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Amniotic Membrane and Amniotic Fluid

Section: Surgery
Effective Date: November 01, 2019
Revised Date: October 07, 2019
Last Reviewed: September 26, 2019

Description

Human amniotic membrane (HAM) forms the innermost layer of the placenta and is harvested from the time of caesarean section. It is cleaned, sterilized and cryo-preserved or dehydrated and can be utilized to facilitate wound healing in diabetic and venous ulcers or sutured onto ocular surfaces.

Amniotic fluid contains a concentration of growth factors and nutrients that promote healing in soft-tissue repair of bone, tendon and cartilage, as well as reducing inflammation and pain, in conditions such as osteoarthritis and plantar fasciitis.

Criteria

Human amniotic membrane (HAM) forms the innermost layer of the placenta and is harvested from the time of caesarean section. Treatment of non-healing diabetic lower-extremity ulcers using ANY of the following HAM products may be considered medically necessary:

  • AmnioBand® Membrane; or
  • Biovance®; or
  • Epifix®; or
  • Grafix™.

Note: Nonhealing is defined as less than a 20% decrease in wound area with standard wound care for at least two (2) weeks.

All other HAM products for the treatment of non-healing diabetic lower-extremity ulcers not listed above are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

Q4132 Q4133 Q4151 Q4154 Q4168 Q4186

Sutured human amniotic membrane HAM grafts may be considered medically necessary for the treatment of ANY of the following ophthalmic indications:

  • Neurotrophic keratitis; or
  • Corneal ulcers and melts; or
  • Pterygium repair; or
  • Stevens-Johnson syndrome; or
  • Persistent epithelial defects.

Note: A persistent epithelial defect is one that failed to close completely after five (5) days of conservative treatment or has failed to demonstrate a decrease in size after two (2) days of conservative treatment. Conservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching.

Sutured HAM grafts are considered experimental/investigational and, therefore, non-covered for the treatment of all other ophthalmic conditions because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

65779 Q4100 V2790

Human amniotic membrane without suture (e.g., Prokera®, AmbioDisk™) for ophthalmic indications is experimental/investigational and, therefore, noncovered
because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

65778 Q4100

All other HAM products  are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

Q4137 Q4138 Q4140 Q4148 Q4150 Q4153 Q4156
Q4157 Q4159 Q4160 Q4163 Q4169 Q4170 Q4173
Q4176 Q4178 Q4180 Q4183 Q4184 Q4185 Q4187
Q4188 Q4189 Q4190 Q4191 Q4192 Q4194 Q4198
Q4195 Q4201 Q4204 Q4205 Q4208 Q4209 Q4210
Q4211 Q4214 Q4216 Q4217 Q4218 Q4219 Q4221

Injection of micronized or particulated human amniotic membrane is considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Injection of human amniotic fluid is considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

Q4100 Q4139 Q4145  Q4155 Q4162 Q4171
Q4174  Q4177 Q4206 Q4212 Q4213 Q4215

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes Q4132, Q4133, Q4151, Q4154, Q4168 and Q4186

*L97.xxx codes must be billed with one of the following Exx.xxx codes from this section: 

E08.621  E08.622 E09.621  E09.622  E10.621  E10.622 E11.621
E11.622  E13.621  E13.622  L97.111  L97.112  L97.113  L97.114
L97.115  L97.116  L97.118  L97.121  L97.122  L97.123  L97.124
L97.125  L97.126 L97.128  L97.201  L97.202  L97.203  L97.204
L97.211  L97.212  L97.213  L97.214  L97.215  L97.216  L97.218
L97.221  L97.222  L97.223  L97.224  L97.225 L97.226  L97.228
L97.301 L97.302  L97.303 L97.304  L97.311  L97.312 L97.313
L97.314 L97.315  L97.316  L97.318 L97.321 L97.322 L97.323
L97.324 L97.325  L97.326  L97.328  L97.401  L97.402  L97.403
L97.404  L97.411  L97.412  L97.413  L97.414  L97.415  L97.416
L97.418  L97.421  L97.422  L97.423  L97.424  L97.425  L97.426
L97.428 L97.501  L97.502 L97.503   L97.504  L97.511 L97.512
L97.513  L97.514 L97.515 L97.516 L97.518  L97.521  L97.522
L97.523  L97.524  L97.525  L97.526  L97.528 L97.801 L97.802
L97.803 L97.804  L97.811  L97.812  L97.813  L97.814  L97.815
L97.816  L97.818 L97.821 L97.822 L97.823 L97.824 L97.825
L97.826 L97.828 L97.901 L97.902 L97.903 L97.904 L97.911
L97.922 L97.923 L97.924 L97.925 L97.926 L97.928

Covered Diagnosis Codes for Procedure Codes 65779, Q4100 and V2790

H11.001 H11.002 H11.003 H11.011 H11.012 H11.013 H11.021
H11.022 H11.023 H11.031 H11.032 H11.033 H11.041 H11.042
H11.043 H11.051 H11.052 H11.053 H11.061 H11.062 H11.063
H16.001 H16.002 H16.003 H16.011 H16.012 H16.013 H16.021
H16.022 H16.023 H16.031 H16.032 H16.033 H16.041 H16.042
H16.043 H16.051 H16.052 H16.053 H16.061 H16.062 H16.063
H16.071 H16.072 H16.073 H16.231 H16.232 H16.233 H18.831
H18.832 H18.833 L51.1

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