AdvaMed: On the Cutting Edge of Advocacy

Originally Published MDDI August 2004

Industry Perspectives



Like MD&DI, AdvaMed has grown up with the industry. As the voice of the industry, the association fosters innovation and helps to ensure industry progress.

Pamela G. Bailey

When the first issue of MD&DI came out 25 years ago, AdvaMed (the Advanced Medical Technology Association) was already celebrating its fifth anniversary. Medical technology regulation was still in its infancy, and AdvaMed was just beginning to find its voice as the leading advocate for the industry and for patient access to state-of-the-art medical technology.

Back then, we were known as the Health Industry Manufacturers Association, HIMA for short. But more than our name has changed since MD&DI first rolled off the presses a quarter century ago. In that time, advances in medical technology have transformed healthcare in the United States (and the world) by allowing for earlier detection of diseases and offering more-effective and less-invasive treatment options. As a result of these innovations, mortality and disability rates are declining, patient recovery times are decreasing, and overall life expectancy is increasing.

As medical technology has progressed over the years, so too has AdvaMed. Our image as a low-key, 
behind-the-scenes supporter of a small, niche constituency is gone. AdvaMed has become a champion of a vital and dynamic industry, representing the diverse needs of large multinational corporations, small start-ups, and everything in between. Our core mission is to promote the benefits of medical technology while breaking down barriers to patient access worldwide.

FDA: An Evolving Relationship

AdvaMed's mission when it comes to the Food and Drug Administration (FDA) has remained consistent over the years, but how the industry has interacted with the agency has had its ups and downs.

One of AdvaMed's earliest goals was to ensure that the regulatory controls in the Medical Device Amendments of 1976 were implemented in a way that would not stifle the innovative spirit of medical technology entrepreneurs and, by extension, threaten patient access to their technologies.

From the beginning, AdvaMed has worked to ensure that all FDA medical technology programs—premarket and postmarket—are developed and implemented in a transparent and straightforward fashion. This activity remains at the core of AdvaMed's regulatory mission.

Equally important, AdvaMed's job at times has been to remind the agency that, unlike the pharmaceutical industry, the medical technology industry is incredibly diverse and requires a more-flexible regulatory approach. AdvaMed has been a leader in resisting any efforts by FDA to take one-size-fits-all approaches that do not account for the great variety in our sector in terms of company size, product type, and complexity. 

While there is always a certain degree of tension between regulators and the regulated, AdvaMed and FDA recognize and respect the role each one plays in ensuring that safe and effective medical technologies are made available to patients in a timely and efficient manner.

That is not to say there haven't been periods of stress between our two organizations. During the early 1990s, AdvaMed frequently confronted the agency on the need to address the skyrocketing review times for PMAs and 510(k)s, as well as the need to address the agency's inconsistent and inappropriate enforcement tactics. However, AdvaMed's relationship with FDA moved beyond those policy differences. Both parties worked together to include much-needed reforms of medical technology regulations in the FDA Modernization Act of 1997 (FDAMA).

Provisions in the law called for early and frequent dialogue between sponsors and reviewers during the premarket review process and required the agency to adopt a “least burdensome” approach to regulatory requirements. This law has fostered greater communications between FDA and manufacturers and has led to a more predictable and more consistent review process.

AdvaMed also backed codification of some FDA reengineering initiatives to streamline medical technology reviews. AdvaMed's relationship with the agency continues to evolve. The passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) marks the beginning of a new phase in our interactions with FDA. Now, more than ever, both parties are dependent upon each other for their growth and success. If the past decade is any indication, AdvaMed and FDA's relationship will change again as new and unforeseen issues confront our industry and the agency. Whatever the challenges, AdvaMed is committed to working with FDA to find creative solutions to achieve our mutual goal of ensuring timely patient access to the latest innovative medical technologies.

Medicare: Clearing the Path to Adequate Reimbursement

While FDA-related issues have always been a primary focus for AdvaMed and its members, we now pay an equal amount of attention to the area of Medicare coverage and payment.

This new focus is one of the most significant changes to affect AdvaMed's mission over the past decade. Just a few years ago, many medical technology firms saw Medicare reimbursement as a secondary concern at times—if they thought about it at all! Now, most companies recognize the importance of developing a reimbursement strategy in tandem with a regulatory strategy. Some venture capital firms are even advising medical technology start-ups to devise a Medicare payment plan before coming up with a business plan.

AdvaMed has been the leader in policy development and advocacy in this area. We have raised awareness within the Centers for Medicare and Medicaid Services (CMS; Baltimore) on how its decisions can have a dramatic effect on the utilization of new medical technologies and their availability to patients. 

AdvaMed was successful in securing reforms to the hospital outpatient prospective payment system in the Balanced Budget Refinement Act of 1999, which established transitional “pass-through” payments for medical technologies. The next year, AdvaMed fought for the creation of a transitional payment system for new technologies used in the inpatient hospital setting as part of the Benefits Improvement and Protection Act of 2000. We also successfully fought for enactment of a more effective appeals process for adverse coverage decisions.

