INDUSTRY ASSOCIATIONS
In the heavily regulated realm of medical devices, manufacturers often rely on trade and professional associations to advocate for the interests of medical technology. The actions and advice of these organizations help to shape the future of the industry for all its players. For this article, MX invited representatives from leading industry organizations—including regional, national, and international entities—to weigh in on key regulatory and legislative areas that are currently in varying stages of development. The final shapes of these and other policy areas promise to have significant implications for firms operating in the medical device field.
AdvaMed
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| AdvaMed's Ubl: Legislative challenges in the United States and abroad |
There are a number of important policy issues on the medical technology industry's radar for 2008. Reforming the nation's system for delivering and paying for healthcare is particularly important in the run-up to the presidential election. That's why AdvaMed (Washington, DC) recently unveiled its health reform plan, under which every American would be offered the opportunity—and given the responsibility—to obtain affordable health insurance.
AdvaMed's proposal pays for expanded healthcare coverage through a four-part strategy to reduce healthcare costs through disease prevention, quality-of-care improvements, efficiency gains in healthcare management, and measures to speed the pace of innovation. In addition to working with policymakers and opinion leaders, the association is meeting with presidential candidates and their staffs to ensure that Americans have access to medical technology at a price individuals and the nation can afford.
In order to improve the quality of care and reduce health-related costs over the long term, the healthcare industry must rein in the cost of disease—and not just focus on cuts in health spending. From a legislative standpoint, AdvaMed is pushing for appropriate Medicare reimbursement for physicians who utilize remote patient-monitoring systems to help manage disease. Remote monitoring of patients with chronic diseases has been shown to reduce hospital visits and overnight stays, but many new remote-management technologies have failed to diffuse rapidly because of inadequate reimbursement.
The industry is also working for legislation to prevent additional payment cuts for imaging procedures. In addition, AdvaMed is continuing efforts to reform Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests, which influence as much as 70% of all healthcare decisions despite accounting for less than 5% of hospital costs and less than 2% of all Medicare costs.
International Issues. AdvaMed is working with the medtech industry in many countries to improve market conditions for medical technology. In Japan, the health ministry is threatening new ways to reduce reimbursement rates as it looks to the next reimbursement cuts in 2010. The medtech industry must improve patient understanding of the benefits of medical technology in Japan to stem the erosion of prices and facilitate regulatory approval.
AdvaMed will continue to vigorously oppose China's proposed strict price controls as unfair, unworkable, and discriminatory. It will also work to ensure that the 100% inspection system proposed in 2007 remains unimplemented.
In Europe, the medtech industry faces policies designed to drive down prices without regard to quality and innovation. AdvaMed will seek the expansion of an innovation clause in Germany, a fast-track reimbursement approval in France, further decentralization of the United Kingdom's procurement process, and mitigation of Italy's central tendering system.
AdvaMed members also face new regulatory challenges in emerging markets. The association will press for the use of international standards as India develops its regulations in 2008, the end to submitting burdensome economic data in Brazil, and harmonized regulations in other countries through the Global Harmonization Task Force.
For further information on these issues, visit www.advamed.org.
—Stephen J. Ubl, president and CEO, AdvaMed
Alliance for a Stronger FDA
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| Grossman of the Alliance for a Strong FDA: A quest for resources |
FDA plays a central role as the gatekeeper for new medical technology. Everyone interested in advancing medical care has an interest in ensuring that FDA can function effectively, efficiently, and knowledgeably in this role.
But FDA is no longer able to keep up with the demands of the scientific, medical, and business communities. The reason is simple: FDA's responsibilities have grown exponentially, while the funding appropriated by Congress has not kept pace. As a result, FDA's ability to fulfill its gatekeeper and consumer protection mission is at risk.
A December 2007 report adopted by FDA's own science board—which is composed of outside scientists—noted that FDA resources have not kept pace with the agency's responsibilities. The report found that "this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic, and device regulatory system, and hence the safety of the public."
Even before that report, the FDA stakeholder community—patients, consumers, health professionals, voluntary health associations, companies, and trade groups—had come together to work for increased appropriations for FDA. The Alliance for a Stronger FDA (Silver Spring, MD) has nearly 200 members from every part of the stakeholder community. The organization has been successful in educating Congress and the media about the challenges posed by chronic underfunding of FDA.
