Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain

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April 12, 2012

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques,

We appreciate the opportunity to provide comments regarding the recent proposal by CMS to restrict Transcutaneous Electrical Nerve Stimulation (TENS) coverage for Mediciare beneficiaries with chronic low back pain. On behalf of Neurotech NA, Inc., I am writing urge CMS to continue coverage for this technology which has provided benefit to seniors and other beneficiaries for over two decades.

Neurotech, NA is a leading developer, manufacturer and supplier of innovative, high quality neurostimulation devices including but not limited to TENS.  We are located in Minneapolis, Minnesota. We distribute our TENS technology through a variety of distributers who work with physicians to provide a continuum of care for patients that suffer from chronic pain including low back pain.

TENS is an FDA cleared treatment for the symptomatic relief of chronic pain.  It is very safe and patients can self administer after training by physicians and other healthcare professionals. The waveform or intensity can be adjusted to accommodate the patient’s needs without causing any harm. It is a low cost therapy with few side effects that provides a simple to use alternative to pain management compared to addictive medications or invasive surgical procedures.

For these reasons, we are very concerned that CMS is now proposing to take this effective therapy away from seniors who may need it most and only allow coverage in very limited circumstances where select patients are enrolled in a randomized clinical trial.  CMS states TENS is not effective based on a review of 6 studies, four of which are foreign based, and not representative of the elderly and disabled population of interest to CMS in the United States.

The one United States-based study that CMS seems to rely on most to conclude that TENS does not reduce pain is Deyo (1990).  Many others have already criticized the Deyo methodology over the years. First it uses old technology with questionable intensity levels. 

Also it is troubling that CMS is looking to Deyo as a key piece of “updated evidence” upon which it decides to reconsider TENS coverage.  We don’t think this is updated evidence since Deyo was published before CMS issued its 1995 national coverage decision for TENS.

Another concern is that the CMS proposal fails to give serious consideration to its own carefully developed national and local coverage policies.  These policies require physicians to complete a certificate of medical necessity (CMN) stating that TENS is indeed effective for their particular pain patients.  Even before a physician can complete the CMN allowing purchase, the policies require a rental prescription to determine if TENS is beneficial for treating long term pain.  For CMS now to reverse its own coverage criteria and interfere with a physician’s professional judgment based on questionable studies is inappropriate.

We also think there are better ways to gather data to answer outcomes questions than to rely solely on a costly and expensive randomized clinical trial that could be unworkable. Instead CMS should consider other data gathering options.  For instance, CMS has been covering TENS for over two decades.  Our assumption is that there must be a tremendous amount of claims data that could help CMS understand the questions it wants answered.  A retrospective review may be one specific option.  There are others such as registries and observational studies and even still more.  The point is that none of these have yet to be considered.

We urge CMS to consider the entire record demonstrating that TENS is effective and beneficial for its Medicare population.  Other considerations include the history of acceptance by the medical community as a whole.

We respectfully request that CMS maintain existing coverage for TENS while gathering other evidence that may help advance the discussion of outcome measures that CMS would like to further investigate.

Sincerely,

John VeLure
Vice President, North American Operations
Neurotech NA, Inc.
+1 952-240-6023

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As a therapist with 14 years of experience I have found TENS units to be extremely effective in treating chronic lower back pain. Due to chronic nature of patient's pain, many of them continue to have success with using home TENS units for more than 90 days. It is important that patient's have access to TENS units for more than a 90 day period to continue their improvement in functional ability and ADLs.

In many cases TENS units are the safest and most effective treatment for my patient's chronic pain issues. Many of my Medicare patients have side effects with pain medications and find TENS units to be more effective.

I strongly urge CMS to continue existing coverage of TENS units.

Sincerely,
Galen Pettey, PT, MSPT

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In the physical therapy clinic where I work as a physical therapist assistant we have great success with the use of TENS units for chronic lower back pain. I strongly support continuation of the existing coverage of TENS units

Our patients have had success with home TENS units that they continue to use for more than 90 days. Many patients report improvement in their activities of daily living and function. If TENS units were not covered by Medicare for more than 90 days it could hinder patients ability to keep up their functional gains.

In many cases TENS units are the safest and most effective treatment for our patient's chronic pain issues and patients are able to avoid the unwanted side effect that many of them experience with pain medications. Please continue the existing coverage of TENS units.

Sincerely,

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Dear CMS,

I strongly support continuing the existing coverage of transcutaneous electrical nerve stimulation (TENS) for patients with chronic lower back pain.

As a therapist with over 20 years of experience I have found TENS units to be extremely effective in treating chronic lower back pain. Due to chronic nature of patient's lower back issues, many of them continue to have success with using TENS units for more than 90 days. It is important that patient's have access to TENS units for more than a 90 day period.

In many cases TENS units are the safest and most effective treatment for my patient's chronic pain issues.

To continue having access to what in many cases is the best treatment alternative I strongly urge CMS to continue existing coverage of TENS units.

Sincerely,

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I am commenting on your plans to eliminate coverage of TENS units for treatment of chronic low back pain after 90-days.
I am a Nurse Case Manager who regularly deals with patients with chronic low back pain. Any plans to eliminate coverage of TENS units after 90-days will further limit treatment options for patients. While I understand the need to consider ways to reduce the escalating cost of health care, it is my belief that your plan only targets a small percentage and therefore will not result in substantial cost savings. Some may prefer a TENS unit over narcotic medications that have harsh side effects, including addiction. The cost of ongoing use of narcotic medications, including laboratory testing, medication management, and rehabilitation due to addiction far exceeds the cost of a TENS unit.

More importantly, many of these patients are debilitated by chronic pain and eliminating TENS unit as a treatment option only further limits available treatment and reduces any potential for quality of life. I urge you to reconsider and not eliminate coverage of TENS units to patients who need to have this as a treatment option.

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April 12, 2012

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments to Proposed Medicare Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CAG-00429N)

Dear Dr. Jacques,

On behalf of the Neurostimulation Device Alliance (NDA), we appreciate this opportunity to provide comments in response to the Center for Medicare & Medicaid Services’ (CMS) Proposed National Coverage Analysis for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain issued on March 13, 2012.

The NDA represents the leading United States manufacturers and providers of high-quality products used for rehabilitation, pain management, and physical therapy. Among other products, NDA members manufacture and distribute home electrotherapy products, which include Transcutaneous Electrical Nerve Stimulation (TENS) devices for pain management and such related supplies as cutaneous electrodes. Our members and affiliates manufacture and provide the vast majority of TENS devices and supplies on the United States market today. We are the market leaders in this medical device sector and have substantial and longstanding clinical, technical, and regulatory expertise.

We have serious concerns with the CMS TENS proposal as written and support continued Medicare coverage of TENS for Medicare patients with chronic low back pain (CLBP).

In brief our position is:

• There is sufficient evidence to meet the statutory requirements to show that TENS is reasonable and necessary to treat Medicare beneficiaries with CLBP.
• CMS’s long-standing coverage requirements already ensure that beneficiaries receive access to only medically necessary TENS.
• Eliminating TENS coverage interferes with the physician’s professional judgment and adversely impacts beneficiary access to effective pain treatment.
• CMS uses flawed studies to deny long standing TENS coverage.
• The CMS analysis ignores research showing the positive benefits of TENS.
• Coverage with evidence development (CED) should not be used to limit coverage of TENS.
• Relying solely on the use of randomized clinical trials as the only means of answering outcome questions, rather than considering more effective and less burdensome methodological approaches, is unduly restrictive.
• CMS should continue to allow seniors with CLBP access to TENS to treat their pain while working collaboratively with stakeholders to develop data collection objectives.

Our comments are more fully discussed in the following sections.

Overview of the CMS Proposal to Restrict TENS Coverage

In its proposed decision, CMS indicates it reviewed select literature and concluded that TENS does not produce sufficient clinically meaningful reduction in pain or other functional improvements in Medicare patients with chronic low back pain (CLBP). In what appears to be an unprecedented action, CMS seeks to use its CED process on existing technology to gather more data to support its hypothesis. As a part of the CED proposal, CMS will deny seniors and other beneficiaries with CLBP future access to this FDA cleared technology unless they are enrolled in a prospective, randomized, controlled, clinical trial.

CMS initially justified its review of existing TENS coverage last fall based on the Dubinsky study which concluded that TENS was ineffective in the treatment of CLBP. In its present analysis, CMS now excludes the Dubinsky study from consideration, indicating the study it relied on for considering changes to TENS’ existing coverage is invalid. This reliance then dismissal of Dukinsky raises questions about the thoroughness of review before relying on research as a basis to reconsider long-standing coverage decisions as is the case with TENS.

After deciding to review TENS coverage based on the Dubinsky study, in its March 13 proposal, CMS identifies five inclusion criteria used for identifying studies it will consider in evaluating TENS. This criteria is extremely limited and inappropriately excludes studies with positive TENS results. For example, it disallows studies of chronic back pain or other chronic pain focusing narrowly on only studies of chronic “low” back pain. Based on this and other criteria it is not surprising that CMS found only six single studies out of the large amount of research conducted on TENS over the years.

In sum, the NDA has major concerns with the new CMS recommendation to limit TENS coverage. CMS’s approach relies on questionable studies to support its initial conclusions, fails to consider other studies showing the benefit of TENS to treat patients with chronic pain including chronic low back pain, ignores the fact that the FDA has approved TENS for this purpose, and overturns long-standing coverage policies which rely on physicians’ medical judgment in determining whether TENS is effective for treating their patients with CLBP.

Evidence Shows that TENS is Reasonable and Necessary for Treating Medicare Beneficiaries with Chronic Low Back Pain

Federal law requires Medicare to cover items or services considered reasonable and necessary for the diagnosis or treatment of illness or injury. §1862(a) (1) (A) of the Social Security Act. In Public Comment guidelines, CMS sets forth the criteria it will use to interpret this statute. While supportive of strong clinical evidence, these standards do not limit coverage to items supported with evidence based solely on the highest levels of evidence such as randomized clinical trials. In fact the guidelines say that the “appropriate weight to be accorded to particular types of evidence may vary depending on a variety factors.”

While it may make sense to impose stricter coverage requirements for new, unproven technology, this is not the case for TENS. TENS is a well-established standard of care and has a unique and long-standing history of adoption and acceptance by the medical community. It is included in state practice guidelines as a modality used by physicians and physical therapists in physical medicine and rehabilitation. TENS is safe, cost-effective, fast-acting and a user-friendly treatment that has very few side effects. It reduces the need for analgesic medications and can be stopped at any time if it is not effective. Patients, physicians, clinicians and even CMS have historically recognized these benefits.

CMS should not ignore this long standing history of acceptance by the medical community in making its coverage determination.

Medicare’s Existing Coverage Requirements Already Ensure Beneficiaries Receive Only Medically Necessary TENS

Medicare has covered TENS for Medicare beneficiaries with CLBP for nearly 25 years. Since first establishing national coverage in 1988, CMS and its DMAC subcontractors have established strict requirements setting forth detailed indications and limitations of coverage including the following:

• Physicians must document the effectiveness of TENS during trial before it is purchased for long term use.
• The pain must be present for at least three months and other modalities must have been tried and failed.
• After the trial a physician must reevaluate the patient and determine significant therapeutic benefit from continuous use over time.
• Before purchase, the treating physician must complete and sign a Certificate of Medical Necessity (CMN), a form CMS developed and requires to demonstrate that TENS is medically necessary.

The medical community has followed these guidelines for two decades. In July 1989, shortly after the first national coverage decisions pertaining to the treatment of chronic pain were implemented, the HHS Office of Inspector General (OIG) surveyed beneficiaries to evaluate Medicare reimbursement for TENS. The OIG concluded by recommending that HCFA (CMS’s predecessor) publish Medicare coverage requirements to the medical community. HCFA did so by requiring its carriers to notify professional societies of the medical guidelines.

Given this long history, CMS should more clearly demonstrate that TENS is not beneficial before CMS disrupts its existing process for determining medical necessity based on physician review.

The CMS Proposal Would Interfere with a Physician’s Professional Judgment Regarding the Benefit of TENS for Individual Patients

The existing CMS coverage policies allow physicians to determine what pain treatments are best for their patients. We support this approach. If the physician cannot demonstrate that a patient is deriving “significant therapeutic benefit”, no CMN will be completed and TENS will not be prescribed for purchase for Medicare patients. If a physician examines the patient and determines TENS would be beneficial, he or she must certify that TENS is effective in treating pain by signing a CMN.

The CMS proposal is dismissive of this approach. Instead, it says TENS is not beneficial based on a review of a small number of six flawed and inconclusive studies. Such an approach seems presumptuous and unduly interferes with the physicians’ and therapists’ medical judgment in determining the best course of action for their patients.

Further evidence that the March 13 proposal disregards the professional medical judgment of physicians and therapists is CMS’s failure to consider the concerns of professional societies whose members are in a superior position to understand the benefits of using TENS. For example, during the initial comment period in October 2011 at least three professional societies submitted comments expressing strong support for continued Medicare coverage of TENS, including the American Society of Anesthesiologists, the American Academy of Pain Medicine, and the American Physical Therapy Association. In its comments, the American Academy of Pain Medicine warned CMS of the potential adverse impact of restricting existing coverage of TENS:

The Academy’s position exemplifies the opinion of physicians and other providers across the country. Although clinical reviews have their place in helping to determine the effectiveness of therapies, they are not the last word. CMS must give greater weight to physicians’ medical judgment and experience.

The CMS Proposal Would Have an Adverse Impact on the Ability of Medicare Beneficiaries to Access Pain Therapy.

If the CMS proposal is implemented, seniors and other Medicare beneficiaries will be denied a non-addictive, therapeutic alternative to pain treatment. The previously identified OIG report found that “nearly 80% (67 of 85 beneficiaries) of beneficiaries who purchased and received TENS found the treatment beneficial.” The majority of surveyed beneficiaries had low-back pain and/or arthritis and had experienced pain for a number of years. A majority of these beneficiaries had taken pain medications with varying results. Despite these findings in support of retaining existing TENS coverage, the March 13 CMS proposal makes no mention of the OIG’s findings.

More recently, patients and their organizations have expressed similar support for existing TENS coverage. In its October 2011 letter to CMS, the American Pain Foundation said it received “countless testimonies from people who have gotten effective relief from TENS…especially older persons who have fewer safe choices for treating their pain.” (Emphasis supplied)

In proposing this more restrictive coverage proposal, CMS has failed to disclose any of its current utilization data regarding the number of seniors that rely on TENS for treatment of CLBP and will be impacted by this proposal. In our opinion if CMS decides to restrict coverage, the number of seniors negatively impacted will be significant. According to the data published in the CMS proposal, Medicare patients purchased nearly 85,000 TENS units in 2010. Since most TENS are purchased based on a physician prescription demonstrating long term therapeutic benefit, it is reasonable to assume that most of these 85,000 units were distributed to patients with chronic pain. A survey of NDA members who file Medicare claims on behalf of patients indicates that most Medicare beneficiaries purchase TENS to treat chronic low back pain.

The virtual elimination of a benefit utilized by a significant number of seniors who have come to rely on TENS to treat chronic low back pain while CMS seeks to justify its decision through additional study is inappropriate and a disservice to the Nation’s elderly. Additionally, CMS’s proposed change to existing coverage of TENS will likely have a significant impact on Medicare cost as these beneficiaries are forced to utilize higher cost alternatives such as narcotics and surgical intervention. Even more troubling is the fact that this proposal is at odds with the growing national concern with overutilization, abuse and diversion of prescription opiods. We find questionable a public health policy that second guesses a physician’s medical judgment and which may have the effect of driving seniors away from TENS – a low risk, low cost therapy toward treatment alternatives with potentially adverse and costly side effects.

CMS Uses Overly Restrictive Criteria to Exclude Review of Positive Evidence

One of the standards CMS uses to determine whether studies are relevant to the review of TENS is the requirement that CMS only consider studies whose participants included adults with “chronic low back pain” present for 3 months or longer. This requirement ignores studies of chronic pain in other anatomical regions including other regions of the back, neck, hip or knee.

We think the approach adopted by CMS is unreasonably restrictive. CMS provides no support for the conclusion that pain varies by its anatomical location. In fact the human nervous system functions in the same manner with regards to motor control and sensory perception regardless of anatomical location. The mechanisms of TENS are well understood and have been extensively documented. In general TENS activates sensory and motor nerves, which stimulate the release of inhibitory neurotransmitters in various locations of the peripheral and central nervous system (often referred to neural gating after the Melzack-Wall gate control theory of pain). These endogenous opiods and inhibitory neurotransmitters activate the body’s natural defense against pain and block pain perception. TENS may assist in modulating central pattern generators for pain which are a key feature in the maintenance of chronic pain syndrome. It should be noted that chronic pain management is generally multimodal and as a result it may be difficult to use or study a single intervention when most often the patient requires multiple approaches for successful treatment. Since the mechanisms of pain management are common regardless of location, we urge CMS to expand its selection criteria to include a more comprehensive review of the existing literature.

One study that CMS should reconsider is the 2007 Johnson and Martinson meta-analysis of electrical nerve stimulation (ENS), including TENS stimulation. CMS makes scant reference to the Johnson and Martinson analysis in its proposal, saying only the analysis was not considered because it included “mixed sample of musculoskeletal conditions.” The authors and other commentators have disputed this interpretation, maintaining that the mechanism of action of pain (gate control theory or release of endorphins) rather than location of pain is the most likely the critical factor for therapy.

