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Draft Local Coverage Article Billing and Coding

Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

DA56696

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Posted: 10/20/2022
Placement of Q4229 in Group 2 was an inadvertent error and placement in group 3 is the correct location of Q4229 for this policy. We apologize for any confusion this has caused. Q4229 like similar amniotic membrane based products, do not meet the coverage requirements outlined in DL36690.

Contractor Information

Draft Article Information

General Information

Source Article ID
A56696
Draft Article ID
DA56696
Draft Article Title
Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
Article Type
Billing and Coding
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Current Dental Terminology © 2022 American Dental Association. All rights reserved.

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CMS National Coverage Policy

Internet-Only Manuals (IOMs):

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    ~ Chapter 15, Section 50.4.1 Approved Use of Drug
  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    ~ Chapter 17, Section 40 Discarded Drugs and Biologicals

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.

Code of Federal Regulations (CFR) References:

  • CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based products

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for Proposed Local Coverage Determination (LCD) DL36690 Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Please refer to the LCD for reasonable and necessary requirements.

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®) codebook definition, skin substitute grafts include non-autologous human 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 application codes are not to be reported for application of non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes.

Do not report non-graft wound dressings or injected skin substitute HCPCS codes with skin substitute graft application codes as this would be considered incorrect coding. Such products are bundled into other standard management procedures if medically necessary and are not separately payable.

Removal of a current graft and/or simple cleansing of the wound and other surgical preparation services are included in the skin substitute graft application codes. Active wound care management (CPT code 97602) procedures should never be reported in conjunction with skin substitute graft application codes.

One would not expect an evaluation and management (E/M) service with each skin replacement surgical procedure (application of skin substitute graft) in an episode of care unless the patient’s condition required a separately identified service.

 

Created on 05/03/2022. Page 3 of 14

 

If reporting a skin substitute product with HCPCS code Q4100 (Skin substitute, not otherwise specified), the product name, package size purchased, amount applied and amount wasted must be reported in the claim narrative/remarks or the claim will be returned to the provider. [HCPCS code A4100 (Skin substitute, FDA cleared as a device, not otherwise specified) will become effective 04/01/2022 and will be added to this paragraph upon finalization of this draft article.]

Skin substitute HCPCS codes included in Group 2 below reported with any application or administration service NOT included in Group 1 below will be denied.

Application codes billed must use the appropriate modifier (e.g., RT, LT) to identify the location where the skin substitute was applied, or the service will be denied.

The appropriate application code must be reported on the same claim as the skin substitute graft code. When the skin substitute graft is denied, the related application code will also be subject to denial.

Skin Substitute Grafts

In order to qualify as skin substitute graft the product must be:

  1. Non-autologous human skin OR
  2. Non-human skin substitute grafts (“ie, xenograft”), OR
  3. form a sheet scaffolding for skin growth

The graft is intended to remain on the recipient and grow in place or have the recipient’s cells grow into the implanted graft material. Products that require regular replacement (i.e. weekly) do not meet this definition.

Utilization Parameters

Application frequency must follow the product labeling. A maximum of four skin substitute graft product applications per wound will be allowed for the episode of skin replacement surgery for wound care (defined as 12-weeks from the first application of a skin substitute graft) for those products recommended per the labeling to require a second application.

Application of a skin substitute graft product beyond the 12-week episode of skin replacement wound care will not be allowed.

Documentation Requirements

  1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
  2. 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.
  3. 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.
  4. The medical record must clearly document that the criteria listed in the LCD has been met, as well as the appropriate diagnosis and response to treatment. Description of the wound(s) must be documented at baseline (prior to beginning conservative wound care measures) relative to size, location, stage, duration, and presence of infection, in addition to the type of conservative treatment given and the response. This information must be updated in the medical record throughout the episode of skin replacement surgery for wound care. The wound description must also be documented pre- and post- treatment with the skin substitute graft being used. The reason(s) for any repeat application should be specifically addressed in the medical record.
  5. Documentation must include an assessment outlining the plan for skin replacement surgery and the choice of skin substitute product for the 12-week period as well as any anticipated repeat applications within the 12-week period. An operative note must support the procedure (e.g., application of skin substitute graft to legs) for the relevant date of service (first application starts the 12-week episode of care) and include the reason for the procedure and a complete description of the procedure including product used (with identifying package label in the chart), and relevant findings.
  6. Any amount of wasted skin substitute must be clearly documented in the procedure note with ALL of the following information (at a minimum): Date, time and location of ulcer(s) treated; Name of skin substitute and 

    package size: Approximate amount of product unit used; Approximate amount of product unit discarded; Reason for the wastage (including the reason for using a package size larger than was necessary for the size of the wound, if applicable); Manufacturer’s serial/lot/batch or other unit identification number of graft material. When the manufacturer does not supply unit identification, the record must document such.

