Clinical Policy Title: Dorsal root ganglion stimulation

Transcription

1 Clinical Policy Title: Dorsal root ganglion stimulation Clinical Policy Number: Effective Date: February 1, 2018 Initial Review Date: November 16, 2017 Most Recent Review Date: January 11, 2018 Next Review Date: January 2019 Policy contains: Dorsal root ganglion stimulation. Spinal cord stimulation. Related policies: CP# CP# CP# CP# Spine pain non-surgical Spinal cord stimulators for chronic pain Spine pain trigger point injections Spine pain facet joint injections ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers dorsal root ganglion stimulation for spine pain management to be investigational/experimental, and therefore not medically necessary. Limitations: None. Alternative covered services: Conventional spinal cord stimulation. Epidural steroid injections. Facet joint injections. Trigger point injections. 1

2 Background Spine pain is a common disorder, associated with improper position or movement of the vertebrae and connecting muscles, nerves, and bones in the spinal column. It may originate from within the spinal column, or manifest as referred pain from another organ. Most cases of spine pain are acute, and will resolve within weeks without major medical interventions often without knowing the cause. Some cases can be chronic, and require medical intervention. A number of therapies can be used for spine pain. Many treatments are non-invasive, including heat treatments, cold compression, medications, exercises, stress reduction, and massage. Other cases can be treated with chiropractic manipulation, acupuncture, laser therapy, various types of injections, and electrotherapies such as transcutaneous electrical nerve stimulation. Those who do not respond to these treatments may be candidates for surgery. One approach to treatment is spinal cord stimulation, which has become more widely used in managing chronic pain unresponsive to more conservative therapies (Jeon, 2012). This approach can involve several modalities, including burst stimulation, high-frequency stimulation, and dorsal root ganglion stimulation (Wong, 2017). A ganglion is a nerve cell cluster comprising small, smooth, round swellings of thick jelly-like material in the autonomic nervous system and sensory system (Harding, 2016). Dorsal root ganglia are located between spinal nerves and the spinal cord, and contain cell bodies of sensory neurons, carrying neural signals from the central to the peripheral nervous system. Dorsal nerve roots control pain and temperature, and can lead to numbness. Causes of dorsal root pain include injury, degenerative disc disease, herniated disc, and bulging disc (LSI, 2017). Spinal nerves in the dorsal root ganglion branch out from the dorsal column to different parts of the body. The stimulator of the dorsal root ganglion treats chronic pain, especially in difficult areas like the hand, chest, abdomen, foot, knee, and groin, as well as the spine. It threads electric leads into the epidural space and into the intervertebral foramen; each lead is tipped by four electrode contacts placed over the ganglion. After surgery, leads can be programmed to stimulate different parts of the dorsal root ganglia, based on a pain pattern, and patients are sent home with a hand-held controller (Deer, 2016). The stimulation is a pulse. In an early study of 76 patients with chronic lumbosacral radicular pain, 70 percent who received pulsed frequency to the dorsal root ganglion/nerve had successful pain reduction after two months. For those initially receiving pulsed frequency, 82 percent had such a reduction; the difference between the two were not statistically significant (Simopoulos, 2008). The U.S. Food and Drug Administration (FDA) approved the St. Jude Medical Asium TM Neurostimulator system for dorsal root ganglion stimulation in February 2016 (St. Jude Medical, 2016). In August 2016, the FDA cleared the Freedom Spinal Cord Stimulator for marketing to treat intractable pain in the trunk and/or lower limbs, including dorsal root ganglion stimulation. 2

3 A guideline from the American Society of Interventional Pain Physicians on ways to manage chronic spinal pain does not mention dorsal root ganglion stimulation (Manchikanti, 2013). The International Association for the Study of Pain s Neuropathic Pain Special Interest Group mentioned dorsal root ganglion stimulation and cited several randomized controlled trials, but made no recommendation on use of this technique (Dworkin, 2013). The American Society of International Pain Physicians issued a guideline on continuing pain from angina in 2007 and updated it in 2011 and 2013; spinal cord stimulation was included in recommendations, but dorsal root ganglion stimulation was not specifically mentioned (Anderson, 2007; Anderson, 2011; Anderson, 2013). Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on October 23, Search term was: dorsal root ganglion stimulation. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Well-designed studies on effectiveness of dorsal root ganglion stimulation are limited (Liem, 2015). A group of Dutch researchers contend that the critical role of the dorsal root ganglion in pain has been overlooked, and that more studies might reveal effective new options for pain management (Liem, 2016). Another group from the Hospital of the University of Pennsylvania notes that spinal cord stimulation has been shown to be superior to conservative medical management after failed back surgery, and thus preliminary results of newer stimulation technologies (including dorsal root ganglion stimulation) find promising results for even better outcomes (Song, 2014). Although there is some evidence on efficacy of this technique, studies are needed to better understand long-term effects (Forget, 2015). 3

