Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-437-7863. A retrospective review is performed if services are not prior authorized.
BCBSMT considers a trial of transcutaneous electrical nerve stimulation (TENS) monitored by a physician medically necessary to establish efficacy for the management of refractory chronic pain (e.g., chronic musculoskeletal or neuropathic pain) that is unresponsive to at least 3 months of conservative medical therapy and causes significant disruption of function.
Continued use of transcutaneous electrical nerve stimulation (TENS) is considered medically necessary for treatment of refractory chronic pain (e.g., chronic musculoskeletal or neuropathic pain) that causes significant disruption of function when the following conditions have been met:
- Efficacy has been demonstrated in an initial therapeutic trial (see policy guidelines); AND
- Compliance has been demonstrated in the therapeutic trial with the device used on a regular basis (e.g., daily or near daily use) throughout the trial period.
BCBSMT considers TENS not medically necessary for the management of acute pain (e.g., postoperative or during labor and delivery).
The use of TENS for any other condition, including the treatment of dementia, is considered not medically necessary.
When the criteria for coverage is not met, BCBSMT encourages all participating providers to have a member complete and sign an Advanced Member Notification (AMN) form stating that BCBSMT will not cover this service, supply, device, or drug. If an AMN is signed prior to delivery of the service, participating providers can balance bill the patient. If an AMN is not signed, participating providers are financially liable and cannot balance bill the BCBSMT member for denied services. Services provided by an out-of-state provider that are denied as not medically necessary are the financial responsibility of the patient even if an AMN is signed.
Refer to the Advanced Member Notification medical policy for more information. The AMN form is available at www.bcbsmt.com (Click on Providers and then Forms).
Refractory chronic pain is defined in this policy as pain that causes significant disruption of function and has not responded to at least 3 months of conservative therapy, including nonsteroidal anti-inflammatory medications, ice, rest and/or physical therapy.
Documentation for the trial should include:
- Initial assessment/evaluation of the nature, duration, and perceived intensity of pain;
- The types and duration of prior treatments;
- Treatment plan including ongoing medications and proposed use of TENS unit including the frequency and duration of treatment.
Clinical summary of the trial to determine efficacy should include:
- Perceived intensity of pain with and without TENS (e.g., 2 point or 30% improvement in visual analog scale [VAS]);
- Ongoing medication requirements for pain relief (if any);
- Other modalities (if any) in use for pain control;
- Actual use of TENS on a daily basis (frequency and duration of application).
TENS devices may be delivered through a practitioner and require a prescription, or obtained without a prescription. It is possible that prescribed devices provide higher intensity stimulation than units sold directly to the public.
This policy was originally based on a 1996 TEC Assessment of TENS for the treatment of chronic and postoperative pain, which concluded that the evidence did not clearly show that the effects of TENS exceeded placebo effects. (1) An updated literature search in October 2002 identified several Cochrane reviews of TENS. (2-7) One of the reviews, last amended in June 2000, addressed chronic pain due to a variety of conditions (e.g., osteoarthritis of the knee, rheumatoid arthritis of the wrist, pancreatic, myofascial trigger points, chronic back pain, temporomandibular joint pain, and a variety of nocioceptive and neuropathic causes of pain). (2) A total of 19 randomized trials were judged as meeting study selection criteria, but due to heterogeneity of methods and inability to extract sufficient dichotomous pain outcomes data, it was concluded that meta-analysis was not possible, and the review of evidence was inconclusive. The trials reviewed did not indicate which stimulation parameters were most likely to provide pain relief, or answer questions about long-term effectiveness. The authors suggested a need for large, multicenter, randomized, controlled trials of TENS in chronic pain.
In a 2004 literature review update, two additional Cochrane Reviews were identified along with several randomized controlled trials (RCTs) on the use of TENS (8-15). Neither the Cochrane Reviews nor any of the RCTs identified were sufficient to alter the previous conclusions. The authors of the Cochrane reviews concluded that the evidence was inadequate to draw conclusions about the effects of TENS.
