Blue Cross Blue Shield Massachusetts Codeing Information

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Medical Policy Amniotic Membrane and Amniotic Fluid Table of Contents • Policy: Commercial • Coding Information • Information Pertaining to All Policies • Policy: Medicare • Description • References • Authorization Information • Policy History Policy Number: 643 BCBSA Reference Number: 7.01.149 NCD/LCD: NA Related Policies • Bioengineered Skin and Soft Tissue Substitutes, #663 • Orthopedic Applications of Stem Cell Therapy, #254 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members Treatment of nonhealing* diabetic lower-extremity ulcers using the following human amniotic membrane products (AmnioBand® Membrane, Biovance®, EpiCord®, Epifix®, Grafix™) may be considered MEDICALLY NECESSARY. *Nonhealing of diabetic wounds is defined as less than a 20% decrease in wound area with standard wound care for at least 2 weeks, based on the entry criteria for clinical trials. Human amniotic membrane grafts with or without suture (eg, Prokera®, AmbioDisk™) may be considered MEDICALLY NECESSARY for the treatment of the following ophthalmic indications: • Neurotrophic keratitis with ocular surface damage and inflammation that does not respond to conservative therapy. Conservative therapy for neurotrophic keratitis may include 5 days of pressure patching, therapeutic contact lens, topical lubricants, and topical antibiotics. • Corneal ulcers and melts that do not respond to initial conservative therapy. Conservative therapy for corneal ulcers and melts may include 2 days of patching, therapeutic contact lens, and topical antimicrobial agents. • Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment; • Bullous keratopathy as a palliative measure in patients who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty); • Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is not sufficient; • Moderate or severe Stevens-Johnson syndrome; 2 • Persistent epithelial defects that do not respond to conservative therapy. A persistent epithelial defect is one that failed to close completely after 5 days of conservative treatment or has failed to demonstrate a decrease in size after 2 days of conservative treatment. Conservative treatment of a persistent epithelial defect may include 5 days of the following: topical lubricants, topical antibiotics, therapeutic contact lens, or patching. • Severe dry eye (DEWS 3 or 4)** with ocular surface damage and inflammation that remains symptomatic after Steps 1, 2, and 3 of the dry eye disease management algorithm*** or • Moderate or severe acute ocular chemical burn. Human amniotic membrane grafts with suture or glue may be considered MEDICALLY NECESSARY for the treatment of the following ophthalmic indications: • Corneal perforation when corneal tissue is not immediately available; or • Pterygium repair when there is insufficient healthy tissue to create a conjunctival autograft. Human amniotic membrane grafts with or without suture are considered INVESTIGATIONAL for all ophthalmic indications not outlined above. Injection of micronized or particulated human amniotic membrane is considered INVESTIGATIONAL for all indications, including but not limited to treatment of osteoarthritis and plantar fasciitis. Injection of human amniotic fluid is considered INVESTIGATIONAL for all indications. All other human amniotic membrane products and indications not listed above are considered INVESTIGATIONAL, including but not limited to treatment of lower-extremity ulcers due to venous insufficiency. ** Dry eye severity level DEWS 3 to 4 Discomfort, severity, and frequency – Severe frequent or constant Visual symptoms – chronic and/or constant, limiting to disabling Conjunctival Injection – +/- or +/+ Conjunctive Staining – moderate to marked Corneal Staining – marked central or severe punctate erosions Corneal/tear signs – Filamentary keratitis, mucus clumping, increase in tear debris Lid/meibomian glands – Frequent Tear film breakup time – < 5 Schirmer score (mm/5 min) – < 5 *** Tear Film and Ocular Surface Society staged management for dry eye disease Step 1: • Education regarding the condition, its management, treatment and prognosis • Modification of local environment • Education regarding potential dietary modifications (including oral essential fatty acid supplementation) • Identification and potential modification/elimination of offending systemic and topical medications • Ocular lubricants of various types (if meibomian gland dysfunction is present, then consider lipid containing supplements) • Lid hygiene and warm compresses of various types Step 2: • If above options are inadequate consider: • Non-preserved ocular lubricants to minimize preservative-induced toxicity • Tea tree oil treatment for Demodex (if present) • Tear conservation • Punctal occlusion 3 • Moisture chamber spectacles/goggles • Overnight treatments (such as ointment or moisture chamber devices) • In-office, physical heating and expression of the meibomian glands • In-office intense pulsed light therapy for meibomian gland dysfunction • Prescription drugs to manage dry eye disease • Topical antibiotic