Medical Policy: 02.01.05 

Original Effective Date: October 2002 

Reviewed: July 2020 

Revised: July 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. It is frequently used in conjunction with other therapies (i.e., relaxation, behavioral management, medication) to reduce the severity and/or frequency of headaches and as a treatment for a variety of diseases and disorders including anxiety, hypertension, movement disorders, incontinence, pain, and asthma. Professionals who use this technique assume that patients who achieve greater biofeedback control over the relevant physiological functions will be more successful in reducing their symptoms.

 

Biofeedback involves the feedback of a variety of types of information not normally available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiological process in some specific way. Biofeedback training is done either in individual or group sessions, alone or in combination with other behavioral therapies designed to teach relaxation. A typical course of treatment consists of 10 to 20 training sessions of 30 to 60 minutes each. Training sessions are conducted in a quiet, non-rousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for successful alteration of the physiologic parameter. This feedback may be signals such as lights or tone, verbal praise, or other auditory or visual stimuli.

 

The various forms of biofeedback differ mainly in the nature of the disease or disorder under treatment, the biologic variable that the individual attempts to control, and the information that is fed back to the individual. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic (EMG) biofeedback; these may be used alone or in conjunction with other therapies. Generally, EMG biofeedback is used to treat tension headaches, and thermal biofeedback is used to treat migraine headaches. In EMG biofeedback, electrodes are attached to the temporal muscles. The degree of muscle tension is fed back to the individual being treated and the subject is asked to reduce muscle tension. For thermal biofeedback, a temperature sensor is placed on the finger, and the subject is taught to increase the temperature, an effect that is mediated through peripheral vasodilation. According to the National Center for Complementary and Alternative Medicine (NCCAM), biofeedback is considered an alternative medicine technique.

 

Electroencephalogram (EEG Biofeedback/Neurofeedback)

Another form of biofeedback is electroencephalogram (EEG) biofeedback, also called neurofeedback, brainwave biofeedback or neurotherapy, which measures alpha (associated with relaxation and meditation) and theta (associated with focused attention) brainwave activity. It is proposed to counterbalance genetic and environmental tendencies by learning to alter brain wave patterns. Neurofeedback describes techniques of providing feedback about neuronal activity, as measured by electroencephalogram (EEG) biofeedback or functional magnetic resonance imaging (fMRI), in order to teach patients to self-regulate brain activity. Neurofeedback may utilize several techniques in an attempt to normalize unusual patterns of brain function in patients with central nervous system (CNS) disorders, such as attention deficit/hyperactivity disorder (ADHD), autism spectrum disorder, substance abuse, epilepsy, and insomnia.

 

Heart Rate Variability (HRV) Biofeedback

Yet another form of biofeedback is Heart Rate Variability (HRV) biofeedback. It is a relatively new technique for training people to change the variability and dominant rhythms of their heart activity. Research is ongoing applying HRV biofeedback techniques to a variety of medical and psychiatric conditions, including: anger, anxiety disorders, asthma, cardiovascular conditions including heart failure, chronic obstructive pulmonary disorder (COPD), depression, irritable bowel syndrome (IBS), chronic fatigue, and chronic pain.

 

Practice Guidelines and Position Statements

The American Academy of Neurology

The American Academy of Neurology’s recommendations for the evaluation and treatment of migraine headaches states that behavioral and physical interventions are used for preventing migraine episodes rather than for alleviating symptoms once an attack has begun. Although these modalities may be effective as monotherapy, they are more commonly used in conjunction with pharmacologic management. Relaxation training, thermal biofeedback combined with relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy may be considered treatment options for prevention of migraine. Specific recommendations regarding which of these to use for specific patients cannot be made.

 

European Federation of Neurological Societies

In 2010, the European Federation of Neurological Societies gave an A-level recommendation for use of EMG biofeedback for the treatment of tension-type headache, based on the meta-analysis by Nestoriuc et al. The guidelines state that the aim of EMG biofeedback is to help the patient to recognize and control muscle tension by providing continuous feedback about muscle activity. Sessions typically include an adaptation phase, baseline phase, training phase, during which feedback is provided, and a self-control phase, during which the patient practices controlling muscle tension without the aid of feedback.

