https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=54117
Billing and Coding: Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds
A54117
Contractor Information
| Contractor Name | Contract Type | Contract Number | Jurisdiction | States |
|---|---|---|---|---|
| Novitas Solutions, Inc. | A and B MAC | 04111 - MAC A | J - H | Colorado |
| Novitas Solutions, Inc. | A and B MAC | 04112 - MAC B | J - H | Colorado |
| Novitas Solutions, Inc. | A and B MAC | 04211 - MAC A | J - H | New Mexico |
| Novitas Solutions, Inc. | A and B MAC | 04212 - MAC B | J - H | New Mexico |
| Novitas Solutions, Inc. | A and B MAC | 04311 - MAC A | J - H | Oklahoma |
| Novitas Solutions, Inc. | A and B MAC | 04312 - MAC B | J - H | Oklahoma |
| Novitas Solutions, Inc. | A and B MAC | 04411 - MAC A | J - H | Texas |
| Novitas Solutions, Inc. | A and B MAC | 04412 - MAC B | J - H | Texas |
| Novitas Solutions, Inc. | A and B MAC | 04911 - MAC A | J - H | Colorado New Mexico Oklahoma Texas |
| Novitas Solutions, Inc. | A and B MAC | 07101 - MAC A | J - H | Arkansas |
| Novitas Solutions, Inc. | A and B MAC | 07102 - MAC B | J - H | Arkansas |
| Novitas Solutions, Inc. | A and B MAC | 07201 - MAC A | J - H | Louisiana |
| Novitas Solutions, Inc. | A and B MAC | 07202 - MAC B | J - H | Louisiana |
| Novitas Solutions, Inc. | A and B MAC | 07301 - MAC A | J - H | Mississippi |
| Novitas Solutions, Inc. | A and B MAC | 07302 - MAC B | J - H | Mississippi |
| Novitas Solutions, Inc. | A and B MAC | 12101 - MAC A | J - L | Delaware |
| Novitas Solutions, Inc. | A and B MAC | 12102 - MAC B | J - L | Delaware |
| Novitas Solutions, Inc. | A and B MAC | 12201 - MAC A | J - L | District of Columbia |
| Novitas Solutions, Inc. | A and B MAC | 12202 - MAC B | J - L | District of Columbia |
| Novitas Solutions, Inc. | A and B MAC | 12301 - MAC A | J - L | Maryland |
| Novitas Solutions, Inc. | A and B MAC | 12302 - MAC B | J - L | Maryland |
| Novitas Solutions, Inc. | A and B MAC | 12401 - MAC A | J - L | New Jersey |
| Novitas Solutions, Inc. | A and B MAC | 12402 - MAC B | J - L | New Jersey |
| Novitas Solutions, Inc. | A and B MAC | 12501 - MAC A | J - L | Pennsylvania |
| Novitas Solutions, Inc. | A and B MAC | 12502 - MAC B | J - L | Pennsylvania |
| Novitas Solutions, Inc. | A and B MAC | 12901 - MAC A | J - L | Delaware District of Columbia Maryland New Jersey Pennsylvania |
Article Information
General Information
A54117
Billing and Coding: Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds
Billing and Coding
10/01/2015
08/13/2020
N/A
N/A
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CMS National Coverage Policy
Social Security Act (Title XVIII) Standard References:
- Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.
Article Guidance
This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L35041, Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds. Please refer to the LCD for reasonable and necessary requirements.
The addition of Skin Substitutes, Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing.
The individual products will continue to be identified with a Level II Healthcare Common Procedure Coding System (HCPCS) supply code from the section of the manual entitled “Skin Substitutes”.
The Current Procedural Terminology (CPT) application CPT codes 15271-15278 intended for the use of skin substitutes is entitled “Skin Substitute Grafts”. The skin replacement surgery Skin Substitute Grafts application guidelines in the current CPT codebook provide an overview of the types of procedures performed, measurement of the wound surface area, and reporting of skin closure, biological dressing, and supply of the skin substitute graft material.
These procedures are not to be reported for application of non-graft wound dressings or for a biologic implant for soft tissue reinforcement.
Coding Guidance:
Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.
Per the Current Procedural Terminology (CPT) definition, skin substitute grafts include non-autologous skin (dermal or epidermal, cellular and acellular) grafts (e.g., homograft, allograft), non-human skin substitute grafts (i.e., xenograft), and biological products that form a sheet scaffolding for skin growth. Skin substitute graft codes are not to be reported for application of non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes.
Non-graft wound dressings or injected skin substitue codes are not used with skin replacement surgery application codes and are considered incorrect coding. Such products are bundled into other standard management procedures if medically necessary and not separately payable.
