POLICY: PG0203 MEDICAL POLICY: Skin Substitutes and LAST ... · As a clinical practice guideline...
Transcript of POLICY: PG0203 MEDICAL POLICY: Skin Substitutes and LAST ... · As a clinical practice guideline...
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™
Breast reconstruction
Covered as medically necessary when used in association with a covered, medically necessary breast reconstruction procedure
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
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
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®
Diabetic foot, ankle, & calf ulcers
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
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
Coverage limited to 1 application per ulcer.
15271-15278 Q4107
GraftJacket® Xpress
Diabetic foot ulcer
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
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
Diabetic foot, ankle, & calf ulcers
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
Breast reconstruction
Covered as medically necessary when used in association with a covered, medically necessary breast reconstruction procedure
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
Covered as medically necessary when BOTH of the following criteria are met:
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
Diabetic foot, ankle, & calf ulcers
Venous stasis ulcer
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, lower extremity venous stasis ulcer of four weeks duration for which standard wound therapy has failed
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
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™
Diabetic foot, ankle, & calf ulcers
Coverage is limited to five applications per ulcer. 15271-15278 Q4127
TenoGlide® Tendon Protector Sheet
Tendon repair No specific code
C9356
TheraSkin®
Diabetic foot, ankle, & calf ulcers
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
Soft tissue reinforcement/repair 15271-15278 15777
Q4100
Tornier® Collagen Coated BioFiber Scaffold
Soft tissue reinforcement/repair 15271-15278 15777
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