Medical Policy and Coding Updates

Effective November 15, 2025

Effective for dates of service on and after November 15, 2025, the following updates will apply to the Carelon MBM, Inc. Clinical Appropriateness Guidelines for Radiology. 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

Imaging of the Brain

• Specification of magnetic resonance imaging (MRI) for amyloid therapy monitoring
• Expansion to remove intervals and include other amyloid therapies
• Updated for non-acute trauma to align with American College of Radiology (ACR) Appropriate Use Criteria (AUC) recommendations, terminology clarifications
• Combined pituitary tumor sections
• Incidentaloma size threshold aligned with cited ACR white paper
• Added allowance for absence seizure, other clarifications aligned with operational intent
• New guideline content for Magnetoencephalography and magnetic source imaging
• Specification of objective findings for dizziness or vertigo aligned with ACR AUC
• Clarified current Hearing loss/Tinnitus allowances to align with ACR AUC
• Specification of prior imaging to allow MRI evaluation for headache

Imaging of the Extremities

• Removal of non-joint modality for joint indication for septic arthritis
• Clarification/expansion to allow imaging confirmation for myositis
• Addition of high-risk site (medial malleolus) for fracture
• Removal of unsupported content for soft tissue mass
• Expanded/simplified criteria aligned with Carelon musculoskeletal (MSK) guidelines for labral tear-shoulder
• Added x-ray per ACR AUC for chronic shoulder pain, alignment with MSK thresholds
• Removal of operationally vague scenario for ligament and tendon injuries- wrist now addressed under unexplained pain not otherwise specified (NOS)
• UE pain section combined with TFCC tear (no content change)
• Simplification of pain description for labral tear and femoral acetabular impingement- hip
• X-ray requirement for labral tear and femoral acetabular impingement aligned with MSK guideline
• Alignment with Carelon MSK Joint surgery guideline thresholds for meniscal tear/injury
• Removal of site-specific exclusions for pain NOS with aligned thresholds for conservative management; updated osteoarthritis grading

Imaging of the Extremities

• Expanded and simplified allowances for axial spondyloarthropathy aligned with cited diagnostic thresholds
• Changes to vertebral compression fracture in alignment with ACR AUC recommendations
• Added specification for new neurologic findings for neck pain and radiculopathy
• Removed intervention candidacy requirement; Removed cervical x-ray requirements aligned with ACR AUC
• Condensed Radiculopathy indication and Adult/Peds criteria
• Removed intervention candidacy requirement for spinal stenosis and spondylolisthesis
• Title clarification: removed scenario addressed in other sections

Vascular Imaging

• Cardiac surgery added to procedure-related imaging (allows computed tomography [CT] or coronary computed tomography angiography [CTA] chest)
• Combined post-revascularization imaging and updated alignment with Society for Vascular Surgery guidelines
• Cardiac surgery item moved to procedure related imaging.
• Simplification for acute/subacute stroke/transient ischemic attack by timing for intracranial and extracranial evaluation
• Specification for same-episode imaging
• Simplification of content by common presentation for venous thrombosis or compression, intracranial, allowance of CT/MRI in lieu of CTA/magnetic resonance angiography
• Added CT allowance for acute aortic syndrome (contrast CT may be sufficient for eval)
• Alignment of preop indications with Duplex ultrasound criteria for physiologic testing for peripheral arterial disease

Imaging of the Heart

• Coronary CT Angiography (CCTA), Cardiac MRI, Perfusion PET, Myocardial Perfusion Imaging (MPI), Stress Echocardiography
  • Defined the term “preceding evaluation for CAD [coronary artery disease]” in scenarios where the appropriateness of imaging is based on whether the patient has had a preceding evaluation
  • Added inconclusive exercise treadmill test as an indication for additional CAD testing
  • Allow preoperative stress testing for CAD to align with the 2024 American College of Cardiology/American Heart Association joint practice guidelines for perioperative cardiovascular management for noncardiac surgery
• Resting Transthoracic Echocardiography (TTE)
  • Surveillance recommended every 3 to 5 years in patients with congenital heart defects (i.e., small atrial septal defect (ASD), small muscular ventricular septal defect (VSD), small non muscular VSD, and small patent ductus arteriosus)
  • One-time evaluation recommended for first-degree relatives of patients with thoracic aortic aneurysm to detect asymptomatic thoracic aneurysms

Effective for dates of service on and after November 16, 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

