evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
The skin substitute graft is applied to an ulcer that has failed to respond to documented conservative wound care measures. Failed response is defined as an ulcer that has increased in size or depth, or no change in baseline size or depth, or no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing). Documentation of response requires measurements of the initial ulcer, measurements at the completion of at least four weeks of conservative wound care measures, and measurements immediately prior to placement of the skin substitute graft for a DFU. For VLUs, conservative wound care measures must continue for no less than four weeks and include on-going compression therapy.7,10,13The medical record documentation specifically addresses the circumstances regarding why the wound has failed to respond to standard wound care treatment of greater than four weeks and references the specific interventions that have failed based on the prior wound evaluation. The record must include an updated medication history, review of pertinent medical problems that may have arisen since the previous wound evaluation, and explanation of the planned skin replacement surgery with choice of skin substitute graft product. The procedure risks and complications must also be reviewed and documented.7,10,13-14Skin substitute grafts utilized per the approved FDA intended use.The patient is under the care of a qualified physician/NPP for their underlying chronic condition.3,9LimitationsThe following are considered not medically reasonable and necessary1-3,9-10:Greater than two applications of a specific skin substitute graft product within the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft).The expectation is treatment will consist of the fewest repeat applications and amount of product to heal the wound. It is expected that products are used per the labeling. It is not expected that every ulcer, in every patient will require the maximum number of applications listed on the product label. This utilization pattern may be subject to focused medical review.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Switching skin substitute graft products in a 12-week episode of skin replacement surgery for wound care. Exceptions should be rare and may be considered on appeal when the medical necessity of the change is clearly documented in the medical record.Application of a skin substitute graft product beyond 12-weeks.Repeat applications of skin substitute grafts when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing).Application of skin substitute grafts in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, active vasculitis).Use of surgical preparation services (for example, debridement), in conjunction with routine, simple and/or repeat skin replacement surgery with a skin substitute graft.Excessive wastage (discarded amount).The skin substitute graft must be used in an efficient manner utilizing the smallest package size available for purchase from the manufacturer that could provide the appropriate amount for the patient.All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliography
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Pourmoussa A, Gardner DJ, Johnson MB, Wong AK. An update and review of cell-based wound dressings and their integration into clinical practice.Ann Transl Med. 2016 Dec;4(23):457. doi:10.21037/atm.2016.12.44.Snyder DL, Sullivan N, Margolis DJ, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Rockville, MD:Agency for Healthcare Research and Quality. February 2020. http://www.ahrq.gov/research/findings/ta/index.html. Accessed April 27, 2021.Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds.Adv Wound Care. 2015 Sep 1;4(9):560-582. doi:10.1089/wound.2015.0635.U.S. Food and Drug Administration. Premarket Notification 510(k).Division of Industry and Consumer Education.March 2020. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Accessed December 9, 2021.U.S. Food and Drug Administration. FDA announces comprehensive regenerative medicine policy framework.FDA News Release. 2017 Nov 15. https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework. Accessed April 27, 2021.U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use-Guidance for Industry and Food and Drug Administration Staff.Center for Biologics Evaluation and Research. Center for Devices and Radiological Health. Office of Combination Products. July 2020. https://www.fda.gov/media/109176/download. Accessed December 9, 2021.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S. doi:10.1016/j.jvs.2015.10.003.Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines.Wound Repair Regen. 2016 Jan-Feb;24(1):112-26. doi:10.1111/wrr.12391.Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers.Wound Repair Regen. 2016 Jan-Feb;24(1):136-44. doi:10.1111/wrr.12394.O'Donnell TF Jr, Passman MA, Marston WA, et al; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi:10.1016/j.jvs.2014.04.049.Rayman G, Vas P, Dhatariya K, et al. International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update).Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi:10.1002/dmrr.3283.Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update).Diabetes Metab Res Rev.2020 Mar;36 Suppl 1:e3266. doi:10.1002/dmrr.3266.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Agency for Healthcare Research and Quality (AHRQ). Evidence-based Practice Center Technical Brief Protocol. Project Title: Skin Substitutes for Treating Chronic Wounds. 2018 (rev 2019). https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/skin-substitute_0.pdf. Accessed April 20, 2021.Nathoo R, Howe N, Cohen G. Skin substitutes: an overview of the key players in wound management.J Clin Aesthet Dermatol. 2014;7(10):44-48.U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. July 2021. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies. Accessed February 16, 2022.Santema TB, Poyck PPC, Ubbink DT. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes.Cochrane Database of Systematic Reviews. 