Wednesday, February 24, 2016

FDA Invites Payers to the Party: Federal Register Notice

On February 24, 2016, the FDA published a two-page Federal Register notice inviting more commercial payers to participate in helping stakeholders understand the mix of regulatory and payer evidence required for coverage decisions.  The respondents could be payers, or third parties like health technology assessors.  The invitation is specifically from the devices division (not the biopharma divisions).  Details after the break.

The FDA's notice is online here.

The Food and Drug
Administration (FDA) is requesting
expressions of interest from
organizations that evaluate clinical
evidence used to support private payer
coverage decisions
for medical devices
(coverage organizations) that wish to
provide input to medical device
developers (sponsors) on clinical trial
design or other plans for gathering
clinical evidence needed to support
positive coverage decisions. These
coverage organizations include third party
commercial health insurance
organizations, payer/provider
organizations, health technology
assessment groups and various
organizations that evaluate clinical
evidence and make coverage
recommendations to and decisions for
private payers and health plans. The
Center for Devices and Radiological
Health (CDRH) is taking this step to
assist sponsors in identifying such
organizations and soliciting clinical trial
design or other evidence-gathering input

from them. 

If coverage organizations express
interest, FDA intends to provide a
for such organizations to
identify themselves so that medical
device sponsors who would like to
obtain coverage input
can voluntarily
contact them to participate in a FDA
Pre-Submission meeting. Early input
from payers regarding their evidentiary
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 medical devices. 

 Coverage at the regulatory website RAPS here, Gray Sheet here.

The Payer/Device Sponsor invitation can be seen in context of other efforts of the FDA to communicate clearly with stakeholders; for a recent guidance document on such communications, from the biopharma side of FDA, here.


It is often possible for companies to get discussion meetings with CMS central office coverage staff. (They advise direct meetings prior to submitting an NCD request.)

 At local MAC contractors, there is a published presubmission advisory review process under the Palmetto MolDX program, here.