evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)
White C, Weinstein MC, Fingeret AL, et al. Is less more? A microsimulation model comparing cost-effectiveness of the revised American Thyroid Association's 2015 to 2009 Guidelines for the management of patients with thyroid nodules and differentiated thyroid Cancer.Ann Surg. 2020;271(4):765-773. doi:10.1097/SLA.0000000000003074Cibas ES, Ali SZ. The 2017 Bethesda system for reporting thyroid cytopathology.Thyroid. 2017;27(11):1341-1346. doi:10.1089/thy.2017.0500Padmanabhan V, Marshall CB, Akdas Barkan G, et al. Reproducibility of atypia of undetermined significance/follicular lesion of undetermined significance category using the Bethesda system for reporting thyroid cytology when reviewing slides from different institutions: a study of interobserver variability among cytopathologists.Diagn Cytopathol. 2017;45(5):399-405. doi:10.1002/dc.23681Kuzan TY, Guzelbey B, Turan Guzel N, Kuzan BN, Cakir MS, Canbey C. Analysis of intra-observer and inter-observer variability of pathologists for non-benign thyroid fine needle aspiration cytology according to Bethesda System categories.Diagn Cytopathol. 2021;49(7):850-855. doi:10.1002/dc.24756Papaleontiou M, Hughes DT, Guo C, Banerjee M, Haymart MR. Population-based assessment of complications following surgery for thyroid cancer.J Clin Endocrinol Metab. 2017;102(7):2543-2551. doi:10.1210/jc.2017-00255National Comprehensive Cancer Network. Thyroid Carcinoma (Version 2.2023). Accessed 6/26/2023.https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf
Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)
National Comprehensive Cancer Network. Thyroid Carcinoma (Version 2.2023). Accessed 6/26/2023.https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdfAlexander EK, Kennedy GC, Baloch ZW, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology.N Engl J Med. 23 2012;367(8):705-715. doi:10.1056/NEJMoa1203208Borowczyk M, Szczepanek-Parulska E, Olejarz M, et al. Evaluation of 167 gene expression classifier (GEC) and ThyroSeq v2 diagnostic accuracy in the preoperative assessment of indeterminate thyroid nodules: bivariate/HROC meta-analysis.Endocr Pathol. 2019;30(1):8-15. doi:10.1007/s12022-018-9560-5Silaghi CA, Lozovanu V, Georgescu CE, et al. Thyroseq v3, Afirma GSC, and microRNA panels versus previous molecular tests in the preoperative diagnosis of indeterminate thyroid nodules: a systematic review and meta-analysis.Front Endocrinol(Lausanne).2021;12:649522. doi:10.3389/fendo.2021.649522Vargas-Salas S, Martinez JR, Urra S, et al. Genetic testing for indeterminate thyroid cytology: review and meta-analysis.Endocr Relat Cancer.2018;25(3):R163-R177. doi:10.1530/ERC-17-0405Al-Qurayshi Z, Deniwar A, Thethi T, et al. Association of malignancy prevalence with test properties and performance of the gene expression classifier in indeterminate thyroid nodules.JAMA Otolaryngol Head Neck Surg. 2017;143(4):403-408. doi:10.1001/jamaoto.2016.3526
Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)
Marti JL, Avadhani V, Donatelli LA, et al. Wide inter-institutional variation in performance of a molecular classifier for indeterminate thyroid Nodules.Ann Surg Oncol. 2015;22(12):3996-4001. doi:10.1245/s10434-015-4486-3Valderrabano P, Hallanger-Johnson JE, Thapa R, Wang X, McIver B. Comparison of postmarketing findings vs the initial clinical validation findings of a thyroid nodule gene expression classifier: a systematic review and meta-analysis.JAMA Otolaryngol Head Neck Surg. 2019;145(9):783-792. doi:10.1001/jamaoto.2019.1449Nikiforov YE, Ohori NP, Hodak SP, et al. Impact of mutational testing on the diagnosis and management of patients with cytologically indeterminate thyroid nodules: a prospective analysis of 1056 FNA samples.J Clin Endocrinol Metab. 