    1. The HCPCS code of the applicable skin substitute and the units billed must be consistent with the medical record regarding wound description and size.
    2. Satisfactory evidence of the U.S. Food and Drug Administration (FDA) regulatory requirements for the skin substitute products included in this billing and coding article includes:
    • A copy of the FDA’s letter to the drug’s manufacturer approving the new drug application (NDA),
    • A listing of the drug or biological in the FDA’s “Approved Drug Products” or “FDA Drug and Device Product Approvals”,
    • A copy of the manufacturer’s package insert approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it, or
    • Information from the FDA’s Website.
    1. For skin substitutes classified as human cells, tissues, and cellular and tissue-based products (HCT/Ps), a letter from the FDA indicating that the HCT/P has met regulatory guidance is acceptable evidence of the FDA regulatory compliance for HCT/Ps regulated under section 361 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act.

Coding Information

CPT/HCPCS Codes

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Group 1

(16 Codes)
Group 1 Paragraph

Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book.

 Group 1 Codes
CodeDescription
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, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
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 THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15275 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
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, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
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 THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
A2001 INNOVAMATRIX AC, PER SQUARE CENTIMETER
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
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)
C5273 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
C5274 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)
C5276 APPLICATION OF LOW COST 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)
C5277 APPLICATION OF LOW COST 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
C5278 APPLICATION OF LOW COST 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)

Group 2

(81 Codes)
Group 2 Paragraph

A CPT/HCPCS code from the Group 1 Codes above must be reported with a HCPCS code from the Group 2 Codes in the table below.

The HCPCS codes included in this list meet the necessary FDA regulatory requirements for indications addressed in this article as of publication. Each product has specific designated approved usage. New products and HCPCS codes will be considered for coverage if meeting the FDA regulatory requirements and criteria.

 

