Medical Policy and Coding Updates

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

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

Effective June 6, 2025

Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis, 2.04.127  Individual | Group
New policy

• Multitarget polymerase chain reaction testing for the diagnosis of bacterial vaginosis is considered investigational

Effective May 6, 2025

Carpal Tunnel Release Surgical Treatments, 7.01.595  Individual | Group
New policy

• Carpal tunnel release surgery is considered medically necessary for individuals with carpal tunnel syndrome who have failed conservative therapy when criteria are met

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  Individual | Group
Drug/medical necessity criteria updated

• Aveed (testosterone undecanoate) and Testopel (testosterone pellets) updated to match criteria for all other brand testosterone products

Pharmacologic Treatment of Transthyretin-Mediated Amyloidosis, 5.01.593Individual | Group
Medical necessity criteria updated

• Amvuttra, Onpattro, and Wainua updated diagnostic criteria

Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  Individual | Group
Medical necessity criteria added

• Tyenne (tocilizumab-aazg) IV added to site of service review

New medical policies
Effective May 1, 2025

Radiofrequency Volumetric Tissue Reduction for Nasal Obstruction, 7.01.597  Individual | Group
New policy

• Radiofrequency volumetric tissue reduction for nasal obstruction due to internal nasal valve collapse is considered investigational. (e.g., VivAer Stylus)
• Radiofrequency ablation or cryoablation for nasal swell body reduction for the treatment of nasal obstruction is considered investigational

Revised medical policies
Effective May 1, 2025

Skilled Hourly Nursing Care in the Home, 11.01.522  Individual | Group
Medical necessity criteria added

• Continuation of care now requires that skilled hourly nursing care is documented in the nursing progress notes and the physician reviews and renews the treatment plan, including discharge planning, every six months

New pharmacy policies
Effective May 1, 2025

Bispecific Antibodies, 5.01.650Individual | Group
New policy

• Rybrevant (amivantamab-vmjw) moved from Epidermal Growth Factor Receptor (EGFR) Inhibitors 5.01.603 to policy 5.01.650 Bispecific Antibodies
• Columvi (glofitamab-gxbm), Epkinly (epcoritamab-bysp), Lunsumio (mosunetuzumab-axgb) moved from Monoclonal Antibodies for the Treatment of Lymphoma 2.03.502 to Bispecific Antibodies 5.01.650
• Blincyto (blinatumomab), Elrexfio (elranatamab-bcmm), Imdelltra (tarlatamab-dlle), Talvey (talquetamab-tgvs), and Tecvayli (teclistamab-cqyv) moved from Miscellaneous Oncology Drugs 5.01.540 to Bispecific Antibodies 5.01.650
  • Blincyto (blinatumomab) coverage criteria to include treatment of standard or high-risk B-cell ALL in pediatric individuals
• Bizengri (zenocutuzumab-zbco) for the treatment of advanced, unresectable, or metastatic pancreatic adenocarcinoma or non-small cell lung cancer when criteria are met
• Ziihera (zanidatamab-hrii) for the treatment of biliary tract cancer when criteria are met

Revised pharmacy policies
Effective May 1, 2025

BRAF and MEK Inhibitors, 5.01.589  Individual | Group
Medical necessity criteria updated

• Braftovi (encorafenib) in combination with Erbitux (cetuximab) and mFOLFOX6 for the treatment of metastatic colorectal cancer

Drug/medical necessity criteria added

• Gomekli (mirdametinib) for the treatment of neurofibromatosis type 1 when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

Drugs for Rare Diseases, 5.01.576  Individual | Group
Medical necessity criteria updated

• Imcivree (setmelanotide) criteria age requirement changed from 6 years to 2 years of age and older

Drug/medical necessity criteria added

• Crenessity (crinecerfont) for the treatment of congenital adrenal hyperplasia when criteria are met

Immune Checkpoint Inhibitors, 5.01.591  Individual | Group
Medical necessity criteria updated

• Tevimbra (tislelizumab-jsgr) for the first-line treatment of esophageal cancer when criteria are met

Intravitreal and Suprachoroidal Corticosteroids, 5.01.619  Individual | Group
Medical necessity criteria updated

• Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

Medical Necessity Criteria and Dispensing Quantity Limits for Metallic Formulary Benefits, 5.01.547  Individual | Group
Title change

• Updated the policy title from “Medical Necessity Criteria and Dispensing Quantity Limits for Exchange Formulary Benefits” to “Medical Necessity Criteria and Dispensing Quantity Limits for Metallic Formulary Benefits.”

Section removed

• ‘Step Therapy Protocol’ and ‘Drugs Subject to the Step Therapy Protocol’ removed

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

• Zunveyl (benzgalantamine) for the treatment of mild to moderate dementia of Alzheimer’s disease when criteria are met
• Flagyl (metronidazole) and Likmez (metronidazole) added to Antibiotics
• Venxxiva (tiopronin delayed-release) added to Cystine Binding Drugs
• Brand metaxalone added to Muscle Relaxants
• PR benzoyl peroxide 7% wash and MetroLotion (metronidazole lotion) added to Brand Topical Acne or Rosacea Agents
• Rocaltrol (calcitriol) oral solution added to Vitamin Agents
• Azmiro (testosterone cypionate) added to Testosterone Replacement Products

Drug/medical necessity criteria removed

• Evekeo ODT removed from brand ADHD Drugs as the product has been discontinued
• Dexonto (dexamethasone) removed from Brand Topical Corticosteroids

Migraine and Cluster Headache Medications, 5.01.503  Individual | Group
Medical necessity criteria updated

• Corrected policy language for drugs with additional quantities from “at least 30 doses per 30 days” to “less than 30 doses per 30 days”

Drug/medical necessity criteria updated

• Symbravo (rizatriptan/meloxicam) for the acute treatment of migraine headaches when criteria are met

Miscellaneous Oncology Drugs, 5.01.540  Individual | Group
Medical necessity criteria updated

• Tabloid (thioguanine) criteria updated to include treatment of acute lymphoblastic leukemia
• Dacogen (decitabine) and generic decitabine coverage criteria to include treatment of acute myeloid leukemia

Drug/medical necessity criteria added

• Revuforj (revumenib) for the treatment of acute leukemia when criteria are met
• Romvimza (vimseltinib) for the treatment of tenosynovial giant cell tumor when criteria are met
• Beizray (docetaxel) for the treatment of various cancers, including breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck when criteria are met

Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502  Individual | Group
Medical necessity criteria updated

• Polivy (polatuzumab vedotin-piiq) criteria to include use as bridging therapy prior to a planned CD-19 CAR-T treatment when criteria are met

Pharmacologic Treatment of Cystic Fibrosis, 5.01.539  Individual | Group
Title change

• Policy title changed from “Pharmacologic Treatment of Cystic Fibrosis with Ivacaftor Products” to “Pharmacologic Treatment of Cystic Fibrosis.”

Drug/medical necessity criteria added

• Alyftrek (vanzacaftor/tezacaftor/ deutivacaftor) for the treatment of cystic fibrosis (CF) when criteria are met

Medical necessity criteria updated

• Clarified that the following drugs cannot be used in combination: Alyftrek (vanzacaftor/tezacaftor/ deutivacaftor), Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), Symdeko (tezacaftor/ivacaftor), and Trikafta (elexacaftor/tezacaftor/ivacaftor)
• Trikafta (elexacaftor/ tezacaftor/ivacaftor) for the treatment of CF who have a mutation that is responsive to Trikafta based on clinical and/or in vitro data when criteria are met
• Quantity limits added per the prescribing information for Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), Symdeko (tezacaftor/ivacaftor), and Trikafta (elexacaftor/tezacaftor/ivacaftor)

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

Pharmacologic Treatment of Hemophilia, 5.01.581  Individual | Group
Drug/medical necessity criteria added

• Alhemo (concizumab-mtci) for the treatment of hemophilia A and hemophilia B when criteria are met
• Qfitlia (fitusiran) for the treatment of hemophilia A and hemophilia B when criteria are met

Medical necessity criteria removed

• Beqvez (fidanacogene elaparvovec-dzkt) removed from policy as the product has been discontinued

Pharmacologic Treatment of High Cholesterol, 5.01.558  Individual | Group

Pharmacologic Treatment of Psoriasis, 5.01.629  Individual | Group
Length of approval criteria updated

• Re-authorization duration of approval changed from 3 years to 12 months

Pharmacologic Treatment of Sickle Cell Disease, 5.01.640  Individual | Group
Drug/medical necessity criteria added

• Xromi (hydroxyurea) to reduce the frequency of painful crises and reduce the need for blood transfusions in individuals with sickle cell anemia with recurrent moderate to severe painful crises when criteria are met

Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group
Medical necessity criteria updated

• Adalimumab products, Enbrel (etanercept), Simponi Aria (golimumab), tocilizumab products, Kevzara (sarilumab), Orencia (abatacept), and Cimzia (certolizumab pegol) polyarticular juvenile idiopathic arthritis (PJIA) criteria updated to require that the individual has aggressive disease
• Tocilizumab products PJIA and rheumatoid arthritis criteria updated to add an exception to the brand step therapy requirement if the individual has heart failure or a previously treated lymphoproliferative disorder
• Kevzara (sarilumab) rheumatoid arthritis criteria updated to add an exception to the brand step therapy requirement if the individual has heart failure or a previously treated lymphoproliferative disorder
• Orencia (abatacept) psoriatic arthritis, rheumatoid arthritis, and PJIA criteria updated to add an exception to the brand step therapy requirement if the individual has heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder
• Kevzara (sarilumab) PJIA criteria updated to add an exception to the brand step therapy requirement if the individual has heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder

Length of approval criteria updated

• Re-authorization duration of approval changed from 3 years to 12 months

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Drugs/medical necessity criteria added

• Omvoh (mirikizumab-mrkz) IV/SC and Tremfya (guselkumab) IV/SC for the treatment of moderately to severely active Crohn’s disease when criteria are met

Length of approval criteria updated

• Re-authorization duration of approval changed from 3 years to 12 months

SGLT2 Inhibitors, 5.01.646  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, E4, M1, M2, and M4) plans
• Section 3 includes separate coverage criteria for the Metallic (individual/small group/student ISHIP) plans

Length of approval criteria updated

• Re-authorization duration of approval changed from 3 years to 12 months

No updates this month.

No updates this month.

Added codes
Effective August 1, 2025

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

S0145

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 May 6, 2025

Carpal Tunnel Release Surgical Treatments, 7.01.595  Individual | Group
Now requires review for medical necessity and prior authorization.

29848, 64721

Effective May 1, 2025

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

J1072

Sinus Surgery in Adults, 7.01.559  Individual | Group
Now requires review for medical necessity, including site of service and prior authorization.

31233, 31235, 31240

Revised codes
Effective May 6, 2025

Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

Q5135

Removed codes
Effective May 1, 2025

Cochlear Implant, 7.01.586  Individual | Group

Implantable Bone-Conduction and Bone-Anchored Hearing Aids, 7.01.547  Individual | Group
No longer requires review.

L8625

Nonpharmacologic Treatment of Hyperhidrosis, 8.01.519  Individual | Group
No longer requires review.

11450, 11451

Pharmacologic Treatment of Hemophilia, 5.01.581  Individual | Group
No longer requires review.

J1414

No updates this month.

No updates this month.

No updates this month.

No updates this month.

Removed codes
Effective May 1, 2025

EviCore Musculoskeletal: Therapies
Now requires review for medical necessity and prior authorization.

97139, 97164

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.

Removed codes
Effective May 1, 2025

InterQual - General Surgery
No longer requires review.

34709, 34711, 34713, 34714, 34715

InterQual - Orthoses, Thoracic, Lumbar and Sacral Spine
No longer requires review.

L0621, L0622, L0623, L0624