Ultrasound Stimulation for Nonunion Fracture Healing

On behalf of my patients and my colleagues, I must object to the decision to require a surgical procedure prior to approving a non-invasive procedure specifically, Exogen Ultrasound stimulation. This requirement is unacceptable from a surgical ethics and patient advocacy standpoint. The requirement would force patients to undergo a surgical procedure with a resultant risk of mortality and morbidity in able to qualify for a proven technology with ABSOLUTELY NO risk of mortality or morbidity. This decision would increase the cost of health care for the patient and society at a time when we should be rewarding technology like the Exogen system for its proven successful and cost-effective mangement of fracture non-unions. There is no requirement currently for previous surgery for the other non-operative option of electrical stimulation which carries a higher cost to patient and society and a lower success rate in the medical literature. The proposal to require previous surgery prior to initiating Exogen treatment would be analogous to asking surgeons to withhold antibiotic treatment for infections until an abscess has formed and surgical drainage required. No ethical caring physician scientist would ever agree to this type of research with the proven benefits of less risky treatments. I have personally used the Exogen system with excellent results in patients suffering from non-unions for over 10 years. Many of these patients were not candidates for surgery due to recent or chronic medical conditions that precluded a surgical option. I urge you as a citizen and physician to please relinquish this unreasonable requirement of surgery prior to non-invasive treatment modalities, specifically the Exogen Ultrasound system.
Sincerely,
Thomas A. Russell, M.D.
Professor of Orthopaedic Surgery
Campbell Clinic-University of Tennessee Department of
Orthopaedic Surgery
University of Tennessee College For The Health Sciences
Memphis, Tennessee

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The surgical caveat on the Exogen is counter productive for the US Government because bone stimulation can, in many cases, obviate surgery entirely. Imobilization and stimulation of high risk and non united fractures is less risky and less expensive. The Exogen is unique in that ultrasound may be effective where electircal stimulation has not. The short treatment time and easy application encourage compliance.
Respectfully,
CAPT Patrick Agnew, MSC, USNR
Director, Eastern Virginia Medical
School Podiatric Surgery Residency

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I have found that Ultrasound stimulation would be beneficial for patients other than those who have surgery and nonunions. US stimulation would be a great modality for older patients with comorbidities - for instance, a 70+ year old woman with osteoporosis and stress fractures of the metatarsals, who is unable to completely non-weight bear cam have acceleration of healing with stimulation and less immobilization time. Also, there are, at times, patients who are not surgical candidates but who would benefit from ultrasound stimulation, especially if started sooner that later.

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I would like to recommend that you remove the caveat stating that surgical intervention is necessary prior to application of a bone stimulator for the stimulator to be a covered expense. I am a foot and ankle physician and surgeon, and if I can take care of a patient's problem without surgery, that is always the best option, especially when dealing with diabetics or the immune compromised. But even with healthy patients, application of a bone stimulator for any type of situation, whether it is after an elective osteotomy or fusion that is well fixated, an osteotomy or fusion site that is at higher risk for a nonunion (due to shifting of fragments or other factors such as smoking or diabetes), or fractures of any type, is a better option than doing another surgery. This would both reduce risk to patients (both anethesia and operative risks)as well as save medicare dollars spent on operating room time, staff, and surgeon's fees.

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As an orthopedic surgeon, it is my responsibility to be concerned for the health and well-being of all my patients. It hardly seems to be in the best interest of many of my Medicare patients that have co-morbidity factors to have to undergo surgery before using Exogen. Exogen should be used to prevent surgical intervention. I also do not see it as financially beneficial for Medicare to pay for surgery and an Exogen unit. Exogen also has the highest heal rate of any of the bone stimulators on the market and is worn for the least amount of time. These factors lead to greater patient compliance and makes my job as a doctor and surgeon worthwhile.

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Ultrasound stimulation has been proven to help with delayed and nonunion of bone. Patients can develop these in both surgical and non-surgical cases. I have used the Exogen device in patients who are not surgical candidates as well as those who had surgery with good results. Surgery should not be the deciding factor.