or antibiotic/steroid combination applied to the lid margins for anterior blepharitis (if present) • Topical corticosteroid (limited-duration) • Topical secretagogues • Topical non-glucocorticoid immunomodulatory drugs (such as cyclosporine) • Topical LFA-1 antagonist drugs (such as lifitegrast) • Oral macrolide or tetracycline antibiotics Step 3: • If above options are inadequate consider: • Oral secretagogues • Autologous/allogeneic serum eye drops • Therapeutic contact lens options • Soft bandage lenses • Rigid scleral lenses Step 4: • If above options are inadequate consider: • Topical corticosteroid for longer duration • Amniotic membrane grafts • Surgical punctal occlusion • Other surgical approaches (eg tarsorrhaphy, salivary gland transplantation) Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient. Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient. Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. The following codes are included below for informational purposes only; this is not an all-inclusive list. 4 The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: HCPCS Codes HCPCS codes: Code Description Q4132 Grafix core and grafixpl core, per square centimeter Q4133 Grafix prime, grafixpl prime, stravix and stravixpl, per square centimeter Q4151 Amnioband or guardian, per square centimeter Q4154 Biovance, per square centimeter Q4168 Amnioband, 1 mg Q4186 Epifix, per square centimeter Q4187 Epicord, per sq cm The following ICD Diagnosis Codes are considered medically necessary when submitted with the HCPCS codes above if medical necessity criteria are met: ICD-10 Diagnosis Coding ICD-10-CMdiagnosis codes: Code Description E08.621 Diabetes mellitus due to underlying condition with foot ulcer E08.622 Diabetes mellitus due to underlying condition with other skin ulcer E09.621 Drug or chemical induced diabetes mellitus with foot ulcer E09.622 Drug or chemical induced diabetes mellitus with other skin ulcer E10.621 Type 1 diabetes mellitus with foot ulcer E10.622 Type 1 diabetes mellitus with other skin ulcer E11.621 Type 2 diabetes mellitus with foot ulcer E11.622 Type 2 diabetes mellitus with other skin ulcer E13.621 Other specified diabetes mellitus with foot ulcer E13.622 Other specified diabetes mellitus with other skin ulcer The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 65779 Placement of amniotic membrane on the ocular surface; single layer, sutured The following ICD Diagnosis Codes are considered medically necessary when submitted with the HCPCS codes above if medical necessity criteria are met: ICD-10 Diagnosis Coding ICD-10-CMdiagnosis codes: Code Description H04.121 Dry eye syndrome of right lacrimal gland H04.122 Dry eye syndrome of left lacrimal gland H04.123 Dry eye syndrome of bilateral lacrimal glands H04.129 Dry eye syndrome of unspecified lacrimal gland 5 H11.001 Unspecified pterygium of right eye H11.002 Unspecified pterygium of left eye H11.003 Unspecified pterygium of eye, bilateral H11.009 Unspecified pterygium of unspecified eye H11.011 Amyloid pterygium of right eye H11.012 Amyloid pterygium of left eye H11.013 Amyloid pterygium of eye, bilateral H11.019 Amyloid pterygium of unspecified eye H11.021 Central pterygium of right eye H11.022 Central pterygium of left eye H11.023 Central pterygium of eye, bilateral H11.029 Central pterygium of unspecified eye H11.031 Double pterygium of right eye H11.032 Double pterygium of left eye H11.033 Double pterygium of eye, bilateral H11.039 Double pterygium of unspecified eye H11.041 Peripheral pterygium, stationary, right eye H11.042 Peripheral pterygium, stationary, left eye H11.043 Peripheral pterygium, stationary, bilateral H11.049 Peripheral pterygium, stationary, unspecified eye H11.051 Peripheral pterygium, progressive, right eye H11.052 Peripheral pterygium, progressive, left eye H11.053 Peripheral pterygium, progressive, bilateral H11.059 Peripheral pterygium, progressive, unspecified eye H11.061 Recurrent pterygium of right eye H11.062 Recurrent pterygium of left eye H11.063 Recurrent pterygium of eye, bilateral H11.069 Recurrent pterygium of unspecified eye H16.001 Unspecified corneal ulcer, right eye H16.002 Unspecified corneal ulcer, left eye H16.003 Unspecified corneal ulcer, bilateral H16.009 Unspecified corneal ulcer, unspecified eye H16.011 Central corneal ulcer, right eye H16.012 Central corneal ulcer, left eye H16.013 Central corneal ulcer, bilateral H16.019 Central corneal ulcer, unspecified eye H16.021 Ring corneal ulcer, right eye H16.022 Ring corneal ulcer, left eye H16.023 Ring corneal ulcer, bilateral H16.029 Ring corneal ulcer, unspecified eye H16.031 Corneal ulcer with hypopyon, right eye H16.032 Corneal ulcer with hypopyon, left eye H16.033 Corneal ulcer with hypopyon, bilateral H16.039 Corneal ulcer with hypopyon, unspecified eye H16.041 Marginal corneal ulcer, right eye H16.042 Marginal corneal ulcer, left eye H16.043 Marginal corneal ulcer, bilateral H16.049 Marginal corneal ulcer, unspecified eye H16.051 Mooren’s corneal ulcer, right eye H16.052 Mooren’s corneal ulcer, left eye H16.053 Mooren’s corneal ulcer, bilateral H16.059 Mooren’s corneal ulcer, unspecified eye H16.061 