POLICY: PG0203 MEDICAL POLICY: Skin Substitutes and LAST ... · As a clinical practice guideline and checklist to wound care, the concept of DOMINATE is an effective and efficient

POLICY: PG0203

ORIGINAL EFFECTIVE: 01/15/09

LAST REVIEW: 10/8/2019

MEDICAL POLICY: Skin Substitutes and

Wound Repair Procedures

GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.

DESCRIPTION The addition of skin substitutes or 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. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. These products may be derived from allogeneic, xenogeneic, synthetic sources or a combination of any or all of these types of materials. However, without the component of the recipient’s own distinct epithelium and cellular skin elements, permanent skin replacement or coverage by the graft cannot be accomplished. As a clinical practice guideline and checklist to wound care, the concept of DOMINATE is an effective and efficient standard of care in improving wound care. DOMINATE guidelines include Debridement of necrotic tissue and biofilm, Offloading (especially diabetic) wound, Moisture balance (also rule out Malignancy and adjust Medications which may be impairing healing), Infection and Inflammation control, Nutrition to assist healing, Arterial assessment to insure adequate perfusion for healing, Technical Advances, Edema control and Education (offloading, abstinence from tobacco, blood sugar control, swelling control). For diabetic foot ulcers and venous stasis ulcers, it is generally felt that if after one month of “good wound care” (which employs DOMINATE), there has not been a significant reduction in wound measurements (40 – 50%), then it is unlikely the wound will heal by 3 months and it is reasonable and even recommended that a different approach be taken. At that time, considering “Technical Advances” (T) can improve healing outcomes. It is then that cellular and tissue based products (skin substitutes) may be appropriate. It should be noted that the DOMINATE category” Technical Advances” also includes consideration for negative pressure wound therapy as well as hyperbaric oxygen therapy both of which can improve the wound bed in preparation for CTPs. Future advances in wound care may positively affect the timing for using these substitute skin products and this should be kept in mind (WOUNDS 2014;26(1):1-12).

POLICY HMO, PPO, Individual Marketplace, Elite

Cellular or tissue based products (CTPs) Q4101, Q4102, Q4103, Q4104, Q4105, Q4106, Q4107, Q4108, Q4110, Q4111, Q4115, Q4117, Q4118, Q4121, Q4122, Q4123, Q4124, Q4126, Q4127, Q4128, Q4131, Q4132, Q4133, Q4134, Q4135, Q4136, Q4137, Q4140, Q4141, Q4145, Q4146, Q4147, Q4148, Q4151, Q4152, Q4153, Q4154, Q4156, Q4157, Q4158, Q4159, Q4160, Q4161, Q4163, Q4164, Q4165, Q4166, Q4169, Q4172, Q4173, Q4174, Q4175, Q4177, Q4178, Q4186, Q4187, Q4195, Q4196, Q4197 do not require prior authorization.

All other skin substitutes are considered to be "biologic wound dressings" which are part of the relevant service provided and not separately payable. Code 46707 is non-covered.

Advantage

Cellular or tissue based products (CTPs) Q4101, Q4102, Q4103, Q4104, Q4105, Q4106, Q4107, Q4108, Q4110, Q4111, Q4112, Q4113, Q4114, Q4115, Q4116, Q4117, Q4121, Q4123, Q4131, Q4132, & Q4133, Q4158, Q4176-Q4182, Q4186, Q4195, Q4196 do not require prior authorization for Advantage. All other skin substitutes are considered non-covered. Code 46707 does not require prior authorization for Advantage.

HMO, PPO, Individual Marketplace, Elite, Advantage

Application of CTPs for the treatment of lower extremity ulcer disease will be covered when the following conditions are met and documented as appropriate for the individual patient: 1. Presence of neuropathic diabetic foot ulcers for greater than four weeks duration 2. Presence of venous stasis ulcers of greater than one month duration that have failed to respond to documented

conservative measures for greater than one month duration

3. Presence of neuropathic diabetic foot ulcers that have failed to respond to documented conservative measures for greater than one-month duration. These measures must include appropriate steps to offload pressure during treatment.

4. Presence of partial or full-thickness ulcers 5. Measurements of the initial ulcer size, the size following cessation of any conservative management and the

size at the beginning of skin substitute treatment. In all cases, the ulcer must be free of infection and underlying osteomyelitis. Documentation must support that these conditions have been successfully treated, resolved, prior to instituting skin substitute treatment.

CTPs are covered only if they meet FDA approval for that intended usage and patient type (i.e., pediatric or adult), and have sufficient scientific evidence to support their application.

The supply of CTP graft(s) should be reported separately in conjunction with the application 15271- 15278. Select the appropriate code from 15271-15278 based upon location and size of the defect. For biological implant for soft tissue reinforcement, use 15777 in conjunction with primary procedure.

