evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Pneumatic Compression Devices (DL33829)
General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include thetreatingpractitionersoffice records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations, and/or Medical NecessitySources of InformationN/ABibliography
Proposed LCD - Pneumatic Compression Devices (DL33829)
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). European Journal of Vascular and Endovascular Surgery. 2007;33(1): S1-S75. doi: 10.1016/j.ejvs.2006.09.024Schainfeld RM. Management of peripheral arterial disease and intermittent claudication. J Am Board Fam Pract. Nov-Dec 2001;14(6):443-50.Kavros SJ, Delis KT, Turner NS, et al. Improving limb salvage in critical ischemia with intermittent pneumatic compression: a controlled study with 18-month follow-up. J Vasc Surg. Mar 2008;47(3):543-9. doi: 10.1016/j.jvs.2007.11.043Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. Jan 2007;45 Suppl S: S5-67. doi: 10.1016/j.jvs.2006.12.037Oresanya L, Mazzei M, Bashir R, et al. Systematic review and meta-analysis of high-pressure intermittent limb compression for the treatment of intermittent claudication. J Vasc Surg. Feb 2018;67(2):620-628 e2. doi: 10.1016/j.jvs.2017.11.044Alvarez OM, Wendelken ME, Markowitz L, Comfort C. Effect of High-pressure, Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemia in Patients Without a Surgical Option. Wounds. Nov 2015;27(11):293-301.Labropoulos N, Leon LR, Jr., Bhatti A, et al. Hemodynamic effects of intermittent pneumatic compression in patients with critical limb ischemia. J Vasc Surg. Oct 2005;42(4):710-6. doi: 10.1016/j.jvs.2005.05.051
Proposed LCD - Pneumatic Compression Devices (DL33829)
Louridas G, Saadia R, Spelay J, et al. The ArtAssist Device in chronic lower limb ischemia. A pilot studies. Int Angiol. Mar 2002;21(1):28-35.Berni A, Tromba L, Falvo L, et al. Randomized study on the effects of different strategies of intermittent pneumatic compression for lower limb claudication. G Chir. Jun-Jul 2009;30(6-7):269-73.Kakkos SK, Geroulakos G, Nicolaides AN. Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic foot and calf compression: a randomised controlled trial. Eur J Vasc Endovasc Surg. Aug 2005;30(2):164-75. doi: 10.1016/j.ejvs.2005.03.011Delis KT, Nicolaides AN. Effect of intermittent pneumatic compression of foot and calf on walking distance, hemodynamics, and quality of life in patients with arterial claudication: a prospective randomized controlled study with 1-year follow-up. Ann Surg. Mar 2005;241(3):431-41. doi: 10.1097/01.sla.0000154358.83898.26Ramaswami G, D'Ayala M, Hollier LH, Deutsch R, McElhinney AJ. Rapid foot and calf compression increases walking distance in patients with intermittent claudication: results of a randomized study. J Vasc Surg. May 2005;41(5):794-801. doi: 10.1016/j.jvs.2005.01.045van den Houten MM, Gommans LN, van der Wees PJ, Teijink JA. Minimally Important Difference of the Absolute and Functional Claudication Distance in Patients with Intermittent Claudication. Eur J Vasc Endovasc Surg. Mar 2016;51(3):404-9. doi: 10.1016/j.ejvs.2015.11.008
Proposed LCD - Pneumatic Compression Devices (DL33829)
McGinigle KL, Minc SD. Disparities in amputation in patients with peripheral arterial disease. Surgery. Jun 2021;169(6):1290-1294. doi: 10.1016/j.surg.2021.01.025Newhall K, Spangler E, Dzebisashvili N, Goodman DC, Goodney P. Amputation Rates for Patients with Diabetes and Peripheral Arterial Disease: The Effects of Race and Region. Ann Vasc Surg. Jan 2016; 30:292-8 e1. doi: 10.1016/j.avsg.2015.07.040Pandit V, Nelson P, Kempe K, et al. Racial and ethnic disparities in lower extremity amputation: Assessing the role of frailty in older adults. Surgery. Dec 2020;168(6):1075-1078. doi: 10.1016/j.surg.2020.07.015O'Donnell TFX, Powell C, Deery SE, et al. Regional variation in racial disparities among patients with peripheral artery disease. J Vasc Surg. Aug 2018;68(2):519-526. doi: 10.1016/j.jvs.2017.10.090Goodney PP, Holman K, Henke PK, et al. Regional intensity of vascular care and lower extremity amputation rates. J Vasc Surg. Jun 2013;57(6):1471-79, 1480 e1-3; discussion 1479-80. doi: 10.1016/j.jvs.2012.11.068Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. Mar 21 2017;135(12):e726-e779. doi:10.1161/CIR.0000000000000471
Proposed LCD - Pneumatic Compression Devices (DL33829)
Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. Jun 2019;69(6S):3S-125S e40. doi: 10.1016/j.jvs.2019.02.016Abu Dabrh AM, Steffen MW, Asi N, et al. Nonrevascularization-based treatments in patients with severe or critical limb ischemia. J Vasc Surg. 2015;62(5):1330-9. e13. doi: 10.1016/j.jvs.2015.07.069Andersen CA, Daab LJ, Le TD, Green DM, Tyminski RL, Ponticello M, Marmolejo V. Treatment of Nonreconstructable Critical Limb Ischemia With Ischemic Wounds Utilizing a Noninvasive Intermittent Pneumatic Compression Device Monitored With Fluorescence Angiography. Wounds. 2018 Jul;30(7):191-196.Bin Azizi, ZA. Determining the Optimum Intermittent Pneumatic Compression Stimulus for Lower Limb Venous Emptying Using Direct Pressure Measurements [dissertation]. London, UK: University of London; 1996.Breu FX, Zelikovski A, Loberman Z, Rauh G. Efficacy and safety of a new pneumatic compression device for peripheral arterial disease with intermittent claudication: A prospective, randomized, multi-center clinical trial: a prospective, randomized, multi-center clinical trial. Phlebologie. 2014; 43:5-11Chang ST, Hsu JT, Chu CM, Pan KL, Jang SJ, Lin PC, Hsu HC, Huang KC. Using intermittent pneumatic compression therapy to improve quality of life for symptomatic patients with infrapopliteal diffuse peripheral obstructive disease. Circ J. 2012;76(4):971-6. doi: 10.1253/circj. cj-11-1229.Delis KT. The case for intermittent pneumatic compression of the lower extremity as a novel treatment in arterial claudication. Perspect Vasc Surg Endovasc Ther. 2005 Mar;17(1):29-42.
Proposed LCD - Pneumatic Compression Devices (DL33829)
Delis KT, Azizi ZA, Stevens RJ, Wolfe JH, Nicolaides AN. Optimum intermittent pneumatic compression stimulus for lower-limb venous emptying. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):261-9.Delis KT, Husmann MJ, Cheshire NJ, Nicolaides AN. Effects of intermittent pneumatic compression of the calf and thigh on arterial calf inflow: a study of normals, claudicants, and grafted arteriopaths. Surgery. 2001 Feb;129(2):188-95.Delis KT, Husmann MJ, Nicolaides AN, Wolfe JH, Cheshire NJ. Enhancing foot skin blood flux in peripheral vascular disease using intermittent pneumatic compression: controlled study on claudicants and grafted arteriopaths. World J Surg. 2002;26(7):861-866.Delis KT, Husmann MJ, Szendro G, Peters NS, Wolfe JH, Mansfield AO. Haemodynamic effect of intermittent pneumatic compression of the leg after infrainguinal arterial bypass grafting. Br J Surg. 2004 Apr;91(4):429-34.Delis KT, Nicolaides AN, Stansby G. Effect of posture on popliteal artery hemodynamics. Arch Surg. 2000 Mar;135(3):265-9.Delis KT, Nicolaides AN, Wolfe JH, Stansby G. Improving walking ability and ankle brachial pressure indices in symptomatic peripheral vascular disease with intermittent pneumatic foot compression: a prospective controlled study with one-year follow-up. J Vasc Surg. 2000 Apr;31(4):650-61.Delis, KT, Slimani, G, Hafez, HM, Nicolaides, AN. Enhancing Venous Outflow in the Lower Limb with Intermittent Pneumatic Compression. A Comparative Haemodynamic Analysis on the Effect of Foot vs. Calf vs. Foot and Calf Compression. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):250-60.
Proposed LCD - Pneumatic Compression Devices (DL33829)
Eton, D, Guolin, Z, Tong, HC, Elsorady, M, Syed, ZA. Enhancing neovascularization in chronic limb-threatening ischemia. J Vasc Surg. 2015; June Suppl: 106SEton D, Yu H. Enhanced cell therapy strategy to treat chronic limb-threatening ischemia. J Vasc Surg. 2010 Jul;52(1):199-204.Eze AR, Cisek PL, Holland BS, Comerota AJ Jr, Verramasuneni R, Comerota AJ. The contributions of arterial and venous volumes to increased cutaneous blood flow during leg compression. Ann Vasc Surg. 1998 Mar;12(2):182-6.Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, Comerota AJ Jr. Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg. 1996 Aug;172(2):130-4; discussion 135.Feuerhake IL, Henneberg EW, Hgh A. Intermitterende pneumatisk kompressions-behandling ved underekstremitetsiskmi uden kirurgiske behandlingstilbud [The use of intermittent pneumatic compression for critical limb ischaemia without vascular surgery reconstruction]. Ugeskr Laeger. 2016;178(11): V12150982.Gardner, AMN, Fox, RH. The Return of Blood to the Heart. London: John Libbey; 1989.GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2020 (developed by Evidence Prime, Inc.). Available from gradepro.org.Guarneri,G, Tiengo, A. Haemorrologic and Clotting Alterations in the Pathogenesis of the Diabetic Foot. In Faglia, E, Giuffrida, G, Oriani, G, ed. The Ischaemic Diabetic Foot. Milano, Italy: Kurtis. 1999: 17-23.