Genetic Liquid Biopsy in the Management of Cancer and Cancer Surveillance

• Guideline renamed to encompass ribonucleic acid (RNA) based liquid biopsy tests
• Liquid circulating tumor deoxyribonucleic acid (DNA) based testing split into General Criteria and Cancer-site Specific Criteria
• General Requirements: Clarified that genomic testing must have established analytical and clinical validity and be performed in an appropriately certified laboratory
• General Criteria for Genetic Liquid Biopsy Testing:
  • Lab developed tests added
  • Additional criteria added to meet medical necessity
• Lung carcinoma: Replaced American Society of Clinical Oncology with European Society for Medical Oncology Scale for Clinical Actionability of molecular Targets – comparable, easier to locate, and updated more frequently
• Biliary tract carcinoma: New criteria added
• Breast carcinoma:
  • Removed restriction of individual needing to be an adult male or postmenopausal female
  • National Comprehensive Cancer Network (NCCN) 2A recommendation added as positive criteria
• Prostate carcinoma: NCCN 2A recommendation added as positive criteria
• Individuals without malignancy for whom liquid biopsy is used for screening: Test name examples added
• Circulating tumor DNA and Minimal Residual Disease: Test name examples added

Somatic Tumor Testing

• General Requirements: Clarified that genomic testing must have established analytical and clinical validity and be performed in an appropriately certified laboratory
• Somatic Testing of Solid Tumors:
  • Clarified that immunohistochemistry is out of scope for genetic testing
  • General Criteria:
    • Lab developed tests added as medically necessary
    • Allow genetic biomarker testing per member's health plan drug-specific policy requirements
• Tissue-agnostic testing for patients with advanced solid tumors:
  • Removal of restrictive criteria
  • Added FGFR biomarkers as medically necessary tumor testing
• Bladder Cancer (Urothelial Carcinoma, including the Upper Tract):
  • NCCN 2A recommendation added to positive criteria
  • Removed restriction to a specific genetic biomarker
• Breast Cancer, localized; early adjuvant setting:
  • Removed Breast Cancer Index (BCI) from early adjuvant setting and a new section was added allowing for the BCI test provided certain criteria are met
  • Added criteria for the Breast Cancer Index in extended adjuvant setting
• Breast Cancer, metastatic and/or locally advanced breast cancer:
  • Expanded genetic marker testing from 4 genes to 50 or fewer
  • NCCN 2A recommendation added to positive criteria
• Cholangiocarcinoma (Biliary Tract Cancers):
  • Added another required genetic marker
  • NCCN 2A recommendation added to positive criteria
• Melanoma: Removed restriction requiring previous BRAF V600E testing
• Non-small Cell Lung Cancer, localized (stage IB-IIIA):
  • Testing for squamous cell histology is now allowed without the requirements of being age ≤50, non-smoker, or light former smoker
  • Added Food and Drug Administration (FDA) label and NCCN 2A recommended treatments as allowed (expanded beyond two specific treatments)
• Non-small Cell Lung Cancer, advanced (previously metastatic):
  • Testing for squamous cell histology is now allowed without the requirements of being aged 50 or younger, non-smoker, or light former smoker
  • Added a marker for additional treatment option
• Ovarian (Epithelial):
  • Removed requirement for an FDA approved test
  • NCCN 2A recommendation added to positive criteria
• Pancreatic Adenocarcinoma:
  • NRG1 added as an additional biomarker based on FDA approval
  • Specify prior tissue-based next-generation sequencing testing
• Prostate Cancer, metastatic:
  • Castrate sensitive metastatic adenocarcinoma of the prostate and castrate resistant metastatic adenocarcinoma of the prostate specified as necessary types of prostate adenocarcinoma
  • NCCN 2A recommendation added to positive criteria
• Sarcoma (including soft tissue sarcoma, bone sarcoma, gastrointestinal stromal tumor, uterine sarcoma): Expanded criteria
• Thyroid Cancer:
  • Removed restrictive indeterminate thyroid nodules (ITNs) ultrasound criteria
  • Allow up to ITNs 4 cm in size
• Somatic Testing of Hematologic Malignancies
  • Somatic Genomic Testing (blood cancer biomarker testing):
    • NCCN 2A recommendation added to positive criteria
    • Allow for member's health plan drug-specific policy requirements to positive criteria
• Blood Cancer-Specific Criteria: Clarified that chromosomal testing is out of scope for genetic testing
• Acute Lymphoblastic Leukemia and Pediatric B-cell Precursor Lymphoblastic Lymphoma: Added another cancer type (pediatric BCP-LBL)
• Acute Myelogenous Leukemia: Added FLT3-ITD as medically necessary
• B-cell Lymphomas: New criteria for B-cell lymphomas 
• Chronic Lymphocytic Leukemia: Criteria added for focused NGS panel for risk stratification
• Chronic Myeloid Leukemia: Clarified use of focused testing
• Myelodysplastic Syndrome: Added genetic marker to examples

Effective for dates of service on and after November 15, 2025, the following updates will apply to the Carelon MBM, Inc. Clinical Appropriateness Guidelines for Sleep. 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

