bringing innovative medical solutions through FDA marketing authorization and CMS coverage determination,” said Patrick Hope, Executive Director of MITA. “Although we stand by this assessment, the decision by CMS to delay implementation of the program provided an opportunity to discuss further improvements to the new coverage pathway. We look forward to working with the administration to ensure a smooth implementation of the MCIT program over the next several months.”
While applauding the MCIT program and the codification of the definition of the “reasonable and necessary” criteria for Medicare coverage, MITA reasserted its position that the new pathway would still leave numerous medical solutions “in limbo.” By expanding the program and developing more expansive inclusion criteria beyond “breakthrough” designated medical devices, MITA argued that the program would ensure more expeditious patient access to a broader scope of innovative medical solutions.
The letter also underscored the position of MITA that CMS should consider extending the coverage period to five years or longer, as opposed to the current four-year coverage period included in the final rule.
“Currently, there is insufficient clarity as to what happens to a device at the end of the four-year automatic coverage period,” added Hope. “We therefore urge CMS to work with product developers on a process for ensuring ongoing coverage after this four-year period expires.”
The letter closed by underscoring the benefits of breakthrough devices for Medicare patients and affirming the safety and efficacy of FDA-approved devices.
