DHCS-08-003

METHOD OF INDICATING CHANGES

The additional changes to regulations for Orthotic and Prosthetic Appliances and

Services, DHCS-08-003, are shown by using double strikethrough for deletions (double strikethrough for deletions) and double underline for additions (double underline for additions).

DHCS-08-003

(1) Amend Section 51161 as follows:

SectionSection 51161.51161. [beginOrth underline]Orthoticotic and Prosthetic aand[endnd Ortho ticunderline] Appliance Prosthetics and Services . [begin strikeout]and Orthotic[end strikeout] Appliances [begin underline]and Prosthetic and orthotic appliances means those appliances prescribed by a Services[end underline]. [begin strikeout]Prosthetic and orthotic appliances meansphysici athosen, de nappliancestist or podiat prescribedrist for the res byto ratia physician,on of functio dentistn or re porla cpodiatristement of b forody thepa rts.restoration of function or replacement of body parts.[end strikeout]

[begin The fo llunderline]Theowing definitions followingshall apply odefinitionsnly to Sectio nshalls 513 apply15, 513 only15.1 a tond Sections51315.2: 51315, 51315.1 and 51315.2: [end underline] [begin (a)underline](a) “Abduction a “Abductionnd Rotation Ba r”and mea Rotationns a rigid ba rBar” that is means attached ato rigidthe fe et barto m thatainta inis a attachedppropriate p otositio thening feet of on eto o rmaintain both feet. appropriate positioning of one(b) or both“Abd ufeet.ction P(b)osition “Abduction, Custom Fitte Position,d Orthosis” Custommeans a cu Fittedstom-fitt ed

Orthosis”-elbo meansw-wrist- haa ncustom-fittedd orthosis designe shoulder-elbow-wrist-handd specifically to control abduction of these orthosisareas. designed specifically to control abduction of these areas. (c) “Above Elbow” means trans-humeral as it relates to prostheses (c) “Above Elbow” means trans-humeral as it relates to prostheses or levels or levels of amputation across the long axis of the humerus. (d) of amputation across the long axis of the humerus. “Above ” means trans-femoral as it relates to prostheses or (d) “Above Knee” means trans-femoral as it relates to prostheses or levels of levels of amputation across the long axis of the femur. (e) amputation across the long axis of the femur. “Activities of Daily Living” or “ADLs” means those activities performed(e) by“Activ anities individual of Daily Liv inforg” oessentialr “ADLs” me alivingns those purposes, activities pe rformsuched asby bathing,an individu eating,al for ess etoileting,ntial living p ambulation,urposes, such a sdressing bathing, ea tiandng, to transferring.ileting, ambulatio n(f), “Addition”dressing an dmeans transferr ingany. provision that is different from or not included(f) in “Adthedition base” me applianceans any provisi thaton th enhancesat is different froorm facilitates or not includ ethed in the intendedbase appli afunctionnce that en hofan theces obaser facilita appliance.tes the intend e(g)d fu n“Ancillaryction of the b Orthoticase applian ce.

Device”(g) means“Ancil laryan Oorthosisrthotic Dev thatice” m isea nnots an otherwiseorthosis that isincluded not otherw iseunder any other orthotic grouping. included under any other orthotic grouping. 1

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(h) “Ankle-Foot Orthosis” means an orthosis that traverses the ankle and foot.

(i) “Anterior-Posterior-Lateral Control Orthosis” means an orthosis that traverses the cervical, thoracic, lumbar andor sacral areas to provide control of anterior, posterior and lateral motion to these areas of the spine.

(j) “Appliance” means an orthosis or prosthesis that is applied to the appropriate body part to modify or replace the structural and functional characteristic of the neuromuscular and skeletal systems.

(k) “Attachment” means any provision that is different from or not included in the base appliance that changes the base appliance’s function beyond its originally intended function.

(l) “Backup Appliance” means another of the same prosthetic or orthotic appliance for the purpose of being used in the event the patient’s primary appliance is unable to be used.

(m) “Base Appliance” means an appliance that provides the essential or fundamental function designed for the appliance.

(n) “Below Elbow” means trans-radial as it relates to prostheses or levels of amputation across the long axis of the radius or ulna.

(o) “Below Knee” means trans-tibial as it relates to prostheses or levels of amputation across the long axis of the tibia or fibula.

(p) “Bilateral” means being of, or pertaining to both sides of the body.

(q) “Body Jacket” means a rigid or semi-rigid orthosis that encompasses the torso to limit spinal motion.

(r) “Cervical and Multiple Post Collar Orthosis” means a collar that fits around the neck to provide support and protection to the cervical spine. 2

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(s) “Cervical Orthosis” means an orthosis that traverses the cervical vertebrae.

(t) “Cervical-Thoracic-Lumbar-Sacral Orthosis” means an orthotic grouping that includes sacroiliac orthoses, lumbar orthoses, lumbar-sacral orthoses, and anterior- posterior-lateral control orthoses; each individual orthosis traverses the cervical, thoracic, lumbar or sacral vertebrae.

(u) “Cervical-Thoracic Orthosis” means an orthosis that traverses the cervical and thoracic vertebrae.

(v) “Compression Burn Garment” means a stocking worn over a burned area(s) of the body that provides pressure as an aid to healing and reduction of scar tissue.

(w) “Computer Aided Design/Computer Aided Manufacture Model” or

“CAD/CAM Model” means an appliance fabricated with the aid of a three-dimensional positive or negative image or digital scanning of the patient’s limb(s).

(x) “Conventional Shoes” means non-orthopedic shoes.

(y) “Cranial Orthosis” means a helmet that fits over the head of the patient for the primary purpose of molding the skull, and may provide some protection.

(z) “Custom Fabricated Appliance” or “Custom Fabrication” means an appliance constructed for a specific patient by obtaining individual measurements, fashioning a pattern or creating a mold, using either a plaster cast, or with a positive or negative impression or using a scanning device.

(aa) “Custom Fitted Appliance” means a prefabricated appliance that requires individual adjustment, alteration or assembly for safe and optimal application to a specific patient. 3

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(bb) “Custom Made” means the same as custom fabricated.

(cc) “Date of Service” means the date the appliance was received by the patient.

(dd) “Definitive Prosthetic Appliance” or “Definitive Prosthesis” means a prosthesis intended for long-term use containing components suitable for the full range of functional activities the amputee may be able to perform.

(ee) “Device” means the same as appliance.

(ff) “Direct Formed Appliance” means an appliance in which material is molded over the involved portion of the patient’s body and ultimately becomes the appliance or an essential part of the appliance for that patient.

(gg) “Dynamic Flexor Hinge, Reciprocal Wrist Extension/Flexion, Finger

Flexion/Extension Orthosis” means a custom-made orthosis that traverses the wrist, hand and fingers to control extension and flexion of these areas.

(hh) “Elbow Orthosis” means an orthosis that traverses the elbow.

(ii)d oske“Enletal Prosthesis” means a prosthe sis that is composed of an internal pylon system that provides structural integrity to the appliance and provides the prosthesis’ main support by accepting the stress of the body’s weight or functional activities.

(jj) “Exoskeletal Prosthesis” means a prosthesis that is composed of a rigid external shell that provides structural integrity to the appliance and provides the prosthesis’ main support by accepting the stress of the body’s weight or functional activity.

(kk) “External Power” means an orthosis or prosthesis that relies on a force other than that from the user’s body to operate, such as from a battery powered motor. 4

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(ll) “Finger(ll) Orthosis”“Finger Orth meansosis” m eanans orthosis an orthosis that that trav traverseserses the f ingtheer. finger. (mm) “Foot ( Orthosis”mm) “F omeansot Orthosis” an m orthosiseans an ort hthatosis ttraverseshat traverses thethe f ofoot.ot. (nn) “Foot Prosthesis”(nno) meansot “FProsthe asis” prosthesis means a prost thathesis replaces that replace alls a llor or papartrt o f ofan an amputatedamputated or or ddeformedeformed foo t.foot. (oo) “Fracture Orthosis” means an orthosis that(oo) traverses“Fracture Ortho thesis” upper means [beginan ortho sisdouble that tra vunderline]orerses the upper olower[endr lower doubleextrem underline]ity to stabiliz eextremity and support to an stabilizeupper extrem andity fract supporture. an [begin double strikeout]upper[end double strikeout] extremity fracture. (pp) “Gradient(pp) “Gra dCompressionient Compression S toStocking”cking” means means a garmen t aw ithgarment variable de gwithrees variableof pressu degreesre, typically f rofom pressure,highest pressu retypically in the dista froml parts ohighestf the garm epressurent with a in thelo wdistaler pressu partsre in t hofe p roxtheim agarmentl parts of the with garme ant. lower pressure in the proximal ( qq parts) “Gro uofping the,” w hgarment.en used with “orth(qq)otic” “Grouping,” or “prosthetic” m wheneans mo usedre than owithne “orthotic”appliance oorr s e“prosthetic”rvice that has be emeansn placed t omoregether inthan the sa oneme proc applianceedural code or serviceclassifica thattion. has been placed together in the same procedural code ( classification.rr) “Hallusx-Va lg(rr)us S “Hallu[beginplint” means a dev icedouble that fits strikeout]over the big to es to[end doublemainta instrikeout] proper anato m[beginical position double of the tounderline]e. x [end double underline]-Valgus (ss) “Halo Proce Splint”dure” m emeansans a met aal struc deviceture co nthatnecte fitsd to aover skull ring the w ithbig toep insto insemaintainrted into th propere skull and anatomical attached to a body position jacket or otofhe rthe orth otoe.sis to (ss)hold th “Haloe Procedure”metal structure means in place in a o rdmetaler to imm structureobilize the ce connectedrvical spine. to a skull ring with ( pinstt) inserted“Hand-Fing intoer Orth theosis” skull mean sand an o rthoattachedsis that trav toerses a bodythe han djacket and or otherfinge orthosisr areas. to hold the metal structure in place in order to immobilize ( uu) the“Han dcervical Orthosis” m spine.eans an o(tt)rtho sis“Hand-Finger that encompasse sOrthosis” the whole or any meanspart of thane h orthosisand. that traverses the hand and finger areas. (uu) “Hand(vv) Orthosis”“Hemipelvecto mmeansy Prosthe ansis” meaorthosisns a prost thathesis encompassesfor an amputation tha tthe is wholeperfo rmore dany throu gparth a p oofrtion the of th hand.e pelvis. (vv) “Hemipelvectomy Prosthesis” means a prosthesis for an amputation that is 5 performed through a portion of the pelvis. DHCS-08-003

(ww) “(ww Disarticulation) “Hip Disarticulat ionProsthesis” Prosthesis” mea meansns a p rosta prosthesishesis for an a mforput aantion amputationthrough the through hip joint. the hip joint. (xx) “Hip-Knee-Ankle-Foot Orthosis” means (xx) an orthosis“Hip-Kn ethate-An kletraverses-Foot Orth othesis” mhip,ean sknee, an orth oanklesis tha t andtrave rsesfoot th areas.e hip,

(yy)kn “Hipee, a nOrthosis”kle and foot ameansreas. an orthosis that traverses the hip area. (zz)

“Immediate(yy) and“Hip Early Orthosis” Post mea nSurgicals an orthosis Procedure” that traverses meansthe hip area amputation. and prosthetic appliance management that begins immediately [begin (zz) “Immediate and Early Post Surgical Procedure” means amputation and double underline] or very soon [end double underline] following prosthetic appliance management that begins immediately or very soon following surgical closure of the original amputation wound or a residual limb surgical closure of the original amputation wound or a residual limb revision wound. revision wound. (aaa) ( “Infantaaa) Immobilizer”“Infant Immob ilmeansizer” mea an sdevice a device that that restrictsrestricts m omovementvement of th eof in fathent infantin o inrde orderr to sta btoiliz stabilizee the infan thet’s ce infant’srvical an dcervical upper tho andracic upperspine a nthoracicd airway. spine and

airway. ( (bbb)bbb) “Initial“Initial Pro Prosthesis”sthesis” mea meansns a dire cta fdirectormed tformedemporary temporary appliance prov applianceided as provided as part of the immediate and early post surgical and prosthetic part of the immediate and early post surgical and prosthetic appliance management. appliance management. (ccc) “Insert” means the same as foot orthosis. (ddd) (ccc) “Instrumental “Insert” Activities means the ofsa mDailye as f oLiving”ot ortho sis.or “IADLs” means those activities ( dddthat) support“Instrumen activitiestal Activities of o dailyf Daily livingLiving” [beginor “IADLs” double mean sunderline] those activities and the thcapacityat support for activ normalities of d activity,aily living aincludingnd the cap aemploymentcity for normal a[endctivity double, including

underline],employm esuchnt, su chas a soutside outside mobmobility,ility, sh oshopping,pping, transp transportation,ortation, housewo housework,rk, hygiene, hygiene, laundry, meal preparation and medication management. laundry, meal preparation and medication management.

( eee) “Knee-Ankle-Foot Orthosis” means an orthosis that traverses the knee,

ankle and foot areas.

( fff) “Knee Disarticulation Prosthesis” means a prosthesis for an amputation

through the knee joint.

(ggg) “Knee Orthosis” means an orthosis that traverses the knee area.

( hhh) “Legg-Perthes Orthosis” means a hip orthosis that is designed especially

for the patient with Legg-Perthes deformity. 6

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(iii) “Lumbar(iii) Orthosis”“Lumbar Orth meansosis” mea nans a northosis orthosis th thatat tra vtraverseserses the lum thebar a lumbarrea. area. ( (jjj)jjj “Lumbar-Sacral) “Lumbar-Sacral Ort Orthosis”hosis” mea nmeanss an ortho ansis torthosishat traverses that the lumbar and traversessacral area thes. lumbar and sacral areas. (kkk) “Mobile Support” means (kkk) an abduction“Mobile Arm position, Support” m customeans an a bfittedduction orthosis position, c uthatstom isfitte designedd orthosis specificallythat is desig forned asp epatientcifically f o[beginr a patie ndoublet in a who strikeout] requires sup pinort a a tt[endached double to a strikeout]wheelcha whoir, cha irrequires or table. support attached to a wheelchair [begin double underline], chair or table [end double underline]. (lll) “Molded(lll) to “Mtheolde Patient”d to the Pmeansatient” m ae acustomns a cust ofabricatedm fabricated appliance. appliance. (mmm) “Off-the-Shelf (mmm) Appliance”“Off-the-She lmeansf Applian cane” morthoticeans an oorrtho prosthetictic or prosth applianceetic appliance that tha tfits a patientfits a pwithoutatient w ithassemblyout assem borly ostructuralr structural modmodification.ification. (nnn) “Orthopedic Footwear” means an orthotic grouping that includes stock orthopedic shoes, ( nnn) “Orthopedic Footwear” means an orthotic grouping that includes stock stock conventional shoes and custom-made orthopedic shoes. (ooo) orthopedic shoes, stock conventional shoes and custom-made orthopedic shoes. “Orthopedic Shoes” means an orthotic grouping that includes Hallu[begin double ( strikeout]s[endooo) “Orthopedic double Shoes” mstrikeout][begineans an orthotic g roudoubleping t hunderline]x[endat includes Hallusx -double underline]-Valgus sp liValgusnt, abdu ctiosplint,n and abduction rotation bars, and orth rotationopedic foo bars,twear aorthopedicnd shoe mod ifootwearfications ando fshoe stock omodificationsrthopedic shoes ofan dstock stock orthopedicconventional sshoeshoes; o rand sho estocks that hconventionalave features shoes; or shoes that have features that are designed for a medical that are designed for a medical condition(s) of the foot or ankle, such as extra room or condition(s) of the foot or ankle, such as extra room or depth, support, or depth, support, or ability to be modified. ability to be modified. (ppp) “Orthosis” means an externally applied appliance used ( to modifyppp) “Or theth ostructuralsis” means aandn ex tefunctionalrnally appli echaracteristicsd appliance used toof mtheodi fy the neuromuscularstructural and fu andnctio nskeletalal charact systems.eristics of th (qqq)e neuro “Orthoticmuscular a Devicesnd skeleta l– sy Lowerstems. Limb

(Extremity)” (qqq )means “Ortho tican De orthoticvices – Lgroupingower Limb (Exthattrem includesity)” mea hipns a northoses, orthotic grou Leggping Perthes orthoses, knee orthoses, ankle-foot orthoses, knee-ankle-foot that includes hip orthoses, Legg Perthes orthoses, knee orthoses, ankle-foot orthoses, orthoses – or any combination, torsion control: hip-knee-ankle-foot orthoses, knee-ankle-foot orthoses – or any combination, torsion control: hip-knee-ankle-foot torsion control: hip-knee-ankle-foot orthoses (tibial fracture casts), torsion control:orthose hip-knee-ankle-foots, torsion control: hip-kn orthosesee-ankle-fo o(femoralt orthoses fracture (tibial fract casts),ure casts), reciprocating torsion gaitcontrol: hip-knee-ankle-foot orthoses (femoral fracture casts), reciprocating gait

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DHCS-08-003 orthoses,orthoses, aandnd ortho orthotictic devices devices – lower li–m blower (extrem limbity) (a (extremity)dditions to lowe (additionsr extremity to lowerortho seextremitys). orthoses). (rrr) “Orthotic Devices – Lower Limb (Extremity) ( rrr) (Additions“Orthotic Dev toices Lower – Lowe rExtremity Limb (Extrem Orthoses)”ity) (Additions tomeans Lower Ex antrem ity orthoticOrthose groupings)” means an that ortho ticincludes grouping additionsthat includes toadd fractureitions to frac orthoses,ture orthose s, additionsadditions ttoo lo lowerwer extr eextremitymity orthose orthoses:s: shoe-ankle -shoe-ankle-shin-knee,shin-knee, additions to straigh t knee additionsor offset kn toee straightjoints (kne eknee joints) or, ad offsetditions: tkneehigh-w ejointsight be a(kneering – g lutjoints),eal/ischia additions:l weight thigh-weight bearing – gluteal/ischial weight bearing, additions: pelvic bearing, additions: pelvic and thoracic control, additions: general, and custom foot and thoracic control, additions: general, and custom foot orthoses. orthoses. (sss) “Orthotic Devices – Procedures” means an orthotic (sss) “Orthotic Devices – Scoliosis Procedures” means an orthotic grouping grouping that includes cervical-thoracic-lumbar-sacral orthoses, that includes cervical-thoracic-lumbar-sacral orthoses, thoracic-lumbar-sacral orthoses thoracic-lumbar-sacral orthoses (low profile) and other scoliosis procedures(low profile) an (bodyd other jackets).scoliosis proce (ttt)du res“Orthotic (body jacke Devicests). – Upper Limb” means ( anttt ) orthotic“Orthotic grouping Devices – Up thatper Liincludesmb” mean sshoulder an orthotic gorthoses;rouping that inelbowcludes orthoses;shoulder orth wrist-hand-fingeroses; elbow orthoses ;orthoses; wrist-hand-f ingadditionser orthoses to; a dupperditions t olimb uppe r limb orthoses;orthoses; ddynamicynamic flex oflexorr hinge, hinge,reciproca reciprocall wrist extension wrist/flexion extension/flexion,, finger fingerflexion flexion/extension/extension orthoses; ex orthoses;ternal power orthexternaloses an dpower other w riorthosesst-hand-fing eandr other wrist-hand-fingerorthoses – custom fit teorthosesd. – custom fitted. (uuu) “Prefabricated

Appliance” ( uuu) means“Prefabri caante dappliance Appliance” m thateans ahasn ap pbeenliance tmanufacturedhat has been from standard molds or patterns [begin double underline] with no specific manufactured from standard molds or patterns with no specific patient in mind. patient in mind [end double underline]. (vvv) “Preparatory Prosthesis” (vvv ) “Preparatory Prosthesis” means a temporary prosthetic appliance utilized means a temporary prosthetic appliance utilized to prepare the to prepare the residual limb for eventual fitting and to evaluate the appropriateness of residual limb for eventual fitting and to evaluate the appropriateness of seselectedlected tec htechnologynology and the andpatien thet’s ab patient’sility to use a abilitydefinitiv eto prost usehe sis.a definitive prosthesis. ( www )(www) “Primary “PrimaryAppliance” m Appliance”eans the princip meansal applia nthece in principaltended to b eappliance used by intendedthe patien tot. be used by the patient.

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(xxx) “Procedure”(xxx) “Proce dorure” “Special or “Specia lProcedure” Procedure” me ameansns an ap panlian ceappliance,, addition, addition,attachm eattachment,nt, adaptation o r adaptationfeature that is doresig featurened to m ethatet a spise cidesignedfic medical ntoee d. meet (yyy) a specific“Prost medicalhesis” mea need.ns an e (yyy)xternall y“Prosthesis” applied applian cemeans used to anrep lace externallywholly, or appliedin part, an aappliancebsent or defici usedent bo dtoy preplaceart. wholly, or in part, an absent (zzz) or deficient“Recipro cabodyting G part.ait Or th(zzz)osis” mea “Reciprocatingns a bilateral hip- knGaitee-a nOrthosis”kle-foot meansorthosis a tbilateralhat transfe rship-knee-ankle-foot motion energy from one le orthosisg to the oth thater, aidi transfersng or enabli nmotiong energyambu latfromion. one leg to the other, aiding or enabling ambulation. (aaaa) “Replacement Glove” means a passive partial hand ( aaaa) “Replacement Glove” means a passive partial hand prosthesis that is prosthesis that is made from an existing mold [begin double made from an existing mold or a cosmetic cover for a passive or functional hand underline] or a cosmetic cover for a passive or functional hand prosthesis. prosthesis [end double underline]. (bbbb) “Rigid”(bbbb) “Ri meansgid” mea nnots no tbending; bending; inf linflexibleexible during [begin normal u doublese and resist ant to underline]normal use during forces. normal use and resistant to normal use forces

[end double(cccc) underline].“Sacroiliac Orth (cccc)osis” me “Sacroiliacans an orthosis Orthosis” that traverses means the pelv ican an d orthosissacral a reathats. traverses the pelvic and sacral areas. (dddd) “Scoliosis Orthosis” means the same as scoliosis procedure. (dddd) “Scoliosis Orthosis” means the same as scoliosis procedure. (eeee) “Scoliosis Procedure” means a spinal orthosis that treats a (eeee) “Scoliosis Procedure” means a spinal orthosis that treats a curvature or curvature or other instability of the spine. (ffff) “Semi-Rigid” means other instability of the spine. partially rigid; having some rigid elements. (gggg) “Services” (ffff) “Semi-Rigid” means partially rigid; having some rigid elements. means activities, including medical examinations, that are related to the (ggg provisiong) “Serv ofices” prosthetic means activ andities, incluorthoticding m eappliances,dical examinati osuchns, tha ast are repairs,related tolaboratory the provisio nwork of pros necessarythetic and orth ofortic aconstructionppliances, such aofs rep theair s, laboratory appliance,work necessa castingry for co nandstruc tiocastn of changes,the appliance realignment, casting and cast or ch aadjustmentnges, of appliances,realignment oapplicationr adjustment o f ofap pdressings,liances, applica measuringtion of dressing ors, fittingmeasuri nforg o r fitting appliances,for appliance straining, training ththee p apatienttient on th one use the an duse care andof the careapplia nofce theand delivery of applianceappliances. and delivery of appliances. 9

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(hhhh) “Shoe Modification” means an addition, modification or service to an off- the-shelf or custom-made shoe to improve its functionality.

( iiii) “Shoe Modifications of Stock Orthopedic Shoes and Stock Conventional

Shoes” means an orthotic grouping that includes shoe modifications – lifts, shoe modifications – wedges, shoe modifications – heels, orthopedic shoe additions, and transfer or replacement.

( jjjj) “Shoulder-Elbow-Wrist-Hand Orthosis” means an orthotic grouping that includes abduction position, custom fitted orthoses; mobile arm supports; additions to mobile arm supports and fracture orthoses; or an orthosis that traverses the shoulder, elbow, wrist and hand areas.

(kkkk) “Shoulder Orthosis” means an orthosis that traverses the shoulder.

( llll) “Spinal Orthosis” means an orthotic grouping where each individual orthosis traverses some part of the spine that includes cranial orthoses, cervical and multiple post collar orthoses, thoracic orthoses ( belts), thoracic orthoses (anterior- posterior-lateral-rotary control), thoracic orthoses (triplanar control – modular segmented spinal system [prefabricated]), thoracic orthoses (triplanar control – rigid frame), and thoracic orthoses (triplanar control – rigid plastic shell).

(mmmm) “Stock” when used with “orthopedic shoes” or “conventional shoes” means a shoe that fits a patient without assembly or structural modification.

( nnnn) “Tension Based Scoliosis Orthosis” means an orthosis that utilizes elastic strapping linked to control pads intended for treatment of adolescent idiopathic scoliosis.

( oooo) “Thoracic-Hip-Knee-Ankle Orthosis” means an orthosis that traverses the thoracic, hip, knee and ankle areas. 10

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(pppp) “Thoracic-Lumbar-Sacral Orthosis” means an orthosis that traverses the

thoracic, lumbar and sacral areas.

(qqqq) “Thoracic Orthosis” means an orthosis that traverses the thoracic area.

(rrrr) “Torsion Control Orthosis” means an orthosis that controls rotation of the

joint in which it traverses.

(ssss) “Truss” means an orthosis used to reduce a hernia via direct external

abdominal pressure.

( tttt) “Wrist-Hand-Finger Orthosis” means an orthosis that traverses the wrist,

hand and finger areas.

( uuuu) “Wrist-Hand Orthosis” means an orthosis that traverses the wrist and hand

areas.

(vvvv) “Wrist Orthosis” means an orthosis that traverses the wrist.

NOTE:NOT AuthorityE: Au thcited:ori ty[begin cite underline]d: Sectio Sectionn 20 ,20, Hea Healthlth aandnd Safety Safe Code;ty Co andde ;[end an dunderline] Sectio Section[beginns 14105 1 0725, underline]s[end14103.7 a underline]nd 1412 [begin4.5, Wstrikeout]14105[endelfare and Institu strikeout]tion s[begin Cod underline]10725,e. Reference 14103.7: Sectio andns 14124.5,[end 14103.7, underline]14105 Welfare.21, 1 4and13 Institutions1, and 1 Code.4132 Reference:, 14133.3 Sections and 1 [begin4133 .9underline]14103.7,, Welfare an d14105.21, Institutio [endns underline] Code. 14131[begin underline],[end underline] [begin strikeout]and[end strikeout] 14132[begin underline], 14133.3 and 14133.9[end underline], Welfare and Institutions Code.

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(2) Amend Section 51315 as follows:

SectionSectio 51315.n 513 1[begin5. Am underline]Amount,ount, Scope, Dura Scope,tion ,Duration, Limitatio Limitationn and P riandor APrioruth oAuthorizationrization of B ofe nBenefitsefits for Orthotic and [end underline] Prosthetic [begin strikeout]and Orthotic [end strikeout] Appliances [begin underline]for Orth andotic Servicesand Pros [endthe underline].tic and Orthotic Appliances and Services. (a) [begin(a) underline]OrthoticOrthotic and prosthe andtic ap pprostheticliances and appliancesservices, to th eand exte services,nt necessa ryto

thefor extentthe rest onecessaryration of functio forn theor re restorationplacement of aof b ofunctiondy part(s) ,or or replacementto support a of a

bodyweake part(s),ned or de [beginformed doublebody memb underline]er, are co vorered to u supportnder the Med a weakenedi-Cal program or a s deformed body member, [end double underline] are covered under the follows: Medi-Cal program as follows: [end underline] [begin underline](1) Except as specified in subsection (a)(2), and subject to Welfare and Institutions Code, Section 14131.10, which excludes coverage for podiatric and adult dental services (with exemptions),(1) E x[endce underline][beginpt as sp strikeout]Allecified prosthetic in su andb seorthoticcti applianceson (a)(2), necessary a forn thed restorationsubject of function to W or replacementelfare aof nbodyd parts as[end strikeout] [begin underline]when[end underline] prescribed by a licensed physician, [begin underline]a licensed[end underline] podiatrist[begin underline],[end underline] [begin strikeout]or[end strikeout]Institu [begin tiunderline]aons Co licensed[endde, S underline]ectio dentist[beginn 1413 strikeout],[end1.10, w strikeout]hich [beginexclud underline]ores ac licensedoverag non-physiciane for medicalpod practitioner[endiatric an dunderline], adu ltwithin the scope of their license, [begin strikeout]are covered when provided[end strikeout] [begin underline]and furnished [end underline]by [begin underline]a certified orthotist,[end underline] a [begin underline]certified[end underline] prosthetist, [begin underline]a certified[end underline] orthoptist[begin underline]/prosthetist,[end underline] [begin strikeout]or the[end strikeout] [begin underline]a[enddental underline] services licensed (w[beginith underline]physician, exemptio a nlicenseds), Adentist,ll p arost licensedh epodiatrist[endtic and underline] orth o[begintic strikeout]practitioner,appliances respectively[end necessa strikeout]ry fo [beginr underline]or a [begin double strikeout]licensed pharmacist or[end double strikeout] [begin double underline]certified [end double underline]pharmacy pursuant to subsection (a)(3) below[end underline]. [begin double underline]A certified orthotist, prosthetist and orthotist/prosthetist shall hold current certification from The American Board for Certification in Orthotics, Prosthetics and thPedorthicse rest or theo ratioBoard ofn Certification/Accreditation of function o orr their re successorplace organizations.[endment of b doubleody underline]parts [begin as strikeout]Awhen written pre prescriptionscribe signedd b yby aa physician, podiatrist, or dentist is always required. In addition, this written, signed prescription shall accompany any request for prior authorization, which is required under the following circumstances:[end strikeout]licensed physician, a licensed podiatrist, or a licensed dentist, or a licensed non-

physician medical practitioner, within the scope of their license, are covered when

provided and furnished by a certified orthotist, a certified prosthetist, a certified

orthotist/prosthetist, or the a licensed physician, a licensed dentist, a licensed podiatrist

practitioner, respectively or a licensed pharmacist or certified pharmacy pursuant to

subsection (a)(3) below. A certified orthotist, prosthetist and orthotist/prosthetist shall

hold current certification from The American Board for Certification in Orthotics,

Prosthetics and Pedorthics or the Board of Certification/Accreditation or their successor

organizations. A written prescription signed by a physician, podiatrist, or dentist is

always required. In addition, this written, signed prescription shall accompany any

request for prior authorization, which is required under the following circumstances:

(2) Stock(2) orthopedic Stock ort andhop estockdic a nconventionald stock conv shoes,entiona pursuantl shoes, ptou rsuSectionant to Section 51315.1(k)(3)(A), are covered when prescribed by a licensed physician or a licensed 51315.1(k)(3)(A), are covered when prescribed by a licensed physician or a licensed 12

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podiatrist[endpodiatrist and fudoublernished underline] by a certifie andd orth furnishedotist, a ce rtibyfied a certifiedprosthetist orthotist, or a certi afi ecertifiedd prosthetistorthotist/prost or hae tist.certified orthotist/prosthetist. (3) Orthotic and prosthetic appliances and services listed in the Medi-Cal provider manual, pursuant to (3) Orthotic and prosthetic appliances and services listed in the Medi-Cal Welfare and Institutions Code Section 14105.21, may be furnished and billed by [beginprovide doubler manu astrikeout]pharmacistsl, pursuant to Welfare a nor[endd Institu doubletions C ostrikeout]de Section pharmacies, 14105.21, ma wheny be the [beginfurnish doubleed and bstrikeout]pharmacistilled by pharmacists or or[endpharma doublecies, wh estrikeout]n the pha rpharmacymacist or p hisa rm[beginacy is double strikeout]licensed[end double strikeout] [begin double underline]certified licensed certified and enrolled in the Medi-Cal program as a provider. [end double underline]and enrolled in the Medi-Cal program as a provider. (b) A written prescription(b) A writt esignedn prescri byptio a nlicensed signed b yphysician, a licensed ap hlicensedysician, a podiatrist, licensed a licensed dentistpodiatrist, or aa licensedlicensed d non-physicianentist or a licens medicaled non-p hpractitioner,ysician medical and pr aclinicalctitione notes/[beginr, and doubleclinical underline]medicalnotes/medical profe ssioprofessionalnal records records[end that documen doublet the me underline]dical necessity that o f the document the medical necessity of the appliance or service, shall be maintained by appliance or service, shall be maintained by the provider in the patient’s medical record, the provider in the patient’s medical record, pursuant to Section 51476. A copy of thepu rsuawritten,nt to Ssignedection 5prescription1476. A cop yor o thef the electronic written, sig image/dataned prescripti transmissionon or the electron ic prescriptionimage/data tran in accordancesmission prescri withpti oHealthn in acco andrda Safetynce with Code, Health Section and Saf e11027ty Cod eand, documentation of medical necessity, as specified in subsection (c), shall Section 11027 and documentation of medical necessity, as specified in subsection (c), accompany the request for prior authorization, which is required under the followingshall acco circumstances:mpany the reque st[end for punderline] (1)rior authorization For, wh orthoticich is req appliancesuired under t h[begine strikeout](procedurefollowing circumstance codess: L0100-L4999)[end strikeout] each time the cumulative costs of purchase, replacement, and repair exceed $250.00 per [begin (1) For orthotic appliances (procedure codes L0100-L4999) each time the strikeout]beneficiary[end strikeout] [begin underline]patient[end underline], per provider,cumulativ pere co sts90-day of pu period.rchase, repThislac 90-dayement, aperiodnd repa ofir etimexcee [begind $250 .0underline]shall[end0 per beneficiary underline]patient, pe rbegin[begin provider, per strikeout]s[end 90-day period. T hstrikeout]is 90-day poneri theod o datef time of sh [beginall beg ins on the strikeout]payment of[end strikeout] the first [begin strikeout]claim [end date of payment of the first claim service after the close of the previous 90-day period of strikeout][begin underline]service [end underline]after the close of the previous 90-daytime du periodring wh ichof timea cla imduring service which, if an ay, [beginwas pa strikeout]claimid provided. [end strikeout][begin underline]service[end(2) For prosth underline],etic applianc ife sany, (proce wasdu r[begine codes strikeout]paid L5000-L8499) e[endach time the strikeout][begin underline]provided[end underline]. (2) For prosthetic appliances cumulative costs of purchase, replacement, and repair exceed $500.00 per beneficiary [begin strikeout](procedure codes L5000-L8499)[end underline] each time the cumulativepatient, per costsprovide ofr, purchase,per 90-day preplacement,eriod. This 90- andday prepaireriod o exceedf time sh a$500.00ll begins peron t h[begine strikeout]beneficiary[end strikeout] [begin underline]patient[end underline], per provider, per 90-day period. This 90-day13 period of time[begin underline] shall[end underline] begins on the DHCS-08-003 datedate of o f[begin payme nstrikeout]paymentt of the first claim se ofrv ice[end af testrikeout]ther the close of first[beginthe previou sstrikeout] 90-day pe claim[endriod of strikeout]time duri n[beging which underline]service a claim service, if a [endny, w underline]afteras paid provided .the close of the previous 90-day period of time during which a[begin strikeout] claim[end strikeout] [begin (3) For all orthotic and prosthetic appliances and services where there is no underline]service[end underline], if any, was [begin strikeout]paid[end strikeout] [beginallowa underline]provided[endble listed procedure code ounderline].r rate of rei m (3)burs eFormen [begint pursu astrikeout]allnt to Welfare [end and strikeout][beginInstitutions Cod eunderline]orthotic Section 14105.21(c) and un liprostheticsted, By Re appliancesport, and By andInvo iceservices prosth ewheretic there is no allowable listed procedure code or rate of reimbursement pursuant to and orthotic appliances. Welfare and Institutions Code Section 14105.21(c)[end underline] [begin strikeout]unlisted,(bc) The pri Byor a Report,uthoriza tioandn req Byu eInvoicest for ortho prosthetictic and p rostandh eorthotictic appli aappliances[endnces and strikeout].services sh ([beginall be auth strikeout]b[endorized when doc ustrikeout][beginmentation includ esunderline]c[end specify the type underline]) of appliance [begin underline]The prior authorization request for orthotic and prosthetic or service; and include the medical diagnosis, and prognosis;, and an explanation of the appliances and services shall be authorized when documentation includes[end underline]purpose th [beginat for th strikeout]specify[ende appliance or service; wstrikeout]ill serve and the su typebsta ofntia appliancetion that th e[begin criteri a underline]orspecified in suservice;[endbsection (c)(1) underline] through (5) [begin below strikeout]and, and the criteri include[enda specified in strikeout]Section the medical diagnosis, [begin underline]and[end underline] prognosis[begin 51315.1 for orthotic appliances and services, or the criteria specified in Section 51315.2 underline];[end underline][begin strikeout], and[end strikeout] an explanation of the purpose[beginfor prosthetic a pstrikeout]pliances a that[endnd services strikeout] are met. [begin underline]for [end underline]the appliance(1) [beginThe ap punderline]orliance or serv service;[endice is medically underline] necessary [begin for the strikeout]willrestoration of serve[end strikeout] [begin underline]and substantiation that the criteria specified in bodily functions, to support a weakened or deformed body member or for the subsection (c)(1) through (5) below, and the criteria specified in Section 51315.1 replacement of a body part and is reasonable and necessary to protect life, to prevent for orthotic appliances and services, or the criteria specified in Section 51315.2 for prostheticsignifican tappliances illness or dis andability services, or to all eareviat met.e sev e (1)re pa in.The appliance or service is medically (2) Th necessarye appliance foror stheerv icerestoration is essentia ofl t obodily perfo rmfunctions[begining activities of ddoubleaily livin underline],g to support a weakened or deformed body member[end double underline] or for the or instrumental activities of daily living. replacement of a body part and is reasonable and necessary to protect life, to prevent (3) Tsignificanthe applian cillnesse or se rvori cedisability, is consist oren tot alleviatewith thseveree patie npain.t’s prev (2)ious Theabili ties applianceand limita tioorn services, as the isy relaessentialte to ac tivto itiesperforming of daily li vingactivities or inst ofrum dailyenta lliving activities or of daily instrumental activities of daily living. (3) The appliance or service is consistent living, prior to the onset of disability or injury, or as appropriate to the patient’s with the patient’s previous abilities and limitations, as they relate to activities of dailychron livingological or instrumentaland developm eactivitiesntal age. of daily living, prior to the onset of disability or injury, or as appropriate to the patient’s chronological and developmental age.[end underline] 14

