Amniotic Membrane and Amniotic Fluid

POLICY NUMBER

A.7.01.149

DESCRIPTION

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 lower-extremity ulcers, venous ulcers, knee osteoarthritis, plantar fasciitis, and ophthalmic conditions.

Human Amniotic Membrane

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.

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. There is evidence that the tissue has anti-inflammatory, antifibroblastic, and antimicrobial properties. HAM is considered nonimmunogenic and has not been observed to cause substantial immune response. It is believed that these properties are retained in cryopreserved HAM and HAM products, resulting in a readily available tissue with regenerative potential. In support, one 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.

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, Stevens-Johnson 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. 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. 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. Amniotic fluid has been compared with synovial fluid, containing hyaluronan, lubricant, cholesterol, and cytokines. Injection of amniotic fluidor 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. 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 separately in the  Orthopedic Applications of Stem Cell Therapy (Including Allografts and Bone Substitutes Used with Autologous Bone Marrow)  medical policy.

In 2024, the U.S. Food and Drug Administration (FDA) issued a public safety notification on amniotic fluid eyedrops. The notice was to inform the public and health care practitioners "that manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns." A list of related warning letters issued by the FDA can be found on the FDA website's Warning Letters page using the search term "amniotic fluid."

On December 19, 2024, the FDA issued a warning letter to Integra LifeSciences Corporation stating: "FDA investigators and a microbiologist determined that the above firms manufacture a variety of neurological and neurosurgical devices, including but not limited to, cranial perforators, disposable cottonoid patties and strips as well as collagen based medical devices, that are used for wound care, soft tissue repair and reconstruction surgery. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body."

The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation, Title 21, parts 1270 and 1271. In 2017, the FDA published clarification of what is considered minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

HCT/Ps are defined as human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If an HCT/P does not meet the criteria below and does not qualify for any of the stated exceptions, the HCT/P will be regulated as a drug, device, and/or biological product and applicable regulations and premarket review will be required.

An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria:

1. "The HCT/P is minimally manipulated;

2. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;

3. The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

4. Either:

   1. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or

   2. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:

      1. Is for autologous use;

      2. Is for allogeneic use in a first-degree or second-degree blood relative; or

      3. Is for reproductive use."

The guidance provides the following specific examples of homologous and non-homologous use for amniotic membrane:

1. "Amniotic membrane is used for bone tissue replacement to support bone regeneration following surgery to repair or replace bone defects. This is not a homologous use because bone regeneration is not a basic function of amniotic membrane.

2. An amniotic membrane product is used for wound healing and/or to reduce scarring and inflammation. This is not homologous use because wound healing and reduction of scarring and inflammation are not basic functions of amniotic membrane.

3. An amniotic membrane product is applied to the surface of the eye to cover or offer protection from the surrounding environment in ocular repair and reconstruction procedures. This is homologous use because serving as a covering and offering protection from the surrounding environment are basic functions of amniotic membrane."

The FDA noted the intention to exercise enforcement discretion for the next 36 months after publication of the guidance.

In 2003, Prokera was cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process for the ophthalmic conformer that incorporates amniotic membrane (K032104). The FDA determined that this device was substantially equivalent to the Symblepharon Ring. The Prokera device is intended “for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.” The development of Prokera, a commercially available product, was supported in part by the National Institute of Health and the National Eye Institute.

Related medical policies –

• Bioengineered Skin and Soft Tissue Substitutes

• Orthopedic Applications of Stem Cell Therapy (Including Allografts and Bone Substitutes Used with Autologous Bone Marrow

POLICY

Treatment of nonhealing diabetic lower-extremity ulcers using the following human amniotic membrane products may be considered medically necessary:

• Affinity®

• AmnioBand® Membrane,

• Biovance®,

• EpiCord®,

• EpiFix®,

• Grafix™,

• NuShield®.