Inclusion of the Johnson and Martinson analysis may have changed the results of CMS’s review. The authors found that a total of 38 studies in 29 papers - which included 335 placebos, 474 ENS, and 418 cross-over (both placebo and at least one ENS treatment) patients – met the inclusion criteria to determine whether electrical nerve stimulation reduces chronic musculoskeletal pain more effective than placebo. The overall results showed a significant decrease in pain with ENS therapy using a random-effects model (p < 0.0005). The results indicate that ENS, including TENS, is an effective treatment modality for chronic musculoskeletal pain including chronic low back pain, and that previous, equivocal results may have been due to underpowered studies.

During the 2011 initial comment period, we also submitted evidence of other positive studies supporting TENS effectiveness. CMS either does not explain why it excluded some of these from consideration or simply discounts them. Leonard and Marchand is just one example of a well-designed study CMS excluded without explanation. Grant, Bishop-Miller, et. al. is an example of a study CMS seemingly disregards because of imprecise location of back pain. Other commenters have already registered in some detail their strong concern about the exclusion by CMS of highly relevant data and we will not repeat those assertions here except to say we share their concern that CMS may be inappropriately excluding data that may better inform CMS’s review. We have no doubt that if included in the review, these studies would provide sufficient evidence of TENS effectiveness in treating patients with chronic low back pain.

CMS Uses Flawed Studies to Deny Long Standing TENS Coverage.

CMS says it is “respectful of the historical Medicare coverage of the use of TENS for CLBP and did not decide lightly to undertake this NCD reconsideration.” We appreciate this sentiment and hope the same holds true before CMS reaches a final decision that would significantly alter existing national coverage on the basis of only six studies. These studies should receive intense scrutiny and not just meet the minimum inclusion criteria CMS has identified.

Following is our review of four studies used by CMS to conclude that TENS does not produce a meaningful reduction in pain in Medicare patients with CLBP. This is an important outcome measure since the FDA has concluded that TENS is indicated for the symptomatic relief of chronic pain.

Deyo, Walsh et. al. (1990)

CMS says it looked at the “updated evidence that has been published since the original national coverage decision, and concluded that it does not believe that this updated evidence base supports the coverage of TENS in CLBP.”

It is hard to imagine that CMS considers Deyo to be the “updated evidence” it looks to in order to reconsider TENS coverage. Deyo was first published in 1990. This was only two years after the original 1988 coverage decisions were published, but still a full five years before CMS published the national coverage determination for TENS (280.13) allowing coverage to treat CLBP and other chronic pain conditions (this NCD has no carve out for specific types of chronic pain). Deyo is an old study well-known by researchers, many payers and critics. Deyo uses older technology and stimulation systems. As we and others stated in the October 2011 comments, there are other concerns with Deyo, including the fact that the treatment parameters were not clearly defined. Recent research by Moran shows that TENS at stronger intensities provides greater effects. A further criticism of the Deyo study is that it uses a hot pack for both the control and placebo groups. It is well documented that heat is used to reduce pain and it provides sensory input much like TENS. Heat provides an additional variable that was uncontrolled and is further evidence of the limitations of the Deyo study.

Given its history, it is now hard to understand why after all these years, Deyo has become the flagship study to discount the use of TENS for CLBP. CMS should fully consider criticisms of the Deyo study before relying on it so heavily to overturn long-standing TENS coverage.

Itoh, Itoh et. al (2009)

This study has a number of weaknesses and should be excluded by CMS. First, it is a “pilot study”. Pilot studies typically have a very small number of patients. Their purpose is to see if there is possibly a benefit (or not) to an intervention so as to determine if a large prospective study is warranted to confirm the results. The results of this study are not intended to change current practice but rather to tell researchers that a larger trial is needed. Moreover the article only has 32 patients divided into 4 groups. Thus, each group only has 8 patients. It is not reasonable to conclude anything meaningful from the data of 8 patients on something as difficult to assess as chronic pain improvement.

A second criticism of this study is that all the participants were Japanese and are thus not an accurate reflection of the patient population of concern to CMS. CMS admits this shortcoming in its review saying “differences in the cultural attitudes and experiences towards pain in individuals from other countries compared to individuals from the United States may influence the outcomes of the research.” CMS states that this is not necessarily a “fatal flaw but could limit the generalizability of the conclusions to the Medicare population.” We are not quite how CMS could interpret this as not being fatal when CMS has repeatedly stated generalizability to the Medicare population is critical for any TENS research and will be important for any future RCT.

CMS is charged with determining the level of evidence applicable to the Medicare population yet too readily includes a small, foreign study as one of only a handful of studies that will serve the basis of future pain coverage for a significant number of Medicare patients. While inclusion of one foreign study may not be a fatal flaw, the fact that four of the six studies used to overturn TENS coverage are foreign raises very serious concerns. Besides Itoh, the other foreign studies are Shimoji (2007) and Yokoyama (2004), both Japanese, and Kofotolis (2008) (Greek).

Given these serious limitations, it is inappropriate to rely on Itoh as evidence of TENS being ineffective to reduce chronic pain.

Kofotolis, Vlachopoulos & Kellis (2008)

This study’s primary outcome was not designed to look at the efficacy of TENS. The author’s principal area of interest was rhythmic stabilization. It is suspect to make conclusions about TENS from a study that was not designed to evaluate the technology’s efficacy as a single modality. This study only includes Greek women between the ages of 34 and 46. As in Itoh, this patient population again is not representative of the CMS population and should therefore be excluded.

Shimoji , Takahashi, et. al. (2007)

This study is published in an obscure journal. The study tests “newly developed bidirectional modulated sine waves (BMW)” and is not testing traditional TENS application. The study does show a significant improvement in pain in patients within the first 60 minutes. This critical finding goes unmentioned in the CMS analysis and it is difficult to understand why reviewers would not consider immediate pain relief within the first 60 minutes as evidence of effectiveness. Despite this confusion, this study, like others relied on by CMS, only include Japanese participants and do not accurately reflect the CMS population that will be affected by the TENS coverage determination.

Conclusion Regarding CMS Studies

In sum, all of the studies used by CMS to discount TENS effectiveness for treating CLBP are fraught with numerous shortcomings and, by CMS’s own admission, flawed. It is inappropriate for CMS to deny TENS coverage on the basis of flawed evidence primarily derived from one U.S. study (Deyo) with methodological shortcomings and four foreign studies that have not been vetted for methodology, adherence to US clinical trial standards, and include study participants that do not accurately reflect the U.S. Medicare population. These studies do not constitute a strong evidentiary basis to reduce access to a technology that patients, physicians, and therapists have come to rely on over the years for safe and effective treatment of lower back pain.

CED Should Not Be Used to Limit Access to TENS

The application of CED to study TENS raises serious concerns. To our knowledge CED has not been applied to a technology such as TENS with a long history of carefully developed coverage guidelines. In fact, the original intent of CED was to allow coverage for promising new technologies and treatments for which evidence and clinical usage has not yet been established. Before applying CED to any existing technology, we think it is important that CMS first define the criteria it plans to use for existing technology. Otherwise, not only TENS, but all medical technologies that don’t meet what CMS defines as the standard for strongest possible evidence may be subject to similar review and possible elimination of national coverage. CMS’s current approach would create uncertainty and significantly dampen the effect on innovation.

In January 2012, we submitted comments to CMS in response to a public solicitation on ways to improve the CED process. We incorporate those comments by reference here and ask that they be seriously considered before any final decision is made to use CED for gathering more evidence regarding TENS.

Finally, we are encouraged by the fact that the MEDCAC will be holding a public meeting in May to discuss revisions to the 2006 CED guidelines. If CMS is serious about applying CED to technologies already covered, it should identify ways that would not restrict current coverage while new evidence is developed.

The Requirement to Only Allow Coverage for Patients Enrolled in a Randomized Controlled Trial is Unduly Burdensome

The draft CMS proposal limits coverage for TENS only to patients enrolled in prospective, randomized, controlled clinical trials (RCTs). This approach is not only costly but could take years to complete even though better alternatives may be available for gathering evidence about a technology with decades of use data.

While RCTs are considered the gold standard of evidence based evaluation, multiple studies have demonstrated disparities between the results of clinical trials and results in actual clinical practice. RCTs are often criticized as not representative of the average physician’s practice and do not mimic the real world. This criticism has lead, in part, to the increased interest in population based observational outcome trials which study a broader group of patients with minimal inclusion/exclusion criteria in an attempt to mimic true clinical conditions. RCTs may work best in a tightly defined population but they lose strength when results are extrapolated to patient populations outside of the narrow group studied. Because of the narrow study population, patient recruitment takes longer and these studies typically cost more. It is also unrealistic to believe that an RCT with a sham comparator could be accomplished with a follow-up time of more than 12 weeks when studying chronic low back pain. The drop out percentage of the patients randomized to the sham arm would be extremely high due to the fact that they are not receiving an effective treatment and they would either drop out or be lost to follow-up.

Additional clinical research is useful for nearly every medical intervention. But other options are available besides RCTs which are not the only legitimate method of data gathering. CMS should encourage use of alternative data collection methodologies besides requiring use of costly and time consuming studies such as RCTs which may be unworkable.

Allow Existing TENS Coverage to Continue and Work with Stakeholders to Develop Collaborative Approach to TENS Research

Sufficient evidence exists to show TENS is effective and meets the statutory standard for Medicare coverage. If CMS determines the need for additional data it should continue coverage until after the evidence is evaluated and then make a decision whether it is appropriate to continue or deny coverage.

CMS should not rule out any particular research approach but should be open to consider all valid methodologies and approaches that are proposed by stakeholders and interested medical specialty groups. We propose that other types of studies be considered rather than just randomized controlled trials. These alternatives include retrospective cost of care analysis of existing CMS claims data, prospective registry data, and prospective observational practice based cohort trials, all of which would be much more relevant to real world practices. Other possibilities include development of beneficiary surveys or other claims-based reporting.

The best approach for determining exactly what methodologies or approaches work best is to collaborate with all interested stakeholders to clearly identify the data collection objectives. For example, professional societies and industry and other experts as well as patient representatives who have the resources, knowledge and expertise regarding the application of TENS technology to the Medicare population with chronic low back pain would be valuable. We strongly encourage CMS to consider these alternatives before settling on an unrealistic, unilateral approach without stakeholder input.

Conclusion

TENS is reasonable and necessary to treat Medicare beneficiaries with chronic low back pain as required under § 1862(a)(1)(A) of the Social Security Act and the evidence standards promulgated by CMS. The weight of the evidence, including clinical studies, physician practice experience with actual Medicare patients, and Medicare’s claim history shows TENS is effective.

CMS should not restrict this long-standing coverage based on questionable review criteria which relies on only six flawed studies while excluding other valid studies and evidence showing the positive benefits of TENS.

If CMS decides additional evidence is needed, it should continue TENS coverage under the existing CMS guidelines during the study period. After new evidence is gathered and analyzed, a decision can be made at that time about future coverage. Finally, we disagree with use of CED and especially with the use of an unduly burdensome and unworkable randomized clinical trial as the only means of studying TENS. We support a more collaborative approach to evidence gathering where CMS works with stakeholders to clearly identify data collection objectives that are reasonable and achievable within a realistic time frame.

Thank you for your consideration of our views on this matter. If you have any questions regarding our comments or require additional information, please contact us.

Sincerely,

Thomas P. Hughes, JD
Executive Director
Neurostimulation Device Alliance
12400 Whitewater Drive, Suite 2010
Minnetonka, Minnesota 55343

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April 11, 2012

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE Comments to Proposed Medicare Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CAG-00429N)

To CMS: Via Email and Web Posting

Dear Dr. Jacques:

On behalf of Electrostim Medical Services, Inc. (otherwise referred to as, EMSI), we appreciate the opportunity to provide comments in response to the Center for Medicare & Medicaid Services’ (CMS) Proposed Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain issued on March 13, 2012.

EMSI is a leading manufacturer and provider of high-quality products used for rehabilitation, pain management, and physical therapy. Among other products, EMSI manufactures and distributes home electrotherapy products, which include Transcutaneous Electrical Nerve Stimulation (TENS) devices for pain management and such related supplies as electrodes and lead wires.

In its proposed decision, CMS states that it has reviewed the available literature and found that TENS does not produce a clinically meaningful improvement in Medicare patients with chronic low back pain (CLBP). Consequently, CMS is proposing to only cover TENS for CLBP when Medicare patients are enrolled in a prospective, randomized clinical trial. EMSI has grave concerns with the CMS TENS proposal as written.

Our concerns are as follows:

• There is sufficient evidence to meet the statutory requirements to show that TENS is reasonable and necessary to treat Medicare beneficiaries with CLBP;
• EMSI supports continued Medicare coverage of TENS for chronic low back pain to preserve Medicare beneficiary access to this longstanding effective technology;
• The CMS proposal will have an adverse impact on Medicare Patients as it unduly interferes with the patient, physician, therapist relationship since local Medicare policies already require a physician to determine that TENS is effective for his/her particular patient ;
• CMS analysis uses flawed data to support non-coverage while other evidence supporting continued coverage is simply dismissed or not even considered;

Coverage for an existing technology such as TENS is inappropriate for consideration under coverage with evidence development since it has only been used to expand coverage for new technologies in the past and the current CED rule under consideration is not final; and,If CMS adopts coverage with evidence development (CED) requirements, we urge CMS to delay any coverage restrictions until at least two years after the final coverage determination is issued. It is important to note that any information collection mechanism will take time to develop and implement; the broad Medicare population should not be denied longstanding Medicare coverage during this evidence gathering process.

Sufficient Evidence Shows that TENS is Reasonable and Necessary for Treating Medicare Beneficiaries with Chronic Low Back Pain

Federal law requires Medicare to cover items/services considered reasonable and necessary for the diagnosis or treatment of illness or injury. While supportive of strong clinical evidence the standards do not limit coverage to items supported with evidence based solely on the highest levels of evidence such as randomized clinical trials – as set forth by CMS. The guidelines actually say that the “appropriate weight to be accorded to particular types of evidence may vary depending on a variety of factors.”

While EMSI agrees that it may make some sense to impose strict coverage requirements for new, unproven technology, this is not the case for TENS. TENS is a safe, cost-effective and user-friendly treatment that has very few side effects. TENS also has a long-standing history of adoption and acceptance by the medical community. Patients, physicians, clinicians and even CMS have historically recognized this treatment as a covered benefit.

Adverse Impact of Noncoverage Decision for Medicare Patients

Medicare has covered TENS for chronic low back pain (CLBP) since 1988 which is nearly 25 years. The medical community has used TENS as a safe and effective alternative or adjunct to pharmacological approaches to pain control for many patients – having minimal side effects and non-addictive qualities. Over those years, CMS and its’ DME MAC subcontractors have refined the coverage process. Specifically, they have developed detailed indications and coverage limitations for use to ensure that patients utilize TENS only when medically reasonable and necessary and the physician has confirmed that TENS is effective in addressing CLBP. Pain physicians understand these requirements and use their clinical judgment to decide whether TENS is appropriate for individual patients. If TENS is now eliminated after so many years of coverage, it would create an extreme burden on patients and physicians who have come to depend on TENS as a non-addictive, low-cost alternative for back pain.

Concerns with CMS Analysis of Evidence

Exclusion criteria and review of other evidence
Also, while we recognize the role CMS has in reviewing evidence regarding technologies and services they cover, we believe there is sufficient evidence in this case to support continued coverage for a technology that is already so widely accepted by the medical community and have questions about the exclusion criteria used in this case.

Requirement to conduct Randomized Clinical Trial
EMSI is supportive of efforts to gather data and other proposed methods which will further determine the reasonable and necessary use of medical treatments – such as TENS. The draft CMS proposal, however, goes too far beyond the need for developing clear and reasonable data collection. It limits coverage for TENS only to patients enrolled in prospective, randomized , controlled clinical trials (RCTs). This approach is not only extremely costly but could take years to complete when there could be better alternatives available for gathering evidence about a technology with decades of use data.

Application of CED to TENS Coverage

The application of CED to study TENS raises important questions. CED has never been applied to existing technologies as CMS proposes here. In fact the original intent was to allow a coverage pathway for promising new technologies for which evidence and clinical usage had not yet been established. Before applying CED to any existing technology, we think it important that CMS define the criteria they will use to do so in rulemaking. Otherwise, not only TENS, but all medical technologies that do not meet what CMS defines as the strongest possible evidence may be subject to similar review and possible elimination of national coverage. CMS should also take this opportunity to review existing CAD requirements. Most importantly, CMS should take this opportunity to use CED to expand coverage beyond the existing, restrictive situations where evidence is collected. As mentioned above CMS should also develop guidance to encourage data collection methodologies besides automatically requiring use of costly and time consuming studies that may be unworkable.

Allow Existing TENS Coverage to Continue and Work with Stakeholders to Develop Collaborative Approach to TENS Research

CMS should not rule out any particular research approach but should be open to consider all valid methodologies and approaches that are proposed by stakeholders and interested medical specialty groups. We propose that other types of studies be considered rather than just randomized controlled trials. These alternatives include retrospective cost of care analysis of existing CMS claims data, prospective registry data, and prospective observational practice based cohort trials, all of which would be much more relevant to real world practices. Other possibilities include development of beneficiary surveys or other claims-based reporting. The best approach for determining exactly what methodologies or approaches work best is to collaborate with professional societies and other experts who have the resources, knowledge and expertise regarding the application of TENS technology to the Medicare population with chronic low back pain. We strongly encourage CMS to consider these alternatives before settling on a unilateral approach without stakeholder input.

