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Witness Testimony of Michael Oros, Board Member, American Orthotic & Prosthetic Association

Good afternoon Chairman Johnson, Ranking Member Donnelly, and Members of the Subcommittee. Thank you for the opportunity to provide testimony today. The American Orthotic and Prosthetic Association (AOPA) is grateful for your work to ensure that Veterans with limb loss and limb impairment receive state of the art prosthetic and orthotic care. We appreciate the invitation to shed some light on current issues facing the fields of prosthetics and orthotics when it comes to procurement of high quality prosthetic and orthotic care for our Veterans.

My name is Michael Oros, and I am a member of the AOPA Board of Directors.  The American Orthotic & Prosthetic Association (AOPA), founded in 1917, is the country’s largest national orthotic and prosthetic trade association.  Our membership draws from all segments of the field of artificial limbs and customized bracing for the benefit of patients who have experienced limb loss, or limb impairment resulting from a traumatic injury, chronic disease or health condition.  AOPA members include patient care facilities, manufacturers and distributors of prostheses (artificial limbs), orthoses (orthopedic braces such as those used by TBI and stroke patients) and related products, and educational and research institutions.    

In my day job, I am a licensed prosthetist and President of Scheck and Siress, Inc., a leading provider of O&P services based in Illinois. Like many other community-based providers, Scheck and Siress is committed to serving Veterans, and does so through contracts with the VA.  Scheck and Siress is also proud to employ Melissa Stockwell, the first American service woman to lose a limb in Iraq. After sustaining the injury that resulted in her limb loss, Ms. Stockwell went on to become a Paralympic athlete, and had the honor of carrying the American flag at the closing ceremonies of the Paralympic Games in Beijing.  Melissa is now a certified prosthetist, and a member of the staff at Scheck and Siress.

I would like to begin by clarifying that my experience is with, and my comments will pertain to, a fairly small, but vitally important, subset of the goods and services that fall within the scope of “prosthetics” at the VA.  If you asked the man on the street what a “prosthesis” is, the response would probably be an artificial leg or arm.  If asked about an “orthosis,” a few folks with family members who have had Traumatic Brain Injury, stroke, or Multiple Sclerosis might be able to describe a custom-made and fitted device to help damaged limbs function properly.  I am certain, however, that nobody would suggest seeing eye dogs, wheelchairs, eyeglasses, hearing aids, or myriad other items that are lumped together by the VA in its “prosthetics” budget.

Why does this matter?  I would suggest that the very broad definition of “prosthetics” can lead to confusion and, worse, application of policies that are inappropriate to replacement limbs and orthotics.  The result:  inappropriate barriers to care for Veterans with limb loss who need timely access to high quality prosthetics in order to go to work, care for their families, and live their everyday lives.

In fact, the Health Subcommittee saw that confusion on display in its hearing in this very room only two weeks ago.  Chairwoman Buerkle held a hearing on “Optimizing Care for Veterans with Prosthetics” on May 16th.  During the hearing, she clarified multiple times that the topic of the hearing was prosthetics as traditionally understood and defined.   During that hearing, the VA’s Chief Procurement and Logistics Officer told the Subcommittee that because changes in procurement policies applied only to items that cost $3,000 or more, those changes would not apply to 97% of the prosthetics budget.   

I’m sure that statement is accurate for everything included in the billion –dollar-plus line item described by the VA as “prosthetics.”  However, for the approximately $58 million portion of that line item spent on replacement limbs and orthoses, that statement is confusing and unhelpful.  Virtually every part of even a fairly low-tech prosthetic limb costs more than $3,000.  So adopting procurement policies with the understanding that the policy does not apply to 97% of prosthetic purchases can lead to decisions that delay specialized and vitally needed care for Veterans with limb loss or limb impairment.   The Veterans we see have already sacrificed enough.  They are working hard to put their personal, family and professional lives back together.  This task should not be made more difficult by the application of overly broad policies that do not take into consideration the very specialized and unique nature of prosthetics and orthotics.

For prosthetics and orthotics are a very specialized medical service.  An artificial leg or arm becomes an extension of the Veteran’s body.  It needs to be checked and potentially adjusted several times a year to maintain maximum comfort and functionality.  If the Veteran loses or gains weight, or as the muscle structure changes, parts of the device may have to be re-fitted.    A prosthesis that no longer fits properly or has come out of alignment is not merely an inconvenience; it can cause debilitating pain and complete loss of function. 

