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Report: Unmet Need Can Trump Modest Data In Quest For Reimbursement

A higher level of evidence did not correlate well with subsequent payor reimbursement, according to a comparison of the coverage success for devices approved via HDE and PMA conducted by Avalere Health for the Pew Charitable Trusts. Perceptions of unmet need tended to serve a bigger factor for coverage, the report said.

Clinical need may be a bigger factor to securing reimbursement for a medical device than a preponderance of data, according to the conclusions of a recent analysis. A study commissioned by the Pew Charitable Trusts and conducted by Avalere Health found that more clinical evidence gathered before device approval does not correlate well with subsequent payor reimbursement. The findings, based on case-study analyses and interviews with insurers, were presented in a report released April 7.

“If you have a compelling enough clinical need that you are able to demonstrate utility for your device, then even...

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