FDA announced last week that the lengthy delay that punctuates the initial approval of a medical product and it reaching the hands of consumers is to be addressed in a planned project in which the Agency will make joint approval decisions with the Medicare division of the Centers for Medicare and Medicaid Services (CMS). The move could potentially benefit the 45 million-strong elderly and disabled population covered by Medicare. But what is the flipside?
FDA aims to instigate a pilot project, due to begin after a public comment period, to explore an ‘overlapping’ decision-making and approval process with CMS — where the product sponsor and both agencies agree to a parallel review — designed to speed up a product’s journey from FDA marketing approval to CMS national coverage determination (NCD).
At present, the process can be frustratingly slow, as products undergo another review by Medicare officials for health insurance coverage purposes after winning FDA approval. In its September 16 notice, FDA conceded that a “positive coverage decision after a long time lag following FDA approval or clearance can delay consumer access to new medical products.”
The planned move could have some far-reaching implications. Reuters highlighted that the process could affect people not on Medicare, as Medicare’s coverage decisions often influence private insurers’ own reimbursement policies. Ultimately, “a decision by Medicare to cover a new product can speed its adoption in the wider marketplace”.
But concerns were voiced by Edward Berger, of Larchmont Strategic Advisors, in a blog post for MassDevice News. Berger raised doubts about the project’s potential for synchronicity, and warned that it could herald the widely feared arrival of health economics to the regulatory approval process, a state of affairs well known in Europe.
“The intrusion of cost-benefit considerations into the regulatory approval equation has for some time defined industry’s worst nightmare and the fear… is that free communication between FDA and CMS would open the door to using cost as a market approval consideration,” said Berger. He added that existing examples of Medicare coverage and payment determinations that “were essentially simultaneous with FDA market clearance” (such as drug-eluting stents), have established that the “vast majority of new technologies and drugs have not benefited from the compressed timeline to coverage that is the attraction of a parallel review process.”
Public comments on the FDA/CMS proposal can be submitted at regulations.gov until December 16.