evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38649)
Batista da Costa J, Gibb EA, Bivalacqua TJ, et al. Molecular characterization of neuroendocrine-like bladder cancer.Clin Cancer Res.2019;25(13):3908-3920.Fryback DG, Thornbury JR. The efficacy of diagnostic imaging.Med Decis Making.1991;11(2):88-94.Centers for Disease Control and Prevention. ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing.https://www.cdc.gov/genomics/gtesting/acce/acce_proj.htm. Accessed April 20, 2022.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Bladder Cancer, Version 6.2021.https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed April 20, 2022.Ross JS, Wang K, Khaira D, et al. Comprehensive genomic profiling of 295 cases of clinically advanced urothelial carcinoma of the urinary bladder reveals a high frequency of clinically relevant genomic alterations.Cancer. 2016;122(5):702-711.Mori K, Abufaraj M, Mostafaei H, et al. A systemic review and meta-analysis of variant histology in urothelial carcinoma of the bladder treated with radical cystectomy.J Urol.2020;204(6):1129-1140.US Food and Drug Administration (FDA). Prescribing Information. BALVERSA (erdafitinib). 2020.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212018s001lbl.pdf. Accessed April 20, 2022.Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma.N Engl J Med.2019;381(4):338-348.
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
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 necessary42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare 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 NecessityThe purpose of this test is to assist dermatopathologists to arrive at the correct diagnosis of melanoma versus non-melanoma when examining skin biopsies.This Medicare contractor will provide limited coverage for molecularDeoxyribonucleic acid (DNA)/Ribonucleic acid(RNA) assays that aid in the diagnosis or exclusion of melanoma from a biopsy when ALL of the following clinical conditions are met:The test is ordered by a board-certified or board-eligible dermatopathologistThe specimen is a primary (non-metastatic, non-re-excision specimen) cutaneous melanocytic neoplasm for which the diagnosis is equivocal/uncertain (i.e., clear distinction between benign or malignant cannot be achieved using clinical and/or histopathological features alone) despite the performance of standard-of-care test procedures and relevant ancillary tests (i.e., immunohistochemical stains)The specimen includes an area representative of the lesion or portion of the lesion that is suspicious for malignancyThe patient may be subjected to additional intervention, such as re-excision and/or sentinel lymph node biopsy, as a result of the diagnostic uncertaintyThe patient has not been tested with the same or similar assay for the same clinical indicationThe test is validated for use in the intended-use population and is performed according to its stated intended-useThe test demonstrates Analytical and Clinical Validity (AV and CV) and Clinical Utility (CU) and undergoes a technical assessment (TA) by MolDxto demonstrate compliance of the service with this policyTests that demonstrate similar indicated uses and equivalent or superior performance to covered tests may similarly be covered under this policy.General InformationAssociated InformationN/ASources of Information
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
Tests that demonstrate similar indicated uses and equivalent or superior performance to covered tests may similarly be covered under this policy.General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
American Cancer Society. Key statistics for melanoma skin cancer.https://www.Cancer.Org/cancer/melanoma-skin-cancer/about/key-statistics.Html. Accessed 02/28/2022.American Cancer Society. Survival rates for melanoma skin cancer.https://www.Cancer.Org/cancer/melanoma-skin-cancer/detection-diagnosis-staging/survival-rates-for-melanoma-skin-cancer-by-stage.Html. Accessed 02/28/2022.Shoo BA, Sagebiel RW, Kashani-Sabet M. Discordance in the histopathologic diagnosis of melanoma at a melanoma referral center.Journal of the American Academy of Dermatology.2010;62(5):751-756.Veenhuizen KC, De Wit PE, Mooi WJ, Scheffer E, Verbeek AL, Ruiter DJ. Quality assessment by expert opinion in melanoma pathology: Experience of the pathology panel of the dutch melanoma working party.The Journal of Pathology.1997;182(3):266-272.Ronen S, Al-Rohil RN, Keiser E, et al. Discordance in diagnosis of melanocytic lesions and its impact on clinical management.Arch Pathol Lab Med.2021;145(12):1505-1515.Piepkorn MW, Longton GM, Reisch LM, et al. Assessment of second-opinion strategies for diagnoses of cutaneous melanocytic lesions.JAMA Network Open.2019;2(10):e1912597.Tosteson ANA, Tapp S, Titus LJ, et al. Association of second-opinion strategies in the histopathologic diagnosis of cutaneous melanocytic lesions with diagnostic accuracy and population-level costs.JAMA Dermatology.2021;157(9):1102-1106.Elder DE, Piepkorn MW, Barnhill RL, et al. Pathologist characteristics associated with accuracy and reproducibility of melanocytic skin lesion interpretation.Journal of the American Academy of Dermatology.2018;79(1):52-59.e55.