Local Medicare Coverage Policies Address Standards for TENS use

Each of the Medicare DME MACs has established local coverage guidelines for TENS, covering both use for acute post-operative pain and chronic pain. The policies establish demanding criteria for determining whether the use of TENS is reasonable and necessary for Medicare beneficiaries on an initial and ongoing basis. With regards to chronic pain:

• The patient’s medical record must document the location of the pain, the presumed etiology of the pain, and the duration of time that the patient has had the pain;
• For chronic pain to be present – the patient must have the pain for at least three months;
• Other treatment modalities must have been tried and failed and the medical record must document what treatments were used;
• The presumed etiology of the pain must be of a type that is accepted as responding to TENS treatment and not linked to a condition that is excluded from coverage, such as headaches;
• When used to treat chronic, intractable pain, the TENS unit must be used or “tried” by the patient on a trial basis for a minimum of one month (30 days), but not to exceed two months;
• The trial period must be monitored by the physician to determine the effectiveness of the TENS unit;
• For coverage of a TENS purchase, the physician must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time;
• The physician must re-evaluate the patient at the end of the trial period and must indicate how often the patient used the TENS unit, the typical duration of use each time, and the results – all of which must be documented in the patient’s medical record;
• The ordering physician must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit; and,
• The ordering physician must also assess the effectiveness for TENS on a patient-by-patient basis by certifying such on the TENS purchase Certificate of Medical Necessity.

All of the above coverage guidelines outlined above ensure proper safeguards are in place to ensure that TENS are used for medically necessary purposes under Medicare. CMS’s national policy should not disrupt this carefully developed local coverage guidance.

The CMS Proposal Will Have an Adverse Impact on the Ability of Medicare Beneficiaries to Access Pain Therapy

If the CMS proposal is implemented, seniors and other Medicare beneficiaries will be denied non-addictive, therapeutic alternative to pain treatment. In proposing this more restrictive coverage proposal, CMS has failed to transparently disclose any of its current utilization data regarding the number of seniors that rely on TENS for treatment of CLBP and will be significantly impacted by this proposal. According to the data published in the CMS proposal, Medicare patients purchased nearly 85,000 TENS units in 2010. The virtual elimination of this benefit utilized by a significant number of seniors who rely on TENS to treat chronic low back pain while CMS seeks to study this issue further is inappropriate. The end result of this change will also financially impact these beneficiaries as they will be forced to utilize higher cost alternatives such as narcotics and surgical intervention.

Conclusion

CMS should continue to allow coverage for TENS for treating chronic low back pain. It is a safe, low-cost, non-addicting treatment alternative for a large population of Medicare patients. Physicians, as demonstrated by support of the professional societies, want continued access to this therapy for their patients. We understand and support the need for additional evidence generation as long as there is continued coverage, but believe there are more clear and reasonable methodological alternatives to a costly RCT which may be simply unworkable. EMSI also supports the revision of the CED process to encourage continued coverage of existing technologies along with development of alternative research methodologies from those presently described by CED guidelines. Finally, for any CMS study recommendations to be workable and accepted by the healthcare community it is important that the Agency work closely with stakeholders – such as EMSI – in order to establish mutually agreed upon data collection requirements and study designs.

The best approach for determining exactly what methodologies or approaches work best is to collaborate with all interested stakeholders to clearly identify the data collection objectives. For example, industry representatives, professional societies, other experts as well as patient representatives who have the resources, knowledge and expertise regarding the application of TENS to the Medicare population with CLBP would be best. EMSI encourages CMS to consider these alternatives before settling on an unrealistic, unilateral approach without stakeholder involvement.

EMSI therefore, strongly urges CMS not to restrict Medicare coverage for TENS for chronic low back pain beyond the criteria established by the DME MACs. If CMS seeks additional information regarding TENS efficacy, we recommend that local Medicare coverage policies remain in effect while this information is collected.

Sincerely,

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To Whom It May Concern,

I have been a Physical Therapist for 17 years and have used TENS throughout the course of my career most often with orthopedic outpatients.

In my experience with the geriatric population, I estimate TENS has played a significant role in approximately 60-70% of my cases involving chronic low back pain. By a ‘significant role’, I mean TENS helps decrease the pain enough to increase tolerance to ADL, or decrease the pain enough to increase tolerance to therapeutic exercise that helps decrease their pain.

Pain decrease is of the order of decreasing from 8-10/10 pain to 4-6/10. This is a significant decrease that increases the patient’s quality of life.

It is well known that prolonged use of pain medication promotes dependency and results in loss of efficacy, neither of which happens with the use of TENS. Additionally, TENS use is cost effective in the long run as compared to medication use. Many patients are very glad to have a drug-free alternative to pain control as they are already taking many medications or have an intolerance for certain pain medications.

It is my urgent request to leave coverage for home TENS units in place and not to adopt the proposed National Coverage Decision(NCD) that would restrict existing TENS coverage for CLBP patients.

Sincerely,

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TO CMS VIA EMAIL/Web Posting-CAGinquiries@cms.hhs.gov

Louis B. Jacques, MD
Brijet Burton, MPP, MS, PA-C
Sarah Meisenberg, MSPH
Susan Miller, MD
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques, Ms. Burton, Ms. Meisenberg, and Dr. Miller:

BioMedical Life Systems, Inc. (BMLS) is pleased to offer the following comments on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)(CAG-00429N).

BMLS is a leading international designer/developer, manufacturer, and distributor of high-quality medical devices that provide drug-free solutions for pain management, musculoskeletal health, and vascular health. Our product line includes electrical stimulation and other associated accessories used for pain management, orthopedic rehabilitation, and physical therapy.

TENS has been covered nationally by Medicare in excess of thirty years, and has been provided to individual beneficiaries based on a physician’s determination that the use of TENS was a reasonable and necessary treatment for a Medicare patient. At the time the current national coverage determinations (NCDs) were issued, I believe Medicare did not provide the public with an explanation of its rationale (or the evidentiary basis) for making its determination. Systematic reviews of the medical literature, and the role they play in national coverage decision-making, are only a relatively recent development in the national coverage process.

According to the proposed coverage decision, CMS’ rationale for initiating this national coverage analysis was based on a 2010 report of the Therapeutic and Technology Assessment Subcommittee of the American Academy of Neurology (AAN), which concluded that TENS was ineffective in the treatment of CLBP, based on a systematic review of the literature. CMS should not base a more restrictive Medicare TENS coverage policy on a single article, which we believe reaches an erroneous conclusion based on a questionable and limited selection of literature.

BMLS supports continued Medicare coverage of TENS for chronic low back pain and the preservation of Medicare beneficiary access to this safe and effective technology. We question CMS’ proposal to deny coverage under the existing criteria, by introducing a cumbersome and expensive clinical evidence development (CED) requirement.

As drafted, this proposed national coverage determination would result in non-coverage for previously covered patients being treated with TENS under the current NCDs. Discontinuing existing TENS coverage would leave few safe options for the millions of Medicare patients suffering painful chronic low back pain conditions, such that they would likely resort to the use of higher health risk alternatives, including anti-inflammatory agents, and opioid and non-opioid (“adjuvant”) analgesics. The proposed NCD specifies that TENS coverage for CLBP would be limited to individuals enrolled in a prospective, randomized, controlled clinical study. Current coverage of TENS is based on a physician’s assessment of the effectiveness for each unique patient combined with the physician’s experience and expertise. Physician medical decision-making for each unique patient should continue to be the determining factor for coverage.

Local Medicare Coverage Policies Carefully Address Standards for TENS Use
Each of the Medicare DME MACs has established a local coverage determination for TENS, covering both use for acute post-operative pain and chronic pain. The policies establish rigorous criteria for determining whether the use of TENS is reasonable and necessary for Medicare beneficiaries on both an initial and ongoing basis. Specifically, with regard to chronic pain:

• The medical record must document the location of the pain, the duration of time the patient has had the pain, and the presumed etiology of the pain.
• The pain must have been present for at least three months.
• Other appropriate treatment modalities must have been tried and failed, and the medical record must document what treatment modalities have been used.
• The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy (certain conditions are excluded from coverage, including tempomandibular joint pain, visceral abdominal pain, headaches, and pelvic pain).
• When used for the treatment of chronic, intractable pain, the TENS unit must be used by the patient on a trial basis for a minimum of one month (30 days), but not to exceed two months.
• The trial period must be monitored by the physician to determine the effectiveness of the TENS unit in modulating the pain.
• For coverage of a purchase, the physician must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time.
• The physician's records must document a reevaluation of the patient at the end of the trial period, must indicate how often the patient used the TENS unit, the typical duration of use each time, and the results.
• The physician ordering the TENS unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit.

These policies already establish sufficient safeguards to ensure that TENS are only prescribed for medically-necessary treatments under the Medicare program.

Study Used by CMS should not be used to deny coverage for Medicare CLBP patients
The recent systematic review by Dubinsky and Miyasaki (2010), on which CMS bases its proposed NCD asserts that “TENS is not recommended for the treatment of chronic low back pain due to lack of proven efficacy.” This assertion was based only on two studies (Warke et al, 2006, and Deyo et al,1990). The first studied back pain in people with multiple sclerosis (MS) and it is likely that the pain of MS is related to direct injury and permanent damage to the central nervous system. Because a study of pain in MS patients cannot adequately represent the vastly complex patient population with chronic low back pain, CMS should not use this study, in isolation, to create a coverage policy for all Medicare beneficiaries with CLBP.

The second study, conducted by Deyo and colleagues, compared TENS with and without exercise, to sham TENS with and without exercise, in patients with chronic low back pain. The subjects were given a period of high frequency TENS, switched to a period of low frequency TENS, and then chose their preferred treatment. Intensity was applied by having subjects set the amplitude to a pre-designated setting on the machine. The type or intensity of stimulation in the patient-selected setting was not reported even though the patient’s preferred mode was the author’s primary outcome measured in the study.

The Deyo study fails to report the intensity of stimulation, and therefore, its outcome measure cannot assess whether subjects received adequate TENS dosage. Because dosage adequacy is essential for TENS effectiveness, the Deyo study fails to sufficiently capture TENS efficacy in chronic low back pain patients.

In fact, Dubinsky and Miyasaki acknowledge that other studies demonstrated a benefit from using TENS devices for chronic back pain. The authors cite two positive Class II trials that on their own would be sufficient to conclude that TENS is an effective treatment for chronic lower back pain under the authors’ standards.

Evidence does Support TENS Efficacy for Chronic Low Back Pain
Existing evidence does suggest TENS efficacy when used to treat chronic low back pain. We believe that CMS should consider the following relevant literature and subsequent relevant factors, which show when TENS is a viable and appropriate intervention for patients with CLBP.

Studies Showing Positive Outcomes
First, and most notably, numerous studies show positive health outcomes attributable to TENS. For example, a rigorous meta-analysis from Johnson and Martinson (2007) including data from 38 randomized trials, reported that TENS had a favorable pooled effect that was greater than a placebo. Johnson and Martinson included patients with chronic (= 3 months) musculoskeletal pain from various anatomical locations (including back, neck, hip and knee). Their rational for a “more inclusive” approach was that TENS mechanisms for pain relief are not specific to an anatomical region. A meta-analysis was performed so that the effects of all studies were considered in the conclusions that TENS had a greater favorable effect than a placebo. Further, the authors analyzed the TENS studies alone and found the results statistically significant for pain reduction.

A study also showed a participant-reported pain reduction of 70-80% with the use of TENS as compared to massage (Melzack et al, 1983). In adults over 60 years of age, another study found an approximate 50% reduction in pain and reduced pain medication intake in subjects with chronic low back pain treated with TENS compared to acupuncture (Grant et al, 1999). Further, Leonard and colleagues studied the efficacy of low and high frequency TENS in opioid-tolerant patients as well as those who were not opioid tolerant (Leonard et al, 2011). The majority of the patient population in this trial had spine pain. The study showed a significant reduction in pain baseline for both the opioid and non-opioid group. For low frequency TENS, the analgesic effect was only observed in the non-opioid group. This further proves the importance of adequate dosage in the efficacy of TENS.

In summary, these studies illustrate that numerous clinical trials demonstrate the value of TENS in relieving chronic lower back pain.

We therefore raise the following specific concerns with the recently-posted proposed coverage decision for TENS:

1. Restricting Coverage for Existing and Future Medicare Patients—This effective means of treating chronic lower back pain should not be denied to the general Medicare population. Also, CED should only be used for new and innovative treatments
2. Restricting Access for Currently Covered Patients Because TENS for chronic low back pain has long been a covered Medicare service upon which many Medicare beneficiaries rely, we question whether CMS must necessarily “turn off” this coverage and deny coverage for monthly TENS supplies to those beneficiaries who are currently using TENS for CLBP while additional data on its impact is being gathered and evaluated.

The access that Medicare beneficiaries have to TENS for CLBP should continue to be based on access to a treating physician’s medical expertise and experience regarding the benefit it provides for an individual, unique patient. Furthermore, we mention again our belief that CMS should not base its decision to implement CED’s based on one literature review.

Additionally, we reiterate our previous comments that CED should not be used for existing technology that has been covered under reimbursement by CMS for many years (i.e., TENS for CLBP, wherein strict standards are already implemented, such as the 30-day trial and determination of medical necessity). A CED requirement should only be used for new and innovative technologies.

In conclusion, BioMedical Life Systems, Inc. appreciates the opportunity to comment on the efficacy of TENS devices for chronic low back pain. We urge CMS to continue to make the benefit of this modality available to Medicare beneficiaries with chronic low back pain under the existing rigorous criteria coverage guidelines. If you have any questions regarding our comment, please contact Richard Saxon, President, BioMedical Life Systems, Inc., at 760-727-5600, ext. 100 or rsaxon@bmls.com.

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The vast majority of our elderly patients with CLBP love their TENS units. These people have "toughed it out" all of their lives. They seek care when the pain is no longer endurable.

With a TENS unit, most of these patients eliminate the need for pain medicine and lengthen the time between office visits because they can safely and effectively manage flare ups at home.

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CMS proposes to cover TENS for chronic low back pain (CLBP) with conditions of evidence development. The conditions are that the patient be enrolled in a well designed, randomized-control trial (RCT), the primary purpose of which is to test whether TENS improves the health outcomes of Medicare beneficiaries by producing a clinically meaningful change in:

• pain, OR
• function, OR
• utilization of other medical treatments or services for CLBP.

The purpose of this document is to discuss issues with and alternatives to this requirement for evidence development. In particular, we would like to emphasize two major points:

• That sufficient evidence already exists to make a coverage determination.
• That if additional evidence is nonetheless considered by CMS, designs other than RCTs can adequately address the relevant coverage questions.

In the Proposed Decision Memorandum for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N), CMS provides its own analysis of the literature on the use of TENS for CLBP. The goal of the analysis is to determine whether there is sufficient evidence to conclude that TENS is beneficial for Medicare beneficiaries in reducing pain, increasing function, or decreasing utilization of other medical treatments or services for CLBP. For several reasons, we find this review insufficient to the task.

The first reason is that the CMS review limited the included references to primary studies or secondary studies of CLBP alone. While there is a long history of clinical evidence addressing the use of TENS to treat pain including chronic pain, there is less evidence specifically focused on CLBP.

So the obvious question is: Can we overcome this limitation? We believe that it can, by including studies on TENS for chronic musculoskeletal pain in any anatomical locations. The Gate Theory has recently come under some criticism, but regardless of the physiological mechanism of action in the nerve fibers, a simple review of anatomy should confirm that it is reasonable to conclude that chronic musculoskeletal pain will respond the same way to TENS regardless of the anatomical location. Does CMS require that pain medications be tested separately in each anatomical location? It does not, and the reason is that the mechanism of action is the same regardless of location.

We made this point in our meta-analysis¹ and again when the TENS Alliance met with the CMS coverage team in December 2011. If the coverage team disputes our claim, we recommend that we survey orthopedists and pain specialists to get their opinions, and that CMS and interested stakeholders agree to abide by the consensus of these specialists.

The second reason is more subtle. The CMS review was not itself a meta-analysis, regardless of the scope of articles included. It was a systematic review: an article-by-article discussion of the merits and findings of each. The problem with this is that systematic reviews can never rise above the strength of the strongest article. All of the articles CSM chose to include were small primary studies, or systematic reviews, or tiny meta-analyses hardly worthy of the name. The two long cables that suspend the Golden Gate Bridge are each made of over 27,000 metal strands, which are individually totally inadequate to carry the weight of that long span. Yet because these strands were twisted together into a single large cable, they have carried the weight of the bridge and its traffic for 75 years.

Twenty years ago, a respected group of Harvard physicians and statisticians published a ground-breaking meta-analysis.² It showed that for years medical science had had enough accumulated data from clinical trials to change medical practice in myocardial infarction from supportive care to aggressive use of anticoagulants. As it was, the combination of inconsistent result of dozens of small studies (many of which were underpowered) and the practice of article-by-article systematic reviews had delayed this realization and resulted in poor outcomes and death for the many patients who had been treated by supportive care all the while. For a review of this history, please refer to the attached article recently published in JAMA.³

While we are not claiming that TENS is a life-saving therapy, we do think this history points to the inadequacy of systematic reviews and the human suffering caused when we do not use the best available evidence to treat patients. We strongly believe that there is more than sufficient evidence to conclude that TENS therapy is superior to sham in the treatment of chronic musculoskeletal pain at any anatomical location.

RCTs have become the gold standard in medical research. But it is well known that they are very expensive, take a long time to complete, and are fraught with practical and ethical problems. Each of these issues is relevant to an RCT of TENS. The expense is considerable and this could last for the several years or even longer it takes to complete an RCT. On the issues of ethical and practical problems, for well established therapies it is usually difficult to find doctors who will randomize their patients and patients who will agree to be randomized (those who doubt this should contact their colleagues at the FDA). With the abundance of evidence showing the efficacy of TENS and competing therapies, is it ethical to ask a patient who is in constant pain to risk (by possible randomization to sham TENS) forgoing treatment for a month or more?