Human amniotic membrane grafts with or without suture 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;

• Corneal ulcers and melts that do not respond to initial conservative therapy;

• 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;

• Persistent epithelial defects that do not respond within 2 days to conservative therapy;

• 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 (see Policy Guidelines); 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 uses reviewed in this policy of the human amniotic products (eg, derived from amnion, chorion, amniotic fluid, umbilical cord, or Wharton's jelly) not listed above are considered investigational (see Policy Guidelines).

All other human amniotic products (e.g., derived from amnion, chorion, amniotic fluid, umbilical cord, or Wharton's jelly) including but not limited to those in Table 2 (see Policy Guidelines) for indications not listed above are considered investigational for indications reviewed in this policy, including but not limited to treatment of lower-extremity ulcers due to venous insufficiency and repair following Mohs micrographic surgery.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Non-healing 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.

This policy covers products that do not require FDA approval or clearance. The list of products named in this policy is not a complete list of all commercially available products. Table 1 lists products included in the Policy statements, and Table 2 lists other amniotic products that have a HCPCS code.

Table 1. Amniotic Products Listed in the Policy Statements

HCPCS: Healthcare Common Procedure Code System.Table 2. Other Amniotic Products with HCPCS Codes

HCPCS: Healthcare Common Procedure Code System; HRT: Human Regenerative Technologies; MTF: Musculoskeletal Transplant FoundationªProcessed by HRT and marketed under different tradename

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

• 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 lymphocyte function-associated antigen-1 (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)

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

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/16/2015: Approved by Medical Policy Advisory Committee.

04/13/2016: Policy description updated regarding amniotic fluid products and FDA regulations. Policy statements unchanged.

06/01/2016: Policy number A.7.01.149 added.

12/30/2016: Code Reference section updated to add new 2017 HCPCS codes Q4168 and Q4171.

04/20/2018: Policy description updated regarding products. Added the following policy statements: 1) Treatment of nonhealing diabetic lower-extremity ulcers using AmnioBand® Membrane, Biovance®, Epifix®, and Grafix™ may be considered medically necessary. 2) Sutured human amniotic membrane grafts may be considered medically necessary for neurotrophic keratitis, corneal ulcers and melts, pterygium repair, Stevens-Johnson syndrome, and persistent epithelial defects. 3) Sutured human amniotic membrane grafts for the treatment of all other ophthalmic conditions are considered investigational. 4) Human amniotic membrane without suture for ophthalmic indications is investigational. 5) All other human amniotic membrane products and indications not listed above are considered investigational. Policy statement revised to include injection of particulated human amniotic membrane as investigational. Investigational statement updated to change "amniotic fluid" to "human amniotic fluid." Policy Guidelines updated to define nonhealing and conservative treatment. Added the following codes as medically necessary: CPT code 65779, HCPCS codes Q4131, Q4132, Q4133, Q4145, Q4151, Q4154, Q4168, ICD-10 diagnoses E08.621, E08.622, E09.621, E09.622, E10.621, E10.622, E11.621, E11.622, E13.621, E13.622, H11.001 - H11.069, H16.001 - H16.079, H16.231 - H16.239, H17.00 - H17.9, H18.831 - H18.839, L51.1, and L51.3. Investigational codes table updated to add CPT code 65778, HCPCS codes Q4100, Q4137, Q4138, Q4140, Q4148, Q4150, Q4153, Q4156, Q4157, Q4159, Q4160, Q4162, Q4163, Q4169, Q4170, Q4173, and Q4174.

12/20/2018: Code Reference section updated to add new 2019 HCPCS codes Q4186, Q4183, Q4184, Q4185, Q4187, Q4188, Q4190, Q4191, Q4193, Q4194, Q4198, Q4200, Q4201, and Q4204. Revised code descriptions for HCPCS codes Q4133 and Q4137, effective 01/01/2019.