CTPs may be used on burns when skin grafting is not the appropriate option. These covered bioengineered skin substitutes are expected to function as a permanent replacement for lost or damaged skin. They may be used for temporary wound coverage or wound closure as appropriate and medically necessary.

A single application of CTP for any particular ulcer is usually all that is required to affect wound healing in those wounds that are likely to be helped by this therapy. More than three applications to a single wound are usually not expected.

If CTP applications and re-applications show no significant improvement after three separate treatments, additional re-applications are inappropriate and other treatment modalities should be considered.

CTP treatments should not last more than twelve weeks. Improvement of fifty per cent or greater must be documented in the medical records for the reimbursement of additional re-applications after twelve weeks of treatment. If after twelve weeks the medical records do not support the significant improvement of the wound using the CTP treatments, Paramount may recoup any inappropriate reimbursement.

Since application of CTP is considered a physician service, it must be applied by either a physician or a nonphysician practitioner (NPP), and NOT by non-advanced practice nurses, therapists or medical assistants.

CTPs are not separately reimbursable in any institutional setting, including long-term care facility, hospital inpatient, outpatient, or emergency room place of service.

Wound preparation is considered part of the procedure. All products, including dressings, are included in the evaluation and management service and are not separately reimbursable.

Claims submitted with unlisted code Q4100 will be denied if the product is a non-covered treatment. An invoice is required for unlisted code Q4100 for covered treatments. Reimbursement is based on review of the product reported per an individual claim basis. The following treatments for wound care are considered experimental and investigational because there is inadequate evidence in the peer-reviewed medical literature to support their clinical effectiveness (this list may not be all-inclusive):

Adherus Dural Sealant

AlloMax for indications other than breast reconstruction

AlloSource cryopreserved human cadaver skin

AmnioCare

AmnioExCel

AmnioFix

AmnioGenix

AmnioHeal amniotic membrane

Amniomatrix

AmnioMTM

AmnioShield

AmnioStrip

Amniotic fluid injection for corneal wound healing and for prevention of adhesions after orthopedic surgery

Amniox (human embryonic membrane) for tarsel tunnel repair and all other indications

Architect ECM

Architect PX

Artacent Wound

Artelon (poly[urethane urea] elastomer) for anterior cruciate ligament reconstruction, rotator cuff repair, trapezio-metacarpal joint osteoarthritis and all other indications

Arthres GraftRope for acromio-clavicular joint separation reconstruction

Avotermin for improvement of skin scarring

BioDexcel

BioDfactor/BioDfence human amniotic allograft

BioDfence Dryflex

BioDmatrix

BioDRestore Elemental Tissue Matrix

Biostat Biologx fibrin sealant for wound healing and all other indications

Biotape reinforcement matrix for soft tissue augmentation and all other indications

CellerateRX

Clarix 100

Clarix Cord 1K

CollaFix

Conexa reconstructive tissue matrix

CorMatrix ECM Patch for cardiac tissue repair and all other indications

Cortiva Allograft Dermis

C-QUR biosynthetic mesh

CRXa

CYGNUS

Cymetra injectable allograft for wound healing

Cytal Burn Matrix

Cytal Multilayer Wound Matrix

Cytal Wound Matrix

Dehydrated human amniotic membrane allograft (e.g., AmnioPro, BioFix and FlowerPatch)

DermaClose continuous external tissue expander for facilitation of wound closure and all other indications

DermaMatrix (formerly InteXen) Porcine Dermal Matrix for wound healing and other indications other than breast reconstruction

DryFlex (human amnion allograft) for shoulder repair and all other indications

DuraGen Plus dural regeneration matrix for surgical repair of soft tissue deficiencies and all other indications

DuraMatrix

DuraSeal

Durepair Regeneration Matrix

Endoform Dermal Template

ENDURAGen

Epicord (non-coverage for the Advantage Product line, per Ohio Department of Medicaid (ODM) fee schedule)

Epidex

EPIFLO transdermal continuous oxygen therapy for wound healing

Equine-derived decellularized collagen products (e.g., OrthADAPT, Unite, and Unite Biomatrix)

E-Z Derm for wound healing and all other indications

Evicel fibrin sealant for repair of cerebrospinal fluid leakage and all other indications

Excellagen

FloGraft

Fortaderm

Fortaderm Antimicrobial

Fortiva Porcine Dermis;

GORE BIO-A Fistula Plug

Guardian

HydroFix

Inforce

Interfyl

LiquidGen

MariGen

Matriderm

MediHoney

Medeor

Menaflex Collagen Meniscus Implant

Meso BioMatrix

MIRODERM

Neoform Dermis for wound healing; for NeoForm for breast reconstruction

Neox Cord 1K

Neuragen

Neuroflex

NuCel liquid wound covering

OrthADAPT Bioimplant (type I collagen scaffold) for tendon repair and all other indications

