Amniotic Membrane and Amniotic Fluid

Section: Surgery

Effective Date: November 01, 2019

Revised Date: June 15, 2020

Revision Effective Date: July 01, 2020

Last Reviewed: June 15, 2020

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

15271	15272	15273	15274	15275	15276	15277
15278	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	Q4195
Q4198	Q4201	Q4204	Q4205	Q4208	Q4209	Q4210
Q4211	Q4214	Q4216	Q4217	Q4218	Q4219	Q4221
Q4227	Q4228	Q4229	Q4230	Q4231	Q4232	Q4233
Q4234	Q4235	Q4236	Q4237	Q4239	Q4240	Q4141
Q4242	Q4244	Q4245	Q4246	Q4247	Q4248

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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 New Policy for ND

Internal Medical Policy Committee 5-19-2020 Adding Application codes 15271 through 15278

Coding- HCPCS Update effective July 1, 2020

Links

References (PDF)

Disclaimer:

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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