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[begin (4)underline](4) The appliance oTher serv applianceice is c onsist ore nservicet with the pisa tieconsistentnt’s overall m withedica l theco npatient’sdition. overall medical condition. (5) The appliance or service (5) T ishe theappli alowestnce or s ecostrvice isappliance the lowest co orst aserviceppliance o thatr serv icemeets that m theeets patient’sthe patien t’smedical medical nneed(s).eed(s). (d) Prior authorization of orthotic and prosthetic (d) Prior au appliancesthorization of o rthoandtic servicesand prosthe ticshall appli notance sbe an dgranted services shforall any of theno t following:be granted fo (1)r an yBackup of the follo appliances,wing: except when the primary appliance must be worn by the patient 24 hours per day or when (1) Backup appliances, except when the primary appliance must be worn by the appliance must be cleaned on a regular basis and cannot be the patient 24 hours per day or when the appliance must be cleaned on a regular basis dried overnight. (2) Appliances or services for the sole purpose of and cannot be dried overnight. cosmetic restoration in the absence of medical necessity as (2) Appliances or services for the sole purpose of cosmetic restoration in the described in subsection (c)(1). (3) Appliances or services for the soleabse purposence of med icofal nrestoringecessity as functionsdescribed in subeyondbsection (c)activities(1). of daily living or instrumental(3) Appliances oactivitiesr services fo ofr th dailye sole pliving,urpose osuchf resto riasng fathleticunctions b activities.eyond (4)activ Appliancesities of daily livi orng servicesor instrumen whental activ theities oappliancef daily living, suorch service as athletic is a ctiva ities. benefit (4) Athatpplia nisce sincluded or services as wh epartn the ofap ptheliance acute or serv inpatientice is a ben ehospitalfit that is stay andinclu theded adates part ofof tservicehe acute in occurspatient ho duringspital sta ythat and thstay.e date (5) of s Repairervice occu ofrs an applianceduring that sta wheny. the repair cost is equal to, or greater than, the cost (5)of purchasingRepair of an aap pnewliance appliance. when the repa (6)ir co sPurchaset is equal to, oorr g reareplacementter than, of an appliance when the patient’s existing appliance can be the cost of purchasing a new appliance. repaired at a cost less than the cost of purchasing a new (6) Purchase or replacement of an appliance when the patient’s existing appliance, unless the existing appliance does not meet the appliance can be repaired at a cost less than the cost of purchasing a new appliance, patient’s medical need(s), as documented by the licensed unless the existing appliance does not meet the patient’s medical need(s), as physician, licensed podiatrist, licensed dentist or licensed non-physiciandocumented by th emedical licensed ppractitioner.[endhysician, licensed pod iatunderline]rist, licensed dentist or licensed non-physician medical practitioner.

15

DHCS-08-003

[begin underline](7)(7) Fitting, measu Fitting,ring, trai measuring,ning or delivery training of the ap porlia deliverynce separat ofe thefrom the applianceprior autho riseparatezation of th frome app litheance p itse riorlf. authorization of the appliance itself.[end(c) Aunderline]uthorization [beginfor repairs shstrikeout](c)all not be gran Authorizationted when the co stfor o f repairsrepairs is shall not be granted when the cost of repairs is e qual to, or more than, the equal to, or more than, the cost of purchasing a new appliance. cost of purchasing a new appliance. (d) Stock conventional and stock (d) Stock conventional and stock orthopedic shoes are covered when orthopedic shoes are covered when p rovided by a prosthetist or orthotistprovided onby athe prost prescriptionhetist or ortho oftist ao nphysician the prescri portio npodiatrist of a physici andan o rw p ohendiatri stat a nd leastwhe none at lea ofst theone shoesof the sh willoes bewill battachede attached to to a pprosthesisrosthesis or braor cebrace.. (1)

Modification(1) Mo dofific stockation o conventionalf stock conventio orna lorthopedic or orthopedic shoesshoes is is co coveredvered whe whenn m edically indicated. (2) Custom-made orthopedic shoes may be medically indicated. authorized when there is a clearly e stablished medical need that cannot (2) Custom-made orthopedic shoes may be authorized when there is a clearly be satisfied by the modification of stock c onventional or stock orthopedicestablished mshoes.edical n (e)eed th aThet can onlynot b eprovider satisfied b typesy the mod authorizedification of sttoo ckfurnish andcon billven tioforna prostheticl or stock ortho andped oic rthoticshoes. appliances are orthotists, as defined in Sections(e) T h51101e only p rovandide 51225,r types a uprosthetists,thorized to furnish a s a definednd bill for inprost Sectionshetic and 51103 and 51230, physicians, as defined in Section 51053, d entists, as orthotic appliances are orthotists, as defined in Sections 51101 and 51225, prosthetists, defined in Sections 51027 and 51223, and podiatrists, as defined in as defined in Sections 51103 and 51230, physicians, as defined in Section 51053, Section 5 1075, acting within the scope of their practice. Prosthetic and orthoticdentists ,appliance as defined i ncodes Sectio nas re51 0listed27 and in 51 the223 , Medi-Caland podiatri providersts, as def inmanual,ed in Sec tion pursuant51075, actin to gWelfare within the and scop Institutionse of their pract Codeice. Prost s hectionetic an d14105.21. orthotic app liAppliancesance codes listedare liste in dthe in t hprovidere Medi-Cal manual provider andmanu designatedal, pursuant to by We doublelfare and aIn sterisksstitutions C (**)ode may be furnished and billed by pharmacists.[end strikeout] ([begin section 14105.21. Appliances listed in the provider manual and designated by double strikeout]f [end strikeout][begin underline]e[end underline]) asterisks (**) may be furnished and billed by pharmacists. Reimbursement for [begin underline]orthotic and[end underline] prosthetic[begin (f e) Reim bstrikeout]andursement for ort orthotic[endhotic and prost hstrikeout]etic and orth appliancesotic applianc e[begins and underline]andservices shall b eservices subject to shallthe fo llbeow ingsubject: to the following[end underline]:

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(1) Shall (1) not Sh aexceedll not exce 80ed percent80 percen oft o fthe the lowestlowest m maximumaximum allo wallowanceance for for

CaliforniaCalifornia eestablishedstablished by tbyhe ftheede ralfederal Medicar Medicaree program foprogramr the sam efor or thesimil asamer or similar appliances [begin underline]or services[end underline]. (2) appliances or services. When there is no comparable Medicare-reimbursed appliance[begin (2) When there is no comparable Medicare-reimbursed appliance or service , underline] or service[end underline], reimbursement shall not exceed an amountreimburse thatme nist sthehall n[beginot exce strikeout]ed an amou nlessert that is [endthe le ssestrikeout][beginr lowest of: underline]lowest (A) The usu [endal cha underline]of:rges made to th e (A) gener aThel pub usuallic for th chargese provisio nmade of the to the generalsame o rpublic similar aforpp litheance provisions or services of, other same or similar appliances[begin underline] or services[end underline], or (B) The maximum (B) The maximum reimbursement rates listed in the Medi-Cal provider reimbursement rates listed in the Medi-Cal provider manual. (3) manual. Maximum reimbursement rates are for the [begin strikeout]basic [end strikeout][begin (3) Maxim uunderline]basem reimbursement rat[endes aunderline]appliancesre for the basic base appli aandnces for aanynd f or componentany compon epartsnt parts that tha tmay may bbee a addeddded to thtoe sethe[begin basic bas strikeout]se[ende appliances. When strikeout]applicable [begin, billings strikeout]basicshall include both t[endhe ba sicstrikeout][begin base appliance a underline]basend the component p[endarts underline]appliances.necessary to complete th eWhen prescri applicable,bed appliance billings. shall include both the [begin strikeout]basic [end strikeout][begin underline]base [end (4) Orthotic and prosthetic appliances and services that do not require prior underline]appliance and the component parts necessary to complete the prescribedauthorizatio nappliance. shall meet th [begine requirem underline](4)ents under Sectio Orthoticn 51315(c) and. prosthetic appliances (4) andNo seservicesparate rei thatmbu rsedom notent frequireor fitting, mprioreasu authorizationring, or delivery o shallf meet theap requirementspliances shall be undermade. Section 51315(c).[end underline] [begin strikeout](4) No separate reimbursement for fitting, measuring, or delivery of appliances shall be made.[end strikeout]

NOTE:NOT AuthorityE: A cited:utho [beginrity underline]Sectioncited: Sectio 20,n Health 20, andHe Safetyalth Code;and and[endSafety underline] Code Sections; and [beginSectio underline]10725,[endns 10725, underline] [begin strikeout]14043.75,[end strikeout] 14105[begin strikeout],[end strikeout][begin underline] and[end underline] 14124.5,[begin strikeout]1404 14132,3.75 ,14132.76, 14105 14132.765, and 1 and41 14133,[end24.5, 1 4strikeout]132, 1Welfare413 2and.7 Institutions6, 1413 Code[begin2.765 a strikeout];nd 141 Chapter33, W 328,el fStatutesare a ofn d 1982;Institu Chaptertio 1381,ns Co Statutesde; ofC 1990;hap andter Section 328, 78, S taChaptertute 146,s o Statutesf 1982 of; 1999[endChapte strikeout].r 138 Reference:1, Statu Sectionstes o f[begin 199 0; and strikeout]14053,Section 7 [end8, Cha strikeout][beginpter 14 underline]14103.7,6, Statutes 14105,[endof 1999 underline]. Refe ren14105.21,ce: S14132[beginections strikeout](k), 14053, 14132.76,14103 .7[end, strikeout][begin14105, 1 underline]14132.10,4105.21, 141 [end32 (k)underline]14132.765,, 14132.76, 14133[begin 14132.1 underline],[end0, 14132 .7underline]65, 1 [begin4133 strikeout]and[end, and 1413 strikeout]3.1(c) , 14133.1[begin14133.3 strikeout](c)[end and 14133 strikeout][begin.9, Welfa reunderline], and I14133.3nstitu andtio 14133.9[endns Code underline],. Welfare and Institutions Code.

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(3) Adopt Section 51315.1 as follows:

[beginSectio nunderline]Section 51315.1. Require m51315.1.ents App liRequirementscable to the Prio Applicabler Authorizatio ton theof Orth Priorotic

AuthorizationAppliances an dof S Orthoticervices. Appliances and Services.[end underline]

[begin Orthunderline]Orthoticotic appliances and se appliancesrvices shall be aandutho riserviceszed under th shalle Med ibe-Cal program authorizedwhen the sup punderorting d othecum Medi-Calentation and aprogramll other req uwheniremen tsthe spe supportingcified in Sectio n documentation51315 and in this s eandction allare metother. requirements specified in Section

51315For and pu rpoin sthises o f sectionthis sectio nare, me met.dical co [beginnditions cite doubled with ea chunderline]For appliance/service purposesor group of aofpp lithisance section,s/services shmedicalall not be cconditionsonstrued to rep citedresen twith an ex heachaustiv e list of appliance/servicemedical conditions app ropor rigroupate to e aofch appliances/servicesappliance/service or group oshallf not be construed to represent an exhaustive list of medical conditions appliances/services. Likewise, such medical conditions may not be appropriate for appropriate to each appliance/service or group of authorization of the requested appliance/service if medical necessity for the specific appliances/services. Likewise, such medical conditions may not appliance/service is not documented. be appropriate for authorization of the requested appliance/service (a) Shoe Suppli eifs medicalfor Diabetics necessity shall includ efor sh othees a nspecificd their fittin g(s) , appliance/servicemodifications and inse rtsis; anotnd sh documented.all be authorized w[endhen t hdoublee patient hunderline] (a)as a diagnosis of Shoediabete Suppliess mellitus a nford req Diabeticsuires one or shallmore o includef the follow shoesing shoe (s)and, sh otheire fitting(s), modificationsmodification(s) o rand shoe inserts;insert(s) to andacco mshallmoda tebe fo rauthorized or prevent foo twhen ulceratio then an d patientrelated fo hasot co nad itiodiagnosisns: of diabetes mellitus and requires one or more (1) of theFor pfollowingrefabricated shoe(s), shoe(s) or shshoeoe ins modification(s)ert(s), or modificatio nor(s) shoeto insert(s)prefabrica tetod saccommodatehoe(s) or shoe inse forrt(s) ,or the prevent patient has foot one oulcerationr more of the andfollow ingrelated foot conditions: (1) For prefabricated shoe(s) or shoe insert(s), medical conditions, appropriate to the requested procedure code(s): or modification(s) to prefabricated shoe(s) or shoe insert(s), the (A) Foot ulcer(s). patient has one or more of the following medical conditions, (B) Previous amputation of the contralateral foot, or part of either foot, due to appropriate to the requested procedure code(s): (A) Foot microvascular disease secondary to diabetes. ulcer(s). (B) Previous amputation of the contralateral foot, or part (C) of Hi eitherstory o f foot,foot u lceraduetio ton(s) microvascular of either foot. disease secondary to 18 diabetes. (C) History of foot ulceration(s) of either foot. [end underline] DHCS-08-003

[begin underline](D)(D) Peripheral ne Peripheraluropathy with e neuropathyvidence of callo uwiths form evidenceation of eithe ofr fo callousot. formation (E) of Defeitherormity foot. of eith (E)er foot, suDeformitych as rocke rof bo teithertom foo tfoot, or Cha suchrcot fo oast. rocker bottom (Ffoot) Comor Charcotpromised vfoot.ascular (F) diseas Compromisede in either foot. vascular disease in either foot.(G) P (G)ositive mPositiveonofilame nmonofilamentt examination indicat examinationing diabetic neu ropindicatingathy. diabetic (2) neuropathy. For custom - (2)made sh Foroe(s) custom-made or shoe insert(s), oshoe(s)r modificat ioorn (s)shoe to cu stom- insert(s), or modification(s) to custom- made shoe(s) or shoe made shoe(s) or shoe insert(s), the patient has one or more of the listed medical insert(s), the patient has one or more of the listed medical conditions conditions in subsection (a)(1), and one or more of the following, appropriate to the in subsection (a)(1), and one or more of the following, appropriate to requested procedure code(s): the requested procedure code(s): (A) Neurological manifestation(s). (A) Neurolog (B)ical m aPeripheralnifestation(s). circulatory disorder(s). (C) Treatment (B) Poreri ppreventionheral circulato ryof d otherisorder( s)foot. conditions secondary to diabetes (C) Trea mellitus.tment or pre (b)vention Compression of other foot conditio Burnns se coGarmentsndary to diab shalletes be authorizedmellitus. when the patient requires a custom-fabricated garment to provide (b) physician-orderedCompression Burn Ga compressionrments shall be au totho rifacilitatezed when t hthee pa healingtient of burnreq utissueires a cu orsto ma -similarfabricated injury, garmen t orto ptorov preventide physici ascarring.n-ordered c o (c)mpression Gradient to

Compressionfacilitate the he aStockingsling of burn tissu shalle or includea similar in custom-madejury, or to prevent sc stockingsarring. and garter belts and shall be authorized when one or both of the (c) Gradient Compression Stockings shall include custom-made stockings following criteria is met, appropriate to the requested procedure and garter belts and shall be authorized when one or both of the following criteria is code(s): (1) For custom-made compression stockings, the patient met, appropriate to the requested procedure code(s): has a medical condition that results in symptomatic venous (1) For custom-made compression stockings, the patient has a medical insufficiency or lymphedema in one or both lower extremities that requiresconditio nthe that useresults of in a sy custom-mademptomatic venous icompressionnsufficiency or lym stocking(s).phedema in one (2)or both Forlow garterer extrem belts,ities th theat re qpatientuires the uhasse o fan a cu existingstom-mad eor co authorizedmpression stocking (s). compression (2) For stocking garter belts, or th eresidual patient has limb an eshrinkerxisting or a uandthori zrequiresed compressi theon use of asto gartercking or beltresidu toal liholdmb sh rithenke rcompression and requires the ustockingse of a garter or b eshrinkerlt to hold th ine place.[endcompression underline] stocking or shrinker in place. 19

