Subject: Document #: Current Effective Date: 04/16/2008 Status: Reviewed (Coding updated 10/01/2008) Last Review Date: 02/21/2008 Description/Scope Biofeedback is a non-invasive form of therapy that trains individuals to alter brain activity, blood pressure, muscle tension, heart rate, and other bodily functions that are not controlled voluntarily. This document addresses biofeedback and home biofeedback devices. Note: Biofeedback therapy related to the treatment of other conditions is addressed separately in: MED.00061 Biofeedback for Fecal Incontinence MED.00062 Biofeedback for Muscle Re-education and Chronic Pain SURG.00010 Treatment of Urinary Incontinence, Urinary Retention, and Sacral Nerve Stimulation CG-SURG-09 Temporomandibular Joint Dysfunction (TMD), Temporomandibular Joint Syndrome (TMJ), Craniomandibular Disorder (CMD) Position Statement Medically Necessary: Biofeedback therapy, thermal biofeedback or biofeedback-assisted relaxation therapy (BFRT) are considered medically necessary as part of a medical care plan in the treatment of adult and pediatric migraines or tension headaches when performed in an outpatient setting under the medical supervision of a qualified clinician, such as an adult or pediatric psychiatrist or psychologist. Investigational and Not Medically Necessary: Biofeedback therapy, thermal biofeedback or biofeedback-assisted relaxation therapy (BFRT) are considered investigational and not medically necessary for all other conditions. Electroencephalogram (EEG) biofeedback, also known as neurofeedback, is considered investigational and not medically necessary for all conditions. The use of home biofeedback devices is considered investigational and not medically necessary for all conditions. Rationale Biofeedback therapy, with or without relaxation techniques, has been studied in children, adolescents and adults experiencing migraine and tension-type headaches. Medical and behavioral therapies are used in the treatment of these types of headaches with varying degrees of success. Psychosocial factors, such as major life events and Page 1 of 6
frequent frustrations, presumably intensifying anxiety and depression, have been associated with chronic headaches. The compendium of evidence for behavioral interventions such as biofeedback-assisted relaxation (BFRT) supports its efficacy in migraine and tension-type headaches. In migraine headaches, thermal biofeedback and passive relaxation are as much as 50% more effective than self-relaxation without instructions or biofeedback alone. BFRT evidence demonstrates a decrease in the headache pain and use of less migraine medication than in the self-relaxation groups. The evidence to support the efficacy of biofeedback therapy for migraine and tension-type headaches has been established through randomized controlled trials and is published in evidenced-based practice guidelines. At this time there is insufficient evidence in the available peer-reviewed medical literature to conclude that biofeedback therapies or EEG biofeedback are effective treatments for other conditions including, but not limited to, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), learning disabilities, seizure disorders, substance abuse-related disorders, menopausal hot flashes, vestibulodynia, pain associated with endometriosis, constipation, anxiety disorders, hypertension, insomnia, movement disorders, asthma, or Raynaud s disease. Background/Overview Description of Relevant Conditions Headaches are the most common pain-related complaint and the seventh leading condition seen in medical practice, accounting for as many as 18 million physician visits a year. The most prevalent type of vascular headache is migraine. Approximately one in eight adults in developed countries have migraine headaches. Women are affected two to three times more than men, predominantly affecting young adults between the age of 25 and 34. Migraines are different from other headaches because they occur with symptoms such as nausea, vomiting, or sensitivity to light. There are three classifications of migraine headaches: common migraine with no warning symptoms or aura; classic migraine with an aura consisting of visual disturbances before the headache starts; and mixed tension migraine with features of both migraines and a tension headache. Migraine, tension-type, and their variants are the headache types most likely to be seen at headache specialty clinics. Well over one-third of the population is affected by tension-type headaches each year. Between 2% and 3% of the population suffer from chronic tensiontype headaches. Pharmacological therapies