The FDA's got an offer that it hopes private health insurers can't refuse because they won't want to refuse.
The federal agency wants health insurer representatives to sit in on medical device pre-submission meetings in order to speed up approval and ensure that the devices are worth covering. "Early input from payers regarding their evidentiary needs can streamline the process from FDA approval or clearance to payer coverage and improve public health by facilitating earlier access to innovative, safe, and effective devices," the FDA said. The notice was published Feb. 24.
The FDA is throwing out the welcome mat for payer organizations to provide input to medical device developers on clinical trial design or other plans for gathering clinical information "needed to support positive coverage decisions." As it stands now, the FDA says, "outcome endpoints needed by payers, such as comparison to other therapies and the associated costs of those therapies, are often not fully collected."
The FDA wants to publish a list of payer organizations that device makers can reach out to in order to ask them to sit in on pre-submission meetings. Payers who want to participate can send an email to Innovation@fda.hhs.gov. The subject line should read: "expression of interest in providing input regarding private payer coverage to medical device sponsors." The email should contain the organization's name, email, and mailing address.