evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Lower Limb Prostheses (DL33787)
A high activity knee control frame (L5930) is covered for beneficiaries whose functional level is 4.A fluid or pneumatic knee unit (L5610, L5613, L5614, L5615, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840), or control addition, fluid (L5848), or electronic/microprocessor (L5856, L5857, L5858) is covered for beneficiaries whose functional level is 3 or above.A fluid or pneumatic knee unit (L5610, L5613, L5614, L5615, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840), or control addition, fluid (L5848), or electronic/microprocessor (L5856, L5857, L5858) is also covered under limited circumstances for beneficiaries whose functional level is 2, when all of the following criteria (1-3) are met (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD related Policy Article):The beneficiary has had a clinical evaluation to determine their functional level (see FUNCTIONAL LEVELS section above); and,Supporting documentation in the medical record outlines, in the context of the beneficiarys overall medical health, the rationale for selection of a fluid, pneumatic, or electronic/microprocessor-controlled knee, including (at minimum) how the selected knee will:Improve the beneficiarys functional health outcomes (e.g., fall reduction, injury prevention, lower energy expenditure); and,Help the beneficiary accomplish their activities of daily living (ADLs); and,All lower-level knee systems (e.g., knee systems which exclude use of fluid, pneumatic, or microprocessor) have been considered and ruled out based on the beneficiarys specific functional and medical needs.
Proposed LCD - Lower Limb Prostheses (DL33787)
In addition, for coverage of an electronic/microprocessor-controlled knee system (L5856, L5857, or L5858 plus associated components) for beneficiaries whose functional level is 2, all of the following criteria (1-4) must also be met (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD related Policy Article):The electronic/microprocessor knee is indicated for functional level 2; and,The electronic/microprocessor knee has integrated technology that allows the knee to detect when the user trips or stumbles and can automatically adjust to stabilize the knee unit (e.g., stumble recovery); and,The beneficiary is able to make use of a product that requires daily charging; and,The beneficiary is able to understand and respond to error alerts and alarms indicating problems with the function of the unit.L5859 (ADDITION TO LOWER EXTREMITY PROSTHESIS, ENDOSKELETAL KNEE-SHIN SYSTEM, POWERED AND PROGRAMMABLE FLEXION/EXTENSION ASSIST CONTROL, INCLUDES ANY TYPE MOTOR(S)) is only covered when the beneficiary meets all of the criteria below:Has a microprocessor (swing and stance phase type (L5856)) controlled (electronic) kneeK3 functional level onlyHas a documented comorbidity of the spine and/or sound limb affecting hip extension and/or quadriceps function that impairs K3 level function with the use of a microprocessor-controlled knee aloneIs able to make use of a product that requires daily chargingIs able to understand and respond to error alerts and alarms indicating problems with the function of the unitIf these coverage criteria for the knee component are not met, L5859 will be denied as not reasonable and necessary.Other knee systems (L5611, L5616, L5710, L5711, L5712, L5714, L5716, L5718, L5810, L5811, L5812, L5816, L5818) are covered for beneficiaries whose functional level is 1 or above.Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of knee. This information must be retained in the treating practitioner's or prosthetist's files.ANKLES:
Proposed LCD - Lower Limb Prostheses (DL33787)
Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of knee. This information must be retained in the treating practitioner's or prosthetist's files.ANKLES:An axial rotation unit (L5982, L5984, L5985, L5986) is covered for beneficiaries whose functional level is 2 or above.HIPS:A pneumatic or hydraulic polycentric hip joint (L5961) is covered for beneficiaries whose functional level is 3 or above.SOCKETS:More than 2 test (diagnostic) sockets (L5618, L5620, L5622, L5624, L5626, L5628) for an individual prosthesis are not reasonable and necessary unless there is documentation in the medical record which justifies the need. Exception: A test socket is not reasonable and necessary for an immediate prosthesis (L5400, L5410, L5420, L5430, L5450,L5460).No more than two of the same socket inserts (L5654, L5655, L5656, L5658, L5661, L5665, L5673, L5679, L5681, L5683) are allowed per individual prosthesis at the same time.Socket replacements are considered reasonable and necessary if there is adequate documentation of functional and/or physiological need. It is recognized that there are situations where the explanation includes but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive beneficiary weight or prosthetic demands of very active amputees.