4 One systematic review identified six studies on neurostimulation of the dorsal root ganglion (compared to seven other studies of other forms of intraspinal stimulation), noting that dorsal root stimulation of the spinal cord provides less than optimal pain relief for certain pain syndromes (Chang Chien, 2017). Another systematic review of 16 studies that compared three approaches to reduce chronic pain via the dorsal root ganglion found limited information to draw conclusions (Pope, 2013). As of September 2017, a summary of the literature on dorsal root ganglion stimulation is still incomplete, but authors state that there is now good randomized clinical trial evidence that DRGS provides superior pain relief to spinal cord stimulation for neuropathic pain (Harrison, 2017). A Hayes review from July 2017 of 15 studies (n=225) reviewed abstracts, but noted that full text review is required to confirm abstract content and, therefore, conclusions about the safety and effectiveness could not be made at the time (Hayes, 2017). A recent randomized controlled trial of 152 persons with complex regional pain syndrome or causalgia in the lower extremities compared pain relief of those undergoing dorsal root ganglion stimulation to those given conventional spinal cord stimulation. The percentage of subjects who had greater than 50 percent pain relief after three months was significantly greater for the dorsal root ganglion group: 81.2 percent versus 55.7 percent, p<0.001 (Deer, 2017). A randomized controlled trial of 50 patients showed that as a means of controlling lumbosacral radicular pain, pulsed radiofrequency stimulation on the dorsal root ganglion can be used for controlling lumbosacral radicular pain. After three months of treatment, decreases in pain intensity over 50 percent were observed and were significantly greater for patients bipolar (76 percent) versus monopolar (50 percent) pulsed radiofrequency groups (Chang, 2017). Another randomized trial of 38 patients with spinal pain who were administered either epidural steroid injections or dorsal root ganglion stimulation showed both resulted in greatly reduced pain intensity scores after 12 weeks, but one treatment was not significantly greater than the other (Lee, 2016). One study analyzed the impact on pain of implanted dorsal root ganglion devices for persons with intractable pain in the back and/or lower limbs. After 12 months, pain was reduced by 56 percent, and 60 percent of subjects reported at least a 50 percent improvement in pain. Measures of quality of life and mood also improved. Authors speculate this technology yields comparable results to traditional spinal cord stimulation (Liem, 2015). Results were comparable to earlier findings after six months in the same study, with 32 subjects enrolled (Liem, 2013). Stimulation of the dorsal root ganglion can also be used for conditions other than spine pain. A noncontrolled review of 25 patients with neuropathic groin pain found that after an average of 27.8 weeks, 82.6 percent experienced at least a 50 percent reduction in their pain at latest follow up (Schu, 2015). A review of 32 patients tested whether dorsal root ganglion stimulation produces intensity changes when the patient is moved from a supine to an upright position, or vice versa (it is known that the change in stimulation intensity can alter intensity of paresthesias). The study showed neuromodulation of the group undergoing dorsal root ganglion stimulation may be less susceptible to these side effects than dorsal column stimulation (Kramer, 2015). Policy updates: 4