 Group 2 Codes
CodeDescription
A2002 MIRRAGEN ADVANCED WOUND MATRIX, PER SQUARE CENTIMETER
A2007 RESTRATA, PER SQUARE CENTIMETER
A2009 SYMPHONY, PER SQUARE CENTIMETER
A2010 APIS, PER SQUARE CENTIMETER
A2011 SUPRA SDRM, PER SQUARE CENTIMETER
A2012 SUPRATHEL, PER SQUARE CENTIMETER
Q4101 APLIGRAF, PER SQUARE CENTIMETER
Q4102 OASIS WOUND MATRIX, PER SQUARE CENTIMETER
Q4104 INTEGRA BILAYER MATRIX WOUND DRESSING (BMWD), PER SQUARE CENTIMETER
Q4105 INTEGRA DERMAL REGENERATION TEMPLATE (DRT) OR INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX, PER SQUARE CENTIMETER
Q4106 DERMAGRAFT, PER SQUARE CENTIMETER
Q4107 GRAFTJACKET, PER SQUARE CENTIMETER
Q4108 INTEGRA MATRIX, PER SQUARE CENTIMETER
Q4110 PRIMATRIX, PER SQUARE CENTIMETER
Q4111 GAMMAGRAFT, PER SQUARE CENTIMETER
Q4115 ALLOSKIN, PER SQUARE CENTIMETER
Q4117 HYALOMATRIX, PER SQUARE CENTIMETER
Q4121 THERASKIN, PER SQUARE CENTIMETER
Q4122 DERMACELL, DERMACELL AWM OR DERMACELL AWM POROUS, PER SQUARE CENTIMETER
Q4123 ALLOSKIN RT, PER SQUARE CENTIMETER
Q4124 OASIS ULTRA TRI-LAYER WOUND MATRIX, PER SQUARE CENTIMETER
Q4127 TALYMED, PER SQUARE CENTIMETER
Q4132 GRAFIX CORE AND GRAFIXPL CORE, PER SQUARE CENTIMETER
Q4133 GRAFIX PRIME, GRAFIXPL PRIME, STRAVIX AND STRAVIXPL, PER SQUARE CENTIMETER
Q4136 EZ-DERM, PER SQUARE CENTIMETER
Q4137 AMNIOEXCEL, AMNIOEXCEL PLUS OR BIODEXCEL, PER SQUARE CENTIMETER
Q4141 ALLOSKIN AC, PER SQUARE CENTIMETER
Q4147 ARCHITECT, ARCHITECT PX, OR ARCHITECT FX, EXTRACELLULAR MATRIX, PER SQUARE CENTIMETER
Q4148 NEOX CORD 1K, NEOX CORD RT, OR CLARIX CORD 1K, PER SQUARE CENTIMETER
Q4151 AMNIOBAND OR GUARDIAN, PER SQUARE CENTIMETER
Q4152 DERMAPURE, PER SQUARE CENTIMETER
Q4153 DERMAVEST AND PLURIVEST, PER SQUARE CENTIMETER
Q4154 BIOVANCE, PER SQUARE CENTIMETER
Q4156 NEOX 100 OR CLARIX 100, PER SQUARE CENTIMETER
Q4157 REVITALON, PER SQUARE CENTIMETER
Q4158 KERECIS OMEGA3, PER SQUARE CENTIMETER
Q4159 AFFINITY, PER SQUARE CENTIMETER
Q4160 NUSHIELD, PER SQUARE CENTIMETER
Q4161 BIO-CONNEKT WOUND MATRIX, PER SQUARE CENTIMETER
Q4163 WOUNDEX, BIOSKIN, PER SQUARE CENTIMETER
Q4164 HELICOLL, PER SQUARE CENTIMETER
Q4165 KERAMATRIX OR KERASORB, PER SQUARE CENTIMETER
Q4166 CYTAL, PER SQUARE CENTIMETER
Q4169 ARTACENT WOUND, PER SQUARE CENTIMETER
Q4170 CYGNUS, PER SQUARE CENTIMETER
Q4173 PALINGEN OR PALINGEN XPLUS, PER SQUARE CENTIMETER
Q4175 MIRODERM, PER SQUARE CENTIMETER
Q4178 FLOWERAMNIOPATCH, PER SQUARE CENTIMETER
Q4179 FLOWERDERM, PER SQUARE CENTIMETER
Q4180 REVITA, PER SQUARE CENTIMETER
Q4182 TRANSCYTE, PER SQUARE CENTIMETER
Q4183 SURGIGRAFT, PER SQUARE CENTIMETER
Q4186 EPIFIX, PER SQUARE CENTIMETER
Q4187 EPICORD, PER SQUARE CENTIMETER
Q4188 AMNIOARMOR, PER SQUARE CENTIMETER
Q4190 ARTACENT AC, PER SQUARE CENTIMETER
Q4191 RESTORIGIN, PER SQUARE CENTIMETER
Q4193 COLL-E-DERM, PER SQUARE CENTIMETER
Q4194 NOVACHOR, PER SQUARE CENTIMETER
Q4199 CYGNUS MATRIX, PER SQUARE CENTIMETER
Q4200 SKIN TE, PER SQUARE CENTIMETER
Q4203 DERMA-GIDE, PER SQUARE CENTIMETER
Q4204 XWRAP, PER SQUARE CENTIMETER
Q4205 MEMBRANE GRAFT OR MEMBRANE WRAP, PER SQUARE CENTIMETER
Q4209 SURGRAFT, PER SQUARE CENTIMETER
Q4214 CELLESTA CORD, PER SQUARE CENTIMETER
Q4216 ARTACENT CORD, PER SQUARE CENTIMETER
Q4222 PROGENAMATRIX, PER SQUARE CENTIMETER
Q4229 COGENEX AMNIOTIC MEMBRANE, PER SQUARE CENTIMETER
Q4232 CORPLEX, PER SQUARE CENTIMETER
Q4234 XCELLERATE, PER SQUARE CENTIMETER
Q4235 AMNIOREPAIR OR ALTIPLY, PER SQUARE CENTIMETER
Q4237 CRYO-CORD, PER SQUARE CENTIMETER
Q4238 DERM-MAXX, PER SQUARE CENTIMETER
Q4239 AMNIO-MAXX OR AMNIO-MAXX LITE, PER SQUARE CENTIMETER
Q4247 AMNIOTEXT PATCH, PER SQUARE CENTIMETER
Q4248 DERMACYTE AMNIOTIC MEMBRANE ALLOGRAFT, PER SQUARE CENTIMETER
Q4249 AMNIPLY, FOR TOPICAL USE ONLY, PER SQUARE CENTIMETER
Q4251 VIM, PER SQUARE CENTIMETER
Q4252 VENDAJE, PER SQUARE CENTIMETER
Q4253 ZENITH AMNIOTIC MEMBRANE, PER SQUARE CENTIMETER

