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Title: CRNP
Organization: The Spine Center
Date: 09/22/2011
TENS unit are very beneficial for my patient's with myofascial pain. I noticed that patient's who use TENS units have a lower narcotic use as well. A few of my patient's that cannot afford the physical therapy copay like that they can use the TENS units at home to treat their Lower Back Pain.
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Title: DC
Date: 09/28/2011
To whom it may concern. I am very concerned about the possibility of Medicare restricting the coverage of TENS for patients suffering with chronic low back pain. As a practicing physician I have seen the positive effects of this modality on hundreds of my own patients. It has proven over and over to be a very effective non narcotic solution to many of my low back patients. It is also very important to understand that one single article in Neurology (Dubinsky and Miyasaki) based on only two Class I studies should not be the basis for restricting coverage of TENS. It is also my understanding that one of these studies included patients with multiple sclerosis whose response to TENS treatment may be atypical, and the other may not have utilized adequate TENS dosing. Please also note that the same article also cited two Class II studies that did show moderate pain reduction benefits, but these studies were not reflected in the author’s recommendations. Other randomized controlled trials also support the use of TENS for low back pain. Even the Neurology editorial that accompanied the Dubinsky article noted that “Taking the favorable benefit-risk ratio when compared with other pain relieving methods into account, TENS remains a valuable part in the armamentarium of pain therapy.” Like any medical technology, additional research could be useful in informing and refining optimal treatment practices. However, Medicare beneficiaries with chronic low back pain should not be denied the pain relief available through TENS use while such studies are ongoing.
CMS should not restrict patient access to technology that benefits Medicare patients by safely and effectively alleviating chronic low back pain, reducing the need for narcotics and in some cases preventing the need for surgical intervention. Thanks is advance for your consideration, Dr. Mike Adamets
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Date: 09/14/2011
I've used TENS units on patients in the 1980's and we had them set at low levels and monitered them. Well, they can be bought at any local event from vendors, sold as Dr. Pain or something like that. You can buy them online. Vendors sell them for about $200-$250. They are set to turn off at 15" intervals and you are given adequate instructions for home use. The DME from pain clinics or other will run continuously, they have a Rep to "train" the patient, covered by insurance( health employment) [PHI Redacted] It's only a distraction and maybe some minor relief, [PHI Redacted] Oral and non narcotic analgesics provide no relief if at all. IV NSAID's, Toradol. [PHI Redacted] it's known that if you drink the injectable, 60mg for 5 days, you will get relief, guaranteed. [PHI Redacted] I'm aware of the renal function affects of this drug. So do IV Cephalosporins and aminoglycocides and IV contrast dyes for MRI's. You can get some relief but, only temporarily. OTC methylsalycilates topical, Bengay or Absorbine Jr help as well as rest, heat pad and massage. It never goes away and affects daily function. A combined non narcotic, home care helps, but true physical therapy with ultrasound and other physcial therapies as heat pack, traction in some cases helped with C-spine pain years ago on active duty. Currently, other issues and illness preside. Narcotics would not resolve the pain in any case. [PHI Redacted] walk around with the TENS unit and get some relief, you have to wear it much longer than the Rep says so you can see/adjust accordingly for pain levels, activity, etc.
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Title: owner
Organization: Allen Family Wellness Center
Date: 09/29/2011
We have used TENS machines in our office for the past 8 years with great results. TENS machines are a wonderful alternative to addicting narcotics for pain management. The cost is reasonable and the benefits impressive.
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Date: 09/27/2011
We have used TENS as a regular part of our patient's home therapy program for 10 years with great success. As TENS reduces pain, it not only helps the patient be more compliant with their excercises away from the clinic, it also reduces their use of pain meds and increases their activity levels. TENS is a very vital part of our patient's therapy success.