5 None. Summary of clinical evidence: Citation Chang Chien (2017) Comparison of types of spinal cord stimulation Deer (2017) Dorsal root ganglion stimulation for complex regional pain and causalgia in lower extremities Song (2014) Review of various types of stimulation to control spinal pain Pope (2013) Review of chronic pain care methods addressing the dorsal root ganglion Content, Methods, Recommendations Key points: Review of 13 articles including cervicomedullary junction, dorsal root ganglion, and conus medullaris neurostimulation. Authors suggest intraspinal stimulation of non-dorsal column targets (the three listed above) might become the preferred mode of neurostimulation as it may be more effective for targets not easily addressed with conventional spinal cord stimulation. Three listed therapies may avoid undesired stimulation induced paraesthesia, particularly in nonpainful areas of the body. Key points: Randomized controlled trial of 152 subjects, receiving either neurostimulation of dorsal root ganglion or conventional dorsal spinal cord stimulation. The dorsal root ganglion group had a higher proportion of subjects with at least a 50 percent reduction in pain (81.2% versus 55.7%, p < 0.001) after 12 months. Dorsal root ganglion treatment also resulted in greater improvements in quality of life and psychological disposition, and less postural variation in paresthesia (p < 0.001). Dorsal root ganglion treatment reduced more extraneous stimulation in nonpainful areas (p = 0.014), suggesting it provided more targeted therapy to painful parts. Key points: Narrative review that shows spinal cord stimulation superior to conservative therapies and re-operation for spine pain after failed back syndrome. Percutaneous hybrid paddle leads, peripheral nerve field stimulation, nerve root stimulation, dorsal root ganglion, and high-frequency stimulation are being refined to address axial low back pain and foot pain. Dorsal root ganglion stimulation and hybrid leads have shown some promising preliminary results in nonrandomized observational trials. Key points: Systematic review of ganglionectomy (seven studies), conventional radiofrequency (14 studies), and pulsed radiofrequency (16 studies) of the dorsal root ganglion. Relatively poor information exists to evaluate efficacy of these strategies. More randomized trials are needed to better understand efficacy. References Professional society guidelines/other: 5

6 Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-st-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007;50(7):e1 e157. Anderson JL, Adams CD, Antman EM, et al ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123(18):e426 e579. Anderson JL, Adams CD, Antman EM, et al ACCF/AHA focused update incorporated into the ACCF/AHA 2007 guidelines for the management of patients with unstable angina/non-st-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(23):e663 e828. Deer T. Dorsal Root Ganglion Stimulation. International Neuromodulation Society, May 3, Accessed September 28, Dworkin RH, O Connor AB, Kent J, et al. International Association for the Study of Pain; Neuropathic Pain Special Interest Group. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013;154(11): Harding M. Ganglion. Patient: Making Lives Better, last reviewed October 19, Accessed October 24, Hayes, Inc. Dorsal root ganglion (DRG) for the treatment of complex regional pain syndrome (CRPS) and lower back pain (LBP). Lansdale, PA: Hayes Inc., July 27, Laser Spine Institute (LSI). DRG (Dorsal Root Ganglion). LSI, Accessed October 24, Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013;16(2 Suppl):S49 - S283. St. Jude Medical Inc. St. Jude Medical Announces FDA Approval of a New Treatment Therapy for Patients Suffering from Chronic Intractable Pain. St. Paul, MN: St. Jude Medical,

7 Announces-FDA-Approval-of-a-New-Treatment-Therapy-for-Patients-Suffering-From-Chronic- Intractable-Pain/default.aspx. Accessed October 24, Peer-reviewed references: Baranidharan G, Titterington J. Recent advances in spinal cord stimulation for pain treatment. Pain Manag. 2016;6(6): Chang Chien GC, Mekhail N. Alternate intraspinal targets for spinal cord stimulation: A systematic review. Neuromodulation. 2017;20(7): Chang MC, Cho YW, Ahn SH. Comparison between bipolar pulsed radiofrequency and monopolar pulsed radiofrequency in chronic lumbosacral radicular pain: A randomized controlled trial. Medicine (Baltimore) Mar;96(9):e6236. doi: /MD Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4): Forget P, Boyer T, Steyaert A, et al. Clinical evidence for dorsal root ganglion stimulation in the treatment of chronic neuropathic pain. A review. Acta Anaesthesiol Belg. 2015;66(2): Harrison C, Epton S, Bolanic S, Green AL, FitzGerald JJ. The efficacy and safety of dorsal root ganglion stimulation as a treatment for neuropathic pain: a literature review. Neuromodulation Sep 28. Doi: /ner [Epub ahead of print]. Jeon YH. Spinal cord stimulation in pain management: a review. Korean J Pain. 2012;25(3): Kramer J, Liem L, Russo M, Smet I, Van Buyten JP, Huygen F. Lack of body positional effects on paresthesias when stimulating the dorsal root ganglion (DRG) in the treatment of chronic pain. Neuromodulation. 2015;18(1): Lee DG, Ahn SH, Lee J. Comparative effectiveness of pulsed radiofrequency and transforaminal steroid injection for radicular pain due to disc herniation: a prospective randomized trial. J Korean Med. Sci. 2016;31(8): Liem L, Russo M, Huygen FJ, et al. One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain. Neuromodulation. 2015;18(1):41 48; discussion Liem L, van Dongen E, Huygen FJ, Staats P, Kramer J. The Dorsal root ganglion as a therapeutic target for chronic pain. Reg Anesth Pain Med. 2016;41(4):