DHCS-08-003

[begin (dunderline](d)) Spinal Orthose sSpinal shall includ Orthosese all of the shallfollowing include: all of the following: (1) Cr (1)anial O Cranialrthoses (he Orthoseslmets) shall (helmets)be authorized shallwhen craben ialauthorized molding is whenrequir ecraniald in child renmolding two yea rsis o requiredf age and y oinun gchildrener with plag twoloce pyearshaly or of age and youngercraniosyn owithstosis. plaglocephaly For purposes of cr oran ialcraniosynostosis. molding in children, th eFor app lipurposesance shall b eof cranialmanufa cmoldingtured by a Feind children,eral Drug Ad theministrat applianceion-approv shalled labo berato rmanufacturedy. by a Federal (2) Cerv Drugical Administration-approvedand Multiple Post Collar Orthoses (colaboratory.llars) shall b e (2) autho riCervicalzed and Multiple Post Collar Orthoses (collars) shall be authorized when the patient has a medical condition(s) or a medical need(s) that requires support when the patient has a medical condition(s) or a medical need(s) to the cervical spine to decrease pain, to increase functional capacity, or to prevent or that requires support to the cervical spine to decrease pain, to ameliorate further injury, such as one of the following, appropriate to the requested increase functional capacity, or to prevent or ameliorate further injury,proced usuchre cod eas(s) :one of the following, appropriate to the requested procedure (A) W code(s):hiplash or o th (A)er inju ryWhiplash to the neck. or other injury to the neck. (B) Post-surgical (B) Post- surepairrgical repofa air ocervicalf a cervical fracture. fracture. (C) Post-surgical treatment (C) Post-su ofrg icala ligamentis treatment of a injuryligamen ortis intorticollis.jury or torticoll (D)is. Treatment in place (D) T ofrea tmensurgicalt in plac interventione of surgical inte forrve natio cervicaln for a cerv fractureical fracture or or ligamentis injury.ligame n (E)tis injury Any. related medical condition that requires support to the cervical(E) An yspine. related m (3)edical Thoraciccondition tha Orthosest requires sup (ribport tbelts)o the ce rvshallical sp beine . authorized when the patient has a medical condition that requires (3) Thoracic Orthoses (rib belts) shall be authorized when the patient has a support to the thoracic area to decrease pain, to increase functional medical condition that requires support to the thoracic area to decrease pain, to capacity, or to prevent or ameliorate further injury, such as for increase functional capacity, or to prevent or ameliorate further injury, such as for fractured or torn intercostal ligaments. (4) Thoracic Orthoses fractured ribs or torn intercostal ligaments. (anterior-posterior-lateral-rotary control) shall be authorized when both (4)of T thehoracic following Orthoses criteria(anterior-p areoste rimet:or-late ral (A)-rotary The control) patient shall hasbe one of theau thfollowingorized whe nmedical both of the conditions: following criteri 1.a are meA t:slipped or herniated disk.[end (A) Tunderline]he patient has one of the following medical conditions: 1. A slipped or herniated disk. 20

DHCS-08-003

[begin2. underline]2. Osteoporosis Osteoporosisof the thoracic area. of the thoracic area. 3. A vertebral3. A vfracture,ertebral fract uwithre, with or o r withoutwithout surg surgery.ery. 4. A related medical4. A condition related medic aofl co thendition thoracic of the thoracic area. area (B). The patient requires (B) Tonehe pa ortien tmore require sof theone o followingr more of the fotreatmentsllowing treatme ntots todecrease decrease pain,pain, toto in crincreaseease functio nfunctionalal capacity, or capacity,to prevent or aorme litoorat prevente further inju orry , ameliorateappropriate to tfurtherhe requeste injury,d proce dappropriateure code(s): to the requested procedure1. Trun kcode(s): support. 1. Trunk support. 2. Reduction of load on the2. intervertebral Reduction of loa discs.d on the in 3.terve rtebReductionral discs. of gross trunk motion3. in theRed usagittalction of gross plane. trunk mo (5)tion in tThoraciche sagittal plan Orthosese. (triplanar control (5) T h–o racicmodular Orthose ssegmented (triplanar control spinal – m systemodular seg m[prefabricated])ented spinal system shall[prefa bberica teauthorizedd]) shall be au thwhenorized w bothhen bo tofh o fthe the fofollowingllowing criteri criteriaa are met: are met: (A) (A)The Th epatient patient h ahass one oneor mo reor o fmore the follo ofwing the med followingical condition s:medical conditions:1. Post n 1.eck or Postback su neckrgery. or back surgery. 2. Post laminectomy.2. Post lamine 3.ctom yA. vertebral fracture. 4. A related medical condition3. A v eofrteb theral f ractthoracicure. area. (B) The patient requires one or both4. Aof rela theted mfollowingedical cond itiontreatments of the thoracic to a redecreasea. pain, to increase (B) Tfunctionalhe patient requ capacity,ires one or boroth to of thprevente following ortrea amelioratetments to decre afurtherse injury:pain, to in 1.crease Reduction functional cap aofcity gross, or to pre trunkvent or motionameliorate infurt hthreeer injury planes:

(sagittal,1. coronalReduction andof gross transverse). trunk motion in th 2.ree plan Spinales (sag ittasupportl, coronal aandnd stabilizationtransverse). or immobilization of the spine. (6) Thoracic

Orthoses2. Sp ina(triplanarl support an dcontrol stabilizatio –n rigidor imm oframe)bilization oshallf the sp beine. authorized when (6) theThoracic patient Orthose hass (trip alan medicalar control condition– rigid fram thate) sh arequiresll be authoriz eoned or morewhen thofe ptheatien tfollowing has a medical [end condition underline] that requires one or more of the following

21

DHCS-08-003

[begintreatme nunderline]ts to decrease ptreatmentsain, to increase ftoun ctdecreaseional capacity ,pain, or to p retove nincreaset or ameliora te functionalfurther injury, capacity,appropriate to orthe toreq upreventested proce ordu reameliorate code(s): further injury, appropriate (A) Red touctio then o f requestedload on the inte rvprocedureertebral discs. code(s): (A) Reduction (B) Red ofu loadction o fon gross the tru nintervertebralk motion in three plan discs.es (sag itta(B)l, co Reductionronal and oftran grosssverse). trunk motion in three planes (sagittal, coronal and transverse). (C) Hyperexte (C)nsion Hyperextensionof the thoracic, lumbar a ofnd stheacra lthoracic, areas of the blumbarack. and sacral (7) Tareashoracic Oofrth otheses (triback.planar co(7)ntrol Thoracic – rigid Orthoses plastic shell) sh(triplanarall be controlauthorize d– wrigidhen th eplastic patient h ashell)s one o fshall the foll obewin gauthorized medical conditi owhenns that req theuir es patientreduction hasof gross one trun ofk m theotion infollowing three plane smedical (sagittal, co conditionsronal and transv thaterse) when requiresspinal supp reductionort and immob ilofiza tiogrossn are re trunkquired tomotion decrease inpa inthree, to incr eplanesase functio nal (sagittal,capacity, or coronalto prevent o andr ame litransverse)orate further injury when: spinal support and immobilization (A) Post neck are surg erequiredry. to decrease pain, to increase functional (B) Po capacity,st back surge ryor (lam toine preventctomy or v eorrteb ameliorateral fracture). further injury: (A) (C )Post A rela teneckd med icsurgery.al condition (B)of the Post neck o rback back. surgery (laminectomy or vertebral(e) Thoracic fracture). Orthoses (sa (C)gitta Al o rrelated sagittal-co ronmedicalal control) condition shall be auth oofriz ethed neckwhen torhe pback.atient h a(e)s a m Thoracicedical condition Orthoses that require s(sagittal one or more or of the following sagittal-coronaltreatments to decrease control) pain, to in crshallease f ubenction authorizedal capacity, or towhen preven thet or a mpatienteliorate hasfurthe ar injmedicalury, approp conditionriate to the req thatueste drequires procedure coonede(s) or: more of the following (1) Red treatmentsuction of load oton thdecreasee intervertebral pain, discs. to increase functional capacity, (2) Red oru ctioto nprevent of gross tru ornk moamelioratetion in the sag ittafurtherl plane. injury, appropriate (3) Redu ctioto nthe of g rossrequested trunk motio nprocedure in the sagittal acode(s):nd coronal p la(1)nes.

Reduction(f) Cervof loadical-Th oonracic the-Lum intervertebralbar-Sacral Orthoses discs.shall includ (2)e a Reductionll of the offo llgrossowing: trunk motion in the sagittal plane. (3) Reduction of gross trunk motion in the sagittal and coronal planes. (f) Cervical-Thoracic-Lumbar-Sacral22 Orthoses shall include all of the following:[end underline] DHCS-08-003

[begin (1) underline](1) Sacroiliac Orthose Sacroiliacs shall be autho Orthosesrized when the shall patien t behas aauthorized medical whenconditio then tha tpatient requires o nhase or mao remedical of the follo conditionwing treatmen tsthat to d erequirescrease pain, oneto or moreincrea seof fu thenctio nfollowingal capacity, o rtreatments to prevent or am toelio decreaserate further inju pain,ry: to increase (A) S functionalupport to the p ecapacity,lvic-sacral area or. to prevent or ameliorate further (B) injury: Redu ctio(A)n oSupportf gross trunk to mo thetion o fpelvic-sacral the sacroiliac joint . area. (B) Reduction (C) Pendulou sof a bgrossdomen s utrunkpport, sumotionch as in se ofve rethe pto sis.sacroiliac joint. (C) Pendulous (2) Lumbar abdomenOrthoses shall support,be authorize dsuch when tashe p aintie nseveret has a m eptosis.dical (2) Lumbarcondition t hOrthosesat requires on eshall or mo rebe of authorizedthe following trea whentments to the decr epatientase pain, tohas a medicalincrease fu conditionnctional capacity that, or torequires prevent or aonemelio ratore morefurther inju ofry the, app rofollowingpriate to the treatmentsrequested proce todu redecrease code(s): pain, to increase functional capacity, or to prevent(A) Suppo rtor to tamelioratehe lumbar area. further injury, appropriate to the requested (B) Red procedureuction of load code(s):on the interv e(A)rteb ralSupport discs. to the lumbar area. (B) (C ) Reduction Reduction of ofgross load trun kon mo tiothen in intervertebralthe sagittal plane. discs. (C) Reduction (D) Pendulou sof a bgrossdomen s utrunkpport, sumotionch as in se inve rethe pto sagittalsis. plane. (D) Pendulous (3) Lumbar -abdomenSacral Orthos esupport,s shall be au thsuchorized aswhe inn t hseveree patient h aptosis.s a (3) Lumbar-Sacralmedical condition tha tOrthoses requires one oshallr more obef th eauthorized following treatme whennts to d theecrea patientse haspain, a to medicalincrease fun conditionctional capacity that, or to requires prevent or a moneeliorat ore fumorerther inju ofry , the followingappropriate ttreatmentso the requested ptoroce decreasedure code(s) : pain, to increase functional capacity, (A) S uorpp otort toprevent the lumba ror-sa crameliorateal areas. further injury, appropriate (B) Red touctio then o f requestedload on the inte rvprocedureertebral discs. code(s): (A) Support to (C the) Redlumbar-sacraluction of gross tru nareas.k motion in(B) the Reductionsagittal or coro nofal p loadlane. on the intervertebral (D) Flexion of th discs.e lumbar s(C)pine .Reduction of gross trunk motion in the sagittal(E) Pen dorulou coronals abdomen plane. support, su(D)ch a Flexions in severe pofto sis.the lumbar spine. (E) Pendulous abdomen support, such as in severe 23 ptosis.[end underline] DHCS-08-003

[begin (4) underline](4) Anterior-Posterior -Anterior-Posterior-LateralLateral Control Orthoses shall be auth oControlrized when the Orthosespatient has a shall medical be con authorizeddition that requir ewhens suppo rtthe and patientmaximum ehasxterna al rmedicalestriction conditionof anterior, p thatosteri orequiresr and lateral motsupportion to th eand cervical, maximum thoracic, lum externalbar and sacr al spine restrictionto decrease p ofain , anterior,to increase fu posteriornctional capa cityand, o r lateralto preven tmotion or amelio rattoe thefurthe r cervical,injury. thoracic, lumbar and sacral spine to decrease pain, to increase(g) Halo functional Procedures capacity,shall include th ore b atose preventappliance a nord a amelioratedditions, and sh all furtherbe autho injury.rized whe n (g) one or Haloboth of tProcedureshe following criteri shalla is me tinclude, appropria tethe to t hbasee appliancerequested proce anddure additions, code(s): and shall be authorized when one or both(1) ofFor the the bfollowingase applianc ecriteria, the patie nist met,has a appropriatemedical condition totha tthe requ ires requestedsupport and m procedureaximum externa code(s):l restriction o f (1) anterio r,For poste therior abasend late ralappliance, motion to the thecerv patientical, thoracic, has lum aba medicalr and sacral conditionspine to decre athatse pa in,requires to increase support functional and maximumcapacity, or to external prevent or ame restrictionliorate furthe ofr in juryanterior,. posterior and lateral motion (2) toFor the the cervical,addition(s), a llthoracic, of the follow inglumbar are met: and sacral spine to decrease (A) pain,The pa tieton t’sincrease medical co nfunctionaldition requires thcapacity,e specific fu norctio ton fo preventr which the ora damelioratedition(s) was de sigfurtherned. injury. (2) For the addition(s), all of the following(B) The ad aredition (s)met: is (A)required Theby the patient’spatient to im pmedicalrove the fun cticonditiononality of the requireshalo proce dtheure, wspecificithout which function the patient’s for me dwhichical nee dthe(s) w oaddition(s)uld not be met. was designed. (C) The patie (B)nt has a nThe existing addition(s) or authorized isha lrequiredo procedure thbyat isthe patient to improvecompatible thewith tfunctionalityhe addition(s). of the halo procedure, without which the patient’s(h) Additio nmedicals to Spinal Ortneed(s)hoses sh awouldll be auth notorize dbe wh emet.n all o f (C)the follo wTheing patientcriteria a rehas met: an existing or authorized halo procedure that is compatible (1) T hwithe patie thent’s medaddition(s).ical condition req (h)uires thAdditionse specific fun toctio nSpinal for which the

Orthosesaddition(s) w shallas desig bened .authorized when all of the following criteria are met: (1) The patient’s medical condition requires the specific function for which the 24addition(s) was designed.[end underline] DHCS-08-003

[begin (2)underline](2) The addition(s) The is addition(s)required by the ispa tirequiredent to improv bye tthehe fu patientnctionality toof the improvespinal ort htheosis ,functionality without which th eof p athetien t’sspinal medical orthosis, need(s) wo withoutuld not be whichmet. the patient’s (3) Th medicale patient ha need(s)s an existing would or auth notorize dbe sp imet.nal orth (3)osis th aThet is c opatientmpatible has anw ithexisting the addition or (s)authorized. spinal orthosis that is compatible with the addition(s). (i) Orth (i)otic De Orthoticvices – DevicesScoliosis P roce– Scoliosisdures shall incluProceduresde all of the shallfollowing : include all of the following: (1) Cervical-Thoracic-Lumbar-Sacral (1) Cervical-Thoracic-Lumbar-Sacral Orthoses Orthoses (A) Shall include all of the following: 1. The Infant (A) Shall include all of the following: Immobilizer shall be authorized only for children under one year of 1. The Infant Immobilizer shall be authorized only for children under one year age for stabilization of the cervical spine, upper thoracic spine and of age for stabilization of the cervical spine, upper thoracic spine and airway. The infant airway. The infant immobilizer shall not be authorized for use in restrainingimmobilizer sha infantsll not b eduring authoriz esurgicald for use in or rest radiologicalraining infants dprocedures.uring surgical or 2. Therad ioloTensiongical proce Baseddures. Scoliosis Orthosis shall be authorized only for a child 2.diagnosed The Tension withBase dadolescent Scoliosis Orth oidiopathicsis shall be a uscoliosisthorized on lyor fo ra a similarchild deformitydiagnosed worith disease. adolescent 3.idiopa tAdditionshic scoliosis otor a similar deformity or disease.

Cervical-Thoracic-Lumbar-Sacral 3. Additions to Cervical-Thoracic-Lu mOrthosesbar-Sacral Orth or oScoliosisses or Scoli oOrthosessis shallOrth obeses authorized shall be autho riwhenzed wh ealln a llof o f thethe fofollowingllowing crite ricriteriaa are me t:are met: a.

The patient’sa. Th emedical patient’s medconditionical cond itiorequiresn requires the the sspecificpecific fun ctiofunctionn for wh ichfor th e which the addition(s) was designed. b. The addition(s) is addition(s) was designed. required by the patient to improve the functionality of the b. The addition(s) is required by the patient to improve the functionality of the cervical-thoracic-lumbar-sacral orthosis or scoliosis orthosis, cervical-thoracic-lumbar-sacral orthosis or scoliosis orthosis, without which the patient’s without which the patient’s medical need(s) would not be met. c. medical need(s) would not be met. The patient has an existing or authorized cervical-thoracic-lumbar-sacralc. The patient has an existing or a uorthosisthorized ce orrvical scoliosis-thoracic-lum orthosisbar-sacr athatl is compatibleorthosis or sc witholiosis theorth oaddition(s).sis that is comp a (B)tible w ithShall the a dbeditio authorizedn(s). when both (B)of Sthehall followingbe authorize dcriteria when bo thare of thmet:[ende following criunderline]teria are met:

25

DHCS-08-003

[begin underline]1.1. The patie Thent ha patients a diagn hasosis oaf scodiagnosisliosis or o ofthe scoliosisr curvature oror insothertabili ty of curvaturethe spine. or instability of the spine. 2. The appliance is appropriate for the patient’s degree and type of scoliosis, or spinal curvature or instability 2. The appliance is appropriate for the patient’s degree and type of scoliosis, in which the degree of spinal curvature or instability, any lower extremity or spinal curvature or instability in which the degree of spinal curvature or instability, any length discrepancy, and goals of treatment are considered. (2) Thoracic-Lumbar-Sacrallower extremity length discre pOrthosesancy, and g (Lowoals o fProfile) treatmen tshall are c oincludensidered .the base appliance (2) Th andoracic additions,-Lumbar-Sa crandal Orth shallose sbe (Lo authorizedw Profile) sha whenll inclu donee the or ba bothse of the followingappliance criteriaand add itionis met,s, an dappropriate shall be autho toriz ethed w hrequesteden one or bo procedureth of the follo wcode(s):ing

(A)criteri Fora is mtheet, abasepprop riappliance,ate to the req bothueste dof p rtheoce dfollowingure code(s) criteria: are met: 1. The patient has a diagnosis of scoliosis or other curvature or instability of (A) For the base appliance, both of the following criteria are met: the spine. 2. The base appliance is appropriate for the patient’s degree and type1. Tofh escoliosis patient ha sor a dspinaliagnosis curvature of scoliosis or or instabilityother curva tuinre which or insta thebility degree of of spinalthe sp curvatureine. or instability, any lower extremity length discrepancy, and goals of2. treatment The base a pareplian considered.ce is appro (B)priate foForr th ethe pati addition(s),ent’s degree a nalld tyofp ethe of followingscoliosis ocriteriar spinal cuarerva met:ture o r 1. insta bTheility inpatient which th hase de garee diagnosis of spinal cu ofrv ascoliosisture or or other curvature or instability of the spine. 2. The patient’s medical instability, any lower extremity length discrepancy, and goals of treatment are condition requires the specific function for which the addition(s) was considered. designed. 3. The addition(s) is required by the patient to improve the functionality (B) Forof thethe athoracic-lumbar-sacralddition(s), all of the following orthosis, criteria are without met: which the patient’s1. medicalThe patien need(s)t has a diag wouldnosis onotf sco beliosis met.[end or other curv underline]ature or instability of

the spine.

