Intrathecal Baclofen for CNS Spasticity

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Intrathecal Baclofen for CNS Spasticity Last Review Date: October 13, 2017 Number: MG.MM.ME.31bC7 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ( EmblemHealth ) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Continuous intrathecal administration of Baclofen, the inhibitory neurotransmitter gamma aminobutyric acid, is used to reduce spasticity and spasm frequency in patients with spinal spasticity who cannot be adequately treated with oral medications. Spasticity of spinal cord or cerebral origin occurs with spinal cord injury, multiple sclerosis, spinal cord tumors, transverse myelitis, amyotrophic lateral sclerosis, familial spastic paresis and cerebral palsy. Oral administration of Baclofen has not been effective in reducing these symptoms, as effective concentrations are difficult to achieve without intolerable systemic effects. Guideline Members with severe spasticity secondary to upper motor neuron origin are eligible for intrathecal Baclofen coverage. The member must be unresponsive to less invasive medical therapy and have undergone physical therapy, but have been either noncompliant or unsuccessful. In addition, the following criteria must also be met: 1. Trial of 6 weeks on oral medication shows that the patient experienced intolerable side effects or that there was a lack of adequate spasticity control. 2. Favorable response to a trial of one intrathecal dose of the antispasmodic drug (Baclofen) prior to pump implantation. 3. Sufficient body mass ( 30 lb.) to support an implanted pump. It is our expectation that there be families and/or caregivers committed to monitoring the patient for signs of withdrawal or overdose, detecting pump malfunctions, and returning for pump refills and patient follow-up care.

Page 2 of 9 Limitations/Exclusions Recommended clinical exclusions for the use of intrathecal Baclofen include any of the following: 1. Presence of another implanted device (e.g., cardiac pacemaker). 2. Pregnancy or lactation unless the benefits outweigh the possible risks. 3. Presence of neurologic disorders including dystonia, extrapyramidal disease, rigidity and lower motor neuron causes (e.g., cauda equina). Applicable Procedure Codes 62311 62318 62319 62322 62323 62324 62325 62326 62327 62350 62351 Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) (Code Deleted 01/01/2017) therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic (Code Deleted 01/01/2017) therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) (Code Deleted 01/01/2017) Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance (New Code: 01/01/2017) Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (ie, fluoroscopy or CT) (New Code: 01/01/2017) therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance (New Code: 01/01/2017) therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (ie, fluoroscopy or CT) (New Code: 01/01/2017) therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance (New Code: 01/01/2017) therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (ie, fluoroscopy or CT) (New Code: 01/01/2017) Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; without laminectomy Implantation, revision or repositioning of tunneled intrathecal or epidural catheter, for long-term medication administration via an external pump or implantable reservoir/infusion pump; with laminectomy 62355 Removal of previously implanted intrathecal or epidural catheter

Page 3 of 9 62360 Implantation or replacement of device for intrathecal or epidural drug infusion; subcutaneous reservoir 62361 Implantation or replacement of device for intrathecal or epidural drug infusion; non programmable pump 62362 Implantation or replacement of device for intrathecal or epidural drug infusion; programmable pump, including preparation of pump, with or without programming 62365 Removal of subcutaneous reservoir or pump, previously implanted for intrathecal or epidural infusion 62367 62368 77003 95990 95991 E0783 E0785 E0786 J0475 J0476 Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); without reprogramming Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); with reprogramming Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid)(list separately in addition to code for primary procedure) (Revised 01/01/2017) Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) or brain (intraventricular), includes electronic analysis of pump, when performed Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) or brain (intraventricular), includes electronic analysis of pump, when performed; requiring skill of a physician or other qualified health care professional Revised code Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.) Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) Injection, baclofen, 10 mg Injection, baclofen, 50 mcg for intrathecal trial Applicable ICD-10 Diagnosis Codes G04.1 Tropical spastic paraplegia G11.4 Hereditary spastic paraplegia G12.21 Amyotrophic lateral sclerosis G12.23 Primary lateral sclerosis (Eff. 10/01/2017) G12.24 Familial motor neuron disease (Eff. 10/01/2017) G12.25 Progressive spinal muscle atrophy (Eff. 10/01/2017) G12.29 Other motor neuron disease G24.09 Other drug induced dystonia G24.2 Idiopathic nonfamilial dystonia G24.8 Other dystonia G35 Multiple sclerosis G37.3 Acute transverse myelitis in demyelinating disease of central nervous system G80.0 Spastic quadriplegic cerebral palsy

