Medical Policy and Coding Updates

Effective September 5, 2025

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  Individual | Group
Drugs/medical necessity criteria added

• Quzyttir (cetirizine) added to Antihistamines, Injection
• Prialt (ziconotide) added to Chronic Pain Drugs
• Visudyne (verteporfin) added to Photoenhancers, Injection
• Veklury (remdesivir) added to SARS-CoV-2 Inhibitors, Infusion

Effective August 1, 2025

Effective for dates of service on and after August 1, 2025, the following update will apply to the Carelon Medical Benefits Management (MBM) Genetic Testing Program. The date of service (DOS) will be defined as the sample or collection date. For archival samples, the sample collection or retrieval date will serve as the DOS for review. In the rare circumstance that an exception is needed, providers may reach out to the Carelon MBM genetic testing team at DL-GeneticTestingSolution@carelon.com.

This update is focused on providing clinically appropriate, safe, and affordable health care services. Providers are reminded that they may submit authorization requests through the Carelon provider portal. Portal access is available 24/7 to process requests in real-time and is the fastest, most convenient way to request an authorization.

Effective July 26, 2025

Effective for dates of service on and after July 26, 2025, the following updates will apply to the Carelon MBM, Inc. Clinical Appropriateness Guidelines for Genetic Testing. As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.

Updates by section

Chromosomal Microarray Analysis

• Postnatal/Pediatric evaluation now includes neonatal death as an indication for chromosomal microarray analysis
• Optical Genome Mapping considered not medically necessary; more studies are needed to validate its use for structural variant analysis

Whole Exome Sequencing and Whole Exome Sequencing

• Clarified and restructured criteria for better readability
• Specified that whole exome sequencing is excluded for early neonatal death

Pharmacogenomic Testing

• Genotyping for biomarkers in Table 1 is medically necessary when conditions are met
• Clarified Table 1 title:
  • Therapies and associated biomarkers considered medically necessary for genotyping
• Biomarkers added to Table 1:
  • Donanemab-azbt added for genotyping ApoE ε4 in Neurology for Alzheimer's treatment
  • Deuruxolitinib added for genotyping CYP2C9 in Dermatology for alopecia areata treatment
  • NUDT15 risk allele added to explain thiopurine-related myelosuppression risk in Asians and Hispanics
• Eliglustat's therapeutic area is clarified as hematology, not pediatrics

Predictive and Prognostic Polygenic Testing

• Guideline reaffirmed; Description/Scope and Rationale edited

For questions related to guidelines, please contact Carelon via email at MedicalBenefitsManagement.guidelines@Carelon.com. Additionally, you may access and download a copy of the current and upcoming guidelines.

Effective July 3, 2025

Bioengineered Skin and Soft Tissue Substitutes, 7.01.582  Individual | Group
Policy renumbered

• This policy replaces Bioengineered Skin and Soft Tissue Substitutes, 7.01.113, which will be deleted following 90-day provider notification

Investigational device added

• BEAR (bridge-enhanced anterior cruciate ligament repair) implant added to investigational list

Catheter Ablation for Atrial Fibrillation, 2.02.516  Individual | Group
New policy

• Transcatheter radiofrequency ablation or cryoablation to treat atrial fibrillation may be considered medically necessary when criteria are met
• Pulsed field ablation incorporated into all medically necessary statements

Effective July 1, 2025

Pharmacologic Treatment of Psoriasis, 5.01.629  Individual | Group
Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556  Individual | Group
Medical necessity criteria updated

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] updated from a preferred to a non-preferred adalimumab product

Use of Granulocyte Colony-Stimulating Factors (G-CSF), 5.01.551  Individual | Group
Medical necessity criteria updated

• Udenyca (pegfilgrastim-cbqv) and Udenyca Onbody (pegfilgrastim-cbqv) moved from second-line to first-line therapy for individuals younger than 18 years of age
• Udenyca (pegfilgrastim-cbqv) and Udenyca Onbody (pegfilgrastim-cbqv) moved from third-line to second-line therapy for individuals aged 18 years and older
• Nyvepria (pegfilgrastim-apgf) moved from first-line to second-line therapy for individuals younger than 18 years of age
• Nyvepria (pegfilgrastim-apgf) moved from second-line to third-line therapy for individuals aged 18 years and older

No updates this month.

Revised pharmacy policies
Effective June 1, 2025

Drugs for Weight Management, 5.01.621  Individual | Group
Medical necessity criteria updated

• Zepbound (tirzepatide) criteria updated to include treatment of moderate to severe obstructive sleep apnea in individuals with obesity when criteria are met

Gene Therapies for Thalassemia, 5.01.42  Individual | Group
Medical necessity criteria added/updated

• Casgevy (exagamglogene autotemcel) criteria updated to specify that the individual must not have an available 10/10 human leukocyte antigen (HLA)-matched related donor, instead of the previous requirement of not having an HLA identical or HLA matched donor
• Casgevy criteria updated from the individual does not have a baseline prothrombin time (PT) or partial thromboplastin time (PTT) greater than 1.5 times the upper limit of normal (ULN) to the individual does not have a baseline PT greater than 1.5 times the ULN
• Casgevy criteria updated to specify that the individual must not have persistent aspartate transaminase, alanine transaminase, or direct bilirubin values greater than 2 times the ULN, instead of the previous threshold of 3 times the ULN
• Casgevy criteria updated from the individual does not have a baseline estimated glomerular filtration rate (eGFR) less than 70 mL/min/1.73m² to the individual does not have a baseline eGFR less than 60 mL/min/1.73m²

Hepatitis C Antiviral Therapy, 5.01.606  Individual | Group
New formatting

• Section 1 includes coverage criteria for Incentive, Open, and Select formulary plans (Rx plan A1, A2, B3, B4, C4, F1, and G3) and plans with no pharmacy benefit coverage
• Section 2 includes separate coverage criteria for Essentials Formulary (Rx plan E1, E3, and E4)
• Section 3 includes separate coverage criteria for the Metallic Formulary plans (Rx plan M1, M2, and M4).

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months unless otherwise noted
• Re-authorization for all drugs listed in this policy is considered investigational

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  Individual | Group
Drugs/medical necessity criteria removed

• Abilify MyCite (aripiprazole) removed from Second Generation Antipsychotics as it has been withdrawn from the market

Drugs/medical necessity criteria added

• Generic albendazole added to Antifungals
• Natesto (testosterone) added to Nonpreferred Testosterone Replacement Agents

Medical necessity criteria updated

• Motegrity (prucalopride) criteria updated to require trial and failure with generic prucalopride
• Xifaxan (rifaximin) criteria updated to include the treatment of intestinal methanogen overgrowth when criteria are met

Pharmacologic Treatment of Atopic Dermatitis, 5.01.628  Individual | Group
Drug/medical necessity criteria added

• Nemluvio (nemolizumab-ilto) added for:
  • the treatment of moderate to severe atopic dermatitis when criteria are met
  • the treatment of adult individuals with prurigo nodularis when criteria are met

Drug/medical necessity criteria added

• Cibinqo (abrocitinib) criteria updated to stipulate that an individual must have experienced an inadequate response or intolerance to Adbry (tralokinumab-ldrm), Dupixent (dupilumab), Ebglyss (lebrikizumab-lbkz), or Rinvoq (upadacitinib)
• Cibinqo (abrocitinib) and Rinvoq (upadacitinib) criteria updated to clarify that an exception can be made for individuals who have had an inadequate response or intolerance to one traditional systemic therapy, provided they have tried Ebglyss (lebrikizumab-lbkz) or Nemluvio (nemolizumab-ilto)

Spravato (esketamine) Nasal Spray, 5.01.609  Individual | Group
Medical necessity criteria updated

• Clarification added specifying that substance use disorder (SUD) in remission requires complete abstinence for at least three months or verification that none of the current diagnostic criteria for a SUD have been met for at least three months
• Specified that individuals treated with Spravato for SUD must agree to abstain from alcohol and non-prescribed drugs after discharge, especially when confined in a hospital or residential treatment facility where access to these substances is not possible
• Restriction added for the concurrent use of any prescribed controlled medications that were not prescribed for the individual
• Language changed from “under a different plan” to “under a non-Company plan” for consistency with other policies

Medical necessity criteria removed

• Removed criteria associated with acute suicidal ideation or behavior

Length of approval criteria updated/removed

• Initial authorization increased from 6 months to 12 months

Effective June 1, 2025

Nerve Repair for Peripheral Nerve Injuries Using Synthetic Conduits or Allografts, 7.01.584

No updates this month.

Added codes
Effective September 5, 2025

Bioengineered Skin and Soft Tissue Substitutes, 7.01.582  Individual | Group
Now requires review for investigational.

C1763

Hepatitis C Antiviral Therapy, 5.01.606  Individual | Group
Now requires review for medical necessity and prior authorization.

S0145

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  Individual | Group
Now requires review for medical necessity and prior authorization.

J0248, J1201, J2278, J3396

Myoelectric Prosthetic and Orthotic Components for the Upper Limb, 1.04.502  Individual | Group
Now requires review for medical necessity and prior authorization.

L6882

Effective August 1, 2025

Implantable Bone-Conduction and Bone-Anchored Hearing Aids, 7.01.547  Individual | Group
Now requires review for medical necessity and prior authorization.

69719

Miscellaneous Oncology Drugs, 5.01.540  Individual | Group
Now requires review for medical necessity and prior authorization.

J0893

Pharmacologic Treatment of Osteoporosis, 5.01.596  Individual | Group
Now requires review for medical necessity and prior authorization.

J0630

Effective June 6, 2025

Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis, 2.04.127  Individual | Group
Now requires review for investigational.

81513, 81514, 0330U

Removed codes
Effective June 1, 2025

Nerve Repair for Peripheral Nerve Injuries Using Synthetic Conduits or Allografts, 7.01.584  Individual | Group
No longer requires review.

67910, 64912, 64913, C9352, C9355, C9361

Effective September 5, 2025

InterQual Criteria

The Plan will begin using InterQual criteria to determine the appropriate level of care for all planned procedures. Criteria within medical policy Site of Service: Select Surgical Procedures, 11.01.524, will continue to apply to the procedures listed within that policy. Prior authorization for all inpatient hospital care (surgical, non-surgical, behavioral health and/or substance abuse) continues to be required.

No updates this month.

No updates this month.

No updates this month.

Added codes
Effective June 1, 2025

InterQual Criteria: Services Reviewed for Medical Necessity, 10.01.531
Now requires review for medical necessity and prior authorization.

T2048

Effective July 3, 2025

Updates to Prior Authorization for Therapy Services

• Prior authorization will be required for physical and occupational therapy services:
  • Applicable to seventh visit onwards
  • The initial six visits do not require review
• These services will continue to be reviewed using InterQual criteria

No updates this month.

No updates this month.

No updates this month.

No updates this month.