GUIDELINE NOTE 56, NON-INTERVENTIONAL TREATMENTS …



Transcutaneous Electrical Neurostimulators (TENS)On September 28, 2017, VbBS and HERC reviewed the meeting materials excerpted below. The staff recommendation to prioritize TENS and other similar technologies on line 660 was accepted.Question: Should transcutaneous electrical nerve stimulation [TENS], Scrambler therapy, and all similar transcutaneous neurostimulators be added to the new treatments with no clinically important benefit line?Question source: HSD staff, HERC staff, Jay Richards, DOIssue: During the initial creation of the Prioritized List in 1999, TENS was considered for the above the line spinal conditions lines and neurologic dysfunction lines but not added. TENS was last reviewed in February, 2010 and found to have no evidence of effectiveness.From the HOSC February, 2010 minutesTENSSmits introduced a summary document reviewing the evidence for the effectiveness for TENS treatment for chronic and acute pain conditions. The HOSC found lack of evidence of effectiveness. Saha reported on a review of back pain treatments by Chou et al in the 2007 Annals of Internal Medicine, which found no benefit for TENS for acute or chronic back pain. The HOSC members agreed that this service should not be covered due to lack of effectiveness.Smits reported that there were additional CPT/HCPCS codes which were not included in the handout that needed to be added to the Never Covered List if TENS is not to be covered.Recommendations: 1) Delete 64550 (Application of surface (transcutaneous) neurostimulator) from Lines 517,546 and 616. Recommend adding 64550 (Application of surface (transcutaneous) neurostimulator) to Never Covered List.2) Delete 97032 from all 57 lines on Prioritized List. Recommend adding 97032 to Never Covered List3) Recommend adding HCPCS codes A4556-A4558, A4595, A4630, E0720, E0730, E0731 to Never Covered ListCurrently, all cutaneous neurostimulator CPT and HCPCS codes are on the Services Recommended for Non-Coverage table.64550 Application of surface (transcutaneous) neurostimulator97014 Application of a modality to 1 or more areas; electrical stimulation (unattended)97032 Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutesE0720 Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulationE0730 Transcutaneous electrical nerve stimulation (tens) device, four or more leads, for multiple nerve stimulationG0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of careGUIDELINE NOTE 56, NON-INTERVENTIONAL TREATMENTS FOR CONDITIONS OF THE BACK AND SPINE includes the following sentence:Transcutaneous electrical nerve stimulation (TENS; CPT 64550, 97014 and 97032) is not included on the Prioritized List for any condition due to lack of evidence of effectiveness.Federal rule no longer allows absolute exclusion for DME. Therefore the GN56 sentence is in conflict with federal rule. In May, 2017, a similar technology, Alpha Stim, was reviewed and found to have no evidence of effectiveness. The following entry was added to GN 172:GUIDELINE NOTE 172, TREATMENTS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONSThe following treatments are prioritized on Line 660, CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS, for the conditions listed here:CONDITIONCPT/HCPCS CodeTREATMENTRationalChronic pain, anxiety, depression, insomnia, all other indicationsCPT 64550, 97014, 97032 HCPCS E0720, E0730 Cranial electrical stimulationNo clinically important benefit for chronic pain; insufficient evidence of effectiveness for all other indicationsScrambler TherapyRecently, the HERC has been contacted about Scrambler therapy, which is a similar electrical stimulation device used to treat chronic pain. It is coded with CPT 0278T (Transcutaneous electrical modulation pain reprocessing (e.g, scrambler therapy), each treatment session (includes placement of electrodes)). Scrambler therapy is a noninvasive pain modifying technique that utilizes transcutaneous electrical stimulation of pain fibers with the intent of re-organizing maladaptive signaling pathways. It is used to treat various types of chronic pain. From Jay Richards, DO:Currently Radiant Pain center in Portland and myself are the only providers in Oregon using this treatment. As a primary care provider in a rural area it has been a huge struggle to provide pain relief options for many of our OHP patients. The population that has been the hardest to treat are those suffering for neuropathic pain. A disproportionately large number of these patients are on chronic narcotics, despite evidence to show this class of medication isn’t indicated. Many also do not get improvement from commonly used medication like gabapentin, the expensive Lyrica and other treatments like physical therapy, chiropractic’s and acupuncture. Promoting exercise in this population is also challenging because the pain is aggravated with movement, which leads to increased sedentary lifestyle.In 2015, I came across a noninvasive, low risk treatment called Scrambler Therapy. It uses electrical impulses delivered through electrodes attached to different dermatomes in areas of normal skin, surrounding the area of neuropathy. The theory is this specialized signal scrambles the burning nerve pain signal delivered by the c-delta pain fibers, which is the hallmark of neuropathy. Over a series of 10 consecutive treatments the burning pain progressively reduces in intensity. After the patient has been without pain for 48 hours the pain is considered to be “in remission”. I met with the device vendor and set up a small demo on a couple of my patients. All of them felt the device helped their pain the first day, but what sold me was one patient with severe diabetic neuropathy returned the following morning asking if he could continue the treatment. Seeing