Polysomnography and Home Sleep Apnea Testing

• Inclusion of devices using peripheral arterial tone as an alternative approach to home sleep apnea study
• Age change to clarify non-adult patients at age 17 years and younger
• Expanded criteria for suspected obstructive sleep apnea (OSA) when etiology is unclear (home and in-lab) while eliminating the contraindications (home only)
• Clarifications for central sleep apnea and periodic limb movement disorder
• Removal of age restriction from auto-titrating positive airway pressure (PAP) contraindications

Multiple Sleep Latency Testing and Maintenance of Wakefulness Testing

• Clarification of idiopathic hypersomnia

Management of OSA using Auto-titrating PAP and Continuous PAP Devices

• Removed extraneous criteria to determine appropriate continuous PAP level
• Removal of age restriction from contraindications to auto-titrating PAP
• Clarification that clinical benefit attestation must come from the treating provider

Bi-Level PAP Devices

• Clarification that clinical benefit attestation must come from the treating provider

Management of OSA using Oral Appliances

• Clarification for patients with periodontal disease or temporomandibular joint dysfunction

Miscellaneous Devices in the Management of OSA and Restless Legs Syndrome

• Added criteria for restless legs syndrome (RLS) – Peroneal nerve stimulation for management of RLS is considered not medically necessary

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 October 3, 2025

Alpha1-Proteinase Inhibitors, 5.01.624  Individual | Group
C3 and C5 Complement Inhibitors, 5.01.571  Individual | Group
CGRP Inhibitors for Migraine Prophylaxis, 5.01.584  Individual | Group
Hereditary Angioedema, 5.01.587Individual | Group
Immune Globulin Therapy, 8.01.503  Individual | Group
Medical Pharmacologic Treatments of Multiple Sclerosis, 5.01.644  Individual | Group
Nulojix (belatacept) for Adults, 5.01.536  Individual | Group
Pharmacologic Treatment of Duchenne Muscular Dystrophy, 5.01.570  Individual | Group
Pharmacologic Treatment of Sickle Cell Disease, 5.01.640  Individual | Group
Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556  Individual | Group
Xolair (omalizumab), 5.01.513  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs

Balloon Spacers for Treatment of Irreparable Rotator Cuffs of the Shoulder, 7.01.180  Individual | Group
New policy

• Subacromial balloon spacer implantation is considered investigational as a treatment for massive, irreparable, full-thickness rotator cuff tears

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

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added for Tepezza (teprotumumab-trbw)

IL-5 Inhibitors, 5.01.559  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added to Fasenra (benralizumab) and Nucala (mepolizumab)

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

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added to the following drugs: Imfinzi (durvalumab), Jemperli (dostarlimab-gxly), Opdivo Qvantig (nivolumab-hyaluronidase-nvhy), Tecentriq (atezolizumab), and Tecentriq Hybreza (atezolizumab-hyaluronidase-tqjs)

Implantable Cardioverter-Defibrillator (ICD), 7.01.44  Individual | Group
New policy

• Automatic implantable cardioverter defibrillators (ICD) for the treatment of heart failure in pediatric and adult individuals may be considered medically necessary when criteria are met
• Subcutaneous ICDs for individuals with an indication for ICD implantation may be considered medically necessary when criteria are met

Miscellaneous Pharmacologic Treatments of Psoriasis, 5.01.652  Individual | Group
New policy

• The following medically necessary drugs (when criteria are met) were moved from Pharmacologic Treatment of Psoriasis, 5.01.629 to Miscellaneous Pharmacologic Treatments of Psoriasis, 5.01.652: Vtama (tapinarof), Zoryve (roflumilast) cream, Duobrii (halobetasol and tazarotene), Enstilar (betamethasone and calcipotriene), Taclonex (betamethasone and calcipotriene), Wynzora (betamethasone and calcipotriene), brand calcipotriene foam, Dovonex (calcipotriene), Sorilux (calcipotriene), Vectical (calcitriol), Soriatane (acitretin), and Spevigo (spesolimab-sbzo)

Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs

Pharmacologic Treatment of Gout, 5.01.616  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added to Ilaris (canakinumab)

Pharmacologic Treatment of Osteoporosis, 5.01.596  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added to the following drugs: Evenity (romosozumab-aqqg)

Medical necessity criteria added

• Generic calcitonin salmon injection and Miacalcin (calcitonin salmon) injection for the treatment of postmenopausal osteoporosis, Paget’s disease of bone, and hypercalcemia when criteria are met

Pharmacologic Treatment of Parkinson's Disease, 5.01.651  Individual | Group
Medical necessity criteria added

