Related Policies:

Medical Policy III.215 Deep Brain Stimulation

Medical Policy III.216 Vagus Nerve Stimulation

Medical Policy III.217 Gastric Stimulation 

I.                A temporary trial Spinal cord stimulator and dorsal ganglion root stimulator insertion may be consisdered Medically Necessary when the following criteria are met:

A.      A diagnosis of failed back surgery syndrome

1.       Patient is 18 years of age or older  AND

2.       ALL the following:

                                     a.  refractory pain following lumbar surgery AND

                                                                                                                         b.   Pain interferes with ADLS AND

                                                                                                                          c.   Continued pain after treatment for equal to or greater than 6 months AND

                                                                                                                         d.      Patient is not a candidate for additional back surgery AND

                                              AND

                                     6.    Patient does NOT have any of the following:

                                              a.  spinal cord compression by history, exam or imaging

                                              b.  mechanical spinal instability by imaging

                c. untreated or uncontrolled psychiatric disorder 

                d. drug or alcohol misuse (patient must be alcohol free for at least 4 weeks)

                e. active immunosuppression 

                f. bleeding disorder

                g. systemic or localized infection at operative site

                h.  cardiac pacemaker, implantable cardioverter or other neurostimulator

                i. pregnant        

B.     Complex regional pain syndrome

1.       Patient is 18 years of age or older AND

2.       Pain or burning that is disproportionate to the inciting event  (may be intermittent or continuous) AND

3.       Patient has two or more of the following involving digit or extremity

                                                                                                 a.       Swelling or tenderness

                                                                                                 b.      Cyanotic or red or pale digit or extremity

                                                                                                  c.      Increased sweating

                                                                                                 d.      Alteration of temperature

                                                                                                 e.      Trophic skin changes

                                                                                                   f.      Flexion contractures

            AND

4.        Patient has tried and failed ALL the following:

                                                                                                 a.      Patient has had a sympathetic block AND

                                                 b.   Home exercise, occupation therapy or physical therapy for 6 months or more AND

                                                                                                  c.     Antidepressant or anti-epileptic drugs for 4 weeks or more

                                       AND

                                       5.    Patient does NOT have any of the following:

                a. untreated or uncontrolled psychiatric disorder 

                b. drug or alcohol misuse (patient must be alcohol free for at least 4 weeks)

                c. active immunosuppression 

                d. bleeding disorder

                e. systemic or localized infection at operative site

                f.  cardiac pacemaker, implantable cardioverter or other neurostimulator

                g. pregnant        

C.    Peripheral Diabetic Neuropathy

1.       Patient is 18 years of age or older AND

2.       Patient has refractory pain or burning in area  AND

3.     Patient has two of the following:

     a.  numbness

     b.  sensory loss 

     c.  paresthesia 

AND

4.       Patient has tried and failed both of the following

                     a.  home exercise, occupational therapy,, or physical therapy for 6 months or more  AND

                     b.  antidepressant or antiepileptic drugs for 4 weeks or more 

AND

5.    Patient does NOT have any of the following:

                a. untreated or uncontrolled psychiatric disorder 

                b. drug or alcohol misuse (patient must be alcohol free for at least 4 weeks)

                c. active immunosuppression 

                d. bleeding disorder

                e. systemic or localized infection at operative site

                f.  cardiac pacemaker, implantable cardioverter or other neurostimulator

                g. pregnant                 

II.              A temporary trial spinal cord stimulator is not Medically Necessary for all other indications. 

III.             A permanent spinal cord stimulator or dorsal ganglion root stimulator insertion imay be considered Medically Necessary for failed back surgery syndrome, complex regional pain syndrome, or diabetic peripheral neuropathy when the following criteria are met:

A.     Trial was performed and the trial period was equal to or greater than 3 days  AND

B.     Patient has documented pain reduction equal to or greater than 50%  AND

C.    Patient has demonstrated understanding use of the stimulator during the trial period.

IV.             A permanent spinal cord stimulator or dorsal ganglion root stimulator insertion is considered not Medically Necessary for all other indications and when the above criteria are not met. 

V.                Battery replacement and revision or replacement of an approved, implanted neurostimulator pulse generator may be considered medically necessary when the battery is at end-of-life status or the device is no longer functioning properly.

VI.              Electronic analysis of an approved, implanted neurostimulator pulse generator (CPT 95970-95972) will be allowed up to 3 times after the initial placement of the stimulator. Prior authorization based on medical necessity is required for additional analyses.

VII.             Removal of an approved, implanted neurostimulator pulse generator does not require prior authorization.

CHRONIC PAIN

Spinal cord stimulation (SCS) has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome (ie, chronic reflex sympathetic dystrophy). There has also been interest in SCS as a treatment of critical limb ischemia, primarily in patients who are poor candidates for revascularization and in patients with refractory chest pain.

Spinal Cord Stimulation

SCS—also called dorsal column stimulation—involves the use of low-level epidural electrical stimulation of the spinal cord dorsal columns. The neurophysiology of pain relief after SCS is uncertain but may be related to either activation of an inhibitory system or blockage of facilitative circuits.

SCS devices consist of several components: (1) the lead that delivers the electrical stimulation to the spinal cord; (2) an extension wire that conducts the electrical stimulation from the power source to the lead; and (3) a power source that generates the electricity. The lead may incorporate from 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns. There are 2 basic types of power source: one type, the power source (battery), can be surgically implanted or worn externally with an antenna over the receiver; the other, a radiofrequency receiver, is implanted. Totally implantable systems are most commonly used.

The patient’s pain distribution pattern dictates at what level of the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used. For example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. Implantation of the spinal cord stimulator is typically a 2-step process. Initially, the electrode is temporarily implanted in the epidural space, allowing a trial period of stimulation. Once treatment effectiveness is confirmed (defined as at least 50% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted.

Successful SCS may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels.

Traditional SCS devices use electrical stimulation with a frequency of 100 to 1000 Hz. In 2015, an SCS device, using a higher frequency (10,000 Hz) than predicate devices, was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. High-frequency stimulation is proposed to be associated with fewer paresthesias, which are a recognized effect of SCS. In 2016, FDA approved a clinician programmer application that allows an SCS device to provide stimulation in bursts rather than at a constant rate. Burst stimulation is proposed to relieve pain with fewer paresthesias. The burst stimulation device works in conjunction with standard SCS devices. With the newly approved app, stimulation is provided in five 500-Hz burst spikes at a rate of 40 Hz, with a pulse width of 1 ms