Medical Policy Biofeedback

Transcription

1 Medical Policy Biofeedback Subject: Biofeedback Background: Biofeedback is a behavioral process that enables an individual to learn how to change physiological activity for the purposes of improving health and performance. The methods are based upon the notion that an individual can learn to control involuntary and subconscious physiologic processes when information regarding these processes is fed back in the form of a visual or auditory signal. Biofeedback involves placing electrodes on the body to measure various functions such as heart rate, blood pressure, or brain waves. The principle behind biofeedback is that by watching these measurements on a monitor, or by being alerted by sound or other sensory modes, an individual can learn to change and/or control the body function. Policy and Coverage Criteria: Harvard Pilgrim Health Care (HPHC) considers biofeedback medically necessary for ANY of the following conditions: Migraine and tension headaches, OR Constipated individuals with dyssynergic defecation (adults only), OR Urinary incontinence, OR Muscle re-education of specific muscle groups, OR Treatment for pathological muscle abnormalities of spasticity, incapacitating muscle spasm or weakness when conventional treatments (i.e. massages, exercise, support) have not been successful Harvard Pilgrim Health Care (HPHC) considers biofeedback therapy as medically necessary for up to 2-3 visits per week for no longer than 6-8 weeks for single or combination medical conditions. Treatment plans with no benefit after 4 weeks of therapy may be re-evaluated. Medical records must also document the individual s ongoing treatment plan for ALL the following when biofeedback therapy is performed: Diagnosis Frequency of treatment Individual instruction (i.e. practice, follow-through) Exclusions: Harvard Pilgrim Health Care (HPHC) considers biofeedback as experimental/investigational for all other indications. In addition, HPHC does not cover: Electroencephalogram (EEG) Biofeedback Ordinary muscle tension Temporomandibular joint disorder (TMJ) Supporting Information: A 2008 Hayes Inc. report states there is sufficient evidence from randomized controlled or comparative trials to conclude that biofeedback can reduce headache in select pediatric patients, however, the magnitude of headache Biofeedback Page 1 of 6

2 activity is difficult to evaluate and definitive patient selection criteria and training protocol have not been established. The use of biofeedback in adults has less evidence regarding the efficacy, although some studies have been positive. Odawara et al (2015) conducted a pilot study to investigate the feasibility of using computerized ecological momentary assessment (EMA) for evaluating the efficacy of biofeedback treatment for migraine. Twenty-seven patients with migraine were randomly assigned to either biofeedback or wait-list control groups. Patients recorded momentary symptoms on a palm-type computer for 4 weeks before and after biofeedback treatment. Biofeedback reduced the duration of headaches by 1.9 days and the frequency of days when intensity was >50 by 2.4 times. Headache-related disability, psychological stress, depression, anxiety, and irritation were significantly improved. The authors concluded that computerized EMA showed that biofeedback improved symptoms of migraine, including psychological stress and headache-related disability. Fernandez-Cuadros et al (2015) conducted a prospective, quasi-experimental before-and-after study to assess the effectiveness and the effect on the quality of life of a pelvic floor muscle training protocol with electromyographybiofeedback (EMG-BFB) with surface electrodes in 61 men. The patients received 20 sessions of EMG-BFB twice a week. Patients were given standards of conduct and questionnaires at the beginning and end of treatment. A significant improvement in both International Consultation on Incontinence-Short Form and Incontinence Qualityof-Life Measure questionnaires was observed when making comparisons regarding the results before and after the EMG-BFB treatment. Powers et al (2013) analyzed the effect of psychological intervention (including biofeedback) combined with pharmacological intervention (amitriptyline) to treat chronic migraines in 135 youth ages Effects were measured at baseline, 20 weeks post treatment, and 3, 6, 9, and 12-month follow-up. The co-primary endpoints were headache frequency and migraine-related disability. Results showed a > 50% headache reduction in 66% at post-treatment, 86% at 12-month follow-up; proportion no longer chronic migraine was 71% at post-treatment, 88% at 12-month follow-up; PedMIDAS score < 20 (mild to no disability) was 75% at post-treatment, 88% at 12- month follow-up. At 12-month follow-up, almost 9 out of 10 subjects no longer had chronic migraines. Pistoia et al (2013) published a review of behavioral therapies to treat chronic migraine. The authors conclude in their review that further evidence is needed to definitively establish the effectiveness of behavioral therapies, including biofeedback, in avoiding the transformation from episodic to chronic migraine. Data suggests that the best improvement is achieved when behavioral therapies are integrated with other treatments, including physical and pharmacological interventions. Lee et al (2015) evaluated the results for 347 constipated patients with dyssynergic defecation who underwent biofeedback therapy for a median of 5 sessions. The initial response rate to biofeedback therapy was 72.3%. The long-term efficacy was assessed in 103 patients who were followed for more than 6 months and the initial effects of biofeedback therapy were maintained in 82.5% of the patients. The authors concluded that the efficacy of biofeedback therapy is maintained for more than 2 years after therapy in a considerable proportion of constipated patients with dyssynergic defecation. Jodorkovsky et al (2013) conducted a retrospective review to determine what percentage of patients referred for biotherapy actually complete therapy and identify barriers to treatment. The authors also aimed to determine the clinical response rate in a heterogenous population of patients undergoing biofeedback. Out of 80 patients who had a recommendation for biofeedback, 39 of the patients underwent biofeedback. Of the patients who Biofeedback Page 2 of 6

