For services prior to June 18, 2011, see policy N-85.

This policy addresses coverage guidelines for spinal cord stimulation (dorsal column stimulation).

Spinal cord stimulation blocks pain conduction pathways to the brain and may stimulate endorphins. The neurostimulator electrodes used for this purpose are implanted percutaneously in the epidural space through a special needle. Some patients may need an open procedure requiring laminectomy to place the electrodes.

After placement of the electrodes, the patient is provided with an external neurostimulator, initially on a trial basis. The trial period may be extended up to four weeks. If during the trial period it is determined that the modality is not effective or it is not acceptable to the patient, the electrodes may be removed.

If the trial has been successful, a spinal neurostimulator and pulse generator are inserted subcutaneously and connected to the implanted electrodes. In some cases, the trial may be conducted using temporary electrodes.

Indications

Dorsal column stimulators may be covered as therapies for the relief of chronic intractable pain under the following circumstances:

• To treat chronic pain caused by lumbosacral arachnoiditis that has not responded to medical management including physical therapy. (Presence of arachnoiditis is usually documented by presence of high levels of proteins in the Cerebrospinal Fluid (CSF) and/or by myelography or Magnetic Resonance Imaging (MRI).
  
  
• To treat intractable pain caused by nerve root injuries, postsurgical or post-traumatic including that of postlaminectomy syndrome (failed back syndrome).
  
  
• To treat intractable pain caused by complex regional pain syndrome I and II.
  
  
• To treat intractable pain caused by phantom limb syndrome that has not responded to medical management.
  
  
• To treat intractable pain caused by end stage peripheral vascular disease, when the patient cannot undergo revascularization or when revascularization has failed to relieve painful symptoms and the pain has not responded to medical management.
  
  
• To treat intractable pain caused by postherpetic neuralgia.
  
  
• To treat intractable pain caused by plexopathy.
  
  
• To treat intractable pain caused by intercostal neuralgia that did not respond to medical management and nerve blocks.
  
  
• To treat intractable pain caused by cauda equina injury.
  
  
• To treat intractable pain caused by incomplete spinal cord injury.

Limitations

No payment may be made for the implantation of dorsal column stimulators or services and supplies related to such implantation unless all the following conditions have been met:

• The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain.
  
  
• Other treatment modalities (pharmacological, surgical, physical or psychological therapies) have been tried and did not prove satisfactory or are judged unsuitable or contraindicated for the given patient.
  
  
• Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation (such screening must include psychological as well as physical evaluation).
  
  
• All facilities, equipment and personnel required for the proper diagnosis, treatment, training and follow-up of the patient must be available.
  
  
• Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation.

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally accepted standards of practice.

Generally, the physician should be able to determine whether the patient is likely to derive a significant therapeutic benefit from continuing use of an implanted nerve stimulator within a trial period of four weeks. In a few cases, this determination may take longer to make. Documentation of the medical necessity for such diagnostic services furnished beyond four weeks must be provided upon request for redetermination.

Generally, electronic analysis services (procedure codes 95970-95973) are not considered medically necessary when provided at a frequency more often than once every 30 days. More frequent analysis may be necessary in the first month after implantation.

Documentation Requirements

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

For procedure codes 63663 and 63664, documentation must include the date the initial insertion was performed.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medicare Benefit Policy Manual - Pub. 100-02.

Medicare National Coverage Determinations Manual - Pub. 100-03, - Chapter 1, Section 160.7 (specific to the coverage of electrical nerve stimulators).

Correct Coding Initiative - Medicare Contractor Beneficiary and Provider Communications Manual - Pub. 100-09, Chapter 5.

Social Security Act (Title XVIII) Standard References, Sections:

• 1862 (a)(1)(A) Medically Reasonable & Necessary.
• 1862 (a)(1)(D) Investigational or Experimental.
• 1833 (e) Incomplete Claim.

Covered Diagnosis Codes

For procedure codes 63650, 63655, and 63685:

Note: Although both the primary and secondary diagnoses must be present on the claim, the order in which these diagnoses are reported on the claim does not impact payment.

Primary Diagnosis Codes

Secondary Diagnosis Codes

Non-Covered Diagnosis Codes

For procedure codes 63650, 63655 and 63685:

Note: codes L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8695 and L8699 are used for various other services. Limited coverage for these codes is not established at this time.