Infrared Therapy Devices

I am the Administrator of a fairly large Home Care Agency in Lake Charles, La. We have serviced hundreds of patients with Anodyne therapy with outstanding results. We are treating patients that have painful Diabetic Neuropathy primarily, that could not be treated with anything else but expensive drugs. We have seen not only outstanding decreases in their stated pain levels, but decreased need for assistive devices with an increase in their sensation to their extremities. They are taking much less Neurotin, that costs them a lot of their monthly budget, not to mention the effect the more medications have on their bodies due to co-morbidities. We have seen huge declines when Anodyne is not continued to the next recertification period, and have had to reinstate this to their care plans. It is a temporary improement, but an essential one. If the patients were allowed by Medicare to own their own unit, most could be taught to administer this therapy them selves or a care giver. We have serviced only a very few patients that did not have outstanding results from this therapy. We have been amazed ourselves even after extensive research. Thank you for your consideration of my comments.

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My name is Jayne Guy and I am the rehab services manager for a SNF which also offfers outpatient therapy services. In my experience, our rehab facility has treated over 300 clients with Anodyne therapy for numerous indicatiors including: Neuropathy, pain, decreased circulation, and wound healing. Outcomes have been overall 90% effective. We have had the pleasure of seeing pain decrease and enable persons to increase quality of life. Many persons treated have been able to decrease need for pain medication. We have seen results in increased circulation and significant healing of wounds. We have also seen restoration of protective sensation in people with neuropathy, which is something no other modality has proven to accomplish.

Anodyne is a non-invasive, inexpensive modality which has proven to be very successful in our facility. I hope CMS will concider this information in the decision to continue coverage for infared therapy.

Thank You, Jayne Guy, OTR/L RSM

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I am the nursing director of a privately owned home health care agency, which was the first home care agency in the state to purchase an Anodyne unit. Since then our agency has purchased three additional units based on positive patient outcomes. The Anodyne units are used by our therapy department for gait, balance, and pain issues caused by pheripheral neuropathy. Patient documentation supports decreased pain, as well as improvement in gait and balance. Patients are encouraged to obtain home units to continue to maintain results that have been achieved with the Anodyne units used during their Medicare episodes. Patient comments indicate failure to continue with the Anodyne modality once home care has ended, results in the loss of progress, increased pain, and patients returning to their initial level of pain and numbness in lower extremities. Significant progress has also been made with wound healing. This agency has also created a power point presentation based on dramatic results with what we considered "non-healing" wounds. Wounds showing little improvement over a 10 to 12 month perioed were healed with the use of Anodyne in addition to the dressing change protocol that had been ordered.It was with much dismay that we received reports of denials for home units and the retraction that the Anodyne company is being required to make regarding improvement in pain. CMS has mandated P4P, OBQI processes where we are required to improve pain, improvement in all ADL's, disease processes and in a population that is in decline due to the natural aging process. We have an opportunity to utilize a modality to make significant improvements in quality of life and chronic diesease processes, however CMS is considering eliminating a mechanism that can help us achieve mandated improvement outcomes. Reimburse for this product and allow treatment to cover pain reduction!

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I have only recently began providing Anodyne Therapy to my patients (January 2006) and have already seen the positive results it offers. The benefits provided by Anodyne Therapy are unique from any other modality we have to offer the patient type treated with Anodyne. I have only treated 4 patients over the last month since I began using this treatment, but have experienced a 100% success rate. Two of the patients were treated for neuropathy, one from Diabetes and one from post-chemo treatments. They both experienced significant decrease in pain, improved sensation and increased ambulatory status. The other two patients were seen for chronic pain and each had a pacemaker making them unable to receive other modalities for pain. The Anodyne helped to reduce pain in both cases.

I am in private practice and, as such, need to be compensated for every treatment provided to stay in business. I have, however, offered this treatment to my patients at no cost to them as I am so pleased and excited by the positive results this therapy has to offer. It is an effective treatment and one that provides relief to individuals that have no other options for treatment and should most certainly be a covered service.

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I am disappointed in Medicare's limited coverage for Anodyne Therapy. There are numerous published studies supporting its efficacy. In additon to this, Anodyne has been effective for several of my patients. Some of the results have been near miraculous. I have witnessed first-hand patients being cured of chronic foot pain. I have seen return of sensation in people that have not felt their feet for years! I feel it is short-sighted not to understand how this will save Medicare in the future.

Derek M. Andrews, DPT

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As an area manager for a multi state home health provider I have heard many anodyne suces stories. Our primary diagnoses of treatment have been Diabetic neuropathy and chronic unresolved pain. We have treated over 100 patients with a significant reduction in reported pain observed by the 4 - 5th treatment. All patients have responded positively some more than others. The more chronic the condition the longer it takes to show an improvement.

One patient story stands out and I would like to share this with you. We saw a patient who had chronic pain and loss of motor function related to diabetic neuropathy. This patient was able to report a decrease in pain from a 10 + to < 3 after 7 treatment sessions. He also showed great imrovement in peripheral sensation and therefore improved his gait from a slow shuffle to heel toe normal gait. The improvement in this patients quality of life was tremendous and would not have occurred had he not received the Anodyne therapy treatment. This patient had tried several other treatment options medications and therapy without any improvement.

Anodyne therapy has been very successful for our patients with the appropriate diagnoses. Please consider these patients and their success when you contemplate the future of this very valuable treatment modality...

Thank you

Melanie Kuehn
Area Manager
LHC Group

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I have been using this modality for the past year after doing my doctrate work on diabetes and treatment options. I was very skeptical of this treatment and kept specific numbers/ outcomes on my patients. I was surprized to find such positive results. I currently use Anodyne still informing patients that is is a out of pocket expense and having them sign ABN for treatments. This past weekend I saw a former patient who came upto me and thanked me for the treatment she had recieved and said she is able to go about her housework without pain, able to shop for food and not spend as much time at the doctors office and reduction in her medication since having treatment and being set up with a home Anodyne unit. I hope you will change your ruling and cover this treatment option. My patients are informed that this is not a cure but a way to manage their neuropathy to allow ADL's.

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I have treated over 100 patients in a home health setting with MIRE over the last 4 years. At first, when this therapy was introduced and I recieved training, I was extremely skeptical that it would provide the advertised results. Much to my surprise, I saw remarkable results of returned sensation in a most patients that had loss of sensation on the bottom of their feet. Since I pre and post test with the patients eyes closed and the patients are unaware whether I am really touching (5.07 monofilament) them, the patients cannot give inaccurate results that I wouldn't know. I have seen significant functional improvement in patients with returning their sensation, people going from falling down regularly to no falls. I have seen many patients with chronic diabetic peripheral neuropathy be able to quit medications such as Neurontin because of a major reduction in pain from MIRE. I have not seen any other modality or treatment that has provided these specific results in my 20 plus years as a physical therapist.

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I have been working with the Anodyne therapy system for over 3 years. Most patients (approximately 85%) who are adherent to the program receive benefits including decreased numbness/tingling/burning, improved (if not return of full) protective sensation, improved balance, ability to distinguish gas and brake pedals, and significant improvements in balance. This has also helped several patients suffering from wounds heal faster and with less pain that they imagined.

If something exists which improves sensation, reduces pain (and therefore the need for medication), reduces risk of falls and other progressive problems due to neuropathy (such as wounds, hospitalization, and amputation), let's use it and get the appropriate coverage for this service. Several peer-reviewed journals have published research indicating just these kinds of positive changes.

Please help those suffering from neuropathy, whether insidious onset, due to diabetes or due to pharmacological problems, by providing improved coverage and continued support of Anodyne therapy.

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I began treating patients with Anodyne Therapy in December, 2004. Since then I have treated approximately 300 patients. Of the 300 patients about 70% are diabetic, the other 30% include patients who had nerve damage from injuries, chemotherapy, and various other causes. Many patients have had chronic numbness while others have chronic pain and then others have both.

My findings clinically are very consistant with the literature. 90% of patients responded to Anodyne Therapy. Some patients only need 5 or 6 treatments to be completely symptom free while others may have 20 treatments and only have 50% relief.

Many patients I have treated who recieved relief had been suffering for many years. Many could not sleep at night. Others had difficulty with balance, couldn't drive because they weren't able to feel the gas and break pedals because fo the severe numbness, and so on.

There is no question that this therapy works and is extremely useful in treating patients with neuropathy and other medical problems that respond to increased circulation to the tissues.

Specifically, when a patient who has numbess can not feel it when they have a blister or open wound or even a fracture, the risk of developing more serious problems occurs. Especially diabetics who don't fight infection well, are at a much higher risk when there is numbness of the feet. Diabetic shoes are covered by Medicare because the literature has shown that proper shoes and insoles can prevent ulcers, infections and amputations.

When sensation can be restored the same results occur; in addition patients can walk better and this results in less falls which means less fractures, head injuries and a huge decrease in healthcare expenses. I would say that most patients see dramatic improvement and almost all see at least marginal improvement of balance and gait with a combination of Anodyne Therapy and physical therapy.

Most (90%) of patient who have been treated at my clinic have had lasting results. of the 10% of so who have not had improvement that has lasted long term (more than one year) usually it only takes a few treatments over a week or two to bring them back to feeling good. Very few patients who have relief need to have regular treatments.

This modality is an extremely useful one that many more patients would benefit from if it was covered by Medicare.

Please contact me if I can be of assistance in supplying any other information.

Brian Gale, DPM, FACFAS

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I utilized Anodyne on a diabetic patient who had already lost one leg and was told by the MD that his other leg would have to be amputated ASAP because of chronic large diabetic wounds. I asked the MD to let us try Anodyne first to save the leg and he agreed but didn't hold out much hope. We had been using standard woundcare techniques on this huge necrotic wound for months but the wound just kept getting worse!! I started Anodyne therapy on March 25th 2005 and the results were so dramatic within the first two weeks. The wound started to pink up and show signs of life. By one month of treatment, the wound was red and beefy and full of granulation tissue. And the last time I saw the patient (in January 2006), who had been sent home from our hospital in September with a home unit, the wound was completely closed!! AND, the MD told me that PRIOR to Anodyne treatment, the patient's Tcpo2 [transcutaneous partial pressure of oxygen] levels were very low (out of potential healing range) but when measured a month ago, the Tcpo2 levels were significantly higher and in a range that was condusive with healing! He is now a believer!! It is my strong belief that Anodyne can heal diabetic wounds, PREVENT the wounds in the first place, save limbs, and save lives!

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As an occupational therapist, I've had the opportunity to use Anodyne with several patients with lateral epicondylitis, infection/edema, and carpal tunnel syndrome. I am currently beginning use of this adjunctive treatment with a stroke victim who has complaints of shoulder pain. My historical use of the infra-red treatment has been very cost effective for our clinic as we were able to decrease the elbow pain due to the lateral epicondylitis, cure the open wound and edema resulting in decreased finger movement and function and decrease the pain and parestesias from the carpal tunnel sydrome. I have only begun using the Anodyne infra-red treatment with a stroke patient and, therefore, do not yet have results. I am also going to begin using this with a 13 year old for contractures following stem cell replacement 2ndary to luekemia. I am confident this treatment will expedite her treatment program and return her to normal motion of both wrists and fingers.

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We have recently started using infrared at a couple of the nursing homes and outpatient clinics that we serve. We've treated roughly 10-15 patients in the last month with good outcomes with a variety of diagnoses: peripheral neuropathy, wound care, contracture management, pain management. One person, having tried traditional treatment options, had a knee flexion contracture improve by 20 degrees in just over a week increasing her functional mobility and safety. It has been effective alternative to traditional treatments methods when they have not been effective. In general, we have been pleasantly surprized with the outcomes.

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I have been using Anodyne therapy in our clinic for several years. I have seen some very good outcomes with increased sensation, decreased levels of pain, improved balance, increased ability to sleep and increased activity levels.

I primarily treat people with diabetic and non-diabetic neuropathies who have been limited by painful, numb feet and legs. These people have usually tried and failed intervention with medicines due to side effects of impaired thinking, impaired balance and poor control of symptoms.

Although Anodyne is not effective for all patients with neuropathy, for the patients that it is effective, it is like a minor miracle. Neuropathy is so overwhelming, patients are highly motivated to participate in any program that provides relief and I have seen good carryover with home unit compliance.

Prior to MIRE, I had little to offer patients with neuropthy and feel MIRE treatment is a reasonable treatment route for many patients.

Thank you for your consideration in this matter.

Anne Bennett, Physical Therapist

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I have found that in the past 2 years of being a provider of Anodyne infared therapy, that it is the single most effective means of treating and managing peripheral neuropathies and peripheral circulatory deficiencies that I can offer as a therapist. Additionally, it provides a wonderful means for patients to progress towards self-management of their own symptoms via a home unit once its treatment efficacy has been established in a clinical setting. Please continue to recognize this as a valuable (and reimbursable) treatment entity.

Thank You,

Eric Pitcher, PT, MS, CSCS

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I have successfully treated, in physical therapy with Anodyne therapy, a patient suffering from bilateral neuropathy causing balance disturbances secondary to diabetes.
The patient received Anodyne therapy for 45 minutes three times per week for 6 weeks in addition to exercises. The patient's pain in bilateral extremeties was 0/10 and his balance score on the Berg balance test at the time of discharge from PT was 53/56. The patient is now safe to return to his previous activity level without fear of falling. This patient is 72 years old. He would continue to benefit from Anodyne as a home treatment to prevent the symptoms of neuropathy from interfering with his balance and safety.

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Infrared therapeutics like anodyne therapy is an important adjunct in the management of chronic diabetes conditions that include peripheral neuropathies that commonly affect our patient population. Medically reviewed literature currently available reveal that this treatment is effective and safe.

With the growing chronic pain population we as providers will need Medicare to stay on top of the latest research that reveals that anodyne and like therapies are effective and medically justifiable.

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Our home care has been using infrared therapy (Anodyne) for the last 4 months. We have treated 8 wounds - the most dramatic (have pictures)was a diabetic foot wound. The client had undergone great toe amputation and had a non-healing diabetic ulcer on the bottom of his foot.

Treatment over the past 3 years included wound vac, debridement, and enzyme therapy. Infrared therapy was initiated on Dec. 21, 2005. On Dec. 27, the area of excoriation was gone and the wound bed was pink and healthy. On Jan. 9, the wound was 25% smaller. On Jan. 11, he called the on-call nurse at 2200hours because of 'something is wrong'. The nurse made a visit and the 'wrong' was the fact he had feeling in his feet - the first time in 8 years! Anodyne was being used for wound care, and he experienced an added benefit of decreased neuropathy.

