- The Washington Times - Tuesday, July 29, 2003

Advances in lifesaving medical technology are occurring every day, yet seniors are being denied access to new FDA-approved treatments because Medicare does not cover these technologies.

A glaring example involves a breakthrough in the prevention of sudden cardiac death (SCD). A major four-year clinical trial demonstrated that implantable cardiac defibrillators can reduce SCD by one-third. Private insurers quickly recognized the benefits of this technology and provided their patients broad access to it. However, it took Medicare a year after FDA approval to make a decision to offer this treatment to only about 30 percent of its eligible patients at risk for SCD.

Imagine that a small company invented a spectacular technology that would make computers 10 times faster, and customers were clamoring for it. You’d be furious if government red tape kept that invention and its benefits off the market for five years.

For Medicare patients, that’s reality. The lifesaving benefits of revolutionary advances in medical technology are routinely denied to our seniors, thanks to unaccountable delays at Medicare.

If there were no other compelling reason to enact broad Medicare reform, this would be enough: Today’s outdated policies turn seniors into second-class citizens when it comes to the benefits of medical technology available to privately insured Americans. These same bureaucratic policies cost taxpayers billions to pay for treatments that could be avoided with new technology.

Thanks to increased research spending, medical technology breakthroughs are making a major difference in our nation’s health. For example, early diagnosis of breast cancer through advanced imaging technologies is enabling treatment at one-third the cost and four to five times the previous level of success. Minimally invasive surgeries are enabling patients to return to productive life in a fraction of the time, and with far fewer complications, meaning seniors can be more independent.

Yet, it currently takes the Centers for Medicare and Medicaid Services (CMS), the agency that runs Medicare, a minimum of 15 months, and in some cases more than five years, to cover and correctly reimburse new, FDA-approved medical technologies. In an era of early disease detection, Medicare still requires an act of Congress to approve a new screening test.

The impact on patients has been alarming:

Medicare’s failure to cover the routine patient care costs associated with clinical trials of breakthrough technologies has slowed the development of left-ventricular assist devices to keep patients alive by helping to pump blood through the body when the heart is too weak to do it alone. Unlike most drug trials, routine patient care costs for many medical technology trials are not covered if they are provided in the course of a clinical trial involving a technology or medical procedure. This makes it difficult or impossible for small companies to start clinical trials of tomorrow’s breakthroughs.

Up to 45,000 Medicare patients are potentially being denied the benefits of a breakthrough spinal fusion procedure, which obviates the need for two procedures — one to harvest small pieces of bone from a patient’s hip and a second to place that bone between two vertebrae to fill space between them. Due to in-patient reimbursement levels based on yesterday’s technology, only 2 to 5 percent of eligible Medicare patients actually receive this new life-improving and cost-saving treatment.

All the while, Americans with private insurance enjoy timely access to these technologies and more.

President Bush states that Medicare’s goal is “to give seniors the best, most innovative care,” and called for “seniors and doctors — not government bureaucrats — to be in charge of the important health care decisions.” To achieve this, we need 21st-century public policy to keep pace with 21st-century medical breakthroughs. Leaders on both sides of the aisle have realized this fact, and included many provisions in both the House and Senate Medicare prescription drug and modernization bills to reform the way Medicare covers and pays for new medical technologies. Like all other aspects of this bill’ however, these reforms must survive the conference process.

The Medicare conferees must be aware that the government-run health program cannot be truly modernized without addressing the issues of patient access to medical technology.

Even the best-run Medicare program, however, will ultimately not be able to keep up with the increasingly rapid changes in medicine. Only a Medicare program based on patient choice and competition can achieve financial stability and improve access to high-quality care.

So long as Medicare policy remains mired in the past and the bureaucracy resistant to change, however, America’s seniors will only be able to watch helplessly as innovation passes them by.

Pamela G. Bailey is president of the trade association AdvaMed.

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