Speedy Medicare breakthrough device coverage plan slated for March

Dive Brief:

CMS is planning to modify the Medicare coverage process to get breakthrough technologies to patients faster. Details of the proposed rule, slated for release in March 2019, are included in the fall rulemaking schedule released by HHS.
The news follows AdvaMed's disclosure that it is working with the Trump administration to cut the lag between FDA approval and Medicare coverage.
Details are scarce at this stage, but HHS' fall rulemaking agenda includes a proposed rule that "modifies the Medicare coverage process to streamline coverage of breakthrough technologies that have the potential to improve patient health outcomes and quality of care." The description echoes the model outlined by AdvaMed last month.

Dive Insight:

The time between approval and reimbursement is a long-standing concern for the medical device industry. Companies can successfully navigate the FDA process only to run into a second set of barriers that delay widespread use of their devices.

As reported by MedTech Dive last month, trade group AdvaMed wants CMS to take steps to limit the delay between approval and reimbursement. The hope is that the agency will revise its Medicare process so that products with breakthrough device designations from FDA are covered upon their approval.

Now, there is evidence that AdvaMed's wish to see CMS take action by the end of the year may be coming, albeit with a delay of a few months.

While the changes will only directly affect Medicare coverage, the influence of CMS decisions means their impact may be felt in the private sector. Medicare decisions guide the actions of many private payers and a fast-tracking

of reimbursement of breakthrough devices by CMS could accelerate uptake across the board.

HHS released details of the proposed Medicare changes on a list of planned activities that features multiple documents relevant to the medical device industry. FDA is responsible for most of the planned publications.

Documents in preparation at FDA include a text intended to make the De Novo pathway more transparent and predictable, and another that will harmonize and update medical device quality system regulations. FDA is also working to amend medical device software regulations.

The history of the rulemaking on the De Novo pathway, quality systems and software regulations shows the timing of the changes is uncertain. Each of those documents were featured on the list HHS released six months ago.