It is vital that Veterans with limb loss identify and have access to a clinician that they trust, who listens to them and works with them to ensure the best possible fit and function of their artificial limb or orthotic brace.  Quite literally, their ability to get out of bed in the morning and go about their lives may depend on that relationship and timely access to appropriate assistance from that orthotic or prosthetic caregiver.

Congress and the VA have acknowledged the vital need for Veterans to have access to a prosthetist they trust by establishing various policies to facilitate Veterans’ timely access to prosthetic services. 

It is the VA’s policy that Veterans may receive prosthetic care from the provider of their choice.  To facilitate high quality, timely care in the communities in which Veterans live, the VA maintains contracts with more than 600 independent prosthetic and orthotic providers, in addition to serving Veterans at VA Medical Centers.

But Congress authorized the VA to go even a step further in ensuring Veterans’ choice and access.  If you are a Veteran in need of prosthetic care, no VA bureaucrat is supposed to limit your choice to a list of “approved” providers that have contracts with the VA.  Veterans are supposed to be able to choose the clinician that they work with best, who best meets their needs, and the VA has been given legal authority to do what it takes to secure prosthetics and orthotics from that provider even in the absence of a pre-existing VA contract.  Congress acknowledged the unique status, role and needs in prosthetics, and took steps to ensure that procurement policies should facilitate, not stand in the way of, Veteran choice.

AOPA agrees that it is necessary and appropriate for the VA to do whatever it takes to ensure that Veterans can receive their prosthetic and orthotic care from the provider of their choice.  AOPA urges this subcommittee to do everything in its power to ensure that the necessary procurement authorities, policies and oversight remain in place to guarantee the Veteran’s right to choose.

It seems like we shouldn’t have to urge the Committee to remain vigilant on this point.  But we do, because AOPA shares the concerns of Paralyzed Veterans of America, the Wounded Warrior Project, Disabled Veterans of America and other Veterans Service Organizations that that right to Veterans’ choice of providers is being eroded.     

Anecdotal evidence from Veterans and providers suggest that there are real, and increasing, procurement barriers to non-VA care being erected. 

Two weeks ago, Veteran John Register, a Board Member for the National Association for the Advancement of Orthotics and Prosthetics and a sophisticated Veteran consumer of prosthetics, testified about his difficulty obtaining an advanced knee.  He was told that he could not receive the knee from the prosthetics practice he sees, seven minutes from his home.  Instead, he was told the only way he could obtain the advanced knee was to go to the VA, seventy miles away.  While he is satisfied with the care he received at the VA, and with the advanced knee, he now has to take time off work several times a year to travel more than an hour away to have his new knee checked, adjusted and maintained.  This is extremely disruptive, particularly when his own qualified prosthetist is just down the road.

I’m aware of another example that arose with one Veteran who had been working with his independent prosthetist for eleven years.  He had never before been to the VA for his prosthesis, in part because it is two hours away.  Recently, this Veteran went to the VA amputee clinic for his prosthetics prescription. The clinic prescribed an above knee prosthesis, including an advanced knee.  As per protocol and the VA contract, the company submitted L codes for approval through the VA to give him his prescribed prosthesis. The Certified Prosthetist-Orthotist (CPO) who works for the VA saw the codes come across his desk and called the Veteran.  The Veteran was told that he had to come to that VA in order to get the prosthesis.

The Veteran preferred to continue to receive his care from the outside provider, because they had taken care of him successfully, close to his home, for more than a decade.  He told his prosthetist what was going on, and the contractor contacted the person in charge of prosthetics at that VISN. The contractor was told that the Veteran had received incorrect information, that Veterans have the right to choose, and since the independent firm had been providing this Veteran’s care for eleven years he could continue.  The VA then put pressure on the Veteran, telling him if he wanted the advanced knee he would still need to come two hours away to the VA.   After more pushback, the VA’s story changed:  the VA told the Veteran he could get the advanced knee immediately, from the VA.  The alternative:  wait months to get it from his regular prosthetist as the approval process would have to start all over again from the beginning.  Ultimately, the Veteran switched to the VA, two hours away, as the VA made him feel that it would be easy and quick to get the technology from the VA, and would be difficult and lengthy to obtain the technology from the community-based provider.

I could go on and on with similar stories.  The question is: why is the VA establishing procurement and other administrative policies to undermine Veteran choice?

