evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Cervical Fusion (DL39793)
Cervical Radiculopathy (Pinched Nerve in Neck). Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/22639-cervical-radiculopathy-pinched-nerve Published 2022. Updated March 29, 2022. Accessed October 18, 2023.Broekema AE, Groen RJ, de Souza NFS, et al. Surgical interventions for cervical radiculopathy without myelopathy: a systematic review and meta-analysis.JBJS.2020;102(24):2182-2196.Fang W, Huang L, Feng F, et al. Anterior cervical discectomy and fusion versus posterior cervical foraminotomy for the treatment of single-level unilateral cervical radiculopathy: a meta-analysis.J Orthop Surg Res.2020;15(1):202.Gao Q-Y, Wei F-L, Zhu K-L, et al. Clinical Efficacy and Safety of Surgical Treatments in Patients With Pure Cervical Radiculopathy.Frontiers in Public Health.2022;10:892042.Goedmakers CMW, Janssen T, Yang X, Arts MP, Bartels R, Vleggeert-Lankamp CLA. Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review.Eur Spine J.2020;29(11):2640-2654.Katsuura Y, York PJ, Goto R, et al. Sagittal Reconstruction and Clinical Outcome Using Traditional ACDF, Versus Stand-alone ACDF Versus TDR: A Systematic Review and Quantitative Analysis.Spine (Phila Pa 1976).2019;44(19):E1151-E1158.Liu WJ, Hu L, Chou PH, Wang JW, Kan WS. Comparison of Anterior Cervical Discectomy and Fusion versus Posterior Cervical Foraminotomy in the Treatment of Cervical Radiculopathy: A Systematic Review.Orthop Surg.2016;8(4):425-431.
Proposed LCD - Cervical Fusion (DL39793)
Zou T, Wang PC, Chen H, Feng XM, Sun HH. Minimally invasive posterior cervical foraminotomy versus anterior cervical discectomy and fusion for cervical radiculopathy: a meta-analysis.Neurosurg Rev.2022;45(6):3609-3618.Gutman G, Rosenzweig DH, Golan JD. Surgical Treatment of Cervical Radiculopathy: Meta-analysis of Randomized Controlled Trials.Spine (Phila Pa 1976).2018;43(6):E365-E372.Fei Q, Li J, Su N, et al. Comparison between anterior cervical discectomy with fusion and anterior cervical corpectomy with fusion for the treatment of cervical spondylotic myelopathy: a meta-analysis.Ther Clin Risk Manag.2015;11:1707-1718.Han YC, Liu ZQ, Wang SJ, Li LJ, Tan J. Is anterior cervical discectomy and fusion superior to corpectomy and fusion for treatment of multilevel cervical spondylotic myelopathy? A systemic review and meta-analysis.PLoS One.2014;9(1):e87191.Li Z, Long C, Li B, Wei J. Efficacy and safety of surgical interventions for treating multilevel cervical spondylotic myelopathy via anterior approach: A network meta-analysis.Pain Physician.2019;22(4):E275.Montano N, Ricciardi L, Olivi A. Comparison of Anterior Cervical Decompression and Fusion versus Laminoplasty in the Treatment of Multilevel Cervical Spondylotic Myelopathy: A Meta-Analysis of Clinical and Radiological Outcomes.World Neurosurg.2019;130:530-536 e532.Schuermans VNE, Smeets A, van de Kar LGC, et al.A Systematic Review on Neurological Outcomes for Cervical Degenerative Myelopathy After Anterior Decompression Surgery: Motion Preservation vs Fusion.Int J Spine Surg.2022;16(6):969-976.
