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, today expressed concern regarding the Centers for Medicare and Medicaid Services (CMS) decision to further delay the Medicare Coverage of Innovative Technology (MCIT) pathway as well as updates to the definition of “reasonable and necessary” for purposes of CMS coverage. 

In a final rule published in the U.S. Federal Register,  CMS opted to delay implementation of the MCIT program and the updates to the coverage criteria until December 15, 2021. The decision was issued despite broad enthusiasm for the new coverage pathway from a wide array of concerned parties. 

“We are greatly disappointed by the CMS decision to postpone implementation of MCIT,” said Patrick Hope, Executive Director of MITA. “Once implemented, MCIT will modernize Medicare's current reimbursement structure, ensuring broader beneficiary access to Food and Drug Administration (FDA)-authorized, breakthrough medical technologies that would otherwise be unavailable. Further delaying this coverage pathway effectively denies patient access to breakthrough technologies and ‘kicks the can down the road,’ leaving patients, healthcare providers, and medical device innovators in limbo.” 

Initially finalized in January of this year, the MCIT pathway, as proposed, would have reduced the gap between FDA marketing authorization and subsequent Medicare coverage for innovative medical devices. However, on March 17, CMS published an interim final rule delaying the effective date of MCIT until May 15. The agency’s most recent decision is an even longer delay of the coverage pathway’s effective date, pending further review and input from interested entities.

“Despite our concerns, we will continue our engagement with the agency to support the implementation of MCIT before the end of 2021,” added Hope.