Should we be making it easier for companies to bring new tests to market, rather than having a process that is so complicated and expensive that they give up? Have we set up a system so complex that we’re inadvertently stifling diagnostic innovations and possibly endangering the health of our nation?
…
Roadblock 1: FDA clearance and payer coverage
[Developers] of diagnostic innovations must demonstrate to both the Centers for Medicare and Medicaid Services and commercial payers, which independently make coverage decisions, that the test or technology meets validity and utility requirements.…
Roadblock 2: clinical adoption and value
[CMS] and most payers require at least two clinical validation studies, which test whether the diagnostic tool matches its intent, and two clinical utility studies, which measure whether the diagnostic supports clinical decision-making and improves outcomes.…
Roadblock 3: international barriers
The U.S. isn’t the only source of clinical innovation. Diagnostic tests and technologies are being developed around the world. Bringing them to market in the U.S. requires overcoming additional obstacles.
…
I worry that the U.S. has set up a system for clearing new diagnostic tools that is so complex that we’re potentially missing out on innovative new approaches, thus preventing the possibility of giving patients the timely, necessary treatments they need.
Read full, original post: Diagnostic innovations are slowed by bureaucratic roadblocks