Mycotic corneal ulcer, right eye 6 H16.062 Mycotic corneal ulcer, left eye H16.063 Mycotic corneal ulcer, bilateral H16.069 Mycotic corneal ulcer, unspecified eye H16.071 Perforated corneal ulcer, right eye H16.072 Perforated corneal ulcer, left eye H16.073 Perforated corneal ulcer, bilateral H16.079 Perforated corneal ulcer, unspecified eye H16.231 Neurotrophic keratoconjunctivitis, right eye H16.232 Neurotrophic keratoconjunctivitis, left eye H16.233 Neurotrophic keratoconjunctivitis, bilateral H16.239 Neurotrophic keratoconjunctivitis, unspecified eye H18.10 Bullous keratopathy, unspecified eye H18.12 Bullous keratopathy, left eye H18.13 Bullous keratopathy, bilateral H18.831 Recurrent erosion of cornea, right eye H18.832 Recurrent erosion of cornea, left eye H18.833 Recurrent erosion of cornea, bilateral H18.839 Recurrent erosion of cornea, unspecified eye L51.1 Stevens-Johnson syndrome T26.50XA Corrosion of unspecified eyelid and periocular area, initial encounter T26.50XD Corrosion of unspecified eyelid and periocular area, subsequent encounter T26.50XS Corrosion of unspecified eyelid and periocular area, sequela T26.51XA Corrosion of right eyelid and periocular area, initial encounter T26.51XD Corrosion of right eyelid and periocular area, subsequent encounter T26.51XS Corrosion of right eyelid and periocular area, sequela T26.52XA Corrosion of left eyelid and periocular area, initial encounter T26.52XD Corrosion of left eyelid and periocular area, subsequent encounter T26.52XS Corrosion of left eyelid and periocular area, sequela T26.60XA Corrosion of cornea and conjunctival sac, unspecified eye, initial encounter T26.60XD Corrosion of cornea and conjunctival sac, unspecified eye, subsequent encounter T26.60XA Corrosion of cornea and conjunctival sac, unspecified eye, sequela T26.61XA Corrosion of cornea and conjunctival sac, right eye, initial encounter T26.61XD Corrosion of cornea and conjunctival sac, right eye, subsequent encounter T26.61XS Corrosion of cornea and conjunctival sac, right eye, sequela T26.62XA Corrosion of cornea and conjunctival sac, left eye, initial encounter T26.62XD Corrosion of cornea and conjunctival sac, left eye, subsequent encounter T26.62XS Corrosion of cornea and conjunctival sac, left eye, sequela T26.70XA Corrosion with resulting rupture and destruction of unspecified eyeball, initial encounter T26.70XD Corrosion with resulting rupture and destruction of unspecified eyeball, subsequent encounter T26.70XS Corrosion with resulting rupture and destruction of unspecified eyeball, sequela T26.71XA Corrosion with resulting rupture and destruction of right eyeball, initial encounter T26.71XD Corrosion with resulting rupture and destruction of right eyeball, subsequent encounter T26.71XS Corrosion with resulting rupture and destruction of right eyeball, sequela T26.72XA Corrosion with resulting rupture and destruction of left eyeball, initial encounter T26.72XD Corrosion with resulting rupture and destruction of left eyeball, subsequent encounter T26.72XS Corrosion with resulting rupture and destruction of left eyeball, sequela T26.80XA Corrosions of other specified parts of unspecified eye and adnexa, initial encounter T26.80XD Corrosions of other specified parts of unspecified eye and adnexa, subsequent encounter T26.80XS Corrosions of other specified parts of unspecified eye and adnexa, sequela 7 T26.81XA Corrosions of other specified parts of right eye and adnexa, initial encounter T26.81XD Corrosions of other specified parts of right eye and adnexa, subsequent encounter T26.81XS Corrosions of other specified parts of right eye and adnexa, sequela T26.82XA Corrosions of other specified parts of left eye and adnexa, initial encounter T26.82XD Corrosions of other specified parts of left eye and adnexa, subsequent encounter T26.82XS Corrosions of other specified parts of left eye and adnexa, sequela T26.90XA Corrosion of unspecified eye and adnexa, part unspecified, initial encounter T26.90XD Corrosion of unspecified eye and adnexa, part unspecified, subsequent encounter T26.90XS Corrosion of unspecified eye and adnexa, part unspecified, sequela T26.91XA Corrosion of right eye and adnexa, part unspecified, initial encounter T26.91XD Corrosion of right eye and adnexa, part unspecified, subsequent encounter T26.91XS Corrosion of right eye and adnexa, part unspecified, sequela T26.92XA Corrosion of left eye and adnexa, part unspecified, initial encounter T26.92XD Corrosion of left eye and adnexa, part unspecified, subsequent encounter T26.92XS Corrosion of left eye and adnexa, part unspecified, sequela The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 65778 Placement of amniotic membrane on the ocular surface; without sutures The following ICD Diagnosis Codes are considered medically necessary when submitted with the HCPCS codes above if medical necessity criteria are met: ICD-10 Diagnosis Coding ICD-10-CMdiagnosis codes: Code Description H04.121 Dry eye syndrome of right lacrimal gland H04.122 Dry eye syndrome of left lacrimal gland H04.123 Dry eye syndrome of bilateral lacrimal glands H04.129 Dry eye syndrome of unspecified lacrimal gland H16.001 Unspecified