Latest Review Date: October 2024

Category: Medical                                                  

POLICY:

For dates of service on or after January 30, 2023:

I. Biofeedback for Behavioral Health Conditions

• Biofeedback in a supervised clinical setting may be considered medically necessary as one component of a comprehensive treatment plan for the following behavioral health conditions:
  • Generalized anxiety;
  • Panic disorders.
• Biofeedback is considered investigational for treatment of all other behavioral health conditions, due to a lack of evidence demonstrating an impact on improved health outcomes.

II. Biofeedback for Medical Conditions

• Biofeedback in a supervised clinical setting may be considered medically necessary as a component of a comprehensive treatment plan for the following medical conditions:
  • Cancer-related pain; 
  • Chronic pain;
  • Dyssynergia-type chronic constipation in adults; 
  • Fecal incontinence in adults; 
  • Intractable musculoskeletal spasm; 
  • Migraine or chronic, recurrent tension-type headache; 
  • Temporomandibular disorder (TMD)
  • Urinary incontinence in adults.
• Biofeedback is considered investigational for treatment of all other medical conditions, including but not limited to the following, due to a lack of evidence demonstrating an impact on improved health outcomes:
  • Asthma;
  • Bell’s palsy; 
  • Chronic fatigue syndrome; 
  • Cluster headache; 
  • Fecal or urinary incontinence in pediatric patients; 
  • Hypertension; 
  • Movement disorders; 
  • Multiple sclerosis; 
  • Ordinary muscle tension; 
  • Pain management during labor; 
  • Prevention of preterm birth; 
  • Raynaud’s disease or phenomenon; 
  • Recovery of motor function after stroke; 
  • Sleep bruxism; 
  • Spinal cord injury; 
  • Tinnitus.

III. Use of biofeedback in the home or an unsupervised setting is considered investigational for all indications due to a lack of clinical evidence demonstrating an impact on improved health outcomes.

For dates of service prior to January 30, 2023:

I.   Biofeedback for Behavioral Health Conditions

• Biofeedback in a supervised clinical setting may be considered medically necessary as one component of a comprehensive treatment plan for behavioral health conditions other than those considered investigative.
• Biofeedback for the following behavioral health conditions is considered investigational due to a lack of evidence demonstrating an impact on improved health outcomes:
  • Acute and chronic psychotic disorders
  • Adjustment disorders
  • Attention deficit hyperactivity disorder
  • Autism spectrum disorders
  • Mood disorders
  • Somatic disorders
  • Substance use disorders

II.  Biofeedback for Medical Conditions

• Biofeedback in a supervised clinical setting may be considered medically necessary as a component of a comprehensive treatment plan for the following medical conditions:
  • Cancer-related pain
  • Chronic pain
  • Dyssynergia-type chronic constipation in adults
  • Fecal incontinence in adults
  • Intractable musculoskeletal spasm
  • Migraine or chronic, recurrent tension-type headache
  • Temporomandibular disorder (TMD).
  • Urinary incontinence in adults
• Biofeedback is considered investigational for treatment of all other medical conditions including but not limited to the following due to a lack of evidence demonstrating an impact on improved health outcomes:
  • Asthma
  • Bell’s palsy
  • Chronic fatigue syndrome
  • Cluster headache
  • Fecal or urinary incontinence in pediatric patients
  • Hypertension
  • Movement disorders
  • Multiple sclerosis
  • Ordinary muscle tension
  • Pain management during labor
  • Prevention of preterm birth
  • Raynaud’s disease or phenomenon
  • Recovery of motor function after stroke
  • Sleep bruxism
  • Spinal cord injury
  • Tinnitus

III. Use of biofeedback in the home or an unsupervised setting for any indication is considered investigational due to a lack of clinical evidence demonstrating an impact on improved health outcomes.

DESCRIPTION OF PROCEDURE OR SERVICE:

Biofeedback is a technique to teach patients self-regulation of physiologic processes not generally considered to be under voluntary control. Biofeedback devices may include electromyography (EMG), electrocardiography (ECG), measures of skin temperature and measures of the skin's electrical conductivity by the amount of sweat produced under stress.

A variety of biofeedback devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. A biofeedback device is defined by the FDA 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."