• Clarified that Apokyn coverage criteria will apply to the medical benefit

Pharmacologic Treatment of Psoriasis, 5.01.629  Individual | Group
Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645  Individual | Group
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs
• Section 1: Stelara (ustekinumab) criteria updated to require trial with Steqeyma (ustekinumab-aauz) and Yesintek (ustekinumab-kfce) for individuals not previously treated
• Sections 2 and 3: Stelara (ustekinumab) criteria updated to require trial with Steqeyma (ustekinumab-aauz) and Yesintek (ustekinumab-kfce)

New formatting

• Section 1 includes Open/Preferred/Select formulary plans and plans with no pharmacy benefit coverage
• Section 2 includes Essentials formulary plans
• Section 3 includes Metallic formulary plans

Pharmacologic Treatment of Psoriasis, 5.01.629  Individual | Group
New formatting

• Different criteria added for Metallic formulary and Essentials formulary plans for the following drugs: Enbrel (etanercept), adalimumab products, infliximab products, Taltz (ixekizumab), ustekinumab products, Skyrizi (risankizumab-rzaa), Tremfya (guselkumab), Otezla (apremilast), Sotyktu (deucravacitinib), Bimzelx (bimekizumab-bkzx), Siliq (brodalumab), Cosentyx (secukinumab), Cimzia (certolizumab pegol), and Ilumya (tildrakizumab-asmn)

Medical necessity criteria removed

• The following medically necessary drugs (when criteria are met) were removed from Pharmacologic Treatment of Psoriasis, 5.01.629 and added to Miscellaneous Pharmacologic Treatments of Psoriasis, 5.01.652: Vtama (tapinarof), Zoryve (roflumilast) cream, Duobrii (halobetasol and tazarotene), Enstilar (betamethasone and calcipotriene), Taclonex (betamethasone and calcipotriene), Wynzora (betamethasone and calcipotriene), brand calcipotriene foam, Dovonex (calcipotriene), Sorilux (calcipotriene), Vectical (calcitriol), Soriatane (acitretin), and Spevigo (spesolimab-sbzo)

Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645  Individual | Group
New formatting

• Different coverage criteria for Metallic formulary and Essentials formulary plans for the following drugs: Enbrel (etanercept), adalimumab products, infliximab products, Taltz (ixekizumab), ustekinumab products, Skyrizi (risankizumab-rzaa), Tremfya (guselkumab), Otezla (apremilast), Bimzelx (bimekizumab-bkzx), Cosentyx (secukinumab), Cimzia (certolizumab pegol), Rinvoq/Rinvoq LQ (upadacitinib), Xeljanz/Xeljanz XR (tofacitinib extended-release), Simponi (golimumab), Simponi Aria (golimumab), Rinvoq LQ (upadacitinib), and Orencia (abatacept)

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Medical necessity criteria updated

• Site of service review added for Zymfentra (infliximab-dyyb)

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added to the following drugs: Saphnelo (aninfrolumab-fnia), Vyvgart (efgartigimod alfa-fcab), and Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc)

Prosthetic Urethral Lift, 7.01.598  Individual | Group
New policy

• Prostatic urethral lift for the treatment of moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia may be considered medically necessary when criteria are met

Site of Service: Drugs and Biologic Agents, 11.01.523  Individual | Group
Title change

• Updated policy title from “Site of Service: Infusion Drugs and Biologic Agents” to “Site of Service: Drugs and Biologic Agents”

Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs

Medical necessity criteria added

• Site of service review added to the following drugs: Evenity (romosozumab-aqqg), Fasenra (benralizumab), Ilaris (canakinumab), Imfinzi (durvalumab), Jemperli (dostarlimab-gxly), Nucala (mepolizumab), Ocrevus Zunovo (ocrelizumab-hyaluronidase-ocsq), Opdivo Qvantig (nivolumab-hyaluronidase-nvhy), Saphnelo (aninfrolumab-fnia), Tecentriq (atezolizumab), Tecentriq Hybreza (atezolizumab-hyaluronidase-tqjs), Tepezza (teprotumumab-trbw), Tezspire (tezepelumab-ekko), Vyepti (eptinezumab-jjmr), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc), Xolair (omalizumab), and Zymfentra (infliximab-dyyb)

Thymic Stromal Lymphopoietin (TSLP) Inhibitors, 5.01.627  Individual | Group
Medical necessity criteria updated

• Clarified that site of service criteria can apply to injection drugs
• Site of service review added for Tezspire (tezepelumab-ekko)

Wearable Cardioverter-Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement, 2.02.506 Individual | Group
Medical necessity criteria removed

• ICD content removed from Wearable Cardioverter-Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement, 2.02.506 and added to Implantable Cardioverter Defibrillators (ICD), 7.01.44

Effective September 20, 2025

Effective for dates of service on and after September 20, 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

