Lower Extremity Amputation (LEA) Considerations / Issues

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1 Lwer Extremity Amputatin (LEA) Cnsideratins / Issues Prviding Te Fillers can be an advantageus resurce fr yur patient and business but it als cmes with certain cnsideratins. Please review this list belw befre yu begin ffering this prduct / service t yur patients: Changes t yur Medicare Applicatin. Sme states require yu have n staff a state licensed Pedrthist r Orthtic Fitter in rder t prvide LEA Te Fillers. Since it is difficult t determine which states have this requirement, we recmmend that yu first amend yur Medicare applicatin. Medicare will then cme back with an authrizatin r ask fr additinal credentials. This seems t be the nly way t find ut with certainty the state requirements. Cnsequently, we recmmend that yu make the fllwing changes t yur Medicare applicatin: Under the Heading Prducts and Services t be Furnished by this Supplier these items shuld be checked: Diabetic Ftwear Orthtics Custm Fabricated Orthtics Nn-Custmized Prsthetics Recmmended types f Te Fillers t prvide. Typically, the type f patient that requires a Te Filler is very high risk. Since they already have a histry f amputatins, yu must take extreme care in prviding and mnitring these devices. It is essential that yu check with the patient n a daily basis the cnditin f their feet mnitring any rubbing r red marks very clsely. Due t the high risk, we recmmend that yu nly prvide these devices fr the cnditins indicated belw. If yu have a Pedrthist, Orthtic Fitter, r ther experienced prfessinal n staff they can use their judgment in prviding mre cmplex devices. Missing Big te Missing Big te and up t tw adjacent tes Te Fillers can be prvided fr individual tes hwever, we d nt recmmend prviding these. Cnsult the patients Dr. when these are requested. When all f the tes are amputated (trans-metatarsal amputatin) we recmmend that the patient is evaluated by a trained prfessinal (Pdiatrist, Orthtist, Pedrthist, r ther qualified prfessinal). Peple with this cnditin typically have ther issues that may nt be bvius befre a Te Filler is recmmended.

2 Lwer Extremity Amputatin (LEA) Diabetic patients with a Lwer Extremity Amputatin (LEA) f the te bnes (phalanges) are at greater risk fr subsequent ulceratin and amputatins. LEA is a cstly and disabling prcedure that disprprtinately affects persns with diabetes. The use f therapeutic shes with custm inserts that have a te filler is beneficial fr bth Hallux (big te) and Tran metatarsal (all tes) LEA patients. The te filler helps fill the vid inside the she due t amputatin. Te fillers shuld nt be used t crrect r realign tes that have migrated due t an amputatin. Te Fillers fr Diabetic LEA Patients Hallux Amputatin Remval f the Big Te Te filler is beneficial t help minimize drifting f the remaining tes tw five. Hallux te filler helps nrmalize the patient s walk r gait. Individual 2 nd, 3 rd, 4 th r 5 th Te Amputatins Te filler is nt beneficial and can cause additinal frictin inside the she. Remaining tes prvide enugh supprt fr prper walk r gait. Tran metatarsal Amputatin - Remval f all five tes at the metatarsal jint This type f amputatin is mre disabling than simple te amputatins. Te filler helps prevent creasing f the she at the pint f the amputatin. Te filler helps prevent the breakdwn and eventual cllapse f the she. Te filler can als help cntrl the remaining ft inside the she, decrease shear, and ften eliminate the need fr a cstly custm-made she. Recmmended shes fr LEA patients Shes fr LEA patients need t have the ability t rck, replacing the mtin lst with the additin f the hard flex/carbn plate. The lss f push-ff in the ball f the ft is chiefly respnsible fr impairment f gait. The bump style shes wrk best fr LEA patients with te fillers. The she size des nt change when the metatarsal heads remain in tact. Imprtant t prtect the remaining prtin f the ft Since an amputatin indicates that a patient has severe ft prblems, special care MUST be taken t prtect the remaining prtin f the ft. It is very imprtant t pay attentin t the presence f skin grafts, scar tissue, r ther pst surgical cmplicatins when fitting fr diabetic shes and custm inserts with te filler.

3 Lwer Extremity Amputatin (LEA) Fitting a Diabetic Patient with a Lwer Extremity Amputatin (LEA), usually cnsist f prviding a te filler, equalizing the patient s weight bearing with custm inserts, and prtecting the remaining prtin f the ft with Therapeutic shes. Hallux Amputatin - Big te Te filler is beneficial t help minimize drifting f the remaining tes tw five and help nrmalize the patient s walk r gait. Right ft Hallux amputatin Left ft Hallux Te Filler Flex Plate Placed under insert A Tran metatarsal Amputatin - All Tes This te filler helps prevent creasing f the she at the tes and helps prevent the breakdwn and eventual cllapse f the she. Right ft Tran metatarsal amputatin Right ft Tran metatarsal Te filler Flex Plate Placed under insert A Flex Plate A thin hard insert Used with a te filler insert Placed under the custm insert Hlds the custm insert in place Prvides mtin gait push-ff

