Summary of Package Insert 1

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1 Summry of Pckge Insert 1 For Sttes with Non-Published Policies Indictions Non-infected prtil nd full-thickness skin ulcers due to VSU 2 of greter thn 1 month durtion nd which hve not dequtely responded to conventionl ulcer therpy. Full-thickness neuropthic DFU 3 of greter thn 3 weeks durtion which hve not dequtely responded to conventionl ulcer therpy nd which extend through the dermis but without tendon, muscle, cpsule or bone exposure. Limittions The sfety nd effectiveness of pligrf hve not been estblished for ptients receiving greter thn 5 device pplictions. oding PT/HPS 1,4 Q4101: pligrf, per squre centimeter For Plmetto G, J modifier must be billed in conjunction with Q4101 long with JW modifier for wstge ppliction odes for Leg 15271: ppliction of skin substitute grft to trunk, rms, legs, totl wound surfce re up to 100 sq cm; first 25 sq cm or less wound surfce re 15272: ppliction of skin substitute grft to trunk, rms, legs, totl wound surfce re up to 100 sq cm; ech dditionl 25 sq cm wound surfce re, or prt thereof (List seprtely in ddition to code for primry procedure) 15273: ppliction of skin substitute grft to trunk, rms, legs, totl wound surfce re greter thn or equl to 100 sq cm; first 100 sq cm wound surfce re 15274: ppliction of skin substitute grft to trunk, rms, legs, totl wound surfce re greter thn or equl to 100 sq cm; ech dditionl 100 sq cm wound surfce re, or prt therof (List seprtely in ddition to code for primry procedure) ppliction odes for Foot 15275: ppliction of skin substitute grft to fce, sclp, eyelids, mouth, neck, ers, orbits, genitli, hnds, feet, nd/or multiple digits, totl wound surfce re up to 100 sq cm; first 25 sq cm or less wound surfce re 15276: ppliction of skin substitute grft to fce, sclp, eyelids, mouth, neck, ers, orbits, genitli, hnds, feet, nd/or multiple digits, totl wound surfce re up to 100 sq cm; ech dditionl 25 sq cm wound surfce re, or prt thereof (List seprtely in ddition to code for primry procedure) 15277: ppliction of skin substitute grft to fce, sclp, eyelids, mouth, neck, ers, orbits, genitli, hnds, feet, nd/or multiple digits, totl wound surfce re greter thn or equl to 100 sq cm; first 100 sq cm wound surfce re 15278: ppliction of skin substitute grft to fce, sclp, eyelids, mouth, neck, ers, orbits, genitli, hnds, feet, nd/or multiple digits, totl wound surfce re greter thn or equl to 100 sq cm; ech dditionl 100 sq cm wound surfce re, or prt therof (List seprtely in ddition to code for primry procedure) 1 This document is for informtionl purposes only. Use of this informtion does not gurntee coverge or pyment for these services by Medicre or other pyors. Physicins nd other providers should use independent judgment when selecting codes tht most ppropritely describe the services provided to ptient. Physicins nd hospitls re solely responsible for complince with Medicre nd other pyors lws, rules, nd requirements. 2 VSU = Venous Stsis Ulcer. 3 DFU = Dibetic Foot Ulcer. 4 PT mericn Medicl ssocition. ll Rights Reserved HEL.2.DY ( ) pligrf is registered trdemrk of Novrtis 2012 Orgnogenesis, Inc.

