Medicare coverage of biofeedback for urinary incontinence

35-27 BIOFEEDBACK THERAPY 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. Biofeedback therapy differs from electromyography, which is a diagnostic procedure used to record and study the electrical properties of skeletal muscle. An electromyography device may be used to provide feedback with certain types of biofeedback. Biofeedback therapy is covered under Medicare only when it is reasonable and necessary for the individual patient for muscle re-education of specific muscle groups or for treating pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or weakness, and more conventional treatments (heat, cold, massage, exercise, support) have not been successful. This therapy is not covered for treatment of ordinary muscle tension states or for psychosomatic conditions. (See HCFA-Pub. 14-3, §§2200ff, 2215, and 4161; HCFA-Pub. 13-3, §§3133.3, 3148, and 3149; HCFA-Pub. 10, §§242 and 242.5 for special physical therapy requirements. See also §35-20 and 65-8.) Rev. 138

35-27.1 BIOFEEDBACK THERAPY FOR THE TREATMENT OF URINARY INCONTINENCE Biofeedback therapy for the treatment of urinary incontinence (Effective for services performed on or after July 1, 2001.) This policy applies to biofeedback therapy rendered by a practitioner in an office or other facility setting. Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME)training. Biofeedback is not a treatment, per se, but a tool to help patients learn how to perform PME. Biofeedback-assisted PME incorporates the use of an electronic or mechanical device to relay visual and/or auditory evidence of pelvic floor muscle tone, in order to improve awareness of pelvic floor musculature and to assist patients in the performance of PME. A failed trial of PME training is defined as no clinically

35-18 ELECTROSLEEP THERAPY–NOT COVERED Electrosleep therapy consists of the application of short duration, low-amplitude pulses of direct current to the patient’s brain via externally placed occipital electrodes. It is commonly used in the treatment of chronic insomnia, anxiety, and depression, but has also been used for psychosomatic disorders such as asthma, spastic colitis, or tension headache, and for organic disorders including essential hypertension. Until scientific assessment of this technique has been completed and its efficacy is established, no program payment may be made for electrosleep therapy.

35-21 INPATIENT HOSPITAL PAIN REHABILITATION PROGRAMS Pain rehabilitation programs are a relatively new and innovative approach to the treatment of intractable pain. The goal of such programs is to give a patient the tools to manage and control his/her pain and thereby improve his/her ability to function independently.

A hospital level pain rehabilitation program is one that employs a coordinated multidisciplinary team to deliver, in a controlled environment, a concentrated program which is designed to modify pain behavior through the treatment of the physiological, psychological, and social aspects of pain. Such programs generally include diagnostic testing, skilled nursing, psychotherapy, structured progressive withdrawal from pain medications, physical therapy and occupational therapy to restore physical fitness (mobility and endurance) to a Rev. 93

09-88 COVERAGE ISSUES – MEDICAL PROCEDURES 35-21 (Cont.) maximal level within the constraints of a patient’s physical disability, and the use of mechanical devices and/or activities to relieve pain or modify a patient’s reaction to it (e.g., nerve stimulator, hydrotherapy, massage, ice, systemic muscle relaxation training, and diversional activities). The nurse’s responsibility in such pain rehabilitation programs is to observe and assess, on a continuing basis, a patient’s condition and response to the program as reflected by his actions while in the nursing unit, and to assure that the atmosphere within the unit is not supportive of pain behavior. The day-to- day activities involved in carrying out the program are under the general supervision and, as needed, direct supervision of a physician.

Since pain rehabilitation programs of a lesser scope than that described above would raise a question as to whether the program could be provided in a less intensive setting than on an inpatient hospital basis, carefully evaluate such programs to determine whether the program does, in fact, necessitate a hospital level of care. Some pain rehabilitation programs may utilize services and devices which are excluded from coverage, e.g., acupuncture (see §35-8), biofeedback (see §35-27), dorsal column stimulator (see §65-8), and family counseling services (see §35-l4). In determining whether the scope of a pain program does necessitate inpatient hospital care, evaluate only those services and devices which are covered. Although diagnostic tests may be an appropriate part of pain rehabilitation programs, such tests would be covered in an individual case only where they can be reasonably related to a patient’s illness, complaint, symptom, or injury and where they do not represent an unnecessary duplication of tests previously performed.

An inpatient program of 4 weeks’ duration is generally required to modify pain behavior. After this period it would be expected that any additional rehabilitation services which might be required could be effectively provided on an outpatient basis under an outpatient pain rehabilitation program (see §35-21.1sf2) or other outpatient program. The first 7-l0 days of such an inpatient program constitute, in effect, an evaluation period. If a patient is unable to adjust to the program within this period, it is generally concluded that it is unlikely that the program will be effective and the patient is discharged from the program. On occasions a program longer than 4 weeks may be required in a particular case. In such a case there should be documentation to substantiate that inpatient care beyond a 4-week period was reasonable and necessary. Similarly, where it appears that a patient participating in a program is being granted frequent outside passes, a question would exist as to whether an inpatient program is reasonable and necessary for the treatment of the patient’s condition.

An inpatient hospital stay for the purpose of participating in a pain rehabilitation program would be covered as reasonable and necessary to the treatment of a patient’s condition where the pain is attributable to a physical cause, the usual methods of treatment have not been successful in alleviating it, and a significant loss of ability to function independently has resulted from the pain. Chronic pain patients often have psychological problems which accompany or stem from the physical pain and it is appropriate to include psychological treatment in the multidisciplinary approach. However, patients whose pain symptoms result from a mental condition, rather than from any physical cause, generally cannot be succesfully treated in a pain rehabilitation program. Rev. 32

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