A randomized study would put patients who would benefit from the use of ultrasound therapy at higher risk for non-unions. Those who need surgery may be placed in the "non-surgical group" and would be at higher risk for non-union. That is not ethical.

I support the use of ultrasound therapy in both groups.

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I have many opportunities to use ultrasound stim for non-union patients and acute fracture in patients at high risk for non-union. Thetreatment is safe and effective and has been a significant benefit to my patients duringtheir recovery period. EXOGEN is a non-invasive means for fracture care that should not be limited to patients that have had failed surgical intervention. Many elderly patients cannot have surgery and their care cannot becompromised by limited their access to this technology. The surgical caveat must beremoved.

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Many of the patients in my practice are elderly with multiple medical problems. These problems encompass Diabetes, Peripheral Vascular Disease, Renal Failure, Immunosupression secondary to disease and medication, Congestive Heart Failure, Obesity, Hypertension, Arthritis (Degenerative and Rheumatoid) and Advanced Age. Many of these patients sustain stress or traumatic fractures. Most of thses patients are poor surgical candidates for ORIF. Even if I was comfortable performing such surgeries, their primary physicians would not consent to surgery. These patients have poor healing potential from the fracture without the added trauma of a surgical procedure. Please remove the surgical caveat so my patients do not face a prolonged healing process or surgical procedures that could render them unable to perform their ADL's. Thank you.

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The Exogen Fracture Healing System has been an invaluable treatment option in my practice. Certain patients who are being treated for fractures in my clinic are POOR or VERY HIGH RISK SURGICAL CANDIDATES. These patients have health concerns such as diabetes, peripheral vascular disease, immuno-suppressed due to medications or other factors, osteoporosis, obesity, arthritic conditions, advanced age, etc. These factors impede the patients ability to heal from a fracture, as well as a surgical intervention. I need to be able to give these type of patients the best treatment for their fractures, considering their health issues, without unnecessary surgery. The Exogen device gives me the ability to treat these patients conservatively and without the added cost or high risks of surgery. It is vital that the surgical caveat be removed so I may offer my patients the best podiatric treatment possible.

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February 24, 2005

Gentlemen:

I have used the Exogen product and I am satisfied with the results.

I understand that Medicare is no longer going to cover this. This is just the population group where it is most important … the elderly with other medical illnesses which makes fractures more likely but makes fracture healing less likely.

The Exogen product is a conservative and non-operative means of getting fractures to heal and I am afraid without this, the likelihood of surgery will increase in some of these people, and therefore actually increase the cost of medical care rather than decrease it.

Thank you.

Jeffrey L. Minikel, M. D.

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I have read with interest the history of the CMS decision to require surgery as a stipulation for access to an ultrasound bone stimulator

In reviewing this history, public comments from both physicians and patients, and the current CMS draft decision, I believe there is sufficient reason for CMS to reconsider its proposed decision altogether.

The requirements you are proposing in your draft seem rather stringent based upon the previously considered studies and the input from both professionals and consumers who have already benefited from this technology. The FDA is satisfied with this product and the success rates are already well documented.

Further delaying coverage will cause many patients to undergo needless surgeries and extended recovery periods not to mention the exorbitant surgery-related costs. The logical next step should be to allow coverage of the ultrasound stimulator based on the information already presented.

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To whom it may concern:

I have been asked to write on behalf of Smith ans Nephew regarding the use of Exogen, low intensity ultra sound to accelerate the healing of fractures.

I am a Podiatrist in Northwest Iowa. I have practiced 27 years here. I first learned how to treat delayed union of fractures from EBI, medical systems. EBI bone healing systems did the research years ago, proving an electrical current promotes bone healing over a fracture or osteotomy site. This research and data helped us in the medical practice, to heal up non-union fractures and delayed delayed healing surgical sites.

Now, a new industry has research to show very good results can occur with the case of low intensity ultra sound.

