A medical imaging trade group today expressed concern over CMS’s decision to further delay Medicare coverage for breakthrough devices.
The Medical Imaging & Technology Alliance (MITA) has joined with other medical technology business groups in expressing disappointment over decision to postpone Medicare of Innovative Technology (MCIT) coverage path until December 15, 2021 .
CMS issued a final rule on MCIT in January, granting coverage for breakthrough devices on the same day as their FDA approvals, for up to four years. Immediately after taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register to consider questions of fact, law and policy that the rules could lift. CMS officials decided that the coverage of revolutionary devices deserved further consideration.
The MCIT rule was supposed to go into effect on March 12, but CMS delayed it for another 60 days to give the public more opportunities to comment. Late last Friday, CMS issued a decision further postponing this coverage until December.
The FDA grants a revolutionary designation to certain devices that allow more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in order to bring them to market more quickly.
MITA represents manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media and focused ultrasound therapy devices. The trade group is also concerned about updates to the definition of “reasonable and necessary” for the purposes of CMS coverage.
The medical technology industry and members of Congress had pressured CMS to enact the final rule. But physician organizations and the insurance industry backed down, citing safety and efficacy concerns for devices that had not been thoroughly tested. The American Medical Association has expressed concern about the lack of opportunity for stakeholders to review and comment on these coverage decisions and to allow private payor coverage policy to determine whether an item is “reasonable and necessary. For the purposes of Medicare coverage.
“We are very disappointed with CMS’s decision to postpone the implementation of MCIT,” MITA Executive Director Patrick Hope said in a press release. “Once implemented, the MCIT will modernize Medicare’s current reimbursement structure, ensuring greater access for beneficiaries to cutting-edge medical technologies authorized by the Food and Drug Administration (FDA) that would otherwise be unavailable. Delaying this route of coverage further effectively denies patients access to cutting-edge technology and “kicks the road”, leaving patients, healthcare providers and medical device innovators in limbo. “
The delay has also raised concern from other medical technology business groups, including AdvaMed and the Medical Device Manufacturers Association. The new deadline allows for more scrutiny by interested parties.
“Despite our concerns, we will continue our engagement with the agency to support the implementation of the MCIT before the end of 2021,” Hope said.