 

American Academy of Neurology (AAN) and the American Clinical Neurophysiology Society (ACNS)

A report from The AAN and the ACNS on the assessment of digital EEG, quantitative EEG, and EEG brain mapping was reaffirmed in 2013. The report states that: :On the basis of current clinical literature, opinions of most experts, and proposed rationales for their use, QEEG remains investigational for clinical use in post concussion syndrome, mild or moderate head injury, learning disability, attention disorders, schizophrenia, depression, alcoholism, and drug abuse."

 

National Cancer Institute (NCI)

In reference to the management of cancer pain, the National Cancer Institute (NCI) (2014) states that alternative therapies (e.g., biofeedback) may be used in conjunction with pain medication in an effort to control pain. NCI stated that even though non-medical therapies have not been tested in cancer pain studies, they may help to relieve pain, stress and anxiety therefore, improving the patient’s quality of life.

 

National Institute for Health and Clinical Excellence (NICE)

The clinical guideline on the management of irritable bowel syndrome (IBS) published by NICE (2008; updated 2017) stated that reviews of biofeedback suggested a positive effect on the control of IBS symptoms, but evidence was limited and not sufficient to make recommendations. A systematic review of the literature identified four randomized controlled trials that met inclusion criteria. One study compared biofeedback to counseling and three studies evaluated multi-component therapy (a combination of educational information, progressive relaxation therapy, thermal biofeedback treatment and training in stress coping strategies) compared to symptom monitoring or attention placebo controls. There was limited, weak evidence to show a statistically significant improvement in global symptoms for biofeedback and reduction in diarrhea compared to symptom monitoring. No significant differences between biofeedback and attention placebo or between symptom monitoring and attention placebo were reported, but there was much uncertainty due to wide confidence intervals. There was insufficient evidence to determine the effects of biofeedback on pain, bloating and constipation.

 

The 2010 guideline (updated 2017) on the management of constipation in children and young adults stated that biofeedback should not be used for ongoing treatment in children and young people with idiopathic constipation. Meta-analysis showed no improvement in outcomes when conventional treatment (e.g., use of laxatives, advice on a high-fiber diet, attempting defecation after meals) was compared to conventional treatment plus biofeedback.

 

National Institute of Neurologic Disorders and Stroke

The National Institute of Neurologic Disorders and Stroke (2018) indicated that when headaches occur 3 or more times a month, preventive treatment is usually recommended:

 

"Drug therapy, biofeedback training, stress reduction, and elimination of certain foods from the diet are the most common methods of preventing and controlling migraine and other vascular headaches. Drug therapy for migraines is often combined with biofeedback and relaxation training."

 

National Comprehensive Cancer Network (NCCN)

Biofeedback for Cancer Pain

In the guidelines on adult cancer pain (V.1.2019), the National Comprehensive Cancer Network (NCCN) recommends biofeedback as an evidence-based treatment modality (2A recommendation).

 

American Academy of Pediatrics

Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. 2019. This guideline states: “Some nonmedication treatments for ADHD-related problems have either too little evidence to recommend them or have been found to have little or no benefit. These include mindfulness, cognitive training, diet modification, EEG biofeedback, and supportive counseling."

 

Canadian ADHD Resource Alliance

Canadian ADHD Practice Guidelines. 2020. This guideline states: "Further research of NF should be conducted with more rigorous research designs and include more subjects. In light of the data available at this stage, we conclude there is insufficient data to recommend NF as a standard treatment for ADHD."

 

Regulatory Status

A variety of biofeedback devices are cleared for marketing through the U.S. Food and Drug Administration (FDA) 510(k) process. These devices are designated by the FDA as class II with special controls and are exempt from the premarket notification requirements. The FDA defines a biofeedback device as "an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters."

 

ECRI Institute (for use of neurofeedback in ADHD)

Neurofeedback (NF) is an interactive technology that uses electroencephalographs (EEGs) to monitor real-time brain activity and help patients control their mental state based on operant-conditioning principles. Feedback consists of auditory or visual cues, such as video games. The report focuses on how well NF works compared with pharmacologic and nonpharmacologic treatments for improving attention and behavioral control in children and adolescents with attention deficit hyperactivity disorder (ADHD).