Prenatal Screening using Cell-free DNA

• Clarified cell free DNA screening for fetal red blood cell antigens is considered not medically necessary

Carrier Screening in the Reproductive Setting

• Expanded carrier screening: Clarified that carrier screening for a single gene condition can also be medically necessary when criteria are met
• Carrier testing based on family history: Expanded criteria to include having a relative who is a documented carrier of a genetic condition

Genetic Testing for Inherited Conditions

• New testing criteria for primary mitochondrial diseases includes mitochondrial DNA genomic sequence, large-deletion, and targeted nuclear mitochondrial gene panel analysis
• Testing for retinal disorders is considered medically necessary when the general requirements or multi-gene panel criteria are met
• Clarified weakly provoking factors for venous thromboembolism in thrombophilia testing

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 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

Revised medical policies
Effective July 1, 2025

Amniotic Membrane and Amniotic Fluid, 7.01.583  Individual | Group
Device added

• NuShield for the treatment of nonhealing diabetic lower-extremity ulcers

Bariatric Surgery, 7.01.516  Individual | Group
Medical necessity criteria added

• Obesity body mass index threshold for Asian populations added to selection criterion for bariatric surgery
• Reoperation for inadequate weight loss is considered medically necessary if the original bariatric procedure fails, such as unsuccessful band adjustments, resulting in less than 50% excess weight loss or less than 20% total weight loss

Deep Brain Stimulation, 7.01.63  Individual | Group
Investigational criteria added

• Adaptive deep brain stimulation in Parkinson disease is considered investigational

Revised pharmacy policies
Effective July 1, 2025

Antibody-Drug Conjugates, 5.01.582  Individual | Group
Medical necessity criteria added

• Adcetris (brentuximab vedotin) and Polivy (polatuzumab vedotin-piiq) moved from policy Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502 to Antibody-Drug Conjugate, 5.01.582
• Datroway (datopotamab deruxtecan-dlnk) for the treatment of unresectable or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer 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

Antidepressants: Pharmacy Medical Necessity Criteria for Brands, 5.01.520  Individual | Group
Medical necessity criteria added

• Raldesy (trazodone oral solution) for the treatment of depression when criteria are met

BCR-ABL Kinase Inhibitors, 5.01.518  Individual | Group
Medical necessity criteria updated

• Scemblix (asciminib) criteria updated to include all previously treated individuals

C3 and C5 Complement Inhibitors, 5.01.571  Individual | Group
Medical necessity criteria updated

• Soliris (eculizumab) criteria updated for the treatment of generalized myasthenia gravis from aged 18 years or older to aged 6 years or older

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

• Nexviazyme criteria updated the maximum dose prescribed
• Rivfloza (nedosiran) criteria updated to manage urinary oxalate levels in individuals aged 2 years and older, and the recommended dosing has been revised for those aged 2 to 11 years

Medical necessity criteria added

• Vykat XR (diazoxide choline extended-release) for the treatment of hyperphagia in individuals with Prader-Willi syndrome when criteria are met
• Ctexli (chenodiol) added for the treatment of cerebrotendinous xanthomatosis when criteria are met

Dupixent (dupilumab), 5.01.575  Individual | Group
Medical necessity criteria updated

• Asthma criteria updated to:
  • Include a forced expiratory volume in 1 second (FEV ₁)/ forced vital capacity (FVC) less than 0.80 as an optional requirement
  • Replace ‘has a dependence on oral corticosteroids of at least 5 mg per day of prednisone or equivalent’ with ‘has asthma that worsens upon tapering of oral corticosteroid therapy’

Medical necessity criteria added

• Indication added for the treatment of chronic spontaneous urticaria when criteria are met

Hereditary Angioedema, 5.01.587  Individual | Group
Medical necessity criteria updated

• Berinert (pdC1-INH), Firazyr (icatibant), Kalbitor (ecallantide), and Ruconest criteria updated to clarify that the generic icatibant step therapy requirement applies to individuals aged 18 years or older who are not currently pregnant
• Sajazir (icatibant) updated from a preferred treatment to a non-preferred agent for acute attacks of hereditary angioedema

IL-5 Inhibitors, 5.01.559  Individual | Group
Thymic Stromal Lymphopoietin (TSLP) Inhibitors, 5.01.627 Individual | Group
Xolair (omalizumab), 5.01.513 Individual | Group
Medical necessity criteria updated

• Asthma criteria updated to:
  • Include a forced expiratory volume in 1 second (FEV ₁)/ forced vital capacity (FVC) less than 0.80 as an optional requirement
  • Replace ‘has a dependence on oral corticosteroids of at least 5 mg per day of prednisone or equivalent’ with ‘has asthma that worsens upon tapering of oral corticosteroid therapy’

