Bioengineered Skin and Tissue Substitutes
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Bioengineered Skin and Tissue Substitutes
Policy Number: PG0203 ADVANTAGE | ELITE | HMO
Last Review: 10/21/2021 INDIVIDUAL MARKETPLACE |
PROMEDICA MEDICARE
PLAN | PPO
GUIDELINES
This policy does not certify benefits or authorization of benefits, which is designated by each individual
policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or
guarantee regarding coverage or reimbursement/payment. Self-Insured group specific policy will
supersede this general policy when group supplementary plan document or individual plan decision
directs otherwise.
Paramount applies coding edits to all medical claims through coding logic software to evaluate the
accuracy and adherence to accepted national standards.
This medical policy is solely for guiding medical necessity and explaining correct procedure reporting
used to assist in making coverage decisions and administering benefits.
SCOPE
X Professional
X Facility Inpatient/Outpatient
DESCRIPTION
The addition of skin substitutes cellular or tissue-based products (CTPs) to certain wounds may afford a healing
advantage over dressings and conservative treatments when these options appear insufficient to affect complete
healing. Presently, there is no universally accepted classification system that allows for simple categorization of all
the products that are commercially available. Skin substitutes can be classified based on clinical features, including
replaced skin component (epidermis, dermis, or both) or required permanence (temporary, permanent), or by
composition, including material used (biologic, synthetic, or both), layering (single layer, bilayer), and cellularity
(acellular, cellular). There are currently wide varieties of bioengineered products available for skin and soft tissue
coverage to affect healing.
Products commonly described as “CTPs” are regulated by FDA. These products may be derived from human
tissue (autologous or allogeneic), nonhuman tissue (xenogeneic), synthetic sources or a combination of any or all
of these types of materials. The goal of Bioengineered Skin and Tissue Substitutes therapy is to provide a
temporary biologic dressing that encourages skin tissue regeneration and wound healing through its own natural
contingent of growth factors and proteins. The bioengineered skin substitute delivers new cells to the wound, which
are able to adjust to the microenvironment of the wound and stimulate healing. There are many potential
applications for these products, including breast reconstruction, chronic full-thickness diabetic lower-extremity
ulcers, venous ulcers, and severe burns.
Consideration is given to the use of dermal or epidermal substitute tissue of human or non-human origin, with or
without bioengineered or processed elements, with or without metabolically active elements, with a designated use
as coverage for a superficial skin deficit that has persisted, despite optimal wound care for a period of 4 weeks or
greater. These products are those referred to as Human Cellular or Tissue Based Products (CTPs) or Skin
Substitutes.
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
PG0203 – 10/21/20212
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.
POLICY
Effective December 1st, 2021 Cellular and Tissue Based Products (CTPs) Coverage/Noncoverage
now also applies to Facility Services.
Effective June 1st, 2021 Cellular and Tissue Based Products (CTPs)
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage
Procedure Q4100-Skin Substitute,nos, requires a prior authorization for ALL product lines
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan
The following covered cellular or tissue based products (CTPs) do not require prior authorization.
Q4101, Q4102, Q4105, Q4106, Q4107, Q4116, Q4122, Q4128, Q4132, Q4133, Q4151, Q4154, Q4186,
Q4187, Q4195, Q4196, Q4197
The following are non-covered cellular or tissue based products (CTPs)
A6460, A6461, Q4103, Q4104, Q4108, Q4110, Q4111, Q4112, Q4113, Q4114, Q4115, Q4117, Q4118,
Q4121, Q4123, Q4124, Q4125, Q4126, Q4127, Q4130, Q4134, Q4135, Q4136, Q4137, Q4138, Q4139,
Q4140, Q4141, Q4142, Q4143, Q4145, Q4146, Q4147, Q4148, Q4149, Q4150, Q4152, Q4153, Q4155,
Q4156, Q4157, Q4158, Q4159, Q4160, Q4161, Q4162, Q4163, Q4164, Q4165, Q4166, Q4167, Q4168,
Q4169, Q4170, Q4171, Q4173, Q4174, Q4175, Q4176, Q4177, Q4178, Q4179, Q4180, Q4181, Q4182,
Q4183, Q4184, Q4185, Q4188, Q4189, Q4190, Q4191, Q4192, Q4193, Q4194, Q4198, Q4200, Q4201,
Q4202, Q4203, Q4204, Q4205, Q4206, Q4208, Q4209, Q4210, Q4211, Q4212, Q4213, Q4214, Q4215,
Q4216, Q4217, Q4218, Q4219, Q4220, Q4221, Q4222, Q4226, Q4227, Q4228, Q4229, Q4230, Q4231,
Q4232, Q4233, Q4234, Q4235, Q4236, Q4237, Q4238, Q4239, Q4240, Q4241, Q4242, Q4244, Q4245,
Q4246, Q4247, Q4248, Q4249, Q4250, Q4254, Q4255
Advantage
The following covered cellular or tissue based products (CTPs) do not require prior authorization.