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Organization: University of Maryland, School of Medicine
Date: 09/30/2011
September 27, 2011
To Whom it May Concern:
CMS is considering revising Medicare coverage for TENS based on a Dubinsky RM, and Miyasaki J. article titled: “Assessment: Efficacy of Transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review) Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.” I have carefully reviewed this article, paying particular attention to the definitions, selective method of reviewed articles, and conclusion drawn by the authors, and find that it does not provide evidence to end Medicare coverage of TENS for chronic low back pain.
Being a reviewer for several journals including Stroke, Archive of Physical Medicine & Rehabilitation, Neuro-rehabilitation and Neural Repair, American Journal of Rehabilitation Medicine and Physical Therapy Journal, I am puzzled by what appears to be a review based more on personal preference than credible meta analysis of published data.
Let me make a few points:
Drs. Dubinsky and Miyasaki state: “Inclusion criteria were clinical trials of TENS compared to placebo or to another therapy for well-defined painful neurologic disorders with more than 10 subjects. The titles and abstracts were reviewed, and articles meeting criteria were reviewed in full and assigned a class of evidence.” Their methodology resulted in the exclusion of well-designed studies that support the use of TENS.
a. In a study by Fisbain D, et al. Transcutaneous electrical nerve stimulation (TENS) treatment outcome in long-term users. Clinical Journal of Pain. 1996;12;201-214, there were 81 patients with low back pain without “well-defined neurologic disorders, many of which appear to have less pain as evidenced by continuous use of TENS. Was this study not reviewed because not all patients had a “well-defined neurological disorder,” or because it was not a double-blind, placebo-controlled study?
If the objective of CMS is to determine whether or not TENS is an efficacious intervention in minimizing low back pain, then a meta-analysis should not exclude studies that are well controlled (to minimize bias). Double-blind placebo or other control group (model used in pharmacological studies) is generally an inadequate and impractical experimental design to address interventions such as exercises and electrical stimulation.
Moreover, any clinician/researcher engaged in the application of TENS should know that even under the best known physiological rationale, most of the pain reduction occurs during (or shortly after) the application of TENS. That was a fatal flaw in the design of Deyo et al (1990) study, which Drs. Dubinsky and Miyasaki consider an exemplary study. Having a title “double-blind, placebo controlled” does not automatically generate credible data, even if published by the N Engl J Med. Furthermore, the Deyo et al study did not include “well-defined” neurological disorder, so what was the rationale to include it in the Dubinsky and Miyaski analysis?
b. Many medical journals publish abstracts without disclosing the number of subjects. Dubinsky and Miyasaki excluded all studies if the number of subjects did not appear in the abstract. Without reading the entire manuscript, how would they know if the study qualifies for inclusion? They also excluded studies with less than 10 subjects. Why is 10 the cut-off? I am not aware that meta-analysis requires such cut-off. Sample size should not be arbitrary, but sufficient to power the statistical findings. If the treatment effect is high and standard deviation is low, a sample of 7 or 8 patients may yield clear statistical difference. How confident can one be that Drs. Dubinsky and Miyasaki made unbiased selection of studies relevant to low back pain and TENS?
c. A principle requirement in any credible study or review is to ascertain that the conclusions are factual, not speculative. Accordingly, Drs. Dubinsky and Miyasaki conclusions and recommendations must be challenged.
Given these shortcomings, CMS should continue to cover TENS for chronic low back pain.
Gad Alon, PhD., PT
Associate Professor
University of Maryland, School of Medicine
Department of Physical Therapy & Rehabilitation Science
Baltimore, MD
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Title: Medical Director, Rehabilitation Programs
Date: 10/10/2011
Transcutaneous Electric Nerve stimulation is a useful treatment for LBP. Many patients respond to this therapy and have improve pain, participation, return to work and improved quality of life. CMS should approve this useful treatment
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Date: 10/10/2011
I have been informed by my specialty society that CMS is considering noncoverage of TENS as a treatment for chronic low back pain. I would encourage CMS to continue coverage of TENS. I have found it to be a useful adjunctive treatment, especially in patients who are not appropriate for invasive treatment such as lumbar spinal injections and/or have difficulty tolerating analgesic medications. While I do believe that measures such as documentation of satisfactory pain relief and regular use of the device should be employed to decrease overutilization, I would discourage blanket noncoverage of this treatment modality as it would be to the detriment of those patients who do derive benefit from TENS.