are the most common and widely used method for treating frequent migraine headaches. There are highly effective medications available for treating migraine and tension-type headaches, however, pharmacologic treatments may prove ineffective, inadequate, or inappropriate for some individuals. Description of Technology Biofeedback is a training program where an individual is given information about physiological processes not usually available with the goal of gaining conscious control of or influence over those processes. Examples of such physiologic processes are heart rate, blood pressure and muscle tension. The theory of biofeedback is if one or more of these processes are related to a disorder such as pain, then by controlling the physiologic process, an individual also controls the disorder. Since individuals are typically not conscious of these physiologic processes, it is necessary to use electrodes or other measurement devices to record physiologic signals, amplify, and convert them to a different, easy to perceive signal. For example, electrodes can be placed over tight muscles with the electrical signals of muscle tension converted to sounds that are fed into earphones. A louder sound or higher pitch in the earphones is associated with greater tension in the muscles under the electrodes. If an individual is successful in Page 2 of 6
learning to control the volume or pitch of the sound in the earphones, then they will be able to control tension in the muscles. Examples of home biofeedback devices include, but are not limited to the BrainMaster TM (BrainMaster Technologies, Inc., Oakwood Village, Ohio) or ProComp-2 TM (Allied Products/Biofeedback Instrument Corporation, New York, NY). Definitions Migraine headache: a type of headache experienced by some individuals repeatedly over time Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. When services are Medically Necessary: CPT 90901 Biofeedback training by any modality Revenue Code 2105 Biofeedback ICD-9 Diagnosis 307.81 Tension headache 339.10-339.12 Tension type headache 346.00-346.93 Migraine When services are Investigational and Not Medically Necessary: For the procedure codes listed above, for all other diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary. When services are also Investigational and Not Medically Necessary: CPT 90911 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry No specific code for EEG biofeedback (neurofeedback) HCPCS E0746 Electromyography (EMG), biofeedback device No specific code for EEG biofeedback (neurofeedback) device Page 3 of 6
ICD-9 Diagnosis All diagnoses References Peer Reviewed Publications: 1. Bergeron S, Binik YM, Khalife S, et al. A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001; 91(3): 297-306. 2. Drechsler R, Straub M, Doehnert M, et al. Controlled evaluation of a neurofeedback training of slow cortical potentials in children with attention deficit/hyperactivity disorder (ADHD). Behav Brain Funct. 2007 Jul 26;3:35. 3. Egner, T, Gruzelier, J.H. EEG biofeedback of low beta band components: frequency-specific effects on variables of attention and event-related brain potentials. Clinical Neurophysiology. 2004; 115:131-139. 4. Gardea M, Gatchel R, Mishra K. Long-term efficacy of biobehavioral treatment of temporomandibular disorders. 2001; 24(4);341-359. 5. Grego D. Management of adolescent chronic pelvic pain for endometriosis: a pain center perspective. Journal Pediatric Adolescent Gynecology. 2003; 16:217-219. 6. Harden RN. New developments in rehabilitation of neuropathic pain syndromes. Neurologic Clinics. 1998; 16(4):937-950. 7. Lake EA. Behavioral and nonpharmacological treatments of headache. Headache. 2001; 85(4):1055-1075. 8. Penzien DB, Rains JC, Andrasik F. Behavioral management of recurrent headache: three decades of experience and empiricism. Appl Psychophysiol Biofeedback. 2002; 27(2):163-181. 9. McGrady AV, Andrasik F, Davies T, et al. Psychophysiologic therapy for chronic headache in primary care. Prim Care Companion J Clin Psychiatry. 1999; 1(4): 96-102. 10. Mestoruis Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007 Mar; 128(1-2):111-127. 11. Meuret A, Wilhelm F, Roth W. Respiratory feedback for treating panic disorder. J Clinical Psychol. In session. 2004; 60 (2):197-207. 12. Middaugh S, Pawlick K. Biofeedback and behavioral treatment of persistent pain in older adult: A review and a study. Applied Psychophysiology Biofeedback. 2002. 27(3):185-201. 13. Neblett R, Mayer TG, Gatchel RJ. Theory and rationale for surface EMG-assisted stretching as an adjunct to chronic musculoskeletal pain rehabilitation. Appl Psychophysiol Biofeedback. 