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Mark E. Brager
February 2, 2015

Study Highlights Tightening Medicare Coverage Requirements for New MedTech

Positive NCD 20 Times Less Likely Now vs. 10 years Ago

WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today on the release of a study in the latest issue of Health Affairs demonstrating Medicare’s rising evidence requirements for new medical technology national coverage determinations:

“The new study by Chambers, et al., ‘Medicare is Scrutinizing Evidence More Tightly for National Coverage Determinations,’ adds to the growing body of evidence that rising evidence requirements for coverage are an increasing obstacle to patient access to new medical technologies.

“The study demonstrates that CMS’s coverage of medical interventions through national coverage determinations since 1999 has become more restrictive. Chambers, et al., found that medical interventions in the most recent time period analyzed were 20 times less likely to receive a positive national coverage determination compared to 10 years ago.

“We recognize CMS has the responsibility to determine whether technologies meet Medicare’s legal standard of being “necessary and appropriate.” But the openness of Medicare’s payment system to adopting new technologies has historically been a major strength of the U.S. health system, leading to improved patient care. The Chambers study suggests that the standard for coverage has shifted too far in the other direction.

“The trend toward more restrictive NCDs raises concerns regarding patient access to new technologies and the challenges companies face in bringing new innovations to market. Start-ups in particular report that one of the first questions potential investors now ask is about the prospects for coverage and payment, while previously the focus was almost exclusively on FDA. Today’s and tomorrow’s senior citizens deserve the best that medicine can offer, and they also deserve to benefit from access to new treatments and cures that only a strong innovation ecosystem can provide.

“The Chambers study dovetails with another recent study that demonstrated private insurers are also increasingly restricting access to clinically appropriate technologies.

“In that analysis, over half of respondents indicated they have become more selective in approving new technologies over the past three years, and more than 40 percent of respondents believe that in the next three years the evidence requirements for approval of a new technology will be higher still.

“We agree with the conclusions of the Chambers study that policy makers need to consider the impact to patients’ access to medical technologies and other interventions when crafting CMS’s coverage policy, and we look forward to working with all stakeholders on this important policy issue.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.