Imaging advocate warns innovation likely to languish if lawmakers don’t act on ‘breakthrough’ device rule
A leading medical imaging advocate is warning that radiology and other technological innovations may suffer if federal regulators don’t reverse their decision to repeal a rule granting faster Medicare coverage to “breakthrough” devices.
The U.S. Centers for Medicare & Medicaid Services finalized the policy in January, expediting the time between FDA approval and CMS coverage. After delaying the go-live date to Dec. 15, the Biden Administration announced plans to repeal the Medicare Coverage of Innovative Technology proposal in September, citing negative feedback.
Now, the Medical Imaging & Technology Alliance says it's “disappointed” in the decision and urged CMS to quickly issue a new proposal. If not, advances in imaging artificial intelligence and other technologies may deteriorate.
“The pathway from regulatory authorization to Medicare beneficiary access must keep pace with innovation, which is expected to accelerate,” MITA Executive Director Patrick Hope said in comments submitted Oct. 15 to CMS Administrator Chiquita Brooks-LaSure. “Otherwise, novel technologies will languish in bureaucratic review, create unnecessary barriers to Medicare beneficiary access and stifle innovation.”
MITA heralded the MCIT rule earlier this year, calling it a “major regulatory win,” but quickly admonished regulators’ decision to postpone it in May. AdvaMed (the Advanced Medical Technology Association) leadership followed a similar trajectory, recently expressing frustration with the lack of progress.
“We urge CMS not to repeal the MCIT final rule and instead work with us and our members to achieve our mutually shared goal of timely access of new innovations in healthcare diagnosis and treatment to patients,” Executive Director Andrew C. Fish said in comments submitted Oct. 15.
At the same time, the American College of Radiology has raised concerns regarding the policy’s lack of transparency, among other issues. Insurance groups have also been among those seeking changes to MCIT.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.