Claims reporting skin substitute grafts must contain the presence of an appropriate application CPT code.
If the service for the application code is denied, the service for the skin substitute will also be denied.
Effective 01/01/2017, per CR 9603, when billing for Part B drugs and biologicals (except those provided under Competitive Acquisition Program [CAP] for Part B drugs and biologicals), the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.
Novitas expects that where multiple sizes of a specific product are available, the size that best fits the wound with the least amount of wastage will be utilized.
When a portion of a drug/biological is discarded, the medical record must clearly document the amount administered and the amount wasted. The documentation must include the date, time, amount of medication wasted, and the reason for the wastage.
In situations where a portion of a single use package must be discarded, payment will be made for the portion discarded along with the amount applied up to the amount of the product on the package label. Medical record documentation must clearly indicate the information noted above.
Note: The unused portion must actually be discarded and may not be used for another patient.
Documentation Requirements
- All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
Coding Information
CPT/HCPCS Codes
Group 1
(22 Codes)Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book.
The following CPT/HCPCS codes outlined in this Billing and Coding Article will not have diagnosis code limitations applied at this time.
Group 1 Codes| Code | Description |
|---|---|
| 15002 | Wound prep trk/arm/leg |
| 15003 | Wound prep addl 100 cm |
| 15004 | Wound prep f/n/hf/g |
| 15005 | Wnd prep f/n/hf/g addl cm |
| 15040 | Harvest cultured skin graft |
| 15050 | Skin pinch graft |
| 15271 | Skin sub graft trnk/arm/leg |
| 15272 | Skin sub graft t/a/l add-on |
| 15273 | Skin sub grft t/arm/lg child |
| 15274 | Skn sub grft t/a/l child add |
| 15275 | Skin sub graft face/nk/hf/g |
| 15276 | Skin sub graft f/n/hf/g addl |
| 15277 | Skn sub grft f/n/hf/g child |
| 15278 | Skn sub grft f/n/hf/g ch add |
| C5271 | Low cost skin substitute app |
| C5272 | Low cost skin substitute app |
| C5273 | Low cost skin substitute app |
| C5274 | Low cost skin substitute app |
| C5275 | Low cost skin substitute app |
| C5276 | Low cost skin substitute app |
| C5277 | Low cost skin substitute app |
| C5278 | Low cost skin substitute app |
CPT/HCPCS Modifiers
N/AICD-10-CM Codes that Support Medical Necessity
Group 1
(1 Code)It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.
Group 1 Codes| Code | Description |
|---|---|
| XX000 | Not Applicable |
ICD-10-CM Codes that DO NOT Support Medical Necessity
Group 1
(1 Code)N/A
Group 1 Codes| Code | Description |
|---|---|
| XX000 | Not Applicable |
Additional ICD-10 Information
N/ABill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.
| Code | Description |
|---|---|
| 999x | Not Applicable |
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.
| Code | Description |
|---|---|
| 99999 | Not Applicable |
Other Coding Information
N/ARevision History Information
| Revision History Date | Revision History Number | Revision History Explanation |
|---|---|---|
| 08/13/2020 | R21 | Article revised and published on 08/13/2020. Based on review of this billing and coding article, the “Coding Guidance” section was updated to include proper coding information in regards to skin replacement surgery application codes and non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes. |
| 07/01/2020 | R20 | Article revised and published on 06/25/2020 effective for dates of service on and after 07/01/2020 to remove the parenthetical note related to examples of procedures not to be reported for application of non-graft wound dressings. Group 2 paragraph and codes have been deleted as Q codes representing skin substitutes, are covered when administered and consistent with the related LCD and billed with application codes. A note was added to the text to indicate HCPCS codes Q4177 and Q4206 are exceptions and do not require an application code. HCPCS codes Q4177 and Q4206 are retroactively covered for all dates of service when not billed with application codes 15271-15278. |
| 04/30/2020 | R19 | Article revised and published on 04/30/2020 effective for dates of service on and after 01/01/2020. The following CPT/HCPCS code has been added to group 2: Q4170. |
| 03/12/2020 | R18 | Article revised and published on 03/12/2020 effective for dates of service on and after 10/01/2019. The following HCPCS code has been added to group 2: Q4226. Standard language and format changes have been made throughout the article. |
| 02/13/2020 | R17 | Article revised and published in response to provider inquiries. Healthcare Common Procedure Coding System (HCPCS) code Q4197 and Q4184 were added to the article on 02/13/2020 effective for dates of services on and after 10/21/2019. |
