Medical device manufacturers have reached an agreement in principle with the Food and Drug Administration to improve upon the fee structure and ensure efficient FDA review of new technologies under the Medical Device User Fee and Modernization Act, which is up for reauthorization this fall, Stephen Ubl, president and chief executive officer of the Advanced Medical Technology Association, told reporters today.
Ubl said the agreement would significantly reduce review times, while ensuring safety and efficacy, and would provide a user fee structure that would offer more
predictability in the year-to-year increases in these fees. In addition, the industry
wants to work with the FDA to identify ways to refine post-market monitoring and
product performance communications, he said.
The speculation is that lawmakers may combine the device act and the Prescription Drug User Fee Act into a single reauthorization bill, Ubl said. AdvaMed, which represents 90% of the medical device industry, will also be pushing Congress to reintroduce a bill this year that would improve reimbursement for clinical laboratory services, and secure appropriate reimbursement for remote patient-monitoring systems.
Ubl said the group would be tracking the CMS upcoming changes to the hospital
inpatient payment system this year, and plans to work with Congress and the
administration to shape pay-for-performance, gain-sharing and physician efficiency
standards. -- by Jennifer Lubell