Tim Watson is a clinical specialist who supports us here in Northwest Iowa. My first case, with exogen, low intensity ultra sound, was used on a high risk, obese, diabetic female, with osteoporosis. She had a non healing fracture of the 4th metatarsal base. Her physician and myself waited and monitored her progress over several months with x-rays, showing delay and non-union with swelling and pain.

I knew surgery was a risk, and I originally wanted EBI on hand, to use their bone stimulators, to enhance my surgery on the fracture site to heal properly.

I trusted Exogen and Tim Watson on this case with the research showing very good statistics on fresh fractures and osteotomies. Please consider this information when you make a decision.

I performed surgery to remove the necrotic non-union bone and internally fixated the fracture site with a metal screw. I then performed an elevating osteotomy to the bone lateral to the fracture site and used k-wire fixation of this osteotomy. She was non weight bearing, again, after several months of non wight bearing, hoping her fracture would heal.

She now has 2 areas of bone healing required, with non use osteoporosis present. She is diabetic, over weight and high risk. Exogen, low intensity ultra sound was started the first day post op and the results 3 weeks later were very positive. She is weight bearing with bone calus present on her x-rays in both sites. The pain and swelling is gone.

Exogen, low intensity helped this case immediately after surgery.

I regret law makers have to make decisions to force insurance companies to pay out for the benefit of folks that need this technology. Insurance companies have been too powerful making too much profit for too many years! They are causing a large amount of Americans to not even afford insurance at their current rates, and if you can afford their premiums, these companies have to have a law, allowing us to use their product on patients that need this technology at the first site of fractures, not 3 months later. The pain and suffering, the delay in getting back to work, or the cost of surgery, hospital and post op care really makes the cost of this form of therapy, very affordable for these insurance companies.

Sincerely

Dr. R.L.Crampton, DPMRLC/cmh

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On behalf of the American College of Foot & Ankle Surgeons (ACFAS), a professional society of nearly 6,000 board-certified foot and ankle surgeons, I am writing to strongly oppose the Centers for Medicare & Medicaid Services (CMS) draft decision issued January 27, 2005, that would retain the failed prior surgery requirement currently in place for coverage of Exogen for Medicare patients.

Below are some of the primary areas of concern the College has regarding the CMS draft decision:

A randomized controlled clinical trial in which patients are randomized to surgery or to Exogen as suggested by the draft decision would not reflect standard protocol, would not provide useful clinical information for decision making and would be highly inappropriate. Such a trial comparing ultrasound to surgery would also be unworkable. If a surgeon wished to perform surgery, then his or her patient would not enroll in the trial, so as to be guaranteed surgical treatment. If a physician wished to prescribe an alternative to surgery, then his or her patient might enroll in the trial, but would drop out if randomized to surgery.

Furthermore, current clinical evidence for Exogen’s success in healing nonunions with or without prior surgery is more than adequate. FDA-reviewed data clearly demonstrates success healing non-unions in Medicare patients without prior surgery and a widely-published economic model indicates Exogen is the most cost-effective stimulator. It seems apparent that CMS has likely based their position on a single study by Saltzman et al. However, that study looked at a relatively small sample size of only one type of operation.

The draft decision by CMS as written would limit physicians’ ability to prescribe FDA-approved bone stimulator products and thus severely limit patient care. Implementation of the decision would deny Medicare beneficiaries access to a non-invasive FDA-approved therapy that their physicians may otherwise wish to prescribe.

The College believes strongly that the use of external bone stimulators can be effective without prior surgery and respectfully requests CMS remove the failed prior surgery requirement currently in place.

Gary P. Jolly, DPM, FACFASPresident

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As a podiatric physician who treats nonunion and delayed union patients, i think is it not in the best interest of the patient to require a failed surgery before qualifying for coverage for a bone stimulator. The bone stimulator may heal the nonunion obviating the need for surgery. If it was your foot or the foot of a family member, wouldn't you want surgery to be the last resort, after all conservative measures are exhausted? I disagree with the new failed surgery limitation on coverage.

respectfully,

Dr. Michael Derouin, Key West

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To whom it may concern: The Exogen Ultrasound Bone Healing system made by Smith&Nephew has been used successfully in my practice. I have applied this tool for difficult to heal foot fractures and non-unions. Typically, the patients who have benefited the most have been at risk for healing complications; diabetics, cigarette smokers, immunocompromised, etc... I feel the surgical requirement for non-unions should be re-considered. As you know, not all non-unions require surgery and not all patients with non-unions are surgical candidates. The Exogen system could expedite fracture/non-union healing resulting in quicker return to function for patients and reduced healthcare costs.