Proposed LCD - Pneumatic Compression Devices (DL33829)
Husmann M, Willenberg T, Keo HH, Spring S, Kalodiki E, Delis KT. Integrity of venoarteriolar reflex determines level of microvascular skin flow enhancement with intermittent pneumatic compression. J Vasc Surg. 2008 Dec;48(6):1509-13.Ishibashi, H, Ohta, T, Hosaka, M, Sugimoto, I, Nehei, T, Kawanishi, J. Intermittent Pneumatic Compression Therapy for Chronically Ischemic Legs. In Iwai, T, Ohta, T, Sasajima, T, Ishibashi, H, and Nishikimi, N, ed. Breakthrough in the Treatment for Critical Limb Ischemia in Japan. Japanese Society for Limb Salvage Research. 2004: 65-71.Jolissaint, J, Shah, SK, Martin, MC, Raffetto, JD, McPhee, JT. Risk Prediction of 30-day mortality after lower extremity major amputation. New England Society for Vascular Surgery. Dec 2019 70(6): 1868-1875.Labropoulos N, Watson WC, Mansour MA, Kang SS, Littooy FN, Baker WH. Acute effects of intermittent pneumatic compression on popliteal artery blood flow. Arch Surg. 1998 Oct;133(10):1072-5.Levin SR, Arinze N, Siracuse JJ. Lower extremity critical limb ischemia: A review of clinical features and management. Trends Cardiovasc Med. 2020 Apr;30(3):125-130.Liu K, Chen LE, Seaber AV, Urbaniak JR. Influences of inflation rate and duration on vasodilatory effect by intermittent pneumatic compression in distant skeletal muscle. J Orthop Res. 1999 May;17(3):415-20.Louridas, G. A Randomized, Placebo-Controlled Limb Salvage Trial Using the ArtAssist Pneumatic Compression Device. Winnipeg Vascular and Endovascular Symposium. Winnipeg, Canada; April 2006.
Proposed LCD - Pneumatic Compression Devices (DL33829)
Louridas, G. A Randomized, Placebo-Controlled Limb Salvage Trial Using the ArtAssist Pneumatic Compression Device. Winnipeg Vascular and Endovascular Symposium. Winnipeg, Canada; April 2006.Manfredini F, Malagoni AM, Felisatti M, Mandini S, Lamberti N, Manfredini R, Mascoli F, Basaglia N, Zamboni P. Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease. BMC Cardiovasc Disord. 2014 Mar 31; 14:40.Mehta T, Venkata Subramaniam A, Chetter I, McCollum P. Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):46-52.Mentias A, Qazi A, McCoy K, Wallace R, Vaughan-Sarrazin M, Girotra S. Trends in Hospitalization, Management, and Clinical Outcomes Among Veterans with Critical Limb Ischemia. Circ Cardiovasc Interv. 2020 Feb;13(2): e008597.Montori VM, Kavros SJ, Walsh EE, Rooke TW. Intermittent compression pump for nonhealing wounds in patients with limb ischemia. The Mayo Clinic experience (1998-2000). Int Angiol. 2002 Dec;21(4):360-6.Moran PS, Teljeur C, Harrington P, Ryan M. A systematic review of intermittent pneumatic compression for critical limb ischaemia. Vasc Med. 2015;20(1):41-50. doi:10.1177/1358863X14552096Pawlaczyk K, Gabriel M, Urbanek T, Dzieciuchowicz L, Krasinski Z, Gabriel Z, Olejniczak-Nowakowska M, Stanisic M. Effects of Intermittent Pneumatic Compression on Reduction of Postoperative Lower Extremity Edema and Normalization of Foot Microcirculation Flow in Patients Undergoing Arterial Revascularization. Med Sci Monit. 2015 Dec 21; 21:3986-92.