2011;96(11):3390-3397. doi:10.1210/jc.2011-1469Nikiforov YE, Carty SE, Chiosea SI, et al. Highly accurate diagnosis of cancer in thyroid nodules with follicular neoplasm/suspicious for a follicular neoplasm cytology by ThyroSeq v2 next-generation sequencing assay.Cancer. 2014;120(23):3627-3634. doi:10.1002/cncr.29038Nikiforov YE, Carty SE, Chiosea SI, et al. Impact of the multi-gene ThyroSeq next-generation sequencing assay on cancer diagnosis in thyroid nodules with atypia of undetermined significance/follicular lesion of undetermined significance cytology.Thyroid. 2015;25(11):1217-1223. doi:10.1089/thy.2015.0305
Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)
Marcadis AR, Valderrabano P, Ho AS, et al. Interinstitutional variation in predictive value of the ThyroSeq v2 genomic classifier for cytologically indeterminate thyroid nodules.Surgery. 2019;165(1):17-24. doi:10.1016/j.surg.2018.04.062Taye A, Gurciullo D, Miles BA, et al. Clinical performance of a next-generation sequencing assay (ThyroSeq v2) in the evaluation of indeterminate thyroid nodules.Surgery. 2018;163(1):97-103. doi:10.1016/j.surg.2017.07.032Valderrabano P, Khazai L, Leon ME, et al. Evaluation of ThyroSeq v2 performance in thyroid nodules with indeterminate cytology.Endocr Relat Cancer. 2017;24(3):127-136. doi:10.1530/ERC-16-0512Patel KN, Angell TE, Babiarz J, et al. Performance of a genomic sequencing classifier for the preoperative diagnosis of cytologically indeterminate thyroid nodules.JAMA Surg. 2018;153(9):817-824. doi:10.1001/jamasurg.2018.1153Nikiforova MN, Mercurio S, Wald AI, et al. Analytical performance of the ThyroSeq v3 genomic classifier for cancer diagnosis in thyroid nodules.Cancer. 15 2018;124(8):1682-1690. doi:10.1002/cncr.31245Lee E, Terhaar S, McDaniel L, et al. Diagnostic performance of the second-generation molecular tests in the assessment of indeterminate thyroid nodules: a systematic review and meta-analysis.Am J Otolaryngol. 2022;43(3):103394. doi:10.1016/j.amjoto.2022.103394
Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)
Patel J, Klopper J, Cottrill EE. Molecular diagnostics in the evaluation of thyroid nodules: Current use and prospective opportunities.Front Endocrinol(Lausanne).2023;14:1101410. doi:10.3389/fendo.2023.1101410Livhits MJ, Zhu CY, Kuo EJ, et al. Effectiveness of molecular testing techniques for diagnosis of indeterminate thyroid nodules: a randomized clinical trial.JAMA Oncol. 2021;7(1):70-77. doi:10.1001/jamaoncol.2020.5935Kim NE, Raghunathan RS, Hughes EG, et al. Bethesda III and IV thyroid nodules managed nonoperatively after molecular testing with Afirma GSC or Thyroseq v3.J Clin Endocrinol Metab. 2023; dgad181. doi:10.1210/clinem/dgad181Kim M, Kim BH. Current guidelines for management of medullary thyroid carcinoma.Endocrinol Metab (Seoul). 2021;36(3):514-524. doi:10.3803/EnM.2021.1082Tao Y, Wang F, Shen X, et al. BRAF V600E status sharply differentiates lymph node metastasis-associated mortality risk in papillary thyroid cancer.J Clin Endocrinol Metab. 2021;106(11):3228-3238.Wells SA, Jr., Asa SL, Dralle H, et al. Revised American Thyroid Association guidelines for the management of medullary thyroid carcinoma.Thyroid. 2015;25(6):567-610.Yip L. Molecular markers for thyroid cancer diagnosis, prognosis, and targeted therapy.J Surg Oncol. 2015;111(1):43-50.Najafian A, Noureldine S, Azar F, et al. RAS Mutations, and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangements are also prevalent in benign thyroid lesions: implications thereof and a systematic review.Thyroid. 2017;27(1):39-48.
