Coverage of Urinary Incontinence Treatment. (Featured CME Topic: Urinary Incontinence).

Coding according to local medical review policy (LMRP) is sometimes easier said than done. An exhaustive search of the SMA territory states' websites for coverage guidelines regarding urinary incontinence treatment quickly became tedious. West Virginia's website (http://www.nationwide-medicare.com) proved most useful for information regarding coverage of urinary incontinence treatment. This one source provided information specifically stating the definition of urinary incontinence, diagnosis codes that support medical necessity, coding guidelines, documentation requirements, and treatment utilization guidelines. The following is coverage and payment information provided by the Centers for Medicare and Medicaid Services, which is freely available for physicians and their staff members.

Urinary incontinence (UI.) is defined as the involuntary loss of urine that is sufficient to be a problem. There are several different types:

* Urge incontinence, usually a result of detrusor instability, detrusor hyperactivity with impaired bladder contractility, or involuntary sphincter relaxation.

* Stress incontinence (SI) resulting from urethral sphincter failure is due to either anatomic changes or intrinsic sphincter deficiency (ISD).

* Overflow incontinence results from hypotonic or underactive detrusor secondary to drugs, fecal impaction, diabetes, lower spinal cord injury, disruption of the motor innervation of the detrusor muscle, urethral obstruction, or genital prolapse.

* Mixed incontinence refers to a combination of urge and stress incontinence, especially common in older women.

URINARY INCONTINENCE TREATMENT

The three major categories of treatment for urinary incontinence are pharmacologic, behavioral, and surgical. In general, the first choice should be the least invasive treatment with the fewest potential adverse complications for the patient. Before treatment commences, a complete evaluation and appropriate urodynamic testing should be completed. The patient's medical record must indicate the medical necessity of services for each date of service billed.

Pharmacologic treatment includes anti-cholinergics and tricyclic antidepressants for urge incontinence. Estrogen therapy and alpha-adrenergic drugs are appropriate for the management of stress incontinence. Estrogen replacement agents are also indicated in the treatment of mixed incontinence.

Urge incontinence due to refractory detrusor instability is treated with augmentation cystoplasty or bladder denervation procedures. For SI caused by hypermobility, the treatment is retropubic suspension, needle bladder neck suspension, or anterior vaginal repair. For SI caused by intrinsic sphincter deficiency, the treatment is a sling procedure (mostly women), artificial sphincter, or penurethral bulking injections. In overflow incontinence caused by obstruction, the treatment is a surgical procedure to relieve the obstruction or intermittent catheterization or indwelling catheter.

Behavioral techniques include toileting assistance, bladder retraining, pelvic muscle exercises (PMEs) or Kegel exercises, PMEs and. bladder inhibition augmented by biofeedback therapy, PMEs augmented with vaginal weight training, and pelvic floor electrical stimulation.

Biofeedback is not a treatment per se, but a tool to help patients learn how to perform pelvic muscle exercise training. 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. Since biofeedback is covered only when there is a lack of response to other therapies, the lack of response to other therapies, conventional and/or drug therapies, should be noted in the medical record.

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 training. A failed trial of pelvic muscle exercise training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength. Biofeedback therapy coverage for the treatment of urinary incontinence applies to biofeedback therapy rendered by a practitioner in an office or other facility setting. Home use of biofeedback therapy is not covered. One to three sessions (initial assessment and training and fo 110w-up visits if needed) of biofeedback are usually sufficient to train the patient for a home program of ongoing daily exercises.

Non-implantable pelvic floor electrical stimulators provide neuromuscular electrical stimulation through the pelvic floor with the intent of strengthening and exercising pelvic floor musculature. The methods of pelvic floor electrical stimulation vary in location, stimulus frequency (Hz), stimulus intensity or amplitude (mA), pulse duration (duty cycle), treatments per day, number of treatment days per week, length of time for each treatment session, overall time period for device use and between clinic and home settings. In general, the stimulus frequency and other parameters are chosen based on the patient's clinical diagnosis.

Non-implantable pelvic floor electrical stimulation is covered for the treatment of stress and/or urge urinary incontinence in cognitively intact, motivated patients who have failed a documented trial of pelvic muscle exercise (PME) training. Non-implantable pelvic floor electrical stimulation is only effective for patients with minimal to moderate anatomic defects. Coverage will be denied for treatment of patients with severe anatomic defects. The non-implantable pelvic floor electrical stimulation device for home use usually requires only one office visit for education and demonstration of the device. Additional visits may be given individual consideration with documentation to support additional visits. It is generally accepted that treatment with the non-implantable pelvic floor electrical stimulation device used in the physician's office requires five to six treatments. Additional treatments may be considered with additional documentation to support the medical necessity of additional treatments.

COLLAGEN OR SYNTHETIC IMPLANT

The collagen implant, which is injected into the submucosal tissues of the urethra and/or the bladder neck and into tissues adjacent to the urethra, is a prosthetic device used in the treatment of SI resulting from ISD. Coverage of a collagen implant, and the procedure to inject it, is limited to the following type of patients with SI due to ISD:

(1) Male or female patients with congenital sphincter weakness secondary to conditions such as myelomeningocele or epispadias or with acquired sphincter weakness secondary to spinal cord lesions;

(2) male patients following trauma, including prostatectomy and/or radiation; and

(3) female patients without hypermobility and with abdominal leak point pressures of 100 cm [H.sub.2]O or less.

Prior to collagen implant therapy, a skin test for collagen sensitivity must be administered and evaluated over a 4-week period. The patient must have a negative response on the skin test with the implant material and should not have a history of severe allergies, anaphylaxis, nor be undergoing desensitization to meat products. In male patients, the evaluation must include a complete history and physical examination and a simple cystometrogram to determine that the bladder fills and stores properly. The patient is then asked to stand upright with a full bladder and to cough or otherwise exert abdominal pressure on his bladder. If the patient leaks, the diagnosis of ISD is established.

In female patients, the evaluation must include a complete history and physical examination (including a pelvic examination) and simple cystometrogram to rule out abnormalities of bladder compliance and abnormalities of urethral support. Following that determination, an abdominal leak point pressure (ALPP) test is performed. Leak point pressure, stated in cm [H.sub.2] O, is defined as the intraabdominal pressure at which leakage occurs from the bladder (around a catheter) when the bladder has been filled with a minimum of 150 cc fluid. If the patient has an ALPP of less than 100 cm [H.sub.2]O, the diagnosis of ISD is established.

Patients whose incontinence does not improve with five injection procedures (five separate treatment sessions) are considered treatment failures, and no further treatment by collagen implant is covered. Patients who have a recurrence of incontinence following successful treatment with collagen implants in the past (eg, 6 to 12 months previously) may benefit from additional treatment sessions. Coverage of additional sessions may be allowed but must be supported by medical justification. Collagen implants should not be used in patients with bladder neck or urethral strictures until such strictures have been corrected. The physician must have urology training in the use of a cystoscope and must complete a collagen implant training program.

SACRAL NERVE STIMULATION

Effective January 1, 2002, sacral nerve stimulation is covered for the treatment of (1) urinary urge incontinence, (2) urgency-frequency syndrome, and (3) urinary retention. Sacral nerve stimulation involves both a temporary test stimulation to determine whether an implantable stimulator would be effective and a permanent implantation in appropriate candidates. Both the test and the permanent implantation are covered. The following limitations for coverage apply to all three indications:

* Patients must be refractory to conventional therapy (documented behavioral, pharmacologic, and/or surgical corrective therapy) and be an appropriate surgical candidate such that implantation with anesthesia can occur.

* Patients with stress incontinence urinary obstruction, and specific neurologic diseases (eg, diabetes with peripheral nerve involvement) which are associated with secondary manifestations of the above three indications are excluded.

* Patients must have had a successful test stimulation in order to support subsequent implantation. Before a patient is eligible for permanent implantation, he/she must demonstrate a 50% or greater improvement through test stimulation. Improvement is measured through voiding diaries.

* Patients must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.

Documentation must be provided indicating that the conservative forms of treatment have been tried and failed prior to the test stimulation. There must also be documentation in the patient's record of the trial test stimulation with the patient's response. The medical record should document how the significant symptoms of urinary incontinence or retention have affected the patient's ability to work or perform activities outside the home.

TREATMENT CODES WITH ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY

Biofeedback: CPT codes 90901 and 90911

599.82   Intrinsic (urethral) sphincter
         deficiency (ISD)
625.6    Stress incontinence, female
728.2    Muscular wasting and disuse atrophy,
         not elsewhere classified
788.30-  Incontinence of urine
788.39   (code 1st underlying condition)

Pelvic Floor Electrical Stimulator:
CPT code 97014

599.82   Intrinsic (urethral) sphincter
         deficiency (ISD)
625.6    Stress incontinence, female
788.31   Urge incontinence
788.32   Stress incontinence, male
788.33   Mixed incontinence, (male) (female)

Sacral Nerve Stimulation: ICD-9-CM
codes that support nedical necessity

596.55   Detrusor sphincter dyssynergia
788.20-  Retention of urine
788.29
788.31   Urge incontinence
788.41   Urinary frequency

CPT and HCPCS codes used in sacral
nerve stimulation:

64561    Percutaneous implantation of
         neurostimulator electrodes;
         sacral nerve (transforaminal
         placement)
64581    Incision for implantation of
         neurostimulator electrodes;
         sacral nerve (transforaminal
         placement).
64585    Revision or removal of
         peripheral neurostimulator
         electrodes

64590    Incision and subcutaneous
         placement of peripheral
         neurostimulator pulse generator
         or receiver, direct or
         inductive coupling

64595    Revision or removal of
         peripheral neurostimulator
         pulse generator or receiver.

A4290    Sacral nerve stimulation test
         lead, each

E0752    Implantable neurostimulator
         electrodes, each

E0756    Implantable neurostimulator
         pulse generator.

ICD-9-CM Codes that support
medical necessity for coverage
of Periurethral Bulking
Injections:

599.82   Intrinsic (urethral) sphincter
         deficiency (ISD)
G0025    Collagen skin test

L8603    Collagen implant, urinary tract,
         per 2.5 cc syringe, (includes
         shipping and necessary
         supplies).

L8606    Injectable bulking agent,
         synthetic implamt, urinary
         tract, 1 mL syringe (includes
         shipping and necessary
         supplies).

51715    Endoscopic injection of
         implant material into the
         submucosal tissues of the
         urethra and/or bladder
         neck.

95028    Intracutaneous (intradermal)
         tests with allergenic extracts,
         delayed type reaction,
         including reading, specify
         number of tests.

For administration of skin test for implant material, CPT code 95028 must be used. HCPCS codes L8603 or L8606 should be submitted when implant material is injected in a physician's office.

From the Department of Practice Management Services, SMA Services, Inc., a subsidiary of Southern Medical Association, 35 Lakeshore Dr, P0 Box 190088, Birmingham, AL 35219-0088.

References

(1.) West Virginia Local Medical Review Policy. Available at http://www.nationwide-medicare.com.

(2.) Coverage and Billing of Sacral Nerve Stimulation. DHHS, CMS Transmittal AB-01-166, November 15, 2001. CMS-Pub. 60A/B. Available at http://www.hcfa.gov/pubforms/transmit/2001/memos/comm_date_dsc.htm

(3.) CPT codes, descriptions and other data only are copyright 2001 American Medical Association.