8 Pope JE, Deer TR, Kramer J. A systematic review: current and future directions of dorsal root ganglion therapeutics to treat chronic pain. Pain Med. 2013;14(10): Schu S, Gulve A, ElDabe S, et al. Spinal cord stimulation of the dorsal root ganglion for groin pain a retrospective review. Pain Pract. 2015;15(4): Simopoulos TT, Kraemer J, Nagda JV, Aner M, Bajwa ZH. Response to pulsed and continuous radiofrequency lesioning of the dorsal root ganglion and segmental nerves in patients with chronic lumbar radicular pain. Pain Physician. 2008;11(2): Song JJ, Popescu A, Bell RL. Present and potential use of spinal cord stimulation to control chronic pain. Pain Physician. 2014;17(3): Wong SS, Chan CW, Cheung CW. Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice. Hong Kong Med J. 2017;23(5): CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Percutaneous implantation of neurostimulator electrode array, epidural Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed 8

9 CPT Code Description Comments Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling Revision or removal of implanted spinal neurostimulator pulse generator or receiver Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming ICD-10 Code Description Comments G56.41 Causalgia of right upper limb G56.42 Causalgia of left upper limb G56.43 Causalgia of bilateral upper limbs G57.71 Causalgia of right lower limb G57.72 Causalgia of left lower limb G57.73 Causalgia of bilateral lower limbs G89.21 Chronic pain due to trauma G89.22 Chronic post-thoracotomy pain G89.28 Other chronic postprocedural pain G89.29 Other chronic pain G89.3 Neoplasm related pain (acute) (chronic) G89.4 Chronic pain syndrome G Complex regional pain syndrome I of right upper limb G Complex regional pain syndrome I of left upper limb G Complex regional pain syndrome I of upper limb, bilateral G Complex regional pain syndrome I of right lower limb G Complex regional pain syndrome I of left lower limb G Complex regional pain syndrome I of lower limb, bilateral G90.59 Complex regional pain syndrome I of other specified site 9

10 ICD-10 Code Description Comments M50.11 Cervical disc disorder with radiculopathy, occipito-atlanto-axial region M Cervical disc disorder at C4-C5 level with radiculopathy M Cervical disc disorder at C5-C6 level with radiculopathy M Cervical disc disorder at C6-C7 level with radiculopathy M50.13 Cervical disc disorder with radiculopathy, cervicothoracic region M51.14 Intervertebral disc disorders with radiculopathy, thoracic region M51.15 Intervertebral disc disorders with radiculopathy, thoracolumbar region M51.16 Intervertebral disc disorders with radiculopathy, lumbar region M51.17 Intervertebral disc disorders with radiculopathy, lumbosacral region M53.81 Other specified dorsopathies, occipito-atlanto-axial region M53.82 Other specified dorsopathies, cervical region M53.83 Other specified dorsopathies, cervicothoracic region M54.11 Radiculopathy, occipito-atlanto-axial region M54.12 Radiculopathy, cervical region M54.13 Radiculopathy, cervicothoracic region M54.14 Radiculopathy, thoracic region M54.15 Radiculopathy, thoracolumbar region M54.16 Radiculopathy, lumbar region M54.17 Radiculopathy, lumbosacral region M54.18 Radiculopathy, sacral and sacrococcygeal region M54.31 Sciatica, right side M54.32 Sciatica, left side M54.41 Lumbago with sciatica, right side M54.42 Lumbago with sciatica, left side M54.6 Pain in thoracic spine M54.81 Occipital neuralgia M79.2 Neuralgia and neuritis, unspecified M Pain in right arm M Pain in left arm M Pain in right leg M Pain in left leg M Pain in left upper arm M Pain in right forearm M Pain in left forearm M Pain in right hand M Pain in left hand M Pain in right finger(s) M Pain in left finger(s) M Pain in right thigh M Pain in left thigh M Pain in right lower leg M Pain in left lower leg M Pain in right foot M Pain in left foot M Pain in right toe(s) M Pain in left toe(s) 10

11 HCPCS Level II Code L8680 L8681 L8685 L8686 L8687 L8688 Description Implantable neurostimulator electrode, each Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension Comments 11