corneal ulcer, right eye H16.002 Unspecified corneal ulcer, left eye H16.003 Unspecified corneal ulcer, bilateral H16.009 Unspecified corneal ulcer, unspecified eye H16.011 Central corneal ulcer, right eye H16.012 Central corneal ulcer, left eye H16.013 Central corneal ulcer, bilateral H16.019 Central corneal ulcer, unspecified eye H16.021 Ring corneal ulcer, right eye H16.022 Ring corneal ulcer, left eye H16.023 Ring corneal ulcer, bilateral H16.029 Ring corneal ulcer, unspecified eye H16.031 Corneal ulcer with hypopyon, right eye H16.032 Corneal ulcer with hypopyon, left eye H16.033 Corneal ulcer with hypopyon, bilateral H16.039 Corneal ulcer with hypopyon, unspecified eye 8 H16.041 Marginal corneal ulcer, right eye H16.042 Marginal corneal ulcer, left eye H16.043 Marginal corneal ulcer, bilateral H16.049 Marginal corneal ulcer, unspecified eye H16.051 Mooren’s corneal ulcer, right eye H16.052 Mooren’s corneal ulcer, left eye H16.053 Mooren’s corneal ulcer, bilateral H16.059 Mooren’s corneal ulcer, unspecified eye H16.061 Mycotic corneal ulcer, right eye H16.062 Mycotic corneal ulcer, left eye H16.063 Mycotic corneal ulcer, bilateral H16.069 Mycotic corneal ulcer, unspecified eye H16.231 Neurotrophic keratoconjunctivitis, right eye H16.232 Neurotrophic keratoconjunctivitis, left eye H16.233 Neurotrophic keratoconjunctivitis, bilateral H16.239 Neurotrophic keratoconjunctivitis, unspecified eye H18.10 Bullous keratopathy, unspecified eye H18.12 Bullous keratopathy, left eye H18.13 Bullous keratopathy, bilateral H18.831 Recurrent erosion of cornea, right eye H18.832 Recurrent erosion of cornea, left eye H18.833 Recurrent erosion of cornea, bilateral H18.839 Recurrent erosion of cornea, unspecified eye L51.1 Stevens-Johnson syndrome T26.50XA Corrosion of unspecified eyelid and periocular area, initial encounter T26.50XD Corrosion of unspecified eyelid and periocular area, subsequent encounter T26.50XS Corrosion of unspecified eyelid and periocular area, sequela T26.51XA Corrosion of right eyelid and periocular area, initial encounter T26.51XD Corrosion of right eyelid and periocular area, subsequent encounter T26.51XS Corrosion of right eyelid and periocular area, sequela T26.52XA Corrosion of left eyelid and periocular area, initial encounter T26.52XD Corrosion of left eyelid and periocular area, subsequent encounter T26.52XS Corrosion of left eyelid and periocular area, sequela T26.60XA Corrosion of cornea and conjunctival sac, unspecified eye, initial encounter T26.60XD Corrosion of cornea and conjunctival sac, unspecified eye, subsequent encounter T26.60XA Corrosion of cornea and conjunctival sac, unspecified eye, sequela T26.61XA Corrosion of cornea and conjunctival sac, right eye, initial encounter T26.61XD Corrosion of cornea and conjunctival sac, right eye, subsequent encounter T26.61XS Corrosion of cornea and conjunctival sac, right eye, sequela T26.62XA Corrosion of cornea and conjunctival sac, left eye, initial encounter T26.62XD Corrosion of cornea and conjunctival sac, left eye, subsequent encounter T26.62XS Corrosion of cornea and conjunctival sac, left eye, sequela T26.70XA Corrosion with resulting rupture and destruction of unspecified eyeball, initial encounter T26.70XD Corrosion with resulting rupture and destruction of unspecified eyeball, subsequent encounter T26.70XS Corrosion with resulting rupture and destruction of unspecified eyeball, sequela T26.71XA Corrosion with resulting rupture and destruction of right eyeball, initial encounter T26.71XD Corrosion with resulting rupture and destruction of right eyeball, subsequent encounter T26.71XS Corrosion with resulting rupture and destruction of right eyeball, sequela T26.72XA Corrosion with resulting rupture and destruction of left eyeball, initial encounter T26.72XD Corrosion with resulting rupture and destruction of left eyeball, subsequent encounter 9 T26.72XS Corrosion with resulting rupture and destruction of left eyeball, sequela T26.80XA Corrosions of other specified parts of unspecified eye and adnexa, initial encounter T26.80XD Corrosions of other specified parts of unspecified eye and adnexa, subsequent encounter T26.80XS Corrosions of other specified parts of unspecified eye and adnexa, sequela T26.81XA Corrosions of other specified parts of right eye and adnexa, initial encounter T26.81XD Corrosions of other specified parts of right eye and adnexa, subsequent encounter T26.81XS Corrosions of other specified parts of right eye and adnexa, sequela T26.82XA Corrosions of other specified parts of left eye and adnexa, initial encounter T26.82XD Corrosions of other specified parts of left eye and adnexa, subsequent encounter T26.82XS Corrosions of other specified parts of left eye and adnexa, sequela T26.90XA Corrosion of unspecified eye and adnexa, part unspecified, initial encounter T26.90XD Corrosion of unspecified eye and adnexa, part unspecified, subsequent encounter T26.90XS Corrosion of unspecified eye and adnexa, part unspecified, sequela T26.91XA Corrosion of right eye and adnexa, part unspecified, initial encounter T26.91XD Corrosion of right eye and adnexa, part unspecified, subsequent encounter T26.91XS