Several healthcare insurers have reportedly decided to participate in a new-fangled federal government program intended to lessen the time duration between the actual coverage decision for the medical equipment and the FDA approval. Sources claim that the move has been initiated in a bid to fast-track the entire recovery process since the insurance claim process currently takes many years to be completed.
According to sources familiar with the development, Humana, CareFirst BlueCross BlueShield, BlueCross BlueShield Association, United Health Group, and Kaiser Permanente have made it to FDA’s list of healthcare insurance corporations taking part in the new program and joining the medical device producer pre-submission conferences.
According to trusted reports, healthcare technology evaluation establishments like the ECRI Institute, National Inst. for Health & Care Excellence, and Duke Evidence Synthesis Group are also some of the participants in the program.
Scott Gottlieb, Food and Drug Administration Commissioner, claimed that ten engagements have already been held amid HTA groups or private financiers and equipment vendors, inclusive of four pre-submission discussions.
The sole purpose of conducting these discussions is to simplify communication between device manufacturers and coverage payers, in a bid to expedite the review process of the regulatory body, Gottlieb added.
According to the FDA Commissioner, the advantage of the novel program for financiers is that they can potentially learn about latest technologies that are beyond their present horizon and can propose what data & analyses could be helpful in assessment, eventually developing insights and improved understanding of the Food and Drug Administration review process.
According to Gottlieb, the Food and Drug Administration entrusts that early engagement with equipment manufacturers and healthcare insurers during the planning stage of medical equipment clinical trials would certainly speed up patient access to safe, superior quality, and effective healthcare devices.
By streamlining the entire process, FDA’s goal is to enhance coordination between stakeholders so that approved products can be accessed without any unnecessary delay, cite credible sources.