 

Conclusions:

Evidence from 3 meta-analyses of low-quality studies and 3 additional randomized controlled trials (RCTs) shows that NF is less effective than pharmacotherapy and behavioral therapy for managing ADHD symptoms. Whether NF is more effective than inactive interventions (sham NF, waiting list, attention training, physical exercise) or placebo is unclear because studies reported mixed findings. Studies used different NF protocols, outcome assessment methods, and patient groups. Larger RCTs using standardized methods for NF are needed to assess comparative safety and effectiveness. Clinical guidelines state that evidence is insufficient to recommend NF for ADHD management.

 

 

Prior Approval:

Not applicable

 

Policy:

See the related policy: Anorectal Biofeedback 02.01.04

 

Biofeedback may be considered medically necessary as part of the overall treatment plans for

  • cancer pain
  • migraine headaches and
  • tension-type headaches

 

Home use of biofeedback equipment is not medically necessary.

 

Devices used in biofeedback therapy (eg, electromyography [EMG], biofeedback device) are not eligible for separate reimbursement because they are inherent to the biofeedback service.

 

The use of biofeedback technology to help children and teenagers enhance their performance in school (i.e. Neurocore) is considered investigational.

 

Heart rate variability (HRV)/ Heart Rate Variability Training (HRVT) type biofeedback is considered investigational for all indications. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this therapy as well as any longevity of benefits with this therapy.

 

Neurofeedback is considered investigational. Neurofeedback and EMG controlled neuromuscular electrical stimulation (e.g., the Care EMG), is considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

 

Biofeedback/Neurofeedback is considered investigational for all indications not listed above including, but not limited to:

  • Addictions
  • Allergies
  • Anger Management
  • Anorectal pain syndrome (Levator ani syndrome)
  • Anxiety disorders
  • Attention deficit disorder
  • Asthma
  • Autism
  • Bell's Palsy
  • Cerebral Palsy
  • Chronic Pain excluding cancer pain
  • Cluster Headaches
  • Concussions
  • Depression
  • Diabetes
  • Epilepsy
  • Fecal and urinary incontinence
  • Gait retraining
  • Hypertension
  • Insomnia
  • Irritable bowel syndrome
  • Motor function after stroke, injury, or lower-limb surgery
  • Movement disorders
  • Multiple Sclerosis
  • Muscle spasm
  • Neuromuscular rehabilitation of stroke and traumatic brain injury (TBI) (frequently done for stroke via the AutoMove AM800 device)
  • Orthostatic hypotension in patients with spinal cord injury
  • Pain management during labor
  • Panic Disorders (e.g. FreeSpria breathing system)
  • Peripheral arterial disease
  • Post-traumatic stress disorder (PTSD)
  • Psychosomatic conditions
  • Raynaud’s disease or phenomenon
  • Sleep bruxism
  • Tinnitus
  • Torticollis
  • Vulvodynia

 

There continues to be insufficient evidence to demonstrate the effectiveness of biofeedback for the miscellaneous conditions listed above. Studies either fail to demonstrate any beneficial impact of biofeedback or have design flaws that leave the durability of effects in question or create uncertainty about the contribution of nonspecific factors such as attention or placebo effects. There is insufficient evidence from high-quality controlled studies that biofeedback improves outcomes in patients with depression.

 

For neurofeedback the evidence is poor in showing effect on health outcomes and a number of questions regarding clinical efficacy remain to be answered.

 

Most of the published randomized controlled trials (RCTs) on biofeedback from chronic pain have not found a significantly greater benefit when biofeedback is offered instead of or in addition to other conservative interventions.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes

  • 90901 Biofeedback training by any modality
  • 90875 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); approximately 20-30 minutes
  • 90876 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); approximately 45-50 minutes
  • E0746 Electromyography (EMG), biofeedback device
  • E1399 Durable medical equipment, miscellaneous (may be used for at home devices or FreeSpira device)

 

Selected References:

