AdvaMed Unveils Innovation Agenda

The Advanced Medical Technology Association (AdvaMed) has released a comprehensive set of policy proposals designed to renew the innovation ecosystem for medical technologies and diagnostics.

AdvaMed’s “Innovation Agenda”outlines a series of specific policy initiatives –regulatory, reimbursement, tax, international and research – which will help speed patient access to the next generation of life-changing innovations.

“Advanced medical technology can provide solutions to the challenges facing global health care systems – improving patient access to high quality, efficient care,” said AdvaMed Board Chairman Vincent A. Forlenza, Chairman, CEO and President, Becton Dickinson & Co. “Our industry is committed to the development of new diagnostics, treatments and cures that improve public health. Policies that promote a sustainable health innovation ecosystem are required in order to put these technologies in the hands of the public.”

“The medical technology sector has the potential to drive the new innovation economy, developing the next generation of cures and treatments and creating well-paying jobs – the types of middle-class jobs the president and Congress want,” said Stephen J. Ubl, President and CEO of AdvaMed. “Our Innovation Agenda lays out a clear framework to make that potential a reality. Implementation of the agenda will make regulatory and reimbursement procedures more efficient and transparent, speed patient access to breakthrough technologies, create a tax system that fosters innovation, and ensure fair access to world markets and continued investment in R&D.”

AdvaMed’s Innovation Agenda includes specific recommendations under five policy pillars:

• — Improving FDA’s regulatory processes so that the cost and time of development and approval of devices and diagnostics is reduced and the CDRH mission statement that American patients will be the first in the world to have access to new devices is achieved, while maintaining the highest standards of safety and efficacy.
• — Restructuring CMS’s coverage and payment processes to support development of new technologies that improve treatment, diagnosis, or prevention and provide prompt patient access to these technologies.
• — Reforming the U.S. tax system to promote innovation, starting with repeal of the medical device excise tax.
• — Improving access to international markets by insisting on free and fair trade in medical technology and working with foreign governments to achieve innovation-friendly regulatory and payment policies.
• — Supporting the maintenance and growth of an R&D infrastructure.
   

Of particular interest was a proposal to provide automatic Medicare coverage for FDA-approved medical device trials. Ubl said the current process followed by the federal Centers for Medicare & Medicaid for reimbursing those trials is unnecessary because the agency almost always decides to support them in the end.

Automatic coverage would bring medical device trials into parity with the payment systems for drug trials, AdvaMed said.

The proposal to provide Medicare coverage for device trials will be a part of the comprehensive 21st Century Cures initiative to overhaul the government’s regulation of the life science industry, Ubl said. Republicans in Congress hope to pass the bill by the end of the year.

The focus on reimbursement highlights the changing concerns of the industry. Under the tenure of FDA commissioner Margaret Hamburg (who’s leaving the post soon), the industry’s relationship with the FDA has improved, but tighter reimbursement and new payment models in the post-Obamacare world are squeezing medical device companies.

For example, Ubl complained that CMS often provides reimbursement for a narrower range of conditions than a devices FDA-approved indication for use.

In addition, Ubl said that in order to cut the gap between approval times of devices in the U.S. and Europe, which can be multiple years, more early-stage clinical trials must be conducted in the country.

The head of the FDA’s device arm (CRDH) Jeffrey Shuren has acknowledged that most device clinical trials are conducted abroad, and made changing that one of his priorities.

Many of AdvaMed’s legislative goals are staked to the passage of the 21st Century Cures initiative, including the development of a “breakthrough pathway” for faster approval of some medical devices. The legislative proposal builds on the FDA’s proposed Expedited Access Pathway, which is currently a draft guidance.

“We hope this framework will guide policymakers as we work toward our shared goal of advancing medical progress and spurring the innovation economy,” said Ubl. “We are committed to working with Congress, the administration and others to enact these policies.”