Physician Office Billing & Payment Guide

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1 Physician Office Billing & Payment Guide Dermal Regeneration Matrix Dermal Repair Scaffold Ag Antimicrobial Dermal Repair Scaffold

2 Physician Office Billing & Payment Guide Billing and Medicare Payment for Omnigraft and Products In the Physician Office Effective January 1, 2017, Omnigraft Dermal Regeneration Matrix (Omnigraft), Dermal Repair Scaffold () and Ag Antimicrobial Dermal Repair Scaffold ( Ag) are no longer included in the Medicare Part B Average Sales (ASP) file published by the Centers of Medicare and Medicaid Services (CMS). This Physician Office Billing and Payment Guide offers guidance on billing and Medicare payment for these products in the physician office setting, reflective of the products no longer being included in the CMS ASP files. CMS instructions indicate that for drugs/biologicals for which the CMS ASP files do not include the product, Medicare Administrative Contractors (MACs) are to reimburse at Wholesale Acquisition Cost (WAC) plus 6% or based on invoice pricing. Based on contacts with individual MACs, most, if not all, base payment on WAC and not invoices. For more detailed explanation regarding reimbursement for drugs/biologicals not listed in the Medicare ASP File, please refer to the CMS Medicare Claims Processing Manual (100-04), Chapter 17, and Section Manuals/Downloads/clm104c17.pdf (Reference provided on page 3) Claim Submission. Since claims should be paid based on WAC, it may be helpful when submitting a claim for one of the products to include the WAC on the claim. The current WAC can be found in the Red Book Database. Red Book is a National Drug Compendia which Medicare references for drug/biological pricing ( For your convenience, we ve attached the official Red Book pricing for the Omnigraft and products (see Attachment A). To enable claims to be processed efficiently, it s important that Item 19 on the CMS 1500 claim form include the Product Name, the NDC, as well as the WAC for the product, the WAC per square centimeter, and the source of the WAC (e.g., Red Book). (see attachment B) It is Important to ensure the appropriate number of billing units are identified in Item 24G. Example: if using a 4x4 piece of, it would be appropriate to bill for 16 units. Important Note about Billing for Biologicals The specific guidance from CMS on payment for drugs/biologicals not included in the ASP files is contained in section of Chapter 17 of the Medicare Claims Processing Manual, and it states in part: The payment allowance limits for drugs and biologicals that are not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, other than new drugs that are produced or distributed under a new drug application (or other application) approved by the Food and Drug Administration, are based on the published Wholesale Acquisition Cost (WAC) or invoice pricing, except under OPPS where the payment allowance limit is 95 percent of the published. In determining the payment limit based on WAC, the contractors follow the methodology specified in Publication , Chapter 17, Drugs and Biologicals, for calculating the, but substitute WAC for. The payment limit is 106 percent of the lesser of the lowestpriced brand or median generic WAC. MACs shall develop payment allowance limits for covered drugs when CMS does not supply the payment allowance limit on the ASP drug pricing file. At the contractors discretion, contractors may contact CMS to obtain payment limits for drugs not included in the quarterly ASP or NOC files or otherwise made available by CMS on the CMS Web site. If the payment limit is available from CMS, contractors will substitute CMS-provided payment limits for pricing based on WAC or invoice pricing. CMS will provide the payment limits either directly to the requesting contractor or via posting an MS Excel file on the CMS Web site. Applying this guidance from CMS to the Omnigraft and products that are no longer in the CMS ASP files: Coverage for Omnigraft and vary by payers and Medicare contractors. Physicians continuing reporting the products on claims as they have been doing - reporting accurate billing units of service consistent with the dosages described in the HCPCS Q code product descriptor. Payment for product used in the physician office is contractor dependent; products may be reported. Many Medicare contractors require providers to include the name of the product on the claim form. Any billing or payment questions, please reach out to Integra s Reimbursement Hotline at , option 3

3 Sample CMS Claim Form 1500 Item 19 Enter Product Name, NDC, WAC, WAC per sq cm, source of WAC Item 24D/1 Enter Product HCPCS and modifier(s) Item 24 F - Enter Charges Item 21 - Enter Diagnosis code(s) Item 21 B Enter Place of Service Item 24D/2 Enter CPT for Application Item 24 G Enter s (cm2) PLEASE PRINT OR TYPE APPROVED OMB FORM 1500 (02-12) Key Data Elements Item 19: Designate specific product, NDC code, and WAC (Refer to Attachment B for NDC Information) Item 21: Patient diagnosis/condition (refer to ICD-10 CM Coding guideline) Item 24: Column B: Place of Service Physician Office (11) Column D: Enter CPT code(s) for application of skin substitute as well as HCPCS code for specific product (Refer to Attachment C for full CPT and HCPCS code descriptions). Enter Modifier JC to indicate the Skin Substitute was used as a graft. Column E: refers to reference number for primary and secondary diagnosis. Column F: Enter the charges for the services Column G: Insert number of units (sq.cm) (Refer to Attachment B for units/sizes) 2