Given these arguments, it would be more reasonable to convene a panel of experts and other interested stakeholders to identify reasonable alternatives for evidence gathering other than an RCT.Clearly, TENS is not the only therapy for which CMS will have to address this issue. If reasonable alternatives exist, CMS could use them in myriad situations like this one.

We commend to your inspection the recent discussion of RCTs and observational studies as alternatives by Bryan Dowd.⁴ He is a well respected health services researcher who has spent his career developing ways to analyze observational data such that the bias in treatment assignment is broken. That is, in RCTs treatment assignment is randomized, with the result that the patient groups in the treatments under study are on average equivalent. Observational studies have the problem that certain types of patients tend to get one therapy and other types get other therapies. This may be because of patient preference or it may be that physicians channel patients with more severe disease or comorbidities preferentially into a certain therapy. The treatment effect is confounded with the patient preference/physician channeling difference. If the analysis is inadequate to break the correlation between patients and treatments, the results are likely to be erroneous.

Statisticians typically attempt to break this correlation by controlling for a number of variables (confounders) that are believed to be associated with the patient’s response to treatment. This serves to balance the treatment comparison on those variables. (A variation on this theme is the propensity score analysis, which is often requested by FDA.) The problem arises when not all confounders are included in the analysis, and often not all confounders are known or have available data. Missing confounders bias the treatment comparison.

By contrast, health services researchers and economists have developed a parallel set of methodologies for dealing with this bias, as Dowd discusses. These are often called “econometric methods”. The most commonly used are instrumental variables (IV) analyses and two-step models. Instrumental variables are variables that are correlated with the treatment but not directly with the response. An over-simplified explanation of how this works is that the variable is used as an instrument (surrogate) for treatment in the analysis, breaking the correlation that biases the results. Another common method is the two-step or two-equation model. The first equation is similar to a propensity score: it is a prediction model for which treatment a patient with a certain set of characteristics is likely to receive. The second equation is the substantive model, that is, the one that analyzes the relationship between the treatment and the response. Again, an over-simplified explanation of how this works is that the correlation between the equations is used to adjust the estimate of the treatment effect, removing the bias (the correlation). The main drawback to these methods is that if the variables are less than optimal at serving as instruments or predicting treatment assignment, the number of subjects in the study must be increased to conserve its power.

In most cases, researchers use these methods on existing observational data sets, and so they have to use whatever variables are available. As such, sometimes the analysis loses power. However, if these techniques could be used on prospective observational data, we would have the option of specifying what data needed to be collected. We could be pretty confident that the methods would work well in those circumstances.

The final point related to the design suggested by CMS is that a sham control may be difficult to ask patients to use and somewhat unethical because there are alternatives to TENS that are known to be effective at reducing pain. We suggest that one of these alternatives, such as prescription-strength analgesics, serve as the control. The comparison between the treatments would be a non-inferiority test of the pain relief (or function, or utilization) of TENS compared to the analgesic(s). That is, if TENS provided at least similar benefit to pharmaceuticals, it would be considered effective.

In summary, we believe that there are several valid alternatives to randomized clinical trials, and that these designs can play an important role in evidence development for established therapies.

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To CMS VIA EMAIL/Web Posting

Louis Jacques, MD
Tamara Syrek Jensen, JD
James Rollins, MD, MSHA, PhD
Brijet Burton, MPP, MS, PA-C
Rosemarie Hakim, PhD
Susan Miller, MD
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques, Ms. Jensen, Dr. Rollins, Ms. Burton, Ms Hakim and Dr. Miller:

At your request, this provides comment on your proposed coverage for Transcutaneous Electrical Nerve Stimulation (TENS) for chronic low back pain (CLBP) only under specific conditions including patient enrollment in a prospective, randomized clinical study.

We Agree

As common citizens, I trust that we agree on the need to provide effective treatments as we lower the cost of healthcare in America. With so many different individual’s interests at stake, we also agree that we need reasonable and simple solutions. With this perspective, I humbly offer the following comments.

Comment on your proposed coverage

In your March 13th proposal, I believe you are asking the right questions about TENS. If CMS is to continue to pay for the technology, you must understand if it reduces pain, improves function and reduces the use of other ways to manage chronic low back pain. However, we differ on the assessment of evidence for TENS and therefore the need for a randomized clinical study. I believe that requiring this type of study is…

• potentially harmful to the enrolled patients that will be treated with a “sham” (non-working) TENS device. My experience is that these patients will likely drop out of the study or turn to addictive narcotics and in some cases surgery.
• too expensive compared to other types of studies. Cost effective alternatives include; simple follow up patient surveys, adding detail to Medicare claims to improve reporting, cost of care analysis on a sample of the 200,000+ Medicare beneficiaries that have received a purchased TENS since 2008, a patient registry and practice based observational trials.
• likely to not provide you with complete answers and only raise more questions. Even the best randomized clinical studies have been debated and criticized. In fact, the study controls will lead to results that are not representative of the real world.

Comment on your approach

Your approach is heavily weighed on your own internal assessment of studies and guidelines. It has also minimized or ignored evidence from additional sources, specifically the…

• decision to avoid an external technology assessment of TENS.
• decision to not hold your own MEDCAC meeting on TENS.
• limited and incomplete assessment of professional society position on TENS.
• limited and incomplete briefing of expert opinion.
• incomplete briefing on public comments.

It appears that CMS is following the lead of some European countries. By that I mean CMS is placing more value on selected, small studies and limited systematic reviews over the first hand experience of physicians, experts and patients. Thousands of physicians have prescribed TENS and hundreds of thousands of patients have used TENS for pain in just the past three years. Yet, your proposal is based on studies published by perhaps 50 or so lead investigators, many of which do not reside or treat patients in the United States. In short, your approach does not allow for a critical appraisal of the evidence on TENS. Undoubtedly, your chosen path enables a faster decision to stop payment/coverage. However, I do not believe it leads to the best decision for Americans suffering from chronic pain or effectively reduce the costs to treat chronic low back pain.

Recommendations

Since a randomized clinical trial is unlikely to provide definitive answers and you have an incomplete assessment to critically appraise the evidence, I recommend the following …

• Continue coverage of TENS under its established local coverage policies which make physicians decide and document its effectiveness in treating individual patients.
• Create a stakeholder group to determine how to best get answers on TENS.
• Get every stakeholder group to contribute with both talent and funding.
• Develop and write a policy that is easy to read and understand.

I am hopeful that with a stakeholder group CMS can create policy that is easy to understand. As recently as March, CMS was publicly criticized for creating “tortuous text”. Providing simple language will improve the efficiency of the hundreds of physicians and individuals that fit and process the paper work required to provide Medicare patients with TENS every day.

Background

For over 31 years I have been working to help develop and provide safe and efficacious medical products. I am proud to be one of countless others to help make the United States #1 in the development of leading edge medical devices having worked for some of the larger companies in medical products including; 3M, Kimberly-Clark, Chiron, Smith & Nephew and Covidien. Since January 2010, I have had the honor to lead RS Medical, a major producer and supplier of products and services that help Physicians reduce the impact of chronic pain. Like many of our peer companies, RS Medical has been working hard and adjusting to changes from healthcare reform including; ICD-10 compliance, the new medical device tax and changes in payment/coverage.

Thank You

On behalf of the entire company, including our employees that help physicians treat over 1,000 Medicare patients every month, thank you for the opportunity to comment on your proposed coverage for TENS. We stand ready to answer any questions you may have or to provide additional information. Further, we would be honored to contribute as a stakeholder as you make further decisions on this important proposal.

Sincerely,

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April 12, 2012

Susan Miller, MD
Lead Medical Officer
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) Proposed Decision Memo for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N)

Dear Dr. Miller:

On behalf of our 82,000 member physical therapists, physical therapist assistants, and students of physical therapy, the American Physical Therapy Association (APTA) is pleased to submit comments on the National Coverage Analysis (NCA) Proposed Decision Memo for transcutaneous electrical nerve stimulation (TENS) for chronic low back pain (CLBP).

Within the memo – issued on March 13, 2012 – CMS proposes to limit Medicare coverage of TENS for CLBP to patients who enroll in an approved prospective clinical study addressing TENS efficacy and meeting other specified standards. APTA is concerned that this requirement to enroll in a clinical study is highly burdensome for the Medicare beneficiary and will severely limit patient access to medically necessary treatment utilized to improve overall function and health.

Physical therapists are licensed health professionals who evaluate and treat Medicare beneficiaries in a variety of practice settings including private practices, hospitals, skilled nursing facilities, home health agencies, rehabilitation agencies and comprehensive outpatient rehabilitation facilities. Within these settings, physical therapists play a vital role in the assessment and management of chronic pain. The TENS unit is among the many tools that a physical therapist may use to meet the needs of a patient with CLBP in combination with other interventions that account for the complexity of the patient.

As mentioned in our previous comments regarding this NCA, a national change in coverage for the TENS unit will have a major impact on the provision of services delivered by physical therapists and physical therapist assistants. Medicare has a longstanding history of covering medically necessary TENS for beneficiaries through local coverage determinations (LCDs). While we understand that there may be a need for additional evidence to support TENS effectiveness in CLBP treatment, we urge CMS to rescind its current national coverage proposal and continue to allow Medicare coverage of this modality through the existing LCDs during the development of such research efforts. If this research development moves forward, we recommend that CMS convene a technical expert panel to further examine the issue. APTA has several member experts that could serve on this panel to aid CMS in this endeavor.

Evidence Does Support TENS Efficacy for CLBP When Utilized Appropriately

Our previous comments, submitted October 13, 2011, highlighted several studies demonstrating positive outcomes for TENS when used appropriately to treat CLBP. CMS discounted many of the studies cited by APTA, stating that all studies in which authors claimed a TENS benefit were “hampered by methodologic limitations.” For example, CMS excluded the rigorous meta-analysis from Johnson and Martinson¹ including data from 38 randomized trials, which reported that TENS had a favorable pooled effect that was greater than placebo. Johnson and Martinson included patients with chronic (= 3 months) musculoskeletal pain from various anatomical locations (including back, neck, hip, and knee). Their rationale for a “more inclusive” approach was that TENS mechanisms for pain relief are not specific to anatomical region. This meta-analysis demonstrated positive outcomes for the treatment of chronic pain by TENS, and should not be discounted simply because of this inclusive approach.

Further, APTA notes that the outcome measured in studies for TENS efficacy for CLBP is very important. For example, recent work with TENS shows that TENS has minimal effect on resting pain but may be better for pain with movement and could improve function.² The majority of studies cited by CMS in this memo only assess resting pain. Few studies have looked at measures beyond resting pain, and few have included function or quality of life as measures typically incorporated in clinical trials. CMS indicates its interest in this aspect of TENS with its second and third questions that must be addressed in the proposed clinical trial requirement in the proposed decision memo: does the use of TENS provide a clinically meaningful improvement in function and does the use of TENS provide a clinically meaningful reduction in other medical treatments or services used in the medical management of CLBP?

In adults over 60 years of age, another study³ found an approximate 50% reduction in pain and reduced pain medication intake in subjects with chronic low back pain treated with TENS compared to acupuncture. CMS excluded this particular study, citing only “imprecise location of back pain” as the reason for exclusion. APTA respectfully disagrees that this is a meaningful reason for exclusion from this coverage analysis, as this study provides an affirmative answer to both of the questions posed in the proposed decision memo regarding meaningful function improvement and meaningful reduction in other medical treatments. In addition, other existing reports⁴ not considered by CMS highlight patient satisfaction with TENS regarding increased function, decreased reliance on pain medication, cost reduction due to the decrease in other medical treatment, and overall improvement in quality of life.

We disagree with the CMS decision to discount the aforementioned evidence supporting TENS treatment for CLBP, as we believe this evidence is sufficient to continue its Medicare coverage.

A National, Restrictive Coverage Policy Is Inappropriate for TENS

In its proposed memo, CMS acknowledges that “the absence of conclusive evidence of benefit does not equate to conclusive evidence of no benefit.” Evidence does exist to support the efficacy of TENS for the treatment of CLBP, albeit evidence that does not meet the stringent qualifications to prevent exclusion from this NCA’s consideration. The absence of evidence meeting these methodologic standards may in fact illuminate a need to conduct new studies regarding TENS effectiveness for CLBP. This absence does not, however, equate to “no benefit” and it does not merit a national restrictive coverage policy that will create further burdens for patients seeking this treatment as well as limit access to many who cannot overcome such burdens.

Therefore, APTA appreciates the need for further evidence development regarding this issue, but we do not support conducting such research at the expense of CLBP patient access to TENS treatment. We believe that if CMS decides to require evidence development for CLBP TENS treatment, such a requirement should not be through the use of a coverage with evidence development (CED) policy. CED policies may be appropriate under some circumstances, such as testing efficacy in the advent of new medical technologies. However, revoking the longstanding coverage of an existing treatment that already has adequate medical necessity assessment safeguards is not an appropriate use of a CED policy.

According to the CMS guidance for “National Coverage Determinations with Data Collection as a Condition for Coverage: Coverage with Evidence Development,” two options for CED are identified: Coverage with Study Participation (CSP), under which CMS provides coverage only to patients enrolled in an approved clinical research study that meets certain rigorous standards; and Coverage with Appropriate Determination (CAD), under which additional clinical data must be submitted by the provider to a database or registry as a condition of the beneficiary’s coverage. We contend that this proposed use of a CSP for existing covered services through a National Coverage Determination (NCD) is inconsistent with the stated purpose of an NCD. Section 1869(f)(1) of the Social Security Act defines an NCD as “a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII…” These determinations are made through an evidence-based process to determine whether items or services are reasonable and necessary within the scope of the Medicare benefit. The use of TENS for CLBP has already been deemed reasonable and necessary under certain circumstances through both national and local coverage policies. We believe that using an NCD to require further research through CSP for a well-established treatment does not meet the original thrust that the NCD process was created to carry out.

As a result, APTA urges CMS to remove the requirement that CLBP patients must enroll in a prospective medical study in order to receive Medicare coverage for TENS. Should CMS decide to proceed with an evidence development requirement, we believe that Medicare beneficiaries should still receive coverage for TENS under the current LCDs.

Standards within Local Coverage Determinations Adequately Address Medical Necessity for TENS Use

In addition to our patient access concerns, APTA is also concerned that this restrictive national policy will eliminate the current appropriate medical necessity assessments by local Medicare Administrative Contractors (MACs). Each Durable Medical Equipment (DME) MAC has established strict criteria for reasonable and necessary treatment with TENS within their LCDs. Among these standards required in all four LCDs is the requirement of a 30-day trial period; failure of other attempted treatment modalities; the presence of pain for over three months; a presumed pain etiology that is accepted as responding to TENS; adequate documentation of therapeutic benefit; and reevaluation documented after the trial period.

The trial required by all four DME MACs addresses the issue of appropriate application of TENS. TENS must be tailored to each patient in an attempt to determine if the patient is a TENS responder or non-responder. Patients are entitled to a trial administered by a therapist who understands the clinical responses and is capable of making appropriate adjustments. These adjustments include a determination of the proper combination of electrode placement, stimulus amplitude, frequency, pulse width, and other modulations that might help the individual patient.

We believe that a successful trial, along with the other standards established by the DME MACs, establishes sufficient safeguards to ensure TENS treatment is medically necessary and appropriate for the patient. Therefore, we strongly believe that CMS should defer to the review of medical necessity on the local MAC level instead of implementing a national policy that hinders patient access to medically necessary services.

Conclusion

APTA greatly appreciates the opportunity to comment on the efficacy of the TENS unit on chronic low back pain. We urge CMS to remove the CED requirement from this proposed decision. Instead, we recommend that CMS continue to make the benefit of this modality available to Medicare beneficiaries with chronic low back pain through local policies if coverage development is required. If you have any questions regarding our comments, please contact Gillian Russell, Senior Regulatory Affairs Specialist, at 703-706-3189 or gillianrussell@apta.org.

Sincerely,

R. Scott Ward, PT, PhD
President

RSW:glr

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Lower back pain is a barrier to completing and complicance with physical and occupational therapy and completing ADLs.

By restricting the coverage of TENS for patients suffering with chronic low back pain we are taking away a conserviative treatment option that allows participation in therapy, ADLS, work and related tasks. i have heard patients report that they have not used as much medications since they started their tens unit, I have heard pts say they have not increased medications and instead pulled out their tens unit and not over used becuase they had another option at home.

TENS for LBP can help empower the patient to take control of exacerbations and flares and save ER visits, increased medications and decreased work abilities.

In this time of high narcotic use, LBP patients need options for maximizing their ability to self manage pain. I have seen patients who have not had to do repeated injections because they used a tens unit adjunctive to their injection and started moving better so they did not need to come back and spend more money on injections.

As a occupational therapist, my collegues and i see the benefit to of lbp patient's improved function, increased participation in ADLs and improved emotional well being on top of decreased symptoms of lbp. This does not work for all, this is why we do a 30 day trial and if this is working than we rejoice in the patient's ability to manage their pain, if it is not working they return it.

TENS is not a cure for lower back pain. It is a tool (like medications these are not cures either) to help the patient and empower the patient to better manage LBP on their own reducing the need for costly injections, costly medication and repeated therapy. TENS can increase compliance to therapy goals, exercises and maximize the benefits of other therapies like cognitive behavioral therapy in addition to physical and occupational therapy.

