Proposed LCD - Intraosseous Basivertebral Nerve Ablation (DL39642)

CMS National Coverage PolicySection 1862(a)(1)(A) of Title XVIII of the Social Security Act excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) of Title XVIII of the Social Security Act prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Manual System. Publication 100-2, Medicare Benefit Policy Manual, Chapter 15, 80 describes coverage for physician supervision of diagnostic x-ray, lab and other diagnostic tests.Coverage Indications, Limitations, and/or Medical NecessityCovered IndicationsThermal ablation of the intraosseous Basivertebral Nerve (BVN) is considered medically reasonable and necessary for the treatment of Chronic Low Back Pain (CLBP) in patient who meet ALL the following criteria for coverage and reimbursement.Individual is skeletally mature and has had CLBP for at least 6 months, with lower back pain as the dominant symptom.Has failed to adequately improve despite documented non-surgical management, to include at least 3 or more of the following modalities:Avoidance of activities that aggravate pain.Course of physical therapy or professionally directed therapeutic exercise program.Chiropractic manipulationCognitive therapyPharmacotherapy, including narcotic and non-narcotic analgesics, muscle relaxants, neuroleptics, and anti-inflammatories.Injection therapy of epidural or facet joint implicated pain sources in the region of concernType 1 or Type 2 Modic changes on MRI: Endplate hyposensitivity (Type 1) or hyperintensity (Type 2) on T1 images plus hyperintensity on T2 images (Type1) involving the endplates between L3 and S1Absence of non-vertebral pathology by physical, history, radiologic or clinical assessment including, but not limited to, fracture, tumor, infection, deformity, trauma, or post-surgical change which could explain or contribute to symptoms or complaints.Screening, evaluation, and diagnosis by a multidisciplinary team to include psychological and physical assessment.LimitationsThermal ablation of the Intraosseous Basivertebral nerve (BVN) is considered contraindicated with any of the following and precluded from coverage and reimbursement by Medicare:Skeletal immaturity (<18 years of age)Evidence on imaging (MRI, flexion/extension radiographs, CT) suggesting alternative etiology for LBP symptoms, including, but not limited to, lumbar spinal stenosis, spondylolisthesis, segmental instability, disc herniation, degenerative scoliosis, facet arthropathy or effusion with clinically suspected facet joint pain.Metabolic bone disease (e.g., osteoporosis with T score<-2.5), treatment of spine fragility fracture, trauma/compression fracture, or spinal primary or metastatic tumor.Active Spine or Systemic InfectionNeurogenic claudication, lumbar radiculopathy, radicular pain, nerve impingement or compression (e.g., NHP, stenosis), as primary symptoms.Patients with severe cardiac or pulmonary compromise, systemic vulnerability to bleeding, or concern for further compromise of existing disease.Patients with implantable pulse generators (e.g., pacemakers, defibrillators, or neurostimulator) and other electronic implants, unless type specific precautions are taken to maintain patient safety.Generalized systemic disease or complaints from which BVN pain cannot be differentiated from other aspects of the patients condition (e.g., morbid obesity, fibromyalgia, rheumatologic disease)Previous history of BVN ablation at the level of treatment.Treatment of more than 4 vertebral bodies per patient lifetime, within the confines of L3-S1 vertebral bodies.Retreatment of a single vertebral body with BVN ablation within the patients lifetime.Ongoing use or abuse of addictive medications without evidence of potential weaning or decreasing use with treatment of this and other causes of chronic pain.General InformationDefinitionsChronic Pain/Chronic Low Back Pain: Pain lasting longer than three months in the same location, seemingly resistant to conservative measures.Conservative Measures/ Non-surgical Managment: Any single or combination use of medication, physical therapeutic regimens, psychological or cognitive therapy designed by a qualified health care provider to affect relief of a disability or disease, based on a patients needs and physical findings. Incidental encounters are not considered therapeutic unless prescribed and monitored for defined purpose, time and frequency by a qualified practitioner.Functional impairment: A physical, functional or physiologic impairment causing deviation from the normal function of a tissue, organ or body member, resulting in a significant limitation or impairment of the capacity to move, coordinate actions or perform physical activities, demonstrated by difficulty performing physical and motor tasks, independent movement or basic life functions.Radicular pain or radiculopathy: pain radiating or identified in the path and distribution or dermatomal pattern of a named spinal nerve. Pain that is localized and does not travel in the distribution of an identified spinal nerve and remains axial in location is considered to have a non-radicular pattern.Spinal stenosis:Narrowing of the central spinal canal and /or the foraminal openings through which nerve or neural tissue are located, causing compression and irritation of the involved neural structures. A wide range of symptoms may be present, contributing to back and extremity pain and dysfunction.General InformationAssociated InformationDocumentation RequirementsMethods used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include, but are not limited to, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment and Pain Disability Assessment Scale (PDAS) Oswestry disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OWS) Quebec Back Pain Disability Scare (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS) and the PROMIS profile domains to assess function.Complete history and physician exam, including laboratory and imaging findings and abnormalities.Patient assessment for pain and related conditions that may contribute to the complaint by a qualified health care provider trained in assessment of spinal and paraspinal disorders with relevant medical history including duration, treatments considered as well as documentation of success and failure of treatments prescribed.Treatments