The policy update in 2007 examined the 10 Cochrane reviews on TENS that had been published over the previous 7 years. Overall, evidence for the efficacy of TENS for different pain conditions was weak. Two Cochrane reviews concluded that there is limited and inconsistent evidence for the use of TENS as an isolated treatment for low back pain, and that results in patients with rheumatoid arthritis of the hand were conflicting. (4, 16) Efficacy of TENS for neck pain, headache, shoulder pain after stroke, and dementia were considered inconclusive in 3 other reviews. (2, 5, 9) One Cochrane review of 9 small, controlled trials found high-frequency TENS to be effective for the treatment of dysmenorrhea. (6) Another review found TENS and acupuncture-like TENS to be more effective than placebo for the treatment of knee osteoarthritis, but indicated that due to heterogeneity of the included studies, more well-designed trials with adequate numbers of participants were needed to conclude effectiveness. (7)
Three additional Cochrane reviews were published in 2008, addressing the topics of TENS for cancer pain, chronic low back pain, and other chronic pain conditions. (17-19) For cancer pain, only 2 RCTs (total of 64 participants) met the selection criteria for inclusion in the systematic review. (17) There were no significant differences between TENS and placebo in the included studies, and results of the review were considered inconclusive due to a lack of suitable RCTs. For the treatment of chronic low back pain, 4 high-quality RCTs (585 patients) met the selection criteria. (18). There was conflicting evidence about whether TENS reduced back pain and consistent evidence from 2 of the trials (410 patients) that it did not improve back-specific functional status. The review concluded that the evidence available at this time does not support the use of TENS in the routine management of chronic low back pain. An updated review of TENS for the treatment of various other chronic pain conditions including rheumatoid arthritis with wrist pain, temporomandibular joint dysfunction, multiple sclerosis with back pain, osteoarthritis with knee pain, neuropathy, pancreatitis, and myofascial trigger points included 25 RCTs (1281 patients). (19) Due to heterogeneity, meta-analysis was not possible; slightly over half of the studies found a positive analgesic outcome in favor of active TENS treatments. The authors concluded that the 6 studies added since the last version of this review did not provide sufficient additional information to change the conclusions, and that the published literature lacks the methodological rigor needed to make confident assessments of the role of TENS in chronic pain management.
An industry-sponsored meta-analysis by Johnson and Martinson included 38 randomized controlled comparisons (1,227 patients from 29 publications) of trans- or percutaneous electrical nerve stimulation (ENS) for chronic musculoskeletal pain, using any stimulation parameters on any location (e.g., back, neck, hip, knee). (20) The data were converted to a percentage improvement in VAS scores, then transformed into standardized mean differences (a continuous measure that adjusts for variability in different outcome measures). Based on the combined standardized difference, the authors concluded that TENS provided pain relief “nearly three times” the pain relief provided by placebo. There are a number of sources of bias in the analysis that seriously limit interpretation of the results. First, the heterogeneity of the individual study results (I2=82%) raises questions about the appropriateness of combining these studies in a meta-analysis (see previous discussion regarding the decision to not combine studies for the 2000 and 2008 Cochrane reviews on chronic pain). Further limiting interpretation is the transformation of data to standardized effect size, which appears to have led to discrepant effect sizes of otherwise similar results. For example, comparison of the untransformed and transformed data shows that while two of the included trials (Deyo et al. 1990 , and Machin et al. 1988 ), found similar percentage point differences in VAS between active and control groups (5% and 8%, respectively), the standardized effect sizes are not equivalent.