Proposed LCD - MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (DL39650)
Guan H, Toraldo G,.Thyroid. 2020;30(4):536-547.Patel KN, Yip L, Lubitz CC, et al. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults.Ann Surg. 2020;271(3):e21-e93.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
CMS National Coverage PolicyItalicizedfont represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) Investigational or ExperimentalIOM Citations:CMS IOM Publication 100-08,Medicare Program Integrity Manual,~ Chapter 13, 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 shall 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.Code of Federal Regulations (CFR) References:CFR, Title 42, Ch. IV,  410.74 Physician assistants services, 410.75 Nurse practitioners services and  410.76 Clinical nurse specialists services.NCDsNCD 30.3.3 Acupuncture for Chronic Low Back PainCoverage Indications, Limitations, and/or Medical NecessityInitial Trigger Point InjectionTrigger point injections (TPI) will be considered medically reasonable and necessary to treat myofascial pain caused by trigger points when all the following requirements are met:There is a focal area of pain in the skeletal muscle.There is clinical evidence of a trigger point defined as pain in a skeletal muscle that is associated with at least 2 of the following findings: the presence of a hyperirritable spot and/or taut band identified by palpation and possible referred painANDThe physical examination identifies a focal hypersensitive bundle or nodule of muscle fiber harder than normal consistency with or without a local twitch response and referred painANDNon-invasive conservative therapy is not successful as first line treatmentORmovement of a joint or limb is limited or blockedORthe TPI is necessary for diagnostic confirmation.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
Non-invasive conservative therapy is not successful as first line treatmentORmovement of a joint or limb is limited or blockedORthe TPI is necessary for diagnostic confirmation.Subsequent TPIRepeat Trigger point injections in previously injected trigger points will be considered medically reasonable and necessary to treat myofascial pain syndrome when all the following requirements are met:There is a positive pain response from the most recent TPI defined as providing consistent minimum of 50% relief of primary (index) pain after the TPI measured by the SAME pain scale* at baseline and post-injectionANDConsistent pain relief from the most recent previous TPI lasting at least 6 weeks1ANDThe myofascial pain has reoccurred and is causing objective functional limitations measured by a functional scale obtained at baseline and after TPI which demonstrated at least 50% improvement from the previous TPI.*Note: The scales used to measure pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, 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 (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.Limitations: No more than three (3) TPI sessions will be reimbursed per rolling 12 months.Requirements:Patients should be part of an ongoing conservative treatment program and documentation to support the patient is actively participating in a rehabilitation program, home exercise program or functional restoration program is in the medical record.There should be at least 6 weeks duration before TPI is repeated in the same location.Trigger point primary index pain must be measured prior to the injection at the beginning of the session.The post procedure pain level must be measured after the TPI at the conclusion of the session using the same scale* utilized at baseline.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
