Cigna Biofeedback - (CPG294) Form

Cigna / ASH Medical Coverage Policies

Cigna / ASH Medical Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document may differ significantly from the standard benefit plans upon which these Cigna / ASH Medical Coverage Policies are based. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Cigna / ASH Medical Coverage Policy. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Determinations in each specific instance may require consideration of:

1. the terms of the applicable benefit plan document in effect on the date of service
2. any applicable laws/regulations
3. any relevant collateral source materials including Cigna-ASH Medical Coverage Policies
4. the specific facts of the particular situation

Where coverage for care or services does not depend on specific circumstances, reimbursement will only be provided if a requested service(s) is submitted in accordance with the relevant guidelines and criteria outlined in this policy, including covered diagnosis and/or procedure code(s) outlined in the Coding Information section of this policy. Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this policy. When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims submitted for services that are not accompanied by covered code(s) under this policy will be denied as not covered.

Cigna / ASH Medical Coverage Policies relate exclusively to the administration of health benefit plans. Cigna / ASH Medical Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. Some information in these Coverage Policies may not apply to all benefit plans administered by Cigna. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make benefit determinations. References to standard benefit plan language and benefit determinations do not apply to those clients.

GUIDELINES

Coverage for biofeedback varies across plans. Refer to the customer’s benefit plan document for coverage details. If coverage is available for biofeedback, the following conditions of coverage apply.

Medically Necessary Biofeedback

Biofeedback performed by a licensed healthcare professional is considered medically necessary for ANY of the following conditions*:

• Chronic constipation with dyssynergic defecation (adults only)

Biofeedback (CPG 294)

• Fecal incontinence for patients with:
  • some degree of rectal sensation, and
  • ability to contract the sphincter voluntarily, and
  • failure/intolerance/contraindication of treatment with dietary changes, devices or drugs
• Stress, urgency, mixed, or overflow urinary incontinence when there is failure/intolerance/contraindication of other nonpharmacologic treatment (e.g., bladder training and/or pelvic floor muscle training [PFMT]) (children and adults)
• Migraine and tension headaches (children and adults) as part of a comprehensive treatment plan
• Muscle re-education of specific extremity muscle groups or for treating pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or weakness when:
  • Patient is diagnosed with stroke, and
  • Failure/intolerance/contraindication of conventional treatments (e.g. modalities, massage, soft tissue mobilization, exercise)
• Refractory levator ani syndrome (e.g.

• Refractory levator ani syndrome (e.g. proctalgia fugax, chronic anal pain syndrome, anal spasm) with dyssynergic defecation when:
  • Condition is not neurological or disease-based
  • Failure/intolerance/contraindication of conservative treatment including:
    • high-fiber diet
    • withdrawal of drugs that cause constipation (e.g., calcium channel blockers, narcotics) or diarrhea (e.g., antibiotics, quinidine, theophylline)
    • perineal strengthening exercises
    • rectal massage
    • warm baths, and
    • drug therapy (e.g., muscle relaxants, non-narcotic analgesics, and sedatives)

NOTE:

Patients must be cognitively intact and willing and motivated to learn and practice the specific tasks needed to correct/improve their problems. There should be a written treatment plan which must include all of the following information:

• The specific diagnosis/conditions to be treated
• Long- and short-term goals
• Measurable objectives
• The time frame and the frequency of treatment in which the goals and objectives will be achieved.

The leva® Pelvic Health System at-home device and remotely delivered program is medically necessary for women with stress, urgency, or mixed urinary incontinence.

Experimental, Investigational, Unproven

EACH of the following is considered experimental, investigational or unproven:

• Electroencephalography (EEG) biofeedback or neurofeedback for any indication including but not limited to:
  • addictions
  • anxiety disorders
  • attention deficit hyperactivity disorder (ADHD)
  • autism spectrum disorders
  • brain injury
  • depression
  • dyslexia
  • epilepsy
• In-home biofeedback devices, except the leva® Pelvic Health System
• Biofeedback (CPG 294)
• pervasive developmental delay/intellectual disability
• substance use disorder
• fibromyalgia
• insomnia
• learning disabilities
• tinnitus
• Biofeedback for ANY other indication is considered experimental, investigational or unproven, including but not limited to:
  • As a rehabilitation modality for spasmodic torticollis, spinal cord injury, or following knee surgeries
  • Attention deficit hyperactivity disorder (ADHD)
  • Autism
  • Bell's palsy (idiopathic facial paralysis)
  • Cardiovascular diseases (e.g., heart failure)
  • Chemotherapy-induced peripheral neuropathy
  • Childhood apraxia of speech
  • Chronic fatigue syndrome
  • Chronic pain (e.g., back pain, fibromyalgia, neck pain) other than migraine and tension headache
  • Epilepsy
  • Essential hypertension (e.g., by means of the RESPeRATE Device)
  • Facial pain
  • Functional dysphonia
  • Neurogenic bladder
  • Non-neuropathic voiding disorders
  • Labor pain
  • Prophylaxis of medication overuse headache and pediatric migraine
  • Raynaud's disease/phenomenon
  • Rheumatoid arthritis
  • Sleep bruxism
  • Spasticity secondary to cerebral palsy
  • Temporomandibular joint (TMJ) syndrome
  • Toe-out gait modification/retraining in people with knee osteoarthritis
  • Vaginismus
  • Vulvodynia
  • Improvement of anorectal/bowel functions after sphincter-saving surgery for rectal cancer