Q4101, Q4102, Q4103, Q4104, Q4105, Q4106, Q4107, Q4108, Q4110, Q4111, Q4112, Q4113, Q4114,
Q4115, Q4116, Q4117, Q4118, Q4121, Q4123, Q4132, Q4133, Q4137, Q4145, Q4151, Q4154, Q4158,
Q4159, Q4160, Q4163, Q4170, Q4173, Q4174, Q4176, Q4177, Q4178, Q4179, Q4180, Q4181, Q4182,
Q4183, Q4184, Q4185, Q4186, Q4187, Q4188, Q4189, Q4190, Q4191, Q4192, Q4193, Q4194, Q4195,
Q4196, Q4197, Q4198, Q4200, Q4201, Q4203, Q4204, Q4205, Q4206, Q4208, Q4209, Q4210, Q4211,
Q4212, Q4213, Q4214, Q4215, Q4216, Q4217, Q4218, Q4219, Q4220, Q4221, Q4222, Q4226, Q4249,
Q4250, Q4254, Q4255
The following are non-covered cellular or tissue based products (CTPs)
A6460, A6461, Q4122, Q4124, Q4125, Q4126, Q4127, Q4128, Q4130, Q4134, Q4135, Q4136, Q4138,
PG0203 – 10/21/20213
Q4139, Q4140, Q4141, Q4142, Q4143, Q4146, Q4147, Q4148, Q4149, Q4150, Q4152, Q4153, Q4155,
Q4156, Q4157, Q4161, Q4162, Q4164, Q4165, Q4166, Q4167, Q4168, Q4169, Q4171, Q4175, Q4202,
Q4227, Q4228, Q4229, Q4230, Q4231, Q4232, Q4233, Q4234, Q4235, Q4236, Q4237, Q4238, Q4239,
Q4240, Q4241, Q4242, Q4244, Q4245, Q4246, Q4247, Q4248
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage
Procedures C1763, C1781, C1849, C5271, C5272, C5273, C5274, C5275, C5276, C5277,
C5278, and C9399 are Not Covered if used to report any skin substitutes cellular or tissue
based products (CTPs) indicated as Not Covered considered experimental/investigational.
Procedures C9352, C9353, C9354, C9356, C9358, C9360, C9361, C9363, and C9364 are Not
Covered considered experimental/investigational.
While codes for skin substitute application (15271-15278, 15777) do not have
preauthorization requirements, they may be denied when used for the application of a
product that does not meet medical necessity criteria.
Bioengineered skin and soft tissue substitute products Not Covered - considered
experimental/investigational, including, but not limited to:
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan
ACell UBM Hydrated
DermaSpan Oasis Ultra
Wound Dressing
ACell UBM Lyophilized DressSkin Durepair
Pelvicol/PelviSoft
Wound Dressing Regeneration Matrix
AlloSkin Endoform Dermal Template Permacol
AlloSkin RT ENDURAGen PriMatrix
PriMatrix Dermal Repair
AlloSkin AC Excellagen
Scaffold
Aongen Collagen Matrix ExpressGraft Puros Dermis
Architect ECM, PX, FX E-Z Derm RegenePro
ArthroFlex (Flex Graft) FlowerDerm Repliform
Atlas Wound Matrix GammaGraft Repriza
Avagen Wound Dressing Helicoll StrataGraft
AxoGuard Nerve Protector
Hyalomatrix Strattice (xenograft)
(AxoGen)
CollaCare Hyalomatrix PA Suprathel
CollaCare Dental hMatrix SurgiMend
Collagen Wound Dressing Integra Bilayer Wound
Talymed
(Oasis Research) Matrix
CollaGUARD Keramatrix TenoGlide
TenSIX Acellular Dermal
CollaMend Kerecis
Matrix
CollaWound MariGen /Kerecis Omega3 TissueMend
Collexa MatriDerm TheraForm Standard/Sheet
Collieva Matrix HD TheraSkin
Conexa Mediskin TransCyte
Coreleader Colla-Pad MemoDerm TruSkin
Microderm biologic wound
CorMatrix Veritas® Collagen Matrix
matrix
Cytal (previously
NeoForm XCM Biologic Tissue Matrix
MatriStem)
Dermadapt Wound
NuCel XenMatrix AB
Dressing
DermaPure Oasis Burn Matrix
PG0203 – 10/21/20214
Advantage
ACell UBM Hydrated Wound Dressing Hyalomatrix PA
ACell UBM Lyophilized Wound Dressing hMatrix
AlloSkin AC Keramatrix
Aongen Collagen Matrix MatriDerm
Architect ECM, PX, FX Matrix HD
ArthroFlex (Flex Graft) Mediskin
Atlas Wound Matrix MemoDerm
Avagen Wound Dressing Microderm biologic wound matrix
AxoGuard Nerve Protector (AxoGen) NeoForm
CollaCare NuCel
CollaCare Dental Oasis Ultra
Collagen Wound Dressing (Oasis
Pelvicol/PelviSoft
Research)
CollaGUARD Permacol
CollaMend PriMatrix Dermal Repair Scaffold
CollaWound Puros Dermis
Collexa RegenePro
Collieva Repliform
Conexa Repriza
Coreleader Colla-Pad StrataGraft
CorMatrix Strattice (xenograft)
Cytal (previously MatriStem) Suprathel
Dermadapt Wound Dressing SurgiMend
DermaPure Talymed
DermaSpan TenoGlide
DressSkin Durepair Regeneration Matrix TenSIX Acellular Dermal Matrix
Endoform Dermal Template TissueMend
ENDURAGen TheraForm Standard/Sheet
Excellagen TruSkin
ExpressGraft Veritas Collagen Matrix
E-Z Derm XCM Biologic Tissue Matrix
Helicoll XenMatrix AB
COVERAGE CRITERIA
HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage
This medical policy addresses CTP’s utilized in breast reconstruction and the management of chronic non-healing
wounds or skin deficits of the lower extremities with the goal of wound and skin closure when standard or
conservative measures have failed. Lower extremity wounds or skin deficits (i.e. ulcers) have numerous causes
such as burns, trauma, immobility, ischemia or other neurologic impairment; over 90% of the lesions are related to
venous stasis disease and diabetic neuropathy.
Tissue engineered skin substitutes may be considered medically necessary when used for the appropriate FDA
approved indications. Specific criteria may also apply as listed below:
The depth of skin loss is the determinant of its ability to return. Full thickness skin loss, implying the loss of all
elements of the epidermis and dermis, will require re-epithelization of the surface once a clean granular base is
established. Both full and partial thickness skin loss may benefit from enhanced products referred to as CTPs.