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

• Yervoy criteria updated for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (CRC) allowing coverage for all lines of therapy when used in combination with Opdivo
• Opdivo criteria updated for the treatment of MSI-H or dMMR unresectable or metastatic CRC allowing coverage for all lines of therapy when used in combination with Yervoy

Medical necessity criteria added

• Yervoy (ipilimumab) indication added for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) when used in combination with Opdivo (nivolumab) when criteria are met
• Opdivo (nivolumab) indication added for the first-line treatment of unresectable or metastatic HCC when used in combination with Yervoy (ipilimumab) when criteria are met
• Imfinzi (durvalumab) indication added for the treatment of muscle invasive bladder cancer when criteria are met

Immune Globulin Therapy, 8.01.503  Individual | Group
Medical necessity criteria added

• Measles post-exposure prophylaxis treatment

Multiple Receptor Tyrosine Kinase Inhibitors, 5.01.534  Individual | Group
Medical necessity criteria updated

• Cabometyx (cabozantinib) criteria updated to include treatment of pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors when criteria are met

Pharmacologic Treatment of Benign Prostatic Hyperplasia, 5.01.545  Individual | Group
Medical necessity criteria added

• Cardura (doxazosin) added for the treatment of benign prostatic hyperplasia (BPH) and hypertension when criteria are met
• Cardura XL (doxazosin extended-release) added for the treatment of BPH when criteria are met

Pharmacologic Treatment of Gout, 5.01.616  Individual | Group
Medical necessity criteria added

• Colcrys (colchicine) added to the list of gout drugs that require the individual has tried generic oral colchicine or generic oral allopurinol first and had an inadequate response

Pharmacologic Treatment of Osteoporosis, 5.01.596  Individual | Group
Medical necessity criteria added

• Calcitonin salmon nasal spray for the treatment of postmenopausal osteoporosis

Pharmacologic Treatment of Parkinson's Disease, 5.01.651  Individual | Group
Medical necessity criteria added

• Onapgo (apomorphine) added for the treatment of motor fluctuations in individuals with advanced Parkinson’s disease when criteria are met

Pharmacologic Treatment of Psoriasis, 5.01.629  Individual | Group
Medical necessity criteria

• Criteria added for Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-ackn), Steqeyma (ustekinumab-stba), ustekinumab (Stelara unbranded), ustekinumab-aekn (Selarsdi unbranded), ustekinumab-ttwe (Pyzchiva unbranded), Yesintek (ustekinumab-kfce), and Wezlana (ustekinumab-auub)

Note updated

• Criteria for Bimzelx (bimekizumab-bkzx), Cimzia (certolizumab pegol), Cosentyx (secukinumab), Ilumya (tildrakizumab-asmn), and Siliq (brodalumab) do not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3), applicable criteria can be found in the Medical Necessity Criteria for Custom Open and Preferred Formularies, 5.01.647

Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645  Individual | Group
New policy

• The following medically necessary criteria (when criteria are met) and drugs were moved from Pharmacotherapy of Arthropathies, 5.01.550 to Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645: Psoriatic arthritis criteria for infliximab products, adalimumab products, Simponi Aria, Enbrel, Taltz, Stelara, Skyrizi, Tremfya, Rinvoq, Rinvoq LQ, Xeljanz, Xeljanz XR, Otezla, Cimzia, Simponi, Bimzelx, Cosentyx, and Orencia
• Medically nescessary criteria added for Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-ackn), Steqeyma (ustekinumab-stba), ustekinumab (Stelara unbranded), ustekinumab-aekn (Selarsdi unbranded), ustekinumab-ttwe (Pyzchiva unbranded), Yesintek (ustekinumab-kfce), and Wezlana (ustekinumab-auub)

Note updated

• Criteria for Bimzelx (bimekizumab-bkzx), Cimzia (certolizumab pegol), Cosentyx (secukinumab) IV/SC, Orencia (abatacept) IV/SC, and Simponi (golimumab) SC do not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3), applicable criteria can be found in the Medical Necessity Criteria for Custom Open and Preferred Formularies, 5.01.647

Pharmacologic Treatment of Sleep Disorders, 5.01.599  Individual | Group
Medical necessity criteria updated

• Lumryz (sodium oxybate) criteria updated age requirement from 18 years or older to 7 years or older
• Lumryz (sodium oxybate), brand sodium oxybate, Wakix (pitolisant), Xyrem (sodium oxybate), and Xywav (calcium, magnesium, potassium, and sodium oxybates) cataplexy criteria updated to clarify that cataplexy is documented by brief episodes of sudden bilateral loss of muscle tone with maintained consciousness that is precipitated by an emotional trigger such as laughter or joking rather than laughter and joking specifically
• Lumryz (sodium oxybate) excessive daytime sleepiness criteria updated to include an age requirement of 7 years or older
• Sunosi (solriamfetol) and Wakix (pitolisant) excessive daytime sleepiness criteria updated to include an age requirement of 18 years or older
• Brand sodium oxybate, Xyrem (sodium oxybate), and Xywav (calcium, magnesium, potassium, and sodium oxybates) excessive daytime sleepiness criteria updated to include an age requirement of 7 years or older