2016, Issue 2. Art. No.: CD011255. doi:10.1002/14651858.CD011255.pub2.Jones JE, Nelson EA, Al-Hity A. Skin grafting for venous leg ulcers.Cochrane Database of Systematic Reviews2013, Issue 1. Art. No.: CD001737. doi:10.1002/14651858.CD001737.pub4.Barbul A, Gurtner GC, Gordon H, Bakewell K, Carter MJ. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions.Wound Repair Regen. 2020 Jan;28(1):81-89. doi:10.1111/wrr.12767.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator.Wound Repair Regen. 2017 May;25(3):483-497. doi:10.1111/wrr.12551.Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment.Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. doi:10.1111/wrr.12357.Lavery LA, Fulmer J, Shebetka KA, et al; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.Int Wound J.2014 Oct;11(5):554-60. doi:10.1111/iwj.12329.Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft.Ostomy Wound Manage. 2014 Sep;60(9):26-38.Zelen CM, Orgill DP, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.Int Wound J. 2017 Apr;14(2):307-315. doi:10.1111/iwj.12600.Cazzell S. A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers.Wounds. 2019 Mar;31(3):68-74.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377)
Cazzell S. A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers.Wounds. 2019 Mar;31(3):68-74.Harding K, Sumner M, Cardinal M. A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers.Int Wound J. 2013 Apr;10(2):132-7. doi:10.1111/iwj.12053.Snyder DL, Sullivan N, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Report Project ID No. HCPR0610. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. HHSA 290-2007-10063) Rockville, MD:Agency for Healthcare Research and Quality. December 2012. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf. Accessed June 11, 2021.
Proposed LCD - Molecular Pathology Procedures (DL35000)
CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityMolecular pathology procedures have broad clinical and research applications. The following examples of applications may not be relevant to a Medicare beneficiary or may not meet a Medicare benefit category and/or reasonable and necessary threshold for coverage. Such examples include Genetic Testing and Genetic Counseling (when applicable) for: Disease Risk, Carrier Screening, Hereditary Cancer Syndromes, Gene Expression Profiling for certain cancers, Prenatal Diagnostic testing, Diagnosis and Monitoring Non-Cancer Indications, and Several Pharmacogenomic applications.This Local Coverage Determination (LCD) addresses the circumstances under which the item or service may be reasonable and necessary. For laboratory services, a service may be reasonable and necessary if the service is safe and effective; and appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis of the patient's condition; furnished in a setting appropriate to the patient's medical needs and condition; ordered and furnished by qualified personnel; one that meets, but does not exceed, the patient's medical need; and is at least as beneficial as an existing and available medically appropriate alternative.
Proposed LCD - Molecular Pathology Procedures (DL35000)
Many applications of the molecular pathology procedures are not covered services given lack of benefit category (e.g., preventive service or screening for a genetic abnormality in the absence of a suspicion of disease) and/or failure to the reasonable and necessary threshold for coverage (e.g., based on quality of clinical evidence and strength of recommendation or when the results would not reasonably be used in the management of a beneficiary). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service may not have been audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary. Certain molecular pathology procedures may be subject to prepayment medical review (records requested) and paid claims must be supportable, if selected, for post payment audit by the MAC or other contractors. Molecular pathology tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or that result in early death (e.g., Canavan disease) could be subject to automatic denials since these tests are not usually relevant to a Medicare beneficiary.This LCD gives general guidance to the medically reasonable and necessary applications of the Molecular Pathology Procedures and Genomic Sequencing Procedures, described in Current Procedural Terminology (CPT).Coding guidance is provided inMolecular Pathology Procedures Article A56199, attached below.Indications:Molecular pathology procedures (Tier1 and Tier 2) may be eligible for coverage whenALLof the following criteria are met:
Proposed LCD - Molecular Pathology Procedures (DL35000)
Indications:Molecular pathology procedures (Tier1 and Tier 2) may be eligible for coverage whenALLof the following criteria are met:Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; ANDAvailability of a clinically valid test, based on published peer reviewed medical literature; ANDTesting assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) of analytical validity and clinical utility; ANDResults of the testing must directly impact treatment or management of the Medicare beneficiary; ANDFor testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test that are reasonable and necessary to obtain necessary information for therapeutic decision making; ANDIndividual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic testing for a disease should be performed once in a lifetime.) Exceptions include clinical scenarios whereby repeat testing of somatically-acquired mutations (for example, pre- and post- therapy) may be required to inform appropriate therapeutic decision-making.Limitations:Any procedures required prior to cell lysisshould be reported separately and utilization must be clearly supported based on the application and clinical utility. Such claims may be subject to prepayment medical review.The medically necessary interpretation and report of a molecular pathology test, written by a pathologist, which is above and beyond the report of standard laboratory results may not be reported by Non- physician practitioners (e.g., PhD, scientists etc.); only physicians are eligible to reportthis service.Testing for quality assurance component of the service is not separately billable.