2. The patient’s medical condition requires the specific function for which the

addition(s) was designed.

3. The addition(s) is required by the patient to improve the functionality of the

thoracic-lumbar-sacral orthosis, without which the patient’s medical need(s) would not

be met.

26

DHCS-08-003

[begin4. underline]4. The patient h aThes an epatientxisting or auhasthori zaned thexistingoracic-lum borar- saauthorizedcral orthosis thoracic-lumbar-sacralthat is compatible with the additio orthosisn(s). that is compatible with the addition(s). (3) Othe (3)r Scolio sisOther Proced Scoliosisures (body jacke Procedurests) shall be auth (bodyoriz ed jackets)when both shallof the befollo wauthorizeding criteria are mewhent: both of the following criteria are met: (A)(A) Th eThe patie npatientt has a diag hasnosis a o f diagnosisscoliosis or oth ofer curv scoliosisature or ins ortab iotherlity of curvaturethe spine. or instability of the spine. (B) The appliance is appropriate (B) The aforppli athence patient’sis appropria degreete for the p aandtient’s typedegree of an dscoliosis type of scoli oorsis spinalor spin acurvaturel curvature or inorsta binstabilityility in which th ine dwhichegree of sptheina l degreecurvature oofr inst spinalability, a ny curvaturelower extrem ityor le instability,ngth discrepan cyany, an dlower goals o fextremity treatment are lengthconsidered . discrepancy, (j) Orthotic Deandvices goals – Lo wofe r treatmentLimb (Extremity are) sha considered.ll include all of the (j)followin g: Orthotic (1) DevicesHip Orthose s– Lower– Flexible Limb shall b e(Extremity) authorized whe nshall both o finclude the followi nallg of thecrite following:ria are met: (1) Hip Orthoses – Flexible shall be authorized (A) The when patient hbothas one ofof ththee fo llfollowingowing medical criteria conditions: are met: (A) The patient1. Con hasgen itaonel hip dofisl othecation following or medical in infants conditions: and children. 1. Congenital2. Post tohiptal h dislocationip replacement w orhen hippost -dysplasiaoperative hip s tainb ilinfantsization is and children.necessary to 2. preve Postnt dislo catotaltion o hipr to fa replacementcilitate healing of a whenfracture. post-operative3. An injured ohipr prev stabilizationiously dislocated hisip necessarythat requires reh toabil itapreventtion as an dislocationalternative to su orrg etory. facilitate healing of a fracture. 3. An injured4. orA relat previouslyed medical co dislocatedndition that req uhipires cothatntrol requiresand stabiliza tion of the rehabilitationhip(s). as an alternative to surgery. 4. A related medical (B) conditionThe patient req thatuires requires one of the controlfollowing trea andtme nstabilizationts to decrease pa inof, to theincre hip(s).ase functi (B)onal ca pTheacity, opatientr to preve nrequirest or ameliorat onee furth ofer injuthery, followingappropriate to the treatmentsrequested proce todu decreasere code(s): pain, to increase functional capacity, or to prevent1. Abductio orn c oamelioratentrol, with or wit hfurtherout ambu latinjury,ion. appropriate to the requested procedure code(s): 27 1. Abduction control, with or without ambulation. [end underline] DHCS-08-003

[begin2. underline]2.Post-operative coPost-operativentrol of hip motion. control of hip motion. 3. Control3. Control of o fadduction adduction or ro taortio nrotationalal guidance of bguidanceoth . of both hips. (2) (2)Legg Pe rtheLeggs Orth Perthesoses shall be Orthoses authorized whe shalln the pa tiebent hauthorizedas a whendiagnosis the of L epatientgg-Calve-P haserthes ade fodiagnosisrmity or simila r ofdefo Legg-Calve-Perthesrmity or disease, and requires control of hip abduction, adduction or weight bearing, appropriate to the requested deformity or similar deformity or disease, and requires procedure code(s). control of hip abduction, adduction or weight bearing, (3) Knee Orthoses shall be authorized when both of the following criteria are appropriate to the requested procedure code(s). (3) met: Knee Orthoses shall be authorized when both of the (A) The patient has a deformity or injury of, or affecting the knee, such as one followingof the following criteria: are met: (A) The patient has a deformity1. Post orsurg injuryical repa irof, of lig oram eaffectingnt tears. the knee, such as one of the2. following: Post arthrosco p 1.y. Post surgical repair of ligament tears.3. 2. Ost Posteoarthritis arthroscopy. or other degenera tiv 3.e joint Osteoarthritis disease. or other degenerative4. Post polio. joint disease. 4. Post polio. 5. Rehabilitation5. Rehabil itaofti oann of ainjuredn injured kn knee.ee. 6. Any related medical6. A nconditiony related medical affecting condition aff ethecting knee.the knee. (B) The patient requires (B) T onehe patie ornt reqmoreuires of on ethe or m ofollowingre of the follow treatmentsing treatments to dtoec rease decreasepain, to increa sepain, functio tona l increasecapacity, or to functionalprevent or ameli ocapacity,rate further inju orry, to preventappropriate or to t hamelioratee requested proce furtherdure code (s)injury,: appropriate to the requested1. Supp oprocedurert or protection o f code(s):the knee. 1. Support or protection 2. Control or restriction of motion of the knee. of the knee. 2. Control or restriction of motion of the 3. Medial-lateral and rotation control of the knee. knee. 3. Medial-lateral and rotation control of the 4. Sagittal plane control of the knee. knee. 4. Sagittal plane control of the knee. 5. 5. Prevention or control of recruvatum (hyperextension of the knee). Prevention or control of recruvatum28 (hyperextension of the knee).[end underline] DHCS-08-003

[begin 6.underline]6. Control of hControlip flexion inof b ehipd. flexion in bed. (4) Ankle-Foot Orthoses(4) Ashallnkle-Foo bet Oauthorizedrthoses shall b whene autho rithezed wpatienthen the phasatien ta h adisease,s a disease , deformity,deformity, inju injuryry or con ord itioncondition of, or aff eof,ctin gor th affectinge lower extrem theity inlower which extremitythe patient in whichexperi ethences patient pain or d imexperiencesinished function apainl cap aorcity diminished of the lower ex trfunctionalemity and req uires capacityone or mo reof o thef the lowerfollowing extremity treatments, aandppro prequiresriate to the roneeque steord more proced uofre the following treatments, appropriate to the requested procedure code(s): code(s): (A) Assistance in specific movements of the ankle and (A) Assistance in specific movements of the ankle and foot. foot. (B) Support to the ankle and foot. (C) Maintenance of (B) Support to the ankle and foot. the foot in a neutral or functional position. (D) Stabilization of (C) Maintenance of the foot in a neutral or functional positi on. the knee or hip. (E) Control of movement of the ankle and foot. (5) (D) SKnee-Ankle-Foottabilization of the knee oOrthosesr hip. – or Any Combination shall be authorized (E) Conwhentrol othef mo vpatientement of hasthe a nakl edisease, and foot. deformity, injury or condition (5) Kne of,e-A norkle -affectingFoot Orthose thes knee– o ror An yankle Comb injoint(s)ation sha inll b ewhich authori zethed patientwhen th eexperiences patient has a disea painse, doref odiminishedrmity, injury or confunctionaldition of, o rcapacity affecting th eof kn theee o r kneeankle orjoin anklet(s) in w hjoint(s)ich the p aandtient erequiresxperiences onepain oorr dim moreinishe dof fu thenctio nfollowingal capacity of treatments,the knee or an appropriatekle joint(s) and req tou irthees o requestedne or more of tprocedurehe following tr ecode(s):atments,

(A)appro pControlriate to th eof req motionuested p roceof thedure knee,code(s) :ankle [begin double strikeout]and[end double strikeout][begin double underline]or[end (A) Control of motion of the knee, ankle andor foot. double underline] foot. (B) Maintenance of the ankle and foot in (B) Maintenance of the ankle and foot in a fixed position. a fixed position. (C) Correction of contractures of the knee and (C) Correction of contractures of the knee and ankle joints. ankle joints. (6) Torsion Control: Hip-Knee-Ankle-Foot (6) Torsion Control: Hip-Knee-Ankle-Foot Orthoses shall be authorized when Orthoses shall be authorized when the patient has a disease, deformity,the patient h ainjurys a dise orase condition, deformity, injuof,ry or or coaffectingndition of, theor aff hip,ecting knee the hip or, kn ankleee or joint(s)ankle join int(s) which in which the the patientpatient ex experiencesperiences pain or paindimin isheor ddiminished functional cap acity of functionalthe hip, kne ecapacity or ankle jo intof(s) the and hip, requ irkneees con trolor anklein rotatio joint(s)n of one o andr both requires hips, controlappropri inate rotationto the requ ofeste oned proce ord bothure co dhips,e(s). appropriate to the requested procedure code(s).[end29 underline]

DHCS-08-003

[begin underline](7)(7) TorsionTorsi Control:on Co Hip-Knee-Ankle-Footntrol: Hip-Kn eOrthosese-An kle(Tibial-Foo Fracturet Orth Cast)o shallses be (T authorizedibial Fr whenactu there patient Ca hasst) a fracture of the tibia or fibula and requires support and stabilization of the fracture site to facilitate healing, to decrease pain, to increase functional capacity, or to preventshall or b amelioratee auth furtherorize injury.d w h (8)en Torsion the p Control:atien Hip-Knee-Ankle-Foott has a fractu reOrthoses of th (Femorale tibia Fracture or fib Cast)ula shallan dbe req authorizeduire swhen the patient has a fracture of the femur and requires support and stabilization of the fracture site to facilitate healing, to decrease pain, to increase functional capacity, or to prevent or ameliorate further injury. (9) Reciprocating Gait Orthoses shall be authorized when chronologically and developmentallysupport appropriateand sta b([beginiliza doubletion underline]beginning[endof the fracture site double to underline] facilita aroundte h etwoa liyearsng, of t oage[begin decre doublease underline]pain, to and up[end double underline]) and all of the following criteria are met: (A) The patient has both of the following conditions: 1. Thoracic or upper lumbarincre spinea lesionsse fu withncti spasticity.onal c 2.ap aRangecity of, omotionr to limitationspreven thatt o neverthelessr amelio ratallowe joints furt toh beer put inju in appropriatery. position for ambulation. (B) The patient does not have any of the following conditions or contraindications: 1. Severe irreducible contractures that prevent establishing (8) normal To alignment.rsion Co 2.n trSevereol: Hip spasticity-Kn ore eother-An involuntarykle-Foo musclet Orth activityose thats (Femoraprevents free land Fr coordinatedacture Cast mobility.) 3. Severe obesity. 4. Poor upper extremity strength. 5. Advanced osteoporosis.[end underline] shall be authorized when the patient has a fracture of the femur and requires support

and stabilization of the fracture site to facilitate healing, to decrease pain, to increase

functional capacity, or to prevent or ameliorate further injury.

(9) Reciprocating Gait Orthoses shall be authorized when chronologically and

developmentally appropriate (beginning around two years of age and up) and all of the

following criteria are met:

(A) The patient has both of the following conditions:

1. Thoracic or upper lumbar spine lesions with spasticity.

2. Range of motion limitations that nevertheless allow joints to be put in

appropriate position for ambulation.

(B) The patient does not have any of the following conditions or

contraindications:

1. Severe irreducible contractures that prevent establishing normal

alignment.

2. Severe spasticity or other involuntary muscle activity that prevents free

and coordinated mobility.

3. Severe obesity.

4. Poor upper extremity strength.

5. Advanced osteoporosis. 30

DHCS-08-003

[begin6. underline]6.A fracture(s) oAr a fracture(s)history of fractu re(s)or a. history of fracture(s). 7. History7. Histo ofry notof no tfollowing following trea treatmenttment plans (n oplansncomplia nce). (noncompliance).8. A pressure sore(s) 8. in a nA a reapressure(s) that wo usore(s)ld be in co nintact an with area(s) the orthosis. that would (C) Docu be minen contacttation within the thepatie northosis.t’s medical rec (C)ord sub sDocumentationtantiates all of the in thefollo patient’swing: medical record substantiates all of the following: 1. Cardiopulmonary1. Cardiopulmonary in integrity.tegrity. 2. That no other orthosis will meet2. theTha t patient’sno other ortho medicalsis will mee tneed(s). the patient’s 3.medic aSpinall need(s) . cord injury 3.level Spina labove cord injury the leve thirdl above lumbarthe third lu mvertebrae.bar vertebrae. 4. No contractures4. No co andntrac tumuscleres and mus atrophycle atroph thaty that wwouldould preclu precludede the use othef the use ofrecip theroca reciprocatingting gait orthosis. gait orthosis. 5. Stability of the spine. 6. No5. S taadvancedbility of the sp iosteoporosisne. or fracture(s). 7. One of the following6. No a diagnoses:dvanced osteopo r a.osis o rParaplegia fracture(s). (diagnosis code 344.1).7. O b.ne of tSpinahe follow ingbifida, diagno sewithouts: mention of hydrocephalus, dorsala. [thoracic]Paraplegia (diag regionnosis co (diagnosisde 344.1 ). code 741.92). c. ,b. without Spina bifida mention, without me ofntio nhydrocephalus, of hydrocephalus, dorsal lumbar [thoracic] region region (diagnosis(diagnosis cod ecode 741.92 741.93).). [begin double underline]d. Any relatedc. Smedicalpina bifida, wconditionithout mentio naffecting of hydrocep hthealus, spine.[end lumbar region (dia doublegnosis underline] (D)code 741.93). For patients 21 years of age and older, in additiond. A tony relathete ddocumentation medical condition affe ctinrequirementsg the spine. specified in subsection(D) For (j)(9)(C)1. patients 21 y ethroughars of age a n7.,d o ldeallr, ofin a theddition following to the docum shallentatio nalso bereq documenteduirements specified inin suthebse ctiopatient’sn (j)(9)(C) 1medical. through 7. ,record: all of the fo 1.llowing shall also Plantigradebe documented infeet. the p a 2.tient’s Minimalmedical rec ocontracturesrd: in the and hips.[end1. Plan underline]tigrade feet.

2. Minimal contractures in the knees and hips. 31

DHCS-08-003

[begin3 underline]3.. Flexible hips Flexiblewithout rigidity hips or spa withoutsticity. rigidity or spasticity. 4. Good4. Goupperod upp eextremityr extremity stren strength.gth. 5. [begin double strikeout]Good5. Good mot motivationivation with rR withealistic r[end goals a ndoubled expecta tiostrikeout][beginns and a family or doubleother su punderline]R[endport system. double underline]ealistic goals and expectations (10)(A) Orth andotic aDe familyvices – L oorwe rother Limb (Ex supporttremity) (A dsystem.ditions to L o (10)(A)wer OrthoticExtremity ODevicesrthoses) sh a–ll incluLowerde all Limbof the fo (Extremity)llowing: (Additions to Lower Extremity1. Ad dOrthoses)itions to Fractu reshall Ortho seincludes. all of the following: 1. Additions2. Ad dtoitio nFractures to Lower Ex Orthoses. 2.tremity Orthoses: Sh oAdditionse-Ankle-Shin -Ktone Lowere. Extremity3. Ad dOrthoses:itions to Straig hShoe-Ankle-Shin-Knee.t Knee or Offset Knee Joints (Knee J 3.oints) . Additions to Straight4. A Kneedditions: orTh igOffseth-Weigh tKnee Bearing Joints– Glu (Kneeteal/Ischial Joints). Weight Be 4.aring. Additions:5. Add itioThigh-Weightns: Pelvic and Tho Bearingracic Control. – Gluteal/Ischial Weight Bearing.6. A d 5.ditions: Additions: General. Pelvic and Thoracic Control. 6. Additions:7. CustGeneral.om Foot Orth 7.ose Customs. Foot Orthoses. (B) Shall be authorized(B) Shall be awhenuthorize alld w hofen theall of tfollowinghe following c ricriteriateria are m areet, a pmet,propriat e appropriateto the requeste dto proce thedu rerequested code(s): procedure code(s): 1. The patient’s1. medicalThe patie nconditiont’s medical co nrequiresdition requir ethes the specificspecific fun ctiofunctionn for which for the whichadditio nthe(s) w aaddition(s)s designed. was designed. 2. The addition(s) is required2. T hbye a dtheditio npatient(s) is reqtou irimproveed by the p athetient tofunctionality improve the fun ctiofon theality o lowerf the extremitylower extrem orthosis,ity orthosis, w withoutithout which which the patie thent’s m patient’sedical need(s) medical would not bneed(s)e met. would 3.not The bepatie met.nt has 3.an existing The or patientauthorized haslower eanxtrem existingity orthosis or tha t is authorizedcompatible with lower the add extremityition(s). orthosis that is compatible with the addition(s). (C) In (C)addition tIno th additione criteria sp etocifi ethed in pcriteriaaragraph (B)specified above, parag inrap h (A)7. paragraph(Custom Foot (B)Orth oabove,ses) shall bparagraphe authorized wh (A)7.en the o (Customrthosis is fabri Footcated fo r a patient

Orthoses)using the patie shallnt’s in dbeividu authorizedal measuremen tswhen or patte thern. Th orthosisis fabricatio nis s hfabricatedall be for a patient using the patient’s32 individual measurements or pattern. This fabrication shall be [end underline] DHCS-08-003

[beginconstruc underline]constructedted using a plaster casting of usingthe patien a t’splaster foot to crea castingte a mo ofld, other with a three- patient’sdimension footal neg toativ createe impressio a nmold, or digita orl sca withnning a (Cthree-ompute dimensionalr-Aided Design/Co mputer negativeAided Ma nimpressionufacture Model or[CA digitalD/CAM]) .scanning The use of f(Computer-Aidedoam boxes shall not be an

Design/Computeracceptable fabrication mAidedethod. Manufacture Model [CAD/CAM]). The use (k)of foamOrth oboxespedic Sh shalloes sh anotll inclu bede an all oacceptablef the following: fabrication method.