OrthoFlo

OsseoGuard

Ovation

PalinGen Flow

PalinGen Hydromembrane

PalinGen Membrane

Palingen SportFlow

PalinGen XPlus Hydromembrane

PalinGen XPlus Membrane

Parietex Composite (PCO) Mesh for the treatment of genito-urinary (e.g., uterine or vaginal vault) prolapse

Peri-Guard Repair Patch

Peri-Strips Dry, and Peri-Strips Dry with Veritas Collagen Matrix

Permacol Biologic Implant for soft tissue surgical repairs, including hernia repair, muscle flap reinforcement, rectal prolapse (including intussusception), rectocele repair, abdominal wall defects, plastic and reconstructive surgery, complex abdominal wall repair and all other indications;

Porcine-derived decellularized collagen products (e.g., Collamend, Cuffpatch, Pelvicol, and Pelvisoft)

Porcine-derived polypropylene composite wound dressing (e.g., Avaulta Plus)

ProMatrX ACF

Promogran Matrix

PTFE felt

Puracol

Puros Dermis

Repliform

Repriza

Seamguard

Silver-coated wound dressings (e.g., Acticoat, Actisorb, and Silversorb) for wound healing and all other indications

Solana allograft

Sonafine wound dressing

SportMatrix

SportMesh

SteriShield II dual layer amnion patch

Strattice Reconstructive Tissue Matrix for wound healing; for Strattice for breast reconstruction

Stravix

Suprathel

Surgisis (including Surgisis AFP Anal Fistula Plug, Surgisis Gold Hernia Repair Grafts, and Surgisis Biodesign)

TenoGlide tendon protector sheet (Tendon WrapTM tendon protector) for the management and protection of tendon injuries and all other indications

TenSIX Acellular Dermal Matrix for tendon repair and all other indications

Tornier BioFiber Absorbable Biological Scaffold, and Tornier Collagen Coated BioFiber Scaffold

Truskin

Unite Biomatrix

Vaso Shield

Veritas Collagen Matrix for use as an implant in the surgical repair of soft tissue deficiencies and all other indications

Viaflow / Viaflow C flowable placental tissue matrices

Vitagel surgical hemostat for wound healing and all other indications

X-Repair

XCM Biologic Tissue Matrix

Xelma

XenMatrix

XWrap Dry or Hydro Plus

Advantage Per the Ohio Department of Medicaid (ODM), providers can request prior authorization to exceed coverage or benefit limits for members under age 21.

Skin Substitute/ Platelet Derived Growth Factor &

Indication

Criteria Surgical

Procedure Codes

DME Item

Adherus Dural Sealant®

Dural repair No specific code

Q4100

Affinity Wound care 15271-15278 Q4159

AlloDerm®

Breast reconstruction

Covered as medically necessary when used in association with a covered, medically necessary breast reconstruction procedure

15271-15274 15777

Q4116

AlloMax™



15271-15274 15777

Q4100

Allopatch HD™ Tendon augmentation No specific code

Q4128

AlloSkin™

Diabetic foot ulcer

Covered as medically necessary when ALL of the following criteria are met: • partial or full-thickness, diabetic foot ulcer of greater than

four weeks duration for which standard wound therapy has failed

• type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12%

• treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of ≥ 0.70

15271-15278 Q4115

AlloSkin RT Wound care 15271-15278 Q4123

Allowrap™ Wound care 15271-15278 Q4150

AmnioBand/Guardian Wound care 15271-15278 Q4151

AmnioCare® Tendon/nerve repair No specific code

Q4100

AmnioExCel

Wound care Soft tissue repair

15271-15278

Q4100

Amniofix®

Tendon/nerve repair

No specific code

Q4100

AmnioMatrix® Wound care 15271-15278 Q4100

Soft tissue repair

AmnioMTM

Wound care Soft tissue repair

15271-15278

Q4100

Apligraf®

Diabetic foot, ankle, & calf ulcers

Venous stasis ulcer

Covered as medically necessary when ALL of the following criteria are met:

full-thickness diabetic foot ulcer of greater than three weeks duration for which standard wound therapy has failed

type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12%

treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of ≥ 0.70

Covered as medically necessary when BOTH of the following criteria are met:

partial- or full-thickness venous stasis ulcer of greater than four weeks duration for which standard wound therapy has failed


Coverage is limited to up to five applications per ulcer.

