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Mark Brager
July 10, 2015

AdvaMed Commends House Passage of 21st Century Cures Act

WASHINGTON, D.C. - Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on House passage of the 21st Century Cures Act (H.R. 6):

“The 21st Century Cures Act represents an important and significant first step toward strengthening the American innovation ecosystem.

“America’s medical technology companies are central to the development of innovative devices and diagnostics that will provide the life-saving, life-enhancing treatments of the future. Patient access to advanced medical technology generates efficiencies and cost savings for the health care system and improves the quality of patient care. But the innovation ecosystem that supports the developments of these technologies is severely stressed. Policy improvements are essential if America is to retain its world leadership and the potential for medical progress is to be fulfilled.

“AdvaMed commends the passage of the 21st Century Cures Act. The bill includes a number of proposals designed to strengthen the innovation ecosystem and support the development of life-saving, life-enhancing medical technology. This includes key improvements to FDA’s premarket program for medical devices – most significantly the establishment of an expedited pathway for breakthrough, innovative technologies – which will increase the efficiency, predictability and transparency of the agency’s review process and improve patient access to the best in medical progress.

“The bill also provides resources to FDA to implement these important reforms and would exempt industry-paid user fees from the threat of sequestration. User fees are not taxpayer funds but rather voluntary fees paid by industry to ensure that FDA can conduct timely reviews.

“While we continue to support the policy reforms included in the underlying bill, the provision that would apply Medicare rates for durable medical equipment (DME) to Medicaid could be detrimental to the health and well-being of beneficiaries. AdvaMed has long maintained that the DME competitive bidding program has been advanced without rigorous evaluation and a clear understanding of its impact on beneficiaries’ access to the products that they and their physicians have determined are necessary for their conditions.

“In light of the need for better information and data on the impact of the competitive bidding program on beneficiary access to products their physicians prefer for their individual conditions and the impact on their health care outcomes, we do not believe this program should be expanded to cover Medicaid where low-income and disabled patients and families may also be vulnerable.

“We look forward to continuing to work with the House and Senate to address our concerns and to advance the positive reforms included in the 21st Century Cures Act. We also look forward to working with Congress to address the coding, coverage and payment challenges that are impacting patient access to new advances in science and medicine.”

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