4 Physician Office Billing & Payment Guide Billing Reminders Modifiers Check to see if modifiers are required with HCPCS Q4105/Q4110 and/or CPT codes used. Common modifiers include: JC - skin substitute used as a graft JW - drug amount discarded/not administered to any patient KX - requirements specified in the medical policy have been met Product Wastage Documentation Requirements Any amount of wasted material should be clearly documented in the medical record with the following information: Date, time, and location of ulcer treated Approximate amount of product unit used Approximate amount of product unit discarded Reason for the wastage Manufacturer s serial/lot/batch or other unit identification number of graft material JW Modifier needs to be included on the claim Wound Size Determining the wound location and surface area is important in order to select the appropriate CPT code. Please reference the CPT descriptions for application of skin substitutes codes (Attachment C). Debridement Debridement of subcutaneous tissue (e.g., Current Procedural Terminology (CPT) codes and 11045, if appropriate) is considered inclusive in the application of skin substitute CPT codes and is not typically separately reimbursed. Payer may have specific guidelines on debridement services, please check with the payer on specific guidance. Diagnosis (s) Order Check with the MAC to ensure diagnoses are in the proper primary and secondary order on claims forms. A Note about the Hotline The Integra Reimbursement Hotline is comprised of a specialized team with experience in wound care reimbursement to support providers and customers in a variety of ways, such as provider education on coverage, coding, and payment mechanisms for Integra products. The Integra Reimbursement Hotline staff provides assistance with the following: General product and service questions Coding and reimbursement education Patient-specific insurance verification Payer policy and LCD review and tracking Prior authorization and pre-determination Claim support Reimbursement Hotline staff can also provide you with information about procedure codes and modifiers, and can help providers review individual payer policies to determine if other codes or a particular modifier is necessary. Staff can provide pre-populated payer prior authorization forms, a template letter of medical necessity submit materials on behalf of the physician and track outcomes until a final reimbursement decision is obtained. 3

5 Attachment A RED BOOK Online Search Results Printing results found for "Product Name: OMNIGRAFT" Applied Filters: Status - Active; Repackagers - Exclude - Results 1-3 of 3 Page 1 of 1 Chg New Product Name Active Ingredient Manufacturer/ Distributor chondroitin 6-sulfate/, OMNIGRAFT bovine chondroitin 6-sulfate/, OMNIGRAFT bovine chondroitin 6-sulfate/, OMNIGRAFT bovine Rpkg Generic Orange Book Identifier Form Strength Route Type SHE -- SHE -- SHE -- Size Dose WAC TOPICAL ea N APPLICATION TOPICAL ea N APPLICATION TOPICAL ea N APPLICATION Copyright Truven Health Analytics Inc. 4

6 Physician Office Billing & Payment Guide Attachment A RED BOOK Online Search Results Printing results found for "Product Name: " Applied Filters: Status - Active; Repackagers - Exclude - Results 1-22 of 22 Page 1 of 1 5 Chg New Product Name Active Manufacturer/ Ingredient Distributor Rpkg Generic Orange Book Identifier Form Strength Route Type Size Dose WAC DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV s ea N

7 Attachment A Results 1-22 of 22 Page 1 of 1 Chg New Product Name Active Manufacturer/ Ingredient Distributor Rpkg Generic Orange Book Identifier Form Strength Route Type Size Dose WAC DEV ea N DEV ea N DEV ea N Copyright Truven Health Analytics Inc. 6

8 Physician Office Billing & Payment Guide Attachment A RED BOOK Online Search Results Printing results found for "Product Name: AG " Applied Filters: Status - Active; Repackagers - Exclude - Results 1-20 of 20 Page 1 of 1 7 Chg New Product Name AG AG AG AG AG AG AG AG AG AG AG AG AG AG AG AG Active Manufacturer/ Ingredient Distributor Rpkg Generic Orange Book Identifier Form Strength Route Type Size Dose WAC DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N DEV ea N