We have also treated 2 clients for neuropathy - each have experienced betterment in their Tinetti scores after 12 treatments, with continued improvement over the next 12 treatments (data available).

Overall, our organization has seen decreased client falls (too early for statistically demonstrated improvement), as well as remarkable wound healing.

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I have had numerous success stories related to the Anodyne infrared unit in my physical therapy practice. The main success stories are related to the neuropathy and wound are patients, but also Raynauds Syndrome, Restless Leg Syndrome, various pain areas, etc. I have treated nearly 20 patients over the 3-4 months since recieving the unit with approximately 90% success rate. HOwever, the reimbursement by MEdicare is non existant and needs to be changed to reflect the benefits companies are providing. We do not have any other modalities that work like the infrared therapy to provide these types of benefits to patients who are unable to exercise due to pain. We are working on getting home units for several patients to continue their care at home. Thanks for reading my comment. Please contact me if you have questions at ***-***-****. Thanks.

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I do marketing for Intrepid USA Homecare. We are a home health agency in Somerset KY. We cover 17 counties and have been using Anodyne in most of these counties now. Some counties do not have Anodyne yet because of Physical Therapy Assistant staffing problems. As soon as we can Anodyne will be in all locations. We have had tremendous success with this therapy. We have prevented amputations, relieved patients of pain, healed wounds, and helped patients walk again. This is a miracle machine. I call on a doctor's office in one of my areas who the nurse in that office had a grandfather facing amputation with heart problems. When she heard about this machine she called here grandfathers doctor and told them to try this. He is now doing well. The surgery has been cancelled and she is so thankful that we were able to help him with this machine. She says it's an amazing machine. When you can help people have back the quality of life they deserve and avoid amputaions, see people walk again, see people live without pain and see wounds healed that people have suffered with for years, that the most wonderful and gratifying feeling you can have. Thats what healthcare is all about.

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To whom it may concern: I have been using Anodyne therapy for the past two years. I have found it to be very effective in peripheral neuropathy patients. They have been able to gain 75%-100% of their protective sensation back in their feet and improve balance to be safe with ambulation with out the risk of falls. I have also used Anodyne therapy with lymphedema management. In patients where the traditional manual lymph drainage and compression wrapping has been done with partial benefits, I have used the Anodyne therapy and reduced limb size by 30%- 50% with decreased pain and tightness from the lymphedema and a significant reduction in infection. One patient in particular was having infections every two months or so. After anodyne therapy she has not had anymore infections and this has been about one year. RuthAnn Burke PT

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I have find that Anodyne Therapy is very beneficial to patients with neuropathy. I have treated 12 patients over the last 9-10 months. My patients have had a 92 % success rate. Only one patient has not benefited to the infrared treatment, and it is questionable to me if he really had neuropathy. Diabetic patients with lack of circulation is the majority of patients I have treated. 2-3 out of the 12 patients have had non-diabetic neuropathy. Because of the great results my my patients have achieved in objective measures and functional improvement as well as subjective improvements, I believe Anodyne is a necessary component for treatment of neuropathy. Most of my patients come to receive this treatment as a last resort. They have not responded to medications, exercise or other treatments. Most say they have lost hope prior to this treament. After recieving about 10 treatments they began to notice a decrease in numbness and pain. After 20-24 treamtents patient had a signficant improvement in mono-filament testing for senasation and improved unilateral balancing.

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We have been using Anodyne (monochromatic infrared light) therapy in our clinic for the last two years for the treatment of diabetic and peripheral neuropathy. We as physical therapists along with podiatrists, were growing frustrated with the lack of success with conventional therapeutic methods in the treatment of the symptoms of neuropathy. A hot-pack used in a therapy setting only penetrates a centimeter or two below the surface of the skin. What Anodyne therapy provides is a "deep" heat that helps provide vaso-dialatory effects beneficial to a neuropathy sufferer. Anodyne therapy should be used in combination with stretching, strenghtening, proprioception/balance training, safety training, and a thorough home exercise program.In our clinic, Anodyne has proven to be effective in decreasing hypersensitivity, along with improving sensation and proprioception, all of which have a direct effect on ambulation quality and safety. Most patients we have treated since using the Anodyne machine were given sensory tests before and after the recommended eighteen treatment sessions. The results were positive and have helped re-enforce Anodyne's claim that it can provide a "ray of light" for diabetic/peripheral neuropathy victims. This sensory information has been instrumental in getting insurance carriers to recognize the effectiveness of monochromatic infrared therapy, and in getting patients home units. I am sure we can arrange a look at some of the pre and post obective information if necessary. A good number of people who suffer with neuropathy fall within the Medicare population. It would be a shame to see this group of people forced to suffer more if Medicare decides not to provide coverage for infrared therapy devices such as Anodyne. I ask that you consider infrared therapy as a safe and effective tool in the conservative treatment of neuropathy symptoms and improving the quality of life. Thank you for your time.

Sincerely,

James Doerbecker P.T.
Performance Sports
Medicine & Rehab.

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I am the director of a small outpatient clinic in Galesburg, IL. We began using Anodyne therapy (infared light therapy) in October 2004 and have seen some remarkable results.

*Have 2 units in clinic
*Typical Rx consists of Anodyne therapy, followed by individualized program to meet the patient's needs: balance/gait retraining, therapeutic exercise, soft tissue mobilizations
*Estimated 85 patients treated with Anodyne, with greater than 80% of patients reporting improved symptoms (decreased pain, improved sensation, improved LE strength and balance)
*I decided to purchase a unit after I saw a 4cm x 7cm wound on a calf that was 5 years old completely close after 9 sessions; this gentleman had a poor healing wound after a motorcycle accident, was in his 50s, and had been treated with various wound care interventions from Mayo Clinic and the University of Iowa
*I have had patients with >25 yr history of peripheral neuropathy reporting ability to distinguish grades in carpeting, feeling rocks in driveway after one month of treatment
*I have had 3 MDs contact me (2 GP and 1 Neurologist) asking for more literature about the Anodyne treatments after their patients had improved balance and sensory testing, as well as reduction in pain medicine and Neurontin intake
*In my 14 years of being a physical therapist, I have not seen any results for wound healing and neuropathic conditions such as observed by myself and my staff with Anodyne therapy

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I am a marketing representative for a home health agency in Longview, Texas. This market is so competitive that I have found our niche to be "Anodyne". My presentations have included physicians, hospitals, rehabilitation and sniff units, assisted living facilites, diabetic awareness groups, and the general senior populous. Although our census is temoporarily small, we are using two Anodyne machines. One for our rehabilitating patients (admin. by PT) and one for our wound care patients (admin. by LVN/RN). We are aggressvie because we are proving positive outcomes. Recently, we finished our first case study on a patient whose wound decresed by half in just four days. We are currently using Anodyne therapy on particular patients, approved by their physician, to assist with cellutis, edema, pain control, and wound care. We are excited with the results. In fact, we began using a physcial therapist who in the beginning did not believe Anodyne therapy was effective. After, using it on our patients, which required the therapy, he now believes it is effective. As we, as a whole, continue to use Anodyne therapy and generate case studies, Medicare will change the way they see this modality. I believe, this is a great benefit to so many who suffer!

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OUR PHYSICAL THERAPY PRACTICE HAS TREATED OVER 3,500 PLUS PATIENTS IN THE PAST 4 YRS. FOR PAINFULL NEUROPATHY, CHRONIC PAIN AND LOSS OF PROTECTIVE SENSATION. WE HAVE FOUND THAT CLINICALLY 90% OF OUR PATIENTS WHO CONSISTANTLY FOLLOW THE PROTOCOL OF TREATMENT DEMONSTRATE SIGNIFICANT IMPROVEMENT IN SYMPTOMSDECREASED PAIN, NUMBNESS, BURNING AND TINGLING WITH AN INCREASED BALANCE SAFETY. IT IS IN OUR STRONG OPIONION AND FINDINGS THAT THESE ABOVE RESULTS COULD NOT BE OBTAINED WITHOUT THE USE OF INFARED THERAPY (ANODYNE) OR WITH OTHER MODALITIES.

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I have treated 49 patients with Anodyne Therapy over the past 25 months. These patients were referred to physical therapy with varying medical diagnoses including diabetic peripheral neuropathy, idopathic peripheral neuropathy, non-healing ulcer of the foot, foot pain, peripheral circulatory diorders, etc. These patients have had varying levels of sucess RE: alleviation of sxs/healing. I have NEVER had a negative consequence. Approximately 50% of patients have had "complete" resolution of symptoms, approximately 25% of patients experience "good" results, and the other 25% report "some" relief. This kind of success has not been possible until Anodyne Therapy became a treatment option for these individuals. Among the many positive comments I have heard from patients, one sticks out in my mind. I had a patient report that his feet had not felt this good in over ten years. My staff spends 1-2 hours weekly preparing paper claim forms because Anodyne therapy is currently considered an "unlisted modality." Thank you for your prompt consideration in this issue. DAVID CROTTS, DPT

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i am a physical therapist who uses the anodyne infrared light therapy often for my patients. it is a remarkable piece of equipment when used in conjunction with our Balance/Fall prevention program especially for those with neuropathy.

i think it would be great for patients to have access to a home unit once they have gone through a round of therapy to see whether or not it is beneficial to them.

if patients can perform anodyne at home along with there exercises, they would not need to return to outpatient PT for the same problem over and over.thanks.-kamal mody, PT

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As an RN we frequently use this form of therapy in conjunction with nursing care. I have seen many patients have significant relief from pain that that have not been able to achieve with traditional medications. I also have observed the healing of stasis ulcers that could not be healed after one year of treatment through wound care clinics. Due to the economic status of this clientele, these patients could not have received this innovative form of treatment without the assistance from Medicare benefits.

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As an administator of a home health agency, we started utilizing the anodyne treatment on numerous patients of ours and we have seen alot of success. The majoritity of our patients have Diabetic Neuropathy and Status ulcers. We have had several patients purchase the home units due to their success of anodyne and the way it has changed their lives. I have a relative who lives in Oregon who is attending nursing school and I told her about this therapy and she has educated her professors along with the local home health agencies. The only drawback is the deductable that the patients have to come up with for a home unit. The majority of our population can hardly pay for their medication and food let alone a $500.00.

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Indications/conditions treated with RevitaMed PILTPeripheral Neuropathy related to Diabetes and idiopathic.

Outcomes/responses to RevitaMed PILT: We have had excellent results with this equipment. Patients have reduced pain in their feet. Patients have improved sensations and reduced numbess leading to improved gait and balance. Patients have also reported reduced tingling and burning in their feet.

Number of patients to date that have received RevitaMed PILT treatment: Approximately 15 patients have been treated with RevitaMed PILT.

Clinical data demonstrating efficacy of RevitaMed PILT treatments: We collect patient data using the pain scale, the monofilament test for sensations, tinetti's balance and gait scale, MMT for strength.
Pain scale: upto 5 points of reduced pain.
Monofilament test: 1-2 points improvement.
Tinetti's scales: 2-3 points improvement.
MMT: 1/3 to 1/2 grade improvement.
The above data differs from patient to patient.

Improvement to patients’ quality of life initiated by RevitaMed PILT treatment: E.g. Improved balance and thus reduced frequency of falls. Easier to get in and out of the chair. Improved posture.Able to sleep better. Improved community ambulation.

How RevitaMed PILT treatments reduced patients’ risks of further complications or injury RevitaMed PILT combined with therapeutic exercises helsp in improving balance, strength, and flexibility in our patients. This reduces their risks of injury due to falls.

Safety of RevitaMed system (i.e. 0 patients have received burn resulting from RevitaMed PILT treatment): No incidents of burns reported from RevitaMed PILT.

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I am an Occupational Therapist that has used infrared treatments for many diagnoses over the past two years. My primary usage has been for pain and improving sensation to restore ability to walk, decrease risk of falls, and use of hands for fine motor coordination. I have mnay success stories. I will share my most recent one...

I started a patient on infrared treatments coupled with occupational therapy treatment including self care skills, fine motor coordination, strengthening, mobility, and safety. Prior to my intervention, she had lived independently in apartment complex, but had declined so much that she gave away or sold all her furniture and moved into a skilled nursing facility. We started working together in Nov. 2005. Daily treatments to first her hands, along with thjerapy as listed above, brought her hands back to functional usage. A time of starting, she was unable to dress herslef, bath herself, walk more then 5 feet, unable to toilet herself or clean after toileting, had great difficulty with self feeding requiring built up adaptive utensils. She improved so dramatically in her sensation becasue of the infrared, that the therapy for strengthening and coordination move quickly, and by dec. right before Christmas, she moved into her own apartment in an assisted living setting. She needed to ask for her furnitur back, and go buy what she couldn't get back! At that time, she was walking independently from bed to toilet, independently dressing and sink side bathing herself, independent in self toileting skills, and bed mobility.

Occupational therapy continued to treat patient in new environment with focus more on sensation in feet as well as to ensure maintainance of function and improve function in areas still difficult. From the end of Dec. 2005 until the beginning of Feb 2006 she was treated, and at time of ending Occupational therapy and infrared treatments, she was independent with walking safely with no falls, about the facility, and has total use of her hands.

Without the infrared treatments coupled with Occupational Therapy, this lady would have spent the rest of her life in a nursing home, draining her finances and ending up on state funding, with poor quality of life. There is little treatmetn that actually works for those stricken with peripheral neuropathy. Since this treatment actually works, why would we want to take it away? Why should she live with pain, when it can be minimized if not eliminated? Why should she be confined to a wheelchair because she can not feel her feet on the floor, when infrared can and did bring back her ability to walk safely again? As a therapist I want to help people. As a person, I want to know that there will be treatment available to me if I ever need it. Please continue to provide coverage of infrared treatments, as it is necessary and works. Thank you.

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Medsource home care began using Anodyne therapy in October of 2004. From October 2004 to October 2005, Medsource had 37.5% of the patients for physical therapy with 15% of those patients receiving Anodyne therapy. The following results show supportive data in the use of Anodyne therapy.

The Performance Improvement Committee compiled retroactive data on all patients that received Anodyne therapy from October 2004 to October 2005. The diagnoses were then divided into three categories of non-diabetic neuropathies, diabetic neuropathies, and wounds. The data analyzed for neuropathies included pain sites, pain intensity (patient rating pain on the Wong-Baker scale 0 to 10), pain type, sensation rating (Semmes-Weinstein), gait balance score (Tinetti), and subjective data of sleep quality, and use of pain medications. The data analyzed for wounds included wound type, wound site, and wound measurements along with the indicators listed for pain and ambulation.