DESCRIPTION

This guideline includes various indications for biofeedback, electroencephalography (EEG) biofeedback or neurofeedback, and in-home biofeedback devices.

GENERAL BACKGROUND

Biofeedback therapy provides visual, auditory or other evidence of the status of certain body functions so that a person can exert voluntary control over the functions, and thereby alleviate an abnormal bodily condition. Biofeedback therapy often uses electrical devices to transform bodily signals indicative of such functions as heart rate, blood pressure, skin temperature, salivation, peripheral vasomotor activity, and gross muscle tone into a tone or light, the loudness or brightness of which shows the extent of activity in the function being measured.

It emphasizes relaxation, enhancement of muscle contraction and/or stress-reduction. Biofeedback is considered an alternative medicine technique (National Center for Complementary and Alternative Medicine [NCCAM], 2017; Holroyd, et al., 2003; Karmody, 2003; Kiresuk, et al., 2005). Biofeedback (CPG 294)

There are several different types of biofeedback. The biofeedback modality selected for therapy depends on the condition to be treated. EMG biofeedback measures muscle tension and is proposed for the treatment of chronic muscle stiffness, injury and pain (e.g., neck and back pain); headaches, asthma, incontinence; and intestinal symptoms. Thermal or temperature biofeedback measures skin temperature and is proposed for the treatment of circulatory disorders, such as headaches, hypertension, and Raynaud’s phenomenon. Galvanic skin response (GSR) biofeedback, also called electrodermal response (EDR), electrodermal activity (EDA), skin conductance response (SCR) or skin conductance level (SCL) biofeedback, measures electrical conductance in the skin associated with sweat gland activity and perspiration. GSR is proposed for the treatment of anxiety disorders and phobias. 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. EEG biofeedback has been proposed for the treatment of multiple conditions including insomnia, attention deficit hyperactivity disorder (ADHD), dyslexia, anxiety disorders, autism spectrum disorders, epilepsy, addictions, tinnitus, brain injury, depression, learning disabilities, pervasive developmental delay/intellectual disability, fibromyalgia, dyslexia. However, the evidence in the published peer-reviewed scientific literature does not support the efficacy of EEG biofeedback.

The three most commonly used forms of biofeedback therapy are: (1) electromyography (EMG), which measures muscle tension; (2) thermal biofeedback, which measures skin temperature; and (3) neurofeedback or electroencephalography (EEG), which measures brain wave activity. Various forms of biofeedback appear to be effective for a narrow range of health problems. Forms of biofeedback have been in use in physical therapy for more than 50 years, where it is beneficial in the management of neuromuscular disorders. Biofeedback techniques have shown benefit when used as part of a physical therapy program for people with motor weakness or dysfunction after stroke, after orthopedic surgery, or due to other neuromuscular diseases. These methods are getting better at training for complex task-oriented activities like walking and grasping objects as technology continues to advance. Aside from neuromuscular retraining, the most common use for biofeedback is to help with chronic symptom management due to anxiety, pain, and urinary and fecal incontinence. These techniques focus on managing the overactive sympathetic response and coordinating muscle activity in gastrointestinal and genitourinary tracts. Biofeedback techniques are generally regarded as safe and free of side effects. For this reason, they are incorporated into treatment plans despite lacking strong evidence to support their benefits (Malik and Dua, 2021). Although there are numerous biofeedback devices available for home use, biofeedback should be performed in a clinical setting with the continuous presence of the physician or by a qualified non-physician practitioner.