3 underwent at least 5 biofeedback sessions, subjective short-term response rates based on patient opinion were 60%. Koh et al (2012) sought to determine the efficacy of biofeedback in 226 patients with dyssynergic defecation. Patients underwent a four-session, structured biofeedback program. The effectiveness of biofeedback was assessed using Eypasch s Gastrointestinal Quality of Life Index (GIQLI). The overall GIQLI score and all other components, except for social function and medication, showed significant improvement post treatment. AT 1 year follow-up, 71% of patients reported that improvements were maintained. The authors concluded that biofeedback is an effective treatment for patients with dyssynergic defecation. Hederschee et al (2011) conducted a review to determine whether feedback or biofeedback adds further benefit to pelvic floor muscle training for women with urinary incontinence. A total of 24 trials involving 1583 women were included in the review. The review showed that women who received biofeedback were significantly more likely to report that their urinary incontinence was cured or improved compared to those who received pelvic floor muscle training alone. The authors concluded that while biofeedback may provide benefit in addition to pelvic floor muscle training, further research is needed. Lee et al (2010) investigated the long-term efficacy of biofeedback therapy in 25 patients with constipation. Patients received 6.2 sessions of biofeedback therapy. A major improvement was seen in 12% of patients, fair in 24%, minor in 44%, and no improvement in 20%. 88.9% of patients who showed major or fair improvement maintained the symptom improvement through the long-term follow-up periods. The authors concluded that symptom improvements after biofeedback therapy were disappointing, however, when symptom improvements were classified as major or fair, the improvements continued for at least a year. Rao et al (2010) compared the 1-year outcome of biofeedback with standard therapy in 26 patients who completed 3 months of either therapy. Assessment was made using stool diaries, VAS, colonic transit, anorectal manometry, and balloon expulsion time at baseline and at 1 year after each treatment. Patients were seen at 3- month intervals. All biofeedback patients and 7 standard therapy patients completed one year. The number of complete spontaneous bowel movements per week increased significantly in the biofeedback group but not in the standard group. There was also a significant improvement in balloon expulsion time, normalization of dyssynergia pattern, increase in defecation index, and normalization in colonic transit time only in the biofeedback group. The authors concluded that biofeedback therapy provides sustained improvement of bowel symptoms and anorectal function in constipated patients with dyssynergic defecation. Rao et al (2007) investigated the efficacy of biofeedback with either sham feedback therapy or standard therapy in 77 subjects with chronic constipation and dyssynergic defecation. Subjects in the biofeedback group were more likely to correct dyssynergia, improve defecation index, and decrease balloon expulsion time than other groups. Colonic transit did not improve after sham, but did improve after biofeedback and standard treatment. The number of spontaneous bowel movements increased in the biofeedback group and was higher than other groups. The authors concluded that biofeedback improves constipation and physiological characteristics of bowel function in patients with dyssynergia. Aukee et al (2004) compared the effectiveness of pelvic floor training with the aid of a home biofeedback device to pelvic floor training alone for urodynamic stress urinary incontinence in 35 women after 1-year follow-up. The intensive training program lasted 12 weeks with a follow-up at 1-year. In the home biofeedback training group 68.8% avoided surgery vs. 52.6% in the pelvic floor training alone group, which was not a significant difference. Biofeedback Page 3 of 6