Trigger point primary index pain must be measured prior to the injection at the beginning of the session.The post procedure pain level must be measured after the TPI at the conclusion of the session using the same scale* utilized at baseline.When documenting the percentage of pain relief from the primary (index) pain compared to the post-injection pain levels, it is insufficient to report only a percentage of pain relief and/or a nonspecific statement of the duration of pain relief. The documentation should include a specific assessment of the duration of relief being consistent or inconsistent with the agent used for the injection and the specific dates the measurements were obtained using the SAME pain scale* used at baseline.When documenting the ability to perform previously painful movements and activities of daily living (ADLs) it is insufficient to provide a vague or nonspecific statement regarding the improvement of previously painful movements and activities of daily living (ADLs). The documentation should include a functional assessment to show clinically meaningful improvement with painful movements and ADLs, if this metric is used to justify the efficacy of the TPI Providers should use established and measurable goals and objective scales to assess functionality and ADLs measures.Limitations:A TPI involves the use of a local anesthetic and does not include injections of biologics (e.g., platelet rich plasma, stem cells, amniotic fluid, etc.) and/or any other injectates.It is not considered medically reasonable and necessary to perform TPI into multiple muscle groups in different anatomical regions during the same session.It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks etc.) during the same session as TPI.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks etc.) during the same session as TPI.Trigger points injections for treatment of headache, neck pain or low back pain in absence of actual trigger points, diffuse muscle pain, a chronic pain syndrome, lumbosacral canal stenosis, fibromyalgia, non-malignant multifocal musculoskeletal pain, complex regional pain syndrome, sexual dysfunction/ pelvic pain, whiplash, neuropathic pain, and hemiplegic shoulder painare considered investigational and therefore are not considered medically reasonable and necessary.Use of fluoroscopy or MRI guidance for performance of TPI is not considered reasonable and necessary.The use of ultrasound guidance for the performance of TPI is considered investigational.Trigger point injections used on a routine basis, e.g., on a regular periodic and continuous basis, for patients with chronic non-malignant pain syndromes are not considered medically necessary.Provider Qualifications:The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.Patient safety and quality of care mandate that healthcare professionals who perform TPI injections/procedures for chronic pain (not surgical anesthesia) are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.2All aspects of care must be within the provider's medical licensure and scope of practice. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this policy only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging, ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
Manchikanti L, Singh V, Kloth D, et al. Interventional techniques in the management of chronic pain: Part 2. Pain Physician 2001;4(1):24Title XVIII of the Social Security Act: Sec. 1861.(s)(2) Part E-Miscellaneous Provisions: Definitions of Services I e. Secondary.https://www.ssa.gov/OP_Home/ssact/title18/1861.htm#ft495.Borg-Stein J, Stein J. Trigger points and tender points: one and the same? Does injection treatment help? Rheum Dis Clin North Am 1996;22(2):305-22 doi: 10.1016/s0889-857x(05)70274-x[published Online First: Epub Date]|.Fernndez-de-Las-Peas C, Dommerholt J. International consensus on diagnostic criteria and clinical considerations of myofascial trigger points: a Delphi study. Pain Medicine 2018;19(1):142-50Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. American family physician 2002;65(4):653Shankar H, Reddy S. Two-and three-dimensional ultrasound imaging to facilitate detection and targeting of taut bands in myofascial pain syndrome. Pain medicine 2012;13(7):971-75Ball A, Perreault T, Fernndez-de-Las-Peas C, Agnone M, Spennato J. Ultrasound Confirmation of the Multiple Loci Hypothesis of the Myofascial Trigger Point and the Diagnostic Importance of Specificity in the Elicitation of the Local Twitch Response. Diagnostics (Basel) 2022;12(2) doi: 10.3390/diagnostics12020321[published Online First: Epub Date]|.Lewis J, Tehan P. A blinded pilot study investigating the use of diagnostic ultrasound for detecting active myofascial trigger points. Pain 1999;79(1):39-44Rha D-w, Shin JC, Kim Y-K, Jung JH, Kim YU, Lee SC. Detecting local twitch responses of myofascial trigger points in the lower-back muscles using ultrasonography. Archives of physical medicine and rehabilitation 2011;92(10):1576-80. e1