Continuous presence requires one-on-one face-to-face involvement with the patient and practitioner during training. Qualified non-physician practitioners include physical and occupational therapists in independent practice, Nurse Practitioners, Physician Assistants, and Clinical Nurse Specialists. Examples of home devices include: StressEraser® (Helicor, Inc., New York, NY) for mind and body relaxation; BrainMaster (BrainMaster Technologies, Inc., Oakwood Village, OH) EEG biofeedback devices; GSR/Temp2XTM (Biofeedback Instrument Corp., New York, NY) temperature biofeedback system; and RESPeRate (Intercure Ltd., Lod, Israel) which uses therapeutic paced breathing to lower blood pressure.

Urinary Incontinence

Urinary incontinence (UI) affects people of all ages, especially elderly women. Among adults, there are 4 prevalent types of UI:

1. stress incontinence (closure problem)
2. urge incontinence (storage problem)
3. overflow incontinence
4. mixed stress and urge incontinence

In women, stress incontinence is generally caused by an incompetent urethral mechanism which arises from damage to the sphincter(s) or weakening of the bladder neck support that typically occurred during childbirth. In men, stress incontinence is usually a consequence of operations for benign prostatic hypertrophy (BPH) or prostate cancer. Urge incontinence is usually associated with an over-activity of the detrusor muscle. When the involuntary contraction of the detrusor muscle is associated with a neurological deficit, it is known as detrusor hyperreflexia. On the other hand, when detrusor over-activity is not associated with any neurological deficit, it is labeled as detrusor instability (unstable bladder). Overflow incontinence may be due to an underactive detrusor muscle or obstruction of the urethra. In men, overflow incontinence associated with obstruction is usually due to prostatic hyperplasia. Urethral obstruction in women may occur as a consequence of anti-incontinence operation or severe prolapse of the uterus or relaxation of the anterior vaginal wall with cystocele or cystourethrocele.

Biofeedback (CPG 294)

Over 20 million women experience stress, urgency, or mixed incontinence (Wu et al., 2009). There are limited non-surgical treatment options available for women with stress, mixed, and urgency UI and most require the involvement of skilled healthcare professionals, which may be limited in number. Additionally, geographical access can be challenging for first line treatment of UI. Studies estimate that at least 50% of women do not seek care for UI (Morrill et al., 2007; Berger et al., 2011).

Disparities specific to urinary incontinence exist relative to race and ethnicity, education, socioeconomic status, knowledge of UI and care, access to care, and treatment (Brown and Simon, 2021). These factors create barriers to health equity. Also inherent in these disparities is the concept that certain populations may be structurally vulnerable to disparate health outcomes because these groups experience individual patient and system mismatches. A few vulnerable groups identified by Brown and Simon (2021) relative to UI include Black and Native women, individuals with language deficiencies, and rural populations. Access to services (or lack thereof) for UI complicate and impact these structurally vulnerable groups further.

First line treatment of urinary incontinence (stress, urgency, mixed) consists of behavioral treatments with an emphasis on improving quality of life because of their relatively non-invasive and low risk nature. Initial treatment includes lifestyle modifications and pelvic floor muscle exercise (Kegel exercises). Biofeedback is used as an adjunct to pelvic floor muscle exercises.

By providing individuals with concurrent feedback on muscle tone, biofeedback is intended to improve the patient’s ability to perform pelvic muscle exercises. Augmented versions also use abdominal and perineal EMG recordings to demonstrate improper contraction of abdominal and gluteal muscles. Pelvic muscle exercises can aid in strengthening the voluntary periurethral and pelvic muscles needed to maintain urinary continence since contractions of these muscles raise the urethral pressure. This form of exercise is indicated for women with stress incontinence, men with incontinence following prostatic surgery, and patients with urge incontinence. Depending on the type of UI, patients are taught to contract the pelvic floor muscles, relax the detrusor and the abdominal muscles, and/or contract the sphincters.

However, patients are often not compliant with their home pelvic floor muscle training programs, with research demonstrating 25%-33% adherence rates (Moen et al., 2009; Porta Roda et al., 2016; Luo et al., 2021). And for those referred for pelvic floor physical therapy, only 50%-66% attend one visit and even less complete the course of care (~3 visits) (Fullerton et al., 2022; Brown et al., 2020; Shannon et al., 2018; Shannon, Adams et al., 2018). And of those who did perform PFMT, fewer than 25% perform them adequately (Moen et al., 2009).

Biofeedback has been suggested to be useful in teaching patients with UI pelvic muscle exercises because it relays to them whether they are contracting the right muscle(s) and provides positive reinforcements as they acquire the skill during training sessions. Biofeedback has also been suggested to improve compliance and performance of PFMT, but studies are not confirmatory in demonstrating this outcome with standard biofeedback unit use (Hagen et al., 2020; Hagen, Bugge et al., 2020).