There were seven cases reviewed with diabetic neuropathies. All of the patients’ sites were to the lower extremities with symptoms of burning, aching, throbbing, and numbness. The initial pain ratings ranged from 7 to 10 with frequency of intermittent to constant. Patients reported pain intensity would increase with ambulation and especially at night while sleeping. The average number of visits was nineteen. All seven patients reported a decrease in pain intensity ranging 0 to 5 with a frequency of intermittent to occasional. Two of the patients rated no pain consistently. Of the four patients with documented decreased Semmes-Weinstein and Tinetti scores, all four showed improvement with initial Semmes-Weinstein scores of 3/5 increasing to 4/5 to 5/5, and initial Tinetti scores of 19/28 increasing to 22/28. Three patients were identified with impaired sleep due to pain. In the post treatment evaluation, all three patients reported sleeping all night consistently.

There were eight cases reviewed for non-diabetic neuropathies. Six of the patients reported pain to the lower extremities, one with pain to the hands and one with pain to the scapula-axillary area (post-herpes polyneuropathy). The patients reported symptoms of tingling, burning, numbness, and cramping. The initial pain ratings ranged from 7 to 10 with frequency of intermittent to constant. Patients reported pain interfering with sleep 5 to 7 nights of the week. The average number of visits in this category was 10-12. All eight patients reported a decrease with pain intensity ranging 0 to 5 with a frequency of intermittent to occasional. One patient reported pain level of 0-2 consistently. There were four patients identified with decreased gait balance scores ranging 13/28 to 19/28 that improved to 18/28 to 26/28. Seven of the patients had decreased sensation ratings ranging 0/5 to 1/5 with improvements of 4/5 to 5/5. The four patients with impaired sleep had improved sleep with decreased pain with reports of sleeping all night, and decreased to no use of sleeping aids or pain medication. There were two patients with edema to the lower extremities. During the Anodyne treatments, documentation shows a decrease of edema with measurements decreased by two centimeters.

For Anodyne Therapy with wounds, there were four cases with treatment for stasis ulcers. Initial pain ratings ranged 7 to 9 on an intermittent frequency. The pain type was described as stabbing, burning pain. All the patients report improvement in pain intensity ranging 0 to 4 with decreased frequency, and decrease in use of pain medications. Each case measurements as follows:

CASE#1- 2cm(L) x 2cm(W) x 0.2cm(D); after 12 treatments wound healed

CASE#2- 2cm(L) x 2cm(W) x 0.2cm(D); after 18 treatments wound healed

CASE#3- 4cm(L) x 7cm(W); after 10 treatments 2cm(L) x 2cm(W)
3cm(L) x 4cm(W); after 10 treatments healed
Wounds present for one year prior to Anodyne therapy

CASE#4- 0.5cm(L) x 1cm(W) with eschar; after 7 treatments healed
2.5cm(L) x 1.6cm(W); after 7 treatments 2.2cm(L) x 1.5cm(W)

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As a therapist in a CORF we introduced infrared therapy services in our clinic in Novemeber. We currently have 15 active clients who have all had varying degrees of success. Some of the success has been remarkable in a clients ability to function and return to daily living tasks. Not all clients have obtained this level but of the 15 each one has had functional change that has improved their quality of life. Initially I was very skeptical, now I am looking at objective data to present as research/educational information for our area. It would be very beneficial to our Medicare clients to have this service covered.

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I have been using the Anodyne treatment system for less than 60 days, and the functional, objective, and subjective improvements are amazing. One patient was unable to sense any touch or heat on both of his legs, and after 1 month of treatment could identify sensation at the protective level at both ankles, and could identify heat/cold and light touch with both feet. Another patient presented with foot drop, no active motion of his toes, and poor sensation, and after 1 month his foot drop is almost resolved, he is stronger, has better balance, and improved sensation. Patients are reporting a large reduction in pain and in the amount of pain medication they take each day. Sleeping is improving, exercise tolerance and strength/balance continues to improve. Another patient had wounds open for 6 months, lymphedema, and peripheral neuropathy. After 1 month of treatment her pain and tingling went away, her lymphedema improved, and 50% of her wounds were completely healed. The other 50% of her wounds are healing well at this time, and responding well to treatment with Anodyne, when traditional bandaging, edema control, and antibiotics for cellulitis were unsuccessful. The patient has had no cellulitis since Anodyne therapy began.

I feel that this treatment is very effective and beneficial to patients that otherwise have very few options. It improves function, quality of life, helps prevent falls, infection, wounds and allows increased independence in conjunction with traditional physical therapy treatment.I strongly support the use of Anodyne and its integration into the approved and reimbursed medicare system. The home unit is a highly important aspect of Anodyne treatment for patients with a chronic condition and the cost of the ABN ($499) can be prohibitive. The patient will simply relapse and require re-initiation of treatment without a home unit. Please consider this in your cost-benefit analysis of covering a home unit without any out of pocket cost to the patient.

Thank you for your time-Jamie Mousaw, PT, DPT

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I am an Occupational Therapist who has been providing Anodyne Therapy to my patients since June of 2005. I have treated 25 patients since beginning to offer infrared as a part of my intervention.My patients have been diagnosed with both Diabetic Peripheral Neuropathy and Non-Diabetic PN and I have noticed a pattern developing which I have found significant. Symptoms include numbness, pain, tingling or spidery sensations, unmanageable hot or cold feet, shooting pains, balance and gait irregularities and awaking at night from either pain or restless legs. I do a monofilament test which involves 5 levels of monofilaments because it is more accurate to determine just how much improvement is achieved rather than just testing for Loss of Protective Sensation. I also do the Tinetti test for balance and gait plus annecdotal comments from my patients.I have found the following to be fairly consistent: Patients first notice a decrease in pain and thermo complaints usually within the first 12-16 sessions. Following this patient's sleep patterns start to improve. The slowest symptom to respond is the numbness. The degree of improvement has been anywhere from one level of sensation to up to three levels. This is the reason I have taken to using multiple monfilaments. In each case the minimum improvement has been to lighten the numbness to diminished protective sensation which allows the patient to note when he/she steps on someting but not identify the object. I find that using the full 36 treatments produces this last result.Of note is the fact that I have been able to identify other possible causes for the pain symptoms to be related to other diagnosed conditions such as spinal stenosis. This pain is not readily responsive to anodyne. Also as an extra benefit has been the ability to deeply probe the patient for symptomatology and I have been able to differentiate vascular numbness from neuropathic numbness and send the patients back to their physician for further treatment.

Another issue which has arisen is the number of patients with spinal stenosis who's symptoms appear so similar to neuropathy patients. I have noted that the pain associated with stenosis does not resolve with anodyne in the first 12-16 weeks as does the pain of peripheral neuropathy. Pain is also more of a complaint with these patients than numbness. In both diabetics and non-diabetics circulation is key. Non-diabetics very often have had some form of circulatory procedures such as angioplasty, stents, open heart surgery etc. Diabetics of course have poor circulation.

One final advantage to doing anodyne is the ability to affect wound issues. Often one finds the patients to be unaware of blisters, ingrown toenails, abrasions and cuts. The anodyne appears to help speed the healing of these conditions.

I also support the anodyne with massage, deep tissue work(myofascial release), point stimulation, exercise, balance and gait and sensory stimulation which magnifies the effectiveness. I must say that approximately 75% of my anodyne patients have seen an improvement in their symptoms to the point that their quality of life is improves. Those with lessr results have had either spinal stenosis or vascular problems unresponsive to increasd blood flow. I have been very pleased with the help this modality has provided to my patients and several are exploring home units to continue the enhanced effect they have experienced. These home unit will ultmately keep them active, grounded in their environment and off the treatment rolls.I hope this is helpful as I believe the since most of my patients are elderly they will be able to avoid falls and injuries for longer periods when they can feel their feet and hands.

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I am a physical therapist and have been using anodyne infrared light therapy for a little over a year now in an outpatient clinic. I was very skeptical about the benefits of this modality initially and was reluctant to use. Since using this modality primarily on patients who have neuropathy (from various causes) I am convinced that it is a useful tool to help treat especially this diagnosis. I have treated over 40 patients and over 80% have benefitted from the use of infrared. Half have gone on to obtain a home unit with some substantial personal cost. Patients have had either a significant reduction in pain complaints and/or a documentable increase in their sensation. Along with this, their balance has improved significantly and they have substantial reduction in falls and fall risk. I do not believe there is any other modality that could provide this benefit for this diagnosis at this time. Please continue to cover this modality and consider changing the current restrictions for patients to obtain a home unit.

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I have referred at least 50 patients for anodyne therapy due to diabetic neuropathy. Every single patient, without exception have had wonderful results. I have 4 patients who avoided toe amputation and 1 who was schedule for a foot amputation who still have all their toes and feet. The biggest complaint I have had from patients is that they are once again ticklish. I have seen patients who had become completely wheelchair bound, physically and mentally as a result of their diabetic neuropathy and a little over half of them now only use their wheelchairs when going out for a long day of shopping. All have reported increased quality of life and several were able to come of disability and return to work in their former jobs. I have had 3 patients that we started on anodyne immediately with the neuropathy diagnosis and avoided putting them on other meds (narcotics and Neurontin). When we figured the cost savings,( we used 1 Vicodan QID and Neurontin BID as our base), the machine paid for itself in less than 18 months didn't even factor in the addition MD visits or DME or additional services such as homecare that would have been required for thier care under traditional approaches.As a nurse case manager in a military institution, I have referred patients to home anodyne, outpatient in our building as well as to podiatry out of our building. Without exception, these patients feel this has been the greatest invention and wish that it had been avaialble to them 20 years ago. I have also seen anodyne used in several other applications besides diabetic neuropathy with almost unbelieveable results. I have seen it heal a wound that was 6 years old with numerous tunnels that had failed to improve with wound vac that would was completely healed in 6 months and that was 3 years ago and it has not reopened at all. I saw it reverse a hand contracture well enough for a patient to self administer his tube feeding and stay at home rather than entering a nursing home. I have seen it used in several chronic pain patients with 50-50 results to the point where patients came totally off their chronic pain meds.So I hardily endorse this product I think every insurance should pay for this. Thank you for the opportunity to put in my 2cents worth.

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I have not had many patients using Anodyne, but the few that I have seen have had very good results with this treatment. These patients usually had a diagnosis of peripheral neuropathy and because of their success with the clinic treatment they then went on to get home units. Their success ranged from increased sensation subjectively and per monofilament testing to decreased occurance of having the "pins and needles" feelings in their feet and increased function during daily activities. Overall the patients I have seen have reacted very well to Anodyne treatment and I feel it is a valuable modality for physical therapy.

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As experienced clinician, I would like to offer my professional opinion about the Anodyne Therapy System.

From 2003-2006, our office here in Elizabethtown, Kentucky has seen around 4,440 patients. 80% of those patients came for neuropathy,5% for wound care, 5% for chronic pain (RSD) and 5% mics. ( i.e MS,work injuries, pre and post surgery fractures, etc.)

We have seen about a 90% success rate for our neuropathy patients and 98% success rate for our wound care patients. With RSD (chronic pain), patients have had a 85% success from their pain. For our MS patients, we have a 100% improvement to some degree.

I have tried other midalities that I will not list here, but none as effective as the Anodyne with both expedient and long lasting improvements.

Please feel free to contact me with any questions you may have regarding the Anodyne System and how I use it in my practice everday. Thank you.

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I am the director of a busy outpatient orthopedic physical therapy clinic. I am also a therapist. We have been using the anodyne system as well as the cold laser for approximately 1 year. Initially I was a skeptic, but our clinical outcomes could not be disputed. The anodyne system has proved highly effective for multiple conditions but especially neuropathies. This is a patient population without much help. So to find a treatment that I have seen personally improve their sensation is remarkable. If infrared treatment including cold laser becomes a denied treatment many patients will suffer and have no help for their malady. I urge coverage for this treatment so we may have the tools to heal our patients.
Respectfully,
Linda Gogl

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To Whom It May Concern,

I am a physical therapist with 20 years of experience and a manual therapy background, which means I don't normally use many machines or modalities other than my hands. I did, however, start to use anodyne on my diabetic and peripheral neuropathy pts starting in August. I was skeptical at best. I have been amazed at the results and hope that you will reconsider denying these charges.

I am the therapist in town who sees the pts no one else can fix or figure out and I have had marginal success with diabetic and peripheral neuropathy. That is, until I started using the anodyne. The majority of pts are having a decrease in pain and an increase in sensation and safety. They are pleased enough that they are sending their friends.

We do objective measures such as the monofilamint and Tinetti scale for balance and gait. These scores are consistently higher with treatment. More dramatic are the pt's functional gains and decreases in pain. If needed, we could pull data from our clinic to support this letter.

We have also seen good improvement in pts with shingles. I have a pt with Charcot-Marie Toothes disease who is making gains as well.

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I have had very positive feedback and objective gains for patients who have been referred for diabetic neuropathy. We, as a clinic, have been utilizing Anodyne therapy in teatment for diabetic neuropathy. Consistent results have been achieved especially in the area of pain relief, sensation return, balance improvement and functional strength gains.

We have not previously been able to consistently achieve results for patients with diabetic neuropathy largely secondary to persistent pain.

Anodyne therapy coupled with physical therapy therapeutic interventions have allowed patients to become more independent and less likely to have to access the medical system for the painful effects of diabetic neuropathy. From a provider's prospective, we have not been able to consistently, successfully treat patient's with diabetic peripheral neuropathy before the use of Anodyne. Anodyne is an important adjunct of physical therapy for patients with peripheral neuropathy with and without diabetes.

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Our clinic has been treating patients with Anodyne therapy for about 7 months. We have treated approximately 20 patients in that time. Results have varied some but the majority of the patients were so pleased with the relief that they got from Anodyne therapy. Several had their symptoms alleviated remarkably, even those who had been suffering with severe pain and/or loss of sensation to the feet for many years. Even skin color and pain improved for some who had had those problems for as much as 10 years.We have treated peripheral neuropathy, diabetic neuropathy, disturbed sensation, chronic pain and wounds with Anodyne therapy. The outcomes we have achieved using Anodyne therapy would not, in my opinion, have been possible using other modalities.