Proposed LCD - Molecular Pathology Procedures (DL35000)
Indications and Limitations of CoverageABL1(ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain is considered medically necessary in patients with acute lymphoblasic leukemia (ALL) and chronic myeloid leukemia (CML) to guide therapeutic decision making.ATP7Bis considered medically necessary in patients with symptoms of Wilsons disease to guide therapeutic decision making.BCR/ABLis indicated in patients with suspected CML with either persistent, unexplained leukocytosis or thrombocytosis. BCR/ABL is considered medically necessary in the evaluation of individuals with chronic myelogenous leukemia or BCR-ABL positive acute lymphoblastic leukemia to evaluate treated individuals who manifest suboptimal response to initial tyrosine kinase inhibitor therapy or loss of response to tyrosine kinase inhibitor therapy.BLM(Bloom syndrome, RecQ helicase-like)(e.g. Bloom syndrome) gene analysis, 2281 del6ins7 variant is considered medically necessary for a beneficiary who may have Bloom syndrome to confirm diagnosis and guide medical decision-making.BRAFgene analysis is considered medically necessary for patients who have malignant melanoma, non-small cell lung cancer, hairy cell leukemia, or metastatic colorectal cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.BRCA1 and BRCA2genetic testing is considered medically necessary for a beneficiary with a current diagnosis or a personal history of a cancer associated with the BRCA mutation who meets one or more of the criteria found in the most recent version of the NCCN guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian or other evidence based guideline addressing genetic testing, and the results will be used to benefit the individual tested in terms of potential to guide therapeutic decision making.Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subtraction of peripheral blood, algorithm reported as rejection risk score is considered medically necessary for heart transplant patients to guide therapeutic decision-making.
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.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: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)
CYP2C9(cytochrome P450, family 2, subfamily D polypeptide 9) (e.g., drug metabolism), gene analysis, is only considered medically necessary for individuals who have relapsing forms of multiple sclerosis, and require CYP2C9 genotyping for dosing in accordance with the FDA prescribing information for Mayzent. CYP2C9 testing must include the *1, *2, and *3 alleles that are necessary to safely dose the FDA-approved drug Mayzent.CYP2D6(cytochrome P450, family 2, subfamily D polypeptide 6) (e.g., drug metabolism), gene analysis, is only considered medically necessary for individuals with Huntingtons disease for whom doses of tetrabenazine greater than 50 mg per day are being considered, and for testing prior to the initiation of CerdelgaTM(eliglustat) for Gauchers disease.EGFR(epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) [when specified as EGFR mutation analysis testing] EGFR testing is considered medically necessary as a technique to predict treatment response for individuals with non-small cell lung cancer undergoing treatment with EGFR tyrosine kinase inhibitor (TKI) therapy (for example, erlotinib [Tarceva ], gefitinib [Iressa ], or afatinib [Gilotrif ]).F2gene (prothrombin coagulation factor II) andF5gene (coagulation factor V) The F2 and F5 genetic tests are not considered to be clinically efficacious; therefore, testing is not medically necessary.FLT3is considered medically necessary in patients with acute myeloid leukemia (AML) to guide therapeutic decision making.Gene Testing for Warfarin ResponsePharmacogenomic Testing for Warfarin Response, gene testing onCYP2C9 and/or VKORC1see NCD 90.1 for coverage information.