A newer at-home biofeedback device and remotely delivered program called leva® Pelvic Health System was developed to mitigate some of these issues. This device and program includes motion sensor technology with personal coaching and app technology to help patients train and strengthen their pelvic floor muscles correctly and decrease the symptoms of UI. It is physician-prescribed and does not require physical therapist involvement. Given this, the remotely delivered leva® Pelvic Health System could address potential access issues for patients who cannot easily receive in person treatment.

Fecal Incontinence

Fecal incontinence is the inability to control bowel movements and may involve leakage of stool. Causes of fecal incontinence include severe constipation, chronic diarrhea, overuse of laxatives, damage to the anal sphincter muscles or nerves, anal surgical procedures, spinal cord injury and stroke. Treatment includes changes in dietary habits, pelvic floor muscle exercises and pharmacotherapy. Fecal incontinence (FI) is fairly common in the elderly and children. Dysfunction/abnormality of one or more of many factors; such as mental function, stool volume and consistency, anorectal sensation and reflexes and anal sphincter function, can result in FI. There are various methods for the treatment of FI including behavioral therapies, drug therapies, and surgical intervention.

Various biofeedback techniques have also been used in the management of FI. In particular, external anal sphincter (EAS) biofeedback training has been shown to be effective in treating FI. This technique teaches patients to increase the strength of contraction of their EAS in response to rectal distention. There is evidence that biofeedback techniques are safe and effective in the treatment of patients with fecal incontinence, especially those who have some degree of rectal sensation and ability to contract the sphincter voluntarily.

Biofeedback training with or without relaxation techniques have also been shown to be effective in treating migraine and tension headache. In particular, thermal biofeedback training has been shown to be effective in treating migraine headache. This technique teaches patients to increase the temperature of their fingers. Supposedly, dilatation of the peripheral blood vessels in the hand is associated with reduced blood flow in the regions of the supra-orbital and superficial temporal arteries, although the exact mechanism by which thermal biofeedback improves migraine headaches is still unclear.

For the management of tension headache, EMG feedback has been employed primarily. Moreover, it has been shown that the combination of thermal and EMG biofeedback has been effective in the control of migraine, tension, and mixed migraine and tension headache. Furthermore, it has been reported that relaxation techniques can produce improvements in headache.

Available evidence indicates that biofeedback techniques (thermal, EMG, and temporal blood volume pulse biofeedback), with or without other behavioral therapies (relaxation and cognitive training), are safe and effective methods for the treatment of migraine and tension headache. This therapeutic modality has no side effects and does not preclude other options.

Unlike migraine and tension headache, there is a lack of published data concerning the safety and effectiveness of biofeedback in the management of cluster headache. Before participating in a biofeedback program, patients should be examined by a physician to ensure that their headaches are not due to pathological conditions such as hematomas, aneurysm, brain tumors, brain edema, or diseases of the eye, ear and sinus. First line approaches, including avoidance of precipitating stimuli and pharmacologic prophylaxis, should have been tried and failed.

Neuromuscular Rehabilitation

Biofeedback (CPG 294)

Typically stroke rehabilitation includes various combinations of range of motion and muscle strengthening exercises, gait and mobility training, and compensatory techniques. Other therapies include neurodevelopmental based methods in which the treatment incorporates neuromuscular re-education techniques where biofeedback may be employed. Among biofeedback techniques employed in neuromuscular rehabilitation, EMG biofeedback is the most common one. It is often utilized by stroke patients for facilitation of contraction (strength) and relaxation of spasticity (inhibition).

Electromyographic biofeedback has also been used to treat patients with spasmodic torticollis and patients with muscular atrophy resulting from surgery. The goals of EMG biofeedback in neuromuscular rehabilitation include relaxation of muscles or recruitment of muscles. Relaxation of muscles is performed where muscles are either trained to relax as a consequence of hyperactivity that may be stress or work related or as a result of spasticity caused by central nervous system dysfunction. Recruitment of muscles is to facilitate increased motor unit output for movement generation or strength. This is most commonly used when muscles have been weakened or inhibited as a result of injury, immobilization or surgical procedure of a limb/joint.

The majority of biofeedback research has focused on the effects of biofeedback therapy in the treatment of upper limb and lower limb motor deficits in neurological disorders (e.g., stroke). Traditionally biofeedback is presented to the patient and the clinician via visual displays, acoustic or vibrotactile feedback. A recent development in rehabilitation is exercising in a gaming or virtual reality (VR) environment, thus providing a novel form of immersive biofeedback.

With VR the measured patient activity is fed back via graphical or audiovisual animations providing a realistic impression to the patient