Positive standardized effect sizes from data that are not statistically or clinically significant (e.g., 47% vs. 42% change from baseline in Deyo et al.) also raises concerns about the appropriateness of the data transformation. Inclusion of poor-quality studies is an additional concern, since several of the studies with the greatest effect sizes reported drop-out rates exceeding 25%. Furthermore, bias for publication of small positive studies may not have been adequately addressed, since the “Fail-safe N” method used to assess publication bias is problematic. Another major limitation in interpretation of this meta-analysis is the absence of information about whether ENS results in a clinically meaningful improvement. For example, there was no discussion of the magnitude of the combined change in VAS scores or of the proportion of patients who achieved clinically meaningful improvements. Examination of the data indicates that there was less than a 15% difference between the ENS and placebo groups (with an average difference of 4%) for 13 of the 38 (34%) comparisons. The small effect observed in many of these small studies raises further questions about the contribution of publication bias to the meta-analysis. Also at issue is the relative contribution of percutaneous ENS (PENS), since meta-regression found PENS to be more effective than TENS. Given the substantial uncertainty regarding the appropriateness of the studies included and how the data were transformed, combined with questions regarding the clinical significance of the results, results from this meta-analysis are considered inconclusive.
Data regarding clinical significance were provided in a meta-analysis by Bjordal et al. on the short-term efficacy of physical interventions for osteoarthritic knee pain. (23) Included in the review were 11 studies (259 subjects on active therapy) using TENS, acupuncture-like TENS (AL-TENS), or interferential stimulation; 9 of the 11 studies were included in the meta-analysis reviewed above. Combined data revealed a 19 mm improvement in VAS over placebo (a “slight improvement”), with a confidence interval ranging from 10 mm (a “minimal perceptible improvement”) to 28 mm (above the 20 mm threshold of an “important improvement”). These results are similar to an earlier Cochrane review (overlap of 6 studies) on the use of TENS or AL-TENS for osteoarthritis of the knee. (7) The inclusion of 2 studies on interferential stimulation (with an unweighted average improvement in VAS of 34 mm over placebo) may also have increased the magnitude of the effect. Considering that the potential for publication bias is high when combining a number of small studies in a meta-analysis (particularly when the effect is small), evidence of short-term relief of chronic musculoskeletal pain remains weak. Results from these positive meta-analyses must also be balanced against other systematic reviews of musculoskeletal pain syndromes that found mixed and inconclusive results.
A recent randomized sham-controlled trial (163 patients with diverse pain states) reported that although no differences in VAS pain scores were observed, more patients were satisfied following 10 days (10-12 hours/day) of TENS (58%) than following use of a sham device (43%). (24) Analysis of the results by type of pain (osteoarthritis-related, neuropathic, or bone/soft tissue/visceral) in a subsequent report showed no difference in patient satisfaction for the group with osteoarthritis and related disorders (39% vs. 31%, n = 31, 26) or in patients with neuropathic pain (63% vs. 48%, n = 16, 25), and greater satisfaction with TENS in the group of patients with injury of bone and soft tissue or visceral pain (74% vs. 48%, n = 34, 31). (25) The nearly 50% patient satisfaction rating in the sham control group suggests a strong nonspecific effect with this treatment protocol.
Recent literature suggests that TENS may alleviate acute pain. For example, one double-blind randomized, sham-controlled trial found that during emergency transport of 101 patients, TENS reduced post-traumatic hip pain with a change in visual analog scale (VAS) from 89 to 59, whereas the sham-stimulated group remained relatively unchanged (86 to 79). (26) In another double-blind study, 40 patients undergoing inguinal herniorrhaphy were randomized to active or placebo TENS for post-surgical pain. (27) Pain scores measured prior to the first treatment were 5.2 on a 10 point scale for the active TENS group and 5.3 for the placebo TENS group. Two 30-minute sessions of TENS at 2 and 4 hours after surgery reduced both analgesic use and pain scores measured up to 24 hours after surgery (mean pain score of 0 vs. 3.4). Blinding appears to have been maintained, as 95% of subjects from both groups reported that they would use TENS again in the future to treat their pain. Confirmation of these results is needed.