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I am a Physical Therapist practicing in South Carolina. We have been using the Anodyne Infrared Unit for approximately 1 year at our clinic and have seen tremendous results. I use it primarily with patients who have diabetic peripheral neuropathy, but have also used it with patients who have unknown etiology for neuropathy. The results have been amazing. The majority of patients have significant improvements. They report decreased leg cramps and pain (usually after 1-3 treatments), increased sensation, and decreased numbness and tingling after an average of 12 visits. Objective findings show improvements in light sensation using a monofilament test, as well as improved strength, ROM and balance. We include a therapeutic exercise component to all our patients receiving Anodyne to address strength, ROM and balance as the nerves are regenerating and increased sensation is regained. I know of no other modality that has shown such significant results in decreasing pain and increasing sensation for patients with peripheral neuropathy. Most patients I treat with Anodyne are Medicare beneficiaries on a limited income and would not be able to afford the treatment on their own. I believe Anodyne Infrared therapy is a modality that is effective and feel it should continue to be covered by Medicare.

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We have used Anodyne in our physical therapy clinic since fall of 2004. We have used it for diabetic and non-diabetic neuropathy diagnoses. It has been successful in treating and managing pain, numbness(decreased sensation). It has been a useful conjunction with physical therapy to help with exercises to further help treat the pain and decreased balance in these patients. These pts are also at risk for falls which causes much increased medical care at that point. approximately two thirds of the patients treated opt to obtain the home unit for further management of the symptoms.

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Hi my name is Dr. Brian C. Karwowski. I have been using Revitamed infrared therapy for approximatley two years now. I have had the opportunity to use the therapy for a wide range of conditions that my patients have presented with. Conditions indclude acute musculoskeletal injuries, chronic musculoskeletal conditions, arthritis, chronic pain, and diabetic neuropathy. I have found this to be a very safe and effective treatment for my patients. I have experienced faster recovery time by patients and an increase in patient satisfaction.

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I am a wound care specialist employed with a home health agency. I have had great success with Anodyne therapy as it relates to wound healing as well as pain control. I have used it for a variety of wounds including pressure ulcers and failed skin flaps and have seen dramatic improvements with each. I am presently treating a pressure ulcer to the heel of a diabetic female who was having considerable pain associated with the wound as well as neuropathy. The wound is being followed by a local podiatrist who is extremely pleased with the results. The patients wound has improved greatly and remarkeably, the pain has resolved. My company has absorbed the cost of the anodyne machine to treat wound since this is not reimbursable.I would like to see Medicare reimburse for Anodyne in the treatment of wounds as well as pain associated with the wounds.

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Re: Medicare National Coverage Analysis

It has been brought to my attention that CMS is requesting comments regarding our experience with Anodyne (MIRE) for the treatment of diabetic peripheral neuropathy (DPN) and other conditions. Based on our extensive experience and quality outcomes we believe that a policy ignoring Anodyne's efficacy would be a grave injustice to the diabetic population desperately seeking relief from a condition so remarkably responsive to Anodyne. This policy is fiscally punitive to the thousands of health care providers who have recognized and experienced the recuperative effects of Anodyne.

Our company is a home health provider based in Texas with offices in Oklahoma, Tennessee, Illinois, Florida and New York. We own 72 Anodyne units, treat hundreds of patients every month with Anodyne and have done so for the past two years. We have invested over half a million dollars in this modality and are not even reimbursed for this service. We don't utilize Anodyne because we are paid for it - we utilize Anodyne because of the improved clinical outcomes it has produced for our patients. Based on our clinical outcomes and the evidence base supporting its use, we believe that Anodyne is a safe and effective treatment for DPN and should be covered for this indication. Please consider the following when making your decision:

We have used an Anodyne unit for 14 months now at our Salinas, CA office with great succes. Having practiced for 17 years, I can not recall having been exited about any new modality coming on the market exept for this form of infrared. We have treated 35 people with anodyne with diagnosises of periferal neuropathy which can be devided in being diabetically induced, chemo therapy induced or there for no apparent reason. The chemo group is our most succesfull group with a 90-100% recovery rate. The diabetes group reports great improvement in aproximately 70% of the patient and 10-15% minimal-moderate improvement. The group with periferal neuropathy without any reason scores the lowest with a 40-50% improvement rate. With the chemo group the Anodyne can be vital to keep patients on their course of chemotherapy and therefore alive since some patients are in so much pain that they want to dicontinue their chemo. Anodyne helps to keep them undergoing chemo without these painfull side effects. All in all, Anodyne is a modality that is very helpfull in the management in treatment of various groups of patients and has gained tremendous popularity among my referring physicians.
Sincerely,
Marcel Lak, PT, MDT
Axis Physical Therapy.

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I have been using Anodyne for the last 6 months and have used it on 50+ patients. I have seen some dramatic improvements in patients balance, sensation and functional ability along with a reduction in pain. I have used it on long standing peripheral neuropathy patients, post total knee replacements, chronic low back pain, shoulder pain and Complex Regional Pain Syndrome (CPRS, formerly RSD) all with very good success. There have been no side effects with any of the treatments and all patients have been very pleased with their results. I have found Anodyne (infrared) therapy to be an extremely effective adjunct to my other treatment options.

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I am very impressed with the outcomes that I have seen with Anodyne Therapy. I have one patient whohad undergone 41 radiation treatments for the treatment of a bone tumor in her pelvis. As a result she suffered from polyneuropathies. She had abnormal R LE sensation and decreased strength. After 6 Anodyne treatments her R ankle strength increased from 1/5 to 3+/5. She also experienced significant improvements with her sensation. In addition she was able to discontinue the use of Neurontin. These improvement occurred after traditional therapies, including therapeutic exercise, gait training, and manual therapy had failed.

Another patient that I am currently treating has had diabetes for seventeen years. Before beginning Anodyne Therapy he suffered from pain in his feet on a daily basis. After just 3 Anodyne treatments, he is no longer having pain and states that he is beginning to get sensation in the areas that were previously numb. He claims that he feels safer with ambulation and is no longer losing balance and falling. After 8 Anodyne treatments his Functional Reach Test has improved by 4 inches and his Berg Balance Test score has also improved.

As a clinician, I am very greatful for Anodyne Therapy as I have been able to provide treatments with successful outcomes that would not have been possible with other modalities.

Thank you for your consideration on providing coverage for infrared therapy devices.

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I am the Chief Physical Therapist at The pain Institute in Merritt Island Florida and I have been using infared therapy for 1-2 months, with great success. Most of my patients have either chronic back pain and/or peripheral neuropathy and most devices are good, but a need for better modalities is called for. Infared therapy has been a greatly needed tool and has provided my patients with relief from burning and decreased sensation in a matter of 3-4 weeks. The treatments are working and a continued support of a home unit would be a tremendous help in providing pain relief and increased functioning to the patient. A majority of my patients are under Medicare, and would benefit from this therapy being covered. In addition, back and neck pain have also been addressed with infared therapy and these patients could also benefit from home units covered by Medicare. Thank you for your time and I hope this can become a part of my patient's continued treatment.

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I am a physical therapist and regularly utilize infrared (Anodyne) for the management of cases where loss of protective sensation, impaired circulation, inflammation or chronic pain is of conern. I have treated over one dozen patients with this device over the past 3 months. My clinical outcomes with infrared have far exceeded my expectations and out performed other contemporary modalities such as TENS, US or paraffin. In the realm of protective sensation I have had 2 of 2 patients achieve full return of protective sensation within 12-20 sessions as compared to complete absence initially. The use of infrared is highly appropriate for a large patient population and should be allowed as a covered benefit for patients in a physical therapy setting. Of note, these devices are more expensive to purchase and more labor intensive to set up than other modalities. Treatment time per session is also greater than other modalities and as such should be reimbursed at a higher rate to reflect the actual cost of performing this valuable service. I wholly endore the usage of this modalities and will continue to utilize it for the effective management and care of my patients.

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I'm a P.T. and owner of Rapides Physical Therapy in Alexandria, Louisiana. I've treated over 200 patients in the out patient and home health settings over the past 2 years with the Anodyne (Infrared light). My patients have noted significant relief with pain, increased sensation, reducing edema, improved mobility and balance with regular anodyne treatments. We have a great deal of success in assisting patients with these problems.

I successfully treated other problems with the Anodyne such as back and neck pain, muscle hypertonicity problems and strains, Reflex sympathetic dystrophy and post herpetic neuraligia (shingles pain), to name a few.

Infrared light treatments are in many cases much more successful than electrical stimulation and ultrasound. It is reimbursed at a much lower rate than these staples of Physical Therapy and reimbursement is extremely out of line with the benefits that are gained as compared to other modalities. Anodyne should be at reimbursed at minimum equal, but realistically higher than electrical stimulation and ultrasound in specific. Other therapists in the area will not utilize the treatments because of the lack of reimbursment even though they know it will help patients.

Anodyne (infrared) has been the best new treatment that I've utilized in physical therapy in the last 10 years.

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To Whom It May Concern
I have been a nurse for the last 16 years. Most of my experince has been in the home health field. Only once in a while does there come a truely beneficial piece of equipment that helps patients that can also be affordable for the patient and the agency. The Anodyne is such a piece of equipment. It maybe a little pricey but the fact of the matter is when it helps patients as much as it does, it's worth it. We have had patients that have not felt their feet in years begin to feel them after a few treatments. It also has been helping with their gait problems. Obviously you do not have loved ones that experience either the terrible pain from Neuropathy nor the difficulty to get around because of the inability to feel your feet. We have seen such things reverse with the Anodyne treatment. We have also been able to see the great healing assistance that this piece of equipment produces. The pain relief is temporary if a home unit is not purchased and continued use is not practiced, but the wound care does not reverse.

Think of all of the money that can be saved by Medicare and the Medicaid programs for decreased ER and hospital visits for the complaints of fall, injuries and pain. I am sure it would be a significant amount. Not to mention how much it would improve the lives of our elderly and even some of our younger patients that suffer from this problem and that are disabled.

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We have been using infrared therapy devices in our outpatient physical therapy department for 2.5 years now, and have noted significantly positive responses to treatment by patients with peripheral neuropathy symptoms from diabetes and other etiology. Improvements range from reduction of pain to return of full tactile and proprioception of the extremities treated. We have not seen 100% recovery 100% of the time. But we have seen at least 25% improvement with greater than 70% of patients treated, and have seen greater than 50% improvement with greater than 40% of pateints treated. Keep in mind that prior to use of infrared therapy we were able to help zero percent of patients with diabetic neuropathy 100% of the time. In addition to helping patients decrease pain and complaints of numbness, the bigger benefit noted to these folks is an opportunity to improve functionally and to improve their safety with gait, transfers and ADL's by reducing their risk for falling. I hope that this is helpful to you.

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In the home health agency that I work for, we see a very large number of patients diagnosed with diabetes. Many of these patients have diabetic peripheral neuropathy. We have utilized the Anodyne Infrared Therapy System combined with physical therapy in the majority of these patients. It is awesome to see these patients regain sensation, have a lower incidence of falls and decreased pain as well as balance improvement.

In the future we hope to use Anodyne in other areas. For now, we are very excited to have it for our diabetic peripheral neuropathy.

Sincerely,

Tammy Bordelon. R.N.
Thompson Home Health
Alexandria, LA

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I have been a Physical Therapist for 25 years. Before Anodyne therapy became available our ability to successfully treat DPN patients was extremely limited, to say the least. Since we have incorporated Anodyne therapy into use at our clinic we have seen a significant improvement of neuropathy symptoms in 75-85% of our DPN patients. These improvements have lead to significant improvements in each patients quality of life and ability to perform activities of daily living. This increase in activity will lead to an improvement in the circulation of each patients lower extremities which should result in a significant decrease in complications typically seen in DPN patients that unfortunately sometimes leads to amputations.

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Gentiva is a Home Health company. Our company has been using Infrared Therapy since 2003. We use Anodyne because they are user friendly with our clients, and have done the most research and development, and in my opinion have the best product. Our recent outcome data had >650 patients that we treated with MIRE with the following results:
Neuropathic Pain Average on admission 6.1/10at D/C 2.5/10 using pain scale 0-10, 0 being no pain, 10 requiring hospitalization
Return of Sensation: average on admission 4/10at D/C 7.6/10 testing 10 points on the bottom of the foot with a 5/07 Semmes Weinstein Monofilament as recommended by the ADA for testing for light touch and protective sensation.
I have been a Physical Therapist for >30 years and this technology helps with neuropathic pain and loss of protective sensation in 85% of the patients we have treated. It works for diabetic, idiopathic, drug induced (chemotherapy) neuropathies.
I have used it for joint pain ie severe OA in a joint that was not a surgical candidate.

I have used it for tendonitis, radicular pain with loss of sensation from nerve root pressure, reflex sympathetic dystrophy.The problem is the relief isn't always permanent. Our company is in the process of collection outcome data on the length of effectiveness. But I know we have multiple repeat cases, where the patient couldn't afford the $499 copayment (so they could have 4 pads) and they couldn't get a home unit. Often we will see them 2-3 times a year as they get worse, become more inactive and have a decline in funciton. To me home use is so much better for these clients once they have had a successful trial with a PT or MD. AND it saves the insurance company and medicare from paying for therapy multilple times a year. They can continue to treatment themselves, they can reduce the amount of medication, and side effects of the medication, and will keep them from getting to the point that their feet are completely "dead" and then are at risk for falls or an amputation. I have worked in geriatrics all of my PT career, and the effects of the quality of life after a fall or an amputation are devistating. This is the first proactive product I have seen for neuropathy.

And I feel my own experience using it as a adjunct to physical therapy treatment has given my a tool that I feel is invaluable.

As a PT, I wouldn't recommend it for every patient that I treat. Only the ones that really got benefit and who had a good outcome with the physical therapy. Compliance would be taken into consideration, before ordering for the client. Physical Therapists in general don't abuse the system by ordering more than the patient needs or would benefits from. And now with the Medicare Part B CAP, we really have to help the patient control their outpatient costs.

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I am a registerd Physical Therapist that is relatively new to the use of Anodyne therapy. I have been using it for approximately 4 months and have used it on approximately 15 patients that have had peripheral neuropathy with concurrent pain,numbness,balance deficit and impaired mobility and ambulation. I was skeptical at first but have been quite impressed with results obtained when Anodyne therapy is used in conjunction with a comprehensive therapy program including balance training, strengthening and a home program. At least 80% of the patients treated have displayed a significant improvement in protective sensation and a marked improvement in balance and gait with a decreased risk of falls when measured using the Tinneti scale. These are patients who have been diagnosed for some time and have tried other therapies that have failed. The clients themselves have been very pleased with the results that they have obtained.