| 01/01/2020 | R16 | Article revised and published on 01/16/2020 effective for dates of service on and after 01/01/2020 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS code(s) have been added to the CPT/HCPCS code Group 2 in the article: Q4208, Q4209, Q4210, Q4211, Q4214, Q4216, Q4217, Q4218, Q4219, Q4220, Q4221 and Q4222. For the following CPT/HCPCS code(s) either the short description and/or the long description has been changed. Depending on which description is used in this article, there may not be any change in how the code displays in the document: Q4122 and Q4165. |
| 10/01/2019 | R15 | Article revised and published on 10/31/2019 in response to the October 2019 Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes. The following HCPCS have undergone a code descriptor change: Q4165 and Q4122. |
| 09/26/2019 | R14 | Article revised and published on 09/26/2019. In addition to the changes made in Revision History Number 13 below, due to system changes, the order of the Coding Section has been revised and new sections for CPT/HCPCS Modifiers and Other Coding Information have been made. |
| 09/26/2019 | R13 | Article revised and published on 09/26/2019 efective for dates of service on and after 02/04/2019 to add codes Q4183, Q4187, Q4188 and Q4203 to Group 2 CPT/HCPCS codes. |
| 03/21/2019 | R12 | Article revised and published on 03/21/2019 All codes from L35041, Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds, have been placed in this article per CMS Change Request 10901. Billing instruction for HCPCS code Q4172 has been removed due to code deleted with 2019 HCPCS Update. Article title has been changed to clarify that the Article is providing billing and coding information. |
| 01/01/2019 | R11 | Article revised and published on 02/14/2019 effective for dates of service on and after 01/01/2019 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS code(s) have been deleted and therefore removed from the Article: Q4131 and Q4172. The following CPT/HCPCS code(s) have been added to Group 2 Codes: Q4186, Q4190, Q4195 and Q4196. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. Depending on which description is used in this Article, there may not be any change in how the code displays in the document: Q4133 and Q4137. |
| 09/17/2018 | R10 | Article revised and published on 11/08/2018 effective for dates of service on and after 09/17/2018 to add the following HCPCS code to CPT/HCPCS Code Group 2: Q4180. |
| 07/26/2018 | R9 | Article revised and published on 07/26/2018 to add HCPCS code Q4178 to CPT/HCPCS Code Group 2 effective for dates of service on and after 04/09/2018. |
| 04/12/2018 | R8 | Article revised and published on 04/12/2018 to revise statement that an appropriate application CPT code is necessary when billing a skin substitute Q code. |
| 01/01/2018 | R7 | Article revised and published on 01/25/2018 effective for dates of service on and after 01/01/2018 to reflect the annual CPT/HCPCS code updates. For the following CPT/HCPCS codes either the short description and/or the long description was changed: Q4132, Q4133, Q4148, Q4156, Q4158, Q4163. Depending on which description is used in this article there may not be any change in how the codes display in the document. |
| 05/05/2017 | R6 | Article revised and published 07/13/2017 effective for dates of service on and after 05/05/2017 to add the following CPT/HCPCS code to Group 2: Q4169. Revision history from 05/11/2017 should reflect that the article (not LCD) was revised. |
| 01/01/2017 | R5 | LCD revised and published on 05/11/2017 effective for dates of service on and after 01/01/2017 to add the following CPT/HCPCS codes to Group 2: Q4173 and Q4175. |
| 01/01/2017 | R4 | Article revised and published on 01/12/2017 effective for dates of service on and after 01/01/2017 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS codes: C9349, Q4119, Q4120, and Q4129 have been deleted and therefore removed from group 2 of the Article. The following CPT/HCPCS codes: Q4166 and Q4172 have been added to group 2 of the Article. References to HCPCS code C9349 in the Coding Guidance section have been revised to HCPCS code Q4172. For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: Q4105 and Q4131. Coding Guidance added regarding use of JW modifier. |
| 04/18/2016 | R3 | Article revised and published on 07/14/2016 effective for dates of service on and after 04/18/2016 to add HCPCS code Q4128 to the Group 2 codes. |
| 01/01/2016 | R2 | Article revised and published on 01/28/2016 effective for dates of service on and after 01/01/2016 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS codes have been added to Group 2: Q4161, Q4163, Q4164, and Q4165. For the following CPT/HCPCS code, either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: Q4153. |
| 10/01/2015 | R1 | Article revised and published on 08/13/2015 to add HCPCS codes Q4146 and Q4147. The HCPCS code descriptor for C9349 has changed in response to the 2015 HCPCS Quarter 3 update. |
Associated Documents
LCDs
L35041 - Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds
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| Updated On | Effective Dates | Status | |
|---|---|---|---|
| 08/06/2020 | 08/13/2020 - N/A | Currently in Effect | You are here |
| Some older versions have been archived. Please visit the MCD Archive Site to retrieve them. | |||