A randomized, controlled trial from Taiwan assessed the efficacy of TENS applied at bilateral acupuncture points (Li4: midpoint between the first and second carpal bones, and Sp 6: 5 cm above the medial malleolus) in 100 women in the first stage of labor (5% dropout due to precipitous labor). (28) Additional medication was allowed, but was not reported. At the end of 30 minutes of treatment, the median VAS score improved in the active TENS group from 8 to 4.5 (10 mm scale), the VAS of the placebo group changed from 8 to 7. Pain relief of greater than 3 points was obtained in 62% of patients in the active group and 14% of patients in the sham group. The median duration of relief from pain following TENS acupuncture was 75 minutes.
Clinical Input Received through Physician Specialty Societies and Academic Medical Centers
In response to requests, input was received through 4 Physician Specialty Societies (5 reviewers) and 3 Academic Medical Centers (4 reviewers) while this policy was under review. While the various Physician Specialty Societies and Academic Medical Centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the Physician Specialty Societies or Academic Medical Centers, unless otherwise noted. Clinical input was generally in agreement that TENS is investigational for the management of acute pain and for other conditions such as dementia. Clinical input was for the most part in agreement that TENS is a generally accepted treatment modality and can be beneficial for the management of chronic pain in some patients. A trial period, similar to Medicare Coverage guidelines, was recommended by some.
Overall, evidence for the use of TENS from high quality trials remains inconclusive. However, clinical input indicates that the use of TENS for the relief of chronic intractable pain has been beneficial in some patients. Therefore, the policy statement has been revised; TENS may be considered medically necessary for the treatment of chronic pain if shown to be effective during a 30 day therapeutic trial.
Technology Assessments, Guidelines and Position Statements
The American Pain Society and American College of Physicians published guidelines on therapies for acute and low back pain in 2007. (29) No recommendations for TENS were made; the panel concluded that TENS had not been proven effective for chronic low back pain.
The European Federation of Neurological Societies published 2007 guidelines on neurostimulation for neuropathic pain. (30) The task force was not able to arrive at conclusive recommendations, with only about 200 patients with different diseases, in studies using different parameters and comparators, and with variable results. The task force concluded that standard high-frequency TENS is possibly (level C) better than placebo, and probably (level B) worse than acupuncture-like or any other kind of electrical stimulation.
The American Geriatrics Society’s 2002 guideline on the management of persistent pain in older persons indicated that TENS offers temporary relief and can be used as adjunctive therapy. (31) This recommendation was based on expert opinion and descriptive studies; clinicians “may or may not follow the recommendation.”
1997 Guidelines on chronic pain management from the American Society of Anesthesiologists recommend that an office or home trial of TENS should be considered as an early management option or as an adjunctive therapy because of its low complexity and low risk. (32)
The American Medical Directors Association created a guideline in 1999 on management of pain for elderly patients in the long-term care setting. Among complementary therapies, transcutaneous electrical nerve stimulation is one for which “Although no scientific evidence supports the effectiveness of these therapies in elderly patients in the long-term care setting, they may be beneficial to some individuals.”
The Department of Defense, Veterans Health Administration, published clinical guidelines for the management of postoperative pain in May 2002. These guidelines indicate that TENS may be useful for postoperative pain relief for a variety of procedures and sites. Except for postoperative abdominal pain and pain from cholecystectomy, all of the recommendations are consensus based. For postoperative abdominal pain and pain from cholecystectomy, the recommendations are based on at least 1 RCT and general agreement that TENS is acceptable.
Medicare National Coverage
The Centers for Medicare and Medicaid Services (CMS) currently have the following national coverage decisions on TENS: (33, 34, 35)
National Coverage Determination for Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES) (160.13) (33)
TENS and/or NMES can ordinarily be delivered to patients through the use of conventional electrodes, adhesive tapes and lead wires. There may be times, however, where it might be medically necessary for certain patients receiving TENS or NMES treatment to use, as an alternative to conventional electrodes, adhesive tapes and lead wires, a form-fitting conductive garment (i.e., a garment with conductive fibers which are separated from the patients' skin by layers of fabric).