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I am a physical therapit. I have successfully used the Anodyne in treating peripheral neuropathy clients having 6 clients with significant improvement and 1 with no improvement. For peripheral neuropathy pain/discomfort, this has worked well in improving sensation and decreasing the client's symptoms. The client's balance has also improved with the Anodyne treatment and with physical therapy. I have assisted 2 client's in obtaining home Anodyne units with continued success. These numbers are small, but show the effectiveness of this treatment. This is also a very small, rural area.Thank you for your time.

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We have been using Anodyne in our clinic for approximately 1 1/2 months now. I personally have treated 5 patients at this time. Two of the most impressive responses are as follows:Adhesive capsulitis(frozen shoulder): This condition can take 1-2 two years to resolve and limits a persons use of there arm. The anodyne therapy reduced this patients pain immediatly and she has regained her ROM a much quicker time of 1-2 months.Peripheral neuropathy: This lady was unable to feel even light touch from 2 inches below her knee level. After 12 treatment she can feel both legs and most of her feet. This improved sensation will benefit her in preventing future wounds and injury as she is a diabetic.The above outcomes are made possible by the anodyne system. I have not seen these results from any other intervention in my 11 years of practice.

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I have worked in the outpatient clinic now for about 1 1/2 years. In that amout of time I have seen about 15-20 patients for anodyne treatment.The majority of patients I have worked with using this modality have had very good results . They have had increased sensation,decreased pain,decreased burning, and increased balance. They have reported better ability to ambulate with fewer falls, and ability to ambulate longer distances. I have used no other modalities for peripheral neuropathy that have had similar results.

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2/13/06

To Whom It May Concern:

I am a physical therapist of 8 years experience and the clinical director at Lumina of Louisville. Our clinic specializes in the treatment of peripheral neuropathy, balance dysfunction, wounds, fibromyalgia, chronic regional pain syndrome and multiple sclerosis. In addition to treating these diagnoses, Lumina is a full service outpatient clinic offering physical therapy and occupational therapy for a wide range of orthopaedic and neurologic dysfunction/disorders. Prior to my experience with Lumina, I worked 6 years as a PT at a regional trauma center, both inpatient and outpatient, gaining considerable experience with the diagnoses listed above. Although, in my experience, therapeutic intervention has proved effective, I have never seen the extent of success I am currently seeing with the addition of Anodyne Therapy.

Anodyne Therapy is a critical feature in our treatment protocol for most if not all of these various diagnoses.

Monochromatic Infrared Energy delivered by means of the Anodyne system is enabling Lumina to effectively and significantly accelerate wound healing, decrease neuropathic and musculoskeletal pain, restore losses of protective and light touch sensation. The results are not fleeting. In each area I listed, the changes that occur longlasting.

Please feel free to contact me with any question or further comment regarding Anodyne Therapy.

Sincerely,Kelly M. Croghan, PT

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I personally have treated about 10-15 patients, using infrared therapy. Our department has treated many more than this. I have used the infrared treatment for painful neuropathy. Many of the patients I have treated have gone through numerous tests and treatments with no success. I have found the infrared treatment to be very helpful in relieving pain and increasing sensation. The amount of relief depends on the severity of the patients' neuropathy. I have had some people who have little to no pain after using infrared therapy, and others where it has just given them the relief to sleep at night. Some of my other collegues have used the infrared therapy for wounds and chronic pain, and have found successful results. Overall, I feel that the infrared therapy has been a successful modality in treating my patients, and feel it would be a dis-service to discontinue insurance based payment.

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Dear Sir/Madam:
Balance/coordination is an intimate relationship of the vestibular, somatosensory, oculomotor and musculoskeletal systems. Anodyne plays a major role in decreasing the loss of distal protective sensation [somatosensory system] experienced by the elderly both for the diabetic and nondiabetic. CMS has identified Diabetic Peripheral Neuropathy is one of the two leading causes for falls in the elderly. Falls are an enormous economic and emotional expense for patient & caregiver. SAFE STRIDES is a balance program provided by Gentiva. Our statistics are as follows:
>95% of patients demonstrated a reduction in falls
>86% of patients demonstrated an increase in protective sensation
>85% of patients demonstrated a decrease in neuropathic pain

Both the increase in protective sensation and decrease in neuropathic pain are secondary to anodyne treatment. Given the position of CMS on falls and the SAFE STRIDES statistics, I urge you to support the continued use of anodyne for neuropathic pain and loss of protective sensation.

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As a Physical Therapist, I have personally treated 300+ patients with infared light therapy/"anodyne". The infared is extremely useful in improving circulation and sensation to light touch in the feet of diabetics, and also my patients most often ALSO report a significant decrease in pain, and clinically I see such a reduction in falls!! The company I am employed with, Gentiva Healthcare Services, is very interested in what the actual "befores" and "afters" are, and so we ask ALL of the Therapists to objectively test upon Eval and upon Discharge. This data is then tracked and compiled and the results from over 1000 patients each year (began in April 2004) are INCREDIBLE!! Pain reduction by average of 40%, sensation improvement by 30%, 50% reduction in patients at high risk of falls.... (These are the results from April 2004- Dec 2004. 2005 infared results are comparative to this, I just dont have those in front of me at the moment) These findings continue to be just as, if not even more impressive as we continue to spread the word. I truly believe this community (Fort Walton Beach, FL) have benefited from infared therapy immensly. I BELIEVE that infared therapy works because I have SEEN it work, tried and true, over and over again with my patients. I strongly encourage you, as a medicare reviewer to consider coverage for the infared home unit. As a practicing Physical Therapist for 9 years, I know that with patient compliance, a home infared unit could decrease the frequency of falls, improve health in the tissues via increased blood flow (reducing diabetic wounds), decrease pain and reduce pain medication, and reduce the frequency for physical therapy re- intervention (as the benefits from our clinician- provided infared treatments wear off, as in some cases). Thank you for your consideration. Feel free to contact me if you would like any of the 2005 data we have collected (over 1000 patients) or if there is anything else I can help you with in regards to this matter! Melanie Broome, Lead Physical Therapist and Branch Preceptor

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I have used the anodyne in the Clinic for over 2 years and succesfully treated Traumatic, diabetic and ideopathic peripheral neuropathic pain in 75 % of the candidates chosen. We have also used it for Bell's Palsy. More than 50% of those chose to continue the tx at home upon finishing the clinical trial succesfully. We feel that we ct to improve patient's ADL's and safe functioning around the house while decreasing the need for meds and reducing side effects of pain meds/narcotics often used for management. Our treatment when combined with therapeutic exercises, unlike when provided in Dr's offices, guides patients to Independent living saving the system a ton of money! I hope legislation takes a close look at who should be providing any therapy sevices and follows St Carolina's ruling prohibiting Physician owned PT clinics!Rudi Ide and Associates Physical Therapy provides PT, OT and Hand therapy services to a geriatric population in South Florida.

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As a physical therapist, I am relatively new to infrared therapy as it was not available at my previous facility. The testing is very non-invasive and easy to administer, as is the treatment itself, making it very efficient for a busy clinic situation worried about productivity. We are finding good results with people who have a recently diagnosed peripheral neuropathy and we have had some success with wound healing as well. I also used it on a man with POEMS syndrome, who was in excruciating pain with no relief with previous treatments trialed. He reported decreased pain and improved circulation was also noted in his legs (which were purple upon the evaluation) upon using the infrared therapy in 12 treatments. Information regarding infrared therapy is becoming more widespread, and we are getting more and more calls from the community for patients looking to receive the treatment as there are so few clinics that offer it.

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I am a P.T. and have been using infared therapy now for about 3 years and have had great success with this treatment. I have used it on wounds that I could not heal with other modalites, even electrical stimulation. I have used it to help control pain and even decrease pain in chronic pain patients to help them gain a better functional outcome with their therapy. I have used Infared therapy in contracture managment in combination with spilnting and manual stretching and have been able to gain ROM that allows the patients to be more functional. I have used it with diabetic neuropathy pt's who couldn't even walk when they came into our facility and at the end of her therapy sessions, she was able to walk out of the facility without any assistance except for the use of a walker. This patient went home with a home unit and as far as I know is still doing well. There are numerous uses for this kind of therapy and it would be a shame not to be able to use it, when it would be very appropriate to use.

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Our out-patient physical therapy facility has been using the Anodyne infrared light therapy unit for approximately two years. While our facility has not kept a detailed summary of outcomes specifically for patients treated with Anodyne, my general experience has been that about 60-80% of patients referred with DIABETIC NEUROPATHY tend to respond favorably enough during their 4-6 weeks of formal treatment that they express interest in acquiring the HOME UNIT. "Favorable response" includes improved light touch/protective sensation of the feet, reduced frequency and/or intensity of pain, reduced use of pain or sleep medications, and improved balance. Of patients referred with IDIOPATHIC or NON-DIABETIC NEUROPATHY, only about 40-50% seem to respond favorably.

I suggest CMS approve payment for home units for patients who respond well to this treatment, as it allows appropriate patients to continue treating themselves effectively at home and reduces their need to continue out-patient medical care.

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Normal balance is maintained by three senses, visual, vestibular, and somatosensory. Patients with neuropathy have decreased somatosensation. Until Infrared was introduced, these patients had to be instructed on compensatory techniques for their loss. I have used Infrared on approximately 10 patients over the last 6 months, and 80% of them demonstrated improvements in sensation when tested with monofilament as well as subjective reports of improvement. This modality is non-invasive and does not have any side effects and provides the opportunity for improvements in sensation when nothing else does. Removing this from coverage would be a detriment to the Medicare population.

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I am a podiatrist, have been using near infrared for three and a half years, primarily for diabetic and non diabetic peripheral polyneuropathy and various inflammatory conditions of the foot and for recovery for injuries, and the treatment of ulcers I LOVE IT! It speeds ulcer healing many times. It is great on diabetic neuropathy and the gains made through a month are maintained if they have a maintenance routine or get their home machine. I did an office study and 15/16 that went to home units had good or excellent maintenance of their improvements, documented by Symmes Weinstein filaments. It often is the answer to plantar fasciitis and achilles tendinitis. It works most of the time in diabetic peripheral polyneuropathy ; and a majority of the time with idiopathic peripheral polyneuropathy. we had three or four second degree nickel sized burns when we were beginning to learn the machine, but never have them now. just a matter of correct setting.

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I have had great success with patients for the treatment of diabetic and idiopathic neuropathy. It reduces pain, improves sensation, speeds wound healing, reduces swelling. Most of my patients have neuropathy secondary to diabetes, but it has also shown effective in neuropathy caused by chemo and radiation therapy. It works wonders for chronic headaches and carpal tunnel syndrome. I have one case in particular for each diagnosis who have had several treatment over a number of years and this was the only thing that worked. The patient with carpal tunnel was treated July 2005 and has not had reoccurence of symptoms as of January 2006.

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From:Shayne Ferguson,PT,PhD.,WCS,GCS
Exectutive Director of Lumina Of Kentucky

Feb10,2006

RE: Success of Anodyne Therapy

To Whom it may concern,

As an experienced clinician, I would like to offer my professional opinion on the Anodyne Therapy System.

From 2003-2006, our office has seen around 4,400 patients. 80% of those patients came for neuropathy, 5% for wound care, 5% for Chronic pain (RSD), and 5% misc.(i.e. MS, worker comp., pre and post surgery, fractures, etc.)

We have seen about a 90% sucess rate for our neuropathy patients, and a 98% sucess rate for our wound care patients. With RSD (chronic pain), patients have had a 85% sucess of releif from their pain. For our MS patients, we have a 100% improvement to some degree.

I have tried other modalities that I will not list here, but none as effective as the Anodyne with both expedient and long lasting improvements.

Please Feel free to contact me with any questions you may have regarding the Anodyne System and how I use it in my practice every day. Thank you.

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I am a physical therapist who has used the anodyne for 2 years. I think Medicare should cover the home unit as well as reimburse for using the unit in conjunction with therapy. We have treated over 100 patients. A study of 60 of our patients demonstrated 80 % improvement in pain level, 88 % improvement in Tinetti's gait and balance score and 68 % improved sensation by 5.07 Semmes-Weinstein monofilament testing. I had one diabetic patient that stepped on his wife's razor when taking a shower and had no sensation of feeling until he was injured. After only a few treatments with the anodyne. He had noted increased protective sensation. He is currently trying to buy his own unit.

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I have treated about 30 patients in the last 9 months. I have had peripheral neuropathy due to diabetes, s/p chemo, chronic pain due to visceral surgery, toxic skin eruptions due to autoimmune reactions,idiopathic p n , back pain, neck pain, joint pain 2nd to joint replacements, arthoscopic surgery, OA, trauma, etc., wounds, and hypersensitivity.

I have had excellent results s/p cancer with chemo: decreased pain,increased well-being,increased appetite and activity after 43 years of misery and "wanting to die" and confinement to bed.

I have had good relief of pain for all orthopedic problems. People are able to use it over joint replacemnts, recent surgeries, back and neck pain.

I am presently treating auto-immune skin reaction-too early to determine benefits.

I have had good results treating wounds when poor results came from conventional treatments.

I have had varied results with idiopathic peripheral neuropathy, and 50% positive results with diabetic peripheral neuropathy.

No specific data has been compiled and studied as yet as to efficacy.

In my opinion, anodyne is a good modality for many conditions,not always beneficial and consistent, but adaptable and comfortable for patients and it is promising. Practitioners need to study cases and report findings.

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I'm a professionally licensed Doctor of Physical Therapy. I've treated approximately 10-20 patients in my clinice with Anodyne for several causes. They include: peripheral neuropathy, painful feet and toes, difficulty ambulating due to loss of balance, decreased prorioception, joint or muscular pain in other parts of the body. In about 80 percent of cases, I've had success in decreasing pain level, improving gait and balance and decreasing the intake of pain medications. In all my patients, I've used other forms of therapy along with anodyne, including gait and balance training, strenghth, flexibility and in some cases manual therapy. However I believe, that with the specific case of peripheral neuropathy due to diabetes or any other reason, anodyne therapy was the only effective therapy, helping to improve function in these patients.

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The therapeutic effect that the Anodyne, as well as other types of light therapy equipment, has been a tremedous benifit for our patients. I find it hard to believe that insurance companies would not embrace this technology as it could sureley save these companies millions of dollars anually not to mention the relief that the patients get from such an affordable therapy. What has happened to our country, were treatments that are not effective and certainly not affordable are paid for all the time by insurance companies. The elderly in our country deserve better than this.
Tom Crandall

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We are a neurological physical therapy clinic and we use Anodyne in conjuction with balance and gait training. Alot of the patients we see have pain, loss of sensation or tingling in their feet and we are having great success with all of our patients. We had a patient who was taking 8 neurotin pills a day and by the time he was done with the 12 session protocol, he was down to one pill a day. They were phenomenal results considering he has been a pain patient for over 12 years. We are thrilled with product and hope Medicare considers making full payment for the pt.