(k) (1) Orthopedic Hallus x Shoes-Valgus S shallplint sh includeall be auth oallriz eofd wthehen following:the patient ha (1)s a med ical Hallu[begin double strikeout]s[end double strikeout][begin double condition of the foot that requires a custom fitted orthosis to hold the big toe in the underline]x[end double underline]-Valgus Splint shall be proper anatomical position. authorized when the patient has a medical condition of the foot (2) Abduction and Rotation Bars shall be authorized when the patient has a that requires a custom fitted orthosis to hold the big toe in the propermedica lanatomical condition of the position. foot (feet) th (2)at requ irAbductiones one or bot hand of th eRotation following trea Barstme nts shallto de becrea authorizedse pain, to incr ewhenase fun ctiothen apatientl capacity ,has or to aprev medicalent or am conditioneliorate furth eofr theinju footry, ap (feet)propriate that to th erequires requested oneproce ordure both code (s)of: the following treatments to decrease(A) In pain,crease dto in teincreasernal or exte rnafunctionall rotation o fcapacity, the foot (fee t).or to prevent or ameliorate (B) Infurtherdepend einjury,nt position appropriateing of the hind tofoo tthe and requestedforefoot for ad dprocedureuction or code(s):abduction . (A) Increased internal or external rotation of the foot

(feet). (3) (B) Orth Independentopedic Footwear shapositioningll include bo thof o fthe the fhindollowing foot: and forefoot for adduction or abduction. (3) Orthopedic Footwear shall (A) Stock Orthopedic Shoes and Stock Conventional Shoes shall include in- include both of the following: (A) Stock Orthopedic Shoes and depth shoes, and shall be authorized when both of the following criteria are met: Stock Conventional Shoes shall include in- depth shoes, and shall 1. At least one of the shoes is attached to a prosthesis or brace. For be authorized when both of the following criteria are met: 1. At purposes of this subsection, the following definitions shall apply: least one of the shoes is attached to a prosthesis or brace. For purposesa. ofA this “bra cesubsection,” means an ort htheosis followinginvolving the definitionsfoot that exten shallds abo vapply:e the a.ankle A a “brace”nd is mad emeans of metal oanr oth orthosiser durable involvingrigid materia lthe that ifootmmo bthatilizes, extends restricts abovemovem theent in ankle a given and directio isn made, controls of m ometalbility, a ssistsor other with m durableovement, rerigidduce s materialweight-be thataring fimmobilizes,orces or holds bo drestrictsy parts in t hmovemente correct positio inn .a given direction, controls mobility, assists with movement,33 reduces weight-bearing forces or holds body parts in the correct position.[end underline] DHCS-08-003

[begin underline]b.b. “Attached to“Att a prosthesisach ore brace”d to means a p therost prosthesishesis or brace o ris permanentlybrace” affixedme toa thens shoe th ase an p integralrost parthe ofsis the shoe.or 2.brace The patient is has a medical condition of the foot (feet) that requires one or more of the following treatments, appropriate to the requested procedure code(s): a. Increased pronation or supination of the foot (feet). b. Post surgical footwear to allow for changes in volume of the foot (feet). c. A shoe that holds the heel firmly in place. d. A firm heel counter and a strong shank. e. Accommodationperma ofn ae deformedntly a footff ix(feet)e dor ato foot th orthosis(es).e sho f.e Footwearas an to allowint eforg changesral p ina volume,rt of fractures, the sh amputationoe. or ulcers of the foot (feet). (B) Custom-Made Orthopedic Shoes shall include both the base shoe(s) and any required addition(s) to the base shoe(s): 1. The base shoe(s) shall be authorized when both of the following criteria are met: a. The patient does not require a shoe(s) provided under the diabetic footwear program covered under subsection (a), but has a medical need(s) that cannot be met by modification(s) to 2.a stock T horthopedice pa tieor stocknt conventionalhas a shoe(s)med coveredical undercon subsectionsdition (k)(3)(A)of th ande fo(k)(4).o tThe (fee prescribingt) th practitionerat req shalluir documentes the nature, cause and severity of the foot problem(s) that substantiates the requirement for a custom-made shoe(s), such as one of the following medical conditions: i. Charcot or rheumatoid foot deformities.[endone or underline] more of the following treatments, appropriate to the requested procedure

code(s):

a. Increased pronation or supination of the foot (feet).

b. Post surgical footwear to allow for changes in volume of the foot

(feet).

c. A shoe that holds the heel firmly in place.

d. A firm heel counter and a strong shank.

e. Accommodation of a deformed foot (feet) or a foot orthosis(es).

f. Footwear to allow for changes in volume, fractures, amputation or

ulcers of the foot (feet).

(B) Custom-Made Orthopedic Shoes shall include both the base shoe(s) and

any required addition(s) to the base shoe(s):

1. The base shoe(s) shall be authorized when both of the following criteria

are met:

a. The patient does not require a shoe(s) provided under the diabetic

footwear program covered under subsection (a), but has a medical need(s) that cannot

be met by modification(s) to a stock orthopedic or stock conventional shoe(s) covered

under subsections (k)(3)(A) and (k)(4). The prescribing practitioner shall document the

nature, cause and severity of the foot problem(s) that substantiates the requirement for

a custom-made shoe(s), such as one of the following medical conditions:

i. Charcot or rheumatoid foot deformities. 34

DHCS-08-003

[beginii. underline]ii.Partial foot am pPartialutation. foot amputation. iii. Post muscleiii. P flapost mu surgeryscle flap surg toery tcovero cover a alarg largee or unu orsua l unusualsoft tissue fo osoftt tissuedefect. foot defect. iv. A related medical condition that iv. A related medical condition that requires a custom-made orthopedic requires a custom-made orthopedic shoe(s), b. The shoe(s), patient’s medical condition of the foot (feet) requires one b. The patient’s medical condition of the foot (feet) requires one or more of or more of the following accommodations, appropriate the following accommodations, appropriate to the requested procedure code(s): to the requested procedure code(s): i. A severely i. A severely deformed foot (feet). deformedii. A toe footor dist a(feet).l partial fo o ii.t amp uAtati toeon. or distal partial foot amputation.iii. A sensitiv iii.e foot ( fAee t),sensitive or a pressure footsore(s) (feet), or area(s) or. a pressure sore(s)iv. Aor relat area(s).ed foot cond iv.ition. A related foot condition. 2.

The base2. The bshoe(s)ase shoe(s) shshallall be abeutho authorizedrized when it has awhenll of the fo itllo haswing all of thecha ractfollowingeristics: characteristics: a. Made and molded to the patienta. Made amodelnd molded forto th ea p aspecifictient model fopatient.r a specific p b.atient. Constructed over ab. positiveConstruc temodeld over a pofositiv thee m opatient’sdel of the pati efoot.nt’s foo t. c. Made from leatherc. Made fro mor le aotherther or o thsuitableer suitable m materialaterial of equ aofl o r equalbetter qu aorlity . better quality.d. d.Has removHasa bremovablele inserts as an in insertstegral part oasf the ansho eintegral that can be part of thealte redshoe or rep thatlaced acans the p beatien t’saltered condition orwarr replacedants. as the patient’s conditione. Haswarrants. some form o e.f shoe cloHassure. some form of shoe closure.

3. The3. The addition(s)addition(s) to the btoase the shoe base shall be shoeauthoriz eshalld when abell of the authorizedfollowing criteria whenare met: all of the following criteria are met: a.

The patient’sa. The p amedicaltient’s medical condition condition requ requiresires the speci ficthe fun ctiospecificn for which the functionaddition(s) wforas d ewhichsigned. the addition(s) was designed.[end underline] 35

DHCS-08-003

[beginb. underline]b.The addition(s) Theis req addition(s)uired by the pati eisnt requiredto improve th eby fu nthection apatientlity of the to improvecustom-ma dthee ortho functionalitypedic shoe(s), w ithofo uthet wh ichcustom-made the patient’s medic orthopedical need(s) would not shoe(s),be met. without which the patient’s medical need(s) would not be met.c. T h c.e patie Thent has patient an existing has or au tanhori zexistinged custom- morad eauthorized orthopedic sho e(s) custom-madethat is compatible w ithorthopedic the addition(s) shoe(s). that is compatible with the addition(s).(4) Shoe Mod (4)ificat Shoeions of S Modificationstock Orthopedic Sho ofes aStocknd Stock OrthopedicConventional ShoesShoes, inclu andding Stock addition s,Conventional modifications and seShoes,rvices: including additions, modifications (A) Shall in cluandde a llservices: (A) of the following: Shall include all of the following:1. Sho e 1. Modi ficatShoeions Modifications– Lifts. – Lifts. 2. Shoe Modifications2. Shoe Mod –ificat Wedges.ions – W 3.edges. Shoe Modifications – Heels. 4. Orthopedic3. Shoe Modificat Shoeions Additions.– Heels. 5. Transfer or Replacement.4. Orthop Foredic S purposeshoe Additions. of subsection (k)(4), the terms “Transfer”5. Tran sandfer or Re“Replacement”placement. For purp meanoses of su standardbsection (k)(4), laboratory the terms procedures“Transfer” and “ Rforeplac generalement” me ashoen stand workard lab oforrato rythe proce purposedures for g eofne raltransfer shoe andwork fixationfor the purpo ofse anof tran orthosissfer and fix fromation o fone an ortho shoesis fro tom o another.ne shoe to a n (B)other. Shall (B)be Sauthorizedhall be authoriz ewhend when aallll o f ofthe thefollow followinging criteria are criteria met: are met: 1. The1. patient’sThe patient’s medical medical co nconditiondition requires requires the specific ftheunctio specificn for which the functionaddition(s) , formod iwhichfication(s) the or serv addition(s),ice(s) was desig modification(s)ned. or service(s) was designed.2. The additio n 2.(s), m oThedificatio addition(s),n(s) or service(s) modification(s) is required by the orpatie nt to service(s)improve the fu isnctio requirednality of the bysho ethe(s), w patientithout which to th improvee patient’s m ethedica l need(s) functionalitywould not be me t.of the shoe(s), without which the patient’s medical3. T hneed(s)e patient ha woulds an existing not o r beauth met.orized sh 3.oe(s) Thethat is patientcompatible has with an existingthe additio nor(s) , authorizedmodification(s) oshoe(s)r service(s) . that is compatible with the addition(s), ( l) Orth modification(s)otic Devices – Upper orLim bservice(s). shall include a ll (l) of the Orthoticfollowing: Devices – Upper Limb shall include36 all of the following:[end underline] DHCS-08-003

[begin (1) underline](1)Shoulder Orthose sShoulder shall be au thOrthosesorized when shallthe pa tiebent authorizedhas a medical when theco npatientdition of, ohasr aff eactin medicalg the shou conditionlder joint tha t of,req uorire saffecting that the sh otheulde rshoulder be held in jointplace that to p revrequiresent or lim ithatt motio then in shoulderorder to pro tebect thhelde sho uinld eplacer joint from to preventinjury or or limitprov motionide suppo inrt/st orderabilizat ionto dprotecturing fun ctiothena shoulderl activities. joint from injury or provide (2) E support/stabilizationlbow Orthoses shall include duringelbow ortho functionalses, elbow- wactivities.rist-hand orth (2)oses

Elbowand elbo Orthosesw-wrist-hand shall-finge rinclude orthoses, elbowand sha llorthoses, be authorize delbow-wrist-hand when the patient has a orthoses and elbow-wrist-hand-finger orthoses, and shall be medical condition of, or affecting the elbow, wrist, hand or finger joint(s) that requires authorized when the patient has a medical condition of, or affecting support, stabilization, restriction or enhancement of movement of the elbow, wrist, hand the elbow, wrist, hand or finger joint(s) that requires support, or finger joint(s) to decrease pain, to increase functional capacity, or to prevent or stabilization, restriction or enhancement of movement of the elbow, wrist,ameli ohandrate fu rthore rfinger injury, ajoint(s)ppropriate to to decreasethe requeste dpain, proced toure increase code(s). functional (3) Wrist capacity,-Hand-Finge orr Orth too preventses shall b eor a uamelioratethorized when tfurtherhe patien tinjury, has a appropriatemedical cond itionto theof, o rrequested affecting the wprocedurerist, hand or f incode(s).ger(s) that req (3)uire s support, Wrist-Hand-Fingerstabilization, restriction oOrthosesr enhancem eshallnt of m beove mauthorizedent of the wrist, when hand other fing patienter(s) to hasdecr ae amedicalse pain, to conditionincrease fun ctioof,n aorl ca affectingpacity, or to the prev ewrist,nt or a mhandeliorate or fu rthfinger(s)er injury, thatapp requiresropriate to t hsupport,e requeste dstabilization, procedure code(s) restriction. or enhancement of movement (4) Additio ofn sthe to Up wrist,per Limb hand Ortho orses finger(s) shall be au thtoo ridecreasezed when all pain,of the to increase functional capacity, or to prevent or ameliorate further following criteria are met: injury, appropriate to the requested procedure code(s). (4) (A) The patient’s medical condition requires the specific function for which the Additions to Upper Limb Orthoses shall be authorized when all of addition(s) was designed. the following criteria are met: (A) The patient’s medical condition (B) The addition(s) is required by the patient to improve the functionality of the requires the specific function for which the addition(s) was designed.upper extre m (B)ity wrist The, fing eaddition(s)r or elbow joint is(s) ,required without wh ichby th thee pa tiepatientnt’s med toical improveneed(s) w theould functionalitynot be met. of the upper extremity wrist, finger or elbow (C) T hjoint(s),e patient hwithoutas an existing which or au thethori zpatient’sed upper ex medicaltremity ortho need(s)sis that is would notco mbepa tibmet.le w ith (C) the ad Thedition (s)patient. has an existing or authorized upper extremity orthosis that is compatible37 with the addition(s).[end underline] DHCS-08-003

[begin underline](5)(5) Dynamic Fl eDynamicxor Hinge, Re Flexorciprocal W Hinge,rist Extension Reciprocal/Flexion, Fing eWristr Extension/Flexion,Flexion/Extension Ortho seFingers shall b Flexion/Extensione authorized when the patie Orthosesnt has a medical shall be authorizedcondition of, whenor affectin theg th epatient wrist, han dhas or fin age medicalr(s) that req uconditionires a custom -of,mad eor affectingorthosis tothe hold wrist, the han dhand, finger oorr w finger(s)rist in a prescri thatbed prequiresosition and t oa e nhance and custom-madecontrol movemen orthosist of the hand to, fing holder or wtherist. hand, finger or wrist in a prescribed (6) Exte rnapositionl Power sh andall be toauth enhanceorized when bandoth o fcontrol the follow ingmovement criteria are of them hand,et: finger or wrist. (6) External Power shall be authorized (A) T whenhe patie nbotht has a ofme dtheical cofollowingndition of, o r criteriaaffecting t haree wri st,met: hand (A)or Thefing patienter(s) that reqhasuir eas amedical custom-ma dconditione, electrically of,pow eorred affecting wrist-hand-fing theer orth wrist,osis to handallo wor eff finger(s)ective movem thatent o f requiresthe wrist, ha nad ocustom-made,r finger(s) in the perfo electricallyrmance of activities poweredof daily li vwrist-hand-fingering or instrumental activities orthosis of daily liv intog . allow effective movement (B) T ofhe ptheatien twrist, is no thand able to oorthe finger(s)rwise effectiv einly uthese a performancemanually operated of activitiesorthosis. of daily living or instrumental activities of daily living. (B) (7)The Otpatienther Wrist -isHa notnd-Fing ableer Orth too sotherwisees – Custom effectively Fitted shall includ usee b oath of manuallythe follow ingoperated: orthosis. (7) Other Wrist-Hand-Finger Orthoses (A) – CustomCustom Fitte Fittedd Wrist-H shalland-Fing includeer Orthos eboths shall ofbe atheutho rifollowing:zed when the (A)patie Customnt has a med Fittedical con dWrist-Hand-Fingerition of, or affecting the wrist, Orthoses hand or finge r(shalls) that berequ ires a authorizedcustom-fitte dwhen orthosis the to prov patientide supp ohasrt, sta bail izmedicalation, restri ctioconditionn or enhan ceof,me ornt o f affectingmoveme nthet of t hwrist,e wrist, hhandand or fiornge finger(s)r(s), appropri athatte to trequireshe requested a p rocedure custom-fittedcode(s). orthosis to provide support, stabilization, restriction (B) Aordd itioenhancementn of a joint(s) to an of up pmovementer extremity ortho ofsis the sha llwrist, be auth ohandrized or finger(s),when all o appropriatef the following crite toria theare m requestedet: procedure code(s).