It can make the difference of the patients work ability and contribution to society, staying on their job or recovery from working when they get home. TENs for lower back pain is non addictive.

Let's look at the research noted the single article in Neurology (Dubinsky and Miyasaki) based on only two Class I studies should not be the basis for restricting coverage of TENS. One of these studies included patients with multiple sclerosis whose response to TENS treatment may be atypical due to their underlying pathology. It should also be noted 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. 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.” As with any medical technology, additional research could be useful in informing and refining optimal treatment practices. Just because there is conflicting data and ongoing studies to help support the use of TENS, should not prevent Medicare beneficiaries with chronic low back pain from pain relief available through TENS.

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 and it can take a patient who is heading for for medicare disability a step further away as many other insurances follow medicare guideliens.

Let's have patients try TENS before injections, before costly surgery and before we put them on narcotics of all kinds.

Please reconsider this ruling on lbp.

Thank you for your attention to this.

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I'm commenting on the possibility of MC eliminating Trancutaneous Electrical Nerve Stimulation as a covered code.

As a large orthopaedic practice that treats thousands of patients each year, we frequently use TENS units as an alternative to costly medications and epidural injections. The positive feedback and clinical results we've received from patients has been excellent, and we often hear from patients how they would be unable to do their normal, daily tasks without the use of their TENS unit. Many patients prefer the TENS unit, because they prefer not to take powerful, pain-killing meds for prolonged periods and also want to avoid any surgical procedures as much as possible.

By eliminating TENS units as a covered product, patients will have no other alternative of getting relief from their pain except for costly, powerful pain meds and/or surgical interventions.

While I understand that MC may be focusing on one study that questions the efficacy of TENS units, there are dozens of clinical studies that state otherwise. As mentioned above, even more powerful is the proof positive that we receive on a daily basis from our patients.

Personally, I know of no other modality that can provide the benefits and pain relief as safely or cost-effectively as TENS units.

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I have only been in the Rehab industry for a year or so, but in that time, I have seen the positive effects of TENS therapy in the lives of patients with chronic back pain.

One of my primary responsibilities is to be the primary contact 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 to speak to them. I am always pleasantly surprised at how often these patient feel the need to tell me how much they like their TENS unit and often they will use the phrase, “I could never live without it”. Their requests for suppliesare sometimes urgent since they are using the TENS unit so regularly as a part of 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 would think 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 us to affirm that they still are using the TENS unit and need additional supplies to continue to use it. So I would think that every time Medicare writes a check for monthly TENS supplies, they couldinfer that this is yet another patient who is using this TENS unit and receiving benefit from it (or else why would they still be using it?)

Anecdotally, I can vouch for the fact that there are many people 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 are ones singing its praises when they do call us. I had a patient today tell me he use to take 4 pain pills a day for his lower back pain. Since his TENS unit he only takes 1 and he has only had his unit for 3 months.

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April 12, 2012

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo 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 support CMS’s efforts to continue furthering research on effective therapies through more rigorous studies. As TENS is not considered an emerging technology, it does not appear to be eligible for Coverage with Evidence Development. Our members recommend that further research be referred to any of the following organizations: the Patient-Centered Outcomes Research Institute (PCORI), AHRQ’sDEcIDE (Developing Evidence to Inform Decisions about Effectiveness) network, or the National Institutes of Health,to validate and answer the appropriate and important comparative effectiveness question of TENS vs. other non-invasive therapeutic alternatives. A useful study comparing effectiveness of TENS to physical therapy and medications, for example, would offer important research on the value of TENS for both Medicare and private payers.

Therefore, our members encourage CMS to support future clinical studies of TENS that include further assessment of overall effectiveness as well as comparative studies through other agencies and mechanisms rather than direct funding and coverage through Medicare. Thank you for the opportunity to comment on this important issue.

Sincerely,

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I am a retired massage therapist and myofascial release specialist with 14 years of experience treating people who suffered from chronic low back pain. I am licensed by the state of Alabama and was nationally certified by NCTMB before my retirement. I had the opportunity to treat many patients who combined my therapies with transcutaneous electrical stimulation from other health providers. Patients who combined the therapies recovered and returned to normal life functions in much greater numbers than those who recieved soft tissue therapy without the benefit of electrical stimulation.

I strongly encourage the rejection of the TENS NCD BY CMS.

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As a Physical Therapist working in the field for over 18 years, I wanted to take a moment to voice my concern about the proposal to discontinue TENS as a source for treatment for Chronic LBP. Contrary to what some believe, that everyone benefits from a TENS treatment, I have taken a more pragmatic approach to my use of the modality in my practice. I believe that exercise is the most beneficial way to treat both acute and chronic back issues. With that being said, There are volumes of research supporting the use of TENS as a modality to help control pain. In the Chronic population this is particularly important because as symptoms worsen, drug use increases and general tolerance to normal day to day function can be drastically affected. This translates into huge physiological and psychological issues, lost days at work and or productivity, and becomes a general burden on the economy of individuals, companies and society. TENS has been shown to dramatically reduce the amount of pain medication people take. Back pain is one of the most complicated and life changing orthopedic problems we see. At times we simply run out of options in our treating of these people and simple pain management is our only option. In these cases, A TENS unit is a very real and viable solution to help people maintain a level of function. Please do don't hand cuff us as providers by eliminating this modality.

Thank you.

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April 12, 2012

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C 1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CAG-00429N)

Dear Dr. Jacques:

The Advanced Medical Technology Association is pleased to offer the following comments on the Centers for Medicare & Medicaid Services' (CMS) Proposed Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)(CAG-00429N).¹ In the proposed decision memorandum, CMS asserts that the available evidence is not sufficient to support a conclusion that TENS produces a clinically meaningful improvement for Medicare beneficiaries with CLBP, and proposes to cover TENS for CLBP only for qualified patients that are enrolled in a prospective, randomized, controlled clinical study.²

AdvaMed's member companies range from the largest to the smallest medical technology innovators and companies; and they produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. In our discussions with CMS coverage policy staff and in our written comments on Medicare coverage policy matters, we have underscored the risks and challenges involved in developing and manufacturing medical devices. We have highlighted the increasing hurdles manufacturers must overcome to obtain and maintain Medicare coverage so that patients may continue to have access to medical technologies.

We are very concerned that this particular proposal advances a new concept in the use of coverage with evidence development (CED). When CMS issued its CED guidance in 2006, the Agency laid out eight principles governing the application of CED, including the principle that CED would, in general, be used to expand access to technologies and treatments for Medicare beneficiaries. CMS also asserted that it expected to use CED infrequently.³ We have consistently commented that AdvaMed supports the use of sound evidence to inform medical practice, and that we consider CED generally to be a means for generating additional evidence in cases where the available evidence regarding a promising medical technology or procedure is lacking, or is not sufficient to support national coverage. In such circumstances, coverage that is contingent on the development of additional evidence can enable beneficiary access to state-ofthe art medical treatments when the alternative may be non-coverage.

However, in the case of the proposed national coverage decision for TENS for CLBP, CMS proposes to reverse coverage of a service that has been Medicare-covered for many years, and to invoke CED to gather evidence prospectively. Like many Medicare coverage determinations, TENS coverage was determined prior to the advent of the national coverage process established in the Medicare Modernization Act of 2003. We do not believe that CED should now be invoked as part of a decision to restrict or limit coverage for Medicare beneficiaries, and one that interferes with the doctor-patient relationship established with existing TENS treatment.

Background

TENS has been covered nationally by Medicare for many years, and has been provided to individual beneficiaries based on a physician's determination that the use of TENS was a reasonable and necessary treatment for the patient in question. At the time the current national coverage determinations (NCDs) were issued, Medicare did not provide the public with an explanation of its rationale (or the evidentiary basis) for making its determination. Systematic reviews of the medical literature, and the role they play in national coverage decision-making, are only a relatively recent development in the national coverage process.

According to the proposed coverage decision, CMS rationale for initiating this national coverage analysis was based in part on a 2010 report of the Therapeutic and Technology Assessment Subcommittee of the American Academy of Neurology (AAN), which concluded that TENS was ineffective in the treatment of CLBP, based on a systematic review of the literature.

As drafted, this proposed national coverage determination would result in non-coverage for previously covered patients being treated with TENS under the current NCDs. The proposed NCD specifies that TENS coverage for CLBP would be limited to individuals enrolled in a prospective, randomized, controlled clinical study.⁴ Current coverage of TENS is based on a physician's assessment of the effectiveness for each unique patient combined with the physician's experience and expertise. Physician medical decision-making for each unique patient should continue to be the determining factor for coverage.

We therefore raise the following specific concerns with the recently-posted proposed coverage decision for TENS:

1. Restricting Coverage for Existing and Future Medicare Patients-CED should not be used to restrict access to treatments that have been covered by CMS for many years. Because TENS for chronic low back pain has long been a covered Medicare service upon which many Medicare beneficiaries rely, we question CMS' decision to "turn off' this coverage and deny access to those beneficiaries who are currently using TENS for CLBP while additional data on its impact is being gathered and evaluated. The access that Medicare beneficiaries have to TENS for CLBP should continue to be based on a treating physician's medical expertise and experience regarding the benefit it provides for an individual, unique patient. Individual access based on a physician's clinical judgment should not be reversed based on a literature review.

2. Prescribing Trial Methodology-CMS proposes to limit coverage of TENS for chronic low back pain to patients enrolled in a specified type of clinical study-a prospective, randomized, controlled clinical study. We are concerned that CMS is arbitrarily ruling out other valid methodological approaches that might be productive in generating sufficient evidence to inform the questions CMS has with respect to this intervention. CMS should not rule out any particular research approach or methodology. Rather, CMS should consider specific methodologies and approaches proposed by stakeholders.

Additionally, we reiterate our previous comments regarding the collection and analysis of clinical data to inform a national coverage determination under CED. We believe such data collection should proceed in a collaborative fashion, so that both CMS and its various stakeholders reach agreement in advance on the data collection objectives of CED, the minimum data necessary to achieve these objectives, the study endpoints for the CED study, and the duration of data collection.

We describe our concerns in greater detail below.

Implications for Existing and Future Medicare Patients

TENS for low back pain has been covered by Medicare for decades, and is a service upon which many Medicare beneficiaries rely. AdvaMed is concerned about the implications of denying coverage for these beneficiaries and limiting coverage to those participating in a randomized, controlled clinical trial. This proposed action would reverse specific findings made by treating physicians that TENS has been shown to have a beneficial impact on individual, unique patients.

This proposed action is not in the best interests of the beneficiaries who rely on TENS for CLBP; and we have serious concerns about the precedent this proposed action would have for other currently-covered items and services.

The use of systematic reviews of the clinical literature to inform coverage decision-making is a relatively recent development at CMS. The m~ority of existing covered services have not likely been the subject of such reviews. Until recently, Medicare has not provided the public with the rationale or the evidentiary basis for the items and services it covers nationally. We disagree with the use of CED for an existing technology that has been covered by Medicare for many years. Should CMS consider restricting beneficiary access to services that are currently covered, the Agency should issue clear guidance as to what circumstances or conditions would trigger the re-opening of an existing NCD and what type of evidence would be necessary in order to take such a significant action.

With respect to the proposed national coverage determination for TENS for CLBP, CMS should not terminate coverage for those beneficiaries who currently receive coverage for TENS based on a physician's professional judgment that the technology is likely to provide a significant therapeutic benefit for the individual, and where medical necessity is documented.⁵ If CMS decides that it will require additional data collection, the Agency should continue to cover TENS for CLBP while the CED studies are conducted, perhaps with an incentive for individuals and sites to participate in the clinical trials (such as reduced coinsurance or designating participating sites as special centers.)

In this way, CMS could gather and evaluate additional clinical information regarding the use of TENS for chronic low back pain, without subjecting currently covered patients to the loss of coverage that their physicians may judge to be clinically appropriate and valuable.

The proposed coverage determination would limit coverage of TENS to individuals with persistent low back pain and who are enrolled in a prospective clinical study that address outcomes such as pain reduction or improved function based on the use of TENS in a randomized, controlled study design.

CMS' current CED guidance document asserts that CMS will not routinely engage in the design, review or execution of research conducted through CED.⁶ Until recently, with the issuance of a proposed NCD for Transcatheter Aortic Valve Replacement (T A VR) in which CMS proposed to limit coverage in clinical studies to superiority study designs, CMS has not specified instructions on the design of the studies that would be eligible for coverage in CED studies, but rather has worked with manufacturers and other stakeholders to reach agreement regarding the particular methodological approach to the trial design.

The recent proposed national coverage determinations for TENS and for T A VR indicate that CMS is moving in a particular direction with respect to study methodology that is contrary to the advice and guidance the Agency has provided to stakeholders since the CED program was initiated. CMS should not rule out any particular research approach or methodology. Rather, CMS should consider specific methodologies and approaches proposed by stakeholders.

AdvaMed has significant concerns that this approach will inhibit evidence generation, and that it will result in denying patients access to promising medical treatments. In the case of TENS, it will reverse coverage and prevent beneficiary access to this treatment method, which today is determined to be medically necessary by the treating physician who can assess a patient's unique medical condition. We have serious concerns about the impact of this proposed course of action.

Finally, we reiterate the position we have shared with CMS in previous comments on the CED process. AdvaMed supports clear and reasonable data collection requirements in cases where Medicare coverage is contingent on the collection of additional clinical or scientific evidence (beyond FDA requirements for safety and efficacy). CED allows CMS to provide coverage within the context of studies that conform to standards detailed in Medicare's Clinical Trial Policy,⁷ which can include a range of research approaches.

We have previously commented that CMS should work closel y with stakeholders to establish such data collection requirements in advance of the data collection effort. When Medicare coverage is contingent on the collection of additional clinical or scientific evidence (beyond FDA requirements for safety and efficacy), CMS should:

1. collaborate with stakeholders to clearly identify the data collection objectives;
2. consider the minimum data necessary to achieve those objectives; and
3. work closely with stakeholders to clearly identify scientifically supported study endpoints and the duration of data collection in advance.

In summary, AdvaMed has serious concerns with the issues raised by the proposed coverage decision for TENS. This proposal would result in denial of coverage for beneficiaries whose physicians have determined the technology to be beneficial for them. Further, it would arbitrarily restrict the type of clinical study in which beneficiaries can participate to generate more evidence on the impact of this technology. Finally, the proposal raises questions concerning CMS' commitment to work collaboratively with stakeholders in generating evidence to inform coverage determinations for promising medical technologies and procedures.

We are also troubled that this proposed national coverage determination points to a trend by CMS to establish higher hurdles in order for Medicare beneficiaries to access FDA-approved medical technologies, and that it could serve as a precedent for reversing existing national coverage determinations based on undefined or subjective criteria. As stated above, the majority of Medicare coverage determinations were made prior to development of the current coverage process and the increased use of CED. If CMS decides to restrict beneficiary access to currently covered services, the Agency must issue clear guidance to describe the circumstances or conditions for re-opening an existing NCD and the type of evidence that would be necessary. We urge CMS to consider the broader consequences of this decision before proceeding.

AdvaMed appreciates the opportunity to comment on these issues. If you have questions regarding these comments or if you require additional information, please contact Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

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Dear CMS,

I am writing to express my support for continuing the existing coverage of transcutaneous electrical nerve stimulation (TENS) for patients with chronic lower back pain.

I have been a Physical Therapist for 4 years. I have found TENS units to be extremely effective in treating chronic lower back pain especially in patients who continue to use TENS units on a regular basis. Due to chronic nature of patient's lower back issues, many of them continue to have success with using TENS units for more than 90 days. It is important that patient's have access to TENS units for more that a 90 day period.

My patients have demonstrated an improvement in functional abilities as a result of their long term use of TENS units. Many are able to complete their activities of daily living with less pain and report that they feel their quality of life improves. The vast majority of my patients report that they feel their TENS unit better controls their lower back pain and doesn't have undesirable side effects when compared with pain medications. In many cases I feel that TENS is the safest and most effective treatment for my patient's chronic pain issues.

I feel strongly that the existing coverage of TENS units should continue.

Sincerely,

Aiyana Meadows, PT, DPT

EPT Rehabilitation
2600 Newburg Drive
Fortuna, CA 95540

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Dear Sir,
I have been a licensed massage therapist for more than 20 years and the TENS is definitely a great pain relieving, drug free tool for lower back pain.

I heartliy ask to you reconsider your faulty policy to drop the TENS from Medicare coverage. As a part of the golden aging baby boomers, we and our socity in general are way to dependent on drugs for a multitude of conditions. Please continue to keep this drug-free method of pain control covered by Medicare...if you have any sense or respect or compassion for a healthier, drug free aging population of American Citizens.
Thanks
Steven Orr
LMT
NYCMASSEUR.COM

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I think it's horrible for Medicare to even consider abolishing coverage for any tens unit or its accessories for several reasons.

[PHI Redacted] Using the machine is both cost-effective & non-addictive. Medicare does not even pay for any medications so why would they also take the tens & electrode pads & batteries away from us. It sounds like Medicare would rather have us pay for expensive pain killer drugs that make you so sleepy & nonproductive. Then the problem is the drugs will be too expensive to purchase, leaving us with absolutely nothing!

If Medicare takes away funding for medically necessary equipment & services, where does that leave the medical professionals who want to prescribe alternatives to their patients? This country will become a dictatorship & we will have no freedom to choose our own health care options.

Why would Medicare rather pay for ongoing doctor visits, specialists & expensive hospital stays when the tens is so economical & FDA approved? If the government is so concerned about cutting costs, why don't they cut Congress & government employees benefits? Let them see what it's like to be on Medicare; struggling to pay for medical insurance that does not deliver!!!!. I'm tired of the middle class getting stepped on all the time.