Indications and Limitations of Coverage
A form-fitting conductive garment (and medically necessary related supplies) may be covered under the program only when:
- It has received permission or approval for marketing by the Food and Drug Administration;
- It has been prescribed by a physician for use in delivering covered TENS or NMES treatment; and
- One of the medical indications outlined below is met:
- The patient cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes and lead wires;
- The patient cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes and lead wires;
- The patient has a documented medical condition such as skin problems that preclude the application of conventional electrodes, adhesive tapes and lead wires;
- The patient requires electrical stimulation beneath a cast either to treat disuse atrophy, where the nerve supply to the muscle is intact, or to treat chronic intractable pain; or
- The patient has a medical need for rehabilitation strengthening (pursuant to a written plan of rehabilitation) following an injury where the nerve supply to the muscle is intact.
A conductive garment is not covered for use with a TENS device during the trial period specified in §160.3 unless:
- The patient has a documented skin problem prior to the start of the trial period; and
- The carrier's medical consultants are satisfied that use of such an item is medically necessary for the patient.
Also see NCDs on NMES in the Treatment of Disuse Atrophy (§150.4), Assessing Patients Suitability for TENS (§160.7), NMES (§160.12), and TENS (§280.13).
National Coverage Determination for Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy (160.7.1) (34)
Indications and Limitations of Coverage
Electrical nerve stimulation is an accepted modality for assessing a patient's suitability for ongoing treatment with a transcutaneous or an implanted nerve stimulator.
Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic usefulness of an electrical nerve stimulator:
A. Transcutaneous Electrical Nerve Stimulation (TENS)
This technique involves attachment of a transcutaneous nerve stimulator to the surface of the skin over the peripheral nerve to be stimulated. It is used by the patient on a trial basis and its effectiveness in modulating pain is monitored by the physician, or physical therapist. Generally, the physician or physical therapist is able to determine whether the patient is likely to derive a significant therapeutic benefit from continuous use of a transcutaneous stimulator within a trial period of 1 month; in a few cases this determination may take longer to make. Document the medical necessity for such services which are furnished beyond the first month. (See §160.13 for an explanation of coverage of medically necessary supplies for the effective use of TENS.)
If TENS significantly alleviates pain, it may be considered as primary treatment; if it produces no relief or greater discomfort than the original pain electrical nerve stimulation therapy is ruled out. However, where TENS produces incomplete relief, further evaluation with percutaneous electrical nerve stimulation may be considered to determine whether an implanted peripheral nerve stimulator would provide significant relief from pain.
Usually, the physician or physical therapist providing the services will furnish the equipment necessary for assessment. Where the physician or physical therapist advises the patient to rent the TENS from a supplier during the trial period rather than supplying it himself/herself, program payment may be made for rental of the TENS as well as for the services of the physician or physical therapist who is evaluating its use. However, the combined program payment which is made for the physician's or physical therapist's services and the rental of the stimulator from a supplier should not exceed the amount which would be payable for the total service, including the stimulator, furnished by the physician or physical therapist alone.
National Coverage Determination for Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain (10.2) (35)
Indications and Limitations of Coverage
The use of TENS for the relief of acute post-operative pain is covered under Medicare. TENS may be covered whether used as an adjunct to the use of drugs, or as an alternative to drugs, in the treatment of acute pain resulting from surgery.
TENS devices, whether durable or disposable, may be sued in furnishing this service. When used for the purpose of treating acute post-operative pain, TENS devices are considered supplies. As such they may be hospital supplies furnished inpatients covered under Part A, or supplies incident to a physician’s service when furnished in connection with surgery done on an outpatient basis, and covered under Part B.
It is expected that TENS, when used for acute post-operative pain, will be necessary for relatively short periods of time, usually 30 days or less. In cases when TENS is used for longer periods, contractors should attempt to ascertain whether TENS is no longer being used for acute pain but rather for chronic pain, in which case the TENS device may be covered as durable medical equipment as described in §280.13.