9 Attachment A Results 1-22 of 22 Page 1 of 1 Chg New Product Name Active Manufacturer/ Ingredient Distributor AG AG AG AG Rpkg Generic Orange Book Identifier Form Strength Route Type Size Dose WAC DEV ea N DEV ea N DEV ea N DEV ea N Copyright Truven Health Analytics Inc. 8

10 Physician Office Billing & Payment Guide Attachment B Product Information Omnigraft Dermal Regeneration Matrix Catalog # Description Billable s DFU25251S DFU4041S DFU7071S NDC/NHRIC Omnigraft 2.5cm x 2.5cm 7cm Omnigraft 4cm x 4cm 16cm Omnigraft 7 x 7 cm Dermal Repair Scaffold cm cm x 4cm 16cm cm x 6 cm 36cm cm x 8cm 64cm Revenue HCPCS Wholesale Acquisition Cost (WAC)* Wholesale Acquisition Cost (WAC)* per cm 2 Q4105 $850 $ Q4105 $1250 $ Q4105 $2500 $51.02 Q4110 $1313 $82.06 Q4110 $2624 $72.89 Q4110 $3555 $55.55 Dermal Repair Scaffold mm Disc 18mm Disc 2cm x 2cm 3cm x 3cm 4cm x 4cm 5cm x 5cm 6cm x 6cm 2cm cm cm cm cm cm cm cm x 8cm 64cm Q4110 $485 $ Q4110 $590 $ Q4110 $698 $ Q4110 $845 $93.89 Q4110 $1444 $90.25 Q4110 $2095 $83.80 Q4110 $2886 $80.17 Q4110 $3910 $61.09

11 Dermal Repair Scaffold Fenestrated Catalog # Description Billable s Fenestrated 4cm x 4cm Fenestrated 6cm x 6cm NDC/NHRIC 16cm cm Fenestrated 8cm x 8cm 64cm Ag Antimicrobial Dermal Repair Scaffold Ag 4cm x 4cm 16cm Ag 6cm x 6cm 36cm Ag 8cm x 8cm 64cm Revenue Ag Antimicrobial Dermal Repair Scaffold Fenestrated Ag Fenestrated 4cm x 4cm Ag Fenestrated 6cm x 6cm Ag Fenestrated 8cm x 8cm 16cm cm cm Ag Antimicrobial Dermal Repair Scaffold 2: Ag 2:1 4cm x 4cm Ag 2:1 6cm x 6cm Ag 2:1 8cm x 8cm 16cm cm cm HCPCS Wholesale Acquisition Cost (WAC)* Wholesale Acquisition Cost (WAC)* per cm 2 Q4110 $1313 $82.06 Q4110 $2624 $72.89 Q4110 $3555 $55.55 Q4110 $1509 $94.31 Q4110 $3018 $83.83 Q4110 $ 4088 $63.88 Q4110 $1509 $94.31 Q4110 $3018 $83.83 Q4110 $ 4088 $63.88 Q4110 $1509 $94.31 Q4110 $3391 $94.19 Q4110 $4594 $71.78 **WAC information is obtained from Red Book; please refer to the Red Book listings in Attachment A for WACs as of March 2,

12 Physician Office Billing & Payment Guide Attachment C CPT/HCPCS s for Physician Office Billing CPT Description 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) 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; first 25 sq cm or less wound surface area 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) 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, or 1% of body area of infants and children 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 thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) HCPCS s Q4105 -Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm Q4110 -, per sq cm Contact Us For information related to or Omnigraft Insurance benefit verifications, prior authorization assistance or claims appeal assistance, please contact our Reimbursement Hotline. Phone: Option 3 then Option 1 Fax: smartreimbursement@integralife.com integralife.com/reimbursement or Omnigraft.com Reference: CPT Book Current Procedural Terminology (CPT) copyright 2016 American Medical Association (AMA). All rights reserved. CPT is a registered trademark of the AMA. Fee Schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. Disclaimer: Integra LifeSciences Corporation intends to use reasonable efforts to provide accurate coding advice, but this advice should not be construed as providing clinical advice, dictating reimbursement policy or substituting for the judgment of a practitioner. It is always the provider s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Each provider is responsible for verifying coverage with the patient s insurance carrier. Integra LifeSciences Corporation assumes no responsibility for the timeliness, accuracy and completeness of the information contained herein. Since reimbursement laws, regulations and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists and/or legal counsel regarding coverage, coding and payment issues. Omnigraft,, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the ed States and/or other countries Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0M EN

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