I would also like to comment on your website's public comment page. Because of my disability, I use of voice activated computer program. This website has not allowed me to enter this comment for my information by myself. This situation should be investigated in order to allow anyone the opportunity to express their opinions totally by themselves

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I have literallly treated thousands of elderly people with low back pain through e stim/TENS . For the past 15 years my practice has helped people decrease opiates, narcotics and anti inflammatory use. The 2008 published randomized meta analysis which was in journal of pain gave a 7 out of 10 reduction in pain for lower back pain. This has been the only hope for peopple that want a portable non addictive way to treat pain and decrease physical therapy costs and pharmaceutical use. Why not attack more detrimental avenues Vs. a proven way to treat pain, swelling and strengthening. Why not call the thousands of people that own units and ask them how it has improved their lives? Thank you for your consideration. I can testify and be an advooate whenever you like .

Kind Regards,

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April 11, 2012

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CAG-00429N)

Dear Dr. Jacques:

The National Association for the Support of Long Term Care (NASL) submits these comments in response to the Center for Medicare & Medicaid Service’ (CMS) Proposed National Coverage Analysis for Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain issued on March 13, 2012.

NASL represents more than 100 companies that provide products, medical supplies, diagnostic testing, professional services, therapy, and information systems for the post-acute care industry. NASL members include providers of physical, occupational, respiratory and speech-language pathology therapies; suppliers and manufacturers of durable medical equipment; and health information technology developers.

NASL has serious concerns with the proposed coverage determination as written and supports continued Medicare coverage of TENS for Medicare patients with chronic low back pain.

In brief our position is:

• Application of Coverage with Evidence Development (CED) to TENS Coverage for Chronic Low Back Pain is Not Appropriate
  • CED was introduced in 2006 as a way to improve patient access to new and promising technologies. It was described at that time as “link[ing] Medicare coverage of specific promising technologies to a requirement that the patients participate in a registry or clinical trial.” It is our understanding that CEDs were not intended to provide broad latitude to CMS for the review of existing covered services, particularly those that had been covered for years. TENS for the treatment of chronic low back pain is an established therapy and standard of care in the rehabilitation community for chronic pain management and is used on label (FDA) for the symptomatic relief of chronic pain.
  • While we believe the application of CED to TENS would be unprecedented and inconsistent with the widely understood intent behind the CED concept, we believe at the very least CMS should delay or re-evaluate any decision relative to the use of CED regarding the use of TENS for the treatment of chronic low back pain until it has completed its on-going analysis of CED.
  • CMS should apply consistent inclusion and exclusion criteria in its evaluation of published data relative to the technology or treatment under review. This does not appear to be the case in its review of TENS for chronic low back pain as it appears that different standards were applied to literature supporting TENS as opposed to literature which did not support TENS efficacy.
  • As CEDs develop under rulemaking, we suggest that CMS consider a collaborative approach towards the development of efficacy reviews of existing or new technologies or treatments, if currently-covered technology is deemed appropriate for the use of CED under final rulemaking.
  • We believe CMS should consider the creation of an expert panel with appropriate representation of stakeholders to develop criteria for continued validation of technologies and services. Members should include clinicians, researchers, TENS suppliers and patients.
• Allow Existing TENS Coverage to Continue
  • CMS should continue to cover TENS and TENS supplies for the treatment of chronic low back pain.
  • TENS is a low cost therapy with few side effects, which provides an easy to use, safe, approach to pain management.
  • TENS provides a positive cost-benefit ratio and safety profile for many patients as compared to costly alternatives such as addicting narcotics and surgery.
  • TENS meets the statutory requirement of § 1862(a) (1) (A) as reasonable and necessary to treat Medicare patients with CLBP and has been covered under national coverage determinations since 1995.
  • TENS for the treatment of chronic and acute pain has been an integral part of Physical Medicine and Rehabilitation and Physical Therapy curriculums on a nationwide basis for more than three decades and is a well-established standard of care.
  • CMS should consider claim history as a guideline for continued coverage. In the case of TENS many hundreds of thousands of patients have and continue to benefit from TENS for the management of chronic pain as evidenced by CMS data on the use of TENS presented in the proposed coverage determination. This evidence alone justifies continued coverage as it would be hard to imagine that physicians are prescribing TENS for the treatment of chronic pain, according to strict well defined coverage criteria for medical necessity without patients having positive clinical outcomes.

In conclusion, the evaluation of continued coverage of services by CMS should not limit Medicare beneficiaries’ access to care or interfere with the physician patient relationship, particularly in the case of existing covered services and technologies. Until a definitive conclusion can be reached using a collaborative approach to evidence development we respectfully request continued coverage of this important modality in the fight against chronic pain. I would be pleased to answer questions or provide further information.

Sincerely,

Cynthia K. Morton
Executive Vice President
National Association for the Support of Long Term Care

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Sent: Tuesday, April 10, 2012 12:23 PM
To: CMS CAGInquiries
Subject: Proposed Decision Memorandum for Transcutaneous Electric Nerve Stimulation for Chronic Low Back Pain (CAG-00429N)

To whom it may concern:
I have been informed about CMS’s intention to discontinue coverage of TENS units for the treatment of chronic low back pain. I find this to be quite absurd, as this is often one of the only non-invasive forms of treatment that is beneficial in the treatment of this difficult segment of patients. As a Neurosurgeon, practicing for over 20 years, I spend a tremendous amount of time treating this type of patient on a daily basis. I have tried to achieve treatment success in this group of patients without surgical intervention, which I feel is extremely costly and with poor long term success rates. The lack of coverage for TENS units will further reduce my treatment options, as restrictions on PT payments already greatly reduces patient access to non-surgical forms of treatment. Black box warnings on the use of NSAID’s has greatly reduced this form of treatment. The statistics regarding the frequency / percentage of patients that suffer from low back pain are astronomical. We are certainly not dealing with a small subset of patients.

Thus after this decision, I will have very little to offer patients for treatment of low back pain. Though I will not personally advise surgery for the treatment of Chronic Mechanical Back pain, these patients will migrate to a surgeon who will perform surgery. What is the costs of lumbar fusion and internal fixation to the government? At least $50,000 per event. The cost of spinal cord stimulation? Just $17,000 at a minimum for the stimulator / leads alone!!
Once again this demonstrates the total incompetence of those in our government that are making decisions that affect our lives and our financial security.

Sincerely,
John Pulliam, MD
Neurosurgery
Mercy Neurosurgical Clinic
Ft. Smith, AR
479-478-6030

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I have been in practice as an orthopedic surgeon for over thirty years. In my experience, TENS effectively treats CLBP patients, especially those patients who continue to use TENS for pain relief beyond 90 days.

My practice depends on continued existing coverage of TENS for treating my patients because it reduces the number of tertiary orthopedic referrals for cervical and lumbar arthrodesis (fusion).

For these reasons, the CMS should continue to allow coverage of TENS for reducing CLBP after 90 days.

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This comment was submitted within the comment period but not posted until June 18, 2012 due to technical difficulties.

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April 6, 2012

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare &Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N)

Dear Dr. Jacques,

I am writing to you on behalf of Covidien to support continuing Medicare coverage of Transcutaneous Electrical Nerve Stimulation (TENS) for the treatment of chronic low back pain. We submit these comments in response to recent decision by the Centers for Medicare and Medicaid Services (CMS).

Covidien is a leading global device developer and manufacturer of stimulating electrodes. Our products are safe, non-invasive, drug-free method of pain management. We are extremely concerned regarding the proposal that would result in denial of coverage for beneficiaries who benefit from this technology as determined by their physician.

TENS has been covered nationally by Medicare for many years. TENS is not new, experimental or investigational. This technology is already approved by CMS and the FDA and has been used by clinicians for many years. Ample evidence through various studies and meta analyses has already been collected and documented to demonstrate the value of TENS in relieving chronic lower back pain. Restricting beneficiary coverage unless consent to participate in patient registries and clinical trial is unjustifiable.

Opening established technologies to NCDs is qualitatively different than doing so with new technologies. It is appropriate to establish a very high bar for walking back established coverage for technologies on which thousands of patients currently depend. CMS should reach out to other relevant practioners and to the patient community before proceeding ahead in opening a NCD.

Additionally, we question CMS’s decision to terminate coverage and access to those currently using this technology which is based on a professionally trained physicians clinical judgment and not a clinical review. CMS should continue coverage while a CED study is conducted and the information gathered is evaluated. This proposal is not in the best interest of the beneficiaries who currently rely on TENS for chronic lower back pain. We urge CMS to consider the significant impact of this decision before proceeding.

Covidien appreciates the opportunity to comment on these issues. Should you have any questions or require additional information please do not hesitate to contact me directly.

Sincerely,

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To Whom It May Concern,

I am a chiropractor at the Back Pain Relief Clinic in Jackson, TN. I am writing this email with concerns about the proposal to eliminate existing coverage for transcutaneous electrical nerve stimulation(TENS). I have been using TENS units in patient care for over a year and I have found that patients find it very helpful for managing chronic low back pain. Most of these patients have tried various medications that have not been helpful for elimination of pain or they have been advised not to take certain medications because of harmful side effects. TENS therapy is a safe option for these people who have tried many other therapies without success.

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I am a Nurse Practitioner at PARS Pain Center at 1212 Garfield Ave St 202 in Parkersburg WV 26101. My phone number is 304-865-7277. Fax is 304-865-7272. I am writing due to the proposal to eliminate existing coverage of a TENS unit. I have personally seen the benefits and improvement in the quality of life that patients experience while using a TENS unit. Without weakness they would not qualify for a muscle stimulator but could still benefit from a tens unit. Please consider this while making the decision to cut coverage for this very useful device. If you have any questions please feel free to contact me. Thank you for you time

Sincerely,

Christina Mayo FNP, BC

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To whom it may concern,

I am a pain physician in Texas. Given all of the problems with narcotic abuse and the risks associated with chronic narcotic therapy, I use a TENS as an extremely safe alternative for management of chronic pain. I would rather my patient use a TENS unit than hydrocodone or oxycodone for managment of his or her chronic pain condition. I have found TENS therapy, on many occasions, to be a highly effective treatment for chronic myofascial pain. I truly hope that TENS therapy remains an option for pain management in the future. There are very few options available to patients that offer as much assistance to chronic pain patients with little to no risk.

Thank you,

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I am a physical medicine and rehabilitation physician and have a busy pain management practice in Tennessee. We have a significant problem with opioids nationally and locally in Tennessee. I have used TENS treatments in most of my chronic low back pain patients as an avenue to treat their pain safely and effectively. Outcome measures for research purposes for any physical treatments (including TENS)in patients with chronic pain is very difficult and therefore has limited research bases or "power". Chronic pain is an epidemic in the US and in Tennessee. Legitimate patients deserve safe and effective treatments. TENS unit clearly is effective in most patients and is much safer than any medication. Why limit one of the safest treatments?? Medications can be limited and in chronic pain we try to find partial improvement through several modalities physical (TENS, heat, ice, exercise, massage, etc) and medications frequently of several classes. One of those classes is NSAIDS like Motrin (Ibuprofen), which can cause stomach bleeding and account for 10,000 + deaths annualy in the US. This costs CMS millions of dollars. TENS units has no side effects, no possible increased cost from new medical complications. Why limit this? In my opinion it may cause an increase in medication use and on a grand scale may increase overall costs to CMS.

Additional concerns:

1. . Represents government interference in the doctor-patient relationship founded on the physician's uncompromising commitment to patient welfare. By severely restricting treatment alternatives currently available to you in treating CLBP patients, the government is substituting its judgment for your judgment regarding the best treatment alternative for your patients;
2. It establishes precedent for future government action to eliminate coverage for other long-standing, cost-effective, and clinically necessary treatments like physical therapy (not every patient is the same and the research outcome are difficult and therefore lack power or support.) Certainly physical therapy is a corner stone to healthy and well being....right.
3. It eliminates patient access to care that has been approved by the FDA as safe and effective for CLBP for at least three decades and covered by Medicare for over 20 years;
4. This would interferes with my and my colleagues’ ability to offer alternatives for your pain patients;
5. It could increase the use of expensive pain medications that would result in outcomes contrary to patient welfare;
6. The industry is very concerned about the extent of our ability to continue providing high quality, prescription TENS coverage if this proposal is enacted;
7. A rigorous randomized clinical trial would be very costly estimated in the millions of dollars and taking up to five years to complete, without the opportunity to defray costs since current coverage would stop until the trial is complete; and,
8. The CMS documentation requirements will create an additional economic burden.

Please reconsider...

Why limit treatment of something that is effective in the treatment of chronic low back pain, espicially something with virtually no side effects, when even OTC medications like Ibuprofen have more significant risks and are used as common alternatives.

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April 10, 2012

To Whom It May Concern,

As President of Golden State Medical, Inc., I am writing you to discuss our company’s data with regard to TENS Units (E0730) and the supplies (A4595), and to ask that you reconsider your proposal to stop reimbursement for these products (Proposed Decision Memorandum for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N)).

Golden State Medical, Inc began in 1991 in Auburn California. Our company is a distributor of TENS Units and supplies to patients. During our 20 years in business, we have collected data demonstrating the efficacy of TENS Units for pain relief and documenting length of use. Golden State Medical, Inc. delivers to and educates patients for all insurance types including Medicare, Medicaid (MediCal), Workers’ Compensation and Private Insurance.

The statistics that follow are from our Medicare population and do not include other insurance types. Golden State Medical, Inc. currently has approximately over 3000 active Medicare patients who have a purchased TENS Unit and are using monthly supplies.

All Medicare patients receive a TENS Unit as a last treatment option to help them with their Pain Management. It is required that recipients have documentation in their medical records that they have tried alternative treatments, i.e. Physical Therapy, Chiropractic Treatments, Acupuncture, Surgery and NSAID’s, and that these treatments have failed (see question #4 on Certificate of Medical Necessity CMS-848 CMN). Patients must have Chronic Pain, defined by CMS as more than 90 days, before they can receive a 30 day trial of a TENS Unit. Following the 30 day trial, if the TENS Unit is successful in reducing their Chronic Pain, the patient must return to their prescribing Physician for a follow up appointment to confirm the positive results and to complete the required Certificate of Medical Necessity (CMN). Our data show that 61% of all Medicare patients that receive a TENS Unit for the 30 day trial convert to the purchase of the Unit. There are many reasons for 39% of the patients not converting to purchase of the TENS Unit (Physician determined that long term use was not indicated, patient was not compliant with TENS Unit protocol, TENS Unit was not effective in reducing patients Chronic Pain and a variety of other reasons that have an effect on the this statistic). We believe a61% purchase rate for patients that have met all the requirements of the CMN is a remarkable success. As previously stated, Golden State Medical, Inc. currently has approximately 3000 active Medicare patients that are contacted every month as required by CMS . The purpose of the contact is to monitor the usage of the TENS Unit and to send replacement supplies (A4595) if required. Of the approximately 3000 active patients, 97.5% continue using the TENS Unit each month. Our data show that a Medicare patient who has a purchased TENS Unit will receive supplies on average for 27 months. These data are consistent with all our patients across the Insurance spectrum Medicaid (MediCal), Workers’ Compensation and Private Insurance.

The recommendation from the Physician prescribing the TENS Unit, the review and the documentation of effectiveness and patient compliance documented by the Physician along with the monthly testimonials by our patients as to the benefits they receive as proven by our monthly contact and verified by our data showing the average length of use to be 27 months all come together to prove that the TENS Unit when used for the treatment of Chronic Pain is a highly effective, non-invasive, non-narcotic treatment modality. We believe the data show that TENS Units are an effective use of reimbursement monies for the treatment of Chronic Pain for Medicare beneficiaries.

Sincerely,

Scott Graves
President
Golden State Medical, Inc.

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Greetings,

I am a physician assistant in an injury recovery center. It came to my attention last week that there is a proposal to stop covering these much needed units. More often than not, my chronic low back pain sufferers benefit from the use of TENS units. Having a home unit is a safe, effective and comparatively inexpensive way to help manage their pain. When the physical therapy ends and the patients are discharged to a home program, this is one of the most effective things patients can do to keep their chronic pain tolerable. It costs less than additional therapy visits over a long period of time and helps to minimize need for narcotic pain medication.

Pleases vote this proposal down!!!

Sincerely,

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To Whom It May Concern:

As a Chiropractic Physician in the state of Tennessee I am opposed to the action of restricting the usage of TENS for chronic lumbalgia patients. This device has proven to be a safe, effective treatment for patients in our office. Some of our patients have tried other treatments such as medication and even spinal injections with less success. With minimal contraindications this device is safer for patients than most treatments. It does the patient a disservice to eliminate a very cost effective treatment that gets results for chronic lumbalgia. With this being a covered service, our Medicare patients rely on TENS since no other physiotherapy services are covered. This would prove to limit the benefit of the treatments received in our office. The ultimate goal is to improve the health and quality of life of our patients. We have some patients that rely on their TENS multiple times daily to lessen the chronic complaints such as lumbalgia. By limiting TENS usage, countless patients would not receive the benefits of lessened chronic pain. In turn it would potentially increase costs due to patients going to their doctors for pain medication or other treatments. I strongly oppose any action restricting patients the right to receive care that has been proven to work.

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To whom it may concern,

I am writing on behalf of my physical therapists at Vector Rehabilitation, Inc. regarding CMS proposal to eliminate existing coverage for transcutaneous electrical nerve stimulation (TENS) for chronic lower back pain. We are a non profit 501 (C) (3) free standing outpatient physical therapy clinic, treating many Medicare beneficiaries. A large percentage of those patients, come to us with chronic back pain and even after utilization of manual therapy and exercise, the single most modality of relief is through a TENS unit. Eliminating coverage do in effect deny access for hundreds of beneficiaries to pain relief for their chronic pain.

We encourage you to re-evaluate your proposal and continue to provide access to this important tool in a physical therapist arsenal.

Regards,

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National Coverage Analysis (NCA) Tracking Sheet for Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N)

As a recent reitired medical director for BCBS Hawaii, I have been dealing with the TENS question for years. A quick check of the Internet shows a number of TENS units available for less than $100 dollars and some as low as $34. The TENS cost considerably less than an office visit or the co-payment for chronic medication.
First, if there is a randomized controlled trail, please mandate that the less than $100 TENS be used rather than the companies that price their products over a thousand. Medicare's eligible has been much higher than an effective unit for years.

Second, as a tax payer, I see little value in spending relatively large sums of money on a clinical trail of a product that is over 20 years old, dirt cheap and if effective at all, is marginal. Let those people that find benefit, buy it on their own the same as one might buy multiple vitamins.

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TENS is one of the most useful tools available for treatment of chronic pain, especially back pain. Its reusable and free of side effects. One unit will last for YEARS and once established, requires little or no physician supervision for continued benefit.

I cannot see any point in eliminating TENS as a benefit, as that would adversely impact patient care and unnecessarily increase reliance on pharmaceuticals to treat the pain. Increased pharmaceutical use increases risk of GI, liver and kidney complications as well. Those risks are unnecessary when a commonly available TENS unit can reduce or eliminate the need for pain medication without any risk at all.

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I have worked with back pain patients for over 7 years.

In that time, I have seen patients who are on suicide watch because their chronic pain was so bad that no pharmaceutical (including injections) would help. I have seen these same patients respond quickly and positively to prescription strength TENS therapy. These severe-pain patients credit their TENS unit with either saving their lives or seriously increasing the quality of their lives.

I have seen over 500 patients benefit enough from TENS that they are able to forgo NSAIDS, and narcotics.

If Medicare ceases to cover TENS, an incredible tool to combat intractable pain will be lost.

Without this option, patients will have no choice but to seek out high risk opioid drugs which are both costly and replete with negative side effects.

TENS ought to be covered as a low cost alternative for those who need it.

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As a regular prescriber of TENS who treats patients with chronic pain including chronic low back pain (CLBP) beyond 90 days that benefits from this technology, I am writing this letter in an effort to help ensure continued coverage of TENS and to stop CMS from adopting the proposed National Coverage Decision (NCD) that would restrict existing TENS coverage for CLBP patients.

I am asking that CMS refrain from taking rash, unwise and uninformed action to eliminate this long-covered, cost-effective, clinically necessary treatment modality for my patients.

Adoption of the TENS NCD by CMS would be severe and potentially irrevocable. If CMS is allowed to restrict coverage of TENS for patients with CLBP, it would:

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It has been my professional experience that the use of TENS to treat chronic lower back pain patients has been of tremendous help in the reduction of pain, especially those suffering beyond 90 days.

My practice depends upon this modality and the continuing coverage for treating those suffering from chronic lower back pain. With the raising costs of health insurance copays and deductibles, further burdening the patients with an additional out of pocket cost associated with it not being a covered modality would force some patients to pick and choose what treatments they should receive, instead of focusing on returning to optimal health.

Adoption of the TENS NCD by CMS would be severe and potentially irrevocable. If CMS is allowed to restrict coverage of TENS for patients with CLBP, it would:

1. Overrule my medical decision that TENS is appropriate to treat my patient’s chronic lower back pain;
2. Eliminate patient access to care that has been approved by the FDA as safe and effective for CLBP for at least three decades and covered by Medicare for two decades;
3. Establish precedent for future government action to eliminate coverage for other long-standing, cost-effective, and clinically necessary treatments on which I rely for treating my patients.
4. Interferes with the doctor-patient relationship founded on the physician's uncompromising commitment to patient welfare. By severely restricting treatment alternatives currently available to you in treating CLBP patients, the government is substituting its judgment for my judgment regarding the best treatment alternative for my patients.

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I'm not sure I understand the logic here and urge you to reconsider. Firstly the criteria for coverage is VERY strict already. It is a 30 day trial period and after that a survey must be complete to show it is working and for medicare to continue payment. Can I ask what doctor would keep prescribing if it is not working?????

Not only that reimbursement is very small. It is a relativley cheap item that has no negative side effects and works great for many.

I'm a pt and have seen hundreds upon hundreds of patients use tens successfully for chronic low back pain. I'd estimate 75%+ find relief and cut down on pain pills with the use of tens.

With all the expensive therapy, pills, and surgery I find it shocking medicare is looking at stopping coverage for tens. Not only that this is a tried and true therapy!

I get cutting costs but this would be like telling patients "take more pills" and forcing them into other, more dangerous, and more costly ways of pain relief.

I do not work for a manufacturer and I don't make money from tens so the only skin I have in the game is patients' health. And this would be a terrible decision.

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I'm a PA working in a neuroscience and spine center and I don't kow how many of our patients would function without portable, at home tens. We run these as a short trial to ensure effectiveness and make sure the patient likes the therapy.

This is one of the biggest leaps I've seen cms take. To just stop coverage on this quite useful therapy does not make sense at all.

So many patients rely on tens therapy to get through day to day work and activity it would truly be a shame to take coverage away. You are only pushign patients towards more and more pain pills.

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Tens is an abosolute must have for me in my clinic when it comes to patients with CLBP. We often will try it in the clnic first to see if it works. If we fill it is effective the patient gets a home unit. This way we have roughly a 80% or so effectiveness rate which I feel is quite high. Most of these patients cut down on pain pills and have quite a bit of relief.

I'm also more than suspect about this one study used to make this decision. It is amateur at best and it is surprising to me cms would use it as the backbone to this decision.

Nobody is saying tens is 100% effective...but nothing is. However, tens is rather cheap, totally safe, and effective for many.

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I am an MD and a Clinical Assistant Professor of Medicine and I'm shocked by this ruling. No therapy is 100% effective but from what I have seen over the years tens has made quite a positive impact on patients with chronic low back pain.

Why not make the coverage criteria easier and more cut and dry? I know these are already done as a rental and they are not a very expensive item so it is hard to understand the strategy here

I know cms needs to cut costs but this is not the place to do it. If anything make it a 30 day rental with review for effectiveness and reimburse $20-$30 for a month. If it's not effective then it's returned. Some sort of change like that makes much more sense rather than stopping coverage on a therapy that truly is helping folks.

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I'm writing as a very concerned [PHI Redacted] healthcare professional. [PHI Redacted] Stopping coverage of tens would be detrimental to so many patients.

Beyond that I am a nurse at a pain management clinic. So many patients are hooked on pain pills and tens is a great way to get lasting releif without all the pills. Not only do tens bring pain relief but I truly feel they save lives.

My docs are shocked at this announcement. Not only that but the study you used to make this decision is quite frankly garbage. I can't believe you are using a study like this which mostly had patients with neurologic disorders to make a blanket statement of no more tens for CLBP.

You are really hurting a lot of patients and doctors with this move and I hope you reconsider.

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TO CMS VIA EMAIL/Web Posting

Brijet Burton, MPP, MS, PA-C
Sarah Meisenberg, MSPH
Susan Miller, MD
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244 T 800.321.9549

Dear Ms. Burton, Ms. Meisenberg, and Dr. Miller:

DJO Global, Inc. (DJO) appreciates the opportunity to submit comments on CMS's Proposed National Coverage Analysis (NCA) regarding Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic low Back Pain (CLB).

DJO is a leading global developer, manufacturer, and distributor of high-quality medical devices and services that provide solutions for pain management, musculoskeletal health, and vascular health. Our products address the continuum of patient care, from injury prevention to rehabilitation after surgery, injury, or from degenerative disease, enabling people to regain or maintain their natural motion. Our Empi product line includes electrical stimulation and other orthopedic products used for pain management, orthopedic rehabilitation, and physical therapy.

As discussed in greater detail below:

• DJO supports continued Medicare coverage of TENS for chronic low back pain to preserve Medicare beneficiary access to this safe and effective technology.
• Numerous clinical studies show positive benefits associated with the use of TENS for chronic musculoskeletal pain, including chronic low back pain. CMS used inappropriate exclusion criteria to disregard the results of positive studies.
• Local Medicare policies already require a physician to determine that TENS is effective for his or her particular patient. By suggesting there is no evidence that TENS is effective, CMS is essentially discounting the medical judgment of every physician that has prescribed TENS for a Medicare beneficiary.
• It is inappropriate to limit coverage of TENS for ClBP to Medicare patients that participate in a clinical trial since there is longstanding Medicare coverage of TENS for ClBP with stringent coverage criteria, and there are no safety concerns regarding the use of TENS.
• While TENS meets the statutory requirement for Medicare coverage under § 1862(a)(1)(A) without the need for additional evidence development, if CMS seeks additional clinical data regarding TENS for ClBP, it should not restrict current coverage while this evidence is developed.
• If CMS is interested in additional data on TENS, it should use a less cumbersome evidence data collection mechanism, such as claims modifiers or beneficiary surveys, or possibly a registry as an altemative to prospective clinical studies, given the unquestioned safety profile for TENS and existing safeguards already in place at the local contractor level.
• If CMS adopts coverage with evidence development (CED) requirements, we urge CMS to delay any coverage restrictions until at least two years after the final coverage determination is issued (although if CMS receives new clinical evidence in the interim that supports existing TENS coverage, CMS should maintain current Medicare coverage). Any information collection mechanism Will take time to develop and implement; the broad Medicare population should not be denied longstanding Medicare coverage during this evidence-gathering process.

• Likewise, ifCMS adopts evidence development requirements for TENS for CLBP, it should streamline the study requirements. While the stringent study protocol may be appropriate for a new, unproven technology with potential safety risks, this is not the case for TENS, since it has been used for decades to bring safe pain relief to the Medicare population.

Our detailed comments follow.

In its Proposed NCA, CMS states that it has determined that the evidence base does not support Medicare coverage of TENS in CLBP. While CMS proposes noncoverage under the Medicare statute, CMS believes that it is appropriate to use CED lito support the generation of more informative evidence" in order to "increase the likelihood that beneficiaries achieve improved health outcomes." Specifically, the Proposed NCA would require that as a condition of Medicare coverage, the patient must be enrolled in a prospective clinical study that addresses one or more aspects of the following questions in a randomized, controlled design using validated and reliable instruments:

1. Does use of TENS provide a clinically meaningful reduction in pain in Medicare beneficiaries with CLBP?
2. Does use of TENS provide a clinically meaningful improvement of function in Medicare beneficiaries with CLBP?
3. Does use of TENS provide a clinically meaningful reduction in other medical treatments or services used in the medical management of CLBP?

Such studies must adhere to specific standards for scientific integrity and relevance to the Medicare population.

If CMS adopts the Proposed NCA, it would supersede longstanding local Medicare coverage policies outlining stringent standards for TENS coverage.

TENS is a noninvasive therapy indicated for the symptomatic relief from, and management of, chronic intractable pain and post-surgical and post-trauma acute pain. For over 30 years, the medical community has used TENS as a safe and effective alternative or adjunct to pharmacological approaches to pain control for many patients. TENS has minimal side effects and is non-addictive.

Numerous studies have indicated positive benefits associated with the use of TENS for chronic musculoskeletal pain, including chronic low back pain. We provided a detailed summary of these studies in our October 3, 2011 submission during the initial comment period on CMS's review of national Medicare coverage of the use of TENS for CLBP. We are attaching a copy of our 2011 comments for your reference.

We are concerned that CMS adopted exclusion criteria that inappropriately prevented studies supporting TENS from being included in CMS's coverage review. This bias against research supporting TENS has virtually eliminated from CMS consideration important research that should be part of eMS's deliberations.

For instance, CMS excluded a Johnson and Martinson meta-analysis published in Pain in 2007¹ on grounds of "mixed sample of musculoskeletal conditions." This exclusion was inappropriate. As we explained in our October 3, 2011 comments, the Johnson and Martinson analysis includes musculoskeletal pain in various anatomical locations (including back, neck. hip. and knee). since "mechanism. rather than anatomical location of pain. is likely to be a critical factor for therapy." The authors note that "both proposed modes of action for ENS (the gate control theory or the release of endogenous endorphins) are not dependent upon anatomical locus." Likewise, a practitioner treats "diagnosis of musculoskeletal pain using a general multimodal approach that is not joint or location specific." By excluding this study. CMS ignored that this meta-analysis of data from 29 papers with 38 studies on the efficacy of transcutaneous and percutaneous electrical nerve stimulation (collectively. ENS) for patients with chronic musculoskeletal pain found that pain was reduCED significantly using ENS compared to the placebo. Moreover. 35 of the 38 studies favored ENS compared to the placebo. with 24 studies showing significant benefit compared the placebo. The pain relief provided by ENS therapy averaged almost three times the relief provided by the placebo. They further show that analyzing TENS studies alone was statistically significant. Johnson and Martinson concluded that the "results showed a significant decrease in pain with ENS therapy .... These results indicate that ENS is an effective treatment modality for chronic musculoskeletal pain and that previous. equivocal results may have been due to underpowered studies."

CMS does not state why it excluded a study by Leonard and colleagues² that examined the efficacy of low and high frequency TENS in patients who were opioid tolerant and those who were not opioid tolerant. They showed a significant reduction in pain during and immediately after conventional TENS (high frequency) when compared to baseline for both the opioid and nonopioid group. For acupuncturelike TENS (low frequency). the analgesic effect of TENS was observed in the nonopioid group. The majority of the patient population in the trial had spine pain. CMS cites this study as part of its discussion of how TENS works. but CMS ignored the positive results of this study in its assessment of the literature.

CMS also discounted the Grant study on the dubious grounds of "imprecise location of back pain." This study of adults over 60 years of age. found approximately a 50% reduction in pain and reduCED pain medication intake in subjects with chronic low back pain treated with TENS compared to acupuncture.3 CMS does not elaborate further on the exclusion of this study focusing on back pain that clearly addressed two of the three questions CMS has identified as relevant to its coverage review (does the use of TENS provide a clinically meaningful reduction in pain in Medicare beneficiaries with CLBP, and does the use of TENS provide a clinically meaningful reduction in other medical treatments or services used in the medical management of CLBP?).

CMS also excluded well-designed trials if the participant did not use TENS for at least 4 weeks. This arbitrary cut-off led to the exclusion of important research by Zambito and colleagues. In two randomized. double-blind. placebo controlled clinical trials focusing on older individuals (over 50 years old). Zambito and colleagues found a significant reduction in pain and disability after treatment with interferential current (a form of TENS) in older adults with vertebral column fractures and in those with degenerative disk disease without radiculopathy.^4,5

We believe that studies cited by DJO and other commenters provide sufficient evidence that TENS used for chronic low back pain meets the statutory criteria under § 1862(a)(1 )(A), as there is ample evidence that TENS, when properly administered, is reasonable and necessary as an effective treatment for low back pain. While additional clinical research is useful for any medical intervention, there simply is insufficient grounds for ending longstanding Medicare coverage for a treatment that physicians determine is effective for certain Medicare patients suffering from CLBP who have not found relief with other interventions.

Each of the Medicare DME MACs has established a local coverage determination for TENS, covering both use for acute post-operative pain and chronic pain. The policies establish rigorous criteria for determining whether the use of TENS is reasonable and necessary for Medicare beneficiaries on both an initial and ongoing basis. Specifically, with regard to chronic pain:

• The medical record must document the location of the pain, the duration of time the patient has had the pain, and the presumed etiology of the pain.
• The pain must have been present for at least three months.
• Other appropriate treatment modalities must have been tried and failed, and the medical record must document what treatment modalities have been used.
• The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy (certain conditions are excluded from coverage, including tempomandibular joint pain, visceral abdominal pain, headaches, and pelvic pain).
• When used for the treatment of chronic, intractable pain, the TENS unit must be used by the patient on a trial basis for a minimum of one month (30 days), but not to exceed two months.
• The trial period must be monitored by the physician to determine the effectiveness of the TENS unit in modulating the pain.
• For coverage of a purchase, the physician must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time.
• The physician's records must document a reevaluation of the patient at the end of the trial period, must indicate how often the patient used the TENS unit, the typical duration of use each time, and the results.
• The physician ordering the TENS unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit.

These policies already establish sufficient safeguards to ensure that TENS are used for medicallynecessary purposes under the Medicare program. CMS's national policy should not disrupt this carefullydeveloped local coverage framework.

CMS says that it should not cover an item or service "in circumstances where treatments are not known to be beneficial." We strongly disagree with CMS's suggestion that TENS is not known to be beneficial. As a condition of coverage under the DME MAC pOlicies, every physician who prescribes TENS for CLBP must assess the effectiveness for TENS on a patient-by-patient basis. Specifically, the policies require that:

By stating that there is no evidence that TENS is effective, CMS is essentially discounting the medical judgment of every physician that has ever prescribed TENS for a Medicare beneficiary based on his or her assessment of the "effectiveness of the TENS unit in modulating the pain." Surely CMS is not suggesting that every physician certification of the effectiveness of TENS has been meaningless.

As CMS points out, "the absence of conclusive evidence of benefit does not equate to conclusive evidence of no benefit." In examining the evidence surrounding TENS, we believe that CMS should give heavier weight to actual physician clinical experience with actual Medicare patients than its selective literature review.