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
Farmer ER, Gonin R, Hanna MP. Discordance in the histopathologic diagnosis of melanoma and melanocytic nevi between expert pathologists.Human Pathology.1996;27(6):528-531.Cerroni L, Barnhill R, Elder D, et al. Melanocytic tumors of uncertain malignant potential: Results of a tutorial held at the XXIX symposium of the International Society of Dermatopathology in Graz, October 2008.The American Journal of Surgical Pathology.2010;34(3):314-326.Hawryluk EB, Sober AJ, Piris A, et al. Histologically challenging melanocytic tumors referred to a tertiary care pigmented lesion clinic.Journal of the American Academy of Dermatology.2012;67(4):727-735.McGinnis KS, Lessin SR, Elder DE, et al. Pathology review of cases presenting to a multidisciplinary pigmented lesion clinic.Archives of Dermatology.2002;138(5):617-621.Warf MB, Flake DD II, Adams D, et al. Analytical validation of a melanoma diagnostic gene signature using formalin-fixed paraffin-embedded melanocytic lesions.Biomarkers in Medicine.2015;9(5):407-416.Clarke LE, Warf MB, Flake DD II, et al. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma.Journal of Cutaneous Pathology.2015;42(4):244-252.Clarke LE, Flake DD II, Busam K, et al. An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi.Cancer.2017;123(4):617-628.Ko JS, Matharoo-Ball B, Billings SD, et al. Diagnostic distinction of malignant melanoma and benign nevi by a gene expression signature and correlation to clinical outcomes.Cancer Epidemiology, Biomarkers & Prevention: A Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology.2017;26(7):1107-1113.
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
Cockerell CJ, Tschen J, Evans B, et al. The influence of a gene expression signature on the diagnosis and recommended treatment of melanocytic tumors by dermatopathologists.Medicine.2016;95(40):e4887.Cockerell C, Tschen J, Billings SD, et al. The influence of a gene-expression signature on the treatment of diagnostically challenging melanocytic lesions.Personalized Medicine.2017;14(2):123-130.Clarke LE, Mabey B, Flake DD II, et al. Clinical validity of a gene expression signature in diagnostically uncertain neoplasms.Personalized Medicine.2020;17(5):361-371.Estrada SI, Cleaver NJ, Depcik-Smith N, et al. Development and validation of a diagnostic 35-gene expression profile test for ambiguous or difficult-to-diagnose suspicious pigmented skin lesions.SKIN J Cutaneous Med.2020;4(6):506-522.Minca EC, Al-Rohil RN, Wang M, et al. Comparison between melanoma gene expression score and fluorescence in situ hybridization for the classification of melanocytic lesions.Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc.2016;29(8):832-843.Farberg AS, Ahmed Kl, Bailey CN, et al. A 35-gene expression profile test for use in suspicious pigmented lesions impacts clinical management decisions of dermatopathologists and dermatologists.SKIN J Cutaneous Med.2020;4(6):523-533.North JP, Vemula SS, Bastian BC. Molecular Diagnostics for Melanoma: Methods and Protocols, in Methods in Molecular Biology. Vol. 1102. Thurin and Marincola (eds), Springer Science+Business Media 2014.Daz A, Valera A, Carrera C, et al. Pigmented spindle cell nevus: Clues for differentiating it from spindle cell malignant melanoma. A comprehensive survey including clinicopathologic, immunohistochemical, and fish studies.The American Journal of Surgical Pathology.2011;35(11):1733-1742.