Summary of Evidence

Biofeedback is a technique to teach patients self-regulation of physiologic processes not generally considered to be under voluntary control. Biofeedback devices may include electromyography (EMG), electrocardiography (ECG), measures of skin temperature and measures of the skin's electrical conductivity by the amount of sweat produced under stress. Biofeedback has been proposed for use in the treatment of multiple disorders, including headache, urinary and fecal incontinence, chronic pain, temporomandibular joint disorder, and many others. Evidence supports the use of biofeedback for multiple disorders; however, additional research is needed to support all for which it is proposed.

Practice Guidelines and Position Statements

American College of Physicians

The American College of Physicians (ACP) published a clinical practice guideline in 2017 addressing noninvasive treatments for acute, subacute, and chronic low back pain. Biofeedback is included in the initial nonpharmacologic treatment of chronic low back pain, as well as exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography, and others. This is a strong recommendation based on low-quality evidence.

American College of Obstetricians and Gynecologists

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society issued a practice bulletin (issued 2015; reaffirmed 2022) on urinary incontinence in women. The practice bulletin states, "Pelvic muscle exercises may be used alone or augmented with bladder training, biofeedback, or electrical stimulation".

American Headache Society

In 2021, the American Headache Society released a consensus statement on integration of new migraine treatments into clinical practice, including biobehavioral therapies (cognitive behavioral therapy, biofeedback, and relaxation). According to the consensus statement, "biobehavioral therapies have Grade A evidence supporting their use as preventive treatments in patients with migraine." The statement notes that biobehavioral therapies are particularly suited for the following individuals:

• Prefer nonpharmacologic interventions;
• Have inadequate response, poor tolerance, or medical contraindications to specific pharmacologic treatments;
• Are pregnant, lactating, or planning to become pregnant;
• Have a history of acute medication overuse or medication-overuse headache;
• Exhibit significant stress or deficient stress-coping skills;
• Have high migraine-related disability, and/or low health-related quality of life, and/or comorbidities.

American Society of Colon and Rectal Surgeons

The American Society of Colon and Rectal Surgeons (2024) includes biofeedback as a first-line treatment for patients with pelvic floor dyssynergia. The is a strong recommendation based on moderate-quality evidence.

American Urological Association and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

In guidelines on treatment of stress urinary incontinence in women, the American Urological Association and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (2017) recommended offering several treatment options including pelvic floor muscle training with biofeedback: "Pelvic floor muscle training and incontinence pessaries are appropriate for patients interested in pursuing therapy that is less invasive than surgical intervention. Pelvic floor physical therapy can be augmented with biofeedback in the appropriate patient. The patient must be willing and able to commit to regularly and consistently performing pelvic floor training for this to be successful."

Canadian Agency for Drugs and Technologies in Health

Canadian Agency for Drugs and Technologies in Health (CADTH) (2017) published a review of clinical effectiveness and guidelines on the use of biofeedback for mood and anxiety disorders with the following key findings:

• Evidence from single randomized controlled trials suggests that compared with no treatment there is a statistically significant improvement in symptoms with neurofeedback treatment in patients with post-traumatic stress disorder (PTSD) or generalized anxiety disorder (GAD).
• A randomized controlled trial (RCT) showed that for patients with PTSD there was an improvement in symptoms with biofeedback (BF) plus treatment as usual (TAU) and also with TAU alone, but the improvement occurred faster in the BF plus TAU group.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

REFERENCES:

1. ACOG Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. Nov 2015; 126(5): e66-e81.
2. Aggarwal VR, Lovell K, Peters S, et al. Psychosocial interventions for the management of chronic orofacial pain. Cochrane Database Syst Rev. Nov 09 2011; (11): CD008456.
3. Ailani J, Burch RC, Robbins MS. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. Jul 2021; 61(7): 1021-1039.
4. Alneyadi M, Drissi N, Almeqbaali M, Ouhbi S. Biofeedback-Based Connected Mental Health Interventions for Anxiety: Systematic Literature Review. JMIR Mhealth Uhealth. 2021;9(4): e26038.
5. Banerjee S, Argáez C. Neurofeedback and Biofeedback for Mood and Anxiety Disorders: A Review of Clinical Effectiveness and Guidelines. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Nov 13.
6. Brazzelli M, Griffiths PV, Cody JD, et al. Behavioural and cognitive interventions with or without other treatments for the management of fecal incontinence in children. Cochrane Database Syst Rev. Dec 07 2011; 2011(12): CD002240.
7. Centers for Medicare & Medicaid Services. National coverage decision (NCD) for biofeedback therapy for the treatment of urinary incontinence (30.1.1). 2001.
8. Chen YF, Huang XY, Chien CH, et al. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. Oct 2017; 53(4): 329-336.
9. Enck P, Van der Voort IR, Klosterhalfen S. Biofeedback therapy in fecal incontinence and constipation. Neurogastroenterol Motil. Nov 2009; 21(11): 1133-1141.
10. Fisher E, Law E, Dudeney J, et al. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. Sep 29 2018; 9(9): CD003968.
11. Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. Nov 2017; 47(15): 2578-2586.
12. Heymen S, Scarlett Y, Jones K, et al. Randomized controlled trial shows biofeedback to be superior to pelvic floor exercises for fecal incontinence. Dis Colon Rectum. Oct 2009; 52(10): 1730-1737.
13. Karim A, Thorsen A, Fang S. et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Evaluation and Management of Chronic Constipation. Diseases of the Colon & Rectum 67(10):p 1244-1257, October 2024.
14. Kobashi KC, Albo ME, Dmochowski RR, et al. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol. Oct 2017; 198(4): 875-883.
15. Lazaridou A, Paschali M, Vilsmark ES, et al. Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study). Digit Health. 2023. 9: 20552076231154386.
16. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. Mar 2007;128(1-2):111-127.
17. Nestoriuc Y, Rief W, Martin A. Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. J Consult Clin Psychol. Jun 2008; 76(3): 379-396.
18. Polak AR, Witteveen AB, Denys D, Olff M. Breathing biofeedback as an adjunct to exposure in cognitive behavioral therapy hastens the reduction of PTSD symptoms: a pilot study. Appl Psychophysiol Biofeedback 2015 [cited 2017 Oct 17];40(1):25-31.
19. Polermo TM, Eccleston C, Lewandowski AS, et al. Randomized controlled trials of psychological therapies for the management of chronic pain in children and adolescents: an updated meta-analytic review. Pain. Mar 2010; 148(3): 387-397.
20. Qaseem A, Wilt T, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530.
21. Sahin N, Yesil H, Gorcan B. The effect of pelvic floor exercises performed with EMG biofeedback or a vaginal cone on incontinence severity, pelvic floor muscle strength, and quality of life in women with stress urinary incontinence: a randomized, 6-month follow-up study. Int Urogynecol J. 2022 Oct;33(10):2773-2779.
22. Simón MA, Bueno AM, Otero P, et al. A Randomized Controlled Trial on the Effects of Electromyographic Biofeedback on Quality of Life and Bowel Symptoms in Elderly Women With Dyssynergic Defecation. Int J Environ Res Public Health. 2019 Sep 4;16(18):3247.
23. Verhagen AP, Damen L, Berger MY, et al. Behavioral treatment of chronic tension-type headache in adults: are they beneficial? CNS Neurosci Ther. 2009; 15(2):183-205.
24. Vonthein R, Heimerl T, Schwandner T, et al. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Int J Colorectal Dis. Nov 2013; 28(11): 1567-1577.
25. Wahbeh H, Goodrich E, Goy E, Oken BS. Mechanistic pathways of mindfulness meditation in combat veterans with posttraumatic stress disorder. J Clin Psychol. 2016 Apr;72(4):365-383
26. Williams ACC, Fisher E, Hearn L, et al. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. Aug 12 2020; 8(8): CD007407.
27. Woodward S, Norton C, Chiarelli P. Biofeedback for treatment of chronic idiopathic constipation in adults. Cochrane Database Syst Rev. Mar 26 2014; (3): CD008486.
28. Zhu D, Xia Z, Yang Z.  Effectiveness of physiotherapy for lower urinary tract symptoms in postpartum women: systematic review and meta-analysis. Int Urogynecol J. 2022 Mar;33(3):507-521.

POLICY HISTORY:

Reviewed and posted September 15, 2021.

November 2022: Updated coverage allows for behavioral health conditions: generalized anxiety and panic disorders to be considered medically necessary. All other behavioral health conditions remain investigational. Previous coverage did not allow coverage for any behavioral health conditions. Policy on draft December 14, 2022 through January 30, 2023.

October 2023: Annual review completed. No change to policy intent.

October 2024: Annual review completed. Updates to Key Points, Practice Guidelines and Position Statements and References. Update to policy statement verbiage (section III) to include “for all indications” and remove “for any indication” No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.