evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Trigger Point Injections (TPI) (DL36859)
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) (DL36859)
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]|.
Proposed LCD - Trigger Point Injections (TPI) (DL36859)
Boelens OB, Scheltinga MR, Houterman S, Roumen RM. Management of anterior cutaneous nerve entrapment syndrome in a cohort of 139 patients. Ann Surg 2011;254(6):1054-8 doi: 10.1097/SLA.0b013e31822d78b8[published Online First: Epub Date]|.Staal JB, de Bie RA, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976) 2009;34(1):49-59 doi: 10.1097/BRS.0b013e3181909558[published Online First: Epub Date]|.Watters WC, 3rd, Resnick DK, Eck JC, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion. J Neurosurg Spine 2014;21(1):79-90 doi: 10.3171/2014.4.SPINE14281[published Online First: Epub Date]|.Di Cesare A, Giombini A, Di Cesare M, Ripani M, Vulpiani MC, Saraceni VM. Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial. Complement Ther Med 2011;19(1):19-26 doi: 10.1016/j.ctim.2010.11.002[published Online First: Epub Date]|.Kocak AO, Ahiskalioglu A, Sengun E, Gur STA, Akbas I. Comparison of intravenous NSAIDs and trigger point injection for low back pain in ED: A prospective randomized study. Am J Emerg Med 2019;37(10):1927-31 doi: 10.1016/j.ajem.2019.01.015[published Online First: Epub Date]|.
Proposed LCD - Trigger Point Injections (TPI) (DL36859)
Saeidian SR, Pipelzadeh MR, Rasras S, Zeinali M. Effect of trigger point injection on lumbosacral radiculopathy source. Anesth Pain Med 2014;4(4):e15500 doi: 10.5812/aapm.15500[published Online First: Epub Date]|.Khoshnazar SS, Farpour HR, Shahriarirad R. A comparison between effectiveness of gluteal trigger point and epidural steroid injection in lumbosacral canal stenosis patients: a randomized clinical trial. Br J Neurosurg 2022:1-7 doi: 10.1080/02688697.2022.2033698[published Online First: Epub Date]|.Chou R, Atlas S. Subacute and chronic low back pain: Nonsurgical interventional treatment. Secondary Subacute and chronic low back pain: Nonsurgical interventional treatment 2016.www.uptodate.com.Peloso PM, Khan M, Gross AR, et al. Pharmacological Interventions Including Medical Injections for Neck Pain: An Overview as Part of the ICON Project. 2013;7(Suppl 4):473-93 doi: 10.2174/1874325001307010473[published Online First: Epub Date]|.Freeman MD, Nystrom A, Centeno C. Chronic whiplash and central sensitization; an evaluation of the role of a myofascial trigger points in pain modulation. J Brachial Plex Peripher Nerve Inj 200923(4):2 doi: 10.1186/1749-7221-4-2.[published Online First: Epub Date]|.Staud R, Weyl E, Bartley E, Price D, Robinson M. Analgesic and anti-hyperalgesic effects of muscle injections with lidocaine or saline in patients with fibromyalgia syndrome. European Journal of Pain 2014;18(6):803-12
Proposed LCD - Trigger Point Injections (TPI) (DL36859)
Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil 1996;77(11):1161-6 doi: 10.1016/s0003-9993(96)90141-0[published Online First: Epub Date]|.Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA 2004;292(19):2388-95 doi: 10.1001/jama.292.19.2388[published Online First: Epub Date]|.Scott NA, Guo B, Barton PM, Gerwin RD. Trigger point injections for chronic non-malignant musculoskeletal pain: a systematic review. Pain Medicine 2009;10(1):54-69Zoorob D, South M, Karram M, et al. A pilot randomized trial of levator injections versus physical therapy for treatment of pelvic floor myalgia and sexual pain. Int Urogynecol J 2015;26(6):845-52 doi: 10.1007/s00192-014-2606-4[published Online First: Epub Date]|.Patil S, Daniel G, Vyas R, et al. Neuromuscular treatment approach for women with chronic pelvic pain syndrome improving pelvic pain and functionality. Neurourol Urodyn 2022;41(1):220-28 doi: 10.1002/nau.24799[published Online First: Epub Date]|.Ratmansky M, Defrin R, Soroker N. A randomized controlled study of segmental neuromyotherapy for post-stroke hemiplegic shoulder pain. J Journal of rehabilitation medicine 2012;44(10):830-36Terlemez R, Ercalik T. Effect of piriformis injection on neuropathic pain. Agri 2019;31(4):178-82 doi: 10.14744/agri.2019.34735[published Online First: Epub Date]|.