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
Absolo A, Vargas MT, Ros-Martn JJ, Trigo I, Arjona A, Gonzlez-Cmpora R. Application of fluorescence in situ hybridization as a diagnostic tool in melanocytic lesions, using paraffin wax-embedded tissues and imprint-cytology specimens.Clinical and Experimental Dermatology.2012;37(8):838-843.Clemente C, Bettio D, Venci A, et al. A fluorescence in situ hybridization (fish) procedure to assist in differentiating benign from malignant melanocytic lesions.Pathologica.2009;101(5):169-174.Gerami P, Jewell SS, Morrison LE, et al. Fluorescence in situ hybridization (fish) as an ancillary diagnostic tool in the diagnosis of melanoma.The American Journal of Surgical Pathology.2009;33(8):1146-1156.Gerami P, Li G, Pouryazdanparast P, et al. A highly specific and discriminatory fish assay for distinguishing between benign and malignant melanocytic neoplasms.The American Journal of Surgical Pathology.2012;36(6):808-817.Bastian BC, LeBoit PE, Hamm H, Brcker EB, Pinkel D. Chromosomal gains and losses in primary cutaneous melanomas detected by comparative genomic hybridization.Cancer Research.1998;58(10):2170-2175.Bastian BC, Olshen AB, LeBoit PE, Pinkel D. Classifying melanocytic tumors based on DNA copy number changes.The American Journal of Pathology.2003;163(5):1765-1770.Wang L, Rao M, Fang Y, et al. A genome-wide high-resolution array-cgh analysis of cutaneous melanoma and comparison of array-cgh to fish in diagnostic evaluation.J Mol Diagn.2013;15(5):581-591.
Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)
Gaiser T, Kutzner H, Palmedo G, et al. Classifying ambiguous melanocytic lesions with fish and correlation with clinical long-term follow up.Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc.2010;23(3):413-419.Lezcano C, Jungbluth AA, Nehal KS, Hollmann TJ, Busam KJ. Prame expression in melanocytic tumors.The American Journal of Surgical Pathology.2018;42(11):1456-1465.Lezcano C, Jungbluth AA, Busam KJ. Comparison of immunohistochemistry for prame with cytogenetic test results in the evaluation of challenging melanocytic tumors.The American Journal of Surgical Pathology.2020;44(7):893-900.Ferris LK, Jansen B, Ho J, et al. Utility of a noninvasive 2-gene molecular assay for cutaneous melanoma and effect on the decision to biopsy.JAMA Dermatology.2017;153(7):675-680.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Melanoma - Cutaneous. Version 1.2022-dec 3, 2021. Melanoma_1_2021_101220.pdf.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)
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 skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers. 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 and/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 skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers 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 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.1 Approved Use of DrugCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 17, Section 40 Discarded Drugs and BiologicalsCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 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 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.Code of Federal Regulations (CFR) References:CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based productsCoverage Indications, Limitations, and/or Medical Necessity
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)
Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationThis LCD addresses the medically reasonable and necessary threshold for coverage of skin replacement surgery for application of skin substitute grafts for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).Application of skin substitute grafts for wound care indications other than for DFU or VLU are not addressed by this LCD. Use of skin substitute grafts must meet the medically reasonable and necessary threshold for coverage and these devices must be used in accordance with their approved United States (U.S.) Food and Drug Administration (FDA) intended use.Chronic wounds of the lower extremities, including venous stasis ulcers, DFUs and pressure sores, are a major public health problem. While lower extremity ulcers have numerous causes such as burns, trauma, mixed venous-arterial disease, immobility, and vasculitis, nutritional or other neuropathy, over 90% of the lesions in the U.S. are related to venous stasis disease and diabetic neuropathy.1-3Generally, depending on the purpose of the product and how it functions, skin substitutes are regulated by the FDA premarket approval (PMA) process, FDA 510(k) premarket notification process, or the FDA regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although skin substitutes have attributes of both biologicals and devices, the current position is that these products are best characterized as surgical supplies or devices because of their required surgical application and their similarity to other surgical supplies. It has been noted that there are instances in which certain products might have a wound healing indication but may not necessarily meet the definition of skin substitutes. Therefore, FDA classification and indication alone does not determine if a product meets the definition of skin substitute and/or meets the medically reasonable and necessary threshold for coverage.