It has been suggested by some that cost may be a factor. AOPA believes that the vast majority of community-based providers working under contract with the VA provide high quality care to Veterans at highly competitive rates – rates, in fact, that represent an average discount of 10% below the published Medicare fee schedule, which establishes the prevailing industry rate (and is followed by insurance companies and other private sector payers).   The IG’s recent Audit of the Management and Acquisition of Prosthetic Limbs issued on March 9, 2012, claimed that the average cost of a prosthetic limb fabricated by the VA in house is $2,900, while the average cost of a limb fabricated by a third party contractor was $12,000. We have been unable to determine precisely which costs were taken into account by the IG when making these calculations, but certainly, it fails to take into consideration VA staff salaries, the cost of benefits, facilities, administration and other overhead.  In addition, it is not unusual for Veterans with extremely complicated devices to choose community-based providers rather than VA staff, which would skew the cost of devices provided in-house downwards.

The IG’s analysis does not present an apples to apples comparison, and the footnote in the report suggests that the difference in price is attributable to private sector profit and overhead.  We reject this suggestion, and this analysis.  We are disappointed that this statement was not challenged by the VA Prosthetics and Sensory Aids staff before the report was published.  This so-called cost comparison offers the Subcommittee and the VA leadership no useful information.  We believe that, with few exceptions, a complete and accurate cost comparison would show that community-based O&P contractors provide excellent value to Veterans and taxpayers.

In fact, forcing Veterans to switch prosthetists can actually generate unnecessary additional costs.  In the example I cited, the VA duplicated the socket the community-based practice had made for him, even though his socket was not due for replacement and was functioning well.  We have heard of many other cases where the VA essentially requires Veterans to switch to VA facilities, and then provides them with a completely new prosthesis to replace a fully functional, warranteed and effective prosthesis that was made by the community-based provider.

The goal of the procurement system for prosthetics and orthotics should be to deliver the highest quality, timely prosthetic and orthotic care possible to all Veterans, regardless of age, geographic location, ability or willingness to become the squeaky wheel and demand appropriate care.  What would such a procurement system drive towards?  I’m not certain that I’ve ever seen an official VA definition of “quality” care, so at the risk of being pushy, I’d like to suggest my own for the purposes of our discussion today.  For me, as a practicing clinician who has been taking care of Veterans with limb loss for 26 years, four major elements comprise quality prosthetic care:

1) Access.  Veterans must be able to receive care on a timely basis, without waiting for weeks or having to travel hundreds of miles for their prostheses to be checked, adjusted, repaired or replaced.

2) Trust.  Veterans must know about and be able to exercise their right to receive care from a provider they trust, who listens to them and works with them to achieve the most functional prosthesis possible.  Fitting a good prosthesis is as much art as it is science, and a positive, ongoing working relationship between the Veteran and the prosthetist is an important element of getting it right.

3) Expertise and experience.  Clinicians serving Veterans must have the training and clinical know-how to select, custom-build, fit and adjust the best possible prosthetic device to address the complex challenges Veterans with limb loss face every day.

4) Outcomes.  The result of high quality prosthetic care is greater comfort, higher activity levels, more independence and greater restoration of function for Veterans with limb loss, so that they can live their everyday lives successfully and continue to do the things they want to do despite the absence of one or more limbs.  

VA procurement policies are critical to all four elements of quality.  Procurement policies should ensure that:

1)     Veterans have access to the prosthetics provider of their choice without having to overcome artificial and unnecessary barriers to care.

2)     Veterans can receive timely care from their provider, whether that provider is in the VA or an independent practice, without artificially created hoops or delays established to influence their choice of caregiver.

3)     Prosthetists serving Veterans do not just have the minimum certifications and qualifications needed, but actually have the training and experience to meet the specialized needs of Veterans.  This will become more and more of a challenge for the VA and for independent O&P practices as the requirement for a master’s degree as an entry-level qualification is implemented.

4)     Contracting (and other) policies should require measurement, and continuous improvement, of Veteran outcomes until Veterans achieve the highest level of restored function possible for that individual Veteran.

I would like to take a few additional minutes to talk in greater detail about this last point, which AOPA believes is critically important.  While AOPA is firm in our belief that the vast majority of private sector clinicians are providing care to Veterans that is as good or better than that they could receive at the VA, we also believe that it is important to hold O&P professionals accountable for the quality of care and the cost of that care.  This poses something of a challenge for the VA, due to the fact that there is currently no body of objective, comparative outcomes research to support evidence-based practice in O&P.  Currently, the only mechanism used by the VA to evaluate the quality of prosthetic and orthotic services offered by any provider – inside or outside the VA – is the patient satisfaction survey.  While community-based providers typically score very highly on such surveys, we know that more could and should be done to evaluate O&P outcomes for Veterans.

