Dive Brief:

• The medical device industry is working closely with the Trump administration on a proposal that aims to speed up government reimbursement of new medical devices approved by FDA, senior AdvaMed officials told reporters at The MedTech Conference in Philadelphia.
• AdvaMed CEO Scott Whitaker said the idea is for CMS to take products FDA awarded a breakthrough device designation and have them be reimbursed by Medicare when approved. If needed, during a temporary period of time, device companies could continue to build evidence for their products, he said.
• The remarks come less than a week after Joe Grogan, associate director of health programs at the Office of Management and Budget, told reporters that the administration is looking at the time it takes CMS to cover medical devices.

Dive Insight:

Grogan emphasized that the Trump administration is keen on protecting the industry from a quickly maturing Chinese sector. It appears that CMS is receptive to AdvaMed’s idea to speed up reimbursement of new devices.

“Some of our policies for new technologies were created decades ago and need to be modernized to reflect new therapies and devices coming to market,” CMS spokesperson Johnathan Monroe told MedTech Dive in an email. “We are working on initiatives to promote access to the latest innovations and are open to a variety of approaches.”

Whitaker said that AdvaMed is pushing CMS to implement the idea by the end of the year, but it is unclear on CMS’ timeline for taking action.

"At least in our conversations with the administration, they have appeared to be open to that type of change," Whitaker said.

Many private payers currently make a coverage decision on a case-by-case basis, according to Don May, AdvaMed EVP of payment and healthcare delivery.

"All private payers go through a different process that they use, a lot of them will follow Medicare, which is why Medicare's decisions are so important," May told reporters.

Currently, FDA is exploring ways for private payers to communicate with medical device makers during pre-submission meetings. The agency recently announced that two of the largest insurers, UnitedHealth Group and CareFirst joined the pilot currently underway, which aims to facilitate a shorter period between FDA approval and coverage by private payers for new products coming to market. 

Grogan's comments suggested that Adam Boehler, deputy administrator and director of the Center for Medicare and Medicaid Innovation, may implement a demonstration project to examine how to balance speeding devices to Medicare patients with the cost implications while ensuring they are medically necessary.

"The pace of advancement of technology is so rapid that we need to make sure that our regulatory structures can keep up," Grogan said. "And it hasn't kept up in the device space. I think that CMS Administrator Seema Verma recognizes it, and we've worked with her team. They have some cool ideas, and hopefully we'll see some things happen over the next six months."