2003; 28(2):139-146. 14. : Proctor ML, Murphy PA, Pattison HM, et al. Behavioural interventions for primary and secondary dysmenorrhoea. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD002248. 15. Saper Jr. Headache disorders. Med Clin North Am. 1999; 83(3):663-690. 16. Scharff L, Marcus DA, Masek BJ. A controlled study of minimal-contact thermal biofeedback treatment in children with migraine. J Pediatr Psychol. 2002; 27(2):109-119. 17. Scott Morey, Sharon. Practice guidelines of the American Academy of Family Physicians. Guidelines on migraine: part 4. General principles of preventive therapy. American Family Physician. November 2000; 62(10). Available at: http://www.aafp.org/afp/20001115/practice.html. Accessed on November 17, 2007. 18. Sierpina V, Astin J, Giordano J. Mind-body therapies for headache. Am Fam Physician. 2007 Nov 15; 76(10):1518-1522. Available at: http://www.aafp.org/afp/20071115/1518.html. Accessed on December 17, 2007. Page 4 of 6
19. Silver N. Headache (chronic tension-type). Am Fam Physician. 2007 Jul 1; 76(1):114-116. Available at: http://www.aafp.org/afp/20070701/bmj.html. Accessed on December 17, 2007. 20. Trautmann E, Lackschewitz H, Kröner-Herwig B. Psychological treatment of recurrent headache in children and adolescents-a meta-analysis. Cephalalgia 2006; 26:1411-1426. 21. Vasudeva S, Claggett AL, Tietjen GE, McGrady AV. Biofeedback-assisted relaxation in migraine headache: relationship to cerebral blood flow velocity in the middle cerebral artery. Headache. 2003; 43(3):245-250. Government Agency, Medical Society, and Other Authoritative Publications: 1. Campbell JK, Penzien DB, Wall EM. Evidenced-based guidelines for migraine headache: Behavioral and physical treatments. U.S. Headache Consortium 2000. Available at: http://www.aan.com/professionals/practice/pdfs/gl0089.pdf. Accessed on November 17, 2007. 2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Biofeedback. NCD #30.1 Effective date not posted. Available at: http://www.cms.hhs.gov. Accessed on November 17, 2007 3. Hayes Inc. Hayes Medical Technology Directory. Biofeedback as an Adjunct to Physical Therapy for Recovery after Stroke. Lansdale, PA: Hayes, Inc.; July 5, 2007. 4. Hayes Inc. Hayes Medical Technology Directory. Biofeedback for Headache and Chronic Musculoskeletal Pain. Lansdale, PA: Hayes, Inc.; November 3, 2004. Updated December 10, 2006. 5. Hayes Inc. Hayes Medical Technology Directory. Biofeedback for the Treatment of Hypertension. Lansdale, PA: Hayes, Inc.; February 24, 2007.. 6. Hayes Inc. Hayes Medical Technology Directory. for Vulvodynia and Vulvar Vestibulitis. Lansdale, PA: Hayes, Inc.; January 9, 2003. Updated February 28, 2007. 7. Hayes Inc. Hayes Medical Technology Directory. Electroencephalogram. Lansdale, PA: Hayes, Inc.; April, 11, 2003. Updated March 8, 2007. 8. National Institute of Child Health and Human Development (NICHD); Children s Hospital, Boston, MA. Migraine and recurrent abdominal pain in children. NLM Identifier: NCT00060619. Last updated on June 23, 2005. Available at http://www.clinicaltrials.gov/ct/show/nct00060619?order=1. Accessed on November 17, 2007. 9. Silberstein, SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000 55: 754-762. Available at: http://www.neurology.org/cgi/reprint/55/6/754.pdf. Accessed on December 17, 2007. 10. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Information on releasable 510(k) Biofeedback Devices. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm. Accessed on November 17, 2007. Index Biofeedback-assisted Relaxation Therapy (BFRT) BrainMaster TM EEG Biofeedback Neurofeedback ProComp-2 Temporomandibular Joint Disorder Thermal Biofeedback TMD Page 5 of 6
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. Document History Status Date Action Reviewed 10/01/2008 Updated coding section with 10/01/2008 ICD-9 changes. Reviewed 02/21/2008 Medical Policy & Technology Assessment (MPTAC) review. Updated description, background, coding and references. The phrase investigational/not medically necessary was clarified to read investigational and not medically necessary. This change was approved at the November 29, 2007 MPTAC meeting. Reviewed 03/08/2007 MPTAC review. References updated. Reviewed 03/23/2006 MPTAC review. Updated references. 11/17/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD). Revised 04/28/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. Pre-Merger Organizations Last Review Date Document Title Number Anthem, Inc. 04/27/2004 WellPoint Health Networks, Inc. 12/02/2004 2.10.16 Biofeedback for Headache 06/24/2004 10.10.01 Neurofeedback Page 6 of 6