The Advanced Medical Technology Association (AdvaMed) released the following statement by Stephen J. Ubl, president and CEO, in response to the President’s FY 2015 budget proposal:
“We applaud the additional funding to support high-technology manufacturing jobs as outlined in the President’s FY 2015 budget proposal. We believe a strong innovation ecosystem is important to medical advancement and to continued economic growth.
“Repealing the medical device tax would support the bipartisan goal of helping companies large and small reinvest in R&D, hire or expand, and address our eroding global leadership in this arena.
“While we are still carefully reviewing the proposal, it appears FDA funding levels for the device center would decline slightly. This decline in funding underscores the need to permanently exempt industry paid user fees from the sequester.
“We have long maintained user fees paid by industry to FDA should not be treated the same way as taxpayer appropriated dollars. User fees are part of an agreement between industry, FDA and Congress under which industry agrees to supplement FDA’s appropriated budget, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process. Restoring these user fee funds upholds that agreement and will help FDA provide the timely and predictable review that is so important to patients and to the device industry.
“We are deeply concerned that some of the policy proposals in the budget such as reductions in payments for clinical lab services, cuts to durable medical equipment in Medicaid and unprecedented prior authorization for advanced imaging under Medicare, will significantly harm patients’ access to life-saving, life-enhancing medical technology. Instead of a continuing series of cuts to the Clinical Lab Fee Schedule, we believe patients would be better served by implementing positive reforms that reflect the value of new diagnostics.
“The medical technology and diagnostics industry has already faced years of successive cuts and borne the medical device tax for more than a year. We fear the cumulative nature of these policy decisions and proposals would chill medical progress for future generations.”