Though no CTPs are capable of replacing the patient’s own skin, they have been demonstrated to allow scaffolding
for the growth of epithelium, enzymatic cleansing and provision of growth factors beneficial to deficit reduction and
re-epithelization
PG0203 – 10/21/20215
Required Documentation:
Medical Record documentation must specifically addressing circumstances as to why the wound or skin deficit has
failed to respond to standard wound care treatment of greater than 4 weeks and must reference specific
interventions that have failed.
The medical record must include:
History and physical/chart notes
Updated medication history
Associated medical comorbidities
Documentation of symptoms, associated diagnoses and treatments
Measurement of the initial wound, measurements at the completion of at least 4 weeks of wound care and
measurements immediately prior to the placement and with each subsequent placement of the CTP.
Review of pertinent medical problems that may have occurred since the previous wound evaluation
Explanation of the planned skin replacement surgery with choice of CTP graft product
The procedure risks and complications should also be reviewed and documented
Documentation of smoking cessation counseling and cessation measures prescribed, if applicable, must
also be documented in the patient's record.
Coverage:
Paramount considers application of the approved CTPS to Breast Reconstructive Surgery following a mastectomy
medically necessary when the following criteria is met:
When there is insufficient tissue expander or implant coverage by the pectoralis major muscle and
additional coverage is required OR
When there is viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or
necrosis OR
The infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-
establishment of these landmarks is needed
Approved CTPS for Breast Reconstructive Surgery:
o AlloDerm
o AlloMend
o Cortiva [AlloMax]
o DermACELL
o DermaMatrix
o FlexHD
o FlexHD Pliable
o Graftjacket.(see coverage approval by product line above)
(For information regarding coverage determination/limitations for breast reconstruction, please refer to
medical policy PG0144 Breast Reconstruction Services)
Paramount covers application of the approved CTPS to wounds or skin deficits (i.e. ulcers), of the lower
extremities, with Failed Response when the following criteria is met:
Wounds or skin deficits which have not adequately responded following 4 weeks of standard wound therapy
Partial- or full-thickness wounds or skin deficits, not involving tendon, muscle, joint capsule or exhibiting
exposed bone or sinus tracts or tunnels, with a clean granular base unless the CTP package label indicates
the CTP is approved for use involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus
tracts, with a clean granular base
Skin deficit at least 1.0 cm² in size
Clean and free of necrotic debris or exudate
Have adequate circulation/oxygenation to support tissue growth/wound healing as evidenced by physical
examination, palpable pedal pulse or by ankle-brachial index 0.65 or greater
For diabetic foot ulcers, the patient’s medical record reflects:
PG0203 – 10/21/20216
o Physician documentation of medical management for clinically documented type 1 or type 2
diabetes
o The wound is a non-infected full thickness diabetic foot ulcer and has been present for a minimum of
3 weeks and at least 1.0cm² in size
o The ulcer is located on the plantar, medial or lateral surface of the foot and is free of infection,
tunnels, tracts, cellulitis, eschar or obvious necrotic material
o The ulcer extends through the dermis but where there is no bone, capsule, muscle or tendon
exposure
o Conservative treatment measures including a non-weight bearing regimen, debridement and
acceptable methods of wound care have been tried for a minimum of 4 weeks and there has been
failure to respond to conservative measures.
o The extremity is free of Charcot’s arthropathy
o There is adequate arterial blood supply to support tissue growth
Approved CTPS for treatment of chronic, non-infected, full-thickness diabetic lower-extremity ulcers:
o AlloPatch
o Apligraft
o Dermagraf
o Epifix
o Integra Flowable Wound Matrix (approved for the Advantage product line only)
o Integra Omnigraft Dermal Regeneration Matrix (also known as Omnigraft)
o Grafix Core
o GrafixPL Core
o Grafix PRIME
o GrafixPL PRIME
o Puraply
o Stravix
o StravixPL (see coverage approval by product line above)
Approved CTPS for treatment of chronic, non-infected, partial or full-thickness lower-extremity skin ulcers
due to venous insufficiency:
o Apligraf
o Oasis Wound Matrix (see coverage approval by product line above)
Approved CTPS for treatment of dystrophic epidermolysis bullosa:
o OrCel (see coverage approval by product line above)
Is considered medically necessary for the treatment of healing donor site wounds in burn
victims, and
For the treatment of mitten-hand deformity when standard wound therapy has failed and
when provided in accordance with the Humanitarian Device Exemption (HDE) specifications
of the FDA treatment of children with recessive epidermolysis bullosa who are undergoing
reconstructive hand surgery
Approved CTPS for treatment of second- and third-degree burns:
o Epicel
o Integra Dermal Regeneration Template
o Biobrane/Biobrane-L (see coverage approval by product line above)
Epicel and Biobrane/Biobrane-L: It is used for the treatment of deep dermal or full-thickness
burns covering a total body surface area ≥30% when provided in accordance with the HDE
specifications of the FDA
Integra® Dermal Regeneration Template: No additional criteria required
Application of the approved CTP graft for lower extremity chronic wound (diabetic foot ulcers (DFU) and venous leg
ulcers (VLU)) will be covered when the following conditions are met for the individual patient:
Presence of neuropathic ulcers and diabetic foot ulcer(s) having failed to respond to documented
PG0203 – 10/21/20217
conservative wound-care measures of greater than four weeks, during which the patient is compliant with
recommendations, and without evidence of underlying osteomyelitis or nidus of infection.
Presence of a venous stasis ulcer for at least 3 months but unresponsive to appropriate wound care for at
least 30 days with documented compliance.
Presence of a full thickness skin loss ulcer that is the result of abscess, injury or trauma that has failed to
respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a
period of 4 weeks or longer.
Care must be under the care of a wound care physician or surgeon
Paramount covers application of the approved medically indicated CTPS for the treatment of corneal injuries and
as a component of corneal or conjunctival surgical repair using any of the following human amniotic membrane
grafts:
AmnioBand Membrane
Biovance
EpiCord
EpiFix
Grafix
Prokera
AmbioDisk (see coverage approval by product line above)
In all wound management, the wounds or skin deficits must be free of infection and underlying osteomyelitis with
documentation of the conditions that have been treated and resolved prior to the institution of CTP therapy.
Appropriate therapy includes, but is not limited to:
o Control of edema, venous hypertension or lymphedema
o Control of any nidus of infection or colonization with bacterial or fungal elements
o Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process
o Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon)
o For diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure
o For venous stasis ulcers, compression therapy provided with documented diligent use of multilayer
dressings, compression stockings of > 20mmHg pressure, or pneumatic compression
o Provision of wound environment to promote healing (protection from trauma and contaminants,
elimination of inciting or aggravating processes)
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.
Limitations:
Partial thickness loss with the retention of epithelial appendages is not a candidate for grafting or
replacement, as epithelium will repopulate the deficit from the appendages, negating the benefit of
overgrafting.
Skin and Tissue Substitutes (CPT) will be allowed for the episode of wound care in compliance with FDA
guidelines for the specific product not to exceed 10 applications or treatments. In situations where more
than one specific product is used, it is expected that the number of applications or treatments will still not
exceed 10.
o Exception: may not be all-inclusive
Diabetic foot ulcer treatment, the following products are limited to no more than 5
applications, at a minimum of 1 week between applications, over the course of 12 weeks:
Apligraf, Dermagraft, EpiFix Amniotic Membrane, Grafix, Core/Grafix, Prime/Grafix, PL
Prime, Integra, Dermal Regeneration Template, Omnigraft Dermal Regeneration Matrix,
Oasis wound, Matrix/Oasis, Ultra Tri-Layer Matrix, TheraSkin
PG0203 – 10/21/20218
And
GraftJacket Regererative Tissue Matrix that is limited to only 1 initial application
Venous stasis ulcer treatment, the following products are limited to no more than 5
applications, at a minimum of 1 week between applications, over the 12 weeks: Apligraf,
EpiFix Amniotic Membrane, Oasis Wound Matrix, TheraSkin
Simultaneous use of more than one product for the episode of wound is not covered. Product change within
the episode of wound is allowed, not to exceed the 10-application limit per wound per 12-week period of
care.
Treatment of any chronic skin wound will typically last no more than twelve (12) weeks.
o The percent change in wound area at 4 weeks is predictive of complete healing at 12 weeks in
patients with diabetic foot ulcers. Thus, minimal improvement at 30 days can be considered as an
indicator that a wound is unlikely to heal in patients with comorbidities known to affect wound
healing.
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.
Retreatment of healed ulcers, those showing greater than 75% size reduction and smaller than .5 sq.cm, is
not considered medically reasonable and necessary.
Skin substitute grafts are contraindicated and are not considered reasonable and necessary in patients with
inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active
infection, and active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking
without physician attempt to effect smoking cessation).
CTP grafts are contraindicated in patients with known hypersensitivity to any component of the CTP graft
(e.g., allergy to avian, bovine, porcine, equine products).
Repeat use of surgical preparation services in conjunction with CTP application codes will be considered
not reasonable and necessary. Wound preparation is considered part of the procedure. It is expected that
each wound will require the use of appropriate wound preparation code at least once at initiation of care
prior to placement of the CTP graft.
Re-treatment within one (1) year of any given course of CTP 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.
Patients receiving a CTP graft must be under the care of a physician licensed by the state with full scope of
practice for the treatment of the systemic disease process(s) etiologic for the condition (e.g., venous insufficiency,
diabetes, neuropathy). If the provider performing the CTP graft/application is not the one providing the treatment for
the systemic condition than a statement in the documentation that (s)he is aware of the systemic condition and that
the patient is under the care of Doctor _____. This concurrent medical management and the identity of the
managing medical physician shall be clearly discernable in the medical record and available upon request.
CTPs are not separately reimbursable in any institutional setting, including long-term care facility, hospital inpatient,
outpatient, or emergency room place of service.
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.
Definitions:
Standard Wound Therapy based on the specific type of wound includes:
PG0203 – 10/21/20219
Appropriate offloading; AND
Assessment of an individual’s vascular status and correction of any amenable vascular problems for
arterial and/or venous ulcers; AND
Compression garments/dressings have been consistently applied for venous ulcers; AND
Frequent repositioning of an individual with pressure injuries (usually every two hours); AND
Improvement of glucose control with documented (within the past 90 days) glycosylated hemoglobin
level (HbA1c) less than 9.0% or blood glucose records demonstrating efforts to sustain blood sugar less
than 200 mg/dL; AND
Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings; AND
Necessary treatment to resolve any infection that may be present (e.g., antibiotics, debridement of
devitalized tissue, surgical management of osteomyelitis); AND
Optimization of nutritional status with documented prealbumin level greater than 20 mg/dL or albumin
level greater than 3.4 g/dL
A Failed Response is defined as wounds or skin deficits that has failed to respond to documented appropriate
wound-care measures, has increased in size or depth, or has not changed in baseline size or depth and has no
indication that improvement is likely (such as granulation, epithelialization or progress towards closing).
Duration of Chronicity: Chronic wounds are defined as wounds that do not respond to standard wound treatment
for at least a 30-day period during organized comprehensive conservative therapy
Autologous skin grafts, also referred to as autografts, are permanent covers that use skin from different parts of
the individual’s body. These grafts consist of the epidermis and a dermal component of variable thickness. A split-
thickness skin graft (STSG) includes the entire epidermis and a portion of the dermis. A full thickness skin graft
(FTSG) includes all layers of the skin.
Allografts which use skin from another human (e.g., cadaver) and Xenografts which use skin from another
species (e.g., porcine or bovine) may also be employed as temporary skin replacements, but they must later be
replaced by an autograft or the ingrowth of the patient’s own skin
Cellular and/or Tissue Based Products (CTPs) have been developed in an attempt to circumvent problems
inherent with autografts, allografts and xenografts. The production of these biologic CTPs varies by company and
product, but generally involves the creation of immunologically inert biological products containing protein,
hormones or enzymes seeded into a matrix, which may provide protein, or growth factors proposed to stimulate or
facilitate healing or promote epithelization.