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 Transthyretin-Mediated Amyloidosis, 5.01.593  Individual | Group
Medical necessity criteria added

• Amvuttra (vutrisiran) indication added for the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis when criteria are met

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

• Psoriatic arthritis criteria for infliximab products, adalimumab products, Simponi Aria, Enbrel, Taltz, Stelara, Skyrizi, Tremfya, Rinvoq, Rinvoq LQ, Xeljanz, Xeljanz XR, Otezla, Cimzia, Simponi, Bimzelx, Cosentyx, and Orencia moved from Pharmacotherapy of Arthropathies, 5.01.550 to Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645

Note updated

• Criteria for Actemra (tocilizumab) IV/SC, Bimzelx (bimekizumab-bkzx), Cimzia (certolizumab pegol), Cosentyx (secukinumab), Kevzara (sarilumab), Kineret (anakinra), Olumiant (baricitinib), Orencia (abatacept), Simponi (golimumab) SC, Tofidence (tocilizumab-bavi) IV, Tyenne (tocilizumab-aazg) IV/SC do not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3), applicable criteria can be found in the Medical Necessity Criteria for Custom Open and Preferred Formularies, 5.01.647

Pharmacotherapy of Type I and Type II Diabetes Mellitus, 5.01.569  Individual | Group
Medical necessity criteria updated

• Victoza (liraglutide) updated from a preferred to a non-preferred GLP-1 agonist

Medical necessity criteria added

• Brynovin (sitagliptin) added as a non-preferred DPP-4 inhibitor
• Generic liraglutide added as a preferred GLP-1 agonist

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556  Individual | Group
Note updated

• Criteria do not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3), applicable criteria can be found in the Medical Necessity Criteria for Custom Open and Preferred Formularies, 5.01.647

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Note updated

• Criteria for Cimzia (certolizumab pegol), Entyvio (vedolizumab) SC, Simponi (golimumab) SC, and Zeposia (ozanimod) do not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3), applicable criteria can be found in the Medical Necessity Criteria for Custom Open and Preferred Formularies, 5.01.647

Medical necessity criteria

• Criteria added for Imuldosa (ustekinumab-srlf), Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-ackn), Steqeyma (ustekinumab-stba), ustekinumab (Stelara unbranded), ustekinumab-aekn (Selarsdi unbranded), ustekinumab-ttwe (Pyzchiva unbranded), Yesintek (ustekinumab-kfce), and Wezlana (ustekinumab-auub)

Prostate Cancer Targeted Therapies, 5.01.544  Individual | Group
Medical necessity criteria added

• Abirtega (abiraterone) added with identical criteria to generic abiraterone

No updates this month.

No updates this month.

Added codes
Effective October 3, 2025

Implantable Cardioverter Defibrillator (ICD), 7.01.44  Individual | Group
Now requires review for medical necessity.

C1721, C1722, C1824, C1882, C1895, C1896, C1899

Now requires review for medical necessity and prior authorization.

33216, 33217, 33230, 33231, 33240, 33249, 33270, 33271, 93260, 93282-93284, 93287, 93289, 0572T

Pharmacologic Treatment of Parkinson's Disease, 5.01.651  Individual | Group
Now requires review for medical necessity and prior authorization.

J0364

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Now requires review for medical necessity and prior authorization.

J1748

Prosthetic Urethral Lift, 7.01.598  Individual | Group
Now requires review for medical necessity.

C9739, C9740

Now requires review for medical necessity and prior authorization.

52441, 52442

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  Individual | Group
Now requires review for medical necessity, including site of service and prior authorization.

J3111, J0517, J0638, J9173, J9272, J2182, J2351, J9622, J0491, J9022, J9024, J3241, J2356, J3032, J9332, J9334, J2357, J1748

Systemic Pharmacologic Treatments of Plaque Psoriasis, 5.01.652  Individual | Group
Now requires review for medical necessity and prior authorization.

J1747

Carelon Management Sleep Disorder Management
Now reviewed by Carelon Specialty Health for medical necessity and prior authorization.

0964T, 0965T, 0966T

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 July 3, 2025

Catheter Ablation for Atrial Fibrillation, 2.02.516  Individual | Group
Now requires review for medical necessity and prior authorization.