(B) Addition1. The patie ofnt haa sjoint(s) a medica l toco nandition upper that req uextremityires the speci forthosisic function fo shallr be wauthorizedhich the joint(s) whenwas desig allne dof. the following criteria are met: 1. The patient has a medical condition38 that requires the specific function for which the joint(s) was designed.[end underline] DHCS-08-003

[begin underline]2.2. The joint(s) The is req joint(s)uired by tishe requiredpatient to im bypro vthee th epatient functiona tolity improveof the theup functionalityper extremity ortho ofsi s,the with upperout which extremity the patient’s orthosis, medical ne withouted(s) wou ldwhich not be mtheet. patient’s3. Tmedicalhe patient need(s)has an existing would or au notthori zbeed umet.pper ex 3.trem ityThe ortho patientsis that is has anco existingmpatible w orith tauthorizedhe joint(s). upper extremity orthosis that is compatible with the(m joint(s).) Shoulde r (m)-Elbow-W Shoulder-Elbow-Wrist-Handrist-Hand Orthoses shall include all of tOrthoseshe following: shall include all of the following: (1) Abduction Position, Custom Fitted (1) Abduction Position, Custom Fitted Orthoses shall be authorized when both Orthoses shall be authorized when both of the following criteria are of the following criteria are met: met: (A) The patient has a medical condition of, or affecting the (A) The patient has a medical condition of, or affecting the shoulder, elbow, shoulder, elbow, wrist or hand, such as one of the following: 1. wrist or hand, such as one of the following: Post surgery of the shoulder, elbow or wrist joint(s). 2. Treatment of Erbs1. Palsy. Post su rg 3.ery o Af th relatede shoulde r,medical elbow or wconditionrist joint(s). of the shoulder, elbow or2. Twristreatmen joints.t of Erbs (B) Palsy .The patient requires a custom-fitted orthosis3. toA rela provideted med icpositioning,al condition of thstabilizatione shoulder, elb oorw o restrictionr wrist joints. of movement (B) T hofe ptheatie nshoulder,t requires aelbow, custom- fwristitted orth oro sishand, to prov appropriateide positioning, to the requestedstabilization procedureor restriction o code(s).f movement (2)of the sh Mobileoulder, e Armlbow, wrSupportsist or hand, shall be authorizedappropriate twheno the req theueste patientd proced umeetsre code (s)the. criteria specified in paragraph (2) Mob il(1)e A rmabove Suppo rtsand sh a[beginll be auth doubleorized wh estrikeout]uses[endn the patient meets the double strikeout][begin double underline]requires such support attached criteria specified in paragraph (1) above and usesrequires such support attached to a to[end double underline] a wheelchair, [begin double wheelchair, chair or table. underline]chair or table[end double underline]. (3) Additions to (3) Additions to Mobile Arm Supports shall include both additions and Mobile Arm Supports shall include both additions and adaptations to athedap tamobiletions to t harme mo bsupportile arm su porpo rtthe or t haddition(s),e addition(s), a nandd sh ashallll be a ubetho rized when authorizedall of the foll owhenwing cri allteri aof are the me t:following criteria are met: (A) The patient’s (A) medical The pa tieconditionnt’s medical requires condition req theuir especifics the speci functionfic function fforor w whichhich the thead addition(s)dition(s) or ada porta tioadaptation(s)n(s) was designe dwas. designed.[end underline]

39

DHCS-08-003

[begin underline](B)(B) The T addition(s)he add oritio adaptation(s)n(s) or isad requiredapta bytio then(s) patient is toreq improveuire thed bfunctionalityy the p ofa tithee nmobilet to armim psupport,rove without the which the patient’s medical [begin double underline]or functional[end double underline] need(s) would not be met. (C) The patient has an existing or authorizedfun ctiomobilen aarmlity support of t hthate ism compatibleobile a withrm thesu addition(s)pport, wor ithadaptation(s).out wh ich (4) thFracturee pa Orthosestient’s shall me bed authorizedical or fwhenunctio the patientnal has a fracture of the upper extremity and requires support and stabilization of the fracture site to facilitate healing, to decrease pain, to increase functional capacity, or to prevent or ameliorate further injury, appropriate to the requested procedure code(s). (n) Repairs for orthotic appliances shall includeneed repairs,(s) w maintenance,ould not replacementsbe met. and associated labor, and shall be authorized when all of the following criteria are met: (1) The patient has an existing orthosis that requires repair, maintenance or replacement. (2) The repair, maintenance or replacement cost(s), including the associated (C) labor Th ise less pa thantie nthet cost(s)has aofn purchasing existing a new or orthotic auth appliance.orized (3)mo bTheile request arm orsu claimpp oincludesrt tha a tlist is of the components to be repaired or replaced and a statement explaining the necessity for the repair or replacement. (o) Ancillary Orthotic Devices shall be authorized when the patientcom haspa atib medicalle w conditionith the that a drequiresdition an(s) upper o ror a lowerdap extremitytation orthosis(s). not otherwise covered under this section to provide support and positioning to an upper or lower extremity joint(s), appropriate to the requested procedure code(s).[end underline] (4) Fracture Orthoses shall be authorized when the patient has a fracture of

the upper extremity and requires support and stabilization of the fracture site to facilitate

healing, to decrease pain, to increase functional capacity, or to prevent or ameliorate

further injury, appropriate to the requested procedure code(s).

(n) Repairs for orthotic appliances shall include repairs, maintenance,

replacements and associated labor, and shall be authorized when all of the following

criteria are met:

(1) The patient has an existing orthosis that requires repair, maintenance or

replacement.

(2) The repair, maintenance or replacement cost(s), including the associated

labor is less than the cost(s) of purchasing a new orthotic appliance.

(3) The request or claim includes a list of the components to be repaired or

replaced and a statement explaining the necessity for the repair or replacement.

(o) Ancillary Orthotic Devices shall be authorized when the patient has a

medical condition that requires an upper or lower extremity orthosis not otherwise

covered under this section to provide support and positioning to an upper or lower

extremity joint(s), appropriate to the requested procedure code(s).

40

DHCS-08-003

[begin underline](p)(p) Trusse Trussess sh ashallll be be a uauthorizedthorized wwhenhen the the patient patie nhast h aans aabdominaln abdom herniainal h e[beginrnia o r double underline]or a similar deformity or disease[end double underline] and requires a truss to reduce the hernia.a similar deformity or disease and requires a truss to reduce the hernia.

NOTE:NOT AuthorityE: Auth ocited:rity citeSectiond: S e20,ctio Healthn 20 ,and Hea Safetylth an Code;d Saf eandty CoSectionsde; a n10725d Sec andtion 14124.5,s 10725 and Welfare1412 and4.5 ,Institutions Welfare a Code.nd In stituReference:tions Co Sectionsde. R e14103.7,ference 14105.21,: Section s14132, 1410 14133,3.7, 14 14133.1,105.21, 14133.31413 2and, 1 414133.9,133, 14 Welfare133.1, 1and41 3Institutions3.3 and 1 Code.[end4133.9, W underline]elfare and Institutions Code.

41

DHCS-08-003

(4) Adopt Section 51315.2 as follows:

[beginSectio nunderline]Section 51315.2. Requireme n51315.2.ts Applicab Requirementsle to the Prior Auth Applicableorization of P torost thehetic PriorAppli aAuthorizationnces and Servic eofs. Prosthetic Appliances and Services.

Prosthetic Prosthetic a pappliancespliances and s eandrvices services shall be au thshallorize dbe un dauthorizeder the Medi-Cal under the Medi-Calprogram wh programen supportin wheng docum supportingentation and a lldocumentation other requirements spandecif iedall inother Sectio n requirements51315 and in this specifiedsection are met in .Section 51315 and in this section are met. [beginFor purpos doublees of this sunderline]Forection, medical co npurposesditions cited wofith this each section, appliance/s ervice medicalor group oconditionsf appliances/se citedrvices shwithall n oeacht be co appliance/servicenstrued to represent an eorxh agroupustive list of o f appliances/servicesmedical conditions approp rishallate to noteach beapp construedliance/service otor g representroup of an exhaustive list of medical conditions appropriate to each appliances/services. Likewise, such medical conditions may not be appropriate for appliance/service or group of appliances/services. Likewise, such authorization of the requested appliance/service if medical necessity for the specific medical conditions may not be appropriate for authorization of the appliance/service is not documented. requested appliance/service if medical necessity for the specific (a) Lower Limb Prostheses: appliance/service is not documented.[end double underline] (a) Lower (1) LimbShall Prostheses:be authorize d (1) when thShalle patie bent h aauthorizeds a functional levwhenel of “on thee” or patienthigher (po hastentia al fofunctionalr ambulation level or oth eofr fu “one”nctiona l oractiv higherites). L o(potentialwer limb pro sthfore ses ambulationshall not be au ortho riotherzed wh functionalen the patien t activites).has a functio nLoweral level o limbf “zero prostheses” (no potential fo r shallambu notlation be or oauthorizedther functional awhenctivites )the. patient has a functional level of

“zero” (2) (noShall potentialinclude all o ffor the ambulationfollowing: or other functional activites).

(2) Shall(A) Pa rtialinclude Foot P allrost hofes thees sh following:all be authori z (A)ed whe nPartial the patie Footnt has had an Prostheses shall be authorized when the patient has had an amputation of part or all of the foot and requires a definitive prosthesis to permit amputation of part or all of the foot and requires a definitive ambulation or other functional activities. prosthesis to permit ambulation or other functional activities. (B) Ankle Prostheses shall be authorized when the patient has had an (B) Ankle Prostheses shall be authorized when the patient has amputation through or at the ankle, such as a Syme’s procedure and requires a had an amputation through or at the ankle, such as a Syme’s proceduredefinitive prost andhesis requires to permit a ma bdefinitiveulation or oth prosthesiser functional a ctivto itiespermit. 42 ambulation or other functional activities.[end underline] DHCS-08-003

[begin (C) B eunderline](C)low Knee Prosthe seBelows shall Kneebe auth oProsthesesrized when the pshallatient hbeas hauthorizedad an whenampu thetation patient between thashe an hadkle an and kn amputationee and requires betweenan exoskelet theal de anklefinitive and kneeprost andhesis torequires permit am anbula exoskeletaltion or other fun cdefinitivetional activities prosthesis. to permit ambulation (D) Knee Disarticu or otherlation functional Prostheses sh activities.all be authori (D)zed whe Kneen the pa Disarticulationtient has

Prostheseshad an ampu tshallation th berou gauthorizedh or near the k nwhenee and therequ irpatientes an exo hasskelet hadal de finitivan e amputationprosthesis to pthroughermit amb uorlatio nearn or o thether fkneeunction aandl activ requiresities. an exoskeletal definitive (E) prosthesisAbove Knee P rostto permitheses sh aambulationll be authorized or wh otheren the pfunctionalatient has ha d an activities. (E) Above Knee Prostheses shall be authorized when amputation between the knee and hip and requires a definitive prosthesis to permit the patient has had an amputation between the knee and hip and ambulation or other functional activities. requires a definitive prosthesis to permit ambulation or other (F) Hip Disarticulation Prostheses shall be authorized when the patient has functional activities. (F) Hip Disarticulation Prostheses shall be had an amputation through or near the hip and requires an exoskeletal definitive authorized when the patient has had an amputation through or nearprost thehesis hip to p andermit arequiresmbulation oran ot hexoskeletaler functional activ definitiveities. prosthesis to permit (G)ambulation Hemipelve orcto mothery Prost functionalheses shall b eactivities. authorized w (G)hen the patient has had Hemipelvectomyan amputation with re Prosthesesmoval of half th eshall pelvis beand authorizedrequires an ex owhenskeleta lthe definitiv patiente hasprost hadhesis an to pamputationermit ambulatio withn or o tremovalher function ofal ahalfctivities the. pelvis and requires an (H exoskeletal) Endoskeleta l definitiveProstheses shprosthesisall be authori ztoed permitwhen the ambulation patient has had or a other functionallower limb aactivities.mputation an d (H) requir eEndoskeletals an endoskeletal Prosthesesdefinitive prosth eshallsis to pbeerm it authorizedambulation or when other f uthenctio patientnal activities has, a phadpropri aate lower to the rlimbequeste amputationd procedure and requires an endoskeletal definitive prosthesis to permit ambulation code(s). or other functional activities, appropriate to the requested (I) Immediate and Early Post Surgical Procedures shall be authorized when procedure code(s). (I) Immediate and Early Post Surgical the patient has had a lower limb amputation and requires one or more of the following, Procedures shall be authorized when the patient has had a lower limbapp roamputationpriate to the req andueste requiresd procedure one code or(s) :more of the following, appropriate to the requested procedure code(s):[end underline]

43

DHCS-08-003

[begin underline]1.1. A temporary A p temporaryrosthesis sha prosthesisll be authorize shalld whe nbe it isauthorized applied soo nwhen after it is appliedamputa soontion be afterfore th amputatione original amp ubeforetation w otheund original or residu aamputationl limb revision wound(s) woun dor h as residualcomple telimbly he revision(s)aled to permit wound some lo whaser ex completelytremity functio healedn. to permit some lower extremity function. 2. An additional cast change(s) and 2. An additional cast change(s) and realignment(s) of the temporary realignment(s) of the temporary prosthesis specified in paragraph 1. aboveprost hshallesis s pbeeci authorizedfied in paragrap whenh 1. a btheove patient shall be ahasutho anrize dexisting when th eor pa authorizedtient has an temporaryexisting or prosthesisauthorized te mthatporary requires prosthe sisthese that reqservices.uires the se 3. serv Aice temporarys. application 3. A ofte map non-weightorary applicatio bearingn of a no nrigid-weig hdressingt bearing rig shallid dressing be authorized shall be whenauth oitri isze dapplied when it issoon appli eafterd soo namputation after amputa tiobeforen befo rethe th eoriginal original aamputationmputation wound or the residual limb revision(s) wound has completely healed, and wound or the residual limb revision(s) wound has completely healed, and when there is when there is no expectation of use of a prosthesis until the wound has no expectation of use of a prosthesis until the wound has completely healed. completely healed. (J) Initial Prostheses shall be authorized when the patient has(J) Inhaditial aP rostlowerhese limbs sha amputationll be authorize dthat whe nrequires the patie nat htemporaryas had a low er prosthesis,limb amputa andtion twhenhat req utheires prosthesisa temporary pisrost appliedhesis, a nafterd whe then th eoriginal prosthesis is amputationapplied afte rwound the orig inaor l theamp residualutation wo ulimbnd o rrevision(s) the residual liwoundmb revisi hason(s) healed wound h abuts the residual limb has not reached its final shape, appropriate to the healed but the residual limb has not reached its final shape, appropriate to the requested procedure code(s). (K) Preparatory Prostheses – Below Knee requested procedure code(s). shall be authorized when the patient has had a below-the-knee amputation (K) P andrepa ratrequiresory Prost ah etemporaryses – Belo prosthesisw Knee shall btoe apermituthoriz esomed when the ambulationpatient has horad other a belo wfunctional-the-knee a activitiesmputation a innd preparationrequires a tem pforora thery p rostfittinghesis of to a definitivepermit so prosthesis,me ambulatio nand or o twhenher fun ctitheon aprosthesisl activities in isprep appliedaration foafterr the thefitting original of a amputation wound or the residual limb revision(s) wound has healed but definitive prosthesis, and when the prosthesis is applied after the original amputation the residual limb has not reached its final shape. (L) Preparatory wound or the residual limb revision(s) wound has healed but the residual limb has not Prostheses – Above Knee shall be authorized when the patient has had anrea above-the-kneeched its final shap eamputation. and requires a temporary prosthesis to permit some(L) Prep ambulationaratory Prost orhe seothers –functional Above Kne eactivities shall be a uinth opreparationrized when the for the fittingpatie ofnt haa s[end had aunderline]n above-the-knee amputation and requires a temporary prosthesis to

permit some ambulation or other functional activities in preparation for the fitting of a 44

DHCS-08-003

[begindefinitiv underline]definitivee prosthesis, and whe nprosthesis, the prosthesi sand is a pwhenplied a fttheer t hprosthesise original am ispu taappliedtion afterwou thend o roriginal the resid amputationual limb revisio woundn(s) wou nord htheas h residualealed but tlimbhe resi revision(s)dual limb ha swound not hasrea healedched its fbutinal shtheap eresidual, appropri alimbte to hasthe req notue stereachedd proce ditsure final code (s)shape,. appropriate to the requested procedure code(s). (M) Additions to Lower (M) Additions to Lower Limb Prostheses: Limb Prostheses: 1. Shall include all of the following: 1. Shall include all of the following:

a. Endoskeletal System – Above Knee.

b. Test Sockets.

c. Socket Variations.

d. Socket Inserts.

e. Suspension – Below Knee.

f. Suspension – Above Knee.

g. Exoskeletal Knee-Shin System.

h. Endoskeletal Knee-Shin System.

i. Miscellaneous.

2. Shall2. be Sh aauthorizedll be authorize dwhen when aallll o f ofthe the follo wfollowinging criteria acriteriare met: are met: a. Thea. patient’sThe patie medicalnt’s medical condition condition req requiresuires the s ptheecific specific function fo functionr which the fora dwhichdition(s) thewas daddition(s)esigned. was designed. b. The addition(s) is required b. Tbyhe athedditio patientn(s) isto req improveuired by t hthee pa tifunctionalityent to improve t hofe fu thencti onality of the prosthesis,prosthesis, w ithwithoutout which which the patie thent’s patient’smedical nee medicald(s) would nneed(s)ot be met. would not be met.c. Th c.e patie Thent ha spatient an existing has or auanth oexistingrized lower or lim bauthorized prosthesis th alowert is limb prosthesiscompatible w thatith th eis a dcompatibledition(s). with the addition(s). (N) Replacements – Feet-Ankle Units shall be authorized when both (N) Replacements – Feet-Ankle Units shall be authorized when both of the of the following criteria are met: [end underline] following criteria are met:

45

DHCS-08-003

[begin underline]1.1. The cost(s) o fThe the re cost(s)placemen tof theis less replacement than the cost(s) is o fless purch athansing a the cost(s)new prost ofh purchasingesis. a new prosthesis. 2. The patient has an existing 2. or Th authorizede patient has a nlower existing limb or au prosthesisthorized lower lithatmb p rostis compatiblehesis that is with theco mreplacement(s).patible with the replace (b)ment(s) Upper. Limb Prostheses shall include all of the (b) following: Upper Lim (1)b Prost Partialheses sh aHandll includ eProstheses all of the follow shalling: be authorized when the patient has had an amputation of part or all of the hand (1) Partial Hand Prostheses shall be authorized when the patient has had an and requires a definitive prosthesis to permit functional use of the amputation of part or all of the hand and requires a definitive prosthesis to permit upper extremity, appropriate to the requested procedure code(s). functional use of the upper extremity, appropriate to the requested procedure code(s). (2) Wrist Disarticulation Prostheses shall be authorized when (2) Wrist Disarticulation Prostheses shall be authorized when the patient has the patient has had an amputation through or near the wrist and requireshad an a manpu texoskeletalation through or definitivenear the wrist prosthesis and requires aton e permitxoskelet afunctionall definitive useprost ofh ethesis toupper permit fextremity.unctional use (3)of the u pElbowper extrem Prosthesesity. shall be authorized (3) Elbo wwhen Prosth etheses patientshall be a uhasthori zhaded wh anen thamputatione patient has h aneard an the elbowampu taandtion nrequiresear the elb oanw a nexoskeletald requires an e xdefinitiveoskeletal de fprosthesisinitive prosthe sisto topermit permit functionalfunctional u usese of thofe theuppe rupper extrem ityextremity,, appropriate appropriate to the requeste dto proce thed urequestedre code(s). procedure (4) Sho ucode(s).lder Prosth e (4)ses sh aShoulderll be authoriz Prosthesesed when the pa tieshallnt ha sbe ha dauthorized an whenampu thetatio npatient through ohasr nea rhad the s hanou ldamputationer and requires through an exoske letora lnear definitiv thee shoulder and requires an exoskeletal definitive prosthesis to prosthesis to permit functional use of the upper extremity. permit functional use of the upper extremity. (5) Interscapular (5) Interscapular Thoracic Prostheses shall be authorized when the patient Thoracic Prostheses shall be authorized when the patient has had has had an amputation with removal of both the shoulder joint and the scapula and an amputation with removal of both the shoulder joint and the scapularequires aandn ex orequiresskeletal de faninitiv exoskeletale prosthesis to pdefinitiveermit functio nprosthesisal use of the u toppe permitr functionalextremity. use of the upper extremity. (6) Immediate and Early Post (6)Surgical Imme Proceduresdiate and Early P shallost Su rgbeical authorized Procedures sh whenall be a uthethori zpatiented when has hadthe anpatie uppernt has h limbad an uamputationpper limb amp uandtation requires and require ones one oror mmoreore of thofe ftheollow ing, following,appropriate appropriate to the requeste dto p rocethed urequestedre code(s): procedure code(s):[end underline] 46

