CHICAGO – Blue Cross Blue Shield Association (BCBSA) today announced its participation in a Federal Drug Administration (FDA) initiative for private payers to advise medical device manufacturers when they design clinical studies. The effort aims to bring patients quicker access to innovative medical devices that are safe and effective.
The FDA’s Payer Communication Task Force (PCTF) is a voluntary program that allows device manufacturers to engage private payers during a FDA pre-submission meeting, so that clinical studies can be designed from the start to meet both regulatory and medical coverage requirements. Often times the data submitted by medical device manufacturers to demonstrate safety and effectiveness to the FDA may not include data needed by payers to make coverage determinations, according to the PCTF website. As a result, after FDA approval or clearance, there may be a delay in coverage, payment and use decisions that may ultimately delay patient access to medical devices.
"We welcome this opportunity to work with the FDA and the device industry to get better evidence faster to patients, clinicians and others who make health care decisions,” said Dr. Trent Haywood, senior vice president and chief medical officer for BCBSA.
Participation is voluntary for both medical device sponsors and private payers and will not change the evidentiary standards the FDA uses for decision-making. By facilitating communication between device manufacturers and payers, the FDA hopes to potentially shorten the time between regulatory approval or clearance and actual coverage decisions.
Participating organizations include third-party commercial health insurers, payer/provider organizations and health technology assessment groups affiliated with payers.
Since 1986, BCBSA has conducted a range of technology evaluation reviews backed by transparent and rigorous research methods and tools to inform and improve evidence-based decision making for patients, payers, providers and policymakers.
Medical device manufacturers interested in this program should visit the PCTF website, select which participant they would like to invite to their pre-submission meeting and send an email identifying these groups to CDRHPayerCommunications@fda.hhs.gov.