Medical Technology for the Future: Ensuring Patient Access to Innovation

Medical Device & Diagnostic Industry Magazine
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An MD&DI November 1999 Column

HIMA's current chairman reviews recent initiatives in regulation and reimbursement and discusses the importance of product development and patient access to new devices.

All of us in the medical device industry have an enormous stake in ensuring patient access to inno-vative medical technology in a de-manding, cost-conscious healthcare environment that is often unfriendly—or even downright hostile—to new ideas and inventions. Patient access to new medical technology is the cornerstone of our industry's marketplace. The key question for the device industry and for HIMA is, What can we do to ensure that the industry's latest and best technology is available to all who need it?

LETTING THE MARKET DEFINE VALUE

First and foremost, medical technology starts with investment in product development. I believe that HIMA and the industry can strongly impact—and perhaps greatly increase—the availability of investment dollars by promoting a reimbursement system based on customer-determined product value. Because investment in product development is the first step in patient access to medical technology, the process that determines the "value" of innovation is incredibly important. We in the industry are willing to stand or fall, to succeed or fail according to the conclusions of a consumer-driven, market-based decision process. Healthcare policymakers must allow the marketplace to make decisions about value, and the industry must be allowed to develop new products for the marketplace.

To help smooth the development of new products, HIMA has worked with FDA to secure an increasingly efficient approval process, and the FDA Modernization Act of 1997 (FDAMA) represents a giant stride in the direction we want to go—without sacrificing patient safety. The act requires a least-burdensome approach for product approvals. This is important, because an appropriate interpretation of "least burdensome" can significantly affect clinical development times. FDAMA also encourages the use of international standards and mandates the establishment of a dispute-resolution procedure. Throughout this past year, HIMA has devoted substantial attention to FDAMA implementation, and it's easy to see why we needed to do that. The way in which this landmark law is put into practice—encompassing as it does new FDA policies and procedures—is vital to our future and to securing the delivery of new technologies to patients more quickly.

When fully implemented, we can expect FDAMA (along with the agency's own internal reengineering efforts) to increase FDA efficiency. In addition to these gains, we can look forward to a reduction in regulatory redundancy and costs for both the industry and the agency as a result of the mutual recognition agreement (MRA), negotiated between the United States and the European Union (EU), with input from HIMA and the industry, in 1997. The MRA, which was formally signed in May 1998, is expected to be fully implemented by December 2001, by which time FDA plans to "normally endorse" inspections and reviews by EU third-party bodies.

CHANGING THE REIMBURSEMENT PROCESS

In order for patients to have access to innovative medical technology, we need to know if, when, and at what level reimbursement will be provided for new products and therapies. Again, we in industry believe that reimbursement decisions should be customer-driven and market-based. However, not every healthcare policymaker supports this concept. In this regard, our work is cut out for us. We must inform, educate, and persuade.

Our efforts in the reimbursement area already extend to the Health Care Financing Administration (HCFA), where we are encouraging a number of substantive changes to Medicare processes and policies. We have welcomed President Clinton's Medicare plan to improve patient access to new procedures and prescription drugs. But we have also expressed concern that the Clinton plan means robbing Peter to pay Paul by helping fund the drug benefit through a new round of provider payment cuts—cuts that could undermine patient access to medical technologies. Ideally, there should be a holistic approach to HCFA's coverage, coding, and payment decisions. HCFA's decision-making processes for new technologies should be transparent to all concerned, and we believe that the developer of the technology under consideration should be included in the process.

The need for change in this domain goes far beyond HCFA. The governments in Japan, France, and Germany are each working through complex healthcare system challenges. These governments clearly need our help in seeing new medical technologies as solutions rather than as cost drivers.

As we make the case for medical technology with policymakers, it is vital to recognize that there is political strength in numbers. We must not forget that, to a large degree, the general public supports our industry and our primary message—that patients should have access to new medical technology.

PUBLIC PERCEPTIONS OF MEDICAL TECHNOLOGY

Let me back up this last assertion with some numbers. In recent research into public perceptions of medical technology, HIMA found that 90% of those surveyed have a favorable impression of the device industry. Moreover, 98% believe that technology saves and improves lives. Between 60 and 65% of respondents say they oppose federal price controls, while 80% believe that price controls could lead to less R&D for medical technology. Any slowdown in innovation is opposed by 80% of those surveyed, and 89% want access to the latest technology when they get sick. Finally, 83% disagree with any plan to control costs by limiting technology, and 94% agree that insurers should pay for a product if FDA approves it.

These public perceptions are critical considerations as we chart our industry's path into the 21st century. We have a great story, and when it is told, patients and consumers are incredibly responsive. We must capture in words and quantify in numbers the benefits to patient outcomes that derive from new technologies. We must make the case that, in those situations when technology does contribute to an increase in expenditures, the investment is more than offset by gains for patients of longer, more productive lives. These are important points, and our responsibility is to ensure that they are never missing from future healthcare policy debates.

One final point must be kept in mind. Whatever health policy challenges the future brings us—as the pace of technological advance becomes ever more rapid and demanding—we must always look to what is best for patients and their doctors. In any future policy debate, this should be the ultimate standard and the deciding factor.

Ronald W. Dollens is president and CEO of Guidant Corp. (Indianapolis) and current chairman of the board of the Health Industry Manufacturers Association (HIMA).

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