Proposed LCD - Cervical Fusion (DL39793)
Wang T, Guo J, Long Y, Hou Z. Comparison of Two Anterior Reconstructive Techniques in the Treatment of 3-Level and 4 Level Cervical Spondylotic Myelopathy: A Meta-analysis of Last Decade.Geriatr Orthop Surg Rehabil.2022;13:21514593221124415.El-Ghandour NMF, Soliman MAR, Ezzat AAM, Mohsen A, Zein-Elabedin M. The safety and efficacy of anterior versus posterior decompression surgery in degenerative cervical myelopathy: a prospective randomized trial.J Neurosurg Spine.2020:1-9.Xu L, Sun H, Li Z, Liu X, Xu G. Anterior cervical discectomy and fusion versus posterior laminoplasty for multilevel cervical myelopathy: A meta-analysis.Int J Surg.2017;48:247-253.Zhao CM, Chen Q, Zhang Y, Huang AB, Ding WY, Zhang W. Anterior cervical discectomy and fusion versus hybrid surgery in multilevel cervical spondylotic myelopathy: A meta-analysis.Medicine (Baltimore).2018;97(34):e11973.Lee NJ, Kim JS, Park P, Riew KD. A comparison of various surgical treatments for degenerative cervical myelopathy: a propensity score matched analysis.Global spine journal.2022;12(6):1109-1118.Medicine JH. Cervical Myelopathy. Johns Hopkins Medicine. Cervical Myelopathy. Accessed November 14, 2023.Ranawat CS, O'Leary P, Pellicci P, Tsairis P, Marchisello P, Dorr L. Cervical spine fusion in rheumatoid arthritis.J Bone Joint Surg Am.1979;61(7):1003-1010.Gillick JL, Wainwright J, Das K. Rheumatoid arthritis and the cervical spine: a review on the role of surgery.International journal of rheumatology.2015;2015.
Proposed LCD - Cervical Fusion (DL39793)
Gillick JL, Wainwright J, Das K. Rheumatoid arthritis and the cervical spine: a review on the role of surgery.International journal of rheumatology.2015;2015.Nunez JH, Escudero B, Omiste I, et al. Outcomes of cervical arthroplasty versus anterior cervical arthrodesis: a systematic review and meta-analysis of randomized clinical trials with a minimum follow-up of 7-year.Eur J Orthop Surg Traumatol.2022.Peng Z, Hong Y, Meng Y, Liu H. A meta-analysis comparing the short- and mid- to long-term outcomes of artificial cervical disc replacement(ACDR) with anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease.Int Orthop.2022;46(7):1609-1625.Xing D, Ma XL, Ma JX, Wang J, Ma T, Chen Y. A meta-analysis of cervical arthroplasty compared to anterior cervical discectomy and fusion for single-level cervical disc disease.J Clin Neurosci.2013;20(7):970-978.Zhang Y, Lv N, He F, et al. Comparison of cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of cervical disc degenerative diseases on the basis of more than 60 months of follow-up: a systematic review and meta-analysis.BMC Neurol.2020;20(1):143.Fehlings MG, Martin AR, Tetreault LA, et al. A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role of Baseline Magnetic Resonance Imaging in Clinical Decision Making and Outcome Prediction.Global Spine J.2017;7(3 Suppl):221S-230S.Zileli M, Maheshwari S, Kale SS, Garg K, Menon SK, Parthiban J. Outcome Measures and Variables Affecting Prognosis of Cervical Spondylotic Myelopathy: WFNS Spine Committee Recommendations.Neurospine.2019;16(3):435-447.
Proposed LCD - Cervical Fusion (DL39793)
Costa F, Anania CD, Agrillo U, et al. Cervical Spondylotic Myelopathy: From the World Federation of Neurosurgical Societies (WFNS) to the Italian Neurosurgical Society (SINch) Recommendations.Neurospine.2023;20(2):415-429.Watanabe M, Chikuda H, Fujiwara Y, et al. Japanese Orthopaedic Association (JOA) Clinical practice guidelines on the Management of Cervical Spondylotic Myelopathy,2020 - Secondary publication.J Orthop Sci.2023;28(1):1-45.Youssef JA, Heiner AD, Montgomery JR, et al. Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis.Spine J.2019;19(10):1714-1729.Mahmoud A, Shanmuganathan K, Montgomery A. Surgical Management of Hangman's Fracture: A Systematic Review.Int J Spine Surg.2023.Lee DY, Park YJ, Song MG, Kim KT, Kim DH. Comparison of anterior-only versus combined anterior and posterior fusion for unstable subaxial cervical injuries: a meta-analysis of biomechanical and clinical studies.Eur Spine J.2021;30(6):1460-1473.Yang JS, Liu P, Liu TJ, et al. When is the circumferential stabilization necessary for subaxial cervical fracture dislocations? The posterior ligament-bone injury classification and severity score: a novel treatment algorithm.Eur Spine J.2021;30(2):524-533.Madan A, Thakur M, Sud S, Jain V, Singh Thakur RP, Negi V. Subaxial Cervical Spine Injuries: Outcomes after Anterior Corpectomy and Instrumentation.Asian J Neurosurg.2019;14(3):843-847.Zheng HL, Li B, Song SK, Chen PB, Jiang LS, Jiang SD. Anterior cervical discectomy and fusion to treat cervical instability with vertigo and dizziness: A single center, retrospective, observational study.Front Surg.2022;9:1047504.