08/01/2019: Policy title updated to remove "Injections." Policy description updated regarding devices. Added EpiCord® to medically necessary statement regarding treatment of nonhealing diabetic lower-extremity ulcers. Human amniotic membrane grafts with or without suture may be considered medically necessary for the ophthalmic indications listed. Added statement that human amniotic membrane grafts with suture or glue may be considered medically necessary for the listed ophthalmic indications. Investigational statement revised to state that human amniotic membrane grafts with or without suture are considered investigational for all ophthalmic indications not outlined above. Policy Guidelines updated regarding conservative therapy and dry eye disease. Code Reference section updated with the following changes: 1) CPT code 65778 and HCPCS code Q4187 moved from investigational to covered; 2) Added CPT codes 65780, V2790, and ICD-10 diagnosis codes H04.121 - H04.129, H18.10 - H18.13, T26.61XA - T26.61XS, T26.62XA - T26.62XS, T26.81XA - T26.81XS, T26.82XA - T26.82XS, T86.842, T86.848, and Z94.7 as covered; 3) Added HCPCS codes Q4189 and Q4192 as investigational.

09/17/2019: Code Reference section updated to add new HCPCS codes Q4205, Q4206, and Q4221. Revised code description for HCPCS code Q4184. Effective 10/01/2019.

06/08/2020: Policy description updated regarding FDA clarification of what is considered minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Removed list of amniotic membrane and amniotic fluid preparations and components. Medically necessary policy statement criteria revised to state: Persistent epithelial defects that do not respond within 2 days to conservative therapy. Policy Guidelines updated to remove definitions for conservative therapy. Code Reference section updated to add HCPCS codes Q4126, Q4208, Q4211, Q4212, Q4213, Q4214, Q4215, Q4217, and Q4218 as investigational. Removed deleted HCPCS code Q4131.

06/29/2020: Code Reference section updated to add new HCPCS codes Q4227, Q4228, Q4229, Q4230, Q4231, Q4232, Q4233, Q4234, Q4235, Q4236, Q4237, Q4239, Q4240, Q4241, Q4242, Q4244, Q4245, Q4246, Q4247, and Q4248, effective 07/01/2020.

09/23/2020: Code Reference section updated to add new HCPCS codes Q4249, Q4250, Q4254, and Q4255, effective 10/01/2020.

10/01/2021: Code Reference section updated to add new HCPCS codes Q4251, Q4252, and Q4253, effective 10/01/2021.

05/01/2022: Policy description updated. Medically necessary statement regarding treatment of nonhealing diabetic lower-extremity ulcers updated to add Affinity®. Added statement that all other human amniotic products (eg, derived from amnion, chorion, amniotic fluid, umbilical cord, or Wharton's jelly) not listed above are considered investigational (see Policy Guidelines). Revised investigational statement to state that all other indications not listed above are considered investigational including but not limited to treatment of lower-extremity ulcers due to venous insufficiency. Policy Guidelines updated regarding amniotic products with HCPCS codes. Code Reference section updated to move HCPCS code Q4159 from investigational to covered. Removed deleted ICD-10 diagnosis codes T86.842 and T86.848. Added the following HCPCS codes as investigational: Q4176, Q4177, Q4178, Q4180, Q4181, Q4209, Q4210, Q4216, Q4219, Q4220, and Q4238. Removed HCPCS codes Q4100, Q4126, Q4193, and Q4200. Added new 04/01/2022 HCPCS codes Q4224, Q4225, Q4256, Q4257, and Q4258.

06/28/2022: Code Reference section updated to add new HCPCS codes Q4259, Q4260, and Q4261, effective 07/01/2022.

12/20/2022: Code Reference section updated to add new HCPCS codes Q4262, Q4263, and Q4264. HCPCS code Q4236 was reinstated, effective 01/01/2023. Removed deleted HCPCS code Q4228.

01/16/2023: Policy reviewed. Policy statement updated to add repair following Mohs micrographic surgery as investigational. Code Reference section updated to add HCPCS codes A2001 and Q4199.

