evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Molecular Pathology Procedures (DL35000)
BibliographyNCCN Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia Version 3.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia Version 1.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms Version 2.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes Version 2.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers NCCN V1.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas Version 3.2018. 2018.NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia Version 1.2018. 2018.MacDermott RP. 6-mercaptopurine (6-MP) metabolite monitoring and TPMT testing in patients with inflammatory bowel disease. 2017.UpToDateWyles DL. Predictors of response to antiviral therapy for chronic hepatitis C virus infection.UpToDateReconsideration Request-CPT Code 0007M March 2017Bodei L, Kidd M, Modlin IM, Severi S, Drozdov I, Nicolini S, Kwekkeboom DJ, Krenning EP, Baum RP, Paganelli G. Measurement of circulating transcripts and gene cluster analysis predicts and defines therapeutic efficacy of Peptide Receptor Radionuclide Therapy (PRRT) in neuroendocrine tumors.EJNMMI. 2016;43:839-851.Pavel M, Jann H, Prasad V, Drozdov I, Modlin IM, Kidd M. NET blood transcript analysis defines the crossing of the clinical Rubicon: when stable disease becomes progressive.Neuroendocrinology. 2017;104:180-182.Modlin IM, Frilling AF, Salem RR, Alaimo D, Drymousis P, Wasan HS, Callahan S, Faiz O, Weng L, Teixeira NS, Bodei L, Drozdov I, Kidd M. Blood measurements of neuroendocrine gene transcripts defines the effectiveness of surgical resection and ablation strategies.Surgery.2016;159:336-347.
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.htmlReconsideration Request- IGH and TP53 October 20221. NCCN Biomarker Compendium , accessed October 20, 2022
Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.6.5 Surgical/Cytopathology ExceptionCoverage Indications, Limitations, and/or Medical NecessityThis policy does not designate specific special histochemical stains (aka special stains) and/or immunohistochemical (IHC) stains that should be used in the differential diagnosis of tissues or neoplasms because this information is readily available in textbooks and various scientific publications. This policy identifies the medically necessary criteria for the use of special stains and/or IHC stains and addresses, based on claims review, the scenarios that may be driving medically unnecessary over-utilization or incorrect billing of these services including:Reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine hematoxylin and eosin (H&E) stain by the pathologist, orUse of special stains and/or IHC stains without clinical evidence that the stain is actionable or provides the treating physician with information that changes patient management, orUse of added stains when the diagnosis is already known based on morphologic evaluation of the primary stain.The surgical pathology report is expected to designate the specific block(s) upon which IHC testing is performed, the reason and results for IHC testing, the specific markers, and whether single antibody(ies) or a cocktail of antibodies is utilized. A statement alone in the pathology report that states IHC confirms the diagnosis will not be covered as reasonable and necessary.General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)
General InformationAssociated InformationN/ASources of InformationN/ABibliographyAllred DC, Carlson RW, Berry DA, et al. NCCN task force report: estrogen receptor and progesterone receptor testing in breast cancer by immunohistochemistry.Journal of the National Comprehensive Cancer Network.2009;7(Suppl_6):S-1-S-21.Burstein HJ, Mangu PB, Somerfield MR, et al. American Society of Clinical Oncology clinical practice guideline update on the use of chemotherapy sensitivity and resistance assays.J Clin Oncol.2011;29(24):3328-3330.CAP. College of American Pathology Cancer Protocol Templates.https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates, 11/2/2020.Fitzgibbons PL, Dillon DA, Alsabeh R, et al. Template for reporting results of biomarker testing of specimens from patients with carcinoma of the breast.Archives of Pathology.2014;138(5):595-601.Allison KH, Hammond MEH, Dowsett M, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update.Journal of Clinical Oncology.2020;38(12):1346-1366.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Breast Cancer Version 4.2022. 2022;https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf, 11/10/2022.
Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)
Harbeck N, Rastogi P, Martin M, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study.Annals of oncology : official journal of the European Society for Medical Oncology.2021;32(12):1571-1581.Nielsen TO, Leung SCY, Rimm DL, et al. Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group.Journal of the National Cancer Institute.2021;113(7):808-819.Martinez AP, Cohen C, Hanley KZ, Li XB. Estrogen Receptor and Cytokeratin 5 Are Reliable Markers to Separate Usual Ductal Hyperplasia From Atypical Ductal Hyperplasia and Low-Grade Ductal Carcinoma In Situ.Archives of pathology & laboratory medicine.2016;140(7):686-689.Batts KP, Ketover S, Kakar S, et al. Appropriate use of special stains for identifying Helicobacter pylori: recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society.The American journal of surgical pathology2013;37(11):e12-e22.Chitkara Y. Upfront special staining for Helicobacter pylori in gastric biopsy specimens is not indicated.American journal of clinical pathology.2015;143(1):84-88.Wright CL, Kelly JK. The use of routine special stains for upper gastrointestinal biopsies.The American journal of surgical pathology2006;30(3):357-361.
Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)
Hartman DJ, Owens SR. Are routine ancillary stains required to diagnose Helicobacter infection in gastric biopsy specimens? An institutional quality assurance review.American journal of clinical pathology.2012;137(2):255-260.Smith SB, Snow AN, Perry RL, Qasem SA. Helicobacter pylori: to stain or not to stain?American journal of clinical pathology.2012;137(5):733-738.Mvundura M, Grosse SD, Hampel H, Palomaki GE. The cost-effectiveness of genetic testing strategies for Lynch syndrome among newly diagnosed patients with colorectal cancer.Genetics in Medicine.2010;12(2):93-104.EGAPP. Recommendations from the EGAPP Working Group: genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives.Genetics in medicine : official journal of the American College of Medical Genetics.2009;11(1):35-41.Morais CL, Han JS, Gordetsky J, et al. Utility of PTEN and ERG immunostaining for distinguishing high grade PIN and intraductal carcinoma of the prostate on needle biopsy.The American journal of surgical pathology.2015;39(2):169.Epstein JI, Egevad L, Humphrey PA, Montironi R, Group IIiDUP. Best practices recommendations in the application of immunohistochemistry in the prostate: report from the International Society of Urologic Pathology consensus conference.The American journal of surgical pathology2014;38(8):e6-e19.
Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)
Varma M, Jasani B. Diagnostic utility of immunohistochemistry in morphologically difficult prostate cancer: review of current literature.Histopathology.2005;47(1):1-16.Lotan TL, Gurel B, Sutcliffe S, et al. PTEN protein loss by immunostaining: analytic validation and prognostic indicator for a high risk surgical cohort of prostate cancer patients.Clinical cancer research.2011;17(20):6563-6573.Shah RB. Clinical applications of novel ERG immunohistochemistry in prostate cancer diagnosis and management.Advances in anatomic pathology2013;20(2):117-124.van Leenders G, van der Kwast TH, Grignon DJ, et al. The 2019 International Society of Urological Pathology (ISUP) Consensus Conference on Grading of Prostatic Carcinoma.The American journal of surgical pathology.2020;44(8):e87-e99.Travis WD, Brambilla E, Noguchi M, et al. Diagnosis of lung cancer in small biopsies and cytology: implications of the 2011 International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society classification.Archives of Pathology.2013;137(5):668-684.Pelosi G, Rindi G, Travis WD, Papotti M. Ki-67 antigen in lung neuroendocrine tumors: unraveling a role in clinical practice.Journal of thoracic oncology.2014;9(3):273-284.North American Neuroendocrine tumor society NANETS Guidelines 2022 edition.https://nanets.net/images/guidelines/21513_NANETS_2022_Guidelines_Compendium.pdf, 11/11/2022.National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer Version 3.2014.https://www.nccn.org/guidelines/category_1, 11/2/2020.
Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)
CMS National Coverage PolicyTitle 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 and treatment of illness or injury or to improve the functioning of a malformed body member.CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2,110.23 Stem Cell TransplantationCMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1 Routine Costs in Clinical TrialsCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 3, 90.3 Stem Cell TransplantationCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing, Chapter 32, 90 Stem Cell Transplantation and 90.1 GeneralCoverage Indications, Limitations, and/or Medical Necessity
Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)
CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing, Chapter 32, 90 Stem Cell Transplantation and 90.1 GeneralCoverage Indications, Limitations, and/or Medical NecessityStem celltransplantation is a process in which stem cellsare harvested from either a patients (autologous) or donors (allogeneic) bone marrow or peripheral blood for intravenous infusion. Autologousstem celltransplantation (AuSCT) is a technique for restoring stemcells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a procedure in which a portion of a healthy donor's stem cells or bone marrow is obtained and prepared for intravenous infusion. Hematopoietic stem cells are multi-potent cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis - a process by which cells that are unneeded or detrimental will self-destruct.The Centers for Medicare & Medicaid Services (CMS) has clarified that bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage.NCD 110.23 Stem Cell Transplantation covers allo-HSCT for the following conditions, when reasonable and necessary:LeukemiaAplastic AnemiaSevere Combined Immunodeficiency disease (SCID)Wiskott-Aldrich SyndromeAllo-HSCTis covered for Medicare beneficiaries with the following indications only when participating in approved prospective clinical studies meeting specific criteria under the Coverage with Evidence Development (CED) paradigm:
Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)
Wiskott-Aldrich SyndromeAllo-HSCTis covered for Medicare beneficiaries with the following indications only when participating in approved prospective clinical studies meeting specific criteria under the Coverage with Evidence Development (CED) paradigm:Myelodysplastic SyndromesMultiple myeloma with Durie-Salmon Stage II or III disease, or International Staging System (ISS) Stage II or Stage III diseaseMyelofibrosis (MF) with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary disease; orSickle cell disease (SCD) that is severe and symptomatic(Please refer to CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual,Chapter 1, Part 2, 110.23 Stem Cell Transplantation)Per the NCD,all other indications forstemcelltransplantation not otherwise noted as covered or non-covered remain at local Medicare Administrative Contractor (MAC) discretion.This policy describes additional locally covered indications for allo-HSCT for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphomas with B-cell or T-cell origin that are medically necessary in patients for whom there are no other curative intent options.Documentation to support the reasonable and necessary nature of allo-HSCTs must speak to the serious illness of the patient, the reasons why the patient is considered to have relapsed or refractory disease, relevant clinical contextual information such as age, frailty, performance status, cardiopulmonary function, any associated organ dysfunction that could impact complications or recovery, screening for infectious diseases that could impact transplant care, nutritional status and patient specific psychosocial and financial support structures. Risk assessment scoring, such as the European Society for Blood and Bone Marrow Transplantation (EBMT) or the HCT Comorbidity Index (HCT-CI), should be strongly considered and in the case of any nationally covered indications per NCD 110.23 would of course be required.General InformationAssociated InformationN/ASources of InformationAmerican Society of HematologyAmerican Society for Transplantation and Cellular TherapyBibliography
Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)
General InformationAssociated InformationN/ASources of InformationAmerican Society of HematologyAmerican Society for Transplantation and Cellular TherapyBibliographyShah NN, Ahn KW, Litovich C, et al. Outcomes for Medicare-age eligible NHL patients receiving RIC allogeneic transplantation: A CIBMTR analysis.Blood Advances.2018;2(8):933-940.Muffly L, Pasquini MC, Martens M, et al. Increasing use of allogeneic hematopoietic cell transplantation in patients aged 70 years and older in the United States.Blood. 2017;130(9):1156-1164.Majhail NS, Farnia SH, Carpenter PA, et al. Indications for autologous and allogeneic hematopoietic cell transplantation: Guidelines from the American society for blood and marrow transplantation.Biol Blood Marrow Transplant. 2015:21(11):1863-1869.Kharfan-Dabaja MA, Kumar A, Ayala E, et al. Clinical practice recommendations on indication and timing of hematopoietic cell transplantation in mature t cell and nk/t cell lymphomas: An international collaborative effort on behalf of the guidelines committee of the American society for blood and marrow transplantation.Biol Blood Marrow Transplant. 2017;23(11):1826-1838.
Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)
DSouza A, Lee S, Zhu X, Pasquini M. Current use and trends in hematopoietic cell transplantation in the United States.Biol Blood Marrow Transplant. 2017;23(9):1417-1421.Kanate AS, Majhail NS, Savani BN, et al. Indications for Hematopoietic cell transplantation and immune effector cell therapy: Guidelines from the American society for transplantation and cellular therapy.Biol Blood Marrow Transplant.2020;26:1247-1256.Deeg HJ, Sandmaier BM. Determining eligibility for allogeneic hematopoietic transplantation. In: Rosmarin AG, ed.UpToDate.2022.Khouri IF, Champlin RE. Nonmyeloablative allogeneic stem cell transplantation for non-hodgkin lymphoma.Cancer J.2012;18(5):457-462.Bellei M, Foss FM, Shustov AR, et al. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: A report from the prospective, international t-Cell project.Haematologica. 2018;103(7):1191-1197.
Proposed LCD - Cataract Surgery in Adults (DL34203)
CMS National Coverage PolicyTitle XVIII of the Social Security Act 1862(a)(7) excludes routine physical examinations.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, 1833(e) prohibits Medicare Payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations 42 CFR CH.IV [411.15(b)(2)&(3)and(o)(1)&(2)] Services excluded from coverageCode of Federal Regulations 42 CFR CH. IV [416.65] Covered surgical proceduresCMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual,Chapter 1, Part 1, 80.10, Phaco-Emulsification Procedure-Cataract ExtractionCMS Manual System, Pub 100-04,Medicare Claims Processing ManualChapter 12, 40.6, 40.7, Claims for Multiple Surgeries, Claims for Bilateral SurgeriesCoverage Indications, Limitations, and/or Medical NecessityCataract is defined as an opacity or loss of optical clarity of the crystalline lens. Cataract development follows a continuum extending from minimal changes in the crystalline lens to the extreme stage of total opacity. Cataracts may be due to a variety of causes. Age-related cataract (senile cataract) is the most common type found in adults. Other types are pediatric (both congenital and acquired), traumatic, toxic and secondary (meaning the result of another disease process) cataract.Most cataracts are not visible to the naked eye until they become dense enough (mature or hypermature) to cause blindness. However, a cataract at any stage of development can be observed through a sufficiently dilated pupil using a slit lamp biomicroscope. In settings where this instrument is unavailable (e.g., skilled nursing facility), a direct ophthalmoscope can be used to assess the degree to which the fundus reflectivity (red reflex) is impaired by the ocular media. There is no scientifically proven medical (i.e., non-surgical) treatment for cataracts.
Proposed LCD - Cataract Surgery in Adults (DL34203)
In general, cataract surgery is performed to alleviate visual impairments attributable to lens opacity. There are uncommon situations when lens extraction becomes medically necessary for anatomic rather than optical reasons. These include lens induced angle closure (e.g., microspherophakia) and lens subluxation (e.g., Marfan syndrome). In other situations, cataract extraction might be medically indicated with relatively less opacity because of intolerable optical imbalance. Most commonly, this would be due to surgically induced anisometropia (a significant difference in refractive errors between the eyes) or aniseikonia (a difference in magnification as a result of prior lens extraction in the one eye). Some patients may elect lens removal and replacement primarily for refractive benefits to reduce their dependence on spectacles. Such elective procedures are not medically necessary and are called refractive lens exchanges to distinguish them from medically indicated cataract surgery. Finally, advanced cataracts may need to be removed to properly visualize, treat, and monitor retinal disease, apart from the patients visual symptoms and potential.This policy statement defines the medical necessity for cataract and other lens extraction in adults, and specifies the required documentation of the preoperative evaluation necessary to justify the procedure.MEDICAL NECESSITYLens extraction is considered medically necessary and therefore covered by Medicare when one (or more) of the following conditions or circumstances are documented in the medical record (see Documentation Requirements):