Proposed LCD - Cervical Fusion (DL39793)
Yang H, Wang H, Zhang B, Sun Y, Wang L, Lu X. Cervical spine fracture-dislocation in patients with ankylosing spondylitis and severe thoracic kyphosis: Application of halo vest before and during surgical management.Clin Neurol Neurosurg.2021;207:106744.Wang L, Wang H, Wang C, Zhang B, Yang H, Lu X. Comparative study of halo-vest reduction and skull traction reduction in the treatment of cervical fracture dislocation in patients with ankylosing spondylitis.Front Surg.2023;10:1129809.Skeppholm M, Svedmark P, Noz ME, Maguire GQ, Jr., Olivecrona H, Olerud C. Evaluation of mobility and stability in the Discover artificial disc: an in vivo motion study using high-accuracy 3D CT data.J Neurosurg Spine.2015;23(3):383-389.Rustagi T, Mashaly H, Mendel E. Posterior occiput-cervical fixation for metastasis to upper cervical spine.J Craniovertebr Junction Spine.2019;10(2):119-126.Luksanapruksa P, Millhouse PW, Carlson V, Ariyawatkul T, Heller J, Kepler CK. Comparison of Surgical Outcomes of the Posterior and Combined Approaches for Repair of Cervical Fractures in Ankylosing Spondylitis.Asian Spine J.2019;13(3):432-440.Li Z, Li F, Hou S, et al. Anterior discectomy/corpectomy and fusion with internal fixation for the treatment of unstable hangman's fractures: a retrospective study of 38 cases.J Neurosurg Spine.2015;22(4):387-393.Lee JS, Son DW, Lee SH, Ki SS, Lee SW, Song GS. Comparative Analysis of Surgical Outcomes of C1-2 Fusion Spine Surgery between Intraoperative Computed Tomography Image Based Navigation-Guided Operation and Fluoroscopy-Guided Operation.J Korean Neurosurg Soc.2020;63(2):237-247.
Proposed LCD - Cervical Fusion (DL39793)
Lang S, Neumann C, Fiedler L, Alt V, Loibl M, Kerschbaum M. Does Dynamic Anterior Plate Fixation Provide Adequate Stability for Traumatic Subaxial Cervical Spine Fractures at Mid-Term Follow-Up?J Clin Med.2021;10(6).Kong W, Yang X, Li Z, Hu B, Song Y. Analysis of the Cervical Sagittal Alignment in Patients with Unstable Hangman Fracture Under C2 approximately 3 Anterior Discectomy and Fusion.World Neurosurg.2020;137:e1-e8.Kim HS, Cloney MB, Koski TR, Smith ZA, Dahdaleh NS. Management of Isolated Atlas Fractures: A Retrospective Study of 65 Patients.World Neurosurg.2018;111:e316-e322.Bakhsheshian J, Sizdahkhani S, Ohiorhenuan I, Buchanan IA, Strickland B, Pham MH. Transpedicular lag screw placement in traumatic cervical spondylolisthesis: Case report and systematic review of the literature.J Clin Neurosci.2019;63:256-262.Jin C, Xie N, Ren Y, et al. How Does Cervical Sagittal Balance Change After Hangman Fracture Treated with Anterior or Posterior Approach Surgery?World Neurosurg.2020;138:e767-e777.Garrido BJ, Myo GK, Sasso RC. Rigid versus nonrigid occipitocervical fusion: a clinical comparison of short-term outcomes.J Spinal Disord Tech.2011;24(1):20-23.Dagtekin A, Avci E, Hamzaoglu V, et al. Management of occipitocervical junction and upper cervical trauma.J Craniovertebr Junction Spine.2018;9(3):148-155.Clark S, Nash A, Shasti M, et al. Mortality Rates After Posterior C1-2 Fusion for Displaced Type II Odontoid Fractures in Octogenarians.Spine (Phila Pa 1976).2018;43(18):E1077-E1081.