CED is a rarely-used pathway to allow Medicare coverage when items or services should be restricted to specific patients or specific providers with special training, if the item may be misused, or if it significantly changes how providers manage patient care, or if additional approved clinical research studies are necessary to gather more evidence.

Specifically, in the current CMS guidance on "National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development," CMS sets forth the option of using CED to permit Medicare coverage under certain circumstances when evidence is not adequate for coverage as reasonable and necessary under Section 1862(a)(1 )(E) of the Social Security Act.6 CMS identifies two "arms" of CED determinations: (1) Coverage with Study Participation (CSP), under which CMS will provide coverage only to patients enrolled in an approved clinical research study that meets certain rigorous standards; and (2) Coverage with Appropriateness Determination (CAD), under which additional clinical data must be submitted by the provider to a database or registry as a condition of the beneficiary's coverage. CMS proposes using the CSP framework for TENS coverage.

We agree that it is valuable to have alternative mechanisms to expand Medicare beneficiary access to new medical technologies while clinical evidence is still emerging to demonstrate that a technology meets the statutory "reasonable and necessary" standard. Situations justifying CSP as a condition of Medicare coverage should be very rare, however, since imposing new clinical trial requirements effectively denies most beneficiaries access to a medical technology for many years. While additional evidence can help refine treatment practices for virtually any medical technology, there are very few circumstances that justify essentially revoking patient access to technology that is long accepted in the medical community and which has no safety concerns while such additional evidence is gathered.

In particular, CSP should not serve as a barrier to widespread patient access to technology like TENS that has longstanding Medicare coverage and that is widely regarded by clinicians as a safe and effective treatment. There is ample evidence that TENS, when properly administered, is reasonable and necessary as an effective treatment for low back pain. In fact, CMS acknowledges in the Proposed NCA that "[i]n the case of TENS for the treatment of CLBP, adverse events are rare ... and usually mild. The basic safety of the patient when using TENS is not in question here."

We urge CMS to ensure that any application of its CED policy does not hinder Medicare beneficiary access to safe, effective medical care, such as the use of TENS for chronic low back pain. We recommend that CMS limit the use of CSP as an alternative to noncoverage for situations in which: (1) there are demonstrated safety concerns associated with a new technology [or new uses of an existing technology], or (2) when there is reliable evidence that a new FDA-approved technology is not reasonable and necessary for use in the Medicare population or a Medicare subpopulation. Since neither condition applies to TENS for CLBP, we urge CMS to maintain current coverage and not impose new CED requirements.

As you know, CMS has suggested revisions to the CED framework, because the agency has determined that there is "room to improve the CED process." The uncertainty associated with the CED policy further complicates the application of this evolving coverage option to TENS.

If CMS adopts coverage with evidence requirements, Medicare beneficiaries should not be denied longstanding Medicare coverage while this evidence-gathering process is conducted. There is no reasonable justification for denying Medicare beneficiaries with chronic low back pain the documented, safe pain relief available through the proper use of TENS while such studies are ongoing. Restricting access to this technology instead could necessitate greater use of potentially addictive narcotics and in some cases result in the need for surgical intervention.

Developing new evidence collection mechanisms, like establishing a registry or conducting clinical trials, is a lengthy and resource-intensive undertaking. In the case of a registry, a sponsor must be identified, the scope of data collection must be developed, data transmission parameters must be established, and providers must be educated. With regard to clinical studies, a study protocol must be developed and approved by CMS, researchers must be identified, funding must be obtained, sites must be identified, patients must be enrolled, the actual study must be conducted, and then the results must be assessed. This process takes years. In addition, only a relatively small number of Medicare beneficiaries who are in the geographic vicinity of the study site(s) realistically can participate in the trial, thus this option is useless for beneficiaries who do not live near a study site.

It is unreasonable to deny Medicare coverage for the vast majority of beneficiaries while an evidencegathering process is designed and conducted. That is why we recommend that CMS continue local Medicare coverage policies while developing any additional research collection mechanism on a parallel track. This would both preserve beneficiary access to TENS for pain relief and permit the development of additional evidence.

If CMS does not support seamless Medicare TENS coverage for the duration of evidence development, CMS should provide ,adequate time for the information collection efforts to get underway before restricting Medicare coverage. We would therefore recommend that CMS delay any CED restrictions for at least two years after the final coverage determination (although if CMS receives new clinical evidence in the interim that supports existing TENS coverage. CMS should maintain current Medicare coverage without triggering the CED requirements}. We believe that such delay is reasonable and in fact necessary to allow for the development, approval, and implementation of the data collection framework. Further, we do not believe such delay is contrary to the reasonable and necessary standard in the Social Security Act because the local contractors have reviewed and determined that TENS is reasonable and necessary within certain parameters. Finally, implementing a delay in this particular case will not set unreasonable preCEDent. We believe that there are very few if any other technologies that have uniform LCOs and such a longstanding and superior safety profile. Thus granting a delay will not open the floodgates for comparable delays with other technologies subject to CED.

As previously stated, we believe that TENS meets the statutory requirement for Medicare coverage since it is reasonable and necessary as an effective treatment for CLBP, without the need for additional evidence development.

Given the unquestioned safety profile for TENS and existing safeguards already in place at the local contractor level, to the extent that CMS wants additional information for Medicare coverage purposes, CMS should explore the use of claims modifiers or other claims-based reporting options that can provide additional details on the specific patient characteristic or treatment parameter of interest to CMS. Altematively, CMS could consider whether beneficiary follow-up surveys would provide the requisite information. This information would be reported directly to CMS or its contractors, bypassing the need for a third party to collect information through a registry and aggregate and submit the data to CMS for further review. It also would permit data collection regarding the care of many more Medicare beneficiaries than would a clinical trial. CMS should set forth clear parameters for ending any data collection, along with timeframes for assessing the collected data and applying the data to Medicare coverage policy.

Likewise, while registries have drawbacks, even a registry would be preferable to the CSP option, given that CSP dramatically restricts the number of eligible Medicare beneficiaries who would be able to continue TENS treatment and discriminates against those Medicare beneficiaries who do not live near a study site. The establishment of a registry is a lengthy, cumbersome process, and reporting to registries is burdensome to impacted providers. This results in many providers electing to "opt-our' of the registry process, leading to the potential for a two tier Medicare system: only the Medicare patients whose providers agree to participate in the process will be eligible to receive the benefit.

More broadly, CMS should ensure that any data collection requirement seeks to furnish very specific information that is necessary to determine a specific Medicare coverage policy issue. It is not appropriate to impose such requirements on providers and other stakeholders simply to further general research goals.

Clinical evidence demonstrates that TENS used for chronic low back pain meets the statutory "reasonable and necessary" criteria under § 1862(a){1 ){A}. OJO therefore strongly urges CMS not to restrict Medicare coverage for TENS for chronic low back pain beyond the criteria established by the OME MACs. IfCMS seeks additional information regarding TENS efficacy, we recommend that local Medicare coverage policies remain in effect while this information is collected. CMS also should explore the use of claims modifiers or other claims-based reporting option, beneficiary studies, or even a patient registry as an alternative to mandated clinical studies.

If CMS does not support maintenance of current coverage for the duration of the information collection, CMS should provide adequate time for the information collection mechanism to get underway before restricting Medicare coverage. We would therefore recommend that CMS delay any coverage restrictions linked to CED until at least two years after the final coverage determination.

We would be pleased to answer any questions you may have or to provide additional information.

Sincerely,

/s/

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CMS - I request your consideration to NOT eliminate coverage for TENS units for chronic low back pain in our medicare population. I am a family physician in Lowell, Arkansas, and have been practicing medicine since 1998. I work 'in the trenches' daily with our medicare patients, and see chronic back pain daily in my office, and in the hospital. Back pain is a frustrating, chronic problem for many of the patients we serve, and there often is no quick-fix. I have heard myself in lectures and articles that the TENS units have questionable efficacy in the treatment of back pain. However, as someone who sees patients on a long-term basis for their pain, I can tell you that many (I would guess about 80%) of my patients feel the TENS unit provides significant relief, either on an intermittent or daily basis. So, please reconsider your elimination proposal for the TENS unit, as it's one less option I will have to help those patients on limited incomes. If they don't use a TENS unit, they will invariably be asking for narcotics, which has many problems itself.

Thank you for your time - Dr. Cheryl Fulton, DO, MS-HCA, Family Physician with Mercy Health Systems of Northwest Arkansas.

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To Whom It May Concern:

I would like to lend my support to Isokinetics, Inc. to overrule your medical decision that TENS is appropriate to treat chronic low back pain. This decision by Medicare seems to be a substitute for the doctor's judgment regarding what is the best treatment for our patients. The TENS unit has been approved by the FDA as safe and effective for chronic low back pain for at least three decades and I feel that it has its place in the treatment plans of these patients.

For Medicare to suddenly cease payment for this appropriate device interferes with my clinical decisions regarding continued treatment.

Please reevaluate your decision to revoke the coverage of TENS units for these chronically ill patients.

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I am a rheumatologist in Little Rock, Arkansas and have been practicing at the Little Rock Diagnostic Clinic for 20 years. During that time, I have seen many patients with chronic pain of different sorts, including chronic back pain. In my experience, I have found little use for transcutaneous electrical nerve stimulation (TENS) and applaud the elimination of existing coverage for this and other unproven and unhelpful (and often expensive) treatments. There is so much waste in health care and anything we can do to save tax dollars is imperative.

Sincerely,

James H. Abraham III M.D.
Little Rock Diagnostic Clinic
Little Rock Arkansas 72205
501-227-8000

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I utilize home TENS units in my practice for relief of chronic pain and feel that TENS is beneficial and cost effective.

There are many issues with this proposal:

• Represents government interference in the doctor-patient relationship founded on the physician's uncompromising commitment to patient welfare. By severely restricting treatment alternatives currently available for treating CLBP patients, the government is substituting its judgment for my judgment regarding the best treatment alternative for your patients;
• It establishes precedent for future government action to eliminate coverage for other long-standing, cost-effective, and clinically necessary treatments on which you rely for treating your patients. If CMS succeeds in restricting TENS coverage, CMS will be emboldened to limit coverage for a variety of currently-covered, long-standing treatments with the knowledge that the medical community can do little to stop it;
• It eliminates patient access to care that has been approved by the FDA as safe and effective for CLBP for at least three decades and covered by Medicare for over 20 years;
• It interferes with me and my colleagues’ ability to offer alternatives for pain patients;
• It could increase the use of expensive pain medications that would result in outcomes contrary to patient welfare;
• CMS could apply these restrictive coverage criteria to other products and services presently rendered and/or prescribed
• A rigorous randomized clinical trial would be very costly estimated in the millions of dollars and taking up to five years to complete, without the opportunity to defray costs since current coverage would stop until the trial is complete; and,
• The CMS documentation requirements will create an additional economic burden on both the patient and the physician.

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I utilize home TENS units in my practice for relief of chronic pain and feel that TENS is beneficial and cost effective.

There are many issues with this proposal:

I utilize home TENS units in my practice for relief of chronic pain and feel that TENS is beneficial and cost effective.

There are many issues with this proposal:

• Represents government interference in the doctor-patient relationship founded on the physician's uncompromising commitment to patient welfare. By severely restricting treatment alternatives currently available for treating CLBP patients, the government is substituting its judgment for my judgment regarding the best treatment alternative for your patients;
• It establishes precedent for future government action to eliminate coverage for other long-standing, cost-effective, and clinically necessary treatments on which you rely for treating your patients. If CMS succeeds in restricting TENS coverage, CMS will be emboldened to limit coverage for a variety of currently-covered, long-standing treatments with the knowledge that the medical community can do little to stop it;
• It eliminates patient access to care that has been approved by the FDA as safe and effective for CLBP for at least three decades and covered by Medicare for over 20 years;
• It interferes with me and my colleagues’ ability to offer alternatives for pain patients;
• It could increase the use of expensive pain medications that would result in outcomes contrary to patient welfare;
• CMS could apply these restrictive coverage criteria to other products and services presently rendered and/or prescribed
• A rigorous randomized clinical trial would be very costly estimated in the millions of dollars and taking up to five years to complete, without the opportunity to defray costs since current coverage would stop until the trial is complete; and,
• The CMS documentation requirements will create an additional economic burden on both the patient and the physician.

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I am writing as a regular prescriber of TENS units for low back pain management. Low back pain is one of the most frequent pain complaints and one of the most common reasons for missed work and productivity. TENS usage allows patients to manage their pain and often return to work, social activities, etc. This treatment lessens the need for addictive opioid analgesic (narcotic) medications as well. This treatment can be used chronically and is cost effective. Home usage allows patients to administer this treatment without physical therapy expenses.

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As a practicing pain physician, there is no doubt that TENS works for patients. Does it work for all? No. Does anything in pain management work for all? No. With the inherent and prevalent issues pertaining to pain medications, especially in the elderly, it would be a shame to take away a pain relieving modality that can limit someones exposure to more toxic and problematic treatment options. Studies regarding TENS will never be very decisive, as pain is such a subjective problem with too many variables which can not be controlled (weather/activity/etc.).

I would certainly not take away TENS as a treatment option. The true OOP cost of these is nothing near the cost one may face with long-term medication management. I think continued requirement for a trial period is sufficient in determining who may or may not benefit from this treatment option.

Additionally I would recommend avoidance of recommendations from a provider organization (AAN in this case) that is not specifically treating the target population on a regular basis.

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In 14 years of practice as a Physical therapist I have found TENS to be extremely helpful in reducing pain, inproving daily function and reducing the amount of pain medication taken by my patients. Contary to what is stated in your report, I very seldom need to see patients for more than one physical therapy visit to allow for proper independant use of TENS by the patient.

I have found that TENS has reduced the number of physical therapy visits needed at times and has allow individuals to continue to work by reducing the level of pain that they experience.

TENS is particularly helpful for those patients with a history of chonic pain for which there is no surgical or medical "fix".
Without TENS as a paid intervention, I clearly see that insurance costs will go up by increased number of healthcare visits and increased pain medication use.
Please be carefull when applying research to your descision. Over the years we have seen research (some properly done and some not so properly done) that will prove and disprove the same point. It is easy to find a research article or two to prove our point even if our point is not fact.

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Dear Medicare

Currently, most, probably 99 percent of insurance companies will pay for a Tens unit for a patient with chronic low back pain. In fact, recently, Blue Cross Blue Shield of Texas and Illinois re instated coverage for tens units.

In order for a patient to receive a tens unit for Medicare,the physician must write an order for a 30 day trial, then within 30-60 days, upon a follow up, when the patient and the physician decide that the tens unit is effective, then a purchase CMN is signed by the physician, authorizing Medicare to pay for the device.

Why would a physician write an order for a Tens unit if it was not effective? Tens units were first approved in 1995 for Medicare patients. Do you think that after 17 years, if Tens was not an effective pain control alternative, that physicians would have quit prescribing them?

Have you considered asking Blue Cross Blue Shield of Texas and Illinois why they decided to reinstate coverage of Tens? The informatio that they have might be helpful to you.

We are a small DME commpany, and have been providing DME to rehabilitation patients since 1987. Tens is only about 8-9 percent of our business, and Medicare tens is only about 5 percent of our business, so I am not writing because your policy will put us in a bind. We will be ok.

My concern is that if you are a Medicare Employee, or other government employee, and your doctor writes an order for a tens unit, and the tens unit is beneficial to you, your insurance company will pay for it. But, with the policy that your are proposing, unless the patient is in a controlled study, there will be no coverage for a Medicare Senior.

Medicare has many patients that receive supplies for tens, and have received supplies for their tens unit for years. Yes, I am sure some folks quit using them after awhile, put the tens unit in a drawer, and then when their pain reappears, they will start using the tens unit again, start doing their exercises that they quite doing, and just keep repeating the cycle.

Have you thought about taking the data that you currently have in your possession and asking the folks that are utilizing tens as part of their pain control program if the tens unit is working for them?

How about asking the patients that quit buying supplies why they quit buying supplies? Maybe they are still using their tens unit, and they are buying electrodes somewhere else? Or maybe theire electrodes are lasting longer?

Outcomes questionnaires have been utilized by many professional assocations to accurately measure the effectiveness of therapies and procedures, from Orthopaedics to Cardiology. You have the datebase, and I am sure that there are millions of patients over the years that you could question about the effectiveness of tens, based on real users of the device.

Tens units do not work for everyone, and that is why there is a thirty day trial to guage the effectivness,prior to purchase. Pain medication does not work for everyone, either, and many patients will start taking pain medication and then quit, for no reason.

I think that a study on the effectiveness of a tens for chronic low back pain should be required and implemented, with a time frame long enough to gather enough data to put the question finally to rest, but in the mean time, I think that you should ocntinue coverage for chronic low back pain patients that are medicare seniors until the study is concluded.

For example, you might find that the tens unit should be rented to patients, with some type of capped rental, and if for some reason, the tens unit quits being effective, the patient returns the unit and the rental stops.

But,in the meantime, denying coverage, using the CED process to limit coverage, rather that use the CED process to expand utilization(the original purpose of the CED process)interfering with the patient/doctor decision making process, is exactly what most folks are concerned with.

Mike Salem
CEO
Isokinetics, Inc.
P.O. Box 21
Dequeen, Arkansas 71832
501-951-3821

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After reading your information on TENS I was appalled that the study shows it to be ineffective. I have been an RN for 36 years and have seen many people have relief of pain along the nerve pathways using the TENS. [PHI Redacted] and can assure you it is a worthwhile treatment. Not all modalities of treatment work for everyone but they work for some of the people. I will soon be of Medicare age myself and believe if you have treatment that works for some people why would you want to take that method of treatment away. It is better than taking pain pills.

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