Medical Policy and Coding Updates August 2025

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 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 for labral tear-shoulder
• Added x-ray per ACR AUC for chronic shoulder pain
• 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 updated
• Removal of site-specific exclusions for pain NOS with aligned thresholds for conservative management; updated osteoarthritis grading

Imaging of the Spine

• 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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
  • Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions, 7.01.48  PBC | Premera HMO
  • Breast Reduction (Mammaplasty), 7.01.503  PBC | Premera HMO
  • Knee Arthroscopy in Adults, 7.01.549  PBC | Premera HMO
  • Meniscal Allografts and Other Meniscal Implants, 7.01.15  PBC | Premera HMO
  • Reconstructive Breast Surgery/Management of Breast Implants, 7.01.533  PBC | Premera HMO
  • Rhinoplasty and Other Nasal Procedures, 7.01.558  PBC | Premera HMO
  • Sinus Surgery, 7.01.559  PBC | Premera HMO
  • Spinal Cord and Dorsal Root Ganglion Stimulation, 7.01.546  PBC | Premera HMO
  • Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome, 7.01.554  PBC | Premera HMO

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 in 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 ambulatory surgical center when criteria are met

Total Ankle Arthroplasty in Adults, 7.01.599  PBC | Premera HMO
New policy

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

Effective October 3, 2025

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

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

Pharmacologic Treatment of Psoriasis, 5.01.629  PBC | Premera HMO
Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645  PBC | Premera HMO
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
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  PBC | Premera HMO
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 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)

Pharmacologic Treatment of Psoriatic Arthritis, 5.01.645  PBC | Premera HMO
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  PBC | Premera HMO
Medical necessity criteria updated

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

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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-Defibrillator (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  PBC | Premera HMO
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 August 1, 2025

Transcatheter Mitral Valve Repair or Replacement, 2.02.30  PBC | Premera HMO

Medical necessity criteria updated

• Risk language changed from “increased” to “intermediate to prohibitive surgical risk”

New pharmacy policies
Effective August 1, 2025

Miscellaneous Intravitreal Drugs, 5.01.653  PBC | Premera HMO
New policy

• Encelto (revakinagene taroretcel-lwey) for the treatment of idiopathic macular telangiectasia type 2 in adults when criteria are met

Revised pharmacy policies
Effective August 1, 2025

Amyotrophic Lateral Sclerosis (ALS) Medications, 5.01.578  PBC | Premera HMO
Medical necessity criteria updated

• Qalsody (tofersen) criteria updated from “SVC [slow vital capacity] of 65% or greater” to “SVC of 65% or greater or force vital capacity of 50% or greater.”

Antibody-Drug Conjugates, 5.01.582  PBC | Premera HMO
Medical necessity criteria added

• Emrelis (telisotuzumab vedotin-tllv) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression when criteria are met

BCR-ABL Kinase Inhibitors, 5.01.518  PBC | Premera HMO
Medical necessity criteria updated

• Danziten (nilotinib) criteria updated to require trial with generic nilotinib

Medical necessity criteria added

• Added coverage criteria for generic nilotinib may be considered medically necessary for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myeloid leukemia when criteria are met

C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
Medical necessity criteria updated

• Empaveli (pegcetacoplan), Fabhalta (iptacopan), and Piasky (crovalimab-akkz) criteria updated from “has completed at least 3 months of therapy with Soliris (eculizumab)” to “has completed at least 3 months of therapy with an eculizumab product”
• myasthenia gravis criteria for Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), and Zilbrysq (zilucoplan) updated to clarify that the medications will not be used concurrently with another eculizumab product

Medical necessity criteria added

• Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh) may be considered medically necessary when criteria are met

Drugs for Weight Management, 5.01.621  PBC | Premera HMO
Medical necessity criteria added/updated

• Updated Contrave (naltrexone-bupropion), Qsymia (phentermine-topiramate), Saxenda (liraglutide), Wegovy (semaglutide), Xenical (orlistat), brand orlistat, and Zepbound (tirzepatide) criteria updated to clarify that the medication is not to be used concurrently with generic phentermine and topiramate extended-release
• Updated Qsymia (phentermine and topiramate extended-release) criteria updated to require trial with generic phentermine and topiramate extended-release first

Medical necessity criteria added/updated

• Generic phentermine and topiramate extended-release criteria added for individuals who are overweight or obese when criteria are met

Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625  PBC | Premera HMO
Medical necessity criteria updated

• Updated gender dysphoria requirement to clarify that for individuals age 23 or older, or post–Tanner stage 5, documentation must show the GnRH analog is needed to prevent or suppress further development of natal secondary sex characteristics, including those not visible on physical exam (e.g., menses, penile erections)
• Updated gender dysphoria criteria note to specify that lab-specific reference ranges should be used to assess Tanner stage 2, and confirmation requires hormone levels that do not overlap with Tanner stage 1. If no lab ranges are provided, default values apply
• Clarified reauthorization criteria to accept evidence of suppression of secondary sex characteristics based on physical exam, self/parent report, or suppression of non-visible characteristics (e.g., menses, penile erections)