his benefit I decided to proceed with the purchase of the device and start an after-hours pain treatment clinic for community patients with neuropathy. Over the course of 2016 I have seen 26 patients. Of these, 12 were eligible for treatment due to having an appropriate condition and ability to pay a sliding fee, which ranged from pro-bono to $150 per treatment session. All patients had a comprehensive review of their pain and medications. Only those with symptoms of neuropathy and an elevated DN4 score, where able to proceed with treatment. The average pain score for the 12 patients prior to the first treatment was 7/10. Of the 12 treated, 5 did not have sustained pain improvement beyond the full 10 treatment course, despite the average pain level during treatment being reduced to 2/10. Interestingly, and what I find to be the most rewarding, is 7 of the 12 patients who completed the full course of treatment achieved pain scores ranging from 0-2/10, which where sustained from 3 months to over a year after treatment. Several patients were also able to reduce or eliminate their medications. Four patients stopped their narcotic and the fifth one is working to reduce her dependence on oxycodone. Also 2 prescriptions for Lyrica were stopped. All 7 with improved pain have increased their activity level and one is actively seeking a job after 8 years of unemployment due to his diabetic neuropathy.Participating in this treatment and experiencing these patient’s improvement has been very rewarding. My experience treating patients with Scrambler Therapy is this can be a viable option for patients with neuropathy, particularly diabetic and chemotherapy induced neuropathy. It is noninvasive and a very low risk procedure. It does not treat all pain and patients should be screened well before starting treatment. The treatment is also very provider dependent so success depends both on treating the correct type of pain and placing the electrodes in the correct locations. I recognize higher power studies are needed to show better evidence-based practice. Hopefully, over the next couple years we will see randomized trials published from Mayo Clinic and Johns Hopkins, who are currently studying Scrambler Therapy.EvidenceMajithea 2016, systematic review of Scrambler therapyNote: no studies identified which were not included in this systematic reviewN=20 studies2 RCTs (N=14 patients in abstract only paper, N=30 patients in published trial), 1 open label RCT (N=52 patients), 11 prospective cohort studies (N=477 patients, 10 in abstract only paper), 5 “clinical practice experience” articles (N=417 patients), 1 retrospective cohort study (N=201 patients)Studies of “varying clinical quality”Studies generally small and short-term, and most lacked a comparator group and were not randomized.Results:RCTs: one study found no difference between treatment and placebo arms (Campbell 2013, N=14, abstract only), the other found significant improvement in reported pain in active treatment group compared to placebo treated group (Starkweather 2015, N=30)The Starkweather study was small and short term and the authors concluded that further research was neededOther articles found significant reduction in pain scoresConclusions: The positive findings from preliminary studies with Scrambler Therapy support that this device provides benefit for patients with refractory pain syndromes. Larger, randomized studies are required to further evaluate the efficacy of this approach.Other policies:Most major insurers do not cover Scrambler therapyClinical practice guidelines: none found recommending Scrambler therapyHERC staff summary:The evidence base regarding the benefits of transcutaneous electrical modulation pain reprocessing (i.e., scrambler therapy) as a treatment for pain from any etiology is extremely limited. Early, pilot studies with small numbers of patients treated for short periods of time are promising, but larger, well conducted, randomized trials are needed. There are no clinical practice guidelines that recommend scrambler therapy and major insurers are not covering this therapy. Based on the limited literature, scrambler therapy appears to be investigational.HERC staff recommendations:Add CPT 64550, 97014 and 97032 and HCPCS E0720, E0730, and G0283 (Transcutaneous electrical nerve stimulation [TENS]; electrical stimulation) to line 660 CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITSAdd CPT 0278T (Transcutaneous electrical modulation pain reprocessing (e.g, scrambler therapy), each treatment session (includes placement of electrodes)) to line 660Delete the following sentence from GUIDELINE NOTE 56, NON-INTERVENTIONAL TREATMENTS FOR CONDITIONS OF THE BACK AND SPINE Transcutaneous electrical nerve stimulation (TENS; CPT 64550, 97014 and 97032) is not included on the Prioritized List for any condition due to lack of evidence of effectiveness.Modify the entry to GN173 adopted in May, 2017 as shown belowGUIDELINE NOTE 173, TREATMENTS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; unproven treatmentsThe following treatments are prioritized on Line 660, CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS, for the conditions listed here:CONDITIONCPT/HCPCS CodeTREATMENTRationalDate of last ReviewAll conditions Chronic pain, anxiety, depression, insomnia, all other indications64550, 97014, 97032, 0278TE0720, E0730, and G0283Transcutaneous electrical nerve stimulation [TENS]; Scrambler therapy; Cranial electrical stimulation; all similar transcutaneous electrical neurostimulation therapies No clinically important benefit (CES) or insufficient evidence of effectiveness (all other) for chronic pain; insufficient evidence of effectiveness for all other indicationsSeptember, 2017 ................
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