03/21/2023: Policy reviewed; no changes.

03/31/2023: Code Reference section updated to add new HCPCS codes Q4265, Q4266, Q4267, Q4268, Q4269, Q4270, and Q4271 as investigational, effective 04/01/2023.

07/01/2023: Code Reference section updated to add new HCPCS codes Q4272, Q4273, Q4274, Q4275, Q4276, Q4277, Q4278, Q4280, Q4281, Q4282, Q4283, and Q4284, effective 07/01/2023.

09/27/2023: Code Reference section updated to add new HCPCS codes Q4285 and Q4286, effective 10/01/2023.

12/21/2023: Code Reference section updated to add new 2024 HCPCS codes Q4304, Q4279, Q4287, Q4288, Q4289, Q4290, Q4291, Q4292, Q4293, Q4294, Q4295, Q4296, Q4297, Q4298, Q4299, Q4300, Q4301, Q4302, and Q4303. Revised the code description for HCPCS code Q4225, effective 01/01/2024.

03/28/2024: Code Reference section updated to add new HCPCS codes Q4305, Q4306, Q4307, Q4308, Q4309, and Q4310, effective 04/01/2024.

06/27/2024: Policy description updated regarding related medical policies. Code Reference section updated to add new HCPCS codes Q4311, Q4312, Q4313, Q4314, Q4315, Q4316, Q4317, Q4318, Q4319, Q4320, Q4321, Q4322, Q4323, Q4324, Q4325, Q4326, Q4327, Q4328, Q4329, Q4330, Q4331, Q4332, and Q4333. Effective 07/01/2024.

07/29/2024: Policy description updated regarding devices. Medically necessary policy statement regarding human amniotic membrane grafts with or without suture updated to remove "Prokera®" and "AmbioDisk™." Investigational statements regarding the use of all other human amniotic products were revised for clarity. Policy Guidelines updated regarding products and to define non-healing of lower-extremity ulcers due to venous insufficiency.

10/01/2024: Code Reference section updated to add new HCPCS codes Q4334, Q4335, Q4336, Q4337, Q4338, Q4339, Q4340, Q4341, Q4342, and Q4344.

12/20/2024: Code Reference section updated to add new HCPCS codes Q4347, Q4348, Q4349, Q4351, and Q4352 effective 01/01/2025.

04/01/2025: Code Reference section updated to add new HCPCS codes Q4361, Q4365, A2035, Q4354, Q4355, Q4356, Q4357, Q4358, Q4359, Q4360, Q4362, Q4363, Q4364, Q4366, and Q4367, effective 04/01/2025. Removed deleted HCPCS code Q4244.

06/15/2025: Policy description updated regarding devices and an FDA public safety notification on amniotic fluid eyedrops. Medically necessary statement regarding treatment of nonhealing diabetic lower-extremity ulcers updated to add NuShield® to the list of human amniotic membrane products. Policy Guidelines updated to remove statement regarding non-healing of lower-extremity ulcers due to venous insufficiency. Revised tables listing amniotic products. Code Reference section updated to move HCPCS code Q4160 from investigational to medically necessary. Added HCPCS codes Q4343, Q4345, Q4346, Q4350, and Q4353 to the Investigational Codes table.

07/18/2025: Code Reference section updated to remove deleted HCPCS codes Q4210 and Q4277. Added new HCPCS codes Q4368, Q4369, Q4370, Q4372, Q4373, Q4375, Q4376, Q4377, Q4378, Q4379, Q4380, and Q4382. Effective 07/01/2025.

10/01/2025: Code Reference section updated to add new HCPCS codes Q4392, Q4383, Q4384, Q4386, Q4387, Q4388, Q4389, Q4390, Q4391, Q4393, and Q4394.

01/01/2026: Code Reference section updated to add new HCPCS codes Q4398 - Q4417 and Q4420.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 7.01.149

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.