Although the alliance's efforts have resulted in increased FDA funding, the agency's need is still far greater and ever more urgent. This year's battle over the fiscal year 2009 budget cycle is likely to be difficult, as the president and Congress seek to cut federal spending. However, the alliance is gaining important momentum toward its goal of adding several hundred million dollars per year to FDA's budget, and sustaining that effort for at least five years.
AdvaMed and the Medical Device Manufacturers Association, in addition to several device companies, are represented and active within the Alliance for a Stronger FDA. The organization encourages such active participation from as many manufacturers as possible. The more members that support the alliance, the stronger its arguments for more FDA funding will become.
For further information on this issue, visit www.strengthenfda.org or contact the Alliance for a Stronger FDA at sgrossman@strengthenfda.org or 301/879-9800.
—Steven Grossman, deputy executive director for government relations and communications, Alliance for a Stronger FDA
Association for the Advancement of Medical Instrumentation
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| AAMI's Miller: Advancing standards, encouraging innovation |
In the 40 years since its founding in 1967, the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, VA) has helped members develop and utilize national and international standards to enhance market and regulatory acceptance and understanding of medical devices. As AAMI looks to its future, many public policy initiatives are under way to continue this work.
Support and Advance Standards. AAMI will continue to work toward harmonization of an expanding base of international standards and regulations, as well as continue to write user practice guidelines. One goal for AAMI is to promote wide-ranging participation in the standards development process; medical device companies should take a seat at the table to participate in this crucial undertaking.
Assist Reimbursement for New Technologies. Gaining regulatory approval for a company's products is only the first step to marketplace acceptance. The Centers for Medicare and Medicaid Services (CMS; Baltimore) and other third-party payers control the purse strings that determine which innovative new technologies will be reimbursed and ultimately adopted. AAMI is evaluating whether it should play an expanded role in the process of gaining CMS reimbursement for new technologies.
Create New Information Platforms. The explosion in information technologies, networking, and data sharing has created new opportunities to aggregate data and use them to improve outcomes—for businesses and for healthcare. AAMI is currently evaluating new information platforms that would anonymously collect and aggregate data to be used for benchmarking and self-assessment.
For further information on these issues, visit www.aami.org or contact AAMI at 703/525-4890.
—Michael J. Miller, CEO, AAMI
Continua Health Alliance
Rising healthcare costs and budget deficits are driving demand for better ways to improve the efficiency and effectiveness of the U.S. healthcare system. The promise of health information technology to transform the way care is delivered is fostering an ever-increasing number of public- and private-sector initiatives, as well as federal legislation.
Technologies such as remote monitoring and telehealth can reduce the number of hospitalizations, emergency room visits, and doctor visits necessary to manage patient care by collecting, analyzing, and transmitting clinical health information to a healthcare practitioner. These technologies can also improve access to care for patients who have difficulty getting to a physician's office due to distance, mobility, or other reasons.
However, the lack of reimbursement for remote disease management services provided by a clinician serves as a barrier to widespread adoption of remote monitoring technologies. Legislation to provide remote monitoring coverage within the Medicare program has been supported in previous Congresses by members on both sides of the aisle, including Senators Jeff Bingaman (D–NM), Norm Coleman (R–MN), and Jay Rockefeller (D–WV), as well as Representatives Anna Eshoo (D–CA), Chip Pickering (R–MS), J. D. Hayworth (R–AZ), and John Tanner (D–TN). In the current Congress, a bill introduced by Senator Coleman in 2007 would provide remote monitoring coverage for five conditions: heart failure, arrhythmias, diabetes, sleep apnea, and epilepsy.
Bills in Congress to provide Medicare reimbursement for remote monitoring and telehealth services are supported by physicians, patient groups, and technology companies. However, fiscal constraints and pay-as-you-go rules—which require Congress to offset measures that would increase federal spending—will present a challenge for lawmakers in advancing broad remote monitoring legislation in the second session of the 110th Congress. Therefore, policymakers may consider an incremental approach that could provide reimbursement for remote monitoring for an initial set of high-cost conditions, such as heart failure. This particular condition affects 14% of Medicare beneficiaries but accounts for 43% of Medicare spending.
An incremental approach to coverage may also provide for a Medicare demonstration program to determine the benefit of using remote monitoring technologies to better manage other chronic conditions. Such legislation would serve as a foundation on which to build in the future.
Continua Health Alliance (Beaverton, OR) is a consortium of information technology (IT) companies, medical equipment manufacturers, and healthcare providers commited to developing a system of connected products and services to facilitate the delivery of healthcare services. It is closely tracking congressional developments related to remote monitoring and telehealth services. For further information, visit www.continuaalliance.org.
—Theresa Doyle, senior director for government affairs at Medtronic Inc., acting chairman of the U.S. government affairs workgroup for Continua Health Alliance
Eucomed
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| Eucomed's Wagner: Preserving framework, resisting reprocessing |
Eucomed (Brussels), the voice of the medical technology industry in Europe, directly and indirectly represents 4500 designers, manufacturers, and suppliers of medical technology. The following are key public policy issues being addressed by Eucomed in 2008.
Medical Devices Directives Transposition. The revised Medical Devices Directives (MDD), also known as 93/42/EEC, is currently in the process of transposition into national legislation in all European member states. The revised MDD framework continues to enable medical technology companies to deliver reliable, innovative solutions to the European markets for the well-being of patients.
Eucomed is working with the national medical technology associations in Europe to closely monitor the transposition in the 27 European member states. The associations' objective is to make sure that the transposition is smooth and fully in line with the new directive, which means, in particular, that no additional legislative requirements should be introduced in the process.
Reprocessing of Single-Use Devices. The reprocessing of medical devices intended for single use only is a common practice in some markets in Europe. These procedures put patients at risk and undermine the reputation of the medical device industry as a provider of innovative, safe, and reliable solutions for patients.
The European Commission is currently analyzing the issue of reprocessing and will come forward with legislative proposals in the near future. Eucomed is currently developing a publication that will provide a complete overview of this complex topic.
Medical devices designed for single use only cannot be reprocessed without altering the basic characteristics of the original product. Consequently, patients are not treated under the same benefit-risk ratio. Reprocessing companies do not take the responsibility for the reprocessed device; therefore, the responsibility, in the case of an accident, remains with the original manufacturer. This is in conflict with the general principles of the Medical Devices Directives. Eucomed is convinced that better understanding and awareness of the risks involved with reprocessing are needed among political stakeholders. Industry executives have an important role to play in that matter.
For further information on these issues, visit www.eucomed.org or e-mail maurice.wagner@eucomed.be.
—Maurice Wagner, director-general, Eucomed
European Diagnostic Manufacturers Association
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| EDMA's Howes: A critical time for IVD manufacturers around the world |
The European Diagnostic Manufacturers Association (EDMA; Brussels) represents national associations and major companies engaged in the research, development, manufacture, and distribution of in vitro diagnostics (IVDs) in Europe. Through its affiliated national associations, EDMA represents more than 500 companies (more than 700 legal entities) across Europe.
The IVD industry faces many regulatory issues in 2008. The information below focuses on key areas that offer both challenges and opportunities to the IVD industry and its European industry trade association.
IVD Directive Revision. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices (IVDMD) is the cornerstone of the regulatory framework for European manufacturers of IVD products. It introduced a regime for controlling the movement of IVDs onto the market that replaced the previous patchwork of control across the European Union. It enables a common acceptance of products in the European community.
The IVDMD is one of three directives that cover medical devices and is based on so-called new approach principles. There is a good level of satisfaction with how the current directive is operating, but a revision of the directive is imminent. Important discussions are already taking place at both global and European levels on the nature of the changes, notably a global model for an IVD classification and conformity assessment system. EDMA is already preparing for the debate and is well placed as a recognized stakeholder by EU institutions and as part of the Global Harmonization Task Force.
Working in a Global Context. The IVD industry works in a global marketplace; however, regulatory frameworks across the world do not reflect a common approach. Thus, it is a challenge for industry to influence and be informed about global regulatory issues in more than 190 countries (though, thankfully, not all countries have distinct systems). The work under the Global Harmonization Task Force is important to the future of the industry. Starting in the early 1990s, the task force has been working toward regulatory convergence using a voluntary partnership between regulators and industry. Tangible outcomes include documents that describe elements of a common regulatory framework. Cooperation activities between national, European, and international trade associations are crucial in developing synergistic activities, obtaining information, and coordinating positions on issues that go beyond national and European community boundaries.
For further information on these issues, visit www.edma-ivd.be or e-mail k.howes@edma-ivd.be.
—Karen Howes, director of regulatory affairs, EDMA
LifeScience Alley
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| LifeScience Alley's Gerhardt: Midwest progress for healthcare stakeholders |
LifeScience Alley (St. Louis Park, MN) is the trade association for Minnesota's life sciences industry. In 2008, its top issues include the following.
Economic Development. Minnesota has invested $500 million in bioscience research and will continue to dedicate significant resources to growing and maintaining its basic and applied research edge for medical devices, biotechnology, and pharmaceuticals. To continue growth in its life sciences cluster, the state is also making investments in resources needed to turn ideas into companies. Such investments include targeted tax incentives, support of the BioBusiness Alliance of Minnesota, and investing in the translational research efforts of the University of Minnesota and Mayo Clinic.
Healthcare Access. The best medical technology in the world is meaningless without adequate healthcare access. LifeScience Alley will monitor and provide input to the Legislative Commission on Health Care Access, Governor Tim Pawlenty's Health Care Transformation Task Force, and other groups that are working to develop better methods for the delivery and payment of care to ensure that the interests of its members are represented.
Medical Records Privacy. Medical data privacy laws in Minnesota should conform to the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). LifeScience Alley will continue to advocate for close conformity with federal HIPAA requirements to reduce the burden placed on medical researchers while respecting an individual's privacy.
For further information on these issues, visit www.lifesciencealley.org or contact LifeScience Alley at info@lifesciencealley.org or 952/746-3822.
—Don Gerhardt, president and CEO, LifeScience Alley
Massachusetts Medical Device Industry Council
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| MassMedic's Sommer: Opportunities and challenges in local legislation |
In 2008, the Massachusetts state legislature will deal with several issues affecting the nation's second-largest medical device cluster.
Governor Deval Patrick's life sciences initiative—a 10-year, $1 billion commitment to growing the industry in Massachusetts—will be reviewed by the legislature. Hearings were held this past fall, and final negotiations will likely lead to passage and enactment in early 2008. The initiative calls for a stem cell bank and RNA interference research center at the University of Massachusetts, as well as funding for research fellowships and company development activities through the Massachusetts Life Sciences Center. The Massachusetts Medical Device Industry Council (MassMedic; Boston) has been actively involved in the development and promotion of this initiative and strongly supports its passage.
The Massachusetts legislature will also continue work on a bill requiring manufacturers to seek alternatives to chemical substances used in all goods manufactured in the state. The Safer Alternatives to Toxic Chemicals Act (S 2406) would permit review of any chemical substance deemed harmful to consumers and mandate the use of alternatives. The medical device industry in Massachusetts is most concerned with restrictions on the use of di(2-ethylhexyl)phthalate (DEHP), a plasticizer found in many medical products. A panel of MassMedic companies appeared before the legislature's environment and natural resources committee in opposition to the legislation in June 2007. Further action is expected early in this year's session. MassMedic has a working group that has developed a position on DEHP restrictions and is monitoring this legislation. All members of the organization are encouraged to participate.
Also pending before the state legislature are bills related to reprocessed single-use devices, marketing of medical devices, and licensing of medtech sales representatives.
An Act Relative to a Patient's Right to Know of the Re-Use of a Certain Medical Device Manufactured for a Single Use (S 1338) would require patients to provide consent if reprocessed single-use devices are to be used in their surgical procedures. MassMedic has had a task force that has followed this issue and has actively lobbied for passage of S 1338.
A variety of bills now pending in the state legislature would restrict sales representatives' access to healthcare providers and require reporting of marketing expenditures by biotech, medical device, and pharmaceutical companies. An Act Requiring Licensure of Health Care Representatives and Gift Ban (S 1239) would establish the licensing of all sales representatives from biomedical companies, charging a $500 fee to be collected by the Massachusetts Department of Public Health. A similar licensing proposal had been unsuccessfully introduced in previous years as an amendment to the senate's version of the state's operating budget.
For further information on these issues, visit www.massmedic.com or contact MassMedic at info@massmedic.com or 617/414-1340.
—Thomas J. Sommer, president, MassMedic
Medical Device Manufacturers Association
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| MDMA's Leahey: Protecting innovation in entrepreneurial companies |
Looking ahead to 2008, the Medical Device Manufacturers Association (MDMA; Washington, DC) will focus on issues that will ensure that innovative, entrepreneurial companies have the ability to develop and market products that improve patient care. These include advocacy efforts to strengthen the patent system, improve FDA reviews of safe and effective products, establish timely and adequate reimbursement, and establish open market access.
Strengthening the Patent System. One of the keys to success for any medical technology company is having strong intellectual property. Unfortunately, Congress is currently considering a bill, the Patent Reform Act of 2007, that would significantly reduce a company's ability to establish and defend its IP. For example, the current bill makes it cheaper and easier to infringe by providing an unlimited window to challenge patents through a postgrant review process. The bill also includes language that would extract all prior art in damages calculations, dramatically reducing disincentives to infringe. Based on recent reports, Congress may take action as early as January this year. It is critical for device executives to contact their senators and representatives and voice their concern about the current bill. For more information, visit www.medicaldevices.org/public/issues/patent.asp.
FDAAA Implementation. With the passage of the FDA Amendments Act of 2007 (FDAAA), the device user fee program was reauthorized for five years. In addition to significant reductions in application fees—especially for companies with annual sales under $100 million—the bill establishes an interactive review process that is intended to help foster better communication between FDA and manufacturers. The bill also establishes the creation of a clinical trial registry and results database. Industry will continue to work with FDA, Congress, and the administration to ensure that the registry and results database is established in a manner that is beneficial to the public while not creating significant administrative burdens for smaller companies.
Reimbursement. In light of increasing budgetary pressures, MDMA will continue to promote the importance of timely and adequate reimbursement for medical technologies. Specifically, MDMA will work with CMS and Congress to address the issues of charge compression, comparative effectiveness, packaging and bundling of services, and gainsharing.
For further information on these issues, visit www.medicaldevices.org.
—Mark Leahey, executive director, MDMA
Medical Imaging & Technology Alliance
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| MITA's Whitman: Imaging technology faces risk of further cuts |
Imaging technologies such as magnetic resonance imaging (MRI), positron emission tomography (PET), computed tomography (CT), dual-energy x-ray absorptiometry (DXA), and ultrasound scans have radically transformed healthcare in America. Imaging is a less invasive, more comfortable, and more effective alternative to surgical procedures, with fewer complications.
Despite the tremendous benefits of imaging, the medical imaging sector faces the challenge of existing cuts and the threat of additional cuts to Medicare reimbursement for these services. The Medical Imaging & Technology Alliance (MITA; Arlington, VA), a division of the National Electrical Manufacturers Association, believes that ensuring that patients have uninterrupted access to high-quality imaging services must be a top priority for policymakers and healthcare providers.
The Deficit Reduction Act of 2005 (DRA), in effect since January 2007, reduced reimbursements for imaging by $13 billion. The healthcare community is only just now beginning to see the dangerous ramifications of these cuts, and yet Congress is looking to cut even more. As a result of DRA, funding for technological innovation has been cut. PET-CT exams used to diagnose cancer have been cut by more than 55%, and MRI scans that identify aneurysms have been cut by more than 40%.
As the impact of DRA continues to become more apparent, threats of more cuts loom. On August 1, 2007, the U.S. House of Representatives passed the Children's Health and Medicare Protection Act, which reauthorizes and expands the hotly contested State Children's Health Insurance Program (SCHIP). The bill includes severe additional cuts to imaging through reduced Medicare reimbursement for medical imaging services performed outside the hospital setting.
Fortunately, the final SCHIP bill did not include Medicare provisions or specific imaging cuts, but the medical imaging community is far from safe. These proposed Medicare cuts remain a core component in Medicare legislation in the U.S. House of Representatives. Also, the Senate is working on its own Medicare bill, which might also include cuts to physician payments related to imaging.
A major reason behind proposed cuts to imaging is concern over increased utilization, which some parties attribute to inappropriate use of these services. There may, in fact, be abuse within the system. If this is the case, MITA encourages lawmakers to enact measures to root out and prevent specific instances of fraud and abuse of the system. However, the primary reason for increased utilization is imaging's ability to improve quality of care and, ultimately, save lives. At the same time, medical imaging directly improves the economic well-being of the healthcare system through reduced disability, shorter hospital stays and recovery time, quicker returns to work, and cost savings through less-expensive and more-successful diagnostic testing.
Ultimately, the medical imaging community must continue to counter any legislation Congress proposes that seeks to use imaging cuts to pay for other federal programs. For further information on this issue, visit www.medicalimaging.org.
—Andrew Whitman, vice president, Medical Imaging & Technology Alliance