2 nytown Hospitl 123 Medicl Drive nytown, NJ PT. 4 TYPE NTL # HI OF ILL b. MED. RE. # 5 FED. T NO. 6 STTEMENT OVERS PERIOD FROM THROUGH 8 PTIENT NME 9 PTIENT DDRESS b b c d 10 IRTHDTE 11 SE DMISSION ONDITION ODES 12 DTE 13 HR 14 TYPE 15 SR 16 DHR 29 DT STT STTE F 2012 No Forml Policy PI pligrf Smple U-04 lim Form Mple venue nytown NJ OURRENE 32 OURRENE 33 OURRENE 34 OURRENE 35 OURRENE SPN 36 OURRENE SPN 37 ODE DTE ODE DTE ODE DTE ODE DTE ODE FROM THROUGH ODE FROM THROUGH e b ll dtes VLUE ODES 40 VLUE ODES 41 VLUE ODES should be in ODE MOUNT ODE MOUNT ODE MOUNT eight digit Jne Smith formt. 111 Mple venue b nytown, NJ c d b REV. D. 43 DESRIPTION 44 HPS / RTE / HIPPS ODE 45 SERV. DTE 46 SERV. UNITS 47 TOTL HRGES 48 NON-OVERED HRGES pligrf Q ppliction, first 25 sq cm ppliction, ech dditionl 25 sq cm Enter pproprite revenue codes for ll services provided. Revenue code 636 should be used when billing for pligrf nd should be used bsed on the size of the wound. For exmple, LEG wound mesuring 30 sq cm, would be billed using (first 25 sq cm or less) nd (dditionl 25 sq cm or prt thereof). pligrf is supplied in 44 units PGE OF RETION DTE TOTLS PYER NME Medicre 51 HELTH PLN ID REL. INFO 53 SG. 54 PRIOR PYMENTS 55 EST. MOUNT DUE 56 NPI EN. 57 OTHER PRV ID 58 INSURED S NME 59 P. REL 60 INSURED S UNIQUE ID 61 GROUP NME 62 INSURNE GROUP NO. 63 TRETMENT UTHORIZTION ODES 64 DOUMENT ONTROL NUMER 65 EMPLOYER NME 66 D xxx.xx 67 Plese refer to odes ommonly Used when illing for pligrf forpproprite ID-9-M dignosis D E F G H codes nd your specific pyer s requirements. I J K L M N O P Q 69 DMIT 70 PTIENT 71 PPS D RESON D b c ODE EI b c 74 PRINIPL PROEDURE. OTHER PROEDURE b. OTHER PROEDURE 75 ODE DTE ODE DTE ODE DTE 76 TTENDING NPI QUL LST FIRST c. OTHER PROEDURE d. OTHER PROEDURE e. OTHER PROEDURE ODE DTE ODE DTE ODE DTE 77 OPERTING NPI QUL LST FIRST 80 REMRKS OTHER NPI QUL b LST FIRST 68 c 79 OTHER NPI QUL U-04 MS-1450 PPROVED OM NO d LST FIRST Ntionl Uniform NU illing ommittee THE ERTIFITIONS ON THE REVERSE PPLY TO THIS ILL ND RE MDE PRT HEREOF.

3 2012 No Forml Policy PI pligrf Smple MS-1500 lim Form Physicin Services in n Outptient Setting ny Street 123 ny Street NYTOWN NJ NYTOWN NJ (973) SIGNTURE ON FILE xxx xx xxx xx Plese refer to odes ommonly Used when illing for pligrf for pproprite ID-9-M dignosis codes nd your specific pyer s requirements nd should be used bsed on the size of the wound. For exmple, LEG wound mesuring 30 sq cm, would be billed using (first 25 sq cm or less) nd (dditionl 25 sq cm or prt thereof)

4 2012 No Forml Policy PI pligrf Smple MS-1500 lim Form Physicin Services in n Office Setting ny Street 123 ny Street NYTOWN NJ NYTOWN NJ (973) SIGNTURE ON FILE xxx xx xxx xx Plese refer to odes ommonly Used when illing for pligrf for pproprite ID-9-M dignosis codes nd your specific pyer s requirements Q pligrf is supplied in 44 units nd should be used bsed on the size of the wound. For exmple, LEG wound mesuring 30 sq cm, would be billed using (first 25 sq cm or less) nd (dditionl 25 sq cm or prt thereof)

5 Model Documenttion Form for No Forml Policy / Summry of Pckge Insert Pretretment: 1. Durtion of ulcer (DFU: 3 weeks, VSU: greter thn 1 month) weeks 2. Document filure to respond to conservtive mesures ( filed response is defined s n ulcer tht hs incresed in size or depth nd no indiction tht improvement is likely e.g., epithelil in growth nd progression towrds closure) 3. Document mesurement of the ulcer t bseline, following cesstion of conservtive mngement. 4. Describe dequte tretment of the underlying disese process contributing to the ulcer 5. Dignosis of ptient VSU: 454.0, 454.1, 454.2, , , , , DFU: , , , , , , , , , , , , , Document tht wound is free of infection, redness, dringe, underlying osteomyelitis, surrounding cellulitis, tunnels nd trcts, eschr or ny necrotic mteril 7. For DFU, document current Hb1 reding (Hb1 should not exceed 12%) 8. Document dequte rteril blood supply s evidenced by n I of 0.65 or greter ontinued on next pge > This document is for informtionl purposes only. Use of this informtion does not gurntee coverge or pyment for these services by Medicre or other pyors. LDs re updted by Medicre nd Medicre contrctors on regulr bsis. Physicins nd other providers should regulrly refer to the pplicble Medicre locl coverge determintions (LDs) for complete informtion on medicl necessity documenttion requirements. Physicins, providers nd hospitls re solely responsible for complince with Medicre nd other pyors lws, rules, nd requirements. pligrf is registered trdemrk of Novrtis 2010 Orgnogenesis, Inc.