Proposed LCD - Lower Limb Prostheses (DL33787)
GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.General InformationAssociated InformationDocumentation Requirements
Proposed LCD - Lower Limb Prostheses (DL33787)
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 the treating practitioner's office 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.AppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations and/or Medical Necessity.Sources of InformationReserved for future use.Bibliography
Proposed LCD - Lower Limb Prostheses (DL33787)
Steiner CA, Karaca Z, Moore BJ, Imshaug MC, Pickens G.Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014.Agency for Healthcare Research and Quality, Rockville, MD;2020.Moxey PW, Gogalniceanu P, Hinchliffe RJ, et al. Lower extremity amputationsa review of global variability in incidence.Diabetic Medicine.2011;28(10):1144-1153.Barnes JA, Eid MA, Creager MA, Goodney PP. Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease.Arterioscler Thromb Vasc Biol.2020;40(8):1808-1817.Thibaut A, Beaudart C, Maertens DENB, Geers S, Kaux JF, Pelzer D. Impact of microprocessor prosthetic knee on mobility and quality of life in patients with lower limb amputation: a systematic review of the literature.Eur J Phys Rehabil Med.2022;58(3):452-461.Clemens S, Doerger C, Lee S-PJCgr. Current and emerging trends in the management of fall risk in people with lower limb amputation. 2020;9(3):134-141.Alzeer AM, Bhaskar Raj N, Shahine EM, Nadiah WA. Impacts of Microprocessor-Controlled Versus Non-microprocessor-Controlled Prosthetic Knee Joints Among Transfemoral Amputees on Functional Outcomes: A Comparative Study.Cureus.2022;14(4):e24331.Sawers AB, Hafner BJ. Outcomes associated with the use of microprocessor-controlled prosthetic knees among individuals with unilateral transfemoral limb loss: a systematic review.Journal of rehabilitation research and development.2013;50(3):273-314.Theeven PJ, Hemmen B, Brink PR, Smeets RJ, Seelen HA. Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review.BMC Musculoskelet Disord.2013;14:333.
Proposed LCD - Lower Limb Prostheses (DL33787)
Berry DJPM, Clinics R. Microprocessor prosthetic knees. 2006;17(1):91-113.Thiele J, Westebbe B, Bellmann M, Kraft M. Designs and performance of microprocessor-controlled knee joints.Biomed Tech (Berl).2014;59(1):65-77.Henrikson NB, Hafner BJ, Dettori JR, et al.Microprocessor-controlled Lower Limb Prostheses Health Technology Assessment.676 Woodland Square Loop SE P.O. Box 42712 Olympia, WA 98504-2712 Washington State Health Care Authority;2011.Hunter SW, Batchelor F, Hill KD, Hill A-M, Mackintosh S, Payne MJP. Risk factors for falls in people with a lower limb amputation: a systematic review. 2017;9(2):170-180. e171.Steinberg N, Gottlieb A, Siev-Ner I, Plotnik M. Fall incidence and associated risk factors among people with a lower limb amputation during various stages of recovery - a systematic review.Disability and rehabilitation.2019;41(15):1778-1787.Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees.Archives of physical medicine and rehabilitation.2001;82(8):1031-1037.Talbot LA, Musiol RJ, Witham EK, Metter EJJBph. Falls in young, middle-aged and older community dwelling adults: perceived cause, environmental factors and injury. 2005;5:1-9.Chihuri ST, Youdan GA, Jr., Wong CK. Quantifying the risk of falls and injuries for amputees beyond annual fall rates-A longitudinal cohort analysis based on person-step exposure over time.Prev Med Rep.2021;24:101626.Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation.Archives of physical medicine and rehabilitation.2007;88(1):109-114.
Proposed LCD - Lower Limb Prostheses (DL33787)
Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation.Archives of physical medicine and rehabilitation.2007;88(1):109-114.Tobaigy M, Hafner BJ, Sawers A. Recalled Number of Falls in the Past Year-Combined With Perceived Mobility-Predicts the Incidence of Future Falls in Unilateral Lower Limb Prosthesis Users.Phys Ther.2022;102(2).Wong CK, Chen CC, Blackwell WM, Rahal RT, Benoy SA. Balance ability measured with the Berg balance scale: a determinant of fall history in community-dwelling adults with leg amputation.Journal of rehabilitation medicine.2015;47(1):80-86.Sions JM, Beisheim EH, Seth M. Selecting, Administering, and Interpreting Outcome Measures among Adults with Lower-Limb Loss: An Update for Clinicians.Curr Phys Med Rehabil Rep.2020;8(3):92-109.Kim J, Major MJ, Hafner B, Sawers A. Frequency and Circumstances of Falls Reported by Ambulatory Unilateral Lower Limb Prosthesis Users: A Secondary Analysis.PM R.2019;11(4):344-353.Gaunaurd I, Spaulding SE, Amtmann D, et al. Use of and confidence in administering outcome measures among clinical prosthetists: results from a national survey and mixed-methods training program. 2015;39(4):314-321.Hafner BJ, Spaulding SE, Salem R, et al. Prosthetists perceptions and use of outcome measures in clinical practice: long-term effects of focused continuing education. 2017;41(3):266-273.Sawers A, Hafner BJ. Using Clinical Balance Tests to Assess Fall Risk among Established Unilateral Lower Limb Prosthesis Users: Cutoff Scores and Associated Validity Indices.PM R.2020;12(1):16-25.