Proposed LCD - Trigger Point Injections (TPI) (DL36859)
American Society of Anesthesiologists Task Force on Chronic Pain Management: 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):810-33Practice 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):810-33 doi: 10.1097/ALN.0b013e3181c43103[published Online First: Epub Date]|.Hegmann K TR, Anderson G etal. . ACOEM GUIDELINES: Invasive Treatments for Low Back Disorders. JOEM 2021;63(4):e215-e41NASS. Diagnosis and Treatment of Low Back Pain. Secondary Diagnosis and Treatment of Low Back Pain 2020.https://www.spine.org/.
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manuals, Pub. 100-02, Medicare Beneficiary Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityDEFINITIONSFor purposes of this policy the following definitions are used:Surveillance (Protocol)  patient is asymptomatic; no clinical signs or symptoms of organ injury/rejection.For-Cause  patient has clinical signs or symptoms of organ injury/rejection.AR  Acute RejectionACR  Acute Cellular RejectionAMR  Antibody-Mediated RejectionAV  Analytical ValidityCV  Clinical ValidityOPTN - Organ Procurement and Transplantation NetworkGEP  Gene Expression Profilingdd cfDNA  Donor-Derived Cell-Free DNAThis Medicare contractor will provide limited coverage for molecular diagnostic tests used in the evaluation and management of patients who have undergone solid organ transplantation. These tests can inform decision making along with standard clinical assessments in their evaluation of organ injury for active rejection (AR).These tests may be ordered by qualified physicians considering the diagnosis of AR, helping to rule in or out this condition when assessing the need for or results of a diagnostic biopsy.They should be considered along with other clinical evaluations and results and may be particularly useful in patients with significant contraindications to invasive procedures.Molecular diagnostic tests that assess a transplanted allograft for rejection status are covered when ALL of the following criteria are met:The test must provide information about at least one of the two following clinical status determinations:AR statusCellular or Antibody-mediated rejection (ACR or AMR) status
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
The test must provide information about at least one of the two following clinical status determinations:AR statusCellular or Antibody-mediated rejection (ACR or AMR) statusThe intended use of the test must be to inform clinical decision making as per the following:To assist in the evaluation of adequacy of immunosuppression, wherein a non-invasive or minimally invasive test can be used in lieu of a tissue biopsy in a patient for whom information from a tissue biopsy would be used to make a management decision regarding immunosuppression, ORAs a rule-out test for AR in validated populations of patients with clinical suspicion of rejection with a non-invasive or minimally invasive test to make a clinical decision regarding obtaining a biopsy, ORFor further evaluation of allograft status for the probability of allograft rejection after a physician-assessed pretest, ORTo assess rejection status in patients that have received a biopsy, but the biopsy results are inconclusive or limited by insufficient material.Therefore, molecular diagnostic tests are not covered if the results will not inform clinical decision making (for example if the patient has undergone a recent biopsy with a definitive diagnosis or has a planned upcoming biopsy that will be performed regardless of the result of the molecular test). Similarly, if a molecular test is performed as a result of findings from a pre-test, this suggests that the molecular test is informed by and performed after the results of the pre-test are known; as such, the molecular tests should be performed after the relevant pre-test(s).