IL-5 Inhibitors, 5.01.559  PBC | Premera HMO
Medical necessity criteria updated

• Nucala (mepolizumab) criteria updated to include treatment of chronic obstructive pulmonary disease when criteria are met

Immune Checkpoint Inhibitors, 5.01.591  PBC | Premera HMO
Medical necessity criteria updated

• Keytruda (pembrolizumab) criteria updated to include treatment of certain individuals with resectable locally advanced head and neck squamous cell cancer
• Keytruda (pembrolizumab) gastric cancer criteria updated to clarify that use is limited to adults whose tumors that express PD-L1
• Opdivo (nivolumab) esophageal cancer criteria updated to clarify that use for first-line treatment is limited to tumors that express PD-L1
• Opdivo (nivolumab) stage IIb-IV classical Hodgkin lymphoma criteria updated age requirement from 18 years or older to 12 years or older
• Zynyz (retifanlimab-dlwr) criteria updated to include treatment of squamous cell carcinoma of the anal canal when used for first-line treatment in combination with carboplatin and paclitaxel or as a single agent in adults with locally recurrent or metastatic disease

Drug/medical necessity criteria added

• Penpulimab-kcqx may be considered medically necessary for:
  • The first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) when used in combination with either cisplatin or carboplatin and gemcitabine
  • Treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy when used as a single agent

Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
Medical necessity criteria added

• Leukeran (chlorambucil) may be considered medically necessary for the treatment of chronic lymphatic (lymphocytic) leukemia or malignant lymphomas when criteria are met

Medical necessity criteria updated

• Matulane criteria updated to require trial of generic procarbazine first
• Added two new indications to all bendamustine products for the treatment of mantle cell lymphoma and for the treatment of follicular lymphoma
• Added generic eribulin mesylate to policy with the same coverage criteria as Halaven (eribulin mesylate)

Migraine and Cluster Headache Medications, 5.01.503  PBC | Premera HMO
Drug/medical necessity criteria added

• Atzumi (dihydroergotamine) may be considered medically necessary for the acute treatment of migraines when criteria are met

Multiple Receptor Tyrosine Kinase Inhibitors, 5.01.534  PBC | Premera HMO
Medical necessity criteria added

• Added coverage criteria for Ibtrozi (taletrectinib) may be considered medically necessary for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer when criteria are met

Pharmacologic Treatment of Epidermolysis Bullosa, 5.01.635  PBC | Premera HMO
Medical necessity criteria added/updated

• Updated Filsuvez (birch triterpenes) Vyjuvek (beremagene geperpavec-svdt), and Zevaskyn (prademagene zamikeracel) will not be used concurrently with one another

Drug/medical necessity criteria added

• Zevaskyn (prademagene zamikeracel) for individuals aged 6 years and older with recessive dystrophic epidermolysis bullosa and confirmed mutation in COL7A1 gene

Pharmacologic Treatment of Hemophilia, 5.01.581  PBC | Premera HMO
Medical necessity criteria updated

• Clarified quantity limit for Alhemo (concizumab-mtci), Hemlibra (emicizumab-kxwh), and Hympavzi (marstacimab-hncq)
• Roctavian (valoctocogene roxaparvovec-rvox) and Hemgenix (etranacogene dezaparvovec-drlb) criteria updated to require that the prescriber attest to providing clinical outcome information within the appropriate provider portal as requested by the Company plan
• Qfitlia (fitusiran) quantity limit updated to one 20 mg vial or 50 mg pen monthly

Pharmacologic Treatment of Seizures, 5.01.649  PBC | Premera HMO
Medical necessity criteria added

• The following criteria will apply to the added multi-source brand-name antiseizure medications (Aptiom [Eslicarbazepine], Carbatrol [carbamazepine extended-release (ER)], brand Carbamazepine chewable tablet, Tegretol [carbamazepine], Tegretol ER [carbamazepine ER], Celontin [methsuximide], Depakote delayed release (DR) [divalproex DR capsules], Depakote ER [divalproex DR tablets], Depakote Sprinkle [divalproex DR sprinkle capsules], Dilantin [phenytoin], Dilantin ER [phenytoin ER], Dilantin Suspension [phenytoin oral suspension], Dilantin Kapseals [phenytoin ER], Dilantin Infatabs [phenytoin chewable tablets], Phenytek [phenytoin ER], Elepsia ER [levetiracetam ER], Eprontia [topiramate oral solution], Equetro [carbamazepine ER], generic eslicarbazepine, Felbatol [felbamate], Keppra [levetiracetam], brand levetiracetam, Keppra ER [levetiracetam ER], Lamictal [lamotrigine tablets], Lamictal Suspension [lamotrigine oral suspension tablets], Lamictal orally disintegrating tablets (ODT) [lamotrigine ODT], Lamictal ER