4 In the home biofeedback group the increase in pelvic floor muscle activity and decrease in leakage index were significantly improved after 12 weeks and pelvic floor activity remained constant. Burgio et al (2002) conducted a prospective, randomized controlled trial to examine the role of biofeedback in a multicomponent behavioral training program for urge incontinence in 222 community-dwelling older women. Patients were randomly assigned to receive 8 weeks (4 visits) of biofeedback-assisted behavioral training, 8 weeks (4 visits) of behavioral training without biofeedback, or 8 weeks of self-administered behavioral treatment using a self-help booklet. The reduction in the number of incontinence episodes was documented in bladder diaries, patients perceptions and satisfaction, and changes in quality of life. The biofeedback group yielded a mean 63.1% reduction in incontinence, verbal feedback a mean 69.4% reduction, and the self-help booklet a mean 8.6% reduction. The differences between groups were not significantly different. Patient satisfaction was reported as complete satisfaction in 75% of the biofeedback group, 85.5% of the verbal feedback group, and 55.7% in the self-help booklet group. The differences between groups were significantly different. All 3 groups showed a significant improvement on 3 quality of life instruments. The authors concluded that all 3 groups achieved comparable improvements in urge incontinence. Guidelines: The American Academy of Neurology (AAN) guidelines for migraine headache state that thermal biofeedback combined with relaxation training and EMG biofeedback may be considered as treatment options for prevention of migraine. Specific recommendations regarding which of these to use for specific patients cannot be made. Biofeedback may be combined with preventive drug therapy for patients to achieve additional clinical improvement for migraine relief. The 2015 position and consensus guidelines from the American Neurogastroenterology and Motility Society (ANMS) and the European Society of Neurogastroenterology and Motility (ESNM) state that biofeedback therapy does not benefit constipated patients without dyssynergic defecation. The American Gastroenterologic Association 2013 guidelines state biofeedback therapy improves symptoms in more than 70% of patients with defecatory disorders. The motivation of the patient and therapist, the frequency and intensity of the retraining program, and the involvement of behavioral psychologists and dietitians as necessary all likely contribute to the chances of success. The schedule of therapy can be tailored to patients' symptoms and varies among centers. The 2011 guidelines from the Association for Applied Psychophysiology and Biofeedback (AAPB) states biofeedback is a process that enables an individual to learn how to change physiological activity for the purposes of improving health and performance. Precise instruments measure physiological activity such as brainwaves, heart function, breathing, muscle activity, and skin temperature. These instruments rapidly and accurately "feedback" information to the user. The presentation of this information often in conjunction with changes in thinking, emotions, and behavior supports desired physiological changes. Over time, these changes can endure without continued use of an instrument. Coding: Codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive. Deleted codes and codes which are not effective at the time the service is rendered may not be eligible. Biofeedback Page 4 of 6

