subject: Medicare and FDA Work Side-by-Side on New Pilot Project [print this page] Medicare and FDA Work Side-by-Side on New Pilot Project
Recent concerns about how long it takes to get products to consumers even after a company has won Food and Drug Administration (FDA) approval is finally being addressed. Under a new pilot program, FDA and the Centers for Medicare and Medicaid (CMS) would work in tandem to get new products approved.
"Once a new product has received FDA approval it still has to go through a second review by Medicare to determine coverage and payment issues," notes Alan Weinstock, insurance broker at www.MedicareSupplementPlans.com. "That long lag time means that products are delayed in reaching elderly and disabled Medicare beneficiaries."
New FDA Pilot Program May Change Process
The FDA indicated that "timely access to new medical technologies is a significant issue in the delivery of health care."
Under the proposal the FDA and CMS would review and make approval decisions concurrently. As it stands, the CMS does not begin its review until after the FDA approves a product. It is hoped that this new process would ensure speedier insurance coverage for new products.
Such an arrangement could have a significant impact on the introduction of new medical technology into the market and on people with non-Medicare insurance because health care providers are usually reluctant to use newly-approved products until they are sure Medicare will cover the costs and private insurers often follow Medicare's lead with regard to reimbursement for new technology.
There are still a lot of loose ends to work out, such as at what point during FDA premarket review for drugs, biologics, and medical devices a parallel Medicare review should begin and how the two agencies would handle medical companies' data and trade secrets.
Impact on Medical Manufacturing Companies
Before steps are taken to implement the pilot project for devices, public comments -- due in about three months -- will need to be reviewed.
In the meantime, the Advance Medical Technology Association (Advamed), representing device makers, indicated it was reviewing the plan and supported efforts to accelerate timely reviews. On the other hand, representatives for the Pharmaceutical Research and Manufacturers of America as well as the Biotechnology Industry Organization, both representing drug makers, had no immediate comment because they were still reviewing the proposal.
Still analysts agree that how this new process would affect medical companies is unclear and is likely to be met with "cautious optimism." It all depends on how the plan is structured and whether it is voluntary. A Medicare coverage decision often can make or break a drug, device or medical procedure. And whether this new collaboration would lead to speedier insurance coverage or higher sales is anyone's guess.