DHCS-08-003

[begin (A)underline](A) A temporary p rostA temporaryhesis shall be prosthesisauthorized whe shalln it is a beppli eauthorizedd soon after whenampu tait tioisn appliedbefore the soonorigina lafter ampu taamputationtion wound or th beforee residu athel lim boriginal revision(s) wound amputationhas complete lywound healed toor p ethermit sresidualome uppe rlimb extrem revision(s)ity function. wound has completely (B) A nhealed additiona tol ca permitst chang esome(s) and reupperalignm eextremitynt(s) of the t efunction.mporary (B)

Anprost additionalhesis speci fcastied in pchange(s)aragraph (A) aandbove realignment(s)shall be authorized wofhe then the temporarypatient has an prosthesis specified in paragraph (A) above shall be authorized existing or authorized temporary prosthesis that requires these services. when the patient has an existing or authorized temporary (C) A temporary application of a non-weight bearing rigid dressing shall be prosthesis that requires these services. (C) A temporary authorized when it is applied soon after amputation before the original amputation application of a non-weight bearing rigid dressing shall be wound or the residual limb revision(s) wound has completely healed, and when there is authorized when it is applied soon after amputation before the originalno expe ctamputationation of use of awound prosthe sisor u thentil th residuale wound h alimbs com revision(s)pletely healed. wound has completely(7) Endoskelet ahealed,l – E andlbow owhenr Shou ldetherer Are ais P rnoosth expectationeses shall be au thofo riusezed of a wprosthesishen the patie nuntilt has hthead a woundn upper e xhastrem itycompletely amputation a nhealed.d requires (7) a definitiv e Endoskeletalprosthesis to pe rm– itElbow function oral u Shoulderse of the upp Areaer extrem Prosthesesity, appropriate shall to the bereq uested authorizedprocedure co whende(s). the patient has had an upper extremity amputation (8) Endosk andeleta requiresl – Inte arsc definitiveapular Thoracic prosthesis Prosthese sto sh permitall be au thfunctionalorized usewh eofn ththee pa uppertient has extremity,had an upper appropriatelimb amputation toan dthe req urequestedires a tempora procedurery or code(s). (8) Endoskeletal – Interscapular Thoracic Prostheses preparatory prosthesis to permit some upper extremity function in preparation for the shall be authorized when the patient has had an upper limb fitting of a definitive prosthesis; and when the prosthesis is applied after the original amputation and requires a temporary or preparatory prosthesis to amputation wound or the residual limb revision(s) wound has healed but the residual permit some upper extremity function in preparation for the fitting of limb has not reached its final shape, appropriate to the requested procedure code(s). a definitive prosthesis; and when the prosthesis is applied after the original (9) A amputationdditions to Upp ewoundr Limb Prost orh theeses residualshall be au thlimborize revision(s)d when all of th wounde hasfoll ohealedwing crite butria a rethe me t:residual limb has not reached its final shape, appropriate (A) Ttohe thepatie requestednt’s medical c oprocedurendition require scode(s). the specif ic (9) functio Additionsn for which th toe Upperadditio nLimb(s) wa sProstheses designed. shall be authorized when all of the following criteria are met: (A) The47 patient’s medical condition requires the specific function for which the addition(s) was designed.[end underline] DHCS-08-003

[begin (B) underline](B) The addition(s) Theis req addition(s)uired by the pati eisnt torequired improve th eby fun thection apatientlity of the top improverosthesis, w iththeout wfunctionalityhich the patient’s medof theical n prosthesis,eed(s) would not withoutbe met. which the (C patient’s) The patien tmedical has an existing need(s) or autho riwouldzed upp enotr lim bbe prost met.hesis th (C)at is The patientcompatib hasle with an the existingaddition(s). or authorized upper limb prosthesis that is(10 )compatible Replacements with for Upp theer Limb addition(s). Prostheses sh (10)all be auth Replacementsorized when both forof Upperthe follow ingLimb crite riProsthesesa are met: shall be authorized when both of the ( followingA) The co criteriast(s) of th eare replace met:men t (A) is less The than tcost(s)he cost(s) ooff p uthercha sing a replacementnew prosthesis. is less than the cost(s) of purchasing a new prosthesis. (B) The p a (B)tient ha sThe an ex istingpatient or au thashorize and up pexistinger limb prost orhe sisauthorized that is uppercompa tiblimble w ithprosthesis the replaceme thatnt(s). is compatible with the replacement(s). (c) Terminal Dev ices (c) sha llTerminal include all of Devicesthe following :shall include all of the following: (1) Hoo (1)ks sha llHooks include b oshallth the bincludease applia nbothce or de thevice baseand any appliancerequired ora ddevicedition(s) oandr attach anymen t(s)required and shall baddition(s)e authorized wh eorn oattachment(s)ne or both of the follo wanding shallcriteri bea is mauthorizedet, appropriate twheno the req oneueste dor pr obothcedure ofco dthee(s): following criteria is met, (A) appropriate For the requeste tod b athese a prequestedpliance or device, procedure both of the fo code(s):llowing criteri a (A) Forare themet: requested base appliance or device, both of the following 1. T hcriteriae patient reqareuir emet:s a 1.termin aThel device patient to permit requiresfunctional us ea o terminalf the upper deviceextremity to. permit functional use of the upper extremity. 2.

The patient2. The phasatient anhas aexistingn existing o ror au tauthorizedhorized upper ex uppertremity p rostextremityhesis that prosthesisis compatible thatwith th ise t ecompatiblerminal device. with the terminal device. (B)

For the(B) requestedFor the requeste addition(s)d addition(s) o ror att aattachment(s),chment(s), all of the fo allllow ingof critheteri a followingare met: criteria are met: 1. The patient’s medical condition requires 1. theTh especific patient’s med functionical cond itioforn reqwhichuires th thee spe addition(s)cific function for worhich the attachment(s)addition(s) or attach wasment(s) designed.[end was designed. underline] 48

DHCS-08-003

[begin 2.underline]2. The addition(s) The or at taddition(s)achment(s) oris reqattachment(s)uired by the patie nist torequired improve th bye thefun patientctionality otof th improvee terminal d theevice, functionality without which th ofe p theatien t’sterminal medical n device,eed(s) wo uld withoutnot be m whichet. the patient’s medical need(s) would not be met. 3. The patient3. The haspatie nant ha sexisting an existing or o rauthorized authorized ter mterminalinal device devicethat is that is compatiblecompatible w ithwith the atheddition addition(s)(s) or attach moren attachment(s).t(s). (2) Hands shall include (2) bothHand sthe sha basell includ appliancee both the base or a pdevicepliance o andr dev iceany an drequired any require d addition(s)addition(s) o r oratt aattachment(s)chment(s) and sha lland be a ushallthoriz ebed w hauthorizeden one or both when of the f oonellowing or both of the following criteria is met, appropriate to the requested criteria is met, appropriate to the requested procedure code(s): procedure code(s): (A) For the base appliance or device, both of (A) For the base appliance or device, both of the following criteria are met: the following criteria are met: 1. The patient requires a terminal 1. The patient requires a terminal device to permit functional use of the upper device to permit functional use of the upper extremity. 2. The extremity. patient has an existing or authorized upper extremity prosthesis that is 2.compatible The patient h withas an ethexisting terminal or autho ridevice.zed uppe r (B) extrem itFory prost thehe sis that addition(s)is compatible orwith attachment(s), the terminal device. all of the following criteria are met: 1. (B)The Forpatient’s the addition medical(s) or att aconditionchment(s), a requiresll of the follo thewing specificcriteria are functionmet: for which1. theTh eaddition(s) patient’s med icalor attachment(s)condition requires th wase spe cidesigned.fic function f o 2.r which The the addition(s)addition(s) o r oratt aattachment(s)chment(s) was desig isn erequiredd. to improve the functionality of the terminal2. The add itiodevice,n(s) or atwithouttachment(s) which is therequ irpatient’sed to impro vmedicale the functi need(s)onality of would not be met. 3. The patient has an existing or authorized the terminal device, without which the patient’s medical need(s) would not be met. terminal device that is compatible with the addition(s) or 3. The patient has an existing or authorized terminal device that is attachment(s). (3) Hand Restoration Procedures shall include compatible with the addition(s) or attachment(s). casts, shading and measurements and shall be authorized when (3) Hand Restoration Procedures shall include casts, shading and one or more of the following criteria is met, appropriate to the requestedmeasureme nprocedurets and shall b ecode(s): authorized (A)when o nFore or mtheore partialof the foll ohandwing cr iteria is prosthesis,met, appropri abothte to t hofe reqtheue stefollowingd procedu recriteria code(s) :are met:[end underline] (A) For the partial hand prosthesis, both of the following criteria are met: 49

DHCS-08-003

[begin 1. underline]1. The patient requ irThees a ppatientartial hand requires prosthesis to a p epartialrmit func tiohandnal use of prosthesisthe upper extrem to itypermit. functional use of the upper extremity. 2. The2. T hpatiente patient hhasas an anexisting existing or autho riorze dauthorized upper extremity upper prosthesis tha t extremityis compatib leprosthesis with the partial thathand pisrost compatiblehesis. with the partial hand prosthesis. (B) For th (B)e replace Formen thet glov ereplacement(s), both of the foll oglove(s),wing criteria abothre met: of the following 1. T hcriteriae patient reqareuire met:s a 1.replace Thement gpatientlove(s) for arequires hand prost haesis. replacement 2. The pa tieglove(s)nt has an eforxisting a ohandr autho riprosthesis.zed hand prosth e 2.sis tha Thet is patient hascom anpatib existingle with the re orplace authorizedment glove(s) . hand prosthesis that is compatible (d) Externa withl Pow ether sha replacementll include all of the foglove(s).llowing: (d) External Power (1) Bshallase De includevices shall allbe a ofuth otherized following: when both of th (1)e follow Baseing crite riDevicesa are shallmet: be authorized when both of the following criteria are met: (A) (A) The p Theatient reqpatientuires requires an upper ex antrem upperity prost hextremityesis with one or more prosthesiselectrically po wwithered foneunctio noral pmorearts or ele electricallyctronic circuitr ypowered that is activa tefunctionald by the patie nt partsto allo orw e ffelectronicective movem ecircuitrynt of the up pthater extrem is activatedity in the perfo rmbya nthece of patientactivities o fto allowdaily lieffectiveving and instrume movementntal activities of of dtheaily livuppering, app extremityropriate to the reqin utheeste d performanceprocedure code(s) of. activities of daily living and instrumental activities (B) Th eof pa dailytient living,is not a appropriateble to otherwise e fftoectiv theely urequestedse a manually operated procedureprosthesis. code(s). (B) The patient is not able to otherwise effectively (2) Term inausel Dev aices manually shall be au toperatedhorized when prosthesis.all of the following (2) criteria are

Terminalmet: Devices shall be authorized when all of the following (A) Th ecriteria patient req areuires met: a (A)terminal dTheevice patientwith one o rrequires more electri caall y terminalpowered f udevicenctional p awithrts or eleonectro noric cirmorecuitry thelectricallyat is activated b ypowered the patient t o allow functionaleffective mov partsement o orf th eelectronic upper extremity circuitry in the perf othatrman cise o factivated activities of d abyily litheving patient to allow effective movement of the upper extremity in the performance of activities of50 daily living [end underline]

DHCS-08-003

[beginand instrume underline]andntal activities of instrumentaldaily living, approp riactivitiesate to the req uofeste dailyd proce living,dure appropriatecode(s). to the requested procedure code(s). (B) The patient (B) Tishe not patie ablent tois n otherwiseot able to othe rweffectivelyise effectively uusese a mana manuallyually operate d operatedprosthesis. prosthesis. (C) The patient has an existing or authorized (C) The patie uppernt has a nextremity existing or au tprosthesishorized upper ex thattremity is p rostcompatiblehesis that with theis coterminalmpatible w ithdevice. the termina (3)l device. Elbow Attachments shall be authorized (3) Elbow whenAttachm eallnts ofsha thell be afollowinguthorized wh ecriterian all of the arefollow met:ing crit e (A)ria Theare mepatientt: requires an elbow joint attachment with one or more (A) electrically The patient req powereduires an functionalelbow joint atta partschment worith electronicone or more circuitryelectricall ythat powe redis activatedfunctional parts by or elethectr opatientnic circuitr toy th allowat is act iveffectiveated by the p atient movementto allow effectiv ofe mtheove mupperent of th eextremity upper extrem inity inthe the pperformanceerformance of activ ofities of activitiesdaily living aofnd dailyinstrume livingntal activ andities oinstrumentalf daily living. activities of daily living. (B) (B) The pa tieThent patientis not ab isle tonot oth eablerwise e toffectiv otherwiseely use a man effectivelyually operated useprost ah emanuallysis. operated prosthesis. (C) The patient has an (Cexisting) The patie ornt h authorizedas an existing o r upperauthorize extremityd upper extrem prosthesisity prosthesis th thatat is compatibleis compatible w withith the theelbo welbow attachm eattachment.nt. (4) Control Modules and (4)Battery Control Components Modules and Batt eshallry Com bepon eauthorizednts shall be auth whenorized w htheen th e patientpatient h hasas an eanxisting existing or autho riorzed authorized upper extremity upperelectrica llextremityy powered pro sthesis electricallythat requires a powered control modu leprosthesis or battery com thatponen requirest for function aal u controlse of the p rostmodulehesis. or battery(e) Brea componentst Prostheses sh aforll be functionalauthorized whe usen the pofatie thent req prosthesis.uires a (e)prost hBreastesis, com pProsthesesonent or attachm eshallnt to rep belace authorized a breast(s) afte rwhen surgical theremo vpatiental, to requiressupport th ea su prosthesis,rgical recovery o componentr to hold the prosth oresis attachment in place. to replace a breast(s) (f) Ge afterneral It esurgicalms shall inc removal,lude all of the tofoll osupportwing: the surgical recovery or to hold the prosthesis in place. (f) General 51 Items shall include all of the following:[end underline] DHCS-08-003

[begin (1) underline](1) Prosthetic Socks s hProstheticall be authoriz eSocksd when b oshallth of th ebe foll oauthorizedwing criteria are when bothmet :of the following criteria are met: (A) The patient requires (A) T honee patie ornt reqmoreuires of the one followingor more of the appliances, following applian ceappropriates, appropriate to tothe the requestedrequested proce proceduredure code(s): code(s): 1. A prosthetic sheath that is placed1. A prosth overetic sh eaat hresidual that is place limbd over anda resid underual limb aand prosthetic under a sock whileprost htheetic soprosthesisck while the p rosisth beingesis is b eworning wo rnto to decrease decrease the irtheritatio irritationn of the of theresid residualual limb. limb. 2. A prosthetic sock that is worn between the residual2. A prost limbhetic sandock th theat is wprosthesisorn between th eto re sidudecreaseal limb and thethe irritation of ptherosth residualesis to decre limb.ase the 3.irritatio nA o fprosthetic the residual lim shrinkerb. that is worn over the3. Aresidual prosthetic slimbhrinke rto tha providet is worn ov epressurer the residua l againstlimb to prov theide residual limbpressu to redecrease against the re accumulationsidual limb to decre aofse afluidccum uinlat iothen of fresidualluid in the resid limb.ual li mb. 4. A 4.thinly A thinly woven woven so sockck that isthat used is ov eusedr the resi overdual li mtheb d uresidualring the fitting limb of duringa prost htheesis. fitting of a prosthesis. (B) The patient has an existing (B) Torhe pauthorizedatient has an e xloweristing or auextremitythorized lower prosthesis extremity prost thathesis istha t is compatiblecompatible w ithwith the ptherosth eprosthetictic sheath, sock sheath, or shrinke r.sock or shrinker. (2) Repairs (2) forRep Prostheticairs for Prosthe Appliancestic Appliances sh ashallll includ includee repairs, m repairs,aintenance , maintenance,replacements and replacements associated labor and and shall bassociatede authorized wh elaborn all of tandhe foll oshallwing be authorizedcriteria are m ewhent: all of the following criteria are met: (A) The patient (A) has Th ean pa tieexistingnt has an eprosthesisxisting prosthesis that that rerequiresquires repa irrepair,, mainten ance or maintenancereplacement. or replacement. (B) The repair, maintenance or replacement (B) The repa ircost(s),, maintena nincludingce or replace mtheent coassociatedst(s), including laborthe asso isciat lessed thanlabo ther is less cost(s) than the ofco st(s)purchasing of purchasing a a nnewew prost prosthetichetic applian ceappliance.. (C) (C) TThehe req requestuest or claim or in cludclaimes a listincludes of the com apo nlistents of to bthee re pcomponentsaired or to berep repairedlaced and a or sta treplacedement explain anding th ea n estatementcessity for the reexplainingpair or replace thement. necessity for the repair or replacement.[end52 underline]

DHCS-08-003

[begin (g underline](g)) Miscellane Miscellaneousous Prosthetic ProstheticAppliances Appliances shall be au shallthori zbeed authorizedwhen the p whenatient the patient has had an amputation or removal of a body part and requires one or more of the has had an amputation or removal of a body part and requires one or more of the following appliances or devices, appropriate to the requested procedure code(s): following appliances or devices, appropriate to the requested procedure code(s):

A prosthetic(1) A prosthe appliancetic appliance oorr serv serviceice that isthat not fuisn ctionotn afunctionallylly equivalent to , or equivalentdoes not mee t to,the dores crdoesiptor fonotr, a nmeet existing the prost descriptorhetic applian cefor, or seanrv iceexisting procedu re prostheticcode(s). appliance or service procedure code(s).

(2) A device to enable speaking in the absence of the larynx.

(3) A device to enable speaking with a tracheostomy.

(4) A replacement battery or accessory for an artificial larynx.

(5) A trachea-esophageal voice prosthesis.

(6) A voiceA voice a amplifier.mplif [endier. underline]

NOTE: Authority cited: Section 20, Health and Safety Code; and Sections 10725 and 14124.5, Welfare and Institutions Code. Reference: Sections 14103.7, 14105.21, 14132, 14133, 14133.1, 14133.3 and 14133.9, Welfare and Institutions Code.

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