DEVICE INDUSTRY LAYS OUT “INNOVATION AGENDA” (Orthopedics This Week)
AdvaMed, the medical device industry’s largest trade group, has unveiled an “Innovation Agenda” which it says will not cost a lot of tax dollars because the recommendations are mostly process reforms.
The set of policy proposals were released on February 10, 2015 and outline a series of regulatory, reimbursement, tax, international trade and R&D reforms which will help “speed patient access to the next generation of life-changing innovations,” according to the group.
The initiative includes specific recommendations under five policy pillars:
Improve FDA’s Regulatory Processes
- 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 Coverage and Payment Processes
- 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 and Repeal of the Medical Device Excise Tax
- 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.
- 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
- 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.
Who Will Pay?
Speeding up FDA reviews, increasing CMS coverage and payments, reforming the U.S. tax system, repealing the medical device tax and funding increases will certainly cost some money. Repealing the excise tax alone would cost $26 billion over the 2015-2024 period, according to Joint Committee on Taxation. But as AdvaMed leaders have told us in the past, it’s not their job to tell Congress where to cut funding to pay for policy initiatives which they believe strengthen U.S. medical device manufacturing.
AdvaMed has laid out an agenda. Policymakers will have to make financial choices.
“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, BD. “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.”