15271-15278 Q4101

ArthroFlex™ (FlexGraft®)

Shoulder reconstruction Achilles tendon repair

No specific code

Q4125

Biobrane

Burn wound

Covered as medically necessary when used for temporary covering of a partial-thickness freshly debrided or excised burn wound

15271-15278

Q4100

Biobrane-L

Burn wound

Covered as medically necessary when BOTH of the following criteria are met: • temporary covering of a partial-thickness freshly debrided or excised burn wound • adjunct to meshed autograft

15271-15278

Q4100

BioDfence/BioDfactor

Dura Repair

No specific code

Q4100

Biodesign® (Surgisis®) AFP™ Anal Fistula Plug

Anal and rectal fistula repair

46707

Q4100

Biodesign® (Surgisis®) Hiatal Hernia Matrix

Hernia repair

No specific code

Q4100

Biodesign® (Surgisis®) Inguinal Hernia Matrix

Hernia repair

No specific code

Q4100

Biodesign® (Surgisis®) RVP™ Recto-Vaginal Fistula Plug

Recto-vaginal fístula repair

No specific code

Q4100

BioVance® Wound Care 15271-15278 Q4154

Clarix® Flo Integumental tissue repair NA Q4155

Conexa™

Tendon repair

No specific code

Q4100

CorMatrix® ECM® for Cardiac Tissue Repair

Intracardiac patch

No specific code

Q4100

CorMatrix® ECM® for Carotid Repair

Carotid artery repair

No specific code

Q4100

CorMatrix® ECM® for Pericardial Closure

Pericardial repair

No specific code

Q4100

CryoSkin® Wound care 15271-15278 Q4100

Cymetra™

Integumental tissue repair

Covered as medically necessary for repair or replacement of damaged or inadequate integumental tissue.

15271-15278 Q4112

Dermacell™

Wound care Breast reconstruction

15271-15278 15777

Q4122

Dermagraft®

Diabetic foot , ankle, & calf ulcers

Covered as medically necessary when ALL of the following criteria are met: • full-thickness diabetic foot ulcer of greater than six weeks

duration for which standard therapy has failed • type I or type II diabetes mellitus with a hemoglobin A1c

(HbA1C) less than 12% • treated foot has adequate blood supply as evidenced by

either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of ≥ 0.70

Frequency is limited to eight applications per ulcer. Paramount does not cover continued reapplication of Dermagraft ® for the same ulcer if satisfactory and reasonable healing progress is not noted after 12 weeks of therapy.

15275-15278

Q4106

DermaMatrix Acellular Dermis

Facial soft tissue defects Breast reconstruction

15271-15278 15777

Q4100

DermaPure™

Wound care

15271-15278

Q4152

DermaSpan™

Wound covering Tendon repair

15275-15278

Q4126

Dermavest Wound care 15271-15278 Q4153

Duraform™ Dural repair No specific code

Q4100

Duragen® Dural repair No specific code

Q4100

DuraMatrix™ Dural repair No specific code

Q4100

DuraSeal™ Dural Sealant System

Dural repair No specific code

Q4100

DuraSeal™ Spine Sealant System

Dural repair

No specific code

Q4100

Durepair Regeneration Matrix®

Dural repair

No specific code

Q4100

Endoform Dermal Template™

Wound care

Covered as medically necessary with documentation of ANY of the following conditions: 1. Chronic vascular ulcers

2. Diabetic ulcers

3. Pressure ulcers

4. Venous ulcers

5. Draining wounds

6. Partial or full thickness wounds

7. Tunneled, undermined wounds

8. Surgical wounds (i.e., donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence)

9. Trauma wounds (i.e., abrasions, lacerations, second-degree burns, skin tears)

15271-15278 C9367

Epicel

Burn wound

Covered as medically necessary when used according to the U.S. Food and Drug Administration (FDA)-approved Humanitarian Device Exemption (HDE) for an individual with deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30%

15150-15157

Q4100

EpiCord™ EpiCord™ Dehydrated Human Umbilical Cord Allograft is intended for homologous use to provide a protective environment for the healing process. EpiCord® provides a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue.

EpiCord is medically necessary for All of the following:

The patient has a partial of full thickness neuropathic diabetic foot ulcers for greater than 6-week’s duration.

No capsule, tendon, or bone are exposed.

The patient has not responded to conventional ulcer therapy such as: moist dressings, non-weight bearing, optimal glycemic management if diabetic, sharp debridement.

Adequate perfusion of the involved limb.

The requested EpiCord skin substitute is being used along with standard ulcer therapy.

Repeat or alternative applications of skin substitute grafts are not considered medically reasonable and necessary when a previous full course of applications was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization or progress towards closing) for a period of 4 weeks past start of therapy. Re-treatment within one (1) year of any given course of Cellular and/or Tissue Based Products (CTPs) treatment for a venous stasis ulcer or (diabetic) neuropathic foot ulcer is considered treatment failure and does not meet reasonable and necessary criteria for re-treatment of that ulcer with a CTP procedure.

15271-15278

Q4187

Epifix®


Venous stasis ulcer

Epifix is an amniotic membrane allograft used in the treatment of chronic and acute wounds. Epifix is indicated for neuropathic diabetic foot ulcer and venous stasis ulcer that have failed to respond to conservative measures. Coverage is limited to five applications per ulcer. Continued reapplication when the treatment is unsuccessful after 30 days of treatment, retreatment of an ulcer following an unsuccessful course of treatment or retreatment of a successfully treated healed ulcer will not be considered medically necessary.

15271-15278

Q4131 (Code deleted 1/1/19) Q4186

EZ Derm™ Wound care 15271-15278

Q4136

FlexHD® Acellular Hydrated Dermis

Integumental/soft tissue repair Breast reconstruction Hernia repair

15271-15278 15777

Q4128

FloGraft™ Tendonitis 15271-15278 15777

Q4100

Fortaderm™ Wound care 15271-15278 C9349

15777

GammaGraft™

Wound care

Indicated in various types of wounds as a temporary dressing that may require multiple applications

15271-15278 Q4111

GORE BIO-A® Fistula Plug

Anorectal fistulas

46707

Q4100

Grafix® Core

Diabetic foot, ulcer

Venous stasis ulcer

Wound Care Coverage is limited to five applications per ulcer.

15271-15278

Q4132

Grafix® Prime

Diabetic foot, ulcer

Venous stasis ulcer

Wound Care Coverage is limited to five applications per ulcer.

15271-15278 Q4133

GraftJacket® Regenerative Tissue Matrix






Coverage limited to 1 application per ulcer.

15271-15278 Q4107

GraftJacket® Xpress

Diabetic foot ulcer





15271-15278 Q4113

hMatrix® Integumental tissue repair 15271-15278 Q4134

Hyalomatrix® PA

Wound care

15271-15278

Q4117

HydroFix® Vaso Shield

Vessel guard

No specific code

Q4100

Integra® Dermal Regeneration Template Integra™ Bilayer Matrix Wound Dressing Integra™ Matrix Wound Dressing

Management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

15271-15278

Q4105 Q4104 Q4108

Integra™ Meshed Bilayer Wound Matrix

Burn wound

Wound care

C9363

Integra™ Flowable Wound Matrix

Wound care

Covered as medically necessary for tunneled or undermined wounds.

15271-15278 Q4114

Kerecis® Omega3 Wound


Venous stasis ulcer

Wound care Coverage is limited to twelve applications per ulcer.

15271-15278 Q4158

MatriStem® Wound care 15271-15278 Q4118

Matrix HD™ Wound care Tendon repair

15271-15278

Q4100

Mediskin™ Wound care 15271-15278 Q4135

MemoDerm™

Wound care Tendon repair

15271-15278 Q4126

NeoForm™ Dermis



15271-15274 15777

Q4100

Neox® Wound Matrix Wound care 15271-15278 Q4148 Q4156

Neox 1K Wound care 15271-15278 Q4148

Neox 100 Wound care 15271-15278 Q4156

Neox® Flo Wound Care NA Q4155

NeuraGen® Nerve Guide

Peripheral nerve repair No specific code

C9352

NeuraWrap™ Nerve Protector

Peripheral nerve repair No specific code

C9353

NuCel™ Tendon repair No specific code

Q4100

NuShield™ Orthopaedics

Tendon repair No specific code

Q4160

NuShield™ Spine Dura repair No specific code

Q4160

Oasis® Burn Matrix

Burn wound


post excisional treatment of a full-thickness or deep partial-thickness burn

sufficient autograft is not available at time of excision or is contraindicated

15271-15278 Q4103

Oasis® Wound Matrix Oasis® Ultra Tri-Layer Matrix

Covered as medically necessary when ALL of the following criteria are met:

partial or full-thickness, diabetic foot ulcer of greater than four weeks duration for which standard wound therapy has

15271-15278

Q4102 Q4124


Venous stasis ulcer

failed

type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12%



partial or full-thickness, lower extremity venous stasis ulcer of four weeks duration for which standard wound therapy has failed


Coverage is limited to 12 weeks of therapy and up to twelve applications of Oasis® (Q4102) per ulcer.

Orcel®

Burn wounds

Covered as medically necessary for either of the following uses:

Dystrophic epidermolysis bullosa in children who are undergoing reconstructive hand surgery.

Full-thickness (3rd degree) and partial-thickness (2nd degree) thermal burns.

Healing donor site wounds in burn victims.

15271-15278 Q4100

OrthADAPT™ Bioimplant

Soft tissue reinforcement 15271-15278 Q4100

OsseoGuard® Oral defects 15275-15278 Q4100

Ovation® Wound healing 15271-15278 Q4100

Peri-Guard® Repair Patch

Soft tissue repair Pericardial and intracardiac repair

15271-15278 Q4100

Peri-Strips® Dry Staple line reinforcement No specific code

Q4100

Peri-Strips Dry with Veritas Collagen Matrix.

Staple line reinforcement No specific code

Q4100

Permacol™ Soft tissue reinforcement/repair 15271-15278 15777

Q4110; C9364

PriMatrix™ Dermal Repair Scaffold

Wound care

Covered as medically necessary with documentation of ANY of the following: 1. Diabetic ulcers

2. Pressure ulcers

3. Venous ulcers

4. Draining wounds

5. Partial or full thickness wounds

6. Tunneled, undermined wounds

7. Surgical wounds (i.e., donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence)

8. Trauma wounds (i.e., abrasions, lacerations, second-degree burns, skin tears)

15271-15278 Q4110

PuraPly Antimicrobial Wound Matrix (PuraPly AM)

Wound Care No specific code

Q4195

PuraPly Wound Matrix (PuraPly)

Wound Care No specific code

Q4196

Restore® Orthobiologic Soft

Soft tissue reinforcement 15777 Q4100

Tissue Implant

Revitalon™ Wound care 15271-15278 Q4157

SportMesh™ Soft tissue reinforcement 15777 Q4100

Strattice™ Reconstructive Tissue Matrix

Soft tissue reinforcement/repair

15271-15278 15777

Q4130

SurgiMend® Collagen Matrix

Soft tissue reinforcement/repair 15271-15278 15777

C9358; C9360

Talymed™


Coverage is limited to five applications per ulcer. 15271-15278 Q4127

TenoGlide® Tendon Protector Sheet

Tendon repair No specific code

C9356

TheraSkin®


Venous stasis ulcer

When used with standard diabetic foot ulcer care for neuropathic Diabetic Foot Ulcer (DFU)s:

Only if the patient has the current medical diagnosis of either Type I or Type II diabetes mellitus;

Only if the patient does not have a current HbA1C reading exceeding 12%;

Only for full thickness ulcers of greater than three weeks in duration, which extend through the dermis, with or without tendon, muscle, capsule or bone exposure;

Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g., diabetes is provided and documented in conjunction with treatment; and

Only for ulcers located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material.

Covered as medically necessary when the following criteria are met for venous stasis ulcer (VSU):

Only for ulcers that have failed to respond to documented conservative measures of greater than six (6) weeks in duration, that have at minimum included regular dressing changes, debridement of necrotic tissue and standard therapeutic compression. A "failed response" is defined as an ulcer that has increased in size or depth, or for which there has been no change in baseline size or depth and no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress towards closing. Documentation of response or lack thereof, requires measurement of the ulcer at baseline, following cessation of conservative or conventional management. Documentation should also include measurement of the ulcer immediately prior to the placement of TheraSkin®.

Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g. hypertension, is provided and documented in conjunction with the treatment; and

Only for ulcers that are free of infection, redness, drainage, underlying osteomyelitis, surround cellulitis, sinus tracts or tunnels, eschar or any necrotic material.

Coverage is limited to five applications per ulcer.

15271-15278 Q4121

TissueMend Soft tissue repair 15271-15278 Q4100

Tendon repair 15777

Tornier® BioFiber Absorbable Biological Scaffold


Q4100

Tornier® Collagen Coated BioFiber Scaffold


Q4100

Transcyte®

Burn wound

Covered as medically necessary when used for temporary covering of a surgically excised deep partial- or full-thickness burn wound as a covering prior to autografting.

15271-15278

Q4182

XCM Biologic Soft tissue reinforcement/repair 15271-15278 Q4100

XenMatrix™ Surgical Graft

Soft tissue reinforcement/repair 15271-15278 C1781

CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered.

CPT CODES

15150 Tissue cultured skin autograft, trunk, arms, legs; first 25 sq cm or less

15151 Tissue cultured skin autograft, trunk, arms, legs; additional 1 sq cm to 75 sq cm

15152 Tissue cultured skin autograft, trunk, arms, legs; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof

15155 Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 25 sq cm or less

15156 Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; additional 1 sq cm to 75 sq cm

15157 Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof

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

15777 Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (eg, breast, trunk) (List separately in addition to code for primary procedure)

46707 Repair of anorectal fistula with plug (eg: porcine small intestine submucosa [SIS])

HCPCS CODES

C1781 Mesh (implantable)

C9349 Fortaderm, and fortaderm antimicrobial, any type, per square centimeter

C9352 Microporous collagen implantable tube (neuragen nerve guide), per centimeter

C9353 Microporous collagen implantable slit tube (neurawrap nerve protector), per centimeter length

C9356 Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (tenoglide tendon protector sheet), per square centimeter

C9358 Dermal substitute, native, non-denatured collagen, fetal bovine origin (surgimend collagen matrix), per 0.5 square centimeters

C9360 Dermal substitute, native, non-denatured collagen, neonatal bovine origin (surgimend collagen matrix), per 0.5 square centimeters

C9363 Skin substitute, integra meshed bilayer wound matrix, per square centimeter

C9364 Porcine implant, permacol, per square centimeter

C9367 Skin substitute, endoform dermal template, per square centimeter

Q4100 Skin substitute, not otherwise classified

Q4101 Apligraf, per square centimeter

Q4102 Oasis wound matrix, per square centimeter

Q4103 Oasis burn 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

Q4112 Cymetra injectable, 1cc

Q4113 Graftjacket Express injectable 1cc

Q4114 Integra flowable wound matrix, injectable, 1cc

Q4115 AlloSkin per square centimeter

Q4116 AlloDerm, per square centimeter

Q4117 Hyalomatrix, per square centimeter

Q4118 MatriStem micromatrix, 1mg

Q4121 TheraSkin, per square centimeter

Q4122 Dermacell, per square centimeter

Q4123 Alloskin RT, per square centimeter

Q4124 Oasis ultra tri-layer wound matrix, per square centimeter

Q4125 Arthroflex, per square centimeter

Q4126 Memoderm, per square centimeter

Q4127 Talymed, per square centimeter

Q4128 Flexhd or allopatch HD, per square centimeter

Q4130 Strattice TM, per square centimeter

Q4131 EpiFix or Epicord, per square centimeter (Deleted code effective 12/31/18)

Q4132 Grafix CORE and GrafixPL CORE, per square centimeter

Q4133 Grafix prime, grafixpl prime, stravix and stravixpl, per square centimeter

Q4134 hMatrix, per square centimeter

Q4135 Mediskin, per square centimeter

Q4136 EZ-derm, per square centimeter

Q4137 Amnioexcel, amnioexcel plus or biodexcel, per square centimeter

Q4138 BioDfence Dryflex, per square centimeter

Q4139 AmnioMatrix or BioDMatrix, injectable, 1 cc

Q4140 BioDfence, per square centimeter

Q4141 Alloskin AC, 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

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

Q4149 Excellagen, 0.1 cc

Q4150 Allowrap DS or Dry, per square centimeter

Q4151 AmnioBand or Guardian, per square centimeter

Q4152 DermaPure, per square centimeter

Q4153 Dermavest, per square centimeter

Q4154 Biovance, per square centimeter

Q4155 NeoxFlo or ClarixFlo, 1 mg

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

Q4162 WoundEx Flow, BioSkin Flow, 0.5 cc

Q4163 WoundEx, BioSkin, per square centimeter

Q4164 Helicoll, per square centimeter

Q4165 Keramatrix, per square centimeter

Q4166 Cytal, per square centimeter

Q4167 Truskin, per square centimeter

Q4168 Amnioband, 1 mg

Q4169 Artacent wound, per square cm

Q4170 Cygnus, per square cm

Q4171 Interfyl, 1 mg

Q4172 PuraPly, PuraPly antimic (Deleted code effective 12/31/18)

Q4173 Palingen or palingen xplus, per sq cm

Q4174 Palingen/Promatrix 0.36mg/0.25 CC

Q4175 Miroderm, per square cm

Q4176 Neopatch, per square centimeter

Q4177 Floweramnioflo, 0.1 cc

Q4178 Floweramniopatch, per square centimeter

Q4179 Flowerderm, per square centimeter

Q4180 Revita, per square centimeter

Q4181 Amnio wound, per square centimeter

Q4182 Transcyte, per square centimeter

Q4183 Surgigraft, per square centimeter

Q4184 Cellesta, per square centimeter

Q4185 Cellesta flowable amnion (25 mg per cc); per 0.5 cc

Q4186 Epifix, per square centimeter

Q4187 Epicord, per square centimeter

Q4188 Amnioarmor, per square centimeter

Q4189 Artacent ac, 1 mg

Q4190 Artacent ac, per square centimeter

Q4191 Restorigin, per square centimeter

Q4192 Restorigin, 1 cc

Q4193 Coll-e-derm, per square centimeter

Q4194 Novachor, per square centimeter

Q4195 Puraply, per square centimeter

Q4196 Puraply am, per square centimeter

Q4197 Puraply xt, per square centimeter

Q4198 Genesis amniotic membrane, per square centimeter

Q4200 Skin te, per square centimeter

Q4201 Matrion, per square centimeter

Q4202 Keroxx (2.5g/cc), 1cc

Q4203 Derma-gide, per square centimeter

Q4204 Xwrap, per square centimeter

REVISION HISTORY EXPLANATION 07/01/09: Added codes 08/15/10: Updated 01/01/11: Added/deleted codes 01/01/12: Deleted Codes Q4109, 15170, 15171, 15175, 15176, 15330, 15331, 15335, 15336, 15340, 15341, 15360, 15361, 15365, 15366, 15400, 15401, 15420, 15421, 15430, 15431. Added Codes 15271, 15272, 15273, 15374, 15275, 15276, 15277, 15278, C9366, Q4117, Q4118, Q4119, Q4120, and Q4121. 03/11/14: C9359 & C9362 codes removed from this policy as they are bone graft substitute codes. Removed codes 15300-15321, C9354, C9355, & C9361. Added codes Q4131-Q4149, C1781, 15777. Policy reviewed and updated to reflect most current clinical evidence. Approved by Medical Policy Steering Committee as revised. 04/14/15: Added new codes effective 1/1/15 Q4150-Q4160 and C9349. Q4150-Q4160 will require prior authorization for Advantage per ODM guidelines. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 10/13/15: Changes in coverage made due to ODM & Medicare guideline changes. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 10/11/16: Added effective 01/01/16 new codes Q4161-Q4165. Changes in coverage made due to ODM & Medicare guideline updates. These codes are also now covered for Advantage: Q9117, Q4132, & Q4133. These codes are also now covered for HMO, PPO, Individual Marketplace, Elite: Q4103, Q4104, Q4105, Q4108, Q4111, Q4115, Q4117, Q4118, Q4119, Q4120, Q4122, Q4123, Q4124, Q4126, Q4127, Q4129, Q4132, Q4133, Q4134, Q4135, Q4136, Q4137, Q4140, Q4141, Q4146, Q 4147, Q4148, Q4151, Q4152, Q4153, Q4154, Q4156, Q4157, Q4158,

Q4159, Q4160, Q4161, Q4163, Q4164, Q4165. Added wound care as criteria for Integra. Added term Cellular or Tissue Based Products (CTPs) to policy. Incorporated the elements of DOMINATE into policy with a citation to the published site. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 01/10/17: Added effective 01/01/17 new codes Q4166-Q4175 as non-covered for all product lines. Cellular or tissue based products (CTPs) Q4101, Q4102, Q4106, Q4107, Q4121, Q4127, Q4131, Q4132, Q4133, Q4158 will be separately reimbursed, and all other skin substitutes are considered to be "biologic wound dressings" which are part of the relevant service provided and not separately payable for HMO, PPO, Individual Marketplace, & Elite per CMS guidelines. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 06/13/17: Deleted effective 01/01/17 codes Q4119, Q4120, & Q4129. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 01/09/18: Added effective 01/01/18 new codes Q4176-Q4181 as non-covered HMO, PPO, Individual Marketplace, Elite and covered for Advantage per ODM guidelines. Added effective 01/01/18 new code Q4182 as covered for all product lines. Revised effective 01/01/18 codes Q4132, Q4133, Q4148, Q4156, Q4158, Q4162, Q4163. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 03/13/18: Added list of treatments for wound care that are non-covered as considered experimental and investigational. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 07/10/18: Code 46707 is non-covered for all product lines. Code Q4158 is now covered for Advantage per ODM guidelines. Codes Q4103, Q4104, Q4105, Q4108, Q4110, Q4111, Q4115, Q4117, Q4118, Q4122, Q4123, Q4124, Q4126, Q4128, Q4134, Q4135, Q4136, Q4137, Q4140, Q4141, Q4145, Q4146, Q4147, Q4148, Q4151, Q4152, Q4153, Q4154, Q4156, Q4157, Q4159, Q4160, Q4161, Q4163, Q4164, Q4165, Q4169, Q4172, Q4173, Q4174, Q4175, Q4177, Q4178 are now covered for HMO, PPO, Individual Marketplace, Elite per CMS guidelines. Code Q4182 is now non-covered for HMO, PPO, Individual Marketplace, Elite per CMS guidelines. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 01/08/19: Code Q4166 is now covered for Elite per CMS guidelines effective 10/01/18. Code 46707 is covered for Advantage per ODM guidelines. Added effective 01/01/19 new codes Q4183, Q4184, Q4185, Q4188, Q4189, Q4190, Q4191, Q4192, Q4193, Q4194, Q4198, Q4200, Q4201, Q4202, Q4203, Q4204 as non-covered for all product lines per CMS & ODM guidelines. Added effective 01/01/19 new codes Q4186, Q4195, Q4196 as covered for all product lines per CMS & ODM guidelines. Added effective 01/01/19 new codes Q4187 and Q4197 as covered for HMO, PPO, Individual Marketplace, Elite and non-covered for Advantage per CMS & ODM guidelines. Deleted effective 12/31/18 codes Q4131 & Q4172. Revised effective 01/01/19 codes Q4133 & Q4137. Removed deleted codes Q4119, Q4120, Q4129 effective 12/31/16. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 03/19/19: Added procedure code Q4187 EpiCord to the Chart, per the coverage documented above date 01/08/19. And clarified non-coverage for procedure code Q4187 for the Advantage product line, per Ohio Department of Medicaid (ODM) noncoverage. 10/08/19: Correct the documentation for Q4195 and Q4196, PuraPly Antimicrobial Wound Matrix (PuraPly AM) and PuraPly Wound Matrix (PuraPly), supporting coverage within the green box for product lines HMO, PPO, Individual Marketplace and Elite and no longer included in the bullets listed as experimental and investigational products.

REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid http://jfs.ohio.gov/ American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review

http://jfs.ohio.gov/

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POLICY: PG0203 MEDICAL POLICY: Skin Substitutes and LAST ... · As a clinical practice guideline and checklist to wound care, the concept of DOMINATE is an effective and efficient