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Our office in Topeka, KS has been using Anodyne therapy since August of 2004. We have treated approximately 58 patients since 8-23-2004. The indications for which we suggest Anodyne therapy are painful neuropathy, diabetic neuropathy or chronic pain in the feet. Many of our patients have been very pleased with the outcomes of the Anodyne unit. A majority of our patients have applied for a home unit through Anodyne to continue their treatment at home. The main reason patients give for not applying for a home unit is the cost. Our office feels that Anodyne is a very beneficial therapy to patients and we would like to continue providing this service.

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I manage therapy for hospital based outpatient department. We have had a unit for over 2 years and have had great success for several patients, including neuropathy and general pain in the feet and hands.

Several patients have gotten the info to get home units, some have proceeded and others have not due to associated costs- but would like to, and often due to re-occuring symptoms are re-seen for treatments.

The unit has also been used in our SNF unit for assisting in circulation and therefore wound healing with good success.

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I have had the opportunity to use anodyne on 15-20 patient in the last year for diabetic neuropathy and have had significant outcomes with all but one of them. Patients have reported significant improvements in sensation and balance as well as greater ease with adl's. Just as described in the literature, this is a treatment that needs to continue on. They have demonstrated decreases in sensation and increase in pain about 2 months following the end of treatment. A few have demonstrated continued improvement. I have only used anodyne on one wound care patient wiht diabetes and vascular decreases, and had tramendous success. This patient had a wound that was open for four months prior to seeing me. With normal wound care techniques and the addition of anodyne, we closed the wound in 2 months. He had been treated by a different therapist for 14 months straight with no success. Six months after the end of treatment, the wound is still closed. If you have any questions for me, I will be glad to discuss anodyne with you.

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Anodyne therapy has been remarkably effective in the treatment of peripheral neuropathy as well as slow healing wounds. The clinical effectiveness is unparalleled as compared to other procedures available. As there is little to no other modality that is effective for peripheral neuropathy, not covering this procedure would seem to be unethical as we would be witholding a treatment that is known to be effective. I strongly encourage you to consider this as a covered service for medicare constituents.

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To Whom It May Concern:

I work in a private practice PT clinic and we frequently use Anodyne therapy for diabetic peripheral neuropathy, chronic pain conditions, as well as for wound healing. We have had great success with this modality which has not been noted in out clinic with other modalities for these conditions. There has been good pain relief reported for diabetic peripheral neuropathy as well as improved balance and sensation. There has been improved symptoms for chronic pain conditions as well as more rapid wound healing in previously chronic wounds. I feel that anodyne therapy is an integral componet for several treatment programs and it is a necessary and effective modality option to help patients recover from previously chronic conditions with few alternatives.
Sincerely,
Stephanie Smith, MSPT

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I am a physical therapist in Northern California. I have been practicing for 10 years. I have been using Anodyne (MIRE) for 9 months. With this treatment, in addition to therapeutic exercise and neuro reeducation (balance training), I have been seeing excellent responses. Most commonly patients are experiecing less pain, better balance, less risk for falling, and generally have more tolerance for physical activity. Some of the folks I have seen have had peripheral neuropathy for years and have tried other options for treatment without effect. The Anodyne has helped them to begin returning to a more normal lifestyle. I am very happy and enthused with the results thus far. I believe that if there is a treatment which can help people to have less pain and be at less risk of falling, then it should be readily available. I suspect the cost of a person falling and being hospitalized will far out-weigh the cost of physical therapy treatments which would include MIRE, therapeutic exercise, and balance training.

Thank you, Rob Brandon, MPT, ATC

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Our Rehabilitation Department obtained one Anodyne unit in August 2005 for a 90 day trial. We had several patients who had such good results using the MIRE we purchased the unit before the end of the trial. These patients have decreased pain and increased sensation as a result of the MIRE. Results are usually evident within a few treatments if it is going to be beneficial. Thus it is well worth the time and effort of trying the MIRE. The small cost involved with the therapy is a drop in the bucket compared to the cost of problems associated with pain and neuropathy. Please continue to cover this service through CMS. Thank you.

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my company has spent 1 1/2 year in studying the use of the Revitalite system which is different than the Anodyne that you have referred to. The Revitalite will not ever burn patients in that the penetration below the surface of the skin is different, and the utilization of the product is either for twice daily for 30 minutes or daily only or 2-3 x a week for a 30 minute time frame. In each situation, the appliance turns off. My clinicians have controlled the setting, the timing and the use of the product and found significant improvement in all types of wounds, even the ones medicare won't pay for, i.e., decubiti ulcers and venous disease. I do have an abstract of my formal study and presentation that was presented in 2005 at the Advanced Wound Care Symposium sponsored by Lippincott Publishers in Las Vegas in October. Withthe use of this product, we realized a 91% improvement/healing rate on cases that previously were non-responsive to other treatments. In addition, this was the only modality to contain gangrene and provided pain relief and increased time to many patients and their families. In some situations, i.e., a paraplegic who had lost all bowel sensory awareness, the utilization of the product on his sacral decubiti resulted in his innervation of the bowel, no longer needing medication or a bowel program, and regular bowel movements!!! I feel this prodcut is an asset to use for wound care, and would love to serve on a committee to determine appropriate criteria for use. Please note, the majority of time, we have not been reimbursed for the use of the product, but so believe that it is efficacious, we continue to do the treatments where we feel appropriately the patient will respond beneficially, because of the need to heal as quickly as possible

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I am a physical therapist for 16 years and have been using infrared, specifically Anodyne Therapyfor approx. 8 months on over 100 patients. It is the most effective modality for treating peripheral neuropathy symptoms, like pain and decreased sensation. I also use this modality for wound care and pain relief in other joints, especially when other modalities are contraindicated (as with patients having implanted electronic devices). Improved sensation and decreased pain in patients with peripheral neuropathy has prevented many patients from further complications to their medical history. Anodyne therapy should definitely have a place in the current procedural terminology coding.

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I am a Physical Therapist and have used the Anodyne for 11 months in a Hospital/Nursing Home and Outpatient facility. Pressure sores in the nursing home have had a 90% improvement. Diabetic neuropathy a 30% improvement (dependent on how long they have had the neuropathy). Slow healing open surgery wounds a 80% improvement.I am presently using it on 4 people and have seen some improvement within 4 treatments. I am convinced that this modality is a valuable asset to have in the Dept. I have had one patient that wanted a home unit but could not pay the $499 (? exact amount) that Medicare requires the patient to pay so she was not able to continue with the therapy.

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My practice, Northern Az OrthoSports Physical Therapy, has been using the Anodyne for treatment of peripheral neuropathy for one year. In that time we have treated approximately 4 patients per month with this modality. It has provided pain relief and improved sensation and balance in about 80-90% of the patients selected to receive it. Many of these patients had lost hope that there was anything that could help with their pain. I have always been a sceptic on the use of modalities but have become a believer in this modality when it is used in appropriate cases. Our patients are the ones telling us they are better with less pain and improved sensation. this contributes to fewer falls and better quality of life. The home units are a must. They keep the benefits going and allow the patient to treat themselves at home. Without the home units they gradually have a return of the neuropathy symptoms.

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I am a Physical Therapist in a home health setting. For the past year, I have successfully treated many patients with the infrared Anodyne therapy unit for diabetic neuropathy, neuropathic pain, wound care, and lymphedema. This treatment reduces patients' pain, increases sensation, and improves functional balance. Not only is it a vital component of a patient's plan of care, but will greatly reduce your long term cost with diabetic patients in terms of amputations resulting from neuropathic complications, circulatory complications, etc.Medicare has an opportunity to provide a cost effective treatment for patients. Home units will only decrease Medicare's expenses and improve patient's lives. It is in the best interest of all current and future patients that Medicare recognizes the long ranging benefits and cost effectiveness of Anodyne therapy.

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Anodyne therapy needs to be covered for the following reasons:

total # of my patients treated: >75
total # of successful treatments of Anodyne: 75%

Patient compliance vs. medications GREATLY enhanced. Patients would rather try this treatment than take NEURONTIN, LYRICA or CYMBALTA, as well as any OPIODS or nerve block treatments.

In addition to outpatient and home use of physical therapy modalities, ANODYNE is the MOST EFFECTIVE NON-INVASIVE TREATMENT FOR NEUROPATHY and is MY PERSONAL treatment of choice.

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My facility has been using Anodyne infrared therapy since December 2004. We have mainly used it as an adjunct to strength, flexibility, and balance training for patients who have altered lower extremity sensation or coordination as a consequence of peripheral neuropathy. The majority of the patients who have received such intervention have noted decreased lower extremity pain, decreased frequency of waking due to lower extremity symptoms, and decreased reliance on medication (typically Neurontin). All of the patients who have received Anodyne Therapy at our clinic for at least twelve visits have demonstrated objective improvement in lower extremity sensation (tested with a 5.07 Semmes-Weinstein monofilament). Multiple research articles have documented a strong correlation between improved sensation and a decrease in frequency of falling.

To date we have had no negative side effects from the use of Anodyne Therapy and patients have been delighted to have an effective, non-pharmacological means by which to help improve their symptoms and function.

There is a great deal of literature supporting the safe, efficacious use of Anodyne Therapy, and unless a more permanent cure for peripheral neuropathy is discovered, Anodyne Therapy appears to be the most effective intervention for large number of patients. Based on my experience, I believe that adjunctive use of Anodyne is of critical importance in helping many of my patients achieve documented functional outcomes through my therapy intervention. I also believe that your failure to provide Medicare funding for this modality will unnecessarily deny access to appropriate care for many patients suffering from potentially debilitating symptoms.

Sincerely,

Michael Daack, MPT, OCS

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To whom it may concern, I have personally used the anodyne infrared unit on multiple patients. In patients with diabetic neuropathy, I have witnessed the measurable objective changes in sensation as measured by S.W. 5.07 monofilament. This has been close to miraculous for many diabetic patients who have literally been without sensation in their feet for many year. I have patients who could return to driving because of the sensation return in their feet. This is the only treatment on the market that returns sensation in neuropathy patients. I have also used the infrared on other patients with diagnoses of arterial insufficiency, muscle spasms, joint contracture, and arthritis. I have seen many patients have therapeutic results from the use of infrared, where other modalities did not help. Infrared does have precautions and contraindications and should be monitored carefully when used in a patient with reduced sensation.Lori Coleman PT

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Here at our outpatient rehab clinic we see nearly 25 Anodyne patients per day. We are seeing those people who need the Anodyne treatments for a couple of reason-wound healing and neuropathy being the main reasons. We have awesome success with our wound patients; wounds that the doctor has giving up on have been healing with the Anodyne. We have even had a patient that didn't have to have her fingers amputated because the Anodyne had worked so well healing her wounds. Our neuropathy patients too have seen amazing results giving them back feeling in their feet and allowing them to get back to activities that they love. I believe that without the anodyne these patient would not have reached the desired results that they achieved. Please keep the Anodyne reimbursable by Medicare, this treatment has proven successful in our clinic!

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I am a physical therapist and have been working with Anodyne for about 6 months. I have had people who self-pay for treatment while waiting to receive their home units, because it helps them sleep through the night. I have seen significant decreases in pain, increases on standardized blanace assessment tests, and occasionally, improvement in the myofilament test. If people who are on a fixed income are willing to pay $499 out of pocket for a unit, they must be noticing real and valuable changes in their day to day lives.

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I am a Register Nurse Case Manager with decision making authority for patient care venues. I handle catastrophic level injuries in conjunction with management of the health care dollars for these patients.I have utilized Anodyne Therapy for the resolution of wounds, neuropathy, and scar tissue. I have had 100% results for all the cases I've been involved.I will continue to recommend this therapy in a facility and for home use as the need arises. Please consider making additional payment available for those requiring this type of management.

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Our company has been using these devices as adjunctive treatment for therapy patients in the homecare setting. We have seen great benefit while using these devices specifically in the treatment of the diabetic peripheral neuropathy patient. We have seen great decreases in pain, increases in sensation, increases in functional abilities, specifically fall risk, and greater quality of life for our patients. By allowing increases peripheral sensation, we have seen greater results from our therapists efforts at restoring balance, thus improving functional scores.It would be worthwhile to cover this treatment both in the professional and home settings.

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We are aware of the proposed policy change for coverage of infrared therapy which includes Anodyne Therapy. We disagree with this proposed policy for the following reasons:

We have used Anodyne in our facility as an adjunctive modality for a wide variety of acute and chronic conditions for more than 14 months on 62 cases and have found Anodyne to be a very safe and effective form of infrared for our patients. Our referring physicians have been satisfied with the clinical outcomes we have achieved with their patients; and are referring a greater variety of patients for treatment.

Anodyne is widely used in the physical medicine and rehabilitation community in California and nationally in thousands of health care facilities.

We have seen intractable cases of wrist extensor tendonitis recover in less than 12 visits.

We have had diabetic patients avoid a toe amputation after success with Anodyne.

We have had diabetic patients with foot diabetic ulcers healed.

Use of Anodyne is supported by many published clinical studies and itls clinical effectiveness is documented in the textbook, Modalities for Therapeutic Intervention.

Many of our diabetic neuropathy patients have received their first relief of neuropathic pain in years with the use of Anodyne Therapy.

Balance and gait skills have improved to such an extent that previously sedentary diabetic patients have begun walking and excercycle progrmas at home.

Based on our clinical judgement, we believe that adjunctive use of Anodyne is of critical importance in helping many of our patients achieve dicumented functional outcomes through our therapy intervention. We also believe that your failure to cover this modality will unnecessarily deny access to appropriate care for many patients.

Sincerely,
Patty Glatfelter, P.T.
ept Rehabilitation - Arcata Division
1551 Giuntoli Lane
Arcata, CA 95521
(707) 825-7250

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I am a physician and have used Anodyne on probably at least 50 patients. The results are overwhelmingly positive. Formerly, I would tell patients there was nothing we could do even though we tried drug therapy, this was rarely successful. I have used Anodyne on cases such as a retired physician who had neuropathy for 22 years and had been everywhere including Mayo and Lahey Clinics. His neuropathy responded after 6 treatments and he was overjoyed. It works on Diabetic neuropathy, alcoholic neuropathy, chemotherapy neuropathy and more. In particular, the chemo patients are eternally grateful for the relief.