  • National Institute of Neurological Disorders and Stroke (NINDS). Headache Information Page
  • Bendtsen L, Evers S, Linde M et al. EFNS guideline on the treatment of tensio-type headache-report of an EFNS task force. Eur J Neurol 2010; 17(11):1318-25.
  • Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain 2007; 128(1-2):111-27.
  • Nestoriuc Y, Rief W, Martin A. Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. J Consult Clin Psychol 2008; 76(3):279-96.
  • Macfarlane GJ, Paudyal P, Doherty M, et al. A systematic review of evidence for the effectiveness of practitioner- based complementary and alternative therapies in the management of rheumatic diseases: osteoarthritis. Rheumatology (Oxford). 2012 Dec;51(12):2224-2233.
  • Jones L, Othman M, Dowswell T, et al. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;3:CD009234.
  • ECRI Institute. [Evidence Reports] Neurofeedback for treatment of attention deficit hyperactivity disorder. 2/2/2007.
  • National Institute of Neurologic Disorders and Stroke. NINDS Headache Information Page
  • Diagnosis and treatment of headache. Executive summary. Bloomington (MN): Institute for Clinical Systems Improvement; 2013 Jan. 2 p.
  • American Academy of Family Practice. Guidelines on migraine: part 4. General principles of preventive therapy Am Fam Physician 2000.
  • Bendtsen L, Evers S, Linde M et al. EFNS guideline on the treatment of tension-type headache - report of an EFNS task force. Eur J Neurol 2010; 17(11):1318-25.
  • National Coverage Determination (NCD) for Biofeedback Therapy (30.1)
  • Mackay AM, Buckingham R, Schwartz RS, et al. The Effect of Biofeedback as a Psychological Intervention in Multiple Sclerosis: A Randomized Controlled Study. Int J MS Care. May-Jun 2015;17(3):101-108. PMID 26052255
  • Hooten WM, Timming R, Belgrade M, Gaul J, Goertz M, Haake B, Myers C, Noonan MP, Owens J, Saeger L, Schweim K, Shteyman G, Walker N. Institute for Clinical Systems Improvement. Assessment and Management of Chronic Pain. Updated November 2013.
  • American Cancer Society. Pain Control: A Non-medical treatments for pain. Sept 23, 2015. Accessed Nov 2, 2015. Available at URL address: Non-medical treatments for cancer pain
  • American College of Obstetricians and Gynecologists (ACOG). Committee on Gynecologic Practice. ACOG Committee Opinion: Number 345: vulvodynia. Oct 2006. Reaffirmed 2015. Available at URL address: Gynecologic Practice
  • National Institute for Health and Clinical Excellence (NICE). Clinical guideline 137 The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. Feb 2014.
  • Association for Applied Psychphysiology and Biofeedback I Standards for Performing Biofeedback. 2013; AAPB Accessed March, 2015.
  • Richards R, van den Noort JC, Dekker J3, Harlaar J. Gait retraining with real-time biofeedback to reduce knee adduction moment: Systematic review of effects and methods used. Arch Phys Med Rehabil. 2016 Jul 30
  • Reiter K, Andersen SB, Carlsson J. Neurofeedback treatment and posttraumatic stress disorder: Effectiveness of neurofeedback on posttraumatic stress disorder and the optimal choice of protocol. J Nerv Ment Dis. 2016;204(2):69-77.
  • Blase KL, van Dijke A, Cluitmans PJ, Vermetten E. Efficacy of HRV-biofeedback as additional treatment of depression and PTSD. Tijdschr Psychiatr. 2016;58(4):292-300.
  • Clamor A, Koenig J, Thayer JF, Lincoln TM. A randomized-controlled trial of heart rate variability biofeedback for psychotic symptoms. Behav Res Ther. 2016;87:207-215.
  • Goessl, V., Curtiss, J., & Hofmann, S. (2017). The effect of heart rate variability biofeedback training on stress and anxiety: A meta-analysis. Psychological Medicine, 47(15), 2578-2586. doi:10.1017/S0033291717001003
  • Stubberud A, Varkey E, McCrory DC, et al. Biofeedback as prophylaxis for pediatric migraine: a meta-analysis. Pediatrics. Aug 2016;138(2). PMID 27462067
  • Shaffer, F., Venner, J. (2013). Heart rate variability: Anatomy & physiology. Biofeedback, 41(1): 13-25.