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Title: md
Organization: pain mgmt and rehab med ctr, pc
Date: 09/21/2011
TENS unit, as a means for analgesia and functional improvement, has a substantial role in the management of chronic axial and radicular spine pain via neuromodulation and, based on my personal experience, is efficacious in at least 50% of the cases for 6-9 month use.
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Organization: Start To Finsh Spine Care
Date: 10/05/2011
back pain can be challenging to treat. in a time with increasing regulations on narcotics modalities such as TENS units should be welcomed as a treatment. TENS units are relatively safe and they have helped many of my patients recieve substantial pain relief and avoid taking excess medications.
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Date: 09/26/2011
Eliminating TENS, will leave our patients without a non-narcotic pain management option that is proven to be effective. Back pain is NOT the only painful condition associated with the use of a TENS unit. Sciatica, Foot and Leg pain, Hip pain, and Shoulder pain to name a few. Try going after the Billions of dollars due to Fraud in the system and if you are going to eliminate something, find something to replace it with, which in this case, you cannot do.
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Title: Manager Therapy
Organization: Holzer Medical Center
Date: 09/29/2011
I am a manager of a hospital based therapy department.
I feel strongly that more clinical research should be done, but from a standpoint of patient use and report I would be losing a wonderful tool and service if I did not have the ability to offer TENS units for our low back patients.
thank you,
Stella
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Date: 09/29/2011
I am a physical therapist who has been treating low back pain for 16 years. I have found TENS to be an effective pain control method for those with chronic low back pain. It offers a safe, drug free alternative method of pain control. The pharmaceutical companies would love for TENS to be eliminated as a competitor to their addictive and expensive products. Clincally TENS continues to be a safe and low cost method to control pain. Please consider the thousands of people who benefit from the use of their units daily before pulling the reimbursement. Thanks for your consideration.
Dan Beckstead, PT
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Date: 09/26/2011
We fit many patients each week with these devices. We fit about 20 patients per week with TENS units. These are more than effective in managing Chronic pain conditions if the patient is correctly instructed on how to use the device and has a diagnosis that is musculoskeletal problem. These do not cure they just help manage the patients pain with minimal to no narcotic use. If these are taken away from patients they will be left with not many options to treat their pain. Narcotics, surgery and or injections which are much more costly and invasive. We have patients that tell us all the time that they could not live without their TENS unit.
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Title: Assistant Professor of Physical Medicine and Rehab
Organization: Eastern Virginia Medical School
Date: 10/11/2011
I frequently prescribe TENS units for our patients with chronic low back pain. A large part of our practice consists of chronic pain management. I have found these devices to be a very effective adjuvant treatment modality, in addition to medications and Physical Therapy. While they are not effective in all patients, the majority of our patients report reduction in pain at their follow-up appointments. Eliminating coverage for these devices would be very unfortunate; chronic pain is very challenging to treat, and TENS units provide an additional non-pharmacological way to help this patient population.
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Date: 09/23/2011
To Whom This May Concern:
The "Tens" unit is a daily part of physical therapy used in this household. Without help from Medicare the "Tens" unit would not be afforded here.
Thank you for allowing me to comment.
Len Berroth
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Date: 09/22/2011
I work in a very busy pain management practice. We use TENS as an early option for individuals with chronic low back pain. This treatment does not help everyone, but certainly helps many individuals. The trial is essential to determine who will benefit from the therapy. TENS is a relatively low cost and non invasive option which gives patients some control over the management of pain. Having non-drug modalities is very important. I have seen very positive results utilizing TENS as a component of multimodal treatment for chronic pain. Thank you.