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I recently read your decision regarding Smith & Nephew's request for reconsideration of the surgical caveat for use of LIPUS in non-unions in the CMS patient population. As a clinical orthopedic surgeon in private practice, I began using ultrasound for stimulation of bone healing in 1995. I tried LIPUS because I was very frustrated and disappointed with the results of my clinical experience with electrical stimulation for my non-union patients. I have found the ultrasound modality to be very well received by my patients, easy to use with very short treatments (20 minutes), and very effective. Often times I have been able to avoid a surgical procedure as a direct result of a successful LIPUS treatment program. I have also become very familiar with the published literature in the area of bone growth stimulation using electrical stimulation or low intensity pulsed ultrasound. The literature clearly shows LIPUS to be as effective and in some studies more effective than electrical stimulation. The overall success rate for LIPUS is in the range of 86%.

This past Monday I attended a seminar in Washington, DC focusing upon LIPUS and its effect upon bone healing. The scientific data is quite remarkable and clearly demonstrates a profound effect of LIPUS upon the bone healing process at the cellular level.

I cannot understand how your committee feels that a controlled trial of Exogen VS surgical intervention is justified or even necessary. One begins to wonder if members of your committee have seen or read the published literature. The type of trial suggested by your committee would be very difficult if not impossible to perform as the vast majority of patients would refuse entry into the trial. The literature presently available clearly demonstrates the efficacy of LIPUS in the non- surgical patient as well as the surgical patient as evidenced by the FDA approval without any surgical restrictions.

I am also surprised that the CMS committee, in this instance, has taken the liberty of limiting the practice of physicians by removing the physician's ability to make a clinical judgement and decision. As a practicing physician, I am now limited in my ability to provide my patients with an efficacious, non- invasive modality which has an 86% success rate of healing a nonunion with or without a surgical intervention. As a professional, dedicated to provide the highest quality of care for my patients, I am offended by the actions of your committee.

I would like to formally register my strongest disagreement possible with your recent decision and request that you immediately reconsider your findings in the best interest of good patient care.

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I would like to voice my opinion about the ultrasound stimulation for nonunion fracture healing. I think the surgery requirement for treating non-unions with this device should be removed. There are a considerable number of my medicare patients who are not surgical candidates. Therefore, to have to require a surgery to use this device is more costly and will limit my ability to treat all of my patients equally. This device can be used as a conservative treatment to avoid surgery therefore saving heal time and money for evryone involved. any questions please contact me at my office. Cy Scully, DPM

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I am writing you in regards to the Surgical caveat required for Medicare patients that have a non-union fracture.

In my clinical experience the best treatment for a particular patient may only require conservative care. It could be potentially harmful to take patients with comorbidities to surgey. Therefore, fractures that can not tolerate surgical intervention benifit from the Exogen bone stimulator. Exogen accelerates healing, increases patient compliance, teatment times are 20 minutes once a day, and no contraindications.

Having this restrictions limits me to provide the best treatment options for my patients.

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Ultasound stimuation for fracture healing both fresh and nonhealing has been an exceelnt and well accepted tool in our private and academic practices. WE currently use the Expogen bobe stimulator from Smith/Nephew and have found patients to very receptive to this treatment. Many fresh fractures are compromized such as smoking, vascular insuff., metabolic disorders etc and this type device has been an excellent tool in this patients. Likeswise surgical areas that have a poor healing rate or trauma sites have respondied well with this device and expediting healing. I hope to see the continuation of this thye treatment for not only nonunion but especially for fresh fractures or areas where potential nonunion can occur with out such device....

