Summary of Package Insert 1 for PuraPly Antimicrobial Wound Matrix

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Summary of Package Insert 1 for PuraPly Antimicrobial Wound Matrix For States with Non-Published Policies-Novitas Indications Indicated for the management of wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing: Partial and full-thickness wounds Pressure ulcers Venous ulcers Diabetic ulcers Chronic vascular ulcers Tunneled/undermined wounds Surgical wounds (donor sites/grafts, post-mohs surgery, post-laser surgery, podiatric, wound dehiscence) Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) Drainage wounds Coding CPT/HCPCS 1,2 Q4172:PuraPly AM, per square centimeter JW Modifier: Effective January 1, 2017 For all sites service. Claims for discarded drug or biological amount not administered to any patient, shall be submitted using the JW modifier. This modifier, billed on a separate line, will provide payment for the amount of discarded drug or biological. Providers must document the discarded drugs or biologicals in patient's medical record Application Codes 15271: Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 15272: Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 15273: Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area 15274: Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part therof (List separately in addition to code for primary procedure) Application Codes 15275: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits,

Summary of Package Insert 1 for PuraPly AM (continued) genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 15276: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 15277: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area 15278: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part therof (List separately in addition to code for primary procedure) 1 This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. Physicians and other providers should use independent judgment when selecting codes that most appropriately describe the services provided to a patient. Physicians and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements. 2 CPT American Medical Association. All Rights Reserved.

2017 Novitas PI PuraPly AM Sample UB-04 Claim Form Hospital 123 Medical Drive, NJ 00000 01011935 HIC 012345678A 01-2345678 07012016 07012016 111 Maple Avenue NJ 00000 131 All dates should be in eight digit format. Jane Smith 111 Maple Avenue, NJ 00000 636 PuraPly AM, per sq cm Q4172 01012017 24 360 PuraPly AM, per sq cm Q4172 JW 01012017 1 360 Application, first 25 sq cm 15271 01012017 1 Enter appropriate revenue codes for all services provided. Revenue code 636 should be used when billing for Puraply AM. 15271 should be used based on the size of the wound. 5x5 piece of Puraply AM 24 sq cm of the product was used on the wound. 1 sq cm of product was discarded and documented as wastage and therefore billed with a JW Modifier. Medicare A987654 xxx.xx

2017 Novitas PI PuraPly AM Sample 1500 Claim Form Sample CMS-1500 Claim Form Physician Services in an Outpatient Setting 123-45-6789A 12 13 35 00000 (973) 555-1234 00000 973 555-1234 SIGNATURE ON FILE 01 01 17 01 01 17 22 15271 15271 should be used based on the size of the wound. 01-2345678 012345678

2017 Medicare PuraPly/ PuraPly AM Sample CMS-1500 Claim Form Physician Services in an Office Setting 123-45-6789A 12 13 35 00000 (973) 555-1234 00000 973 555-1234 SIGNATURE ON FILE In Box 19 please include name of product, (PuraPly Antimicrobial or PuraPly), and size of product. 01 01 17 01 01 17 11 Q4172 01 01 17 01 01 17 11 Q4172 JW 01 01 17 01 01 17 11 15271 15271 should be used based on the size of the wound. 24 1 1 5x5 piece of Puraply 24 sq cm of the product was used on the wound. 1 sq cm of product was discarded and documented as wastage and therefore billed with a JW Modifier. 01-2345678 012345678

Model Documentation Form for Novitas / Summary of Package Insert for PuraPly Antimicrobial Wound Matrix Treatment: 1. PuraPly AM should not be applied until excessive exudates, bleeding, acute swelling and infection are controlled 2. Duration of ulcer weeks 3. Describe adequate treatment of the underlying disease process contributing to the ulcer 4. Diagnosis of patient 5. Document measurement of ulcer (width and length or circumference and depth) immediately prior to application of PuraPly AM sq cm 6. Document whether this is an initial application of PuraPly AM or a reapplication. 7. For PuraPly AM reapplications, document that applications have been successful (e.g. decrease in size or depth, increase in granulation tissue) 8. Document the wound dressing changes and the standard conservative measures accompanying the wound treatment with PuraPly AM 9. Document how the wound site was prepared, and how PuraPly AM was fixated on the wound Modifiers: JW- Skin substitute not applied to wound, wastage. Product Wastage Documentation Requirements: Date and Time: This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. LCDs are updated by Medicare and Medicare contractors on a regular basis. Physicians and other providers should regularly refer to the applicable Medicare local coverage determinations (LCDs) for complete information on medical necessity documentation requirements. Physicians, providers and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements.

Location of ulcer: Approximate amount of product unit used: Approximate amount of product unit discarded: Reason for the wastage: Manufacture s serial/lot/batch number This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. LCDs are updated by Medicare and Medicare contractors on a regular basis. Physicians and other providers should regularly refer to the applicable Medicare local coverage determinations (LCDs) for complete information on medical necessity documentation requirements. Physicians, providers and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements.