DRAFT LCD Reference Article Billing and Coding Article

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

DA57680

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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.

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Contractor Information

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General Information

Source Article ID
A57680
Draft Article ID
DA57680
Original ICD-9 Article ID
Not Applicable
Draft Article Title
Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
Article Type
Billing and Coding
Original Effective Date
N/A
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
ANTICIPATED 07/25/2024
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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.

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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) DL36377 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.

If reporting a skin substitute product with HCPCS code Q4100 (Skin substitute, not otherwise specified) or HCPCS code A4100 (Skin substitute, FDA cleared as a device, 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.

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.

Satisfactory Evidence of FDA Regulatory Requirements

  1. Satisfactory evidence of the U.S. Food and Drug Administration (FDA) regulatory requirements for the skin substitute grafts or cellular and/or tissue-based products (CTPs) 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.
  2. For skin substitute grafts or CTPs 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.

It is recommended that the manufacturer of the particular skin substitute graft or CTP product obtain the appropriate information for FDA regulatory compliance and send to the MAC along with evidence-based literature, if available. Once this information has been received by the MAC, the product will be considered for coverage and placed into the appropriate Code Group.

Utilization Parameters

Application frequency must follow the product labeling. A maximum of two 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.
  7. The HCPCS code of the applicable skin substitute and the units billed must be consistent with the medical record regarding wound description and size.

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description
999x Not Applicable
N/A

Revenue Codes

Code Description
99999 Not Applicable
N/A

CPT/HCPCS Codes

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
Code Description
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

Group 2

(39 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
Code Description
A2002 Mirragen adv wnd mat per sq
A2007 Restrata, per sq cm
A2009 Symphony, per sq cm
A2010 Apis, per square centimeter
A2011 Supra sdrm, per sq cm
A2012 Suprathel, per sq cm
Q4101 Apligraf
Q4102 Oasis wound matrix
Q4104 Integra bmwd
Q4105 Integra drt or omnigraft
Q4106 Dermagraft
Q4107 Graftjacket
Q4108 Integra matrix
Q4110 Primatrix
Q4111 Gammagraft
Q4115 Alloskin
Q4117 Hyalomatrix
Q4121 Theraskin
Q4122 Dermacell, awm, porous sq cm
Q4123 Alloskin
Q4124 Oasis tri-layer wound matrix
Q4127 Talymed
Q4132 Grafix core, grafixpl core
Q4133 Grafix stravix prime pl sqcm
Q4136 Ezderm
Q4141 Alloskin ac, 1 cm
Q4152 Dermapure 1 square cm
Q4158 Kerecis omega3, per sq cm
Q4161 Bio-connekt per square cm
Q4164 Helicoll, per square cm
Q4165 Keramatrix, kerasorb sq cm
Q4166 Cytal, per square centimeter
Q4175 Miroderm
Q4179 Flowerderm, per sq cm
Q4193 Coll-e-derm 1 sq cm
Q4200 Skin te 1 sq cm
Q4203 Derma-gide, 1 sq cm
Q4222 Progenamatrix, per sq cm
Q4238 Derm-maxx, per sq cm

Group 3

(122 Codes)
Group 3 Paragraph

Group 3 Codes:

The following HCPCS codes are Non-Covered:

Group 3 Codes
Code Description
A2001 Innovamatrix ac, per sq cm
A2004 Xcellistem, per sq cm
A2005 Microlyte matrix, per sq cm
A2006 Novosorb synpath per sq cm
A2008 Theragenesis, per sq cm
A2013 Innovamatrix fs, per sq cm
Q4103 Oasis burn matrix
Q4112 Cymetra injectable
Q4113 Graftjacket xpress
Q4114 Integra flowable wound matri
Q4116 Alloderm
Q4118 Matristem micromatrix
Q4125 Arthroflex
Q4126 Memoderm/derma/tranz/integup
Q4128 Flexhd/allopatchhd/matrixhd
Q4130 Strattice tm
Q4134 Hmatrix
Q4135 Mediskin
Q4137 Amnioexcel biodexcel 1sq cm
Q4138 Biodfence dryflex, 1cm
Q4139 Amnio or biodmatrix, inj 1cc
Q4140 Biodfence 1cm
Q4142 Xcm biologic tiss matrix 1cm
Q4143 Repriza, 1cm
Q4145 Epifix, inj, 1mg
Q4146 Tensix, 1cm
Q4147 Architect ecm px fx 1 sq cm
Q4148 Neox neox rt or clarix cord
Q4149 Excellagen, 0.1 cc
Q4150 Allowrap ds or dry 1 sq cm
Q4151 Amnioband, guardian 1 sq cm
Q4153 Dermavest, plurivest sq cm
Q4154 Biovance 1 square cm
Q4155 Neoxflo or clarixflo 1 mg
Q4156 Neox 100 or clarix 100
Q4157 Revitalon 1 square cm
Q4159 Affinity1 square cm
Q4160 Nushield 1 square cm
Q4162 Wndex flw, bioskn flw, 0.5cc
Q4163 Woundex, bioskin, per sq cm
Q4167 Truskin, per sq centimeter
Q4168 Amnioband, 1 mg
Q4169 Artacent wound, per sq cm
Q4170 Cygnus, per sq cm
Q4171 Interfyl, 1 mg
Q4173 Palingen or palingen xplus
Q4174 Palingen or promatrx
Q4176 Neopatch or therion, 1 sq cm
Q4177 Floweramnioflo, 0.1 cc
Q4178 Floweramniopatch, per sq cm
Q4180 Revita, per sq cm
Q4181 Amnio wound, per square cm
Q4182 Transcyte, per sq centimeter
Q4183 Surgigraft, 1 sq cm
Q4184 Cellesta or duo per sq cm
Q4185 Cellesta flowab amnion 0.5cc
Q4186 Epifix 1 sq cm
Q4187 Epicord 1 sq cm
Q4188 Amnioarmor 1 sq cm
Q4189 Artacent ac, 1 mg
Q4190 Artacent ac 1 sq cm
Q4191 Restorigin 1 sq cm
Q4192 Restorigin, 1 cc
Q4194 Novachor 1 sq cm
Q4195 Puraply 1 sq cm
Q4196 Puraply am 1 sq cm
Q4197 Puraply xt 1 sq cm
Q4198 Genesis amnio membrane 1sqcm
Q4199 Cygnus matrix, per sq cm
Q4201 Matrion 1 sq cm
Q4202 Keroxx (2.5g/cc), 1cc
Q4204 Xwrap 1 sq cm
Q4205 Membrane graft or wrap sq cm
Q4206 Fluid flow or fluid gf 1 cc
Q4208 Novafix per sq cm
Q4209 Surgraft per sq cm
Q4210 Axolotl graf dualgraf sq cm
Q4211 Amnion bio or axobio sq cm
Q4212 Allogen, per cc
Q4213 Ascent, 0.5 mg
Q4214 Cellesta cord per sq cm
Q4215 Axolotl ambient, cryo 0.1 mg
Q4216 Artacent cord per sq cm
Q4217 Woundfix biowound plus xplus
Q4218 Surgicord per sq cm
Q4219 Surgigraft dual per sq cm
Q4220 Bellacell hd, surederm sq cm
Q4221 Amniowrap2 per sq cm
Q4224 Hhf10-p per sq cm
Q4225 Amniobind, per sq cm
Q4226 Myown harv prep proc sq cm
Q4227 Amniocore per sq cm
Q4229 Cogenex amnio memb per sq cm
Q4230 Cogenex flow amnion 0.5 cc
Q4231 Corplex p, per cc
Q4232 Corplex, per sq cm
Q4233 Surfactor /nudyn per 0.5 cc
Q4234 Xcellerate, per sq cm
Q4235 Amniorepair or altiply sq cm
Q4237 Cryo-cord, per sq cm
Q4239 Amnio-maxx or lite per sq cm
Q4240 Corecyte topical only 0.5 cc
Q4241 Polycyte, topical only 0.5cc
Q4242 Amniocyte plus, per 0.5 cc
Q4244 Procenta, per 200 mg
Q4245 Amniotext, per cc
Q4246 Coretext or protext, per cc
Q4247 Amniotext patch, per sq cm
Q4248 Dermacyte amn mem allo sq cm
Q4249 Amniply, per sq cm
Q4250 Amnioamp-mp per sq cm
Q4251 Vim, per square centimeter
Q4252 Vendaje, per square centimet
Q4253 Zenith amniotic membrane psc
Q4254 Novafix dl per sq cm
Q4255 Reguard, topical use per sq
Q4256 Mlg complet, per sq cm
Q4257 Relese, per sq cm
Q4258 Enverse, per sq cm
Q4259 Celera per sq cm
Q4260 Signature apatch, per sq cm
Q4261 Tag, per square centimeter
N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

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
Code Description
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).

N/A

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

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
XX000 Not Applicable
N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

N/A

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.

Code Description
999x Not Applicable
N/A

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
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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