Spinal cord stimulation delivers low-voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain; this is achieved through a surgically implanted spinal cord stimulation device, which comes equipped with a radiofrequency receiver. The neurostimulator device is also issued with a standard power source (battery) that can be implanted or worn externally. Other neurostimulators target the dorsal root ganglion.
For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive standard spinal cord stimulation, the evidence includes systematic reviews and randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Available RCTs are heterogeneous regarding underlying diagnoses in select patient populations. However, the trials including patients with underlying neuropathic pain processes have shown a significant benefit with spinal cord stimulation. Systematic reviews have supported the use of spinal cord stimulation to treat refractory trunk or limb pain, and patients who have failed all other treatment modalities have few options. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive high-frequency spinal cord stimulation, the evidence includes a systematic review and RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Two RCTs that enrolled participants not previously treated with spinal cord stimulation reported clinically and statistically significant benefits associated with high-frequency spinal cord stimulation. Another RCT in patients who had chronic pain despite previous treatment with standard spinal cord stimulation found no benefit for those receiving high-frequency stimulation compared with sham-control; however, it is difficult to compare these findings with other trials of spinal cord stimulation due to the different patient populations, short treatment periods, and the crossover period effect. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive dorsal root ganglion neurostimulation, the evidence includes a systematic review, an RCT, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The unblinded RCT found that patients receiving dorsal root ganglion neurostimulation had significantly higher rates of treatment success (physical functioning score and quality of life measures), at 3 and 12 months compared with those receiving standard spinal cord stimulation devices. Dorsal root ganglion neurostimulation was found to be noninferior to spinal cord stimulation in the percentage achieving >50% pain reduction, emotional functioning score, and 36-Item Short-Form Health Survey scores. Both groups experienced paresthesias but patients in the dorsal root ganglion group reported less postural variation in paresthesia and reduced extraneous stimulation in nonpainful areas. Rates of serious adverse events were similar between the 2 study arms. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have critical limb ischemia who receive spinal cord stimulation, the evidence includes systematic reviews of several small RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. In pooled analyses, spinal cord stimulation was associated with a lower risk of amputation versus control, but results were not consistently statistically significant due to differences in methodologies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have treatment-refractory angina pectoris who receive spinal cord stimulation, the evidence includes systematic reviews and RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. Numerous small RCTs have evaluated spinal cord stimulation as a treatment for refractory angina. While some have reported benefits, most have not. In 2 recent RCTs, there was no significant benefit in the primary outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have heart failure who receive spinal cord stimulation, the evidence includes RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. An RCT (N=66) comparing spinal cord stimulation using active stimulation with sham-control in patients who had New York Heart Association functional class III heart failure and a left ventricular ejection fraction of 35% or less did not find significant differences between groups, but might have been underpowered to do so. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.
For individuals who have cancer-related pain who receive spinal cord stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, medication use, and treatment-related morbidity. No RCTs evaluating spinal cord stimulation in this population were identified. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.
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.
Spinal cord stimulation with standard or high-frequency stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies when performed according to policy guidelines.
Dorsal root ganglion neurostimulation is considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies when performed according to policy guidelines.
Spinal cord stimulation is considered investigational in all other situations including, but not limited to, treatment of critical limb ischemia to forestall amputation and treatment of refractory angina pectoris, heart failure, and cancer-related pain.