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)
Amniotic/chorionic-based products are HCT/Ps as defined in 21 CFR 1271.3(d) and must meet criteria in 21 CFR 1271 and 361 of the Public Health Service Act (PHS Act). The HCT/Ps not regulated under 361 are regulated as drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product's intended use.4-6Standard treatment of lower extremity ulcers (e.g., DFUs and/or VLUs) may include mechanical offloading, infection control, mechanical compression, limb elevation, debridement of necrotic tissue, management of systemic disease and medications, nutrition assessment, tissue perfusion and oxygenation, and counseling on the risk of continued tobacco use. In addition, maintenance of a moist wound environment through appropriate dressings facilitates development of healthy granulation tissue and epithelialization and thus may potentiate complete healing at a wound site. Dressings are an integral part of wound management by not only maintaining a moist environment but by stopping contamination and absorbing exudate.7-12Despite advancements in various synthetic occlusive dressings some ulcers fail to heal. The development of skin substitutes has been employed as an adjunct to established wound care methods to increase the chances of healing.1,13Chronic wounds and frequently recurring wounds related to DFUs and VLUs are a challenge to treat effectively. Chronic wounds may be unresponsive to initial therapy or persist despite additional care. A wound that has not healed within one to three months may be considered chronic and the application of a skin substitute graft, an advanced treatment modality, may be considered medically reasonable and necessary for certain patients.1-3
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)
Patients receiving skin replacement surgery with a skin substitute graft should be under the care of a physician/non-physician practitioner (NPP) for the treatment of their systemic disease process (e.g., diabetes mellitus, chronic venous insufficiency, and/or peripheral vascular disease). It is imperative that their systemic disease be monitored/treated in order to ensure adequate healing of the wound site.3,9It is the expectation that a specific skin substitute graft product will be used for the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft) assuming its use is not in conflict with the FDA assessments (e.g., indications, contraindications, how supplied and directions for use, etc.) and/or the American Association of Tissue Banks (AATB) approved use and assuming there is one related wound. Repeat application of a skin substitute graft within the 12-week episode of skin replacement surgery for wound care may be appropriate per the package insert based on wound re-assessment and must be supported in the medical record documentation for that encounter. Additional applications of a skin substitute product beyond the 12-week episode of skin replacement wound care are not expected if the wound has responded to the skin replacement surgery with epithelialization and other progression. This LCD does not endorse particular products for separate payment. The medical record documentation must support the medical necessity for skin replacement surgery and that the product is being used within its approved FDA indications.Covered IndicationsIf the patient meets all of the criteria as outlined in this LCD, application of a skin substitute graft for lower extremity DFU or VLU is considered medically reasonable and necessary for the following:
Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)
The presence of a chronic, non-infected DFU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.7The presence of a chronic, non-infected VLU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.10For purposes of this LCD, conservative wound care measures include, but are not limited to2,7-12:Comprehensive patient assessment (history, exam, Ankle-Brachial Index [ABI]) and diagnostic tests as indicated) and implemented treatment plan.For patients with a DFU - assessment of Type 1 vs. Type 2 diabetes and management history with attention to certain comorbidities (e.g., vascular disease, neuropathy, osteomyelitis), review of current blood glucose levels/hemoglobin A1c (HbA1c), diet and nutritional status, activity level, physical exam that includes assessment of skin and wound, ABI, and check of off-loading device or assessment of appropriate footwear.3For patients with a VLU - assessment of clinical history (prior ulcers, thrombosis risks), physical exam (edema, skin changes), ABI, diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic (or acute) venous thrombosis. In this regard, venous duplex ultrasound is recommended to confirm the Clinical class, Etiology, Anatomy, and Pathophysiology (CEAP) classification and categorize the patients chronic venous disorder to guide the analysis of management alternatives. The Venous Clinical Severity Score (VCSS) is used to assess changes in response to therapy.An implemented treatment plan demonstrating all of the following:Debridement as appropriate.Some form of offloading for DFUs and some form of compression for VLUs.Infection control.Management of exudate - maintenance of a moist environment (moist saline gauze, other classic dressings, bioactive dressing, etc.).Patient is a nonsmoker or has refrained from smoking for at least 6 weeks prior to planned skin replacement surgery or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation.