Clinical Policy Title: Spinal cord stimulators for chronic pain

Transcription

1 Clinical Policy Title: Spinal cord stimulators for chronic pain Clinical Policy Number: Effective Date: October 1, 2014 Initial Review Date: March 19, 2014 Most Recent Review Date: April 19, 2017 Next Review Date: April 2018 Policy contains: Spinal cord stimulator. Neuropathic pain. Failed back surgery syndrome. Complex regional pain syndrome. Related policies: CP# CP# CP# CP# CP# CP# CP# CP# CP# CP# CP# Ketamine therapy for CRPS Hierarchy of chronic pain Chiropractic care Radiofrequency ablation treatment for spine pain Intrathecal opioid therapy for chronic nonmalignant pain Spinal surgeries Spine pain epidural pain Biofeedback for chronic pain Spine pain facet joint injection Spine pain trigger point injection Cryoneurolysis ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First 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 peer-reviewed 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 Keystone First 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. Keystone First 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. Keystone First s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First s clinical policies are not guarantees of payment. Coverage policy Keystone First considers the use of spinal cord stimulators (SCS) to be clinically proven and, therefore, medically necessary when all of the following criteria are met: Diagnosed with neuropathic or other types of chronic and severe, intractable pain (e.g., failed back surgery syndrome [FBSS], complex regional pain syndrome [CPRS], or diabetic peripheral neuropathy [DPN]). 1

2 Documentation of: Ineffective results with more conservative approaches such as medications, physical therapy, surgery, psychological therapy, and other modalities. - Careful screening, evaluation (including behavioral health), and diagnosis by a multidisciplinary team prior to implantation. - Patient education, discussion, and disclosure of the risks and benefits of this therapy. - A temporary trial (three to seven days) with a percutaneously implanted neurostimulator electrode that resulted in significant pain reduction ( 50 percent). Implantation was performed in either: An acute care or outpatient hospital setting. An office setting if both criteria are met: o All the sterility, equipment, professional training, and support personnel required for the proper surgery and follow-up of the patient are available. o Physicians performing SCS trials in the office setting have like privileges at a local hospital. No contraindications to the procedure. Limitations: All other uses of SCS are not medically necessary, including treatment of refractory angina pectoris and cancer-related pain. Keystone First will reimburse for placement of a maximum of two leads or 16 contacts, and for two SCS trials per anatomic spinal region per patient per lifetime. If a trial fails, a repeat trial is not medically necessary unless there are extenuating circumstances that lead to trial failure. Appropriate medical documentation to support a repeat trial is required on appeal. Contraindications to SCS include: Anticoagulation disorders. Local or systemic sepsis. Immunosuppressive disorders. Pregnancy. Active or untreated abuse of alcohol, drugs, or medication. Major psychiatric disorders, including somatization. Severe cognitive impairment rendering a patient incapable of giving informed consent for the procedure or operating the device. Presence of a demand pacemaker or implanted defibrillator. Therapeutic diathermy. Alternative covered services: 2

3 Including, but not limited to, the following: Pharmaceuticals (e.g., analgesics, non-steroidal anti-inflammatories, and antidepressants). Chiropractic care. Surgery. Psychological/behavioral treatment. Physical therapy. Interventional procedures (e.g., nerve blocks, spinal injections) for administering local anesthesia. Trigger point injections. Transcutaneous electrical stimulation. Background Managing patients with chronic pain is intellectually and physically challenging. The underlying pain etiology is often difficult or impossible to diagnose with certainty, and patients may require special attention and be emotionally distraught when they present. The traditional approach of seeking an obscure organic pathology is often unhelpful for treating chronic pain. An emerging methodology of psychological evaluation and behavioral therapies may be more effective than the traditional therapies, particularly in multidisciplinary pain management settings. Areas in the patient s history to which special attention should be paid include depression (mood, appetite, sleep patterns and daily activity), pain occurring in multiple unrelated sites, a pattern of recurrent but separate pain episodes beginning in childhood or adolescence, pain beginning at a time of emotional trauma, physical or sexual abuse, and any pertinent history of substance abuse. Several factors may cause, perpetuate, or exacerbate chronic pain: A disease that is characteristically painful and without cure (such as arthritis, cancer, fibromyalgia, chronic daily headaches and diabetic neuropathy). Secondary perpetuating factors initiated by disease and persisting after resolution (such as damaged sensory nerves, sympathetic efferent activity, and painful reflex muscle contraction). A variety of psychological conditions, such as depression. Some newer, relatively invasive procedures may benefit patients with chronic pain when they are applied judiciously. These include image-guided interventions (epidural injections of glucocorticoids for radicular pain), radiofrequency treatment of facet joints, and implanted intra-spinal electrodes. SCS: SCS is an implanted device that electrically stimulates a patient's spinal cord to relieve severe, intractable pain. Its mechanism of action directs mild electrical pulses to interfere with pain messages 3