CTPs are classified into the following types:
Human skin allografts derived from donated human skin
Allogeneic matrices derived from human tissue (fibroblasts or membrane)
Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen
Acellular matrices derived from xenogeneic collagen or tissue
Human Skin Allografts are bioengineered from human skin components and human tissue, which have
had intact cells removed or treated to avoid immunologic rejection. They are available in different forms
promoted to allow scaffolding, soft tissue filling, growth factors and other bioavailable hormonal or
PG0203 – 10/21/202110
enzymatic activity.
Allogeneic Matrices are usually derived from human neonatal fibroblasts of the foreskin that may contain
metabolically active or regenerative components primarily used for soft tissue support, though some have
been approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and
disappear after 3-4 weeks implantation.
Composite Matrices are derived from human keratinocytes and fibroblasts supported by a scaffold of
synthetic mesh or xenogeneic collagen. These are also referred to as human skin equivalent but are unable
to be used as autografts due to immunologic rejection or degradation of the living components by the host.
Active cellular components continue to generate bioactive compounds and protein that may accelerate
wound healing and epithelial regrowth.
Acellular Matrices are derived from other than human skin and include the majority of CTPs. All are
composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants proposed to
simulate or exaggerate the characteristics of human skin. All propose to promote healing by the creation of
localized intensification of an array of hormonal and enzymatic activity to accelerate closure by migration of
native dermal and epithelial components, rather than function as distinctly incorporated tissue closing the
skin defect.
ADVANTAGE: Per the Ohio Department of Medicaid (ODM), providers can request prior authorization to exceed
coverage or benefit limits for members under age 21.
CODING/BILLING INFORMATION
The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in
this clinical policy are for informational purposes only.
Codes that are covered may have selection criteria that must be met.
Payment for supplies may be included in payment for other services rendered.
Product
HCPCS Description
Codes
Synthetic resorbable wound dressing, sterile, pad size 16 sq in or less, without adhesive
A6460
border, each dressing
Synthetic resorbable wound dressing, sterile, pad size more than 16 sq in but less than or
A6461
equal to 48 sq in, without adhesive border, each dressing
Q4100 Skin substitute, nos
Q4101 Apligraf, per sq cm
Q4102 Oasis wound matrix
Q4103 Oasis burn matrix
Q4104 Integra bilayer matrix
Q4105 Integra dermal regeneration template (also known as Omnigraft)
Q4106 Dermagraft, per sq cm
Q4107 GraftJacket
Q4108 Integra matrix
Q4110 PriMatrix, per sq cm
Q4111 GammaGraft, per sq cm
Q4112 Cymetra, injectable, 1 cc
Q4113 GraftJacket Xpress, 1 cc
Q4114 Integra flowable wound matrix, injectable, 1cc
Q4115 AlloSkin, per sq cm
Q4116 AlloDerm, per sq cm
PG0203 – 10/21/202111
Q4117 HYALOMATRIX, per sq cm
Q4118 MatriStem micromatrix, 1 mg
Q4121 TheraSkin, per sq cm
Q4122 DermACELL, per sq cm
Q4123 AlloSkin RT, per sq cm
Q4124 Oasis tri-layer wound matrix
Q4125 Arthroflex, per sq cm
Q4126 MemoDerm, DermaSpan, TranZgraft or InteguPly, per sq cm
Q4127 Talymed, per sq cm
Q4128 FlexHD/AllopatchHD/MatrixHD
Q4130 Strattice TM, per sq cm
Q4132 Grafix Core and GrafixPL Core, per sq cm
Q4133 Grafix PRIME, GrafixPL PRIME, Stravix and StravixPL, per sq cm
Q4134 HMatrix, per sq cm
Q4135 Mediskin, per sq cm
Q4136 Ez-derm, per sq cm
Q4137 AmnioExcel, AmnioExcel Plus or BioDExcel, per sq cm
Q4138 BioDFence DryFlex, per sq cm
Q4139 AmnioMatrix or BioDMatrix, injectable, 1 cc
Q4140 BioDFence, per sq cm
Q4141 AlloSkin AC, per sq cm
Q4142 Xcm biologic tissue matrix, per sq cm
Q4143 Repriza, per sq cm
Q4145 EpiFix, injectable, 1 mg
Q4146 Tensix, per sq cm
Q4147 Architect, Architect PX, or Architect FX, extracellular matrix, per sq cm
Q4148 Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm
Q4149 Excellagen, 0.1cc
Q4150 AlloWrap DS or dry, per sq cm
Q4151 AmnioBand or Guardian, per sq cm
Q4152 DermaPure, per sq cm
Q4153 Dermavest and Plurivest, per sq cm
Q4154 Biovance, per sq cm
Q4155 Neox Flo or Clarix Flo 1 mg
Q4156 Neox 100 or Clarix 100, per sq cm
Q4157 Revitalon, per sq cm
Q4158 Kerecis Omega3, per sq cm
Q4159 Affinity, per sq cm
Q4160 Nushield, per sq cm
Q4161 Bio-connekt wound matrix, per sq cm
Amniopro Flow, Amniogen-a, Amniogen-c, BioRenew Flo, WoundEx Flow, BioSkin Flow,
Q4162
0.5 cc
Q4163 Amniopro, Amniogen-45, Amniogen-200, WoundEx, BioSkin, per sq cm
Q4164 Helicoll, per sq cm
Q4165 Keramatrix, per sq cm
Q4166 Cytal, per sq cm
Q4167 Truskin, per sq cm
Q4168 Amnioband, 1 mg
Q4169 Artacent wound, per sq cm
Q4170 Cygnus, -Matrix, Max, Solo, per sq cm
Q4171 Interfyl, 1 mg
PG0203 – 10/21/202112
Q4173 PalinGen or palingen xplus, per sq cm
Q4174 PalinGen or ProMatrX, 0.36 mg per 0.25 cc
Q4175 Miroderm, per sq cm
Q4176 Neopatch, per sq cm
Q4177 Floweramnioflo, 0.1 cc
Q4178 Floweramniopatch, per sq cm
Q4179 Flowerderm, per sq cm
Q4180 Revita, per sq cm
Q4181 Amnio wound, per sq cm
Q4182 Transcyte, per sq cm
Q4183 Surgigraft, per sq cm
Q4184 Cellesta, per sq cm
Q4185 Cellesta Flowable Amnion (25 mg per cc); per 0.5
Q4186 Epifix, per sq cm