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
IF the molecular diagnostic test is performed in-lieu of a surveillance (protocol) biopsy, the testing frequency must be no more frequent than the OPTN center-specific surveillance biopsy schedule.The test demonstrates analytical validity (AV), including an analytical and clinical validation for any given measured analytes, and has demonstrated equivalence or superiority for sensitivity or specificity (depending on intended use) of detecting allograft rejection to other already-accepted tests for the same intended use measuring the same or directly comparable analytes.Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population. The degree of validity must be similar or superior to established and covered tests (see associated coverage Articles). If conducted with concordance to tissue histologic evaluation the most current Banff Classification for renal allografts or other accepted criteria (if existing) for other organs must be used.The test is being used in a patient who is part of the population in which the test was analytically validated and has demonstrated CV.For a given patient encounter, only one molecular test for assessing allograft status may be performed.For minimally or non-invasive tests, the benefit to risk profile of the molecular test is considered by the ordering clinician to be more favorable than the benefit to risk profile of a tissue biopsy, or a tissue biopsy cannot be obtained. For example, this may be the case if a biopsy is considered medically contraindicated in a patient.The test successfully completes a Molecular Diagnostic Services Program (MolDX) Technical Assessment that will ensure that AV, CV, and clinical utility criteria set in this policy are met to establish the test as Reasonable and Necessary.Covered tests with AV that is significantly below similar services may have coverage rescinded.General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
USRDS Coordinating Center United States Renal Data System. 2018;USRDS. Accessed 6/2/2023.Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC.Eur J Heart Fail. 2016;18(8):891-975.Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2013;62(16):e147-239.United States Government Accountability Office. End-Stage Renal Disease: Characteristics of Kidney Transplant Recipients, Frequency of Transplant Failures, and Cost to Medicare. In:2007.Seron D, Arns W, Chapman JR. Chronic allograft nephropathyclinical guidance for early detection and early intervention strategies.Nephrol Dial Transplant. 2008;23(8):2467-2473.Lamb KE, Lodhi S, Meier-Kriesche HU. Long-term renal allograft survival in the United States: a critical reappraisal.Am J Transplant. 2011;11(3):450-462.Stegall MD, Gaston RS, Cosio FG, Matas A. Through a glass darkly: seeking clarity in preventing late kidney transplant failure.J Am Soc Nephrol. 2015;26(1):20-29.Stehlik J, Kobashigawa J, Hunt SA, Reichenspurner H, Kirklin JK. Honoring 50 years of clinical heart transplantation inCirculation: in-depth state-of-the-art review.Circulation. 2018;137(1):71-87.McManigle W, Pavlisko EN, Martinu T. Acute cellular and antibody-mediated allograft rejection.Semin Respir Crit Care Med. 2013;34(3):320-335.
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
McManigle W, Pavlisko EN, Martinu T. Acute cellular and antibody-mediated allograft rejection.Semin Respir Crit Care Med. 2013;34(3):320-335.Haas M, Loupy A, Lefaucheur C, et al. The Banff 2017 kidney meeting report: revised diagnostic criteria for chronic active T cellmediated rejection, antibody-mediated rejection, and prospects for integrative endpoints for next-generation clinical trials.Am J Transplant. 2018;18(2):293-307.Solez K, Axelsen RA, Benediktsson H, et al. International standardization of criteria for the histologic diagnosis of renal allograft rejection: the Banff working classification of kidney transplant pathology.Kidney Int. 1993;44(2):411-422.Bruneval P, Angelini A, Miller D, et al. The XIIIth Banff conference on allograft pathology: The Banff 2015 heart meeting report: improving antibody-mediated rejection diagnostics: strengths, unmet needs, and future directions.Am J Transplant. 2017;17(1):42-53.Stewart S, Winters GL, Fishbein MC, et al. Revision of the 1990 working formulation for the standardization of nomenclature in the diagnosis of heart rejection.J Heart Lung Transplant. 2005;24(11):1710-1720.Mehr MR. Heart transplantation at 50.Lancet. 2017;390(10111):E43-E45.Nankivell BJ, Alexander SI. Rejection of the kidney allograft.N Engl J Med. 2010;363(15):1451-1462.Richmond ME, Zangwill SD, Kindel SJ, et al. Donor fraction cell-free DNA and rejection in adult and pediatric heart transplantation.J Heart Lung Transplant. 2020;39(5):454-463.Levitsky J, Asrani SK, Schiano T, et al. Discovery and validation of a novel blood-based molecular biomarker of rejection following liver transplantation.Am J Transplant. 2020;20(8):2173-2183.