93655, 93656, 93657

Effective July 1, 2025

Amniotic Membrane and Amniotic Fluid, 7.01.583  Individual | Group
Now requires review for investigational.

Q4368, Q4369, Q4370, Q4371, Q4372, Q4373, Q4375, Q4376, Q4377, Q4378, Q4379, Q4380, Q4382

Antibody-Drug Conjugates, 5.01.582  Individual | Group
Now requires review for medical necessity.

C9174

Bispecific Antibodies, 5.01.650  Individual | Group
Now requires review for medical necessity and prior authorization.

J9276. J9382

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63  Individual | Group
Now requires review for medical necessity and prior authorization.

Q2058

Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  Individual | Group
Now requires review for investigational.

0568U

Focal Treatments for Prostate Cancer, 8.01.61  Individual | Group
Now requires review for investigational.

0950T

Gene Therapies for Rare Diseases, 5.01.642  Individual | Group
Now requires review for medical necessity and prior authorization.

J3391

Immune Checkpoint Inhibitors, 5.01.591  Individual | Group
Now requires review for medical necessity and prior authorization.

J9275, J9289

Laboratory Testing Investigational Services, 2.04.520  Individual | Group
Now requires review for investigational.

0558U, 0559U, 0563U, 0564U, 0570U, 0572U, 0573U, 0574U

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

J1326, J9341, J9174

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

0557U

Non-covered Experimental/Investigational Services, 10.01.533  Individual | Group
Now requires review for investigational.

0948T, 0949T, 0956T, 0957T, 0958T, 0959T, 0960T, 0961T, 0962T, 0964T, 0965T, 0966T, 0967T, 0968T, 0969T, 0970T, 0971T, 0972T, 0973T, 0974T, 0975T, 0976T, 0978T, 0979T, 0980T, 0981T, 0982T, 0983T, 0984T, 0985T, 0986T, 0987T, C8005

Non-covered Services and Procedures, 10.01.517  Individual | Group
No longer covered.

A6610, E0201, E1022, E1023

Pharmacologic Treatment of Hemophilia, 5.01.581  Individual | Group
Now requires review for medical necessity and prior authorization.

J7172

Pharmacologic Treatment of Parkinson's Disease, 5.01.651  Individual | Group
Now requires review for medical necessity and prior authorization.

J7356

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Now requires review for medical necessity and prior authorization.

Q9997

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Pharmacologic Treatment of Psoriasis, 5.01.629 Individual | Group
Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645  Individual | Group
Now requires review for medical necessity and prior authorization.

Q5098, Q5099, Q5100, Q5137, Q5138, Q9996, Q9998, Q9999

Semi-Implantable and Fully Implantable Middle Ear Hearing Aids, 7.01.84  Individual | Group
Now requires review for investigational.

0951T, 0952T, 0953T, 0954T, 0955T

Site of Service: Select Surgical Procedures, 11.01.524  Individual | Group
Now requires review for medical necessity, including site of service and prior authorization.

31233, 31235, 31240

Carelon Management Genetic Testing
Now reviewed by Carelon Specialty Health for medical necessity and prior authorization.

0552U, 0553U, 0554U, 0555U, 0560U, 0561U, 0562U,0565U, 0566U, 0567U, 0569U, 0571U

Revised codes
Effective October 3, 2025

Alpha1-Proteinase Inhibitors, 5.01.624  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J0491, J9332, J9334

CGRP Inhibitors for Migraine Prophylaxis, 5.01.584  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J3032

Drugs for Rare Diseases, 5.01.576  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J3241

IL-5 Inhibitors, 5.01.559  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J0517, J2182

Immune Checkpoint Inhibitors, 5.01.591  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J9024, J9173, J9272, J9289, J9622

Pharmacologic Treatment of Gout, 5.01.616  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J0638

Medical Pharmacologic Treatments of Multiple Sclerosis, 5.01.644  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J2351

Pharmacologic Treatment of Osteoporosis, 5.01.596  Individual | Group
Now requires review for investigational.

J3111

No longer requires review for site of service. Review for medical necessity and prior authorization still required.

J0893

Thymic Stromal Lymphopoietin (TSLP) Inhibitors, 5.01.627  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J2356

Xolair (omalizumab), 5.01.513  Individual | Group
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J2357

Removed codes
Effective July 1, 2025

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63  Individual | Group
Code terminated

C9301

Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625  Individual | Group
Code terminated

J9225

Miscellaneous Oncology Drugs, 5.01.540  Individual | Group
Code terminated

C9303

Pharmacologic Treatment of Hemophilia, 5.01.581  Individual | Group
Code terminated

C9304

Use of Granulocyte Colony-Stimulating Factors (G-CSF), 5.01.551  Individual | Group
Code terminated

C9173

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.

No updates this month.

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.