Give Innovative Medtech and Patients a Future with MCIT

Breakthrough technologies have the potential to turn our healthcare hopes into medical miracles: A next-generation gene sequencing test to detect advanced cancer, a wearable artificial kidney, and an eye scanner that can diagnose Alzheimer’s disease are all real innovations in the regulatory pipeline. Unfortunately, that’s no guarantee that they’ll reach patients. The current coverage and reimbursement landscape is standing in their way.

Right now, breakthrough technologies – those that treat life-threatening or irreversibly debilitating conditions or conditions for which there are no alternative treatment options – are expedited through the Food and Drug Administration for speedy approval and access. However, since there is no equivalent expeditated process at the Centers for Medicare and Medicaid Services (CMS), these technologies can wait years payment and coverage under Medicare.

“The mere introduction of MCIT has already moved the needle in the right direction.”

That means doctors won’t prescribe breakthrough technologies, because patients can’t afford them. Patients continue to suffer, while the breakthrough technologies that could help them stay on the shelf. It’s a dangerous cycle with deadly consequences – first and foremost for patients, but also for the innovative medical technology companies that work on their behalf. Without evidence of patient impact or market viability, investors and other financial stakeholders decline to support development of these technologies. In fact, a recently conducted NVCA survey revealed that more than 75% of respondents were less willing or not willing to invest in novel medical technologies that need to establish coverage following FDA approval.

That’s a serious problem, but there’s a simple solution: Last year, CMS proposed a new Medicare coverage pathway for breakthrough technologies called Medicare Coverage of Innovative Technology (MCIT). Via the MCIT pathway, FDA-designated and approved breakthrough technologies, which are approved for program participation, would be covered by Medicare for up to four years. The automatic coverage provided through the MCIT program would allow for the continued collection of evidence to prove these products benefit to Medicare patients specifically.

The mere introduction of MCIT has already moved the needle in the right direction. One AdvaMed Accel company, Renalytix, explained that the news on MCIT was a major determining factor in expanding their team from 8 employees to 47 employees – and that they plan to grow to 120 employees if MCIT is finalized. Justin Klein and Kirk Nielsen, a team of medical technology investors, shared that, thanks to MCIT’s potential, they’ve been proactively considering breakthrough products as part of their assessment of new opportunities. Since then, they’ve made commitments to three companies with breakthrough-designated products.

It’s critical that we leverage this momentum – and yet we’re on the verge of losing it. The Biden Administration has delayed the implementation of the MCIT pathway for 60 days while it seeks public comment. AdvaMed has submitted comments, and we’ve encouraged other associations and businesses to do the same. Now, we’re calling on everyone else. Urge President Biden to implement MCIT fully, as well as strengthen and improve it. The innovative businesses ushering in the future of health care – the gene sequencing tests, artificial kidneys, and eye scanners – may not have a future without it.