4 Prescriptin & Letter f Medical Necessity Fr Therapeutic Shes & Custm Inserts with Te Filler fr LEA Patient Name Last First Middle Address City State Zip Cde Date f Birth Physician s Rx ( MM / DD / YYYY ) I certify that the fllwing statement is true: The Patient listed abve has Diabetes Mellitus: ICD-9 Diagnsis Cde: (check Dx that applies) Rx Yes N Gender: Male Female Other Partial r cmplete amputatin f the ft: Left Right Area f Amputatin (LEA) Date f Lwer Extremity Amputatin (LEA) (mm/dd/yy) I am treating this patient under a cmprehensive plan f care fr diabetes mellitus. Yes N This patient needs extra depth shes with a te filler intergrated in the multiple density inserts because f his/hers diabetes and LEA. I certify that all f the cnditins checked abve are in my dctr s ntes. Yes N Yes N * (Physician Signature M.D. r D.O.) Date * If a CRNP r PA signs Rx, t meet Insurance Guidelines an M.D. r D.O. wet ink r stamped Signature must accmpany signature.* Physician Infrmatin: Dr. Name UPIN # Address City State Zip Cde Office Phne Office Fax

5 Rights Respnsibilities and Sales Agreement Therapeutic Shes & Custm Inserts with Te Filler She Certificatin I understand that Medicare will nly cver ne pair f diabetic shes each calendar year. I have nt received diabetic shes frm any ther Medicare r insurance supplier this year, nr will I accept them frm any ther cmpany at anther time this year. I als understand that if I request, r accept mre than ne pair in a calendar year, I will be held liable fr the full cst f the secnd rder, including the inserts. Te Filler & She/Insert Break-in Schedule Diabetic patients with a Lwer Extremity Amputatin (LEA) f the phalanges r te bnes are at greater risk fr subsequent ulceratin and amputatins. It is imperative that the patient fllw she break-in schedule. I acknwledge receiving instructins and agree t fllw the She Break-in schedule listed belw. I understand that it is recmmended that I check my feet every hur fr the first week f the break-in. If I see anything that lks different than nrmal r ut f the rdinary that may result in scratches, blisters, cuts, etc. I will stp wearing the shes and inserts and discntinue use immediately. I will nt hld the diabetic she supplier, cmpany, r fitter liable in anyway whatsever fr any persnal injury r prperty damage that the shes r inserts may cause. Custm Inserts with Te Filler & She Wearing Time Check Feet Often Day 1-3 Day 4-6 Day 7-9 Day hur each AM + PM 2 hurs each AM + PM 3 hurs each AM + PM 4 hurs each AM + PM Custm Inserts I acknwledge receiving instructins and agree t fllw the scheduled dates listed t change the custm inserts in my Therapeutic Shes. Change Inserts (4 mnths) Change Inserts (8 mnths) (mm/dd/yy) (mm/dd/yy) Return Plicy & Equipment Warranty Return sales will be accepted within 14 days frm the date merchandise is received and refunds will be issued fr such merchandise. Items must be returned in re-salable cnditin, in the riginal bxes. Dirty r usedlking items will nt be accepted. Returns after 14 days and Custm Order Items are subject t fees. DME will ntify all Medicare beneficiaries f the warranty cverage, and we will hnr all warranties under applicable law. DME will repair r replace, free f charge, Medicare-cvered equipment that is under warranty. Instructin t Patient-Return/Demnstratin Acknwledgement I acknwledge receiving instructins in the prper use and care f the equipment and/r supplies described. I have had my financial respnsibilities explained. I als acknwledge and agree t this entire agreement. I, have read and acknwledged the abve infrmatin Date: (PATIENT SIGNATURE)

6 Dctr Rx Ft Evaluatin Lwer Extremity Amputatin (LEA) Include area f amputatin Date f amputatin Custm Inserts Impressin Bx She Order Frm Patient Prcedures Dcument the LEA and circle area n the ft diagram. Te filler is incrprated nt patient s custm inserts. Take an impressin f BOTH feet. Label impressin bx with: Patient name Te filler Type-in Other Infrmatin bx te filler infrmatin Hallux te filler rder r Tran metatarsal te filler rder Ft diagrams n printed she rder Circle area f amputatin Te Filler Order Expectatins Te fillers take Evlutin Labs 2-3 weeks t make. Patient expectatins, she delivery in 6-8 weeks frm impressin bx shipment. She Break-in Perid is VERY imprtant fr LEA patients. Since an LEA indicates that a patient has had severe ft prblems, special care MUST be taken t prtect the remaining prtin f the at-risk ft. Advise LEA Patients t remve their shes and check their feet every hur when wearing the shes during the first week f the She Break-in schedule. Fllw-up calls with handwritten ntes dcumenting patient s status very imprtant.

7 When t Bill Medicare Billing Medicare & Supplemental Insurance 2007 fees Therapeutic Shes, Custm Inserts with Te fillers Once the diabetic shes and inserts have been delivered t the patient. The patient is satisfied with the prducts and signed all necessary papers. Descriptin HCPCS Qty Amunt Therapeutic Shes A $124 Custm Inserts - One Ft A $113 Custm Inserts with Hallux (Big Te) Filler - One ft L $493 * Ttal Billed $730 Medicare Reimburse 80% $584 Average Cst $280 ** Medicare Margin $304 Other 20% Margin $146 Ttal Ptential Margin $450 Descriptin HCPCS Qty Amunt Therapeutic Shes A $ 124 Custm Inserts One Ft A $ 113 Custm Insert with Tran metatarsal (All Tes) Filler - One ft Ability t bill max 3 tes. L $1,479 * Ttal Billed $1,716 Medicare Reimburse 80% $1,372 Average Cst $ 580 Medicare Margin $ 792 Other 20% Margin $ 343 Ttal Ptential Margin $1,135 * L5000 average reimbursement $493. State reimbursement $ t $ per Te. See 2007 Medicare fee schedule fr specific State reimbursement amunt. ** Average Cst includes: $50 per te filler. 3 te filler add-n t inserts cst $150. Average cst f shes and six custm inserts are $130. Ttal average cst is $280.

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