Proposed LCD - Pneumatic Compression Devices (DL33829)
Pfizenmaier DH 2nd, Kavros SJ, Liedl DA, Cooper LT. Use of intermittent pneumatic compression for treatment of upper extremity vascular ulcers. Angiology. 2005 Jul-Aug;56(4):417-22.Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from guidelinedevelopment.org/handbook.Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366: l4898. Published 2019 Aug 28. doi:10.1136/bmj. l4898Sultan S, Esan O, Fahy A. Nonoperative active management of critical limb ischemia: initial experience using a sequential compression biomechanical device for limb salvage. Vascular. 2008 May-Jun;16(3):130-9. doi: 10.2310/6670.2008.00021.Sultan S, Hamada N, Soylu E, Fahy A, Hynes N, Tawfick W. Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease. J Vasc Surg. 2011 Aug;54(2):440-6; discussion 446-7. doi: 10.1016/j.jvs.2011.02.057.Tawfick WA, Hamada N, Soylu E, Fahy A, Hynes N, Sultan S. Sequential compression biomechanical device versus primary amputation in patients with critical limb ischemia. Vasc Endovascular Surg. 2013 Oct;47(7):532-9.van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, Ramsey DE, Sumner DS. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg. 1994 Jun;19(6):1052-8.
Proposed LCD - Pneumatic Compression Devices (DL33829)
van Bemmelen PS, Weiss-Olmanni J, Ricotta JJ. Rapid intermittent compression increases skin circulation in chronically ischemic legs with infra-popliteal arterial obstruction. Vasa. 2000 Feb;29(1):47-52.van Bemmelen PS, Choudry RG, Salvatore MD, Goldenberg M, Goldman BI, Blebea J. Long-term intermittent compression increases arteriographic collaterals in a rabbit model of femoral artery occlusion. Eur J Vasc Endovasc Surg. 2007 Sep;34(3):340-6.van Bemmelen P, Char D, Giron F, Ricotta JJ. Angiographic improvement after rapid intermittent compression treatment [ArtAssist] for small vessel obstruction. Ann Vasc Surg. 2003 Mar;17(2):224-8.van Bemmelen PS, Gitlitz DB, Faruqi RM, et al. Limb salvage using high-pressure intermittent compression arterial assist device in cases unsuitable for surgical revascularization. Arch Surg. 2001;136(11):1280-1286.Williams KJ, Babber A, Ravikumar R, Davies AH. Non-Invasive Management of Peripheral Arterial Disease. Adv Exp Med Biol. 2017; 906:387-406. doi:10.1007/5584_2016_129Zaki M, Elsherif M, Tawfick W, El Sharkawy M, Hynes N, Sultan S. The Role of Sequential Pneumatic Compression in Limb Salvage in Non-reconstructable Critical Limb Ischemia. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):565-71. doi: 10.1016/j.ejvs.2015.12.025.Zaleska MT, Olszewski WL, Ross J. The long-term arterial assist intermittent pneumatic compression generating venous flow obstruction is responsible for improvement of arterial flow in ischemic legs. PLoS One. 2019 Dec 11;14(12): e0225950.
Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38586)
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 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met:The beneficiary is being actively managed for bladder cancer.The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.At least 1of the 2 criteria are met:The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments.ORb. The patient is a candidate for multiple therapies, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized society consensus guidelines (i.e., National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], Society of Urologic Oncology [SUO], or American Urological Association [AUA]).
Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38586)
The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm.The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population.The test successfully completes a Molecular Diagnostic Services Program (MolDX)technical assessment that ensures the test is reasonable and necessary as described in 4. and 5. above.General InformationAssociated InformationN/ASources of InformationN/ABibliography
Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38586)
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021.CA Cancer J Clin.2021;71(1):7-33.Flaig TW, Spiess PE, Agarwal N, et al. Bladder cancer, version 3.2020, NCCN clinical practice guidelines in oncology.J Natl Compr Canc Netw.2020;18(3): 329-354.Svatek RS, Shariat SF, Novara G, et al. Discrepancy between clinical and pathological stage: external validation of the impact on prognosis in an international radical cystectomy cohort.BJU Int.2011;107(6):898-904.U.S. Food and Drug Administration (FDA).Balversa prescribing information. Accessed April 20, 2022.Helpap B. Morphology and therapeutic strategies for neuroendocrine tumors of the genitourinary tract.Cancer.2002;95(7):1415-1420.Ali SZ, Reuter VE, Zakowski MF. Small cell neuroendocrine carcinoma of the urinary bladder: a clinicopathologic study with emphasis on cytologic features.Cancer.1997;79(2):356-361.National Cancer Institute. Cancer Stat Facts: Bladder Cancer.https://seer.cancer.gov/statfacts/html/urinb.htmlAccessed April 20, 2022.Seiler R, Ashab HAD, Erho N, et al. Impact of molecular subtypes in muscle-invasive bladder cancer on predicting response and survival after neoadjuvant chemotherapy.Eur Urol.2017;72(4):544-554.Lotan Y, Boorjian SA, Zhang J, et al. Molecular subtyping of clinically localized urothelial carcinoma reveals lower rates of pathological upstaging at radical cystectomy among luminal tumors.Eur Urol.2019;76(2):200-206.
Proposed LCD - MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (DL38586)
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.