Coverage and Clinical Guidelines update November 1, 2025

Effective November 1, 2025, Anthem Blue Cross and Blue Shield and its affiliate HealthKeepers, Inc. will implement the following new and revised Coverage Guidelines. These guidelines were among those recently approved at the Medical Policy and Technology Assessment Committee meeting held on May 8, 2025.

Note:

• HealthKeepers, Inc. requires prior authorization for the services addressed in the Coverage Guidelines below.
• Pre‑determination can be requested for our Anthem PPO products.

The guidelines addressed in this edition of Provider News are:

• DME.00054 Gait Modulation Systems Using Rhythmic Auditory Stimulation
• MED.00153 Encapsulated Cell Therapy for Degenerative Ocular Disease
• MED.00155 Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cell Therapy
• SURG.00011 Products for Wound Healing and Soft Tissue Grafting: Investigational
• CG-SURG-127 Products for Wound Healing and Soft Tissue Grafting: Medically Necessary Uses
• CG-MED-26 Neonatal Levels of Care
• SURG.00163 Autologous Cell Sheet Based Gene Therapy for Treatment of Dystrophic Epidermolysis Bullosa
• CG-MED-99 Intradialytic Parenteral Nutrition
• CG-SURG-126 Tibial Nerve Stimulation

Gait Modulation Systems Using Rhythmic Auditory Stimulation (DME.00054)

This new coverage guideline addresses the use of gait modulation systems using rhythmic auditory stimulation (RAS), also known as neurologic music therapy.

Gait modulation systems using rhythmic auditory stimulation (RAS), also referred to as neurologic music therapy, is considered investigational and not medically necessary for all indications.

The HCPCS code associated with this coverage guideline is E3200.

Encapsulated Cell Therapy for Degenerative Ocular Disease (MED.00153)

This new coverage guideline addresses therapy using encapsulated cells, which are genetically engineered to secrete the protein ciliary neurotrophic factor (CNTF).

Ocular encapsulated cell therapy using revakinagene taroretcel‑lwey is considered medically necessary when the individual has met all (A, B, C, and D) of the following criteria:

1. Adults aged 18 years or older; and
2. Diagnosis of macular telangiectasia type 2 in at least one eye with both (1 and 2) of the following:
   1. Evidence of fluorescein leakage; and
   2. One or more of the following features:
      • Hyperpigmentation outside a 500‑micron radius from the center of the fovea; or
      • Retinal opacification; or
      • Crystalline deposits; or
      • Right‑angle vessels; or
      • Inner/outer lamellar cavities; and
3. Inner segment-outer segment junction line photoreceptor break; and
4. Best corrected visual acuity (BCVA) of 54 or greater measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

Ocular encapsulated cell therapy is considered investigational and not medically necessary when the criteria above are not met.

The CPT and HCPCS codes associated with this coverage guideline are 67027, C9399, J3490, and J3590.

Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cell Therapy (MED.00155)

This new coverage guideline addresses allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, which has been studied as a treatment for steroid refractory acute graft versus host disease (SR-aGvHD).

An initial course of treatment (twice per week for four weeks) with remestemcel-L-rknd (Ryoncil) is considered medically necessary in individuals when all of the following criteria are met:

1. Diagnosed with SR-aGvHD grade B to D (excluding skin-only grade B) after receiving allogeneic hematopoietic stem cell transplantation (HSCT); and
2. Aged 2 months to 17 years; and
3. Have no known incidence of any of the following:
   1. Active treatment for a solid tumor malignancy; or
   2. Evidence of diffuse alveolar hemorrhage or other active pulmonary disease; or
   3. Evidence of severe hepatic veno-occlusive disease or sinusoidal obstruction; or
   4. HSCT for a solid tumor disease; or
   5. Hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins; or
   6. Prior treatment with MSCs, including remestemcel-L-rknd.

A repeat course of treatment with remestemcel-L-rknd (Ryoncil) is considered medically necessary when the following criteria have been met:

1. Partial or mixed response to the initial treatment (repeat once per week for four weeks); or
2. Recurrence of SR-aGvHD after complete response (repeat twice per week for four weeks).

Repeat treatment with remestemcel-L-rknd (Ryoncil) is considered not medically necessary when the initial treatment has resulted in either of the following:

1. Complete response; or
2. No response.

Initial or repeat treatment with remestemcel-L-rknd (Ryoncil) is considered investigational and not medically necessary when any of the medically necessary criteria above are not met.

The HCPCS codes associated with this new coverage guideline are C9399, J3490, and J3590.

Products for Wound Healing and Soft Tissue Grafting: Investigational (SURG.00011)

This coverage guideline addresses soft tissue (e.g., skin, ligament, cartilage, etc.) substitutes which are considered investigational.

Revisions to this guideline include the addition of MiroTract^® Wound Matrix to the list of products considered investigational and not medically necessary for all uses.

The CPT and HCPCS codes associated with this guideline are 31574, 46707, 0627T, 0628T, 0629T, 0630T, 15150, 15151, 15152, 15155, 15156, 15157, 15271,15272, 15273 , 15274 , 15275, 15276, 15277, 15278, 15777, 17999, 29999, C5271, C5272, C5273, C5274, C5275, C5276, C5277, C5278, A2001, A2002, A2004, A2005, A2006, A2007, A2008, A2009, A2010, A2011, A2012 , A2013 , A2014, A2015, A2016, A2017, A2018, A2019, A2020, A2021, A2022, A2023, A2024, A2025, A2026, A2027, A2028, A2029, A2030, A2031, A2032, A2033, A2034, A2035, A4100, C1763, C9352, C9353, C9354, C9355, C9356, C9361, C9364, C9399, C9796, G0428, Q4100, Q4103, Q4108, Q4111, Q4112, Q4113, Q4114, Q4117, Q4118, Q4123, Q4125, Q4126, Q4127, Q4132, Q4134, Q4135, Q4137, Q4138, Q4139, Q4140, Q4141, Q4142, Q4143, Q4145, Q4146, Q4147, Q4148, Q4149, Q4150, Q4152, 4153, Q4155, Q4156, Q4157, Q4159, Q4161, Q4162, Q4163, Q4164, Q4165, Q4166, Q4167, Q4169, Q4170, Q4171, Q4173, Q4174, Q4175, Q4176, Q4177, Q4178, Q4179, Q4180, Q4181, Q4183, Q4184, Q4185, Q4188, Q4189, Q4190, Q4191, Q4192, Q4193, Q4194, Q4195, Q4196, Q4197, Q4198, Q4199, Q4200, Q4201, Q4202, Q4203, Q4204, Q4205, Q4206, Q4208, Q4209, Q4211, Q4212, Q4213, Q4214, Q4215, Q4216, Q4217, Q4218, Q4219, Q4220, Q4221, Q4222, Q4224, Q4225, Q4226, Q4227, Q4229, Q4230, Q4232, Q4233, Q4234, Q4235, Q4236, Q4237, Q4238, Q4239, Q4240, Q4241, Q4242, Q4245, Q4246, Q4247, Q4248, Q4249, Q4250, Q4251, Q4252, Q4253, Q4254, Q4255, Q4256, Q4257, Q4258, Q4259, Q4260, Q4261, Q4262, Q4263, Q4264, Q4265, Q4266, Q4267, Q4268, Q4269, Q4270, Q4271, Q4272, Q4273, Q4274, Q4275, Q4276, Q4278, Q4279, Q4280, Q4281, Q4282, Q4284, Q4285, Q4286, Q4287, Q4288, Q4289, Q4290, Q4291, Q4292, Q4293, Q4294, Q4295, Q4296, Q4297, Q4298, Q4299, Q4300, Q4301, Q4302, Q4303, Q4304, Q4305, Q4306, Q4307, Q4308, Q4309, Q4310, Q4311, Q4312, Q4313, Q4314, Q4315, Q4316, Q4317, Q4318, Q4319, Q4320, Q4321, Q4322, Q4323, Q4324, Q4325, Q4326, Q4327, Q4328, Q4329, Q4330, Q4331, Q4332, Q4333, Q4336, Q4337, Q4338, Q4339, Q4340, Q4341, Q4342, Q4343, Q4344, Q4345, Q4346, Q4347, Q4348, Q4349, Q4350, Q4351, Q4352, Q4353, Q4354, Q4355, Q4356, Q4357, Q4358, Q4359, Q4360, Q4361, Q4362, Q4363, Q4364, Q4365, Q4366, and Q4367.

Products for Wound Healing and Soft Tissue Grafting: Medically Necessary Uses (CG-SURG-127)

This clinical guideline addresses the use of soft tissue (e.g., skin, ligament, cartilage, etc.) substitutes in wound healing and surgical procedures.

Revisions include the removal of products for non-healing complex wounds and addition of a section that outlines products considered medically necessary for complex abdominal wall reconstruction. The following products are considered medically necessary for complex abdominal wall reconstruction:

1. AlloDerm Regenerative Tissue Matrix (aseptic or sterile); or
2. Strattice; or
3. OviTex™; or
4. Phasix™ Mesh; or
5. Phasix™ ST Mesh.

The CPT and HCPCS codes associated with this revised clinical guideline are 15150, 15151, 15152, 15155, 15156, 15157, 15271, 15272, 15273 , 15274 , 15275, 15276, 15277, 15278, 15777, 17999, C5271, C5272, C5273, C5274, C5275, C5276, C5277, C5278, C9358, C9360, C9399, Q4100, Q4116, Q4122, Q4128, Q4130, 15011, 15012, 15013, 15014, 15015, 15016, 15017, 15018, A4100, C1832, C8002, C9363, Q4104, Q4105, Q4115, Q4121, Q4136, C9399, Q4116, Q4130, Q4106, Q4133, Q4151, Q4154, Q4158, Q4160, Q4186, Q4187, Q4283, Q4101, Q4102, Q4107, Q4110, Q4124, Q4186, 65778, 65779, 65780, Q4283, Q4334, Q4335, Q4369, and V2790.

Neonatal Levels of Care (CG-MED-26)

This clinical guideline addresses levels of care for neonates who meet criteria for inpatient care under applicable inpatient care guidelines.

Changes to this guideline include revisions to IV therapy, hyperbilirubinemia, and sepsis examples.

Level I Surveillance Special Care Nursery:

This level of care covers neonates who are medically stable but require surveillance/care at a higher level than provided in the general nursery.

Examples of types of services neonates receive or clinical conditions managed at this level are:

• Apnea/Bradycardia
  • Oral pharmacologic therapy for a baby who has been apnea-free for at least 72 hours; or
  • Surveillance without pharmacological intervention and 48 hours or more since last episode requiring intervention;
• Diagnostic work-up/surveillance, on an otherwise stable neonate, under 35 weeks gestational age, where no therapy is initiated;
• Hyperbilirubinemia requiring phototherapy with evidence of hemolysis;
• Infants transferred from a higher level of care who are physiologically stable, breathing room air, in an open crib, and taking either no medications or on a stable or declining dose of oral medications and requiring observation to document successful nipple feeding;
• Initial sepsis evaluation without antibiotic treatment for an asymptomatic neonate receiving monitoring (for example, CBC, blood culture);
• Antibiotic administration pending culture results (48 hours of incubation) in asymptomatic infants with normal sepsis screening laboratory tests who are taking enteral feedings and IV is for antibiotic administration only;
• IV fluids and enteral feedings, as follows:
  • IV fluids administered at 50 ml/kg/day or less for routine fluid, electrolyte, glucose and nutritional purposes in stable infants who are being weaned off of IV fluids and receiving enteral feedings by any combination of nasogastric, gastrostomy or nipple feedings, without other clinical conditions qualifying for a higher level of care; or
  • Nipple feedings are greater than 50% of total enteral feedings;
• Services rendered for neonatal abstinence syndrome:
  • Continuation of medication weaning for infants whose neonatal abstinence scores are 8 or less; or
  • Non-pharmacologic management of neonatal abstinence scores by provision of a non-stimulating environment, which may include maternal rooming-in or care in a non-NICU setting;
• Services rendered to a growing premature infant without supplemental oxygen or IV fluid needs or environmental control needs (other than blankets, cap, swaddling, etc.);

Services rendered for stable infants on nasal cannula flow support, with or without supplemental oxygen, where clinical discharge milestones set by hospital are met and infant will be discharged with durable medical equipment (DME); parental training on DME should be completed while infant still requires hospitalization.

Level II Neonatal Intensive Care:

Newborns admitted or treated at this level are those with physiological immaturity combined with medical instabilities.

Examples of types of services neonates receive or clinical conditions managed at this level of care are:

• Infants born 32 weeks gestation or greater and under 35 weeks gestation or infants weighing 1500 grams or more who have physiologic immaturity and who are moderately ill with problems that are expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis;
• Apnea or Bradycardia:
  • Apnea or Bradycardia episode requiring stimulation; or
  • Oral pharmacologic treatment for apnea or bradycardic episodes when last episode requiring intervention was less than 72 hours ago;
• Enteral feedings as follows:
  • Enteral feedings via a feeding tube located within the duodenum or jejunum; or
  • In infants receiving gavage and nipple feedings, where the volume delivered by gavage feedings is at 50% or greater of the total enteral feeding volume;
• Incubator or Warmer therapies:
  • Documented need for environmental control via an incubator/warmer for thermoregulation; or
  • Physiologically stable infants in the process of being weaned from an incubator/warmer to an open crib;
• IV Therapy:
  • IV fluids, inclusive of total parenteral nutrition, greater than or equal to 50 ml/kg/day; or
  • IV medications in a physiologically/clinically stable infant via PICC line or peripheral IV; or
  • IV treatment of hypoglycemia;
• Respiratory support:
  • Nasal cannula with flow less than or equal to 2 liters per minute or continuous positive airway pressure (CPAP) less than or equal to 4 cm H2O pressure; or
  • Supplemental oxygen via oxygen hood or nasal cannula when the effective fraction of inspired oxygen (FiO2) of less than or equal to 40% is sufficient to maintain acceptable blood oxygen saturation; or
  • Infants with stable respiratory status transitioning to home on a home ventilator, awaiting family teaching and/or placement availability;
• Sepsis:
  • Initial sepsis evaluation (CBC, blood culture, and other blood tests or cultures) for an asymptomatic neonate who requires antibiotic treatment pending laboratory and/or culture results; or
  • Documented sepsis;
• Pharmacologic treatment of neonatal abstinence syndrome:
  • The score is greater than or equal to 8, and non-pharmacologic therapy has failed; or
  • Infant is unable to meet any one of the following parameters while provided supportive care in a non-stimulating environment:
    • Able to be breastfed or take greater than or equal to 1 ounce from a bottle per feed; or
    • Able to sleep undisturbed for greater than or equal to 1 hour; or
    • Able to be consoled within 10 minutes after the onset of crying.

Autologous Cell Sheet-Based Gene Therapy for Treatment of Dystrophic Epidermolysis Bullosa (SURG.00163)

This new clinical guideline addresses the use of autologous cell sheet-based gene therapy for the treatment of wounds caused by recessive dystrophic epidermolysis bullosa (RDEB), for example prademagene zamikeracel (Zevaskyn™ [formerly pz-cel and EB-101], Abeona Therapeutics, Inc., Cleveland, OH).

Use of autologous cell sheet-based gene therapy for wounds caused by recessive dystrophic epidermolysis bullosa (RDEB), for example, prademagene zamikeracel is considered investigational and not medically necessary.

The CPT and HCPCS codes associated with this guideline are 17999, C9399, and J3590.

Intradialytic Parenteral Nutrition (CG-MED-99)

This new clinical guideline addresses intradialytic parenteral nutrition (IDPN).

Intradialytic parenteral nutrition is considered not medically necessary for all indications.

The HCPCS codes associated with this guideline are B4164, B4168, B4172, B4176, B4178, B4180, B4185, B4187, B4189, B4193, B4197, B4199, B4216, B4220, B4222, B4224, B5000, B5100, and B5200.

Tibial Nerve Stimulation (CG-SURG-126)

This clinical guideline addresses tibial nerve stimulation (TNS) in individuals with urinary retention, chronic urinary incontinence, and chronic fecal incontinence.

An initial 12-week trial of percutaneous tibial nerve stimulation is considered medically necessary when the following criteria are met (A and B):

1. Any of the following are present for at least 3 months, and not due to a neurological condition:
   1. Urinary urge incontinence; or
   2. Urinary urgency/frequency; or
   3. Non-obstructive urinary retention; and
2. Criteria 1 and 2 below are met:
   1. Clinically significant symptoms are present (for example, frequency, or severity impacts ability to work or participate in activities outside of the home); and
   2. Symptoms are refractory to, or individual could not tolerate, conservative treatment (for example, medication, pelvic floor muscle exercises, pelvic floor physical exercises with biofeedback, bladder training, or intermittent catheterizations for non-obstructive urinary retention) for at least a sufficient duration to fully assess treatment effect.*

* Note: The time frame for prior conservative treatment measures to demonstrate a refractory response is generally considered to be 2 to 3 months’ duration, subject to individual variability.

Continuation of percutaneous tibial nerve stimulation with monthly treatment is considered medically necessary when the following criteria are met (A and B):

1. An initial 12-week trial demonstrated improved urinary dysfunction meeting treatment goals, defined as:
   1. For urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes, or the number of pads/diapers used per day; or
   2. For urinary urgency/frequency: At least 50% reduction in the number of voids daily, or 50% increase in volume voided per void; or
   3. For urinary retention: At least a 50% reduction in catheter volume/catheterization; and
2. Annual evaluation indicates that the condition for which the treatment was initiated is still present.

An implantable tibial nerve stimulator is considered medically necessary for individuals when the following criteria are met (A and B):

1. The individual has met the criteria above for evaluation for a temporary percutaneous tibial nerve stimulator; and
2. The individual has demonstrated a successful response to a percutaneous tibial nerve stimulation defined as:
   1. For urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes, or the number of pads/diapers used per day; or
   2. For urinary urgency/frequency: At least 50% reduction in the number of voids daily, or 50% increase in volume voided per void; or
   3. For urinary retention: At least a 50% reduction in catheter volume/catheterization.

Replacement or revision of a percutaneous or implantable tibial nerve stimulator (with or without lead changes) is considered medically necessary when the current implanted device is no longer functioning appropriately.

Not Medically Necessary:

Percutaneous or implantable tibial nerve stimulation is considered not medically necessary when the medically necessary criteria above have not been met.

Replacement or revision of a percutaneous or implantable tibial nerve stimulator is considered not medically necessary when the above medically necessary criteria for replacement or revision have not been met.

Transcutaneous tibial nerve stimulation, including tibial nerve neuromodulation, is considered not medically necessary for all indications.

The CPT and HCPCS codes associated with this guideline are 64566, 0587T, 0588T, 0816T, 0817T, 0818T, 0819T, A4545, E0736, and E0737.

These coverage guidelines are available for review on our website at Anthem.com.