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Title: Vice President
Organization: Patient's Choice
Date: 10/07/2011
I have been in the Rehab industry for over 12 years. In that time, I have seen thousands of patients with chronic back pain receive pain reducing benefit from the use of TENS units. Like any medication or modality, it does not work 100% of the time with 100% of the patients, but for those who derive benefit, it can be an invaluable tool to help them decrease the pain they continually live in.
I am surprised that CMS is hanging their hat on this particular research. It is not centered on patient care and I don’t see how it reflects the experiences I have seen in the lives of patients for over a decade. The review was conducted with TENS amplitude output in the sensory levels. At sensory levels, there is no motor level recruitment of muscle fibers which result in the body’s natural release of endorphins. This is a tremendous oversight in the research Medicare is using to base this large decision on.
Medicare already has built into their system the checks and balances for efficacy of TENS therapy. Medicare mandates an initial trial period. Only if that initial trial shows success does the patient then return to their physician for a follow-up visit. If the patient shows a reduction in pain and other symptoms, the physician then completes the required CMN. This process eliminates us of TENS for any patients in acute pain, or for patients that are non-compliant with TENS therapy, or when physicians do not see the benefit of continued TENS therapy. This process also mandates that other forms of pain management have already been tried and failed before resorting to TENS therapy. Thousands of physicians would not be completing CMN’s for their patients every month if they didn’t see the benefit in TENS therapy to help their patients with chronic back pain.
Eliminating TENS therapy as one of the tools to manage chronic back pain will have unintended consequences. It will result in the increased use of powerful pain killing drugs with addictive side effects that will cost the tax payer more money in the long run. Even in patients who do not turn to an opiate based medication, they may turn to NSAIDs, which have been proven to have a long list of negative side effects. And more patients will turn to invasive surgery to help minimize their pain. This is both risky and more expensive to the tax payer in the long run also. TENS is an effective tool to help patients avoid addictive and invasive options for their pain management. Not to mention that this will appear to the American people as yet another reduction of benefits instead of actually cutting costs.
Please don’t make this decision without fully researching the issue. Your short 30 day window of time is insufficient. Interview the thousands of Medicare patients who benefit from TENS units. Interview the thousands of physicians who prescribe TENS for their patients with chronic low back pain. You will see for yourself that TENS can be an effective tool at reducing back pain and that your studies are misguided and too narrow in their focus.
Feel free to contact me further with any additional questions you may have. I would love to be a resource in your understanding of these issues.
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Date: 10/11/2011
I have only been in the Rehab industry for a year or so, butin that time, I have seen the positive effects of TENS therapy in the lives ofpatients with chronic back pain.
One of my primary responsibilities is to be the primarycontact person at our company for patients who need to re-order supplies inorder to continue to use their TENS units. So when patients call our company to request more electrodes, I get tospeak to them. I am always pleasantlysurprised at how often these patient feel the need to tell me how much theylike their TENS unit and often they will use the phrase, “I could never livewithout it”. Their requests for suppliesare sometimes urgent since they are using the TENS unit so regularly as a partof their pain management, that the thought of going even a few days without useof their TENS unit makes them emotional.
I am not an expert on all of these matters, but I wouldthink that Medicare’s procedures that are in place for monthly supply re-ordersare a very telling endorsement of TENS therapy being effective. Patients must be in regular contact with usto affirm that they still are using the TENS unit and need additional suppliesto continue to use it. So I would thinkthat every time Medicare writes a check for monthly TENS supplies, they couldinfer that this is yet another patient who is using this TENS unit andreceiving benefit from it (or else why would they still be using it?)
Anecdotally, I can vouch for the fact that there are manypeople each month with chronic back pain who are receiving benefit from the useof TENS units as one of the tools they use to manage their chronic pain. They are the ones routinely calling me torequest additional supplies to continue the use of the TENS unit and they areones singing its praises when they do call us.
Thank You,
Michelle Bird
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Date: 10/07/2011
Coverage for Tens unit should be restricted. many of my patient have found they significantly reduce there pain especially when they are unable to tolerate medications. Physical therapy is not a life long option for anyone. Patients need to be able to manage their pain as conservatively as possible and to that managment should not reduce their ability to function day to day. We are in the business of improving quality of life not just quantity
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Title: EVP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans (AHIP)
Date: 10/12/2011
October 12, 2011
Sarah Meisenberg, MSPH
Lead Analyst
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Dear Ms. Meisenberg:
Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Analysis (NCA) Tracking Sheet for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.
General Comments
AHIP and our member health plans encourage CMS to ensure that all patients receive safe, effective and evidence-based treatments. Our members strongly support CMS reviewing the available evidence on the use of transcutaneous electrical nerve stimulators (TENS) for the treatment of chronic low back pain. In 2010 the American Academy of Neurology’s Therapeutics and Technology Assessment Committee’s published review concluded that TENS for treating chronic low back pain is not recommended[i]. In addition, the Cochrane Review (last updated in 2008) also did not support routine clinical usage of TENS for chronic low back pain[ii].
Although TENS is widely used, its use for treating chronic low back pain is not supported by published clinical evidence. Because it is not an emerging technology, our members believe TENS for the treatment of chronic low back does not warrant a Coverage with Evidence Development (CED) approach by CMS.
Thank you for the opportunity to comment on this important issue.
Sincerely,
/s/
Carmella Bocchino
Executive Vice President
Clinical Affairs and Strategic Planning
[i] Dubinsky RM, Miyasaki J. Assessment: Efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence based review). Neurology, v. 74 no. 2, p. 173-176.
[ii] Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD003222. DOI: 10.1002/14651858.CD003222.pub2
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Date: 09/26/2011
[PHI Redacted] this is ridiculous to take away non-invasive, non-narcotic means of therapy when there are so many clinical studies that say it is effective. What is going to be left for my generation besides taking a pill, which the implications of can be far more detrimental than a TENS device. I would suggest if you are looking to save money on your budget perhaps goign after more more invasive and costly procedures would be more beneficial, especially when you examine efficacy vs potential harm to patient.
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Title: physician and Medical Director
Organization: Siskin Hospital for Physical Rehabilitation
Date: 10/11/2011
In our rehabilitation practice we treat a number of chronic back pain patients. No treatment or modality works very well for chronic pain as the studies bear witness. When left with nothing that works reliably, you try one thing after another is seems reasonable. TENS does work for some, not most. When it works, its usefulness is limited; it does not take all the pain away, but does help reduce its severity.
The current policy allows for a one month TENS rental and follow up visit to determine the effectiveness. The effectiveness of the TENS unit needs to be documented in the physician's office note before approval is given for purchase.
The current policy is fair, requiring verification that the treatment modality is effective, yet providing for payment if helpful.
I would strongly recommend against eliminating TENS as an option for the treatment of chronic pain.
Thank you,
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Title: Physical Therapist
Organization: GWCH
Date: 09/29/2011
I urge you not to discountinue giving benefits for TENS units for chronic back pain. I am a physical therapist who has used and given out many TENS units for chronic back pain. I have never had a patient that has not had at least some decrease in pain with the TENS unit. Some patients have 75% to 100% reduction in pain. I have had many patients reduce their pain medication intake after using TENS units. For some patients surgery is not an option and the TENS unit gives the patient at least some relief to be able to sleep or perform activities they enjoy. Do not let one study harm patients from getting the relief they deserve.
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Date: 09/27/2011
We have used TENS for over a decade for a conservative pain-management option for patients that don't want or cannot tolerate expensive and dangerous pain medications. Cancelling TENS is just putting more money in the coffers of the drug companies that make pain meds and will absolutely result in increased drug-dependence and serious drug side-effects.
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