6 Tretment: 9. Document mesurement of ulcer (width nd length or circumference nd depth) immeditely prior to ppliction of pligrf sq cm 10. Document whether this is n initil ppliction of pligrf or reppliction. (pligrf is limited to 5 pplictions per ulcer) 11. For pligrf repplictions, document tht pplictions hve been successful (e.g. decrese in size or depth, increse in grnultion tissue) 12. Document the wound dressing chnges nd the stndrd conservtive mesures ccompnying the wound tretment with pligrf 13. Document how the wound site ws prepred, nd how pligrf ws fixted on the wound This document is for informtionl purposes only. Use of this informtion does not gurntee coverge or pyment for these services by Medicre or other pyors. LDs re updted by Medicre nd Medicre contrctors on regulr bsis. Physicins nd other providers should regulrly refer to the pplicble Medicre locl coverge determintions (LDs) for complete informtion on medicl necessity documenttion requirements. Physicins, providers nd hospitls re solely responsible for complince with Medicre nd other pyors lws, rules, nd requirements. pligrf is registered trdemrk of Novrtis 2010 Orgnogenesis, Inc.

7 ID-9 M odes commonly used when billing for pligrf Vricose veins of lower extremities, with ulcer Vricose veins of lower extremities, with inflmmtion Vricose veins of lower extremities, with ulcer nd inflmmtion Postphlebitic syndrome with ulcer Postphlebitic syndrome with ulcer nd inflmmtion hronic venous hypertension with ulcer hronic venous hypertension with ulcer nd inflmmtion Other specified disorders of circultory system, venous (peripherl) insufficiency, unspecified Ulcer of lower limb, unspecified Ulcer of thigh Ulcer of clf Ulcer of nkle Ulcer of heel nd midfoot (Plntr surfce of midfoot) Ulcer of other prt of foot (Toes) Ulcer of other prt of lower limb hronic ulcer of other specified sites Secondry dibetes mellitus without mention of compliction, not stted s uncontrolled, Secondry dibetes mellitus without mention of compliction, uncontrolled Secondry dibetes mellitus with ketocidosis, not stted s uncontrolled, Secondry dibetes mellitus with ketocidosis, uncontrolled Secondry dibetes mellitus with hyperosmolrity, not stted s uncontrolled, Secondry dibetes mellitus with hyperosmolrity, uncontrolled Secondry dibetes mellitus with other com, not stted s uncontrolled, Secondry dibetes mellitus with other com, uncontrolled ontinued on next pge > pligrf is registered trdemrk of Novrtis 2010 Orgnogenesis, Inc.

8 Secondry dibetes mellitus with renl mnifesttions, not stted s uncontrolled, Secondry dibetes mellitus with renl mnifesttions, uncontrolled Secondry dibetes mellitus with ophthlmic mnifesttions, not stted s uncontrolled, Secondry dibetes mellitus with ophthlmic mnifesttions, uncontrolled Secondry dibetes mellitus with neurologicl mnifesttions, not stted s uncontrolled, Secondry dibetes mellitus with neurologicl mnifesttions, uncontrolled Secondry dibetes mellitus with peripherl circultory disorders, not stted s uncontrolled, Secondry dibetes mellitus with peripherl circultory disorders, uncontrolled Secondry dibetes mellitus with other specified mnifesttions, not stted s uncontrolled, Secondry dibetes mellitus with other specified mnifesttions, uncontrolled Secondry dibetes mellitus with unspecified compliction, not stted s uncontrolled, Secondry dibetes mellitus with unspecified compliction, uncontrolled Dibetes With Neurologicl Mnifesttions, Type II Or Unspecified Type, not stted s uncontrolled Dibetes With Neurologicl Mnifesttions, Type I (Juvenile Type), not stted s uncontrolled Dibetes With Neurologicl Mnifesttions, Type II Or Unspecified Type, uncontrolled Dibetes With Neurologicl Mnifesttions, Type I (Juvenile Type), uncontrolled Dibetes With Peripherl ircultory Disorders, Type II Or Unspecified type, not stted s uncontrolled Dibetes With Peripherl ircultory Disorders, Type I (Juvenile Type), not stted s uncontrolled Dibetes With Peripherl ircultory Disorders, Type II Or Unspecified type, uncontrolled Dibetes With Peripherl ircultory Disorders, Type I (Juvenile Type), uncontrolled Dibetes with other specified mnifesttions, type II type, not stted s uncontrolled Dibetes with other specified mnifesttions, type I, not stted s uncontrolled Dibetes with other specified mnifesttions, type II type, uncontrolled Dibetes with other specified mnifesttions, type I, uncontrolled 1 This brief summry is provided for considertion only. ll codes provided herein re for informtion purposes only nd shll not be construed s sttement, promise, or gurntee tht these codes re ccurte or reimbursement will be received. oding requirements re subject to chnge t ny time, therefore check with your locl pyer regulrly to verify prior uthoriztion requirements. pligrf is registered trdemrk of Novrtis 2010 Orgnogenesis, Inc.