Corrosion of right eye and adnexa, part unspecified, sequela T26.92XA Corrosion of left eye and adnexa, part unspecified, initial encounter T26.92XD Corrosion of left eye and adnexa, part unspecified, subsequent encounter T26.92XS Corrosion of left eye and adnexa, part unspecified, sequela The following HCPCS codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: HCPCS Codes HCPCS codes: Code Description 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 Q4145 EpiFix, injectable, 1 mg Q4148 Neox cord 1k, neox cord rt, or clarix cord 1k, per square centimeter Q4150 Allowrap ds or dry, per square centimeter Q4153 Dermavest and plurivest, per square centimeter Q4155 NeoxFlo or ClarixFlo, 1 mg Q4156 Neox 100 or clarix 100, per square centimeter Q4157 Kerecis omega3, per square centimeter Q4159 Affinity, per square centimeter Q4160 Nushield, per square centimeter Q4162 Woundex flow, bioskin flow, 0.5 cc Q4163 Woundex, bioskin, per square centimeter Q4169 Artacent wound, per square centimeter Q4170 Cygnus, per square centimeter Q4171 Interfyl, 1 mg Q4173 Palingen or palingen xplus, per square centimeter Q4174 Palingen or promatrx, 0.36 mg per 0.25 cc Q4176 Neopatch, per square centimeter Q4177 Floweramnioflo, 0.1 cc Q4178 Floweramniopatch, per square centimeter 10 Q4179 Flowerderm, per square centimeter Q4180 Revita, per square centimeter Q4181 Amnio Wound, per sq cm Q4183 Surgigraft, per square centimeter Q4184 Cellesta, per square centimeter Q4185 Cellesta flowable amnion (25 mg per cc); per 0.5 cc 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 Q4194 Novachor, per square centimeter Q4198 Genesis amniotic membrane, per square centimeter Q4201 Matrion, per square centimeter Q4204 Xwrap, per square centimeter Q4205 Membrane graft or membrane wrap, per square centimeter Q4206 Fluid flow or fluid GF, 1 cc Q4208 Novafix, per square centimeter Q4209 Surgraft, per square centimeter Q4210 Axolotl graft or axolotl dualgraft, per square centimeter Q4211 Amnion bio or Axobiomembrane, per square centimeter Q4212 Allogen, per cc Q4213 Ascent, 0.5 mg Q4214 Cellesta cord, per square centimeter Q4215 Axolotl ambient or axolotl cryo, 0.1 mg Q4216 Artacent cord, per square centimeter Q4217 Woundfix, BioWound, Woundfix Plus, BioWound Plus, Woundfix Xplus or BioWound Xplus, per square centimeter Q4218 Surgicord, per square centimeter Q4219 Surgigraft-dual, per square centimeter Q4221 Amniowrap2, per square centimeter Description Human Amniotic Membrane HAM consists of two conjoined layers, the amnion, and chorion, and forms the innermost lining of the amniotic sac or placenta. When prepared for use as an allograft, the membrane is harvested immediately after birth, cleaned, sterilized, and either cryopreserved or dehydrated. Many products available using amnion, chorion, amniotic fluid, and umbilical cord are being studied for the treatment of a variety of conditions, including chronic full-thickness diabetic lower-extremity ulcers, venous ulcers, knee osteoarthritis, plantar fasciitis, and ophthalmic conditions. The products are formulated either as patches, which can be applied as wound covers, or as suspensions or particulates, or connective tissue extractions, which can be injected or applied topically (see Table 1). The fresh amniotic membrane contains collagen, fibronectin, and hyaluronic acid, along with a combination of growth factors, cytokines, and anti-inflammatory proteins such as interleukin-1 receptor antagonist.1 There is evidence the tissue has anti-inflammatory, antifibroblastic, and antimicrobial properties. HAM is considered nonimmunogenic and has not been observed to cause a substantial immune response. It is believed these properties are retained in cryopreserved HAM and dehydrated HAM products, resulting in a readily available tissue with regenerative potential. In support, one dehydrated HAM product has been shown to elute growth factors into saline and stimulate the migration of mesenchymal stem cells, both in vitro and in vivo.2 11 Use of a HAM graft, which is fixated by sutures, is an established treatment for disorders of the corneal surface, including neurotrophic keratitis, corneal ulcers and melts, following pterygium repair, StevensJohnson syndrome, and persistent epithelial defects. Amniotic membrane products that are inserted like a contact lens have more recently been investigated for the treatment of corneal and ocular surface disorders. Amniotic membrane patches are also being evaluated for the treatment of various other conditions, including skin wounds, burns, leg ulcers, and prevention of tissue adhesion in surgical procedures.1 Additional indications studied in preclinical models include tendonitis, tendon repair, and nerve repair. The availability of HAM opens the possibility of regenerative medicine for an array of conditions. Amniotic Fluid Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. In the second half of gestation, most of the fluid is a result of micturition and secretion from the respiratory tract and gastrointestinal tract of the fetus, along with urea.1 The fluid contains proteins, carbohydrates, peptides, fats, amino acids, enzymes, hormones, pigments, and