Clarifying Q-Codes with FlexHD Acellular Hydrated Dermis+ and XCM BIOLOGIC Tissue Matrix

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1 Clarifying Q-Codes with FlexHD Acellular Hydrated Dermis+ and XCM BIOLOGIC Tissue Matrix The information contained in this document is provided for informational purposes only and represents no statement, promise, or guarantee by Ethicon concerning levels of reimbursement, payment, or charge. Similarly, all CPT, ICD-10 and HCPCS codes are supplied for informational purposes only and represent no statement, promise, or guarantee by Ethicon that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payor. CPT codes and descriptions are copyright 2015 American Medical Association. ICD-10 codes and descriptions are copyright 2015 World Health Organization; revise for use in the United States by the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention s (CDC) ational Center for Health Statistics (CHS). Healthcare Common Procedure Coding System (HCPCS) Level II codes and descriptions are copyright 2015 CMS. While we have made an effort to provide information that is current at the time of its issue, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult your counsel, reimbursement specialist or payor organization with regard to reimbursement policies. Physicians should refer to their provider Carrier Manual for their geographic payment. Executive Summary HCPCS is the acronym for the Healthcare Common Procedure Coding System. These codes are frequently used to report supplies and services that are not assigned a Level II CPT code. In some instances, private payor and/or Medicare may provide additional reimbursement for some HCPCS codes. Facilities may use them to track device costs on the facility charge master or super bill. Q-codes are HCPCS codes used in the hospital outpatient setting; not in the hospital inpatient setting. Q-codes were reimbursed separately in the Medicare hospital outpatient until December 31, Applicable skin substitute codes referenced: Effective January 1, 2014 most Q-codes are packaged within an Ambulatory Payment Classification (APC). Q4128 Flex HD, Allopatch HD, or Matrix HD, per square cm (packaged as part of the primary procedure and not separately paid). Q4142 XCM biologic tissue matrix, per square cm (packaged as part of the primary procedure and not separately paid). Hospital Outpatient Facility Center for Medicare and Medicaid Services (CMS) has changed the use of Q-codes in the hospital outpatient setting; CMS is packaging all drugs and biologicals that function as supplies when used in a surgical procedure. This means that Q-codes must be reported, but are not. CMS has assigned Q-codes to 2 categories: 1. High cost skin substitutes (more than $32 per sq. cm) and 2. Low cost skin substitutes (less than $32 per sq. cm). CMS categorizes skin substitutes as high or low cost based on an analysis of average historical cost reported in claims data for each Q-code published annually. 1 Based on the new category requirements, hospitals will have to report the following: High Cost Skin Substitutes (more than $32 per sq. cm) Skin Substitutes assigned to the high cost categories will be reported with Current Procedural Terminology (CPT) codes through and the appropriate Q-code. CPT codes through are for the application of skin substitutes by body area and size (100 sq. cm or larger). Low Cost Skin Substitutes (less than $32 per sq. cm) Skin Substitutes assigned to the low cost categories will be reported with C-codes C5271 through C5278 and the appropriate HCPCS Q-code. Codes C5271 through C5278 are low cost application of skin substitutes by body area and size (100 sq. cm or larger).

2 Surgeon CPT, HCPCS, APC & ASC Codes Surgeon Reimbursement Surgeon CPT Code 2 Procedure High Cost Skin Substitute Graft Application Medicare Payment ational Average Facility 3 Medicare Payment ational Average on-facility 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 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) 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, or 1% of body area of infants and children 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 thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) 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 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) 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, or 1% of body area of infants and children 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 thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) Hospital Outpatient Reimbursement $87 $ Ø9 3Ø HCPCS Code 3 Procedure Status APC Medicare Payment High Cost Skin Substitute Graft Application 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 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) 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, or 1% of body area of infants and children 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 thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) T 5054 $1,411 /A T ,137 /A

3 HCPCS Code 3 Procedure Status APC Medicare Payment 4 High Cost Skin Substitute Graft Application (continued) surface area up to 100 sq cm; first 25 sq cm or less wound surface area T 5054 $1, 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) /A surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children T , surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) /A Low Cost Skin Substitute Graft Application C5271 Application of low cost 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 T C5272 Application of low cost 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) /A C5273 C5274 C5275 C5276 C5277 Application of low cost 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, or 1% of body area of infants and children Application of low cost 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 thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure) total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 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) total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children T ,137 /A T /A separately reimbursed T ,411

