Medical Policy and Coding Updates

Effective January 1, 2026

Effective for dates of service on and after January 1, 2026, site of service will be reviewed for advanced imaging services using the following criteria and administered through Carelon Medical Benefits Management, Inc. Site of Care for Advanced Imaging.

Hospital Outpatient Site of Care (HOPD)

HOPD is considered medically necessary when:

• Ancillary services are required and not available at freestanding centers in the same geographic area, including:
  • Moderate sedation, deep sedation, or general anesthesia
  • Obstetrical or perinatology observation
  • Support for establishing or maintaining intravenous access in patients with prior access difficulty
  • Transfer or positioning assistance for bedbound patients or those with stage 3–4 decubitus ulcers
  • Additional nursing or facility resources to support patients on contact or airborne precautions
  • Rapid response capability for patients with high-risk medical conditions (e.g., contrast allergy, implantable cardiac devices, ventilator dependence, high risk of airway compromise)
• Specialized resources are needed and not available or infrequently performed at freestanding centers in the same area, such as:
  • Modalities requiring specialized hardware, software, or imaging protocols
  • Expertise from subspecialty radiologists not available in the community, including pediatric radiology
  • Technology such as open or large bore magnetic resonance imaging (MRI), for patients with claustrophobia, or equipment suitable for patients with very high body mass index
• Continuity of care considerations apply, including:
  • Follow-up imaging previously performed at the same HOPD when technique consistency is needed for comparison
  • Imaging required for pre-procedural planning when the procedure is scheduled at the same hospital
  • Clinically significant delays in care would be expected if imaging were redirected outside the HOPD

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 December 4, 2025

Botulinum Toxins, 5.01.512  Individual | Group
Medical necessity criteria updated

• Botox (onabotulinumtoxinA), Daxxify (daxibotulinumtoxinA-lanm), Dysport (abobotulinumtoxinA), Myobloc (rimabotulinumtoxinB), and Xeomin (incobotulinumtoxinA) updated throughout the policy to indicate that these drugs are not to be used concurrently

Negative Pressure Wound Therapy (NPWT) Devices in Adults, 1.01.508  Individual | Group
New policy

• NPWT devices are considered medically necessary when criteria are met

Effective November 15, 2025

Effective for dates of service on and after November 15, 2025, the following updates will apply to the Carelon Medical Benefits Management, 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)
• Upper extremity pain section combined with triangular fibrocartilage complex 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 15, 2025, the following updates will apply to the Carelon Medical Benefits Management, 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 Medical Benefits Management, 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

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 November 7, 2025

Bariatric Surgery, 7.01.516  Individual | Group
Medical necessity criteria added

• 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

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

• Docivyx (docetaxel) may be considered medically necessary as a single agent for locally advanced or metastatic breast cancer after chemotherapy failure when criteria are met
• Treanda (bendamustine) may be considered medically necessary for the treatment of chronic lymphatic leukemia or indolent B-cell non-Hodgkin lymphoma relapsed within 6 months of bendamustine-rituximab; first-line for follicular lymphoma with rituximab; first-line for untreated mantle cell lymphoma (MCL) in hematopoietic stem cell transplantation ineligible patients when used with bendamustine, Calquence, and rituximab
• Dactinomycin may be considered medically necessary for various FDA approved oncologic indications
• Doxil (doxorubicin hydrochloride liposome) and generic doxorubicin hydrochloride liposome may be considered medically necessary for the treatment of ovarian cancer, acquired immunodeficiency syndrome-related Kaposi’s sarcoma, multiple myeloma (MM) when criteria are met
• Evomela (melphalan) may be considered medically necessary for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in individuals with MM
• Floxuridine may be considered medically necessary for the palliative management of gastrointestinal adenocarcinoma metastatic to the liver in individuals who are considered incurable by surgery or other means
• Grafapex (treosulfan) may be considered medically necessary for the treatment of acute myeloid leukemia or myelodysplastic syndrome when criteria are met
• Generic eribulin mesylate may be considered medically necessary for the treatment of metastatic breast cancer and unresectable or metastatic liposarcoma when criteria are met
• Kepivance (palifermin) may be considered medically necessary to decrease the incidence and duration of severe oral mucositis when criteria are met
• Khapzory (levoleucovorin) may be medically necessary for methotrexate rescue in osteosarcoma, folic acid antagonist overdose, impaired methotrexate elimination, or with fluorouracil for metastatic colorectal cancer when criteria are met
• Portrazza (necitumumab) Portrazza (necitumumab) may be considered medically necessary for the treatment of metastatic squamous non-small cell lung cancer
• Trisenox (arsenic trioxide) may be medically necessary for low-risk acute promyelocytic leukemia (APL) with t(15;17) or PML/RARα, in combination with tretinoin, or for relapsed/refractory APL after retinoid and anthracycline therapy when criteria are met

Percutaneous Coronary Intervention, Angioplasty, Non-Emergent in Adults, 2.02.508  Individual | Group
New policy

• Percutaneous coronary intervention is considered medically necessary for select conditions when criteria are met

Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures, 11.01.525  Individual | Group
New policy

• Site of Service for ASC for Select Surgical Procedures will be considered medically necessary when criteria are met
• This policy will apply to the following policies:
  • Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions, 7.01.78  Individual | Group
  • Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions, 7.01.48  Individual | Group
  • Breast Reduction (Mammaplasty), 7.01.503  Individual | Group
  • Knee Arthroscopy in Adults, 7.01.549  Individual | Group
  • Meniscal Allografts and Other Meniscal Implants, 7.01.15  Individual | Group
  • Reconstructive Breast Surgery/Management of Breast Implants, 7.01.533  Individual | Group
  • Rhinoplasty and Other Nasal Procedures, 7.01.558  Individual | Group
  • Sinus Surgery, 7.01.559  Individual | Group
  • Spinal Cord and Dorsal Root Ganglion Stimulation, 7.01.546  Individual | Group
  • Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome, 7.01.554  Individual | Group

Medical necessity criteria added

• Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures, 11.01.525 criteria added
• These services, which were previously reviewed for site of service in the inpatient setting, will now be reviewed for site of service when requested outside of the ASC setting
• An elective surgical procedure performed in a hospital outpatient department may be considered medically necessary if there is no access to an ASC when criteria are met

Total Ankle Arthroplasty in Adults, 7.01.599  Individual | Group
New policy

• Total ankle arthroplasty may be considered medically necessary when criteria are met

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, 5.01.587  Individual | 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 may be considered medically necessary 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)

Prostatic 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 Medical Benefits Management, 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

Revised medical policies
Effective September 1, 2025

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

• Alinia (nitazoxanide) updated to include requirement for individual to have tried and had an inadequate response or intolerance to generic nitazoxanide
• Inhaled Corticosteroids criteria updated to include an exception for individuals who are pregnant and already being treated with the medication

Drugs/medical necessity criteria added

• Widaplik (telmisartan/amlodipine/ indapamide) added to Angiotensin II Receptor Blocker Combinations, Brand criteria
• Dartisla ODT (glycopyrrolate) added to Anticholinergics, Oral
• Generic nitazoxanide added to Antiprotozoal Agents
• Sotylize (sotalol oral solution) added to Beta Blockers, Oral
• Khindivi (hydrocortisone) added to Oral Corticosteroid, Brand criteria
• Combogesic (acetaminophen and ibuprofen) added to Nonsteroidal Anti-Inflammatory Drugs and Combinations
• Blujepa (gepotidacin) added to Brand Oral Antibiotics
• Dolobid (diflunisal) added to Brand Oral NSAIDs
• Livtencity (maribavir) added to Antivirals, Brand

Prescription Digital Therapeutics, 13.01.500  Individual | Group
Investigational criteria updated

• CT-132 is considered investigational

Pulsed Radiofrequency for the Treatment of Chronic Pain, 7.01.564  Individual | Group
Title changed

• Title changed from Pulsed Radiofrequency to Pulsed Radiofrequency for the Treatment of Chronic Pain

Investigational criteria added

• Treatment of auriculotemporal neuralgia, genitofemoral neuralgia and postoperative abdominal wall paint are considered investigational

Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation for Benign Prostatic Hyperplasia, 2.01.544  Individual | Group
Title changed/policy renumbered

• Title and policy number changed from Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hyperplasia, 2.01.49 to Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation for Benign Prostatic Hyperplasia, 2.01.544

Medical necessity criteria updated

• Transurethral water vapor thermal therapy (e.g., Rezum) and transurethral waterjet ablation (e.g., Aquablation) are considered medically necessary for the treatment of moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia when criteria are met

Investigational criteria added

• Repeat procedures are considered investigational

Upper Gastrointestinal (UGI) Endoscopy, 2.01.533  Individual | Group
Medical necessity criteria updated

• Clarified that the policy statement regarding UGI is considered medically necessary for individuals with a history of adenomatous or sessile polyps including polyps in the gastric, duodenal, and esophageal regions, not just the gastric area alone
• UGI is considered not medically necessary for confirming helicobacter pylori eradication

New pharmacy policies
Effective September 1, 2025

Drug Quantity Management, 5.01.656  Individual | Group
New policy

• This policy includes targeted drugs that may be considered medically necessary when the dose prescribed aligns with the FDA labeled dosing
• To help streamline the maintenance of this list, the targeted drugs will be detailed in a separate PDF linked to the policy which will include infomnation such as: the drugs brand name, generic name, strength, dose description, route, and quantity limit

Revised pharmacy policies
Effective September 1, 2025

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

• Datroway (datopotamab deruxtecan-dlnk) for the treatment of non-small cell lung cancer (NSCLC) may be considered medically necessary when the individual is aged 18 years or older; when criteria are met

BCR-ABL Kinase Inhibitors, 5.01.518  Individual | Group
Drug added

• Brand nilotinib tartrate for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) may be considered medically necessary when criteria are met

Medical necessity criteria updated

• Updated generic nilotinib coverage criteria to include coverage for adults with Ph+ acute lymphoblastic leukemia and pediatric individuals 1 year of age or older with Ph+ CML in chronic phase

Bispecific Antibodies, 5.01.650  Individual | Group
Drug added

• Lynozyfic (linvoseltamab-gcpt) for the treatment of relapsed or refractory multiple myeloma in individuals aged 18 years or older may be considered medically necessary when criteria are met

BRAF and MEK Inhibitors, 5.01.589 Individual | Group
Drug added

• Avmapki (avutometinib) and Fakzynja (defactinib) combination regimen may be considered medically necessary for the treatment of KRAS-mutated recurrent low-grade serous ovarian cancer who have received at least 1 prior platinum-based regimen in individuals aged 18 years or older

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

• Dupixent may be considered medically necessary for the treatment of bullous pemphigoid in adults when the medication is prescribed by or in consultation with a dermatologist

Medical necessity criteria updated

• Clarified that Dupixent may not be used in combination with Nucala or Ohtuvayre when these medications are also being used for the treatment of chronic obstructive pulmonary disease

Epidermal Growth Factor Receptor (EGFR) Inhibitors, 5.01.603  Individual | Group
Drug added

• Zegfrovy (sunvozertinib) may be considered medically necessary for the treatment of adult individuals with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations

Hepatitis C Antiviral Therapy, 5.01.606  Individual | Group
Drug added

• Mavyret (glecaprevir and pibrentasvir) added as a preferred drug for the treatment of individuals with acute hepatitis C virus infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)

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

• Fasenra (benralizumab) and Nucala (mepolizumab) eosinophilic granulomatosis with polyangiitis criteria updated from at least 1,500 cells/mcL to 1,000 cells/mcL

Insulin Therapy, 5.01.648  Individual | Group
Drug added

• Afrezza (insulin human) added as a non-preferred rapid-acting insulin

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

• Zejula (niraparib) for the maintenance treatment of advanced epithelial, ovarian, fallopian tube, or primary peritoneal cancer may be considered medically necessary for adults as the first-line treatment and is limited to those with homologous recombination deficiency positive tumors only
• Jakafi (ruxolitinib) dosage limit 50 mg daily and two tablets daily
• Welireg (belzutifan) for the treatment of advanced renal cell carcinoma with a clear cell component may be considered medically necessary
• Welireg may be considered medically necessary for the treatment of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma when criteria are met
• Brand bendamustine, Belrapzo (bendamustine), Bendeka (bendamustine), and Vivimusta (bendamustine) for treatment of follicular lymphoma in combination with rituximab is not limited to first-line use
• Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) for treatment of high-risk smoldering multiple myeloma may be considered medically necessary when criteria are met
• IVRA (melphalan) may be considered medically necessary for palliative treatment of individuals with multiple myeloma for whom oral therapy is not appropriate
• Zusduri (mitomycin) may be considered medically necessary for treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

Monoclonal Antibodies, 2.03.502  Individual | Group
Medical necessity criteria updated

• Monjuvi (tafasitamab-cxix) for the treatment of relapsed or refractory follicular lymphoma (FL) may be considered medically necessary when the individual is aged 18 years and older; has tried at least 1 prior therapy to treat FL; and will be used in combination with lenalidomide and rituximab

Pharmacologic Treatment of Clostridioides Difficile, 5.01.631  Individual | Group
Drug added

• Dificid (fidaxomicin) may be considered medically necessary for the treatment of Clostridioides difficile in individuals aged 6 months or older when criteria are met

Pharmacologic Treatment of Neuropathy, Fibromyalgia, and Seizure Disorders, 5.01.521  Individual | Group
Drug added

• Neurontin (gabapentin) may be considered medically necessary for the treatment of neuropathic pain when the individual is aged 18 years or older; has tried and had an inadequate response or intolerance to generic gabapentin; has tried and had an inadequate response or intolerance to 1 of the following generic medications:
  • A tricyclic antidepressant (e.g., amitriptyline)
  • An SNRI (e.g., duloxetine, venlafaxine); and
  • Has tried and had an inadequate response or intolerance to generic pregabalin or generic pregabalin extended-release
• Neurontin (gabapentin) for the treatment of a seizure disorder may be considered medically necessary when the individual is aged three years or older; and, has tried and had an inadequate response or intolerance to generic gabapentin

Pharmacologic Treatment of Seizures, 5.01.649  Individual | Group
Medical necessity criteria updated

• Aptiom (eslicarbazepine) criteria updated from requiring 1 trial of additional generic anti-seizure medications to requiring 2 trials of additional generic anti-seizure medications
• Fycompa (perampanel) criteria updated to require:
  • Individual to have tried and had an inadequate response or intolerance to generic perampanel, and
  • Indiviudal to have tried and had an inadequate response or intolerance to two other generic antiseizure medications

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

• Nuvigil (armodafinil) to improve wakefulness in individuals with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD) may be considered medically necessary when criteria are met
• Provigil (modafinil) to improve wakefulness in individuals with excessive sleepiness associated with narcolepsy, OSA, or SWD may be considered medically necessary when criteria are met

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

• Uplizna (inebilizumab-cdon) for treatment of immunoglobulin G4-related disease (IgG4-RD) may be considered medically necessary when criteria are met
• Actemra (tocilizumab), Tyenne (tocilizumab-aazg), and Tofidence (tocilizumab-bavi) giant cell arteritis criteria requirement changed from has tried one systemic corticosteroid to has tried or currently is taking a systemic corticosteroid
• Fabhalta (iptacopan) for treatment of complement 3 glomerulopathy (C3G), to reduce proteinuria in adults with biopsy-proven C3G may be considered medically necessary when criteria are met
• Ryoncil (remestemcel-L-rknd) criteria to include a quantity limit per the prescribing information and to remove the requirement to try one other therapy (e.g., ruxolitinib or mycophenolate mofetil)
• Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of myasthenia gravis may not be used concurrently with Imaavy (nipocalimab-aahu) or an eculizumab product

Medical necessity criteria added

• Rinvoq (upadacitinib) for the treatment of giant cell arteritis may be considered medically necessary when there has been an inadequate response to, or is currently taking a systemic corticosteroid and the medication is prescribed by or in consultation with a rheumatologist
• Imaavy (nipocalimab-aahu) for the treatment of generalized myasthenia gravis in individuals 12 years or older may be considered medically necessary when criteria are met
• Vanrafia (atrasentan) to reduce proteinuria in adults with biopsy-proven primary immunoglobulin A nephropathy at risk of rapid disease progression may be considered medically necessary when criteria are met

Use of Vascular Endothelial Growth Factor Receptor (VEGF) Inhibitors and Other Angiogenesis Inhibitors in Oncology Treatment, 5.01.517  Individual | Group
Drugs added

• Jobevne (bevacizumab-nwgd) added to non-preferred bevacizumab products

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620  Individual | Group
Medical necessity criteria updated

• Susvimo (ranibizumab) for the treatment of diabetic retinopathy may be considered medically necessary when criteria are met

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

• New indication added to Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer (use can now be either with or without docetaxel)

Xolair (omalizumab), 5.01.513  Individual | Group
Medical necessity criteria updated

• Clarified that the individual has been diagnosed with inadequately controlled bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) confirmed by physical examination, sinus CT scan, or nasal endoscopy
• Treatment of CRSwNP criteria to include two of the following:
  • Facial pressure or pain
  • moderate to severe nasal congestion, drainage or obstruction, or
  • significant loss of smell
• Added requirement for use of systemic corticosteroids to treat nasal polyps in the last 2 years, contraindication to systemic corticosteroid therapy, or previous surgical removal of bilateral nasal polyps

No updates this month.

Effective September 1, 2025

Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hyperplasia, 2.01.49

• This policy is replaced with Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation for Benign Prostatic Hyperplasia, 2.01.544

Added codes
Effective December 4, 2025

Negative Pressure Wound Therapy (NPWT) Devices, 1.01.508  Individual | Group
Now requires review for medical necessity and prior authorization.

97605, 97606, 97607, 97608, A6550, A7000, A7001, A9272, E2402, K0743, K0744, K0745, K0746

Effective November 15, 2025

Carelon Radiology Benefit Management Program
Now reviewed by Carelon Specialty Health for medical necessity and prior authorization.

95965, 95966

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

A4544, E0743

Effective November 7, 2025

Eye-Anterior Segment Optical Coherence Tomography, 9.03.509  Individual | Group
Now requires review for medical necessity and prior authorization.

92133, 92134, 92137

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

J9120, J9172, Q2050, J9246, J2425, J9200, J9295, J9017, J9033

Percutaneous Coronary Intervention, Angioplasty, Non-Urgent in Adults, 2.02.508  Individual | Group
Now requires review for medical necessity.

C9600, C9601, C9602, C9603

Now requires review for medical necessity and prior authorization.

92920, 92921, 92924, 92925, 92928, 92929, 92933, 92934, 92937,92938, 92941, 92943, 92944, 92980, 92982

Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures, 11.01.525  Individual | Group
Now requires review for medical necessity, including site of service and prior authorization.

19318, 27412, 27415, 27416, 28446, 29866, 29867, 29871, 29873, 29874, 29875, 29876, 29877, 29879, 29880, 29881, 29882, 29883, 29884, 29888, 29889, 30400, 30410, 30420, 30430, 30435, 30450, 31233, 31235, 31240, 31253, 31254, 31255, 31256, 31257, 31259, 31267, 31276, 31287, 31288, 31295, 31296, 31297, 31298, 42145, 63650, 63655, 63661, 63662, 63663, 63664, 63685, 63688, J7330, S2112

Total Ankle Arthroplasty in Adults, 7.01.599  Individual | Group
Now requires review for medical necessity and prior authorization.

27700, 27702, 27703

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

Prostatic 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: 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 September 1, 2025

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

J9249

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

Effective September 1, 2025

Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hyperplasia, 2.01.544  Individual | Group
No longer requires review for investigational. Now requires review for medical necessity.

C2596

Effective September 5, 2025

InterQual Criteria

The Plan will begin using InterQual criteria to determine the appropriate level of care for all planned procedures. Site of service criteria for certain procedures will apply when listed in the individual medical 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.

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.