and procedures utilized for pain control including pertinent evaluation, medications, imaging and testing. Must include MRI documentation and reports demonstrating Modic changes (Type 1 or 2) in the L3-S1 vertebral body endplates.Provider assessment with order or recommendation for treatment including indication, method, and associated medications and therapies prescribed with provider signature and date. Patient acknowledgement of method, potential adverse effects and expected outcome, with consent for treatment.Provider qualificationsMedicare considers BasiVertebral Nerve (BVN) ablation reasonable and necessary when furnished in accordance with the accepted standards of medical practice, furnished in a setting appropriate to the patients medical needs and condition, meets but does not exceed the patients medical need, and when ordered and furnished by qualified personnel, meeting the requirements of this LCD. Patient safety and consideration for coverage and reimbursement mandate that all provisions specified in the CMS policy manuals be followed.BVN ablation services must be performed in a place of service demonstrating the appropriate equipment (e.g., fluoroscopy, CT, medical emergency equipment). It is expected that all clinical staff maintain appropriate training and credentials to support their role as first responders to potential medical emergencies.Procedures listed and included in this LCD do not constitute anesthesia services. Evaluation, methods and techniques specified are not considered routine for surgical or perioperative anesthesia. Procedures to remedy pain emanating from the BasiVertebral Nerve constitute surgical intervention of a diseased body part, for which evaluation, diagnosis and management must be established by a medical provider trained in the specific discipline. It is expected that all providers of BVN ablative services are appropriately trained and credentialed by a formal residency/ fellowship program accredited by a nationally recognized organization or post-graduate training course accredited by an established national credentialing body in a relevant specialty.*Services will be considered medically reasonable and necessary only if both of the following criteria are met:All aspects of the procedure and its related care are within the scope of practice of the providers professional licensure; andAll procedures are performed by appropriately trained providers in the appropriate setting. Patient safety and quality of care mandate that healthcare professionals who perform injections or ablative techniques for treatment of specific nerve maladies and dysfunction are appropriately trained and are competent to perform all aspects of these procedures safely and effectively. The core curriculum of any training program should include the performance and management of the procedures addressed in this policy with documentation of trainee competency assessment by formal examination and case history document review.*Health care providers performing intraosseous BVN nerve ablation must be appropriately trained and credentials by a formal residency or fellowship training program recognized in the United States or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics, proficiency in evaluation, diagnosis and management of diseases necessitating the procedures, technical performance of the procedure and performing and interpreting medically reasonable imaging modalities required for procedure performance (imaging technique, contrast material use, and image interpretation) as well as the evaluation, diagnosis and management of potential complications from the intervention. If a procedure requires facility credentialing or privilege approval when performed in an inpatient or outpatient hospital setting, the provider must possess those credentials to receive reimbursement for that procedure when performed in a healthcare facility or elsewhere. Only those settings with immediate availability of equivalent support services and personnel as those in a hospital will be considered appropriate place of service for purposes of Medicare reimbursement.Reimbursement for procedures utilizing imaging may be made to providers who meet training requirements for the procedures in this policy when permitted under relevant state professional practice acts. In addition, all providers who seek Medicare payment for the procedures included in this policy must meet any applicable federal, state, or local licensing requirements and statutes for owning, operating, handling, or utilizing ionizing radiation, and relevant imaging equipment, materials, and contrast.Utilization GuidelinesAll aspects of evaluation and treatment must be documented in the patients chart, to include time, date and signature of the providing clinician and made available to Medicare on request.All medications, and equipment utilized in the procedure must be documented at the time of the procedure, including name, identification/ serial number, dose, route of administration and site of administration. Therapeutic equipment including type, brand name, energy level attained and method of deployment must be documented in the patients record, including pertinent identifying imaging used for deployment. All documentation must be made available to Medicare on request.No payment will be made for procedures not performed with appropriate imaging (fluoroscopic or computerized tomography) with formal report or reproduced images documented in the patient record and made available to Medicare on request.It is not expected that anesthesia for the procedure will require other than administration of local anesthetizing agents at the site of entrance, with addition mild sedation. The rationale for the use of higher levels of sedation or general anesthesia should be documented in the patients record, without which denial of claim reimbursement may be made.The injection of medications other than agents recognized as local anesthetics are not considered reasonable or medically appropriate at the site of administration of this procedure and will result in claim denial as inconsistent with patient safety. This specifically applies to the use of steroids, anti-inflammatories, biologics and any form of pharmaceutical not specifically designated as a local anesthetic agent.Sources of InformationN/ABibliography