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I have recentlty been made aware that Medicare will not pay for an Exogen bone stimulator unless surgery is performed. This is abosolutely absurd. The cost of surgery is a far greater expense and risk with a probable chance that a stimulator will still be needed.

A study of surgery vs. stimulator isn't needed since studies have already showed Exogen's accelleration in acute and delayed fracture healing. It isn't practical from a surgeons and ethical stand point in my opinion.

For the last 7 years or so, I have used only Exogen stimulators for delayed and nonunions. This has been in large on patients who have had no surgery and came to me as a second opinion. I offered them a stimulator instead of surgery as a first option and all healed their fractures. These included stress fractures of the tibia, metatarsals, and periprosthetic fractures in total joint replacements.

I feel that the Exogen is by far the most superior stimulator on the market, and I've used a variety of other brands.

I believe it is unethical to withhold an FDA approved treatment for fracture care.

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My practice sometimes receives referals from other Orthopaedics surgeons in smaller communities. I have found ultrasound stimulation to be a vital component in treating non-unions or fractures in patients who might be a great predisposition for non-union. In addition to non-union of fractures, it has a role in non-unions of arthrodesis as well. Unfortunately, it is not covered for the last two cases. It is covered for non-union of fractures only. Opportunities to avoid revision surgery are being potentially lost.

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As a foot and ankle surgeon, I have seen the evidence that this type of modality for treatment of non-union fractures really works. It is an essential part of the practicioners arsenal in order to treat these in a manner that is consistent with the standards of care. Especially if the patient is not a surgical candidate...ie, co-morbidity, uncontrolled diabetes, poor circulation...just to name a few. Without this type of madality, I think that the only person who suffers is the patient. I have treated patients with this modality that had significant improvement within 6-8 weeks after failing on other bone stimulators that had been used for 3 months or so. There should be considerable consideration in this matter as to the benefit of the patient.

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As an Orthopedic surgeon at the Mayo Clinic, I am pleased with the science behind the Exogen unit. No other Bone Growth Stimulator has the important clinical science information like the Exogen Bone Stimulator. I am also pleased with the high rate of compliance the Exogen has compared with other Bone Stimulators. 20 minutes vs. 10-12 hours.

Please consider removing the surgical intervention restriction regarding the Exogen Unit in order to level the playing field and to give these patients a better chance of not having to go through painstaking surgery.

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As an Orthopedic surgeon at the Mayo Clinic, I am pleased with the science behind the Exogen unit. No other Bone Growth Stimulator has the important clinical science information like the Exogen Bone Stimulator. I am also pleased with the high rate of compliance the Exogen has compared with other Bone Stimulators. 20 minutes vs. 10-12 hours.Please consider removing the surgical intervention restriction regarding the Exogen Unit in order to level the playing field and to give these patients a better chance of not having to go through painstaking surgery.

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I am writing in response to the use of the exogen bone healing system.The surgical caveat should definatley be removed. Many patients have multiple comorbidities and are not surgical candidates. The ability to use the exogen system can often eliminate entirely the need for costly and risky surgeries.The use of the system on fresh fractures also is very beneficial to the patient in terms of healing time. To wait ninety days is preposterous if the system were applied imediatley when necessary the fracture will be healed in ninety days. Thank You for taking the time to read this comment.Sincerely Michael Smith PA-C.

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In my practice, the use of ultrasound bone healing therapy has been an asset to my patients outcome. As cortical and cancellous bone carry the same properties in every bone; I use ultrasound healing therapy for all osteo-defects. Not only do I use it in adjunct to surgery but lieu of surgery for non surgical candidates. Many of my medicare patients tend to be non surgical candidates and therefore these patient have limited treatment options. Currently commercial insurances approve ultrasound therapy for fresh fractures and non unions without regard to surgery but according to the patient's prognosis. I would like to see these options for medicare patients.