  • Wheat, A., Larkin, K. (2010). Biofeedback of heart rate variability and related physiology: A critical review. Applied Psychophysiology & Biofeedback, 35, 229-242.
  • Lehrer, Paul & Vaschillo, Bronya & Zucker, Terri & Graves, Jessica & Katsamanis, Maria & Aviles, Milisyaris & Wamboldt, Frederick. (2013). Protocol for Heart Rate Variability Biofeedback Training. Biofeedback. 41. 98-109. 10.5298/1081-5937-41.3.08.
  • Moayyedi, P., Mearin, F., Azpiroz, F., Andresen, V., Barbara, G., Corsetti, M., … Tack, J. (2017). Irritable bowel syndrome diagnosis and management: A simplified algorithm for clinical practice. United European Gastroenterology Journal, 5(6), 773–788.
  • National Institute of Neurologic Disorders and Stroke. Headache information page. 2018; 
  • American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Persistent vulvar pain. Published September 2016.
  • Lehrer, P. M., Irvin, C. G., Lu, S. E., Scardella, A., Roehmheld-Hamm, B., Aviles-Velez, M., … Wamboldt, F. S. (2018). Heart Rate Variability Biofeedback Does Not Substitute for Asthma Steroid Controller Medication. Applied psychophysiology and biofeedback, 43(1), 57–73. doi:10.1007/s10484-017-9382-0
  • UpToDate, Inc. Autism spectrum disorder in children and adolescents: complementary and alternative therapies. Updated October 2018.
  • UpToDate, Inc. Chronic migraine. Updated October 2018.
  • Criswell SR, Sherman R, Krippner S. Cognitive behavioral therapy with heart rate variability biofeedback for adults with persistent noncombat-related posttraumatic stress disorder. Perm J. 2018;22.
  • Yan L, Zhang J, Yuan Y, Cortese S. Effects of neurofeedback versus methylphenidate for the treatment of attention-deficit/hyperactivity disorder protocol for a systematic review and meta-analysis of head-to-head trials. Medicine (Baltimore). 2018;97(39):e12623
  • Jokubauskas L, Baltrusaityte A. Efficacy of biofeedback therapy on sleep bruxism: A systematic review and meta-analysis. J Oral Rehabil. 2018;45(6):485-495.
  • Alayan N, Eller L, Bates ME, Carmody DP. Current evidence on heart rate variability biofeedback as a complementary anticraving intervention. J Altern Complement Med. 2018;24(11):1039-1050.
  • MacIntosh A, Lam E, Vigneron V, et al. Biofeedback interventions for individuals with cerebral palsy: A systematic review. Disabil Rehabil. 2018 May 12:1-23 [Epub ahead of print].
  • Benfield JK, Everton LF, Bath PM, England TJ. Does therapy with biofeedback improve swallowing in adults with dysphagia? A systematic review and meta-analysis. Arch Phys Med Rehabil. 2018 May 30. [Epub ahead of print].
  • ECRI Institute. Neurofeedback for Treating Attention Deficit Hyperactivity Disorder in Children and Adolescents. Plymouth Meeting (PA): ECRI Institute; 2020 Mar 04. (Custom Rapid Responses).
  • Burch JB, Ginsberg JP, McLain AC, Franco R, Stokes S, Susko K, Hendry W, Crowley E, Christ A, Hanna J, Anderson A, Hébert JR, O'Rourke MA. Symptom Management Among Cancer Survivors: Randomized Pilot Intervention Trial of Heart Rate Variability Biofeedback. Appl Psychophysiol Biofeedback. 2020 Jun;45(2):99-108. doi: 10.1007/s10484-020-09462-3.
  • Ferreira S, Pego JM, Morgado P. The efficacy of biofeedback approaches for obsessive-compulsive and related disorders: A systematic review and meta-analysis. Psychiatry Res. 2019;272:237-245.
  • Sugden E, Lloyd S, Lam J, Cleland J. Systematic review of ultrasound visual biofeedback in intervention for speech sound disorders. Int J Lang Commun Disord. 2019;54(5):705-728.

 

Policy History:

  • July 2020 - Annual Review, Policy Revised
  • July 2019 - Annual Review, Policy Revised
  • July 2018 - Annual Review, Policy Revised
  • July 2017 - Annual Review, Policy Revised
  • July 2016 - Annual Review, Policy Revised
  • August 2015 - Annual Review, Policy Revised
  • Septemeber 2014 - Annual Review, Policy Revised
  • October 2013 - Annual Review, Policy Renewed
  • December 2012 - Annual Review, Policy Renewed
  • December 2011 - Annual Review, Policy Renewed
  • December 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.