For example, the “Amputee Mobility Predictor” and the “Timed Up and Go” are two validated instruments to determine a baseline functional level that could be administered in the prosthetic clinic at the time the prescription is generated. Functional level can then be re-documented at routine intervals during the rehab process to record and evaluate progress in terms of functional activity.  Quality prosthetic outcomes should mean functional mobility improvements.  College Park’s iPecs and Orthocare Innovations’ Compas systems measure forces and provide objective data regarding proper alignment.   Orthocare Innovations’ Stepwatch and Galileo system are another example of a simple data collection device and software application to record real-world activity outside the clinic.  Having the ability to “see” our patients’ real activity once they leave our facility is the best, most objective and most accurate measure of how successful the rehab process was. 

This leads me to my final point.  Unlike other health professions, there is no body of comparative outcomes research to guide O&P professionals.  Their judgments about which prosthetic device, service or support is most appropriate for which patient is based largely on personal experience and expertise developed over years in the field.  However, there is almost no objective research on outcomes to validate or inform that experience.

To give simplest of examples, there are more than 20 prosthetic feet on the market.  The lowest tech, least expensive cost about $3,000.  A little more than a year ago, CMS approved a foot that costs more than $15,000.  Now, there is a new foot that will cost about $125,000.  But there is no research to suggest and document which Veteran will benefit most from which foot.

Please do not misunderstand me.  I do not believe that cost considerations should guide selection of prosthetic components for Veterans.   In some cases, the most expensive foot may restore significant additional functionality.  But in other cases, Veterans may actually have better outcomes with less expensive or lower-tech components.   It would be helpful to have objective research documenting which Veterans have the best outcomes from which prosthetic devices, services and supports.

There are multiple elements of a coherent O&P research agenda, including but not limited to comparative outcomes of prosthetic components, that are vitally important to ensuring that Veterans receive appropriate, necessary care as well as to eliminating unnecessary future health care costs.  An outcomes-based research portfolio, and the resulting body of evidence, in the field of O&P would increase the quality of care for Veterans and others with limb loss.  It would give the VA an appropriate management tool for overseeing a decentralized system with procurement of prosthetics and orthotics from more than 600 VA and external sites.  It would protect taxpayers by ensuring that patients receive the most appropriate care from the beginning, and that quality and cost effectiveness objectives are attained in a data-driven manner that generates the best possible outcomes.  AOPA has invested significantly in the area of outcomes research, having developed two study instruments—accessing data from both patients and their O&P providers on outcomes.   AOPA has both spearheaded and supported financially pending comparative effectiveness studies involving dynamic/non-dynamic response prosthetic feet, and microprocessor/non-microprocessor controlled prosthetic knees, and we support an annual program with thousands of dollars in grants from the underlying clinical research that are the building blocks of evidence-based practice.  AOPA would greatly welcome and value the opportunity to work with the VA in tracking patient outcomes and comparative effectiveness.

AOPA applauds the VA for working toward this end by joining with the Department of Defense in March of 2010 to hold the joint State of the Art Conference on Orthotics and Prosthetics. This conference generated much discussion related to the creation and execution of an outcomes-based research portfolio in the field of O&P. While the discussion was encouraging, we have been disappointed to see that no progress toward the implementation of the recommendations has been made. No report on the conference has ever been made publicly available, and so far as we can tell, no steps have been taken by the VA or DoD to implement any of the conference recommendations.  

Despite the government-wide focus on health care outcomes, there is currently no federal research agenda on prosthetic and orthotic outcomes.  Not at the VA.  Not at the DoD.  Not at the NIH, the CDC, or NIDRR.  AOPA strongly encourages the VA, DoD and NIH to help improve the care for Veterans, service members, and seniors by implementing a robust comparative outcomes research agenda that addresses the questions in the field and helps to inform effective, efficient delivery of O&P care for the Veterans, seniors and civilians with limb loss and limb impairment.  We believe this will also yield dividends in assuring that the major technological advances precipitated by research commitments from VA and DoD for Veterans and active duty military are actually pulled through to have a practical impact on care provided to our nation’s seniors and other members of the general public.

Mister Chairman, Members of the Committee, thank you very much for the invitation to testify, and for your commitment to providing the highest quality prosthetic and orthotic care to our nation’s Veterans.   I look forward to answering any questions that you might have.