4 reaching the brain. SCS consists of a receiver with thin wire electrodes placed in the epidural space and a generator that transmits pulses across the patient's skin to the receiver (21CFR ). SCS placement consists of a short trial with an externally-placed pulse generator to determine efficacy and patient acceptability, followed by subcutaneously implanting the generator. SCS is a reversible procedure. There are two types of SCS an implantable pulse generator (IPG) or radio frequency (RF) (Food and Drug Administration [FDA, 2017). The IPG contains either a chargeable or rechargeable battery. A chargeable battery requires a minor surgical procedure when the battery needs replacement, whereas a rechargeable battery uses an external wireless power charger. RF SCS consists of a transmitter worn outside the body that delivers radio waves through the skin to an implanted receiver. The transmitter contains an antenna, electronics, and a replaceable or rechargeable battery. Both the IPG and RF SCS may use remote programming devices to adjust the intensity of the stimulation. Searches Keystone First 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 February 14, Search terms were: spinal cord stimulation (MeSH) and chronic pain (MeSH). 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 SCS implantation is an invasive procedure best reserved for cases of severe intractable and chronic pain (FBSS, CPRS, or non-cardiac ischemic pain) that have failed to respond to standard medical or less invasive approaches. The evidence base is sparse: while some small randomized or controlled clinical trials with short-term follow-up have been published for some chronic pain indications, the literature 4

5 remains incomplete and systematic reviewers were required to include sub-optimal study designs in addressing their question. A randomized controlled trial (RCT) by Davis (2015) compared pain, functioning, and psychological measures of patients referred for SCS (73 patients) or behavioral pain management (BPM) (29 patients) for treatment of chronic low back pain (LBP). Patients referred for BPM and SCS reported similar pain, functioning, and coping, but SCS patients reported fewer psychological symptoms. This could indicate patient reporting bias or clinical referral bias. Patients should be carefully selected after multidisciplinary pain team evaluation that includes behavioral health specialists. Policy update: We added one new systematic review of chronic spine pain (Grider, 2016) and one update of a previously included systematic review of neuropathic pain (Hayes, 2016) treated with SCS. Both reviews found sufficient evidence from RCTs to support SCS for treatment of lumbar FBSS. Hayes (2016) also found sufficient high quality evidence of treatment efficacy for CRPS and DPN. In all cases, patients were referred for SCS after an inadequate response to standard non-surgical therapies. These findings do not change this policy s previous conclusions. However, we clarified the policy to specifically exclude malignant and cardio-ischemic causes of chronic pain, and include important contraindications to the procedure. Summary of clinical evidence: Citation Grider (2016) Chronic spine pain Hayes (2016) Neuropathic pain Content, Methods, Recommendations Systematic review of six RCTs comprising three efficacy trials, three trials that evaluated adaptive stimulation, high frequency stimulation, and burst stimulation, and two cost effectiveness studies. Overall quality: variable and limited in quantity based on level of evidence scale 1 to 4. High quality level 1 and 2 evidence of efficacy supports SCS in lumbar FBSS (two RCTs). Moderate quality Level 2-3 evidence to support high frequency stimulation (one RCT). Insufficient evidence to support adaptive stimulation and burst stimulation (low quality). Systematic review of eight RCTs, four randomized crossover trials, and 10 nonrandomized cohort or observational studies, and two earlier systematic reviews. Overall quality: moderate for neuropathic pain; low for modifications to SCS; low for methods for prognosis of SCS treatment efficacy. SCS is relatively safe, but rare serious and major complications can occur. Sufficient evidence supports SCS for chronic neuropathic pain associated with FBSS, CRPS, or DPN that has not responded adequately to standard nonsurgical therapies. Contraindications: uncontrolled bleeding disorder; ongoing anticoagulant therapy; local 5

6 Citation Taylor (2014) Predictors of pain relief following SCS in chronic back and leg pain and FBSS Hooten (2013) for the Institute for Clinical Systems Improvement Guideline: chronic pain Manchikanti (2013) for the American Society of Interventional Pain Physicians Guideline: chronic spine pain Lihua (2013) Cochrane review Cancer-related pain American Society of Anesthesiologists Task Force on Chronic Pain Management and American Society of Regional Anesthesia and Pain Medicine (2010) Content, Methods, Recommendations or systemic sepsis; presence of a demand pacemaker or implanted defibrillator; immunosuppression; pregnancy; and active or untreated abuse of alcohol, drugs, or medication. Systematic review and meta-analysis of 74 studies of all designs (3,025 total patients) with CBLP); 63 studies reported data to allow inclusion in a quantitative analysis. SCS was effective in reducing pain irrespective of the location of chronic back and leg pain or prior history of back surgery (mean level of pain relief across studies 58%, 95% confidence interval [CI] 53% to 64%, random effects) at an average follow-up of 24 months); substantial statistical heterogeneity (P < ) in level of pain relief noted. Multivariable meta-regression analysis showed no predictive patient or technology factors. RCTs are needed to confirm the effectiveness and cost-effectiveness of SCS in this population. Interventional techniques should be performed in conjunction with a comprehensive treatment plan that includes pharmacologic, rehabilitative, and psychological interventions. Many of the procedures provide both diagnostic and therapeutic benefits; others are reserved for patients who have failed conventional treatment. The role of intervention modalities is different for chronic pain than acute and should be carefully evaluated by a pain specialist. Interventional techniques refer to procedures including spinal injections, nerve blocks, SCS, and implantable intrathecal drug delivery systems that are performed in an attempt to diagnose and treat chronic pain. The evidence for SCS is fair for treating FBBS. SCS is indicated in chronic LBP with lower extremity pain secondary to FBBS, after exhausting multiple conservative and interventional modalities. Systematic review of four before-and-after case series studies (92 total participants), no RCTs. High risk of bias. Insufficient evidence. SCS may be used in the multimodal treatment of persistent radicular pain in patients who have not responded to other therapies. SCS may also be considered for other selected patients (e.g., CRPS, peripheral neuropathic pain, peripheral vascular disease and post-herpetic neuralgia). Shared decision making regarding SCS should include a specific discussion of potential complications associated with spinal cord stimulator placement. 6