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To whom this may concern, I have been using Exogen for the past 2 years and my concern regards Medicare patients not medically fit for surgery. Often these patients have fractures which need all forms of conservative treatment available without jeopardizing the patient’s health by going in for surgery. Using Exogen on patients that are not surgical candidates allows me to treat their condition aggressively, and at the same time as minimally invasive as I can. By deciding to remove the surgical caveat under the current guidelines will allow me to confidently treat patients aggressively, as well as maintain their current health status.
Thank you,
Aaron Daluiski

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I have been Practicing orthopaedic surgery in private practice in Long Island, New York since 1978. I have an active pratice which includes trauma, sports, and joint replacements. I have had the opportunity to use Exogen for approximatly 5 years and have had only positive results. I have used it for fracture healing primarily and all have had accelerated heal times whether it be fresh fractures, delayed union, or non-union fractures. I, therefore, would like to continue to use Exogen in my practice on all of my patients as proactivly as possible including those who have Medicare and not subject to surgery. Many of my patients with Medicare are of an older population and are not condidates for surgery or would not be able to tolerate surgery do do their advanced age. Therefore, I want to treat them with Exogen as quickly as possible and have them heal faster, and throw out the possibility of complicating the situation if the patient doesn't get their range of motion back, or something worse, becuase their fracture didn't heal on it's own and they cannot have surgery.

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I am writing this email regarding the use of low-pulse ultasound stimulation "EXOGEN". In my experience as a doctor and surgeon, I have used this unit for several different applications. The product has changed many aspects of my clinical decisions making process when confronted with difficult fractures and patients with comorbidities with increase risks during surgery.

The largest group of patients that have benefited from the device are my workers compensation patients. This is because the worker compensation carriers have agreed without hesitation to approve the use of the device for fresh and complicated fracture as well as non- unions without surgery. They understand that getting a person back to work faster and healing fractures without requiring surgery is better for them and for their client.

There is so much data supporting the use of non- invasive ultrasound therapy that I won't bother you with the details. It is all readily available.

I would be happy to present you with the abstracts if you would like. Needless to say. My patients are greatly benefiting from its use. I am unable to offer this great treatment option to my patients with medicare.

I must explain to medicare patients that I have a great treatment that will heal their fracture quicker and in many cases, without surgery, but that medicare will not cover it. Many patients are left wondering why they can't benefit from this, they feel discriminated against because they have medicare.

When I explain to them that medicare requires that I do surgery on them and then wait several months, they are left very confused. This confusion is well justified. It is my opinion that the decision to not cover this treatment modality puts medicare recipients at greater risk for complications and a much longer recover. I know from my experience that the longer it takes a patient to recover, the more chance of additional problems with their overall health and wellbeing.

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I work in a podiatrist office and have seen and heard first hand from patients the wonderful results achieved by using the bone stimulator on fresh fractures. Many of the patients I have seen have diabetes and a list of health problems which made it difficult for them to have surgery. Using the bone stimulator has helped them to recover from their fractures before complications set in and in some cases preventing the need for surgery. I would recommend highly allowing the use of bone stimulators on fresh fractures.

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The exogen system is undoubtedly one of the best ultrasonic bone stimulator systems available in our tools for treating fractures, specifically new or fresh fractures as a result of trauma or in patients who have severe risk factors for poor bone healing. I have had the unfortunate experience of seeing many patients whom are diabetic, have osteoperosis, poor circulation, smoke, and in general are poor candidates for healing much less having surgery for fixation of these fractures. These patients whom often are not good "bone healers" go on often to have poor results in terms of bone healing and end up with expensive follow up and treatment for non-unions and malunions when this couldve been prevented and treated in the first place with a bone stimulator. I know that when I do use a bone stim with surgeries on high risk patients the results are fabulous and the patients are happy and healthy. I whole heartedly endorse this product for use with new fractures and hope you'll understand the need for this tremendous modality.

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The Exogen device has shown in studies to greatly increase the healing rate of non-union and fresh fractures. The surgical caveat for this device should not be considered. No other bone growth stimulators currently on the market have this caveat and moreover, consider the costs involved in the patient having surgery vs an Exogen placed on the patient. Many times patients are placed with an Exogen who are not a surgical candidate because of the risks involved and survivability. Consideration for this device should be consistant with other similar stimulators.