Group 3

(65 Codes)
Group 3 Paragraph

The following HCPCS codes are Non-Covered:
Group 3 Codes: (79 Codes)

 Group 3 Codes
CodeDescription
A2001 INNOVAMATRIX AC, PER SQUARE CENTIMETER
A2004 XCELLISTEM, 1 MG
A2005 MICROLYTE MATRIX, PER SQUARE CENTIMETER
A2006 NOVOSORB SYNPATH DERMAL MATRIX, PER SQUARE CENTIMETER
A2008 THERAGENESIS, PER SQUARE CENTIMETER
A2013 INNOVAMATRIX FS, PER SQUARE CENTIMETER
Q4103 OASIS BURN MATRIX, PER SQUARE CENTIMETER
Q4112 CYMETRA, INJECTABLE, 1 CC
Q4113 GRAFTJACKET XPRESS, INJECTABLE, 1 CC
Q4114 INTEGRA FLOWABLE WOUND MATRIX, INJECTABLE, 1 CC
Q4116 ALLODERM, PER SQUARE CENTIMETER
Q4118 MATRISTEM MICROMATRIX, 1 MG
Q4125 ARTHROFLEX, PER SQUARE CENTIMETER
Q4126 MEMODERM, DERMASPAN, TRANZGRAFT OR INTEGUPLY, PER SQUARE CENTIMETER
Q4128 FLEX HD, OR ALLOPATCH HD, PER SQUARE CENTIMETER
Q4130 STRATTICE TM, PER SQUARE CENTIMETER
Q4134 HMATRIX, PER SQUARE CENTIMETER
Q4135 MEDISKIN, PER SQUARE CENTIMETER
Q4138 BIODFENCE DRYFLEX, PER SQUARE CENTIMETER
Q4139 AMNIOMATRIX OR BIODMATRIX, INJECTABLE, 1 CC
Q4140 BIODFENCE, PER SQUARE CENTIMETER
Q4142 XCM BIOLOGIC TISSUE MATRIX, PER SQUARE CENTIMETER
Q4143 REPRIZA, PER SQUARE CENTIMETER
Q4145 EPIFIX, INJECTABLE, 1 MG
Q4146 TENSIX, PER SQUARE CENTIMETER
Q4149 EXCELLAGEN, 0.1 CC
Q4150 ALLOWRAP DS OR DRY, PER SQUARE CENTIMETER
Q4155 NEOXFLO OR CLARIXFLO, 1 MG
Q4162 WOUNDEX FLOW, BIOSKIN FLOW, 0.5 CC
Q4167 TRUSKIN, PER SQUARE CENTIMETER
Q4168 AMNIOBAND, 1 MG
Q4171 INTERFYL, 1 MG
Q4174 PALINGEN OR PROMATRX, 0.36 MG PER 0.25 CC
Q4176 NEOPATCH OR THERION, PER SQUARE CENTIMETER
Q4177 FLOWERAMNIOFLO, 0.1 CC
Q4181 AMNIO WOUND, PER SQUARE CENTIMETER
Q4184 CELLESTA OR CELLESTA DUO, PER SQUARE CENTIMETER
Q4185 CELLESTA FLOWABLE AMNION (25 MG PER CC); PER 0.5 CC
Q4189 ARTACENT AC, 1 MG
Q4192 RESTORIGIN, 1 CC
Q4195 PURAPLY, PER SQUARE CENTIMETER
Q4196 PURAPLY AM, PER SQUARE CENTIMETER
Q4197 PURAPLY XT, PER SQUARE CENTIMETER
Q4198 GENESIS AMNIOTIC MEMBRANE, PER SQUARE CENTIMETER
Q4201 MATRION, PER SQUARE CENTIMETER
Q4202 KEROXX (2.5G/CC), 1CC
Q4206 FLUID FLOW OR FLUID GF, 1 CC
Q4208 NOVAFIX, PER SQUARE CENITMETER
Q4210 AXOLOTL GRAFT OR AXOLOTL DUALGRAFT, PER SQUARE CENTIMETER
Q4211 AMNION BIO OR AXOBIOMEMBRANE, PER SQUARE CENTIMETER
Q4212 ALLOGEN, PER CC
Q4213 ASCENT, 0.5 MG
Q4215 AXOLOTL AMBIENT OR AXOLOTL CRYO, 0.1 MG
Q4217 WOUNDFIX, BIOWOUND, WOUNDFIX PLUS, BIOWOUND PLUS, WOUNDFIX XPLUS OR BIOWOUND XPLUS, PER SQUARE CENTIMETER
Q4218 SURGICORD, PER SQUARE CENTIMETER
Q4219 SURGIGRAFT-DUAL, PER SQUARE CENTIMETER
Q4220 BELLACELL HD OR SUREDERM, PER SQUARE CENTIMETER
Q4221 AMNIOWRAP2, PER SQUARE CENTIMETER
Q4224 HUMAN HEALTH FACTOR 10 AMNIOTIC PATCH (HHF10-P), PER SQUARE CENTIMETER
Q4225 AMNIOBIND, PER SQUARE CENTIMETER
Q4229 COGENEX AMNIOTIC MEMBRANE, PER SQUARE CENTIMETER
Q4230 COGENEX FLOWABLE AMNION, PER 0.5 CC
Q4256 MLG-COMPLETE, PER SQUARE CENTIMETER
Q4257 RELESE, PER SQUARE CENTIMETER
Q4258 ENVERSE, PER SQUARE CENTIMETER