7 Citation Content, Methods, Recommendations A SCS trial should be performed before considering permanent implantation of a stimulation device. References Professional society guidelines/other: American Society of Anesthesiologists Task Force on Chronic Pain Management (ASA), American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010; 112(4): Hooten WM, Timming R, Belgrade M, et al. Assessment and management of chronic pain. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2013 Nov. 105 p. [168 references.] 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): S Peer-reviewed references: 21CFR Davis C, Kyle B, Thorp J, Wu Q, Firnhaber J. Comparison of Pain, Functioning, Coping, and Psychological Distress in Patients with Chronic Low Back Pain Evaluated for Spinal Cord Stimulator Implant or Behavioral Pain Management. Pain Medicine. 2015; 16(4); Grider JS, Manchikanti L, Carayannopoulos A, et al. Effectiveness of Spinal Cord Stimulation in Chronic Spinal Pain: A Systematic Review. Pain Physician. 2016; 19(1): E Hayes, Inc. Hayes Medical Technology Report. Spinal cord stimulation for relief of neuropathic pain. Lansdale, PA: Hayes, Inc Updated Lihua P, Su M, Zejun Z, Ke W, Bennett MI. Spinal cord stimulation for cancer-related pain in adults. Cochrane Db Syst Rev. 2013; 2: Cd Taylor RS, Desai MJ, Rigoard P, Taylor RJ. Predictors of pain relief following spinal cord stimulation in chronic back and leg pain and failed back surgery syndrome: a systematic review and meta-regression analysis. Pain Practice. 2014; 14(6): CMS National Coverage Determination (NCDs): 7

8 160.7 Electrical Nerve Stimulators. CMS website. Local Coverage Determinations (LCDs): L36035 Spinal Cord Stimulation for Chronic Pain. CMS website. L35136 Spinal Cord Stimulators for Chronic Pain. CMS website. L36204 Spinal Cord Stimulators for Chronic Pain. CMS website. L34556 Spinal Cord Stimulators for Chronic Pain. CMS website. DL36879 Surgery: Spinal Cord Stimulators for Chronic Pain. CMS website. 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 Comment Single catheter electrode array inserted percutaneously into epidural space laminectomy for implantation of electrodes or plate/paddle, epidural Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Removal of spinal neurostimulator electrode plate/paddles(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 Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddles(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed 8

9 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 ICD-10 Code Description Comment G56.40 Complex regional pain syndrome type II unspecified upper limb G56.41 Complex regional pain syndrome type II of right upper limb G56.42 Complex regional pain syndrome type II of left upper limb G57.70 Complex regional pain syndrome type II of unspecified lower limb G57.71 Complex regional pain syndrome type II of right lower limb G57.72 Complex regional pain syndrome type II of left lower limb G89.21 Chronic pain due to trauma G89.22 Chronic post-thoracotomy pain G89.28 Other chronic postoperative pain G89.29 Other chronic pain G89.4 Chronic pain syndrome G90.50 Complex regional pain syndrome 1, unspecified G Complex regional pain syndrome 1 of right upper limb G90.59 Complex regional pain syndrome I of unspecified lower limb G Complex regional pain syndrome 1 of left upper limb G Complex regional pain syndrome I of upper limb, bilateral G Complex regional pain syndrome 1 of unspecified upper limb 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 HCPCS Level II C1767 C1778 C1816 C1820 C1822 C1883 C1897 L8679 L8680 L8682 L8683 L8685 Description Generator, neurostimulator (implantable), nonrechargeable Lead, neurostimulator (implantable) Receiver and/or transmitter, neurostimulator (implantable) Generator, neurostimulator (implantable), with rechargeable battery and charging system Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system Adaptor/extension, pacing lead or neurostimulator lead (implantable) Lead, neurostimulator test kit (implantable) Implantable neurostimulator, pulse generator, any type Implantable neurostimulator electrode, each Implantable neurostimulator radiofrequency receiver Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Comment 9

10 HCPCS Level II L8686 L8687 L8688 L8695 Description 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 External recharging system for battery (external) for use with implantable neurostimulator, replacement only Comment 10