Rebuilding MCIT

In the months that have gone by since the CMS repealed the Medicare Coverage of Innovative Technology program, stakeholders have not sat still. There have been a number of efforts from within the medtech community to lobby the government to restore the program or else pass new legislation that codifies the important elements of the original rule, which promised vendors who received breakthrough device designation four years of Medicare coverage upon FDA approval.

One noteworthy effort to restore MCIT came from a team of academics at Stanford University and the Stanford Byers Center for Biodesign. Josh Makower, director and co-founder of the Byers Center and professor of bioengineering and medicine at Stanford, played a major role in assembling the team, which included Sandra Waugh Ruggles, Juliana Perl, and Zachary Sexton from the Byers Center, plus Kevin Schulman, a professor at Stanford’s medical and business schools.

While other critics of CMS’ decision have sought to refute the reasons that the agency gave for the repeal, the Stanford group sought to help devise an amended program that addresses the agency’s objections. The group conducted a survey of healthcare innovators and investors to assess the need for the program and they published their results on-line in the journal Health Management Policy & Innovation. “A well-designed MCIT program that enables both coverage and continuing evidence collection could greatly accelerate patient access to important health advances and encourage invention and investment in areas of critically important unmet clinical needs,” the authors argue.

Among the findings of the survey of 381 medtech manufacturers and investors was that on average, it takes vendors 2.6 years to obtain coding for their new therapy, 3.3 years to establish Medicare payment, 3.6 years to obtain local coverage, and 4.7 years for nationwide coverage. The survey also found that 87 percent of respondents indicated that they normally collect additional clinical data or real-world evidence post approval. This would lend support for a provision in a modified MCIT program that requires post-market surveillance, something that CMS decried was absent from the original rule. Among the investor responders, 84 percent reported that they would increase their investment levels if a new MCI program were to be available.

The HMPI publication also lent support for a revision that allows CMS to withdraw coverage as a result of a safety issue, again an important issue in the agency’s critique of the original rule. And to address another complaint, the authors argued that it seems reasonable that the modified MCIT include real-world evidence collection in at least a subset of the Medicare population post-approval.

We applaud this effort and hope that it registers with CMS.

James Cavuoto
Editor and Publisher