Proposed LCD - Lower Limb Prostheses (DL33787)
Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees.Clinical biomechanics (Bristol, Avon).2018;58:116-122.Hafner BJ, Gaunaurd IA, Morgan SJ, Amtmann D, Salem R, Gailey RS. Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation.Archives of physical medicine and rehabilitation.2017;98(2):277-285.Nugent K, Payne MW, Viana R, Hunter SWJP. The reliability of four standardized concern for falling scales among adults with a major lower extremity amputation. 2022.Nugent K, Payne MW, Viana R, Unger J, Hunter SWJIjorr. A concern for falling impacts quality of life for people with a lower limb amputation. 2022;45(3):253-259.Major MJ, Fatone S, Roth EJ. Validity and reliability of the Berg Balance Scale for community-dwelling persons with lower-limb amputation.Archives of physical medicine and rehabilitation.2013;94(11):2194-2202.Wong CK, Rheinstein J, Stern MA. Benefits for Adults with Transfemoral Amputations and Peripheral Artery Disease Using Microprocessor Compared with Nonmicroprocessor Prosthetic Knees.American journal of physical medicine & rehabilitation.2015;94(10):804-810.Hahn A, Bueschges S, Prager M, Kannenberg A. The effect of microprocessor controlled exo-prosthetic knees on limited community ambulators: systematic review and meta-analysis.Disability and rehabilitation.2021:1-19.Kahle JT, Highsmith MJ, Schaepper H, et al. Predicting walking ability following lower limb amputation: an updated systematic literature review. 2016;18(2-3):125-137.
Proposed LCD - Lower Limb Prostheses (DL33787)
Kahle JT, Highsmith MJ, Schaepper H, et al. Predicting walking ability following lower limb amputation: an updated systematic literature review. 2016;18(2-3):125-137.Borrenpohl D, Kaluf B, Major MJJAopm, rehabilitation. Survey of US practitioners on the validity of the medicare functional classification level system and utility of clinical outcome measures for aiding K-level assignment. 2016;97(7):1053-1063.Dillon MP, Major MJ, Kaluf B, Balasanov Y, Fatone SJP, international o. Predict the Medicare Functional Classification Level (K-level) using the Amputee Mobility Predictor in people with unilateral transfemoral and transtibial amputation: A pilot study. 2018;42(2):191-197.Gailey RS, Roach KE, Applegate EB, et al. The amputee mobility predictor: an instrument to assess determinants of the lower-limb amputee's ability to ambulate. 2002;83(5):613-627.Norvell DC, Thompson ML, Baraff A, et al. AMPREDICT PROsthetics-Predicting Prosthesis Mobility to aid in prosthetic prescription and rehabilitation planning. 2022.Wurdeman SR, Stevens PM, Campbell JHJD, Technology RA. Mobility Analysis of AmpuTees (MAAT 4): Classification tree analysis for probability of lower limb prosthesis user functional potential. 2019.US Food and Drug Administration. (2001). Code of Federal Regulations: 21 CFR 890.3420. Physical medicine devices, physical medicine prosthetic devices, external limb prosthetic component, revised July 25, 2001.US Food and Drug Administration. (1998). Code of Federal Regulations: 21 CFR 890.3500. Physical medicine devices, physical medicine prosthetic devices, external assembled lower limb prosthesis, revised November 3, 1998.