However, our most significant achievement in this area is the inclusion of several key medical technology provisions in the landmark Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

MMA sets strict time frames for CMS to make coverage decisions. It also streamlines the process for obtaining appropriate payment rates for new technologies. New procedures are also in place for determining the basis and amount of payment for clinical diagnostic laboratory tests.
In addition, MMA requires creation of a new Council of Technology and Innovation at CMS which will serve as a focal point for coverage, coding, and payment issues for new medical technology. The council will afford industry unprecedented access and input into the Medicare process.

Politics: A Respected Player in Healthcare Policy

AdvaMed's ability to move key pieces of legislation such as MDUFMA and MMA speaks to our growing influence with lawmakers and our success in positioning the association as an important player in the healthcare policy realm.

Health staffers and policymakers on Capitol Hill recognize AdvaMed as the primary source for information on medical technology and its impact on larger healthcare issues, and that recognition allows our message to reach the highest levels of government. 

To further strengthen our advocacy efforts at the state and local levels, AdvaMed's new “grassroots initiative” provides representatives from member companies with educational materials and other tools to better communicate industry concerns with their local officials.

Global: Worldwide Advocates

As global demand grows for medical technology innovation, AdvaMed increasingly serves as a worldwide advocate for the industry. Our experience and expertise in dealing with FDA and CMS proves invaluable when dealing with foreign governments, some of whom may be only beginning to develop regulatory systems or reimbursement programs for medical technology.

In the European Union, Japan, China, and elsewhere, AdvaMed works to ensure that regulatory policies do not adversely, or unfairly, affect U.S. medical technology manufacturers, and that their products receive appropriate reimbursement.

AdvaMed's political prowess serves us internationally as well. We can garner the support of our congressional allies as well as government entities such as the U.S. Department of Commerce to promote our agenda abroad. As overseas demand for innovative medical technology expands, manufacturers need consistent and predictable rules to ensure that products get to market as efficiently as possible. Toward that end, AdvaMed has long been an active supporter of the Global Harmonization Task Force (GHTF).

The GHTF has made great strides in developing harmonized premarket, postmarket, and quality systems requirements for medical technology firms, which, in the very near future, could form the basis of a single global regulatory system. With only one set of regulatory requirements to fulfill, manufacturers would face fewer obstacles in providing their lifesaving and life-enhancing products to the patients who need them.

Conclusion: A Future of Challenges and Innovation

Over the past 25 years, MD&DI has chronicled the incredible change and growth in the medical technology industry. During that time, AdvaMed has been a tireless advocate for industry, encouraging policies that foster innovation, ensure patient access to medical technology, apply appropriate regulatory controls, and provide adequate payment for products.

AdvaMed can cite progress in achieving all these objectives, but much work still needs to be done to fulfill the promise of medical technology and ensure that patients receive the maximum benefit from the innovative products our members produce. Our industry is robust and dynamic, but unfair regulatory and reimbursement policies can have a chilling effect on innovation. AdvaMed's advocacy efforts always take into account the fact that two-thirds of our members are emerging growth companies with less than $30 million in U.S. sales per year.

As new issues develop that affect industry, AdvaMed will be at the forefront offering creative policy solutions. For example, in response to the recent upsurge in fraud and enforcement actions across the healthcare industry, AdvaMed updated its “Code of Ethics on Interactions with Health Care Professionals.” The code sets the guidelines for industry by providing relevant ethical behavior to members and their constituents, addressing the many ways in which industry partners with healthcare professionals to develop and use life-enhancing and lifesaving technology.

AdvaMed also is seeking to have an effect on the current debate on rising healthcare costs by focusing on the value provided by investment in medical technology. To further our argument that medical technology is the solution, not the problem, the association founded the Institute for Medical Technology Innovation. The institute, which will operate independently of AdvaMed, will examine the value of advances in medical technology and their contributions to the healthcare system and the economy.

Few could have predicted the stunning advances brought about by medical technology over the last 25 years. But that progress is about to be dwarfed by coming innovations which will revolutionize the way healthcare and treatment are delivered. Some of those advances might include:

•Increased miniaturization of medical devices will allow for more-targeted delivery of therapies.
•Advances in developing replacement organs and in tissue engineering will provide radical new options for addressing the most serious disease conditions.
•Increasingly sophisticated and accurate diagnostics will detect disease earlier, improving patient
outcomes and lowering treatment costs.
•Information technology advances will allow immediate processing and transmission of critical medical data, saving both patients and physicians time and speeding 
delivery of treatment.

Helping to realize the potential of those and other future medical technology breakthroughs has been AdvaMed's mission for 30 years, and we will continue to promote innovation as the answer to patients' healthcare needs. 

Copyright ©2004 Medical Device & Diagnostic Industry