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

(21 Codes)
Group 1 Paragraph

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.

The following ICD-10-CM codes support medical necessity and provide coverage for the HCPCS codes in Group 2 above.

 

 Group 1 Codes
CodeDescription
E08.621* Diabetes mellitus due to underlying condition with foot ulcer
E09.621* Drug or chemical induced diabetes mellitus with foot ulcer
E10.621* Type 1 diabetes mellitus with foot ulcer
E11.621* Type 2 diabetes mellitus with foot ulcer
E13.621* Other specified diabetes mellitus with foot ulcer
I87.311* Chronic venous hypertension (idiopathic) with ulcer of right lower extremity
I87.312* Chronic venous hypertension (idiopathic) with ulcer of left lower extremity
I87.313* Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity
I87.331* Chronic venous hypertension (idiopathic) with ulcer and inflammation of right lower extremity
I87.332* Chronic venous hypertension (idiopathic) with ulcer and inflammation of left lower extremity
I87.333* Chronic venous hypertension (idiopathic) with ulcer and inflammation of bilateral lower extremity
L97.112 Non-pressure chronic ulcer of right thigh with fat layer exposed
L97.122 Non-pressure chronic ulcer of left thigh with fat layer exposed
L97.212 Non-pressure chronic ulcer of right calf with fat layer exposed
L97.222 Non-pressure chronic ulcer of left calf with fat layer exposed
L97.312 Non-pressure chronic ulcer of right ankle with fat layer exposed
L97.322 Non-pressure chronic ulcer of left ankle with fat layer exposed
L97.412 Non-pressure chronic ulcer of right heel and midfoot with fat layer exposed
L97.422 Non-pressure chronic ulcer of left heel and midfoot with fat layer exposed
L97.812 Non-pressure chronic ulcer of other part of right lower leg with fat layer exposed
L97.822 Non-pressure chronic ulcer of other part of left lower leg with fat layer exposed
Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*When reporting E08.621, E09.621, E10.621, E11.621, E13.621, I87.311, I87.312, I87.313, I87.331, I87.332 or I87.333, one of the L97 ICD-10 codes in the above table must also be reported (the L97 codes are standalone codes if they are listed in the table above).

ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Additional ICD-10 Information

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Bill 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.

CodeDescription
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.

99999


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Other Coding Information

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Associated Documents

Related National Coverage Documents
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CMS Manual Explanations URLs
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09/26/2022 N/A N/A You are here

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