fetal cells. Use of human and bovine amniotic fluid for orthopedic conditions was first reported in 1927.3 Amniotic fluid has been compared with synovial fluid, containing hyaluronan, lubricant, cholesterol, and cytokines. Injection of amniotic fluid or amniotic fluid‒derived cells is currently being evaluated for the treatment of osteoarthritis and plantar fasciitis. Amniotic membrane and amniotic fluid are also being investigated as sources of pluripotent stem cells.1 Pluripotent stem cells can be cultured and are capable of differentiation toward any cell type. The use of stem cells in orthopedic applications is addressed in policy #254. Table 1. Amniotic Membrane and Amniotic Fluid Preparations: Preparation and Components Product (Supplier) Preparation Components Cryopreserved, Dehydrated, or Extracted Amnion Chorion Amniotic Fluid Umbilical Cord Patch Affinity™ (NuTech Medical) C X AlloWrap™ (AlloSource) NS X AmbioDisk® ( IOP Ophthalmics) D AmbioDry5® (IOP Ophthalmics) D AmnioBand® Membrane (MTF Wound Care) D X X AmnioClear™ (Liventa Bioscience) NS X X AmnioExcel® (Derma Sciences) D X AmnioFix® (MiMedx) D X AmnioGraft® (Bio-Tissue) C X Artacent® Wound (Tides Medical) D X BioDDryFlex® (BioD) D X BioDfence™ (BioD) D X X BioSkin (HRT)a D X X Biovance® (Alliqua Biomedical) D X Clarix® (Amniox Medical) C X X Cygnus (Vivex Biomedical) D X Cygnus Max (Vivex Biomedical) D X EpiCord™ (MiMedx) D X EpiFix® (MiMedx) D X X Dermavest™ (Aedicell)a C X X X Grafix® (Osiris) C X X 12 Product (Supplier) Preparation Components Guardian/AmnioBand® (MTF Wound Care) D X X Neox® 100 (Amniox Medical) C X X Neox® Cord (Amniox Medical) C X X Neox® Wound Allograft (Amniox Medical) C X X NuShield™ (NuTech Medical) D X X PalinGen® Membrane (Amnio ReGen Solutions) C X Plurivest™ (Aedicell)a C X X X Prokera® (Bio-Tissue) C Revitalon™ (Medline Industries) D X X WoundEx® (Skye Biologics)a D X X Suspension, particulate, or extraction AmnioBand® Particulate (MTF Wound Care) D X X AmnioMatrix® (Derma Sciences) D X X AmnioVisc™ (Lattice Biologics) NS X BioSkin® Flow (HRT)b E X X X X Clarix® Flo (Amniox Medical) C X X Interfyl™ (Alliqua Biomedical) NS X X Neox® Flo (Amniox Medical) C X X OrthoFlo™ (MiMedx) D X PalinGen® Flow (Amnio ReGen Solutions) C X X PalinGen® SportFlow (Amnio ReGen Solutions) C X X ProMatrX™ ACF (Amnio ReGen Solutions) C X X ReNu™ (NuTech Medical) D X X WoundEx® Flow (Skye Biologics)b E X X X X C: cryopreserved; D: dehydrated; E: extracted connective tissue; HRT: Human Regenerative Technologies; MTF: Musculoskeletal Transplant Foundation; NS: not specified. a,b Processed by HRT and marketed by under different tradenames. Summary Several commercially available forms of human amniotic membrane (HAM) and amniotic fluid can be administered by patches, topical application, or injection. Amniotic membrane and amniotic fluid are being evaluated for the treatment of a variety of conditions, including chronic full-thickness diabetic lowerextremity ulcers, venous ulcers, knee osteoarthritis, plantar fasciitis, and ophthalmic conditions. Diabetic Lower-Extremity Ulcers For individuals who have non-healing diabetic lower-extremity ulcers who receive a patch or flowable formulation of HAM or placental membrane (ie, AmnioBand Membrane, AmnioExcel, Biovance, EpiCord, EpiFix, Grafix), the evidence includes randomized controlled trials (RCTs). The relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life (QOL). The RCTs evaluating amniotic and placental membrane products for the treatment of non-healing (<20% healing with ≥2 weeks of standard care) diabetic lower-extremity ulcers have compared HAM with standard care or with an established advanced wound care product. These trials used wound closure as the primary outcome measure, and some used power analysis, blinded assessment of wound healing, and intention-to-treat analysis. For the HAM products that have been sufficiently evaluated (ie, AmnioBand Membrane, Biovance, EpiCord, EpiFix, Grafix), results have shown improved outcomes compared with standard care, and outcomes that are at least as good as an established advanced wound care product. Improved health outcomes in the RCTs are supported by multicenter registries. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. 13 Lower-Extremity Ulcers due to Venous Insufficiency For individuals who have lower-extremity ulcers due to venous insufficiency who receive a patch or flowable formulation of HAM, the evidence includes two RCTs. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. The evidence on HAM for the treatment of lower-extremity venous ulcers includes two multicenter RCTs with EpiFix. One RCT reported larger percent wound closure at four weeks, but the percentage of patients with complete wound closure did not differ between EpiFix and standard of care. A second multicenter RCT reported a significant difference in complete healing at 12 weeks, but the interpretation is limited by methodologic concerns. Well-designed and wellconducted RCTs that compare HAM with the standard of care for venous insufficiency ulcers are needed. The evidence is insufficient to determine the effects of the technology on health outcomes. Osteoarthritis For individuals who have knee osteoarthritis who receive an injection of suspension or particulate formulation of HAM or amniotic fluid, the evidence includes a feasibility study. The relevant outcomes are symptoms, functional outcomes, QOL, and treatment-related morbidity. The pilot study assessed the feasibility of a larger RCT evaluating HAM injection. Additional trials, which will have a larger sample size and longer follow-up, are needed to permit conclusions on the effect of this treatment. The evidence is insufficient to determine the effects of the technology on health outcomes. Plantar Fasciitis The evidence on injection of amniotic membrane for the treatment of plantar fasciitis includes preliminary studies and a larger (n=145) patient-blinded comparison of micronized injectable-HAM and placebo control. Injection of micronized amniotic membrane resulted in greater improvements in the Visual Analog Score for pain and the Foot Functional Index compared to placebo controls. The primary limitation of the study is that this is an interim report with 12-month results pending. The evidence is insufficient to determine the effects of the technology on health outcomes. Ophthalmic Conditions Neurotrophic Keratitis with Ocular Surface Damage and Inflammation That Does Not Respond to Conservative Therapy For individuals who have neurotrophic keratitis with ocular surface damage and inflammation that does not respond to conservative therapy who receive HAM, the evidence includes an RCT. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. An RCT of 30 patients showed no benefit of sutured HAM graft compared to tarsorrhaphy or bandage contact lens. Based on clinical input, HAM might be considered for patients who did not respond to conservative therapy. Clinical input indicated that non-sutured HAM in an office setting would be preferred to avoid a delay in treatment associated with scheduling a surgical treatment. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Corneal Ulcers and Melts That Does Not Respond to Initial Medical Therapy For individuals who have corneal ulcers and melts, that does not respond to initial medical therapy who receive HAM, the evidence is limited. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. Corneal ulcers and melts are uncommon and variable and RCTs are not expected. Based on clinical input, HAM might be considered for patients who did not respond to conservative therapy. Clinical input indicated that non-sutured HAM in an office setting would be preferred to avoid a delay in treatment associated with scheduling a surgical treatment. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Corneal Perforation When There is Active Inflammation After Corneal Transplant Requiring Adjunctive Treatment For individuals who have corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment who receive HAM, the evidence is limited. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. No comparative evidence was identified for this indication. Clinical input supported the use of HAM to reduce inflammation and promote epithelial 14 healing with active inflammation following corneal transplantation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Bullous Keratopathy as a Palliative Measure in Patients Who are not Candidates for a Curative Treatment (eg, endothelial or penetrating keratoplasty) For individuals who have bullous keratopathy and who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty) who receive HAM, the evidence includes an RCT. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. An RCT found no advantage of sutured HAM over the simpler stromal puncture procedure for the treatment of pain from bullous keratopathy. Based on clinical input, non-sutured HAM could be used as an alternative to stromal puncture. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Partial Limbal Stem Cell Deficiency with Extensive Diseased Tissue Where Selective Removal Alone is not Sufficient For individuals who have partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is not sufficient who receive HAM, the evidence is limited. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. No RCTs were identified on HAM for limbal stem cell deficiency. Improvement in visual acuity has been reported for some patients who have received HAM in conjunction with removal of the diseased limbus. Clinical input noted the limitations of performing an RCT and supported the use of HAM for this indication. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Moderate or Severe Stevens-Johnson Syndrome For individuals who have moderate or severe Stevens-Johnson syndrome who receive HAM, the evidence includes an RCT. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. The evidence on HAM for the treatment of Stevens-Johnson includes one RCT with 25 patients (50 eyes) that found improved symptoms and function with HAM compared to medical therapy alone. Clinical input indicated that large RCTs are unlikely due to the severity and rarity of the disease, supported the use of HAM for moderate or severe Stevens-Johnson syndrome. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Persistent Epithelial Defects and Ulceration That Do Not Respond to Conservative Therapy For individuals who have persistent epithelial defects that do not respond to conservative therapy who receive HAM, the evidence is limited. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. No RCTs were identified on persistent epithelial defects and ulceration. Clinical input noted the difficulty in conducting RCTs for this indication and supported the use of amniotic membrane for persistent epithelial defects and ulcerations that do not respond to conservative therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Severe Dry Eye with Ocular Surface Damage and Inflammation That Does Not Respond to Conservative Therapy For individuals who have severe dry eye with ocular surface damage and inflammation that does not respond to conservative therapy, who receive HAM, the evidence includes an RCT and a large case series. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. The evidence on HAM for severe dry eye with ocular surface damage and inflammation includes an RCT with 20 patients and a retrospective series of 84 patients (97 eyes). Placement of self-retained HAM for 2 to 11 days reduced symptoms and restored a smooth corneal surface and corneal nerve density for as long as 3 months. Clinical input supported HAM in cases of severe dry eye with ocular surface damage and inflammation that does not respond to conservative therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Moderate or Severe Acute Ocular Chemical Burns For individuals who have moderate or severe acute ocular chemical burn who receive HAM, the evidence includes an RCT. The relevant outcomes are symptoms, morbid events, functional outcomes, and 15 QOL. Evidence includes an RCT of 100 patients with acute ocular chemical burns who were treated with HAM transplantation plus medical therapy or medical therapy alone. Patients in the HAM group had a faster rate of epithelial healing, without a significant benefit for other outcomes. Clinical input was in support of HAM for acute ocular chemical burn. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Corneal Perforation When Corneal Tissue is not Immediately Available For individuals who have corneal perforation when corneal tissue is not immediately available who receive sutured HAM, the evidence is limited. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. The standard treatment for corneal perforation is corneal transplantation. Based on clinical input, sutured HAM may be used as a temporary measure when corneal tissue is not immediately available. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Pterygium Repair When There is Insufficient Healthy Tissue to Create a Conjunctival Autograft For individuals who have pterygium repair when there is insufficient healthy tissue to create a conjunctival autograft who receive HAM, the evidence includes RCTs and systematic reviews of RCTs. The relevant outcomes are symptoms, morbid events, functional outcomes, and QOL. Systematic reviews of RCTs have been published that found that conjunctival or limbal autograft is more effective than HAM graft in reducing the rate of pterygium recurrence. Based on clinical input, sutured or glued HAM may be considered when there is insufficient healthy tissue to create a conjunctival autograft (eg, extensive, double, or recurrent pterygium). The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Policy History Date Action 10/2019 Clarified coding information. 7/2019 BCBSA National medical policy review. New medically necessary and investigational indications described. EpiCord added to medically necessary statement for diabetic lower extremity ulcers. Clarified coding information. Effective 7/1/2019. 1/2019 Clarified coding information. 7/2018 BCBSA National medical policy review. Investigational indications added. Clarified coding information. Effective 7/1/2018. 1/2018 Clarified coding information. 10/2017 BCBSA National medical policy review. New medically necessary and investigational indications described. Ophthalmic products added and discontinued product names removed from Table 1. Clarified coding information. Effective 10/1/2017. 6/2017 BCBSA National medical policy. New medically necessary and investigational indications described. Clarified coding information. Effective 6/1/2017. 9/2015 New medical policy describing investigational indications. Effective 9/1/2015. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References 1. Parolini O, Soncini M, Evangelista M, et al. Amniotic membrane and amniotic fluid-derived cells: potential tools for regenerative medicine? Regen Med. Mar 2009;4(2):275-291. PMID 19317646. 16 2. Koob TJ, Rennert R, Zabek N, et al. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. Oct 2013;10(5):493-500. PMID 23902526. 3. Shimberg M, Wadsworth K. The use of amniotic-fluid concentrate in orthopaedic conditions. J Bone Joint Surg. 1938;20(I):167-177. PMID. 4. Food and Drug Administration. 510(k) Summary: ProKeraTM Bio-Tissue Inc. (K032104). 2003; https://www.accessdata.fda.gov/cdrh_docs/pdf3/K032104.pdf. 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