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I have seen impressive clinical results with the Exogen unit in my practice. I think of this modality as an alternative to more traditional surgical procedures for nonunions. Several symptomatic metatarsal nonunions have healed or greatly improved with the use of this unit. I would like to have this modality as a treatment option for my Medicare patients prior to taking them to surgery. Also there are many patients that have medical conditions that would prohibit a surgical nonunion repair in which case the Exogen unit would be and excellent therapeutic choice.

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I am a current physician using Exogen. The documented evidence for Exogen's success in healing nonunions with without prior surgery is adequate. Implementation of this decision to continue with this surgical caveat would deny Medicare beneficiaries access to this FDA approved device. Many patients can successfully be treated with Exogen and therefore avoid any surgical intervention. This proposed decision would limit my ability as a physician to prescribe this FDA approved device and therefore would limit patient care.

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I believe it is imperative that Usx for non union of fractures be taken into consideration without the need for surgery or a delay of 90 days. In the long run not only will it benefit the patient in facilitation of healing fractures, but would save the healthcare system significant amount of Healthcare dollars. I believe the addage 'Lets not be penny wise and pound foolish' should play an integral role in this decision making process. This will enable physicians to treat patinets with vascular disease and diabetes without surgical intervention for those appropriate patients who meet criterea set forth by physicians.

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I use Exogen because my patients way of life isthe most important aspect of my practice. Ifthere is a product that can get my patients backto their everyday way of life faster and as minimally invasive as possible I will use it. Iam very much concerned about the surgical caveatthat is attached to the medicare guidlines forthe use of the Exogen Ultrasound BoneStimulator. In the past I have had patients that were notmedically fit for surgery and I needed a way toaccelerate their healing. Although Exogen isproven to accelerate healing, I was not able toget the machine approved becuase the patientneeded to have one failed surgery. To have adevice that is proven to accelerate bone growthis a benefit to physicians, patients andinsurance providers alike. Doctors are able toprescribe Exogen for their patients, thereforeusing all necessary means possible to help theirpatients go back to 100% of their dailyactivities. Patients who receive Exogenaccelerate their healing process and get on theroad to recovery faster, are back to theireveryday earlier, and understand their doctor hasdone everything possible to help them heal. Insurance providers who approve Exogen have theability to cut their costs down because thepatient does not have to get as many x-rays done,does not have to go to the office as often, hasthe possibility to forgo surgery becuase they arealready healed, etc. I believe that dropping the surgical caveat isbeneficial to all parties involved, and firmlybelieve that the patients are the group thatbenefits the greatest.
Thank you kindly,
John Kennedy, MD, FRCS

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Dear CMS,

I am writing to you to recommend that your current guilines for bone stimulators NOT be changed.

The proposed changes would bring unneccessary and obtrussive citeria to a modality that has been demonstrated to be effective with out the use of surgery.

As a Foot Surgeon, I reccommend that bone stimulation be used as a stand alone therapy with out the need of surgery as a prerequisite for it's use. Surgery can evoke a plethora of unneccessary risks and complications , especially on the geriatric popiulation who have diminished circulation and a lowered healing potential.Please DO NOT change your guideline. Thank YouDr. Oliva - Miami, Florida

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We have been greatly pleased with the success of the Exogen Fracture Healing System in place of operating on the fracture. Often times there are certain patients who, due to age, bone density or chronic illness that are not candidates for surgery, like most Medicare patients, but would benefit from the use of an Exogen unit.Medicare currently does not offer reimbursement for patients who have not had surgery. It makes absolute sense to remove this guidline and save both systems money and the patient a surgery.

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I am a podiatrist who is concerned about the decision CMS has made to exclude Ultrasound Stimumlation for Nonunion Fracture Healing without prior failed surgery. It is in my opinion many of the patients who fall into this category are not candidates for surgery due to their inability to heal due to their age and associated vascular diseases. Also the bones involved are sometimes too small for fixation but still causing severe pain as with any other broken bone. I would think the least invasive method would be the best approach for someone of this age. I have experienced good results with bone stimulation and the patient has not had to undergo invasive techniques.