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
Sigdel TK, Archila FA, Constantin T, et al. Optimizing detection of kidney transplant injury by assessment of donor-derived cell-free DNA via massively multiplex PCR.J Clin Med. 2018;8(1).Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and active rejection in kidney allografts.J Am Soc Nephrol. 2017;28(7):2221-2232.Bromberg JS, Brennan DC, Poggio E, et al. Biological variation of donor-derived cell-free DNA in renal transplant recipients: clinical implications.J App Lab Med. 2017;2(3):309-321.Grskovic M, Hiller DJ, Eubank LA, et al. Validation of a clinical-grade assay to measure donor-derived cell-free DNA in solid organ transplant recipients.J Mol Diagn. 2016;18(6):890-902.First MR, Whisenant T, Friedewald JJ, et al. Clinical utility of peripheral blood gene expression profiling of kidney transplant recipients to assess the need for surveillance biopsies in subjects with stable renal function.J Transplant Technol Res. 2017;7(3).Marsh C, Kurian SM, Rice J, et al. Application of TruGraf v1: a novel molecular biomarker for managing kidney transplant recipients with stable renal function.Transplant Proc. 2019;51(3):722-728.Roedder S, Sigdel T, Salomonis N, et al. The kSORT assay to detect renal transplant patients at high risk for acute rejection: results of the multicenter AART study.PLoS Med. 2014;11(11).Beck J, Oellerich M, Schulz U, et al. Donor-derived cell-free DNA is a novel universal biomarker for allograft rejection in solid organ transplantation.Transplant Proc. 2015;47(8):2400-2403.Kurian S, Velazquez E, Thompson R, et al. Orthogonal comparison of molecular signatures of kidney transplants with subclinical and clinical acute rejection: equivalent performance is agnostic to both technology and platform.Am J Transplant. 2017;17(8):2103-2116.
Proposed LCD - MolDX: Molecular Testing for Solid Organ Allograft Rejection (DL38582)
Pham MX, Teuteberg JJ, Kfoury AG, et al. Gene-expression profiling for rejection surveillance after cardiac transplantation.N Engl J Med. 2010;362(20):1890-1900.Khush KK, Patel J, Pinney S, et al. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: a prospective multicenter study.Am J Transplant. 2019;19(10):2889-2899.Pattar SKG, Steven C. Circulating nucleic acids as biomarkers for allograft injury after solid organ transplantation: current state-of-the-art.Transplant Research and Risk Management. 2019;11:17-27.Schutz E, Fischer A, Beck J, et al. Graft-derived cell-free DNA, a noninvasive early rejection and graft damage marker in liver transplantation: a prospective, observational, multicenter cohort study.PLoS Med. 2017;14(4):e1002286.Guzzi F, Cirillo L, Buti E, et al. Urinary biomarkers for diagnosis and prediction of acute kidney allograft rejection: a systematic review.Int J Mol Sci.2020;21(18).Adam B, Afzali B, Dominy KM, et al. Multiplexed color-coded probe-based gene expression assessment for clinical molecular diagnostics in formalin-fixed paraffin-embedded human renal allograft tissue.Clin Transplant. 2016;30(3):295-305.Sigdel T, Nguyen M, Liberto J, et al. Assessment of 19 genes and validation of CRM gene panel for quantitative transcriptional analysis of molecular rejection and inflammation in archival kidney transplant biopsies.Front Med (Lausanne). 2019;6:213.Depasquale E, Hall S, Crespo-Leiro M, Kao A, Teuteberg J, Hiller D, Yee J. Combination of cell-free DNA with gene-expression profiling in the diagnosis of acute rejection.J Heart Lung Transplant. 2019;38:S387.Fryback DG, Thornbury JR. The efficacy of diagnostic imaging.Med Decis Making. 1991;11(2):88-94.
Proposed LCD - Allergen Immunotherapy (DL36240)
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 allergen immunotherapy services. 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 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 allergen immunotherapy services 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 regarding allergen immunotherapy services may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Sections 20.2 Physician Expense for Allergy Treatment, 50.4.4.1 Antigens, 60.1 Direct Personal Supervision, and 60.2 Services of Nonphysician Personnel Furnished Incident To Physician's ServicesCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 2, Sections 110.9 Antigens Prepared for Sublingual Administration and 110.11 Food Allergy Testing and TreatmentCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 12, Section 200 Allergy Testing and ImmunotherapyCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDsSocial 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