Q4187 Epicord, per sq cm
Q4188 AmnioArmor, per sq cm
Q4189 Artacent AC, 1 mg
Q4190 Artacent AC, per sq cm
Q4191 Restorigin, per sq cm
Q4192 Restorigin, 1 cc
Q4193 Coll-e-Derm, per sq cm
Q4194 Novachor, per sq cm
Q4195 PuraPly, per sq cm
Q4196 PuraPly AM, per sq cm
Q4197 PuraPly XT, per sq cm
Q4198 Genesis Amniotic Membrane, per sq cm
Q4200 SkinTE, per sq cm
Q4201 Matrion, per sq cm
Q4202 Keroxx (2.5 g/cc), 1 cc
Q4203 Derma-Gide, per sq cm
Q4204 XWRAP, per sq cm
Q4205 Membrane graft or membrane wrap, per sq cm
Q4206 Fluid Flow or Fluid GF, 1 cc
Q4208 Novafix, per sq cm
Q4209 SurGraft, per sq cm
Q4210 Axolotl Graft or Axolotl DualGraft, per sq cm
Q4211 Amnion Bio or AxoBioMembrane, per sq cm
Q4212 AlloGen, per cc
Q4213 Ascent, 0.5 mg
Q4214 Cellesta Cord, per sq cm
Q4215 Axolotl Ambient or Axolotl Cryo, 0.1 mg
Q4216 Artacent Cord, per sq cm
WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound
Q4217
Xplus, per sq cm
Q4218 SurgiCORD, per sq cm
Q4219 SurgiGRAFT-DUAL, per sq cm
Q4220 BellaCell HD or Surederm, per sq cm
Q4221 Amnio Wrap2, per sq cm
Q4222 ProgenaMatrix, per sq cm
Q4226 MyOwn Skin, includes harvesting and preparation procedures, per sq cm
Q4227 AmmioCore, per sq cm
PG0203 – 10/21/202113
Q4228 BioNextPATCH, per sq cm
Q4229 Cogenex Amniotic Membrane, per sq cm
Q4230 Cogenex Flowable Amnion
Q4231 Corplex P, per cc
Q4232 Corplex, per sq cm
Q4233 NuDyn, SurFactor, per 0.5cc
Q4234 XCellerate, per sq cm
Q4235 AMNIOREPAIR or AltiPly, per sq cm
Q4236 carePATCH, per sq cm
Q4237 Cryo-Cord, per sq cm
Q4238 Derm-Maxx, per sq cm
Q4239 Amnio-Maxx or Amnio-Maxx Lite, per sq cm
Q4241 PolyCyte, for topical use only, per 0.5cc
Q4240 CoreCyte
Q4242 Amniocyte Plus, per 0.5cc
Q4244 Procenta, per 200mg
Q4245 Amniotext, per cc
Q4246 CoreText, ProText
Q4247 Amniotext patch, per sq cm
Q4248 Dermacyte Amniotic Membrane Allograft, per sq cm
Q4249 AMNIPLY, for topical use only, per sq cm
Q4250 AmnioAmp-MP, per sq cm
Q4254 Novafix DL, per sq cm
Q4255 REGUaRD, for topical use only, per sq cm
CPT/HCPCS
DESCRIPTION COVERAGE DETERMINATION
CODE
Application of skin
substitute graft to trunk,
arms, legs, total wound
15271
surface area up to 100 sq
cm; first 25 sq cm or less
wound surface area
Application of skin
substitute graft to trunk,
arms, legs, total wound
surface area up to 100 sq
NOTE: While codes for skin substitute application (15271-
15272 cm; each additional 25 sq
15278, 15777) do not have preauthorization requirements,
cm wound surface area, or
they may be denied when used for the application of a
part thereof (List separately
product that does not meet medical necessity criteria
in addition to code for
primary procedure)
Application of skin
substitute graft to trunk,
arms, legs, total wound
surface area greater than
15273
or equal to 100 sq cm; first
100 sq cm wound surface
area, or 1% of body area of
infants and children
PG0203 – 10/21/202114
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
15274 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)
Application of skin
substitute graft to face,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia,
15275 hands, feet, and/or multiple
digits, total wound surface
area up to 100 sq cm; first
25 sq cm or less wound
surface area
Application of skin
substitute graft to face,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia,
hands, feet, and/or multiple
digits, total wound surface
15276 area up to 100 sq cm; 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)
Application of skin
substitute graft to face,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia,
hands, feet, and/or multiple
15277 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
Application of skin
substitute graft to face,
scalp, eyelids, mouth, neck,
15278
ears, orbits, genitalia,
hands, feet, and/or multiple
digits, total wound surface
PG0203 – 10/21/202115
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)
Implantation of biologic
implant (eg, acellular
dermal matrix) for soft
15777 tissue reinforcement (ie,
breast, trunk) (List
separately in addition to
code for primary procedure)
Avance Nerve Graft
Processed, decellularized
CPT codes
nerve allograft
64912 and Not Covered considered experimental/investigational
(Alternative to nerve
64913
conduits for nerve repair
procedures)
Connective tissue,
nonhuman (includes
synthetic)
Not an all-inclusive list:
AxoGuard – Nerve
Connector, Nerve Protector
Biodesign – Dural Graft,
Duraplasty Graft, ENT
Repair Graft, Otologic
Repair Graft Not Covered if used to report any skin substitutes cellular
C1763
or tissue based products (CTPs) indicated as Not Covered
Biodesign – considered experimental/investigational
Enterocutaneous Fistula
Plug and Fistula Plug
Biodesign – Hernia, Hiatal
Hernia, Incision Graft
Biodesign Tissue Graft – 1
layer, 4 layer
CopiOs Pericardium
Membrane
CorMatrix ECM
PG0203 – 10/21/202116
Cortiva Allograft Dermis
Gentrix Surgical Matrix
(formerly MatriStem
Surgical Matrix)
NeuraGen Nerve Guide,
NeuraWrap Nerve
Protector
Tutomesh, Tutopatch
XenMatrix
Mesh (implantable)
Not an all-inclusive list: Not Covered if used to report any skin substitutes cellular
C1781 or tissue based products (CTPs) indicated as Not Covered
Gentrix Surgical Matrix considered experimental/investigational
(formerly MatriStem
Surgical Matrix)
Skin substitute, synthetic,
resorbable, per sq cm
Not Covered if used to report any skin substitutes cellular
C1849 or tissue based products (CTPs) indicated as Not Covered
Not an all-inclusive list:
considered experimental/investigational
Suprathel
Application of low cost skin
substitute grafts to trunk,
Not Covered if used to report any skin substitutes cellular
arms, legs, total wound
C5271 or tissue based products (CTPs) indicated as Not Covered
surface area up to 100 sq
considered experimental/investigational
cm; first 25 sq cm or less
would surface area
Application of low cost skin
substitute grafts to trunk,
arms, legs, total wound Not Covered if used to report any skin substitutes cellular
C5272 surface area up to 100 sq or tissue based products (CTPs) indicated as Not Covered
cm; each additional 25 sq considered experimental/investigational
cm would surface area, or
part thereof
Application of low cost skin
substitute grafts to trunk,
arms, legs, total wound
Not Covered if used to report any skin substitutes cellular
surface area greater than
C5273 or tissue based products (CTPs) indicated as Not Covered
or equal to 100 sq cm; first
considered experimental/investigational
100 sq cm would surface
area, or 1% of body area of
infants and children
Application of low cost skin
Not Covered if used to report any skin substitutes cellular
substitute grafts to trunk,
C5274 or tissue based products (CTPs) indicated as Not Covered
arms, legs, total wound
considered experimental/investigational
surface area greater than
PG0203 – 10/21/202117
or equal to 100 sq cm;each
additional 100 sq cm would
surface area, or part
thereof, or each additional
1% of body area of infants
and children, or part thereof
Application of low cost skin
substitute graft to face ,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia, Not Covered if used to report any skin substitutes cellular
C5275 hands, fee, and/or multiple or tissue based products (CTPs) indicated as Not Covered
digits, total wound surface considered experimental/investigational
area up to 100 sq cm; first
25 sq cm or less wound
surface area
Application of low cost skin
substitute graft to face ,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia,
Not Covered if used to report any skin substitutes cellular
hands, fee, and/or multiple
C5276 or tissue based products (CTPs) indicated as Not Covered
digits, total wound surface
considered experimental/investigational
area up to 100 sq cm;
each additional 25 sq cm
wound surface area, or part
thereof
Application of low cost skin
substitute graft to face ,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia,
Not Covered if used to report any skin substitutes cellular
hands, fee, and/or multiple
C5277 or tissue based products (CTPs) indicated as Not Covered
digits, total wound surface
considered experimental/investigational
area up to 100 sq cm; first
100 sq cm wound surface
area, or 1% of body area of
infants and children
Application of low cost skin
substitute graft to face ,
scalp, eyelids, mouth, neck,
ears, orbits, genitalia,
hands, fee, and/or multiple
Not Covered if used to report any skin substitutes cellular
digits, total wound surface
C5278 or tissue based products (CTPs) indicated as Not Covered
area up to 100 sq cm;
considered experimental/investigational
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
Microporous collagen
implantable tube
C9352 Not Covered considered experimental/investigational
(NeuraGen Nerve Guide),
per centimeter length
PG0203 – 10/21/202118
Microporous collagen
implantable slit tube
C9353 (NeuraWrap Nerve Not Covered considered experimental/investigational
Protector), per centimeter
length
Acellular pericardial tissue
C9354 matrix of nonhuman origin Not Covered considered experimental/investigational
(Veritas), per sq cm
Tendon, porous matrix of
cross-linked collagen and
C9356 glycosaminoglycan matrix Not Covered considered experimental/investigational
(TenoGlide Tendon
Protector Sheet), per sq cm
Dermal substitute, native,
nondenatured collagen,
C9358 fetal bovine origin Not Covered considered experimental/investigational
(SurgiMend Collagen
Matrix), per 0.5 sq cm
Dermal substitute, native,
nondenatured collagen,
C9360 neonatal bovine origin Not Covered considered experimental/investigational
(SurgiMend Collagen
Matrix), per 0.5 sq cm
Collagen matrix nerve wrap
(NeuroMend Collagen
C9361 Not Covered considered experimental/investigational
Nerve Wrap), per 0.5 cm
length
Skin substitute (Integra
C9363 Meshed Bilayer Wound Not Covered considered experimental/investigational
Matrix), per square cm
Porcine implant, Permacol,
C9364 Not Covered considered experimental/investigational
per sq cm
Not Covered if used to report any skin substitutes cellular
Unclassified drugs or
C9399 or tissue based products (CTPs) indicated as Not Covered
biologicals
considered experimental/investigational
Not Covered if used to report any skin substitutes cellular
Collagen based would filler,
A6021 or tissue based products (CTPs) indicated as Not Covered
gel/past, per g of collagen
considered experimental/investigational
Not Covered if used to report any skin substitutes cellular
Collagen dressing, sterile,
A6022 or tissue based products (CTPs) indicated as Not Covered
size 16 sq in or less, each
considered experimental/investigational
Not Covered considered experimental/investigational: These are considered experimental/investigational, as
they are not identified as widely used and generally accepted for any other proposed uses, there is
inadequate evidence in the peer-reviewed medical literature to support their clinical effectiveness.