| CPT | 63650 | Percutaneous implantation of neurostimulator electrode array; epidural |
| 63655 | Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural | |
| 63661 | Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed | |
| 63662 | Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed | |
| 63663 | Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed | |
| 63664 | Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed | |
| 63685 | Insertion or replacement of spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver (revised eff 01/01/2024) | |
| 63688 | Revision or removal of implanted spinal neurostimulator pulse generator or receiver, with detachable connection to electrode array (revised eff 01/01/2024) | |
| 95970-95972 | Neurostimulator programming and analysis code range |
| HCPCS | C1767 | Generator, neurostimulator (implantable), nonrechargeable |
| C1778 | Lead, neurostimulator (implantable) | |
| C1787 | Patient programmer, neurostimulator | |
| C1820 | Generator, neurostimulator (implantable), with rechargeable battery and charging system (to be used for non-high frequency generators) | |
| C1822 | Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system | |
| C1826 | Generator, neurostimulator (implantable), includes closed feedback loop leads and all implantable components, with rechargeable battery and charging system | |
| C1883 | Adaptor/extension, pacing lead or neurostimulator lead (implantable) | |
| C1897 | Lead, neurostimulator test kit (implantable) | |
| L8679 | Implantable neurostimulator pulse generator, any type | |
| L8680 | Implantable neurostimulator electrode, each | |
| L8685 | Implantable neurostimulator pulse generator, single array, rechargeable, includes extension | |
| L8686 | Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension | |
| L8687 | Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension | |
| L8688 | Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension | |
| ICD-10-CM | This list is a representative list of severe and chronic pain of the trunk and limbs diagnosis codes | |
| G56.40-G56.43 | Causalgia of upper limb code range | |
| G57.70-G57.73 | Causalgia of lower limb code range | |
| G89.21-G89.29 | Chronic pain, not elsewhere classified, code range | |
| G89.4 | Chronic pain syndrome | |
| G90.50-G90.59 | Complex regional pain syndrome I (CRPS I), code range | |
| M25.50-M25.579 | Pain in joint, code range | |
| M54.10-M54.18 | Radiculopathy, code range | |
| M54.30-M54.32 | Sciatica, code range | |
| M54.40-M54.42 | Lumbago with sciatica, code range | |
| M54.50-M54.59 | Low back pain, code range | |
| M54.6 | Pain in thoracic spine | |
| M54.81, M54.89 | Other dorsalgia codes | |
| M54.9 | Dorsalgia, unspecified | |
| M79.10-M79.18 | Myalgia code range | |
| M79.601-M79.676 | Pain in limb, hand, foot, fingers and toes code range | |
| R52 | Pain, unspecified |
| ICD-10-PCS | ICD-10-PCS codes are only used for inpatient services | |
| 00HU0MZ, 00HU3MZ,00HU4MZ | Surgical, central nervous system, insertion, spinal canal, neurostimulator lead, code by approach | |
| 00HV0MZ, 00HV3MZ, 00HV4MZ | Surgical, central nervous system, insertion, spinal cord, neurostimulator lead, code by approach | |
| 00WU0MZ, 00WU3MZ, 00WU4MZ | Surgical, central nervous system, removal, spinal canal, neurostimulator lead, code by approach | |
| 00PV0MZ, 00PV3MZ, 00PV4MZ | Surgical, central nervous system, removal, spinal cord, neurostimulator lead, code by approach | |
| 00WU0MZ, 00WU3MZ, 00WU4MZ | Surgical, central nervous system, revision, spinal canal, neurostimulator lead, code by approach | |
| 00WV0MZ, 00WV3MZ, 00WV4MZ | Surgical, central nervous system, revision, spinal cord, neurostimulator lead, code by approach | |
| 0JH60M6, 0JH60M7, 0JH60M8, 0JH60M9, 0JH63M6, 0JH63M7, 0JH63M8, 0JH63M9, 0JH70M6, 0JH70M7, 0JH70M8, 0JH70M9, 0JH73M6, 0JH73M7, 0JH73M8, 0JH73M9, 0JH80M6, 0JH80M7, 0JH80M8, 0JH80M9, 0JH83M6, 0JH83M7, 0JH83M8, 0JH83M9 | Surgical, subcutaneous tissue and fascia, insertion, stimulator generator, code by body part, approach, number of arrays and whether rechargeable or not | |
| 0JPT0MZ, 0JPT3MZ | Surgical, subcutaneous tissue and fascia, removal, subcutaneous tissue and fascia, trunk, stimulator generator, code by approach (there aren’t ICD-10-PCS codes for removal of stimulator generator from other body parts) | |
| Type of service | Surgical | |
| Place of service | Inpatient/Outpatient |
Candidate selection focuses on determining whether the individual is refractory to other types of treatment. The following considerations may apply.
The treatment is used only as a last resort; other treatment modalities (pharmacologic, surgical, psychological, physical, if applicable) have failed or are judged to be unsuitable or contraindicated;
Pain is neuropathic in nature (ie, resulting from actual damage to the peripheral nerves). Common indications include, but are not limited to, failed back surgery syndrome, complex regional pain syndrome (ie, reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy, and painful diabetic neuropathy. Spinal cord stimulation is generally not effective in treating nociceptive pain (resulting from irritation, not damage to the nerves) and central deafferentation pain (related to central nervous system damage from a stroke or spinal cord injury);
No serious untreated drug habituation exists;
Demonstration of at least 50% pain relief with a temporarily implanted electrode precedes permanent implantation;
All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, and follow-up of the individual are available.
"Burst" neurostimulation is an alternate programming of a standard spinal cord stimulation device. A clinician programmer application is used to configure a standard spinal cord stimulation device to provide stimulation in "bursts" rather than at a constant ("tonic") rate.