5 CPT Code Description Biofeedback training by any modality [when done for medically necessary indications] Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry List of medically necessary ICD-10 codes for Billing Guidelines: Member s medical records must document that services are medically necessary for the care provided. Harvard Pilgrim Health Care maintains the right to audit the services provided to our members, regardless of the participation status of the provider. All documentation must be available to HPHC upon request. Failure to produce the requested information may result in denial or retraction of payment. References: 1. Aukee, P., Immonen, P., Laaksonen, DE., Laippala, P., Penttinen, J., Airaksinen, O. The effect of home biofeedback training on stress incontinence. Acta Obstet Gynecol Scand. 2004; 83(10): Bharucha, A.E., Pemberton, J.H., and Locke, G.R. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013; 144: Biofeedback. U.S. National Library of Medicine. Bethesda, MD. NIH. Accessed August 14, Burgio, KL., Goode, PS., Locher, JL., Umlauf, MG., Roth, DL., Richter, HE., Varner, RE., Lloyd, LK. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002; 288(18): Campbell, KJ., Penzien, DB., Wall, EM. Evidence-based guidelines for migraine headache: behavioral and physical treatments. American Academy of Neurology. Accessed August 17, Ding, M., Lin, Z., Lin, L., Zhang, H., Wang, M. The effect of biofeedback training on patients with functional constipation. Gastroenterol Nurs. 2012; 35(2): Effective Health Care Program. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Agency for Healthcare Research Quality Available at: Accessed August 19, Fernandez-Cuadros, ME., Nieto-Blasco, J., Geanini-Yaquez, A., Ciprian-Nieto, D., Padilla-Fernandez, B., Lorenzo-Gomez, MF. Male urinary incontinence: associated risk factors and electromyography biofeedback results in quality of life. Am J Mens Health. 2015; June Hayes, Inc. Medical Technology Directory. Biofeedback for headache and chronic musculoskeletal pain. Lansdale, PA. Hayes, Inc. December 7, Herderschee, R., Hay-Smith, EJ., Herbison, GP., Roovers, JP., Heineman, MJ. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev Jodorkovsky, D., Dunbar, KB., Gearhart, SL., Stein, EM., Clarke, JO. Biofeedback therapy for defacatory dysfunction: real life experience. J Clin Gastroenterol. 2013; 47(3): Koh, D., Lim, JF., Quah, HM., Tang, CL. Biofeedback is an effective treatment for patients with dyssynergic defaecation. Singapore Med J. 2012; 53(6): Lacroix, JM., Clarke, MA., Bock, JC., Doxey, N., Woood, A., Lavis, S. Biofeedback and relaxation in the treatment of migraine headaches: comparative effectiveness and physiological correlates. J Neurol Neurosurg Psychiatry. 1983; 46(6): Biofeedback Page 5 of 6

6 14. Lee, BH., Kim, N., Kang, SB., Kim, SY., Lee, KH., Im, BY., Jee, JH., Oh, JC., Park, YS., Lee, DH. The longterm clinical efficacy of biofeedback therapy for patients with constipation or fecal incontinence. J Neurogastroenterol Motil. 2010; 16(2): Lee, HJ., Boo, SJ., Jung, KW., Han, S., Seo, SY., Koo, HS., Yoon, IJ., Park, SH., Yang, DH., Kim, KJ., Ye, BD., Byeon, JS., Yang, SK., Kim, JH., Myung, SJ. Long-term efficacy of biofeedback therapy in patients with dyssynergic defecation: results of a median 44 months follow-up. Neurogastroenterol Motil. 2015; 27(6): Odawara, M., Hashizume, M., Yoshiuchi, K., Tsuboi, K. Real-time assessment of the effect of biofeedback therapy with migraine: a pilot study. Int J Behav Med. 2015; Feb Pistoia, F., Sacco, S., Carolei, A. Behavioral therapy for chronic migraine. Curr Pain Headache Rep. 2013; 17: Powers, SW., Kashikar, ZS., Allen, J., LeCates, S., Rausch, J., Hershey, AD. Cognitive behavioral treatment plus amitriptyline leads to clinically significant reductions in headache frequency and migraine-related disability: A randomized clinical trial in pediatric chronic migraine. Cephalaigia. 2013; 33(1): Rao S, Benninga M, Bharucha A, Chiarioni G, Di Lorenzo C, Whitehead W. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterology & Motility. 2015;27(5): doi: /nmo Rao, SS., Seaton, K., Miller, M., Brown, K., Nygaard, I., Stumbo, P., Zimmerman, B., Schulze, K. Randomized controlled trial of feedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007; 5(3): Sargent, J., Solbach., Coyne, L., Spohn, H., Segerson, J. Results of a controlled, experimental, outcome study of nondrug treatments for the control of migraine headaches. J Behav Med. 1986; 9(3): Wald, A. Poor quality evidence to support the use of biofeedback for the treatment of functional constipation in adults. Evid Based Nurs. 2015; 18(2): Woodward, S., Norton, C., Chiarelli, P. Biofeedback for the treatment of chronic idiopathic constipation in adults. Cochrane Database Systematic Rev. 2014; 26(3):CD Summary of Changes: Date Change 1/18 Policy coverage criteria refined; guidelines and references updated Approved by Medical Policy Review Committee: 1/16/18 Reviewed/Revised: 7/16; 1/18 Initiated: 7/16 Biofeedback Page 6 of 6