This treatment has become an integral part of my practice and I get referrals far and wide for it.

I strongly urge you to cover this vital modality.

Dr Kuvent

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I am the Director of Rehabilitation for a large home care agency centered in Buffalo, NY. We have utilized the Anodyne Therapy System Infrared) device for approximately 18 months to treat chronic pain from compression fractures, peripheral neuropathy, and chronic wounds. In keeping with my educational background in research and evidence-based practice, I reviewed the existing literature prior to beginning the program, and have closely tracked outcomes since initiating the program. Our results are as follows:Wounds (n=27) - Measure - total surface area - mean improvement of 73 percent- 10 chronic wounds to full closure - 9 chronic wounds 50 - 98 %healed<- 8 chonic wounds 0 - 47 % healed but all with mitigating factorsPain (n=27) - Measure - 0 to 10 subjective scale mean improvement of 69 percent - 9 patients with 100 % improvement - 11 patients with 50-78 % - 6 cases with 23-49 % - 1 case no improvement Balance (n=17)- Measure - Tinetti assessment Mean increase of 4.6 +/- 2.3 points on the Tinetti scale Sensation(n=30)-Measure - sites sensitive to 5.07 Semmes Weinstein mono- filament - mean increase of 4.8 +/- 2.8 sites These outcomes were presented at the national meeting of the APTA combined sections in San Diego California on February 2, 2006.

While not a clinical trial, all areas of improvement are clinically and functionally significant.

Subjective validation from patients is present in nearly all cases, this is an effective treatment that has changed the lives of many people, and saved countless thousands of dollars in medical costs for wounds, amputations, injury from falls, etc.

If you would like the tracking sheets from our patient outcomes I can send the current spreadsheets.

Thank you.

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As a Therapist that has been using the Anodyne systems in our clinic for the last 4 years my feelings that we have save Medicare thousands of dollars in medical bills. How do you ask? We have prevented falls with the potential of broken bones, prevention of amputations, wound healing and many more examples of ways to save money all with a 92-95 sucess rate. Just think how many units that $650,000.00 could buy to help someone. Please I beg someone to call or e-mail me and lets talk. there are so many ways to save money on your end and help so many on this end.

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I am a CPTA in a 77 skilled bed nursing home. We've had anodyne for 1 1/2 years and had more then 50 patients receiving treatment (both inpatient and outpatient). We use the anodyne for pain from strokes, falls, and post-op surgeries. Anodyne has flexible pads they can go over knees, elbows, shoulders, and feet. Anodyne has only 2 contrindications, so more patients are able to use this modality. Unlike E-stim, pts with a pacemaker can use the anodyne. I have also treated and healed many wounds, one of my pts should of lost her foot, but the doctor allowed 1 try and after 3 months healed, she was tunneled to the bone. I also have had several (about 8) outpatients that have applied and received home units. One older lady had neuropathy so bad she was ready to die, she could bearly walk, couldn't tell the difference in hot and cold water, and unable to sleep due to the pain. After about 20-30 Rx's and a home unit she can walk without a walker, can tell the difference between hot and cold water and can sleep without taking any pain meds or sleeping pills. So as a therapist, I have seen sufficient evidence to support infrared therapy including Anodyne Therapy in allowing patients/outpatients to be free of pain, increase ROM, promote healing of wounds and fractures, decrease falls and so much more. It would be a great loss to our society if we would not be able to provide such a great modality for the benefit of our patients and their well being. So I hope you consider to keep paying for this modality so we can continue to see great success.

Thank you

Amy Schoenthaler

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I am a physical therapist and we have been using Anodyne (Infrared Therapy)in our clinic for approximately 2 years now. We have found that this technology relieves burning pain in approximately 70% of our patients with diabetic peripheral neuropathy which allows them to be more active as their feet don't hurt with walking. Also, they are able to fall asleep more easily and sleep more soundly because the pain does not interfere. In approximately 60% of our patients with diabetic neuropathy, there is some return of protective sensation over a 4 week period. The return of this sensation is crucial for these patients as it allows them to feel when their feet are sore or getting blisters or if they have stepped on something that would otherwise cause an open ulcer on the foot. This return of sensation saves Medicare from paying for treatment for these ulcers including podiatry visits, surgical debridement and often times amputation. The patients that have been sent to us for Anodyne treatment have tried literally every other treatment that is available to them without success and are thrilled when the Anodyne works for them. In the patients that do not benefit from Anodyne, there is no harm done and the cost to Medicare is around $4 per treatment. Over the recommended trial of 12 visits, then, the cost to Medicare is around $48. That's less than one visit to a podiatrist. Using this device will likely save Medicare hundreds of thousands of dollars. Many of my patients who have found success with the Anodyne have also purchased a unit for home to maintain or continue its benefits. To have this at home, the patient must pay $500 out of pocket (not reimbursed by secondary insurance) and I guarantee that if it did not work, they would not spend that kind of money.

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I have personally used the Anodyne infrared phothotherapy equipment to treat diabetic neuropathy. I find that the treatment has been successful in controlling pain and/or restoring sensation in every case of diabetic neuropathy that I have encountered to date (about 5 or 6 cases). In most if not all cases other forms of medical treatment have not provided similar positive results. Anodyne also has been successful in another case of familial neuropathy in the lower extremities.

WPS (our local part B carrier) considers Anodyne as an unskilled treatment for physical therapy and only will cover it on a trial basis if at all and then apearently prefers to have the treatments done unsupervised with a home unit. However, I do not believt that Anodyne should ever be considered safe as a non skilled therapy, particularly in the case of decreased sensation when the potential for burns is greatly increased. A limited trial of a treatemnt or 2 will not likely be able to reverse sensory changes enough to make this treatment safe for home use, which is what WPS advocates (BAD POLICY). I also believe that anodyne treatment is best used in conjunction with exercise, balance or gait retraining when used with diabetic neuropathy. Patient invariably have secondary problems thet can most effectively be treated when anodyne or similar infrared is used togather.

Anodyne and other high powered narrow spectrum infrared devices are costly and do not appear to have the same therapeutic benifits of "heat lamps" which are used primarily for their radiant heating effect. They should not be clasified as the same treatments by Medicare when considering reimbursement.

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I am the manager of the Diabetes Program in Coos Bay, Oregon and for many years I've seen the crippling effect of neuropathy. The severe pain and risks associated with becoming insensate like wounds that don't heal and bad falls that eventually make someone homebound was to be expected. In the last couple of years a clinic in our community started to offer MIRE, Anodyne treatments and I have been fortunate to see over 200 of my patients reverse their symptoms of neuropathy! At first this was hard to believe, but I can now tell my patients that about 8 to 9 out of 10 of my diabetic patients have excellent to total reversal. The quality of life that these patients have had restored is really spectacular and I can't say enough how grateful and fortunate we are to have this available. I have been dissapointed that Medicare has not covered this treatment, because not only would this make it available to more that need it, but the cost to benefit factors are huge. Medicare would save from lack of broken hips, wounds that don't heal, amputations that continue to move up the extremity and the cost of disability that goes with all of these as well as the mountains of medications that don't do much (like Neurotin, a very expensive drug and Vicodin). This is really much more effective and very inexpensive in comparison. It is worth considering... Please do!

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I am a Physical Therapist and have been using the Anodyne Infrared Therapy for 6 months and have seen excellent results in that amount of time. They are as follows:- 21 patients- Incidations: Diabetic Neuropathy, Loss of Balance, Loss of Coordination, Neuropathy from Chemotherapy, Wounds, Post-surgical pain and edema, peripheral vasculature disease and dysfunction, Raynaud's Disease, low back pain.- Clinical outcomes have been very favorable: decrease in medication, return of peripheral sensation(enough to return to prior level of function), the use of closed toed shoes after 2 years of inability to do so, increased Tinetti scores, increased sleep ability, ability to continue chemotherapy - otherwise it was too painful, complete closure and healing of sacral and ischial ulcers, decrease in falls and recovery of peripheral burning from nerve pain.- I have been a praciticing PT for 6 years and I do not believe any other modality works as fast, as effectively, is easy to administer, is as comfortable, and is non-invasive as well as having no side effects and few precautions.

Please do not take away this therapy. It has given hope and function back to so many of my patients.

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I am a pain management physician in the state of Wisconsin. I am an anesthesiologist with extra credentials in pain management. I believe the infrared light therapy system should be reimbursed by Medicare. I have treated over 2 dozen patients with the unit and would have treated many more if reimbursement for the treatment were available. I have had good success with the unit in treating diabetic neuropathy and fair success in treating non-diabetic neuropathy. In addition, I have treated muscle pain and joint pain with the unit and achieved fairly good result. Most important however is the really fantastic results that I have achieved with wound healing. This is a medical device that needs to become the standard of care for all diabetics just as glucose monitoring devices are standard of care. With this unit we will decrease the amount of neuropathy and avoid extensive tissue damage in many of our diabetes thereby avoiding amputations, falls, injuries and many other complications of chronic degenerative disorders, not just diabetes. It would eliminate much of the need for stronger drugs such as neurontin and narcotics. Please give real consideration to covering this service at a reimbursement rate that makes it available to all.

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We have been using Infrared Therapy in our outpatient clinic for the past year. We have treated approximately 50 patients in 2005. We initially used Anodyne Therapy's unit and have recently added Solaris Infrared Pad.

We have had excellent results in treating neuropathies and wound care. Specifically diabetic neuropathy and idiopathic neuropathy with sensation loss and/or chronic pain.

We are using Infrared Therapy with the Anodyne therapy unit in our balance clinic with often AMAZING RESULTS in patient confort, decreased falls, increased balance and ADL function. The improved sensation and proprioception sense that is gained with Infrared Therapy allows our patients to make dramatic improvment in balance and recovery. It decreases their pain and fear of falling. Many patients return to functional status again after being confined to wheelchair or walker use for a long time.

The results that we have observed have created an increased demand for Infrared Therapy in our clinic and required us to purchase another unit.

The results are unmistakable. Infrared Therapy is definitely a valuable addition to the tools we have at our disposal. It has achieved results not realized by any other treatment available.

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I am a physical therapist who works in a clinic that uses Anodyne infrared therapy for the treatment of peripheral neuropathy and various other mononeuropathies such as carpal tunnel syndrome and Bell's Palsy. We have had tremendous results in patient's reports of pain and objective improvements in the sensation in their feet and/or hands following consistant treatments using infrared therapy. Many of these people have been on multiple drugs that attempted to give them some relief from their pain, and their doctors had told them that there was nothing else that could work. They have found their way to our clinic, and no less than 75% of our clients have made significant enough improvement in their pain and sensation to warrant the request of an infrared unit for home. This is a therapy that does work and has research to back it up. It will help in preventing many of the lower extremity complications that are the result of diabetes and other neuropathies. I am asking that you do not stop paying for this service that has helped so many people.

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My name is John Welsheimer PT and I am director of Outpatient services at Kings Daughters Medical Center in Ashland KY.We recently purchased the Anodyne machine for use with our patients suffering from peripheral neuropathy. We have tried various treatment modalities over the years with only limited success. Since purchang the Anadyne unit, we have treated approx 75 patients all of which have shown posative results. Some of our patients have shown near complete resolution of their painful, numb symptoms. Most importantly, these patients were able to increase their function by being able to live more comfortably and increase their independance with their acivities of daily living.I am asking that you please consider the use of anodyne for the use of our patients with neuropathies and create the appropriete coding mechanisms.Thank you for your consideration.

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As owner of a small Medicare certified home health agency, I strongly recommend anodyne therapy to be included as a tool for home health personnel to use in treating diabetic neuropathy and in wound care. We have had outstanding success in treating both diagnosis. Our patients that have received this therapy in conjunction with other therapies have had great outcomes in feeling, mobility, gait, and in the case of wounds, greater results in healing and a reduction of time needed for home health. Thank you.

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We have been using anodyne therapy in our clinic for 3 yrs.We have treated over 500 pts. The diagnosis have included diabetic & nondiabetic peripheral neuropathy,bell's palsy,shingles, & chronic inflammatory demylelinating peripheral neuropathy. We have had excellent success using this. Greater than 75 percent of our neuropathy pts. have made significant improvement including improved protective sensation,improved balance,decreased pain,& decreased number of falls. This has a direct effect on decreasing further medical costs that would have resulted from wound care and injuries from falls

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We have used the MIRE (Anodyne) in ten of our offices for almost two years as an adjunctive modality for the treatment of peripheral neuropathy. We have found that Anodyne treatment is effective, safe, non-invasive and virtually free of side effects with this patient population. Both the referring physicians as well as the patients have been very satisfied with the positive clinical and functional outcomes. A confounding factor is that, aside from the MIRE, there are no effective treatments for peripheral neuropathy currently available that do not carry significant side effects (i.e. drug therapy).

The MIRE provides a non-invasive, safe, cost effective intervention for patients, specifically those suffering from peripheral neuropathy. I believe that this effective intervention can save countless dollars and suffering by effectively treating peripheral neuropathy and avoiding the sequelae of this disease process – namely amputations and falls. I am sure that you are aware of the enormous public health problem our country is currently facing due to health problems directly and indirectly related to amputation and falls.Based on my clinical judgment as well as an outcome study we have done within our facilities taht objectively evaluated imprvements in senation, balance and pain; I believe MIRE is a critical component in achieving documented functional outcomes in our physical therapy treatment courses. Thank you for your time and consideration.

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We have had Anodyne Therapy in our clinic for about a year now and have found it to be helpful when other modalties have not in some patients with neuropathy as a complication of DM, peripheral neuropathy, and spinal neuropathy. We have also had success with application to ischemic wounds. We have equipped 2 patients with home units and they continue to reap benefits with routine use of the modality...one with peripheral neuropathy: one with spinal neuropathy.Therapeutic effects of infrared light have long been acknowledged, and Anodyne has researched to find the most therapeutic range of that light spectrum. We need viable avenues of treatment for an ever increasing patient population of seniors who want to lead active lifestyles.

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To whom it may concern,We have been using anodyne therapy in our neurology rehabilitation clinic for nearly three years. During that time, we have treated over 500 patients using anodyne therapy. Diagnosis have included diabetic and non-diabetic peripheral neuropathy, bell's palsy, shingles, and chronic inflammatory demylelinating peripheral neuropathy. We have had excellent success using this modality. Greater than 75 percent of our neuropathy patients have made significant improvements including improved protective sensation, improved balance, decreased pain, and decreased number of falls. This has a direct effect on decreasing further medical costs that would have resulted from wound care and injuries from falls.

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I cannot imagine doing my job as an outpatient care and wound care therapist without the use of Anodyne. We have healed so many unresponsive wounds and improved the quality of life of those with neuropathy, that if this modality was removed from our arsenal, I don't think we would have half the success we've had. Patients that were on caseload for over a year with little progress using standard wound care responded to this treatment and healed in weeks. There's a huge cost benefit to providers for us to USE this product.

How can a provider argue with the facts? This product works and I have hundreds of patients that will testify to the same. It makes no sense...pay the cost of neurontin for life or cover the cost of outpatient therapy and a home unit. Sometimes, those in charge need to climb into a trench or two to find out what REALLY works.

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I have been a Private Insurance Specialist and Customer Care Representative with Anodyne Therapy,LLC/Medassist-OP, Inc. for the past two years; I am not a commissioned sales person. Prior to that, I worked for two years at a major hospital billing company and four years with a third party administrator for Medicare supplemental insurance. However, even with my background, before working for Anodyne Therapy, I have had little to no knowledge of Monochromatic Infrared Photo Energy or MIRE and its use.Now that I have been educated as to the purpose behind this type of treatment and after speaking with hundreds of patients, doctors and therapists, I understand how important this is for a patient’s well being and helping them is what makes my job so rewarding. Even though I deal with the private insurance aspect, the majority of our patients also have a diagnosis of peripheral neuropathy and are in a tremendous amount of pain, the same as Medicare patients. Most of them are on high doses of medications. Some cannot walk without the help of special shoes, canes, walkers and wheelchairs. Others have gaping wounds that have not been able to heal for months, even years. And still, there are the unfortunate ones who have lost limbs from amputations after all of their efforts have failed. I have had patients literally cry on the phone about how Anodyne Therapy has been the only treatment that has helped them relieve their pain. One gentleman, in his mid-forties, stated last week that he has never felt better in 20 years and finally able to get out of the house regularly after several treatments with Anodyne Therapy. Another patient, also in her mid-forties, was helped so much by Anodyne Therapy that she wanted to become a spokesperson. I will never forget the person who was so excited because he could finally stand up straight in the shower and not lean against the wall! These are just some small examples of the hundreds of statements I have heard and why continued treatment at home for these patients is so crucial after their therapy benefits have been exhausted. Usually, Anodyne Therapy is prescribed for their lifetime use and the reason that home units are being ordered by their physicians. Most private insurance patients are paying over $1000.00 out of pocket for the Anodyne Therapy home unit and over 200 private insurance companies have reimbursed us in claims. It is obvious that patients would not pay this kind of expense on something that did not help them. Also, this treatment is being prescribed by highly respected physicians, used in over 4000 hospitals, physical therapy and home health facilities, in the United States and about to go worldwide. Even the US Navy Seals are using Anodyne Therapy. Thank you for giving me the opportunity to make a comment.

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I am the Rehabilitation Director at a Medical Center in Charlotte NC area. I am in the process of completing independent research combining cold laser with Aquatic and land based exercises. I have a total of 70+ subjects and have 5 measurement criteria with statistically significant results. My approach has been purely scientific and I have puroposely kept companies like anodyne out of the process to ensure that my results remain unbiased. We have improved sensation, balance, area of numbness, fall risk assessments and range of motion at rates between 65% and 92% of all patients we have treated. If you need a independent clinical person to present the case I feel that I am well qualified.

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I started implementing anondyne therapy for may diabetic patients afflicted with neuropathy in the fall of 2005. My experience is somewhat limited as far as the number of patients (10 - 15). However with those patients,I have seen a significant improvement with the alleviation of pain and also there ability to ambulate with more stability. Patient's have noticed an increase in feeling which I find remarkable.

At this point in my practice if a patient presents with findings of diabetic neuropathy, my first line of defense is anodyne therapy. I think 4 or 5 of my patients have purchased the home unit with the help of Medicare and are using the device with no complications.

Patient's are very consciencious of the cost of medications. When they present to our office they are already on a multiple medications, i.e. diabetic meds., antihypertension meds, cholesteral meds. etc. Now Primary Dr.'s or Neurologist are attempting Amytrptiline, Neurontin, Cymbalta, and Lyrica. These all have side effects and many patients are very reluctant to add these meds. Anodyne offers a viable alternative for DPN with no side effects, and it works! Save $$ in the long run! Medicare: Don't be "penny wise and pound foolish" This technology is visionary and should be used appropriately for decreasing pain and increasing circulation. Thank you for listening.

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We have been treating patients with Anodyne Therapy since October 2005, and have been VERY pleased with our outcomes. ALL of our patients with diabetic neuropathy have shown improvement in protective sensation, and in balance scores when tested by Tinetti's scale. We have had several wounds heal. We have seen no ill effeects. Several patients have felt so much better that they have either purchased or are considering a home unit. Since this is not a cheap endeavor for them I think it says a lot that they are wiling to sacrifice other things in life to continue this teratment. None of our clients have been well-off financially, so I see their sacrifice as testimony to the effectiveness of the treatment.

We have seen moderate results with non-diabetic neuropathy, but have little experience treating pain to this point. Hopefully, we will be able to track pain scores in the future as well.

Overall, we have been very pleased with our outcomes, and have recommended Anodyne to patients, family and friends.

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Our outpatient clinic sees a number of patients with peripheral neuropathy and wounds. The Anodyne treatments are the first that I have seen to really reduce the pain to a very low and tolerable level for most patients with peripheral neuropathy. The Anodyne has also shown amazing results in regards to wound care. Difficult, complex patients with diabetes, for example, who are functionally limited have benefitted from the Anodyne treatment for wound healing. When other modalities and approaches have not worked, the Anodyne has helped increase the blood flow to promote healing. This has been a very beneficial modality for a number of people that have walked through the door. It has also been beneficial for those patients dealing with swelling. We have used the Anodyne on those with localized swelling, lymphadema, etc to prepare them for further treatment.

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We have been using Anodyne monochromatic near infrared light therapy in our clinic for ayear with positive reults with patients suffering both diabetic and non-diabetic peripheral neuropathy. Our outpatient physical therapy clinic has noted improvements in day pain, night pain, sensation to light touch as well as functional balance and gait improvements with most of these patients. The cost of the home unit is prohibitive for many patients. I would encourage you to continue funcing for this valuable treatment modality. Phil Schaible, MS, PT

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I have been personally involved in the treatment of over 350 patients with the Anodyne Therapy System. I can tell you unequivicably that Anodyne is the most cost efficient and clinically effective way to help patietns that suffer from various neuropathies. We have prevented numerous patients from having expensive amputations, have made wheelchair bound patients ambulatory and have reduced the rate of falls in other patients. PLEASE consider Anodyne for an NCD for the home equipment. There is no other proven modality for this common problem and the cost savings will be profound, should you make the right decision and allow for payment of the home units.

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I have had the pleasure of processing Anodyne home unit orders since August 1, 2005. Everyday, I talk to therapy patients, and see thier therapy notes and the improvements are outstanding. What is so sad that not all beneficiaries can afford to pay $499.00 and therefore can not get the home unit. Within a short amount of time, they are suffering with the same symptoms. Anodyne therapy works, it maintains the levels of improvement made, and by continuing with the home therapy, patients continue to experience a more active, productive life without pain and suffering. I hope that Medicare will reconsider thier coverage policy and help out the beneficiaries and give full coverage for the therapy, and home units.

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I have been a PT for over 15 years and used a variety of electrical modalities to treat neuropathy and wound patients. I was very interested in the MIRE unit and its reported clinical results. Upon utilization, I discovered that both my neuropathy and wound patients displayed significant improvement when compared to other modalities or without modalities. My wound patients reported a decrease in pain level after treatment which was substantiated by a decrease in required pain medication. Overall the wounds healed faster with proliferation of granulation tissue and margin contraction. The neuropathy patients reported an increased level of sensation to the LE's. Berg and Tinnetti balance tests demonstrated improvement and skin sensory testing showed dermatomal pattern increase. Patients overall coordination and balance with gait skills allowed many to move to a lesser assistive device and in some cases completely away from device use altogether. I would ask that CMS reconsider their position on use of this modality as evidenced by clinical results. Thank you.

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As a the Director of Physical Therapy services I have treated upwards of 100 individuals with neuropathy of many origins. Main life changing circumstances include: ability to ambulate in the community, reduction of pain from 9/10 to 0/10 numerous times, Tinetti gait and balance scores dramatically increased, patient to be able to return to shopping and regained independence with driving vehicles where as before treatment they could not sense their feet.I have not seen any integument burns do to MIRE. On behalf of many patients this device will allow more individuals to lead a productive lifestyle. The use of this device as a common integrative part of therapy makes so much sense. Thank you.

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COMMENTS ON ANODYNE: We are an Outpatent Physical Therapy Company with3 offices in the Southeast Michigan area and havebeen using ANODYNE THERAPY as an adjunct tocomprehensive Outpatient PT evaluation andtreatments since early 2003. I have been directlyinvolved since December 2003 and have been veryimpressed with the results. Many of our patients(approximately 70% of our patients) have hadsignificant decrease in their symptoms of diabeticand peripheral neuropathy, decreased edema in thelower extremities, increased overall strength andmobility, and improved gait patterns and balance. We have not done exact tracking of these resultsbut our clinicians have been impressed with theimprovement in our clientele in many instances. We have also used the ANODYNE THERAPY forpost-operative Podiatry cases of repair for ankleinstability and other poidatric surgicalintervenitions with excellent results. THeClinicians at Progressive Rehab Network haveenjoyed the use of ANODYNE THERAPY for apopulation of patients, namely the diabetic andperipheral neuropathy patients, who before anodynehad very limited improvement due to the lack ofother successful interventions. This non-invasivetreatment has been excellent for our patients inso many instances. Using ANODYNE THERAPY withother conventional PT interventions, Range ofMotion, Strengthening , Balance and Gait Trainingis a wonderful approach to helping people withDiabetic Neuropathy, Peripheral Neuropathy,Post-operative ANkle instability repairs, TarsalTunnel Disorders, Posterior Tibial Neuritis andother musculoskeletal disorders and mildlymphedema of the lower extremiites. We see approximately 50-60 patients a day foranodyne therapy with a full PT treatment protocol(approxiimate numbers) in our three clinics. Wehave not had any burns or complications from theANODYNE THERAPY to my knowledge. We have somepatients that do not improve with it but that is asmall percentage of all our cases.Accessiblity to ANODYNE for more individuals withthese disorders on a more on-going basis (medicareand other insurance coverage beyond one or twomonths) would be my first suggestion. My secondsuggestion would be access to the home units AFTERPT is discontinued for patients if there symptomsstart to return once the PT sessions arediscontinued. Now access to the home units isexpensive.Thank you for your attention to this matter.

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We have used infrared therapy in our clinic for wounds, neuropathy and lymphedema with great result. Of all beneficiaries receiving the treatment for neuropathy, each one of them have felt some relief. We also perform the Tinetti balance of each person receiving the treatment and each beneficiary also improved on their balance scores. I encourage Medicare to continue to cover such services. It ahs truly helped a multitude of beneficiaries. It helps to decrease pain and improve function with a decrease risk for falls.

Sincerely,
Lisa Chance PT

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I have many patients who have had improvment with the use of MIRE therapy during the past 2 years. Patients have had a decrease in pain as it relates to periphera neuropathy as well as increased sensation. Many patients have been able to eliminate (or atleast decrease) the use of medications such as Neurontin (decreasing the side effects as well). A great number of patients have purchased there own machines (at their own cost) from the manufacturer which is further proof of the benefits of the MIRE therapy. I would hope that you consider this a covered benefit.

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Recently, we began partnering with local home care agencies in wound care initiatives and as well as peripheral neuropathy cases. Since adding anodyne therapy, we have been able to heal wounds faster and improve sensation. We have trialed anodyne in our own 250 bed facility with promising results. Our length of stay for sub acute, medically complex patients has been reduced. We are able discharge patients safely, knowing that the anodyne treatments that produced such significant results will continue in home care, sooner than previous to anodyne. Upon exit interviews, all patients report significant improvemnt in wounds or sensation. Typically, LOS is approximately 2 weeks. As with any modality, skilled therapist must prescribe and monitor. Burns can happen with any transfer energy modality. Currently we track wounds with photos and sensation with Semmes-Weinstein filaments. It is my professional opinion that anodyne is not only effective, but proves to be more clinically sound than most currently approved modalities. I strongly urge CMS to consider the clinical results and approve anodyne for wound care and peripheral neuropathy. We are all cognizant of the continued rationing and capping of therapy benefits, however please champion for the patient on this issue.

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Light therapy of all types has been used in other countries for a significant period of time to treat the conditions listed in this NCA and various other conditions.

Attempts to resolve these conditions with infrared therapy prior to more invasive and expensive madalities would appear to be beneficial to the patient and cost effective for the Medicare program.

As a beneficiary and a Registered Nurse I encourage coverage of this therapy prior to more invasive modalities and procedures to resolve the conditions mentioned in this NCA.

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Theodore A Pappas, DPT conducted a study of Infrared energy on the geriatric population. He only provided Infrared and no other therapeutic intervention. As the patients sensation returned following 12 sessions each patient who prior to treatment was bed bound and non-ambulatory regained independence with ambulation in the home and community. I urge you to included in your review "Monochromatic Infrared Photo Energy: A windo of opportunity in the treatment of peripheral neuropathy" published in Gerinotes Vol 13, No 1 from the geriatrics section of the American Physical Therapy Association.

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California Part B (NHIC) was aware of coverage versus noncoverage in different Medicare jurisdictions. In a 2005 PT LCD, NHIC proposed noncoverage for our state for Part B. Quite extensive feedback by CA providers and our state PT association requested at least limited coverage. As another factor, limited coverage also brought CA Part B and A into concordance for this therapy. (The final LCD is still being prepared for publication, but it will remove the flat noncoverage statement.) That said, we look forward to the results of the NCA/NCD.

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Have purchased and are using MIRE in 8 of my buildings. Have seen dramatic results in reversing the effect of diabetic neuropathy. Have seen patients return to walking from being in a wheelchair. Have seen difficult wounds heal in half the time as normal methods and at reduced cost. Proper precautions should be exercised as with any modality. US, , electrical stim, hot packs,diathermy, even cold, can cause burns...and they are acceptable methods of treatment. This is not the IR from 30 years ago...it is a new and innovative means of treating patients. Dramatic reduction in medications as well. Cost impact significant in reducing Medicare payment for other conservative methods of treatment. Please approve use and reimbursement.

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