Proposed LCD - Cervical Fusion (DL39793)
Candura D, Perna A, Velluto C, et al. Conservative management of Anderson Type II odontoid fractures in octogenarians: is radiological union what we are searching for?Eur Rev Med Pharmacol Sci.2022;26(1 Suppl):33-42.Aldrian S, Erhart J, Schuster R, et al. Surgical vs nonoperative treatment of Hadley type IIA odontoid fractures.Neurosurgery.2012;70(3):676-682; discussion 682-673.Ghogawala Z, Terrin N, Dunbar MR, et al. Effect of ventral vs dorsal spinal surgery on patient-reported physical functioning in patients with cervical spondylotic myelopathy: a randomized clinical trial.Jama.2021;325(10):942-951.de Dios Perez E. Degenerative cervical myelopathy: Surgical treatment, imaging evaluation, and outcome. 2023.Sattari SA, Ghanavatian M, Feghali J, et al. Anterior cervical discectomy and fusion versus posterior decompression in patients with degenerative cervical myelopathy: a systematic review and meta-analysis.J Neurosurg Spine.2023:1-13.Selph SS SA, Jungbauer RM, Brodt E, et al. Cervical Degenerative Disease Treatment: A Systematic Review. Comparative Effectiveness Review No. 266. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 75Q80120D00006.). AHRQ Publication No. 24-EHC001.Rockville, MD: Agency for Healthcare Research and Quality;. https://effectivehealthcare.ahrq.gov/products/cervical-degenerative-disease/research. Accessed November 28, 2023.
Proposed LCD - Cervical Fusion (DL39793)
Industries. WSDoL. Labor and Industries Industrial Insurance Medical Advisory Committee (IIMAC). Guideline for diagnosis and treatment of cervical radiculopathy and myelopathy. . https://www.lni.wa.gov/patient-care/treating-patients/treatment-guidelines-and-resources/_docs/2014CervicalGuideline-FINAL.pdf [lni.wa.gov]. Updated Effective December 2014, Hyperlinks and minor corrections June 2023. . Accessed November 28, 2023.Cohen SP. Epidemiology, diagnosis, and treatment of neck pain.Mayo Clin Proc.2015;90(2):284-299.Ohnari H, Sasai K, Akagi S, Iida H, Takanori S, Kato I. Investigation of axial symptoms after cervical laminoplasty, using questionnaire survey.Spine J.2006;6(3):221-227.(NASS) NASS. Appropriate Use Criteria: Cervical Fusion (2013) North American Spine Society (NASS). North American Spine Society: Appropriate Use Criteria for Cervical Fusion Web site. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/CervicalFusionAUC.pdf. Published 2013. Accessed November 14, 2023.van Middelkoop M, Rubinstein SM, Ostelo R, et al. No additional value of fusion techniques on anterior discectomy for neck pain: a systematic review.Pain.2012;153(11):2167-2173.Riew KD, Ecker E, Dettori JR. Anterior cervical discectomy and fusion for the management of axial neck pain in the absence of radiculopathy or myelopathy.Evid Based Spine Care J.2010;1(3):45-50.Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.Spine (Phila Pa 1976).2008;33(4 Suppl):S153-169.
Proposed LCD - Cervical Fusion (DL39793)
Palit M, Schofferman J, Goldthwaite N, et al. Anterior discectomy and fusion for the management of neck pain.Spine (Phila Pa 1976).1999;24(21):2224-2228.Garvey TA, Transfeldt EE, Malcolm JR, Kos P. Outcome of anterior cervical discectomy and fusion as perceived by patients treated for dominant axial-mechanical cervical spine pain.Spine (Phila Pa 1976).2002;27(17):1887-1895; discussion 1895.Whitecloud TS, 3rd, Seago RA. Cervical discogenic syndrome. Results of operative intervention in patients with positive discography.Spine (Phila Pa 1976).1987;12(4):313-316.Simmons EH, Bhalla SK. Anterior cervical discectomy and fusion. A clinical and biomechanical study with eight-year follow-up.J Bone Joint Surg Br.1969;51(2):225-237.Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.J Manipulative Physiol Ther.2009;32(2 Suppl):S176-193.Nystrom B, Svensson E, Larsson S, Schillberg B, Mork A, Taube A. A small group Whiplash-Associated-Disorders (WAD) patients with central neck pain and movement induced stabbing pain, the painful segment determined by mechanical provocation: Fusion surgery was superior to multimodal rehabilitation in a randomized trial.Scand J Pain.2016;12:33-42.Kreiner DS, Shaffer WO, Baisden JL, et al. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update).Spine J.2013;13(7):734-743.Isaac Z, Atlas SJ, K L. Management of non-radicular neck pain in adults. UpToDate. www.uptodate.com. Published 2023. Updated October 4, 2023. Accessed October 30, 2023.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38664)
CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Implantable Continuous Glucose Monitors (I-CGM). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Implantable Continuous Glucose Monitors (I-CGM) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical Necessity
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38664)
Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationDiabetes mellitus (DM) is a chronic metabolic disease involving an underproduction or resistance to insulin, resulting in elevated blood glucose levels. The two most common types of diabetes are type 1 (T1DM) and type 2 (T2DM).1T1DM comprises approximately 5-10% of diabetes cases and describes an etiology in which an autoimmune response damages the insulin-producing beta cells of the pancreas, resulting in insufficient insulin production. Conversely, T2DM is characterized by insulin resistance.1,2In T2DM, an individuals insulin production fails to offset the deficit that is created by the resistance.1T2DM constitutes an estimated 90%-95% of diabetes cases.2Approximately 11.3% of Americans have diagnosed diabetes, and an additional 3.4% of Americans are estimated to have undiagnosed diabetes. The prevalence of diabetes is known to increase with age. In Medicare-aged populations in the United States ( 65 years of age), 22.4% of the population has diagnosed diabetes, with an additional 4.7% estimated to have undiagnosed diabetes.3Economic evaluations have estimated that diabetes annually accounts for $237 billion in direct US medical expenditure, and an additional $90 billion in lost productivity.4Acute complications of diabetes include hypoglycemia, hyperglycemia, diabetic coma, and nonketotic hyperosmolar coma. Chronic hyperglycemia, resulting from poorly controlled diabetes, may result in serious and life-threatening damage, including dysfunction and failure of the eyes, kidneys, nervous system and cardiovascular system. The complications of diabetes mellitus are far less common and less severe in people who have well-controlled blood sugar levels.1
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38664)
To prevent and/or delay the development of both short- and long-term complications of diabetes, the American Diabetes Association (ADA) recommends person-centered care aimed at timely treatment decisions following evidence-based guidelines. Person-centered care goals include minimizing the progression of hyperglycemia with more intensive approaches for individuals at higher risk which include those with higher glucose levels (e.g., fasting blood glucose 110-125 mg/dL, 2-hour post-challenge glucose 173-199 mg/dL, A1C  6.0%).5Diabetes treatment relies on diet, exercise, lifestyle modifications, and in many, medications in order to keep their blood sugar under a stable and controlled level. Close glucose monitoring either multiple times a day or continuously may be warranted in those diabetics that are having difficulty maintaining that level.1,6Continuous glucose monitoring (CGM) devices measure glucose via interstitial fluid instead of blood. CGM systems traditionally rely on a multi-part system that often involves: 1.) a sensor that is inserted into subcutaneous tissue; 2.) a receiver/mobile application consisting of a display and interface; 3.) a transmitter component that is attached to the sensor and worn externally.6,7The sensors for these subcutaneous CGM systems need to be removed and replaced every 4 to 6 days depending upon the system.6Despite the number of benefits that subcutaneous CGM offer in the DM management paradigm, some CGM studies have reported relatively high attrition rates that patients attributed to discomfort, contact dermatitis, issues changing the sensors, and physical interference with activities of daily living.8The rationale for implantable continuous glucose monitoring (I-CGM) seeks to circumvent these negative patient experiences. Unlike with subcutaneous CGM, I-CGM involves a sensor that is surgically implanted for longer spans of time between replacement, allowing for skin barrier closure, and less frequent manipulation.Covered IndicationsTherapeutic I-CGMs are considered medically reasonable and necessary by Medicare when all of the following coverage criteria (1-4) are met:
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38664)
The beneficiary has diabetes mellitus;and,The beneficiarys treating practitioner has concluded that the beneficiary (or beneficiarys caregiver) has sufficient training using the I-CGM prescribed as evidenced by providing a prescription;and,The I-CGM is prescribed in accordance with its FDA indications for use;and,The beneficiary for whom an I- CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:The beneficiary is insulin-treated; or,The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL [3.0mmol/L]) that persists despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,A history of one level 3 hypoglycemic event (glucose <54mg/dL [3.0mmol/L]) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia.ICGM Continued CoverageEvery six months following the initial prescription of the I-CGM, the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the beneficiary to document adherence to their I-CGM regimen and diabetes treatment plan.LimitationsI-CGM devices will be considered not medically reasonable and necessary for short-term (72 hours to 1 week) use.Exception:Beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic/non-adjunctive and non-therapeutic/adjunctive continuous glucose monitor through the Medicare DME benefit may subsequently choose to switch to the implantable device with a provider order. However, all other coverage criteria above must be fulfilled in order for Medicare payment.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated Information