Proposed LCD - Lower Limb Prostheses (DL33787)
US Food and Drug Administration. (1998). Code of Federal Regulations: 21 CFR 890.3500. Physical medicine devices, physical medicine prosthetic devices, external assembled lower limb prosthesis, revised November 3, 1998.Davie-Smith F, Carse B. Comparison of patient-reported and functional outcomes following transition from mechanical to microprocessor knee in the low-activity user with a unilateral transfemoral amputation.Prosthetics and orthotics international.2021;45(3):198-204.Lansade C, Vicaut E, Paysant J, et al. Mobility and satisfaction with a microprocessor-controlled knee in moderately active amputees: A multi-centric randomized crossover trial.Annals of physical and rehabilitation medicine.2018;61(5):278-285.Hahn A, Lang MJJJoP, Orthotics. Effects of mobility grade, age, and etiology on functional benefit and safety of subjects evaluated in more than 1200 C-leg trial fittings in Germany. 2015;27(3):86-94.Hafner BJ, Smith DG. Differences in function and safety between Medicare Functional Classification Level-2 and -3 transfemoral amputees and influence of prosthetic knee joint control.Journal of rehabilitation research and development.2009;46(3):417-433.Kahle JT, Highsmith MJ, Hubbard SL. Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference.Journal of rehabilitation research and development.2008;45(1):1-14.Mileusnic MP, Hahn A, Reiter SJJJoP, Orthotics. Effects of a novel microprocessor-controlled knee, kenevo, on the safety, mobility, and satisfaction of lower-activity patients with transfemoral amputation. 2017;29(4):198-205.
Proposed LCD - Lower Limb Prostheses (DL33787)
Jayaraman C, Mummidisetty CK, Albert MV, et al. Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial.Journal of neuroengineering and rehabilitation.2021;18(1):88.Campbell JH, Stevens PM, Wurdeman SR. OASIS 1: Retrospective analysis of four different microprocessor knee types.Journal of rehabilitation and assistive technologies engineering.2020;7:2055668320968476.Theeven P, Hemmen B, Rings F, et al. Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees.Journal of rehabilitation medicine.2011;43(10):906-915.Fard B, Persoon S, Jutte PC, et al. Amputation and prosthetics of the lower extremity: The 2020 Dutch evidence-based multidisciplinary guideline.Prosthetics and orthotics international.2023;47(1):69-80.Webster JB, Crunkhorn A, Sall J, Highsmith MJ, Pruziner A, Randolph BJ. Clinical Practice Guidelines for the Rehabilitation of Lower Limb Amputation: An Update from the Department of Veterans Affairs and Department of Defense.American journal of physical medicine & rehabilitation.2019;98(9):820-829.Sedki I, Fisher K. Developing prescribing guidelines for microprocessor-controlled prosthetic knees in the South East England.Prosthetics and orthotics international.2015;39(3):250-254.Centers for Medicare & Medicaid. Health Technology Assessment: Lower Limb Prosthetic Workgroup Consensus Document. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/LLP_Consensus_Document.pdf. 2017. Accessed September 6, 2023.
Proposed LCD - Lower Limb Prostheses (DL33787)
Kuhlmann A, Kruger H, Seidinger S, Hahn A. Cost-effectiveness and budget impact of the microprocessor-controlled knee C-Leg in transfemoral amputees with and without diabetes mellitus. Eur J Health Econ. 2020;21(3):437-449.Chen C, Hanson M, Chaturvedi R, Mattke S, Hillestad R, Liu HH. Economic benefits of microprocessor controlled prosthetic knees: a modeling study. Journal of neuroengineering and rehabilitation. 2018;15(Suppl 1):62.Sterne JAC SJ, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng H-Y, Corbett MS, Eldridge SM, Hernn MA, Hopewell S, Hrbjartsson A, Junqueira DR, Jni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.Higgins J LT, Sterne J. Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB2) Additional Considerations for Crossover Trials. https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-crossover-trials. 2021. Accessed September 6, 2023.
Proposed LCD - Lower Limb Prostheses (DL33787)
Sterne JAC HM, Reeves BC, Savovic J, Berkman ND, Viswanathan M, Henry D, Altman DG, Ansari MT, Boutron I, Carpenter JR, Chan AW, Churchill R, Deeks JJ, Hrbjartsson A, Kirkham J, Jni P, Loke YK, Pigott TD, Ramsay CR, Regidor D, Rothstein HR, Sandhu L, Santaguida PL, Schnemann HJ, Shea B, Shrier I, Tugwell P, Turner L, Valentine JC, Waddington H, Waters E, Wells GA, Whiting PF, Higgins JPT. ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions. BMJ 2016; 355; i4919; doi: 10.1136/bmj.i4919.GDT: G. GRADEpro Guideline Development Tool [Software]. McMaster University, 2015 (developed by Evidence Prime, Inc.). gradepro.org. (Accessed February 7, 2023).