Innovative healthcare technology is well accepted today, particularly in prosthetic rehabilitation. This is at least partly a result of the tremendous overall improvement in the state of the art in recent decades, which creates the expectation that every new idea will be substantially better than its predecessor.

At the same time, the most common cause of amputation in North America is poor circulation, with or without associated diseases such as diabetes, and the average age of the new amputee has been steadily increasing. Third parties such as Medicare and private insurers are understandably worried about the ubiquitous application of the "latest and greatest and most expensive" technology, fearing that prescriptions might be generated more by enthusiasm than any other factor.

Most clinicians make a concerted effort to keep up with new advances; however, some are very conservative and therefore reluctant to suggest newer approaches until they are well established clinically and have been reviewed in the literature. How can the amputee decide if a particular new component or socket design is "right" for them? How can you guarantee access to the most appropriate solutions for your particular situation?

Right to consideration

Obviously, some people are not candidates for many of the high-tech options available; however, I feel strongly that every amputee has the right to be "seriously considered" for the full range of treatment options.

There are no absolute contraindications to modern prosthetic components and methods. Each case must be individually considered. No one is "too old" or "too disabled" to be evaluated for today’s advanced-technology solutions.

If you are interested in a carbon fiber dynamic response foot with vertical shock absorption, your rehab team should consider providing it. Though there may be specific reasons why this would not be the best approach for you (i.e., your amputation level doesn’t allow sufficient room to physically install the component), you are entitled to a reasonable explanation, presented in terms you can understand and accept.

You might then ask about similar alternatives that might work for you. In this example, perhaps the lower-profile combination of differing components could be used to overcome the space limitations in your prosthesis. An experienced rehabilitation team will be familiar with literally dozens of options and will gladly explain the individual advantages and disadvantages of each to you.

Advantages of advanced-technology prostheses

Virtually every innovative prosthetic development is intended to overcome recognized limitations of earlier technology. Manufacturers don’t invest time and money developing advanced-technology solutions just because they are glitzy, but rather because they promise a better solution than less-sophisticated approaches. Effective low-cost solutions will quickly predominate in clinical practice and therefore generate a far higher return on investment for manufacturers than more-costly designs that are used infrequently. One of the major advantages of using high-tech components and designs is that they are usually lighter and more responsive than earlier solutions.

In addition, it’s exciting to participate in pushing the limits of rehabilitation forward. Some amputees and clinicians are eager to try new ideas and then enjoy sharing their experiences with interested colleagues and patients. Such "early adopters" play a very important role in rehabilitation because their work helps identify limitations that still need to be overcome, paving the way for more wide-spread adoption of a new concept or method.

Finally, even small improvements in overall function can be very significant when you are wearing the prosthetic device up to 20 continuous hours every day. Amputees are generally acutely aware of the limitations of their prostheses, and it is their constructive criticisms of existing solutions that continue to drive the direction of future developments.

Limitations of advanced-technology prostheses

One of the biggest drawbacks to cutting-edge applications is the learning curve required when you are among the first to explore a new concept. Prosthetists must often devote several hours to reading and understanding the manufacturer’s literature on new devices; in some cases, they must travel to a distant location or successfully complete training courses to learn about the product.

The amputee, too, is entering uncharted waters with new prosthetic technology and there may not be much guidance. Being comfortable with a "learn as you go" experience is essential for both prosthetists and amputees trying innovative solutions for the first time. If you don’t have the time or inclination for such an adventure, you will be happier with "tried and true" solutions.

The ability to tolerate frustration is even more crucial in the initial period following the release of a new product. Virtually every prosthetic innovation is carefully tested in the laboratory for durability and safety; however, there is no shortcut for the real-world experience of daily use by amputees. If you want to be the first on the block to have the latest doo-dad, rest assured that you will also likely be the first to discover its weaknesses.

If you are easily discouraged or so busy that any interruption in the function of your prosthesis will wreck your day, you are probably not a good candidate to try new ideas. Let someone else play that role, and take your clinic team’s advice to stick with components and designs that have been thoroughly debugged over several years of clinical application.

The upfront costs for advanced-technology solutions are generally higher than for designs that have been around for decades. This is partly because older materials tend to cost less. In addition, the development costs for older technologies have probably been amortized long ago, so the remaining costs are just for production and distribution.

As a general rule, there is no point in paying for more technology than you can reasonably expect to be able to use. If your heart condition and chronic shortness of breath limit your walking to a maximum of 15 or 20 steps, you will probably do best with a mechanically simple prosthesis that emphasizes light weight and solid stability. Even if you somehow wrangle a prosthesis more suitable for a Paralympic sprinter, you won’t walk any better or any farther.

Virtually all clinics and practitioners agree that the best practice is to recommend the least expensive alternative available that will fully meet your rehabilitation goals and abilities. Your prosthesis should never hold you back but there is really no point in obtaining technology that you cannot use effectively.

Many reimbursement authorities will encourage the use of rudimentary components in your first prosthesis, noting correctly that you can obtain more sophisticated solutions in subsequent limbs. It is false economy, however, to provide an inferior artificial limb first and then replace it later with the one you actually needed. This practice is even more questionable if you have one of those inadequate insurance policies that only covers "one artificial limb per lifetime" or has a ridiculously low coverage cap of a few hundred dollars per prosthesis. The most cost-effective approach is to start with a prosthesis that is designed to fully meet your needs, so you can literally "start out on the right foot."

The Medicare policy requiring that the provision of specific prosthetic alternatives be based on your "actual or potential functional ability" is a sound one. In the absence of any other documented mitigating factors, you should expect to gradually return to approximately the same level of activity you enjoyed before the amputation. If you previously walked every day for cardiac conditioning, this is likely still a plausible goal, and you should receive components that are suitable for this level of activity. If there is a reason this is not realistic in your particular situation, your rehabilitation team will be able to explain why in terms you can understand.

Common myths about advanced technology

Unfortunately, there are a number of myths about advanced technology that persist. The four most common feeble excuses given to deny legitimate access to modern prosthetic technology are:

• Advanced-technology prostheses are only suitable for athletes.
• Advanced-technology prostheses are cost-prohibitive.
• Advanced-technology prostheses are not covered by your policy.
• Advanced-technology prostheses are experimental and unproven.

Although each of these myths started from a grain of truth, none are valid reasons to deny prosthetic rehabilitation.

Myth 1: Advanced-technology prostheses are only suitable for athletes

It is true that many innovations are tested under high-performance conditions such as competitive sports. The stresses that athletes put on their prostheses help engineers and designers discover limitations in the products and strengthen the design. And these lessons are quickly applied to the entire product line, benefiting amputees who have no intention of ever jogging or running.

The development of automobile tires illustrates this well. Originally, only racing cars used tires made with an expensive new technology called "radial ply construction." Now, almost every passenger car and truck in America has radial tires, and the added cost is well accepted due to the proven advantages of this technology.

In prosthetic practice, too, yesterday’s innovation becomes today’s mainstream standard. Carbon fiber, dynamic-response feet are suitable for most amputees, and are now routinely provided as part of a "typical" prosthesis. Worldwide clinical experience has shown that even less-active individuals generally prefer more-responsive feet, and manufacturers have responded by developing lower-cost but technologically sophisticated products specifically optimized for the person who walks moderate distances and has no interest in competitive sports.

Myth 2: Advanced-technology prostheses are cost-prohibitive

Of course, innovative technology is often more expensive than soon-to-be-obsolete alternatives. As any product nears the end of its useful life cycle, manufacturers progressively lower the costs to eke out a few more years of profits before it is displaced by improved solutions. This can be a tremendous bargain if such older technology can fully meet your needs.

Even the most sophisticated prosthetic technology, however, may cost substantially less in the long run than it appears at first glance. For example, Canadian researchers demonstrated several decades ago that while electronic upper-limb prostheses cost several times as much as the simpler mechanical ones, over a 10-year period much of this disparity disappeared when the number of repairs and replacements for the mechanical devices were taken into account.

The auto industry has had the same experience. Today’s cars are certainly more expensive than they were 20 years ago, but they are also safer, more reliable, more energy efficient, and last longer than ever before. Modern prosthetic limbs offer similar advantages. In fact, the warranty period for advanced-technology prosthetic components has gradually increased from 6 months in the 1960s to 36 months in 2001. Recent Medicare regulations have recognized this fact, and three years is now considered a typical life span for most leg prostheses.

So, the cost of advanced technology can be justified by the long-term benefits it offers. In addition, it is important that we continue to adopt new technology as it becomes available. Otherwise, manufacturers will soon realize that there is no return on their research investments, and they will simply stop developing such innovations.

Myth 3: Advanced-technology prostheses are not covered by your policy

Low-quality insurance policies sometimes specifically exclude coverage for prosthetic and orthotic rehabilitation. In addition, some sneaky insurance companies effectively deny rehab by hiding in policy language ridiculous exclusions such as "one prosthesis per lifetime" or "$900 total prosthesis benefit."

Is this legal? Unfortunately, yes. If you have such a policy, complain to your insurance agent, congressmen, and employer - and plan to switch to a more realistic policy at the next open enrollment. The only long-term solution to this problem is federal legislation requiring full rehabilitation coverage on a national basis.

Unless such specific exclusions are included in your policy, you should have access to all reasonable technology. As a general rule, the legal requirements to obtain appropriate prosthetic care are:

1. Obtaining a comprehensive written prescription from your physician
2. Selecting a prosthetist with the training and experience to provide the prescribed artificial limb
3. Filing the proper paperwork, in the proper order, according to your insurance or Medicare regulations

It is critical that all three requirements are fully met because any lapse will trigger a denial of coverage for all or part of your prosthesis. For example, if one digit or one letter in your Medicare number is recorded incorrectly, the entire claim will be rejected. Please work closely with your doctor and prosthetist to be certain that all details in your claim are precisely specified and absolutely correct.

Unfortunately, some insurance companies will deny coverage for your prosthesis even though everything has been done correctly; however, such mistakes can usually be overcome if you refuse to accept "no" for an answer.

In my experience, most denials of this kind are simply errors that happen when the personnel determining eligibility don’t under-stand prosthetic rehabilitation. There is always an initial appeal process available, and you should ask your prosthetist and doctor to help prepare and submit the paperwork to force your insurer to reconsider your claim. In many cases, simply explaining in detail what your doctor has prescribed and why it will be beneficial in your specific situation is all it takes to overturn such inappropriate denials of coverage. If this is not enough documentation, many policies allow for another independent review by a different insurance company employee, and you can speak directly to him or her either in person or over the phone. If the denial is based on a lack of understanding, this level of appeal is almost always successful in obtaining approval for your prescribed prosthesis.

Sometimes the insurance company will still deny coverage for what your doctor has prescribed despite both written and in-person appeals. If that happens, then you may need to contact your lawyer and take appropriate legal action.

Fortunately, it is rarely necessary to hire a lawyer to receive reimbursement for your prosthesis, but you should not hesitate to assert your rights to the full limit of the law. As a practical matter, in every Administrative Law Judge hearing about prostheses that I am familiar with, the judge has immediately overturned the incorrect denial and ordered the insurance company to pay the claim in full without further delay. Such a result officially notifies your insurer that such technology must be covered under proper circumstances and makes it much less likely that you will have problems with them in the future.

Myth 4: Advanced-technology prostheses are experimental and unproven

Statements such as this are simply an excuse to avoid considering modern rehabilitation options. No commercially available prosthetic components have ever been considered "experimental" by the United States Food and Drug Administration. In fact, limb prosthetic products are generally classified as "Class One -Exempt," which means that they use such well-established technology that no significant risks to the user are anticipated and no special pre-market testing is mandated.

Carbon-fiber composites have been used in aerospace applications for many decades; microprocessor controls are commonplace in the appliance and automotive industries; and silicone materials have long been used in medical applications. These innovations entered the prosthetic realm only after they enjoyed mainstream success in larger-volume applications, after processing and safety rules were established, and after the cost of such materials was substantially lowered by widespread commercial production. Food and Drug Administration (FDA) regulations explicitly recognize that techniques we consider novel in prosthetic rehabilitation are actually a new adaptation of pre-existing technologies.

Finally, rehabilitation experts have a very good track record in critically evaluating new products and methods. The limitations in poorly executed products are quickly identified through limited clinical applications, and, unless they are immediately addressed, such technology quickly disappears from the marketplace.

Today, prosthetic devices using carbon-fiber composites, on-board microprocessors, and silicone cushioning materials are routinely prescribed and successfully used by amputees worldwide. The successful clinical use of such technologies by thousands and thousands of amputees worldwide has clearly demonstrated their value in prosthetic rehabilitation.

Advanced-technology prostheses cannot be summarily dismissed as being too exotic or too specialized for general use. Although there may be specific reasons why a particular prosthetic alternative is not indicated for an individual amputee, the range of designs currently available means that most modern prostheses will include one or more of the lightweight, comfortable, and responsive components now available. When proper justification is provided, Medicare and private insurances routinely cover advanced-technology prostheses.

Figures & Legends

(All illustrations provided courtesy of Ossur)

	Although particularly well accepted by highly active individuals, modern prostheses that offer a dynamic push-off combined with shock-absorption features have been successfully utilized by a wide range of amputees.
	Your rehab team can suggest particular components that are well suited for use when it is important to minimize the overall height of your prosthesis.
	Some highly specialized prostheses are designed for use by competitive athletes with the physical ability to utilize the advanced performance offered.
	Manufacturers often make lower-cost devices for general prosthetic use, based on their experience with specialized designs for more demanding situations such as Paralympic competitions.
	For less active individuals, some manufacturers offer lower-cost components that use simplified versions of technology originally developed for highly active amputees.

About the Author:

John W. Michael, MEd, CPO, has been an ABC-certified practitioner for more than 25 years and is currently the president of CPO Services, Inc., an independent consulting firm. He can be contacted at JWM@CPOServices.com

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