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It is well known in the orthopaedic community that the Exogen fracture healing system consistently heals fresh fractures faster and also is very effective in healing non union fractures whether or not a patient has had a previous failed surgical intervention. It is also very clearly understood that many patients are simply not good candidates for surgery because of age and poor health and that these are the patients who most need and can most benefit from the Exogen non invasive ultrasound therapy. Use of the Exogen device in these patients can often negate the need for risky and expensive surgery, usually requiring bone grafting and it's resulting morbidity.

Implementation of this policy would cause physicians to treat some patients differently than others (i.e. reducing care) strictly based on their age.

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To limit the use of ultrasonic bone stimulation to non-unions only after surgery is at best, illogical. The literature and my personal experience as a podiatric foot surgeon with nearly 20 years in practice have demonstrated the efficacy of this device without prior surgery. It is much easier to use than magnetic units and the success rate in my practice has been essentially 100%. To deprive my patients of this modality because of a study prompted by competing industries does not serve the public interest.

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To whom this may concern,

I've used Exogen for many years in my practice, and I believe it is an excellent product. My patients have benefited from the use of Exogen Ultrasound Bone Stimulator greatly and I personally find it dishartening that it was not approved for patients unless there is one failed surgical intervention prior to its use. In many cases, when patients are not medically fit for surgery I seek ways to treat them as aggressivly as possible in order to reduce the instance of a non-union, and to aviod future surgery which could pose further problems for the patient.

I believe it to be beneficial to all patients if Exogen was indicated for fractures that are not healing and either do not want to go for surgery, or are not medically fit for surgery do to comorbidities.
Thank you very much,
S. Robert Rozbruch
Orthopaedic Surgeon
Director, Institute for Limb Lengthening and
Reconstruction
Hospital for Special Surgery

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The Exogen pulsed US unit has been shown in the literature to accelerate fresh fracture healing as well as to have about an 85% success rate minimum of healing a nonunion. It is absolutely STUPID to require the nonunion to develope first and especially require an attempt at surgery to solve the problem before allowing use of the Exogen unit. I'm an Orthopedist with 16 years of private practice experience using stim to heal things faster. I also did some experimental work at The Univ of PA where I did my Medical School and Residency training. We showed nicely there that these things worked.Make them available, and costs of fracture can will go down, and patient satisfaction and results will go up.

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I hope the necessity for a failed surgery is removed from the required criteria for ultrasonic bone stimulators. I treat many elderly men and women with impaired circulation to the lower extremities who would not heal well from an attempted surgery, but they generally respond quite well to use of a bone stimulator. I would also think it would be in Medicare's best interest (financially speaking) to reimburse for use of a bone stimulator rather than reimbursing for a surgery. I try to treat most fractures conservatively if possible, which is generally the recommended protocol.

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As a Orthopedic Surgeon, I have the occasion to treat numerous people who for one reason or another do not heal their fractures in a reasonable amount of time. I have found that the EXOGEN unit is as good as, if not better than any other bone stimulators currently available. If we could employ these stimulators PRIOR to surgical intervention, we would save Medicare MANY hundreds of thousands of dollars per year by avoiding surgical costs. This would also save patients from the pain of having an operation. Now, while nothing is 100% effective, I feel that if this machine is good enough for pro atheletes to buy and use for fresh fractures, it should be good enough for us to use on the Medicare population. Thank You for your time.

R. B. Williams D.O.

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Ultrasound use for nonunions has been found to be efficacious by the orthopedic literature and my personal use. Medicare has approved postsurgical use confirming they agree it is a useful treatment. It is thus illogical to restrict its use to postsurgical patients. Requiring elderly patients with multiple medical problems, diminished circulation, etc. to wait many months and then undergo surgery before being allowed to use ultrasound not only exposes them to increased complications but considerably increases the total expense to Medicare. I would strongly encourage approval for coverage of ultasound stimulation both for the benefit of patients as well as decreasing Medicare expenditures.

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