The Advanced Medical Technology Association (AdvaMed) on February 10th released a comprehensive set of policy proposals designed to renew the innovation ecosystem for medical technologies and diagnostics.
"[T]he innovation ecosystem that supports medical technology is severely stressed, states AdvaMed. "The U.S. has historically been the world leader in medical technology, but our leadership is eroding. Venture capital investment, especially investment in the start-up firms that are the seed corn of the industry, has plummeted."
"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." (Fierce Medical Devices)
The Proposal lays out five strategies as part of this framework:
Improve the FDA's Regulatory process
- Meet and exceed the groundbreaking 2012 user fee agreement goals for such key objectives as reductions in total review times and more frequent and substantive interactions between FDA and product sponsors.
- Revitalize the “least burdensome standard” for regulatory review through enhanced reviewer training and encouraging the use of valid scientific evidence from such sources as registries, experience in foreign markets, and peer-reviewed journal articles, where appropriate, to support safety or effectiveness determinations.
- Encourage FDA to accept international consensus standards.
- Streamline the CLIA waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients.
- Allow the use of central Institutional Review Boards to facilitate the conduct of multicenter clinical trials.
- Reduce the review burden on FDA and companies by allowing companies to self-certify minor changes to devices if their quality system has been certified as capable of evaluating such changes.
- Improve the advisory committee process to reduce delays in product approvals and enhance the fairness and transparency of the process.
- Encourage the development of technologies for rare diseases and pediatric populations.
- Work with FDA to assure that post-market surveillance is effective and efficient; provides timely, reliable, and actionable data; minimizes unnecessary burdens on providers and industry; and is facilitated by smooth implementation of the Unique Device Identifier program.
Restructure CMS's Process and Payment Structure
- Establish automatic Medicare coverage of FDA-approved clinical trials rather than requiring a duplicative and potentially time-consuming separate Medicare approval process.
- Expand coverage of telehealth services, including remote monitoring, and of disposable, prevention and treatment technologies used in the home.
- Streamline Medicare’s process for granting temporary outpatient and physician payment codes to new technologies and prohibit Medicare contractors from arbitrarily denying payment for these technologies.
- Require state Medicaid programs to take patient views into account in making coverage decisions.
- Increase the transparency and fairness of the local coverage determination process.
- Improve the new technology add-on payment program to capture a larger share of important new technologies and set payments more appropriately.
- Establish payment levels more promptly for new technologies used in the inpatient setting, using the best available data.
- Improve the methodology for establishing payment for technologies used in the outpatient setting and for updating payments to ambulatory surgical centers.
- Implement ICD-10 this fiscal year.
Reform the U.S. tax system
- Repeal the medical device excise tax.
- In the context of comprehensive tax reform, create a level competitive playing field for made-in-America medical technology:
**Enact new tax incentives to invest in start-up companies creating new treatments and diagnostics;
**Lower the overall corporate tax rate;
**Provide incentives comparable to those of other countries for development and manufacturing of technology; and
**Conform the treatment of international earnings to that of competitor nations.
Improve access to international markets
- Work with the U.S. government to encourage foreign governments to establish regulatory and payment systems for medical technology that are fair, transparent, nondiscriminatory and based on international best practices.
- Enact Trade Promotion Authority to negotiate the Trans-Pacific Partnership and the TransAtlantic Trade and Investment Partnership, and assure that those agreements include provisions that improve market access for medical technology.
- Enforce provisions of existing trade agreements such as the U.S.-Korea Free Trade Agreement to assure fair access for U.S. technology products.
Support the maintenance and growth of an R&D infrastructure second to none
- Provide steady growth in funding for the National Institutes of Health and the National Science Foundation.
- Improve the Small Business Innovation Research and Small Business Technology Transfer programs by raising the amount of funding (in the context of rising NIH and NSF funding), allowing larger individual grants to better recognize the costs actually incurred by start-up companies.
- More effectively tap the vast intellectual resources of our nation’s universities and academic health centers by providing federal technical assistance to establish and diffuse technology transfer best practices.
- Streamline Institutional Review Board activities to reduce barriers to initiating collection of clinical data on new treatments, particularly for multicenter trials, without sacrificing protection of human subjects.