evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Facet Joint Interventions for Pain Management (DL38773)
There are various methods that may be used in performing facet joint denervation. Percutaneous radiofrequency ablation (RFA) is a minimally invasive procedure done with imaging guidance (fluoroscopy or CT per code descriptor) and involves using energy in the radiofrequency range to cause necrosis of specific nerves (medial branches of the dorsal rami), preventing the neural transmission of pain. Conventional radiofrequency ablation (non- pulsed or continuous) applies thermal energy of typically 80 to 85 degrees Celsius. The terms radiofrequency ablation (RFA) and radiofrequency neurotomy are used interchangeably. Both terms refer to a procedure that destroys the functionality of the nerve using radiofrequency energy. Non-thermal methods of denervation include chemical (chemodenervation), low-grade thermal energy (less than 80 degrees Celsius), pulsed RFA, laser neurolysis, and cryoablation1.Throughout this document, societal recommendations with the grading of evidence are referenced. There are multiple systems to grade or rank the quality of medical evidence and develop evidence-based recommendations. Not all grading systems are equivalent, so while there are typically similarities in the grades or recommendations from various grading systems, they must be considered independent of the other. The references in this document refer to the following grading systems.
Proposed LCD - Facet Joint Interventions for Pain Management (DL38773)
GRADE Guidelines used in some systematic reviews, the basis for NASS recommendations aligns with GRADE.A Modified approach to the grading of evidence2and development of interventional pain management specific instrument3used in ASIPP Guidelines and some systematic reviews.US Preventive Services Task Force grading of evidence guidelines used by 2020 Consensus Guidelines by Cohen et al4.Levels of Evidence for Primary Research Question and Grades of Recommendation for Summaries or Review of Studies adopted by North American Spine Society (NASS)5.A Multi-MAC Subject Matter Expert (SME) Panel on Facet Joint and Medial Nerve Branch Procedures meeting on was held on 5/28/2020.General InformationAssociated InformationPlease refer to the Local Coverage Article: Billing and Coding: Facet Joint Interventions for Pain Management (A58364) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.Sources of InformationN/ABibliography
Proposed LCD - Molecular Pathology Procedures (DL35000)
CEBPA(CCAAT/enhancer binding protein [C/EBP], alpha) (eg, acute myeloid leukemia), full gene sequence is considered medically necessary in patients with acute myelogenous leukemia (AML) to guide therapeutic decision making.CALR(calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9 is considered medically necessary in the initial diagnostic work-up of BCR-ABL negative, JAK2-negative adults with clinical, laboratory, or pathological findings suggesting polycythemia vera (PV), essential thrombocythemia (ET) or primary myelofibrosis (PMF).CCND1/IGH(BCL1/IgH, t)(eg, mantle cell lymphoma) translocation analysis, major breakpoint, qualitative and quantitative, if performed is considered medical necessary for patients who have non- Hodgkins lymphoma to guide therapeutic decision-making.Ceramides Risk Score(Ceramides by liquid chromatography-tandem mass spectrometry, plasma, quantitative report with risk score for major cardiac events) is considered not medically necessary.CFTR(cystic fibrosis transmembrane conductance regulator) (e.g.cystic fibrosis) gene analysis, common variants (e.g. ACMG/ACOG guidelines) is considered medically necessary for a beneficiary who has or may have cystic fibrosis to guide therapeutic decision-making.Chimerism analysisto identify appropriate donors and monitor engraftment success or disease reoccurrence is considered medically necessary.CYP2C619-cytochrome P450 CYP2C6 19-cytochrome P450 Based on the FDAs Black Box warning for clopidogrel, the effectiveness of clopidogrel is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. CYP2C619 genotyping may be medically necessary once per lifetime to identify individuals:
Proposed LCD - Molecular Pathology Procedures (DL35000)
Who are poor metabolizers of clopidogrel, so that alternative treatment or treatment strategies can be consideredWho are poor metabolizers of clopidogrel with acute coronary syndrome or who are undergoing percutaneous coronary intervention
Proposed LCD - Molecular Pathology Procedures (DL35000)
RARS(SF3B1 mutation) is considered medically necessary in patients with Myelodysplastic Syndrome to guide therapeutic decision-making.RET(ret-proto-oncogene) is considered medically necessary in patients with medullary CA of thyroid, multiple endocrine neoplasia, pheochromocytoma, and parathyroid tumors) to guide therapeutic decision making.ROSproto-oncogene 1, receptor tyrosine kinase, is considered medically necessary in patients with non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individuals specific clinical presentation.SERPINA1(serpin peptidase inhibitor, clade A, alpha-1- antiproteinase, antitrypsin, member 1) (e.g., antitrypsin deficiency), gene analysis, common variants (e.g. *S and *Z) is considered medically necessary for patients who have antitrypsin deficiency to guide therapeutic decision-making.Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (EG, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed is considered not medically necessary except when used to guide treatment decision making in individuals with non-small cell lung cancer (please refer to LCD L37810).TP53(tumor protein 53) (e.g. tumor samples), targeted sequence analysis of 2-5 exons, and CPT code 81405 TP53 (tumor protein 53) (e.g. Li-Fraumeni syndrome, tumor samples), full gene sequence or targeted sequence analysis of >5 exons are considered medically necessary in individuals who have Acute Myelogenous Leukemia, chronic lymphocytic leukemia (CLL), or Myelodysplastic Disease to guide therapeutic decision-making.
Proposed LCD - Molecular Pathology Procedures (DL35000)
H19HADHA (hydroxyacyl-CoA dehydrogenase/3-ketoacyl-CoA thiolase/enoyl-CoA hydratase [trifunctional protein] alpha subunit)HAX1 (HAX1_HUMAN, HCLS1- associated protein X-1, HCLSBP1, HS1-associating protein X-1, HS1 binding protein, HS1-binding protein 1, HS1BP1, HSP1BP-1)HEXA (hexosaminidase A, alpha polypeptide)HNF1B (HNF1 homeobox B)HRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog Costello syndrome)HRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog)HTT (huntingtin)IL28BIVDKCNJ10 (potassium inwardly-rectifying channel, subfamily J, member 10)KCNQ10T1 (KCNQ1 overlapping transcript 1)KIF6Level 8 Molecular Pathology ProceduresLevel 9 Molecular Pathology ProceduresLMNA (lamin A/C)LPA intron 25 genotypeMEFV (Mediterranean fever) (eg, familial Mediterranean fever)MEG3/DLK1MEK1MLL/AFFMPZ (myelin protein zero)MT-ATP6MT-ND4, MT-ND6MT-ND5 mitochondrially encoded tRNA leucine 1 [UUA/G] mitochondrially encoded NADH dehydrogenase 5)MT-RNR1 (mitochondrially encoded 12S RNA)MT-RNR1 (mitochondrially encoded 12S RNA)MT-TK (mitochondrially encoded tRNA lysine)MT-TL1MT-TS1MT-TS1 (mitochondrially encoded tRNA serine 1)MUTYH (mutY homolog [E. coli])NF2 (neurofibromin 2 [merlin])NSD1 (nuclear receptor binding SET domain protein 1)PAH (phenylalanine hydroxylase)PAX2 (paired box 2)PDHA1 (pyruvate dehydrogenase [lipoamide] alpha1)
Proposed LCD - Molecular Pathology Procedures (DL35000)
Cwikla JB, Bodei L, Cwikla A, Sankowski A, Alaimo D, Modlin IM, Kidd M. Gene Transcript analysis in advanced gastroenteropancreatic neuroendocrine tumors treated with somatostatin analogs defines stable and progressive disease.J Clin Endocrinol Metabolism. 2015;100:E1437-1445.Peczkowska M, Cwikla J, Kidd M, Lewczuk A, Kolasinska-Cwikla A, Niec D, Michalowska I, Prejbisz A, Januszewicz A, Chiarelli J, Bodei L, Modlin I. The clinical utility of circulating neuroendocrine gene transcript analysis in well-differentiated paragangliomas and pheochromocytomas.Eur J Endocrinol. 2017;176:143-157.Modlin IM, Drozdov I, Bodei L, Kidd M. Blood transcript analysis and metastatic recurrent small bowel carcinoid management. BMCCancer. 2014;14:564.Reconsideration Request- CPT Code 0007MJuly 2017Verbeek WH, Korse CM, Tesselaar ME. GEP-NETs UPDATE: Secreting gastro-enteropancreatic neuroendocrine tumours and biomarkers.Eur J Endocrinol. 2016;174(1):R1-7.Oberg K, Modlin IM, De Herder W, et al. Consensus on biomarkers for neuroendocrine tumour disease.Lancet Oncol. 2015;16(9):e435-e446.Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors. NCT02948946.https://clinicaltrials.gov/ct2/show/study/NCT02948946Aetna Number: 0352. Tumor Markers.http://www.aetna.com/cpb/medical/data/300_399/0352.html
Proposed LCD - Molecular Pathology Procedures (DL35000)
Aetna Number: 0352. Tumor Markers.http://www.aetna.com/cpb/medical/data/300_399/0352.htmlReconsideration Request- IGH and TP53 October 20221. NCCN Biomarker Compendium , accessed October 20, 2022New LCD Request- Ceramides Risk Score- October 2022Mantovani A, Dugo C. Ceramides and risk of major adverse cardiovascular events: A meta-analysis of longitudinal studies.J Clin Lipidol. 2020;14(2):176-185. doi:10.1016/j.jacl.2020.01.005UpToDate accessed 4/5/2023Park LK, Garr Barry V, Hong J, Heebink J, Sah R, Peterson LR. Links between ceramides and cardiac function.Curr Opin Lipidol. 2022;33(1):47-56. doi:10.1097/MOL.0000000000000802
Proposed LCD - Molecular Pathology Procedures (DL35000)
Hilvo M, Vasile VC, Donato LJ, Hurme R, Laaksonen R. Ceramides and Ceramide Scores: Clinical Applications for Cardiometabolic Risk Stratification.Front Endocrinol (Lausanne). 2020;11:570628. Published 2020 Sep 29. doi:10.3389/fendo.2020.570628Laaksonen R, Ekroos K, Sysi-Aho M, et al. Plasma ceramides predict cardiovascular death in patients with stable coronary artery disease and acute coronary syndromes beyond LDL-cholesterol.Eur Heart J. 2016;37(25):1967-1976. doi:10.1093/eurheartj/ehw148Havulinna AS, Sysi-Aho M, Hilvo M, et al. Circulating Ceramides Predict Cardiovascular Outcomes in the Population-Based FINRISK 2002 Cohort.Arterioscler Thromb Vasc Biol. 2016;36(12):2424-2430. doi:10.1161/ATVBAHA.116.307497Meeusen JW, Donato LJ, Bryant SC, Baudhuin LM, Berger PB, Jaffe AS. Plasma Ceramides.Arterioscler Thromb Vasc Biol. 2018;38(8):1933-1939. doi:10.1161/ATVBAHA.118.311199Hilvo M, Vasile VC, Donato LJ, Hurme R, Laaksonen R. Ceramides and Ceramide Scores: Clinical Applications for Cardiometabolic Risk Stratification.Front Endocrinol (Lausanne). 2020;11:570628. Published 2020 Sep 29. doi:10.3389/fendo.2020.570628Mantovani A, Dugo C. Ceramides and risk of major adverse cardiovascular events: A meta-analysis of longitudinal studies.J Clin Lipidol. 2020 Mar-Apr;14(2):176-185. doi: 10.1016/j.jacl.2020.01.005.
Proposed LCD - Molecular Pathology Procedures (DL35000)
Meeusen JW, Donato LJ, Kopecky SL, Vasile VC, Jaffe AS, Laaksonen R. Ceramides improve atherosclerotic cardiovascular disease risk assessment beyond standard risk factors.Clin Chim Acta. 2020;511:138-142. doi:10.1016/j.cca.2020.10.005Vasile VC, Jaffe AS. An enhanced ceramide-based approach for primary prevention of atherosclerotic events.Eur Heart J Open. 2021;1(3):oeab016. Published 2021 Aug 12. doi:10.1093/ehjopen/oeab016Vasile VC, Meeusen JW, Medina Inojosa JR, et al. Ceramide Scores Predict Cardiovascular Risk in the Community.Arterioscler Thromb Vasc Biol. 2021;41(4):1558-1569. doi:10.1161/ATVBAHA.120.315530Akhiyat N, Vasile V, Ahmad A, et al. Plasma Ceramide Levels Are Elevated in Patients With Early Coronary Atherosclerosis and Endothelial Dysfunction.J Am Heart Assoc. 2022;11(7):e022852. doi:10.1161/JAHA.121.022852
Proposed LCD - Cervical Fusion (DL39741)
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 cervical fusion procedures for pain management. 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, de?nitions and 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 EPIDURAL procedures for pain management 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 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.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and General InformationCovered IndicationsA. Cervical fusion surgery is considered medically reasonable and necessary for the decompression of symptomatic cervical nerve root impingement when all of the following requirements are met:
Proposed LCD - Cervical Fusion (DL39741)
Persistent or recurrent moderate or severe arm pain (4 or more on the visual analog scale or equivalent) present for a minimum of 12 weeks within the current episode of neck pain with documented failure to respond to multimodal conservative management (as tolerated) in the absence of exceptional circumstances (below)ANDNerve compression negatively impacts activities of daily livingANDAll other potential sources of pain/neurological deficit have been excludedANDImaging (MRI or CT) evidence of central, lateral recess or foraminal stenosis at the level corresponding with clinical myotome signs or symptoms and including at least one of the following:Cervical degenerative disc disease as indicated by the presence of one or more of the following findings: herniated nucleus pulposus, narrowing of the intervertebral disc, disc osteophytes, facet hypertrophy, or synovial cysts.Tumors (primary or metastatic)Post infection radiographic findingsSpinal instability as defined by subluxation or translation more than 3.5 mm on static lateral views or dynamic radiographs OR sagittal plane angulation of more than 11 degrees between adjacent segments.1LimitationsThe following is considered not reasonable and necessary for the decompression of symptomatic cervical nerve root impingement:Isolated chronic axial cervical painExceptions to conservative therapy requirement for decompression of symptomatic cervical nerve root impingement:MyelopathyCervical myelopathy class III or aboveORProgression of neurological deficits during the trial of conservative treatment.RadiculopathyPresenting with progressive motor weaknessORSignificant motor weakness interfering with ADLsSevere radicular pain defined as pain limiting ability to perform activities of daily living (AOLs) and 7/10 on VAS or equivalent scale2 AND associated with confirmatory imaging (computed tomography, magnetic resonance imaging) and clinical-radiological correlationCauda equina syndrome
Proposed LCD - Cervical Fusion (DL39741)
Cauda equina syndromeB. Cervical fusion surgery is considered reasonable and necessary for the decompression of symptomatic cervical canal stenosis when the following requirements are met:1. Persistent or recurrent moderate or severe arm pain (4 or more on the visual analog scale or equivalent) present for a minimum of 12 weeks within the episode of arm pain with documented failure to respond to multimodal conservative management (as tolerated) in the absence of exceptional circumstances (below)OR2. Nerve compression negatively impacts activities of daily livingOR3. Spastic gait, loss of manual dexterity, problems with sphincter controlAND4. All other potential sources of pain/neurological deficit have been excludedAND5. Imaging (MRI or CT) evidence of central stenosis at the level corresponding with clinical signs or symptoms and including at least one of the following:Cervical degenerative disc disease as indicated by the presence of one or more of the following findings: herniated nucleus pulposus, narrowing of the intervertebral disc, disc osteophytes, facet hypertrophy, or synovial cysts.Congenital short pediclesTumors (primary or metastatic)Post infection radiographic findingsOssification of the posterior longitudinal ligament.Spinal instability as defined by subluxation or translation more than 3.5 mm on static lateral views or dynamic radiographs OR sagittal plane angulation of more than 11 degrees between adjacent segments.Cord compression with or without increased cord signal.LimitationsThe following are considered not reasonable and necessary fordecompression of symptomatic cervical canal stenosis:Isolated chronic axial cervical pain.Asymptomatic myelopathy (regardless of severity on imaging findings).Exceptions to conservative therapy requirement for decompression of symptomatic cervical canal stenosis:MyelopathyCervical myelopathy class III or aboveORProgression of neurological deficits during the trial of conservative treatment.RadiculopathyPresenting with progressive motor weaknessORSignificant motor weakness interfering with ADLsORSevere radicular pain defined as pain limiting ability to perform activities of daily living (AOLs) and 7/10 on Visual Analog Scale (VAS) or equivalent scale2AND associated with confirmatory imaging (computed tomography, magnetic resonance imaging) and clinical-radiological correlation.Cauda equina syndrome
Proposed LCD - Cervical Fusion (DL39741)
Cauda equina syndromeC. Cervical fusion surgery is considered reasonable and necessary for the decompression or stabilization of the cervical spine for the following indications:1. Traumatic injuries including fractures, dislocations, facture-dislocations, or traumatic ligamentous disruption when3:Fractures or dislocations which are likely to result spinal instability without neurological defectsORFractures or dislocations associated with neurological defects at the affected levelORInstability is present.2. Spinal tumors involving the spine or spinal canal when:3Malignant or benign tumors which have caused instability or neurologic deficit where treatment of the tumor will likely require stabilization of the spine.4ORExpected treatment of the tumor whether by chemotherapy or radiation therapy or surgery will likely cause spinal instability or neurologic deficits.4ORInstability is present.3.Infection involving the spine in the form of discitis, osteomyelitis, or epidural abscess when3:Imaging or other studies (MRI, biopsy, bone aspirate) demonstrating infectionANDImaging evidence of vertebral body destruction OR documentation that spinal debridement will cause vertebral instability5,6ORInstability is present.4. Deformities that include the cervical spine including when3:Cervical kyphosis associated with cord compression or Atlantoaxial (C1-C2) subluxation or Basilar invagination of the odontoid process into the foramen magnum;orSubaxial (C2-T1) instability kyphosis, head drop syndrome, post-laminectomy deformity ORSymptomatic pseudarthrosis (non-union of prior fusion) with radiological (e.g., CT or MRI) demonstration of non-union of prior fusion (lack of bridging bone or abnormal motion at fused segment) after 12 months since fusion surgeryorwith radiographic evidence of hardware failure (fracture or displacement). ORSpinal instability after laminectomyORRheumatoid arthritis with associated instabilityORCervical degenerative spondylolisthesis with spinal instability (Anterolisthesis/Posterolisthesis)
Proposed LCD - Cervical Fusion (DL39741)
ANDf. Substantial functional limitation is present such as severe neck pain, difficulty ambulating and decrease ability to perform ADLs or ability to maintain forward gaze.ANDg. Progression of deformityLimitationsCervical Fusion for the decompression or stabilization of the cervical spineis not reasonable and necessary when all the above criteria are not fulfilled.Provider QualificationsThe Medicare Program Integrity Manual states services will be considered reasonable and necessary only if performed by appropriately trained providers.Patient safety and quality of care mandate that healthcare professionals who perform cervical fusion are appropriately trained and credentialed by a formal residency/fellowship program. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.All aspects of care must be within the providers 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.Notice:Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.DefinitionsAcute Painan unpleasant sensory and emotional experience associated with actual or potential tissue damage which is present for up to 6 weeks.7Baseline Pain-An initial measurement of the pain which is taken at a specified time point and used for comparison over time to look for changes in the pain levels.Cervical Radiculopathy-Pain in a radicular pattern in one or both upper extremities related to compression and irritation of one or more cervical nerve roots.8