Page 4 of 9 G80.1 Spastic diplegic cerebral palsy G80.2 Spastic hemiplegic cerebral palsy G80.4 Ataxic cerebral palsy G80.8 Other cerebral palsy G80.9 Cerebral palsy, unspecified G81.10 Spastic hemiplegia affecting unspecified side G81.11 Spastic hemiplegia affecting right dominant side G81.12 Spastic hemiplegia affecting left dominant side G81.13 Spastic hemiplegia affecting right nondominant side G81.14 Spastic hemiplegia affecting left nondominant side G82.20 Paraplegia, unspecified G82.21 Paraplegia, complete G82.22 Paraplegia, incomplete G82.50 Quadriplegia, unspecified G82.51 Quadriplegia, C1-C4 complete G82.52 Quadriplegia, C1-C4 incomplete G82.53 Quadriplegia, C5-C7 complete G82.54 Quadriplegia, C5-C7 incomplete G83.0 Diplegia of upper limbs G83.10 Monoplegia of lower limb affecting unspecified side G83.11 Monoplegia of lower limb affecting right dominant side G83.12 Monoplegia of lower limb affecting left dominant side G83.13 Monoplegia of lower limb affecting right nondominant side G83.14 Monoplegia of lower limb affecting left nondominant side G83.20 Monoplegia of upper limb affecting unspecified side G83.21 Monoplegia of upper limb affecting right dominant side G83.22 Monoplegia of upper limb affecting left dominant side G83.23 Monoplegia of upper limb affecting right nondominant side G83.24 Monoplegia of upper limb affecting left nondominant side G83.30 Monoplegia, unspecified affecting unspecified side G83.31 Monoplegia, unspecified affecting right dominant side G83.32 Monoplegia, unspecified affecting left dominant side G83.33 Monoplegia, unspecified affecting right nondominant side G83.34 Monoplegia, unspecified affecting left nondominant side

Page 5 of 9 G83.5 Locked-in state G83.81 Brown-Sequard syndrome G83.82 Anterior cord syndrome G83.83 Posterior cord syndrome I69.031 Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side I69.032 Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left dominant side I69.033 Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right non-dominant side I69.034 Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I69.039 Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting unspecified side I69.041 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right dominant side I69.042 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left dominant side I69.043 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting right non-dominant side I69.044 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I69.049 Monoplegia of lower limb following nontraumatic subarachnoid hemorrhage affecting unspecified side I69.051 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side I69.052 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left dominant side I69.053 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non-dominant side I69.054 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I69.059 Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting unspecified side I69.061 Other paralytic syndrome following nontraumatic subarachnoid hemorrhage affecting right dominant side I69.062 Other paralytic syndrome following nontraumatic subarachnoid hemorrhage affecting left dominant side I69.063 Other paralytic syndrome following nontraumatic subarachnoid hemorrhage affecting right non-dominant side I69.064 Other paralytic syndrome following nontraumatic subarachnoid hemorrhage affecting left non-dominant side I69.065 Other paralytic syndrome following nontraumatic subarachnoid hemorrhage, bilateral I69.069 Other paralytic syndrome following nontraumatic subarachnoid hemorrhage affecting unspecified side I69.131 Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right dominant side I69.132 Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left dominant side I69.133 Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting right non-dominant side I69.134 Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side I69.139 Monoplegia of upper limb following nontraumatic intracerebral hemorrhage affecting unspecified side I69.141 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right dominant side I69.142 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left dominant side I69.143 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting right non-dominant side I69.144 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting left non-dominant side

Page 6 of 9 I69.149 Monoplegia of lower limb following nontraumatic intracerebral hemorrhage affecting unspecified side I69.151 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right dominant side I69.152 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left dominant side I69.153 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting right non-dominant side I69.154 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting left non-dominant side I69.159 Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting unspecified side I69.161 Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting right dominant side I69.162 Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting left dominant side I69.163 Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting right non-dominant side I69.164 Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting left non-dominant side I69.165 Other paralytic syndrome following nontraumatic intracerebral hemorrhage, bilateral I69.169 Other paralytic syndrome following nontraumatic intracerebral hemorrhage affecting unspecified side I69.231 Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right dominant side I69.232 Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left dominant side I69.233 Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting right non-dominant side I69.234 Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I69.239 Monoplegia of upper limb following other nontraumatic intracranial hemorrhage affecting unspecified side I69.241 Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right dominant side I69.242 Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left dominant side I69.243 Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting right non-dominant side I69.244 Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting left non-dominant side I69.249 Monoplegia of lower limb following other nontraumatic intracranial hemorrhage affecting unspecified side I69.251 Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right dominant side I69.252 Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left dominant side I69.253 Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting right non-dominant side I69.254 Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting left non-dominant side I69.259 Hemiplegia and hemiparesis following other nontraumatic intracranial hemorrhage affecting unspecified side I69.261 Other paralytic syndrome following other nontraumatic intracranial hemorrhage affecting right dominant side I69.262 Other paralytic syndrome following other nontraumatic intracranial hemorrhage affecting left dominant side I69.263 Other paralytic syndrome following other nontraumatic intracranial hemorrhage affecting right non-dominant side I69.264 Other paralytic syndrome following other nontraumatic intracranial hemorrhage affecting left non-dominant side I69.265 Other paralytic syndrome following other nontraumatic intracranial hemorrhage, bilateral I69.269 Other paralytic syndrome following other nontraumatic intracranial hemorrhage affecting unspecified side I69.331 Monoplegia of upper limb following cerebral infarction affecting right dominant side

Page 7 of 9 I69.332 Monoplegia of upper limb following cerebral infarction affecting left dominant side I69.333 Monoplegia of upper limb following cerebral infarction affecting right non-dominant side I69.334 Monoplegia of upper limb following cerebral infarction affecting left non-dominant side I69.339 Monoplegia of upper limb following cerebral infarction affecting unspecified side I69.341 Monoplegia of lower limb following cerebral infarction affecting right dominant side I69.342 Monoplegia of lower limb following cerebral infarction affecting left dominant side I69.343 Monoplegia of lower limb following cerebral infarction affecting right non-dominant side I69.344 Monoplegia of lower limb following cerebral infarction affecting left non-dominant side I69.349 Monoplegia of lower limb following cerebral infarction affecting unspecified side I69.351 Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side I69.352 Hemiplegia and hemiparesis following cerebral infarction affecting left dominant side I69.353 Hemiplegia and hemiparesis following cerebral infarction affecting right non-dominant side I69.354 Hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side I69.359 Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side I69.361 Other paralytic syndrome following cerebral infarction affecting right dominant side I69.362 Other paralytic syndrome following cerebral infarction affecting left dominant side I69.363 Other paralytic syndrome following cerebral infarction affecting right non-dominant side I69.364 Other paralytic syndrome following cerebral infarction affecting left non-dominant side I69.365 Other paralytic syndrome following cerebral infarction, bilateral I69.369 Other paralytic syndrome following cerebral infarction affecting unspecified side I69.831 Monoplegia of upper limb following other cerebrovascular disease affecting right dominant side I69.832 Monoplegia of upper limb following other cerebrovascular disease affecting left dominant side I69.833 Monoplegia of upper limb following other cerebrovascular disease affecting right non-dominant side I69.834 Monoplegia of upper limb following other cerebrovascular disease affecting left non-dominant side I69.839 Monoplegia of upper limb following other cerebrovascular disease affecting unspecified side I69.841 Monoplegia of lower limb following other cerebrovascular disease affecting right dominant side I69.842 Monoplegia of lower limb following other cerebrovascular disease affecting left dominant side I69.843 Monoplegia of lower limb following other cerebrovascular disease affecting right non-dominant side I69.844 Monoplegia of lower limb following other cerebrovascular disease affecting left non-dominant side I69.849 Monoplegia of lower limb following other cerebrovascular disease affecting unspecified side I69.851 Hemiplegia and hemiparesis following other cerebrovascular disease affecting right dominant side I69.852 Hemiplegia and hemiparesis following other cerebrovascular disease affecting left dominant side I69.853 Hemiplegia and hemiparesis following other cerebrovascular disease affecting right non-dominant side I69.854 Hemiplegia and hemiparesis following other cerebrovascular disease affecting left non-dominant side

Page 8 of 9 I69.859 Hemiplegia and hemiparesis following other cerebrovascular disease affecting unspecified side I69.861 Other paralytic syndrome following other cerebrovascular disease affecting right dominant side I69.862 Other paralytic syndrome following other cerebrovascular disease affecting left dominant side I69.863 Other paralytic syndrome following other cerebrovascular disease affecting right non-dominant side I69.864 Other paralytic syndrome following other cerebrovascular disease affecting left non-dominant side I69.865 Other paralytic syndrome following other cerebrovascular disease, bilateral I69.869 Other paralytic syndrome following other cerebrovascular disease affecting unspecified side I69.931 Monoplegia of upper limb following unspecified cerebrovascular disease affecting right dominant side I69.932 Monoplegia of upper limb following unspecified cerebrovascular disease affecting left dominant side I69.933 Monoplegia of upper limb following unspecified cerebrovascular disease affecting right non-dominant side I69.934 Monoplegia of upper limb following unspecified cerebrovascular disease affecting left non-dominant side I69.939 Monoplegia of upper limb following unspecified cerebrovascular disease affecting unspecified side I69.941 Monoplegia of lower limb following unspecified cerebrovascular disease affecting right dominant side I69.942 Monoplegia of lower limb following unspecified cerebrovascular disease affecting left dominant side I69.943 Monoplegia of lower limb following unspecified cerebrovascular disease affecting right non-dominant side I69.944 Monoplegia of lower limb following unspecified cerebrovascular disease affecting left non-dominant side I69.949 Monoplegia of lower limb following unspecified cerebrovascular disease affecting unspecified side I69.951 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right dominant side I69.952 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left dominant side I69.953 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right non-dominant side I69.954 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting left non-dominant side I69.959 Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting unspecified side I69.961 Other paralytic syndrome following unspecified cerebrovascular disease affecting right dominant side I69.962 Other paralytic syndrome following unspecified cerebrovascular disease affecting left dominant side I69.963 Other paralytic syndrome following unspecified cerebrovascular disease affecting right non-dominant side I69.964 Other paralytic syndrome following unspecified cerebrovascular disease affecting left non-dominant side I69.965 Other paralytic syndrome following unspecified cerebrovascular disease, bilateral I69.969 Other paralytic syndrome following unspecified cerebrovascular disease affecting unspecified side References BlueCross Blue Shield Association Medical Policy Reference Manual, Policy No. 7.01.41. Hayes Medical Technology Directory Hayes, Inc. Intrathecal Baclofen for Cerebral Palsy. Hayes Medical Technology Directory. Lansdale, Penn: Winifred S. Hayes, Inc.; November 10, 2005. Hayes Medical Technology Directory Hayes, Inc. Intrathecal Baclofen for Spasticity of Spinal Origin or due to Multiple Sclerosis. Hayes Medical Technology Directory. Lansdale, Penn: Winifred S. Hayes, Inc.; December 15, 2005. Kumar K, Kelly M, Pirlot T. Continuous intrathecal morphine treatment for chronic pain of non malignant etiology: long-term

Page 9 of 9 benefits and efficacy. Surg Neurol 2001: 79-86; discussion 86-8. Specialty-matched clinical peer review. Thimineur MA, Kravitz E, Vodapally MS. Intrathecal opioid treatment for chronic non-malignant pain: a 3-year prospective study. Pain, 2004;109(3):242-9.