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
Sikdar S, Shah JP, Gebreab T, et al. Novel applications of ultrasound technology to visualize and characterize myofascial trigger points and surrounding soft tissue. Archives of physical medicine and rehabilitation 2009;90(11):1829-38Cojocaru MC, Cojocaru IM, Voiculescu VM, Cojan-Carlea NA, Dumitru VL, Berteanu M. Trigger pointsultrasound and thermal findings. J Med Life 2015;8(3):315-8Kang JJ, Kim J, Park S, Paek S, Kim TH, Kim DK. Feasibility of Ultrasound-Guided Trigger Point Injection in Patients with Myofascial Pain Syndrome. Healthcare (Basel) 2019;7(4) doi: 10.3390/healthcare7040118[published Online First: Epub Date]|.Botwin KP, Sharma K, Saliba R, Patel BC. Ultrasound-guided trigger point injections in the cervicothoracic musculature: a new and unreported technique. Pain Physician 2008;11(6):885-9Quintner JL, Bove GM, Cohen ML. A critical evaluation of the trigger point phenomenon. Rheumatology 2014;54(3):392-99 doi: 10.1093/rheumatology/keu471[published Online First: Epub Date]|.Shipton B, Sagar S, Mall JK. Trigger Point Management. Am Fam Physician 2023;107(2):159-64Ahmed S, Subramaniam S, Sidhu K, et al. Effect of Local Anesthetic Versus Botulinum Toxin-A Injections for Myofascial Pain Disorders: A Systematic Review and Meta-Analysis. Clin J Pain 2019;35(4):353-67 doi: 10.1097/AJP.0000000000000681[published Online First: Epub Date]|.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
Nouged E, Dajani J, Ku B, Al-Eryani K, Padilla M, Enciso R. Local Anesthetic Injections for the Short-Term Treatment of Head and Neck Myofascial Pain Syndrome: A Systematic Review with Meta-Analysis. Journal of Oral & Facial Pain & Headache 2019;33(2)Lugo LH, Garca H, Rogers H, Plata JA. Treatment of myofascial pain syndrome with lidocaine injection and physical therapy, alone or in combination: a single blind, randomized, controlled clinical trial. BMC musculoskeletal disorders 2016;17(1):1-11Xie P, Qin B, Yang F, et al. Lidocaine Injection in the Intramuscular Innervation Zone Can Effectively Treat Chronic Neck Pain Caused by MTrPs in the Trapezius Muscle. Pain Physician 2015;18(5):E815-26Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg 2021;79(1):88 e1-88 e9 doi: 10.1016/j.joms.2020.09.013[published Online First: Epub Date]|.Barad M, Ailani J, Hakim SM, Kissoon NR, Schuster NM. Percutaneous Interventional Strategies for Migraine Prevention: A Systematic Review and Practice Guideline. Pain Med 2022;23(1):164-88 doi: 10.1093/pm/pnab236[published Online First: Epub Date]|.Sabatke S, Scola RH, Paiva ES, Kowacs PA. Injection of trigger points in the temporal muscles of patients with miofascial syndrome. Arq Neuropsiquiatr 2015;73(10):861-6 doi: 10.1590/0004-282X20150135[published Online First: Epub Date]|.
Proposed LCD - Trigger Point Injections (TPI) (DL39656)
Karadas O, Inan LE, Ulas U, Odabasi Z. Efficacy of local lidocaine application on anxiety and depression and its curative effect on patients with chronic tension-type headache. Eur Neurol 2013;70(1-2):95-101 doi: 10.1159/000350619[published Online First: Epub Date]|.Baron EP, Cherian N, Tepper SJ. Role of greater occipital nerve blocks and trigger point injections for patients with dizziness and headache. Neurologist 2011;17(6):312-7 doi: 10.1097/NRL.0b013e318234e966[published Online First: Epub Date]|.Ashkenazi A, Blumenfeld A, Napchan U, et al. Peripheral nerve blocks and trigger point injections in headache management - a systematic review and suggestions for future research. Headache 2010;50(6):943-52 doi: 10.1111/j.1526-4610.2010.01675.x[published Online First: Epub Date]|.Venancio Rde A, Alencar FG, Jr., Zamperini C. Botulinum toxin, lidocaine, and dry-needling injections in patients with myofascial pain and headaches. Cranio 2009;27(1):46-53 doi: 10.1179/crn.2009.008[published Online First: Epub Date]|.Boelens OBA, Scheltinga MR, Houterman S, Roumen RM. Randomized clinical trial of trigger point infiltration with lidocaine to diagnose anterior cutaneous nerve entrapment syndrome. Br J Surg 2013;100(2):217-21 doi: 10.1002/bjs.8958[published Online First: Epub Date]|.Oor JE, Unlu C, Hazebroek EJ. A systematic review of the treatment for abdominal cutaneous nerve entrapment syndrome. Am J Surg 2016;212(1):165-74 doi: 10.1016/j.amjsurg.2015.12.013[published Online First: Epub Date]|.