Paramount reserves the right to review and revise our policies periodically when necessary. When
there is an update, we will publish the most current policy to
https://www.paramounthealthcare.com/services/providers/medical-policies/ .
PG0203 – 10/21/202119
REVISION HISTORY EXPLANATION
ORIGINAL EFFECTIVE DATE: 01/15/2009
Date Explanation & Changes
07/01/09 Added codes
08/15/10 Updated
01/01/11 Added/deleted codes
Deleted Codes Q4109, 15170, 15171, 15175, 15176, 15330, 15331, 15335, 15336, 15340,
15341, 15360, 15361, 15365, 15366, 15400, 15401, 15420, 15421, 15430, 15431
01/01/12
Added Codes 15271, 15272, 15273, 15374, 15275, 15276, 15277, 15278, C9366, Q4117,
Q4118, Q4119, Q4120, and Q4121
C9359 & C9362 codes removed from this policy as they are bone graft substitute codes
Removed codes 15300-15321, C9354, C9355, & C9361
03/11/14 Added codes Q4131-Q4149, C1781, 15777
Policy reviewed and updated to reflect most current clinical evidence
Approved by Medical Policy Steering Committee as revised
Added new codes effective 1/1/15 Q4150-Q4160 and C9349
Q4150-Q4160 will require prior authorization for Advantage per ODM guidelines
04/14/15
Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
Changes in coverage made due to ODM & Medicare guideline changes
10/13/15 Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
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,
10/11/16 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
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
01/10/17
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
Deleted effective 01/01/17 codes Q4119, Q4120, & Q4129
06/13/17 Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
Added effective 01/01/18 new codes Q4176-Q4181 as non-covered HMO, PPO, Individual
Marketplace, Elite and covered for Advantage per ODM guidelines
01/09/18
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
PG0203 – 10/21/202120
Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
Added list of treatments for wound care that are non-covered as considered experimental
and investigational
03/13/18
Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
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,
07/10/18 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
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
01/08/19
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
Added procedure code Q4187 EpiCord to the Chart, per the coverage documented above
date 01/08/19
03/19/19
And clarified non-coverage for procedure code Q4187 for the Advantage product line, per
Ohio Department of Medicaid (ODM) noncoverage
Correct the documentation for Q4195 and Q4196, PuraPly Antimicrobial Wound Matrix
(PuraPly AM) and PuraPly Wound Matrix (PuraPly), supporting coverage within the green
10/08/19
box for product lines HMO, PPO, Individual Marketplace and Elite and no longer included in
the bullets listed as experimental and investigational products
12/16/2020 Medical policy placed on the new Paramount Medical Policy Format
Changed Medical Policy Title from Skin Substitutes and Wound Repair Procedures to
Bioengineered Skin and Tissue Substitutes
Policy reviewed and updated to reflect most current clinical evidence
Policy updated/added with missing and new HCPCS codes
04/07/2021
Coverage/NonCoverage documentation clarified, see policy for covered and noncovered
bioengineered skin and tissue substitutes
Effective June 1, 2021 procedure Q4100-Skin Substitute,nos, requires a prior authorization
for ALL product lines
Corrected a mistype, in the listed codes that are noncovered procedure Q4240 entered
04/29/2021
twice, one of the procedures Q4240 should be Q4241.
10/21/2021 Added procedure codes C5271-C5278, C9356, C9363
PG0203 – 10/21/202121
Procedures C1763, C1781, C1849, C5271, C5272, C5273, C5274, C5275, C5276, C5277,
C5278, and C9399 are Not Covered if used to report any skin substitutes cellular or tissue
based products (CTPs) indicated as Not Covered considered experimental/investigational.
Procedures C9352. C9353, C9354, C9356, C9358, C9360, C9361, C9363, and C9364 are
Not Covered considered experimental/investigational
Added procedure codes 15271-15278, 15777
While codes for skin substitute application (15271-15278, 15777) do not have
preauthorization requirements, they may be denied when used for the application of a
product that does not meet medical necessity criteria
Added Facility to the Scope of Coverage Note: Coverage/Noncoverage applies to both
professional and facility services
SCOPE
X Professional
X Facility Inpatient/Outpatient
Effective 12/1/2021 coverage/noncoverage will also apply to facility services, along with the
already coverage/noncoverage of professional services
Added Epifix-Q4186 and Puraply-Q4195, Q4196, Q4197 to the approved CTPS for
treatment of chronic, non-infected, full-thickness diabetic lower-extremity ulcers listing
Documented that Integra Omnigraft Dermal regeneration Matrix for the treatment of chronic,
non-infected, full-thickness diabetic lower-extremity ulcers is only approved on the listing for
the Advantage Product line.
Removed the conflicting limitations documentation regarding treatment time-frames “If CTP
applications and re-applications show no significant improvement after three separate
treatments, additional re-applications are considered not medically necessary and other
treatment modalities should be considered”
Removed the conflicting limitations documentation regarding epithelial appendages “Partial
thickness loss with the retention of epithelial appendages is not a candidate for grafting or
replacement, as epithelium will repopulate the deficit from the appendages, negating the
benefit of overgrafting”
Added documentation exceptions related to application limits for specific products, others
than the 10-application limit
REFERENCES/RESOURCES
Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and
services
Ohio Department of Medicaid
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
Hayes, Inc.
Industry Standard Review
PG0203 – 10/21/2021You can also read