4 HCPCS Code 3 Procedure Status APC Medicare Payment 4 Low Cost Skin Substitute Graft Application (continued) C5278 total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure) /A Skin Substitute Supply Codes C9349 FortaDerm, FortaDerm antimicrobial G 1657 $109 Q4121 Theraskin G 1479 $36 OTE: Status code Items and Services Packaged into APC rates (packaged); Status code T Procedure or Service, Multiple Procedure Reduction Applies (separate APC payment); Status code G onpass-through Drugs and onimplantable Biologicals, Including Therapeutic Radiopharmaceuticals (separate APC payment) Free-Standing Ambulatory Surgery Center HCPCS Code 4 Status Medicare Payment 4 High Cost Skin Substitute Graft Application 15271, G2 $ , G2 1, , 15274, 15276, Low Cost Skin Substitute Graft Application separately reimbursed C5271, C5275 G2 240 C5273 G2 1,195 C5277 G2 789 C5272, C5274, C5276, C Skin Substitute Supply Codes separately reimbursed C9349 K2 109 Q4121 K2 36 OTE: Status code 1 Items and Services Packaged into APC rates (packaged); Status code G2 payment based on OPPS relative payment weight; K2 - Drugs and biologicals paid separately when provided integral to a surgical procedure on ASC list, payment based on OPPS rate. HCPCS Code 4 HCPCS Description (per sq. cm.) Status Skin Substitute Assignments to High Cost and Low Cost Groups 5 Skin Substitute Assignments to High Cost and Low Cost Groups C9349 FortaDerm, FortaDerm antimicrobial G High C9358 SurgiMend, fetal ot Listed C936Ø SurgiMend, neonatal ot Listed C9363 Integra Meshed Bil Wound Matrix High Q41ØØ Skin substitute, OS Low Q41Ø1 Apligraf High Q41Ø2 Oasis Wound Matrix Low Q41Ø3 Oasis Burn Matrix High Q41Ø4 Integra Bilayer Matrix Wound Dressing (BMWD) High Q41Ø5 Integra Dermal Regeneration Template (DRT) High Q41Ø6 Dermagraft High Q41Ø7 Graftjacket High Q41Ø8 Integra Matrix High

5 HCPCS Code 4 HCPCS Description (per sq. cm.) Status Skin Substitute Assignments to High Cost and Low Cost Groups 6 Skin Substitute Assignments to High Cost and Low Cost Groups Q411Ø Primatrix High Q4111 GammaGraft Low Q4112 Cymetra, injectable ot Listed Q4113 GraftJacket Xpress ot Listed Q4114 Integra Flowable Wound Matrix ot Listed Q4115 AlloSkin Low Q4116 AlloDerm High Q4117 Hyalomatrix Low Q4118 Matristem Micromatrix ot Listed Q4119 MatriStem Wound Matrix Low Q412Ø MatriStem Burn Matrix High Q4121 Theraskin G High Q4122 DermACELL High Q4123 AlloSkin RT High Q4124 OASIS Ultra Tri-Iayer Wound Matrix Low Q4125 ArthroFlex ot Listed Q4126 MemoDerm, DermaSpan, TranZgraft, or InteguPly High Q4127 Talymed High Q4128 FlexHD, AllopatchHD, or Matrix HD Low Q4129 Unite Biomatrix ot Listed Q413Ø Strattice ot Listed Q4131 Epifix High Q4132 Grafix Core High Q4133 Grafix Prime High Q4134 hmatrix High Q4135 Mediskin Low Q4136 E-Z Derm Low Q4137 AMIOEXCEL or BIODEXCEL High Q4138 Biodfence DryFlex High Q4139 Amnio or BioDMatrix, injectable ot Listed Q414Ø BioDFence High Q4141 AlloSkin AC High Q4142 XCM Biologic Tissue Matrix ot Listed Q4143 Repriza Low Q4145 Epifix, injectable /A Q4146 Tensix Low Q4147 Architect, Architect PX, Architect FX High Q4148 EOX 1K High Q4149 Excellagen ot Listed Q415Ø AlloWrap DS or Dry High Q4151 AmnioBand, Guardian Low

6 HCPCS Code 4 HCPCS Description (per sq. cm.) Status Skin Substitute Assignments to High Cost and Low Cost Groups 6 Q4152 DermaPure Low Q4153 Dermavest High Q4154 BIOVACE Low Q4155 EOXFLO or CLARIXFLO ot Listed Q4156 EOX 100 Low Q4157 Revitalon Low Q4158 MariGen Low Q4159 Affinity High Q416Ø ushield High Q4161 Bio-connekt Low Q4162 Amnio bio and woundex flow Low Q4163 Amnio bio and woundex Low Q4164 Helicoll Low Q4165 Keramatrix Low OTE: Status code Items and Services Packaged into APC rates (packaged); Status code G onpass-through Drugs and onimplantable Biologicals, Including Therapeutic Radiopharmaceuticals (separate APC payment) OTE: Several of these codes were not assigned to a Low/High Cost skin substitute bucket; however, they have status code packaged. 1. Federal Register, Vol. 79, o. 217, Monday, ovember 10, 2014/Rules and Regulations; Final Hospital Outpatient Payment. 2. All Current Procedural Terminology (CPT) five-digit numeric codes, descriptions, numeric modifiers, instructions, guidelines and other material are copyright 2015 American Medical Association. 3. Federal Register, Vol. 80, o. 221, Monday, ovember 16, 2015/Rules and Regulations Physician Conversion Factor (CF) = $35, All Healthcare Common Procedure Coding System (HCPCS) Level II alpha-numeric codes, descriptions, instructions, guidelines and other material are copyright 2015 Centers for Medicare & Medicaid Services (CMS). All Rights Reserved. 5. Federal Register, Vol. 80, o. 220, Friday, ovember 13, 2015/Rules and Regulations; Final Ambulatory Surgery Center Payment. 6. Federal Register, Vol. 79, o. 217, FY 2016 Final HOPPS Rule; Table 50- Skin Substitute Assignments to High Cost and Low Cost Groups Ethicon Reimbursement Support Program (888) accesstocare@its.jnj.com 2016 Ethicon US, LLC. All rights reserved