Sacral Nerve Stimulation for Urinary Incontinence CPT 64561, 64581, A4290, L8680

Sacral nerve stimulation is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder function. This treatment is one of several alternative modalities for patients with urge urinary incontinence whose incontinence has been refractory to behavioral and pharmacologic treatment.

This treatment involves electrical stimulation of the sacral nerves in the lower region of the spine via a totally implantable system. System components include a lead, an implantable pulse generator and an extension that connects the lead to the pulse generator. It is expected that the physician performing this service has completed a training course in the use and implantation of the device.

Sacral nerve stimulation is covered for the following indications and limitations under CMS National Coverage Determination 230.18:

Indications:

• Urinary urge incontinence.
• Urgency-frequency syndrome.
• Urinary retention.

Sacral nerve stimulation involves both a temporary test stimulation to determine if an implantable stimulator would be effective and a permanent implantation is appropriate for candidates. Both the test and the permanent implantation are covered.

Limitations:

• Patient 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 disease (e.g., diabetes with peripheral nerve involvement) that are associated with secondary manifestations of the above three indications are excluded.
• Patient 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 percent or greater improvement through test stimulation. Improvement is measured through voiding diaries.
• Patient must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.

Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:

• Safe and effective.
• Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
• Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
  • Furnished in a setting appropriate to the patient’s medical needs and condition.
  • Ordered and furnished by qualified personnel.
  • One that meets, but does not exceed, the patient’s medical need.
  • At least as beneficial as an existing and available medically appropriate alternative.

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

12X, 13X, 83X, 85X

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/orRevenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Publication 100-04, Claims Processing Manual, for further guidance.

036X

CPT/HCPCS Codes

Note:	Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
64561©	Implant neuroelectrodes
64581©	Implant neuroelectrodes
64585©	Revise/remove neuroelectrode
A4290	Sacral nerve stimulation test lead, each (Part B only)
L8680	Implt neurostim elctr each (Part B only)

ICD-9-CM Codes that Support Medical Necessity

The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.

Medicare is establishing the following limited coverage for CPT/HCPCS codes 64561, 64581 and A4290:

596.52	Low bladder compliance
596.55	Detrusor sphincter dyssynergia
788.20–788.21	Retention of urine
788.29	Other specified retention of urine
788.30–788.33	Urinary incontinence
788.41	Urinary frequency
788.64	Urinary hesitancy
788.91	Functional urinary incontinence
788.99	Other symptoms involving urinary system

Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.

Note: CPT/HCPCS codes L8680 and 64585 are used for various other services. Medicare is not establishing limited coverage for these codes at this time.

Diagnoses That Support Medical Necessity

N/A

ICD-9-CM Codes That DO NOT Support Medical Necessity

N/A

Diagnoses That DO NOT Support Medical Necessity

All diagnoses not listed in the “ICD-9-CM Codes that Support Medical Necessity” section of this LCD.

Documentation Requirements

Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.

Documentation must include objective evidence supporting a covered indication and objective evidence that the nationally prescribed indications and limitations are met. Such documentation should include the conservative measure used, the length of time it was tried, and any other information to support coverage.

Appendices

N/A

Utilization Guidelines

This treatment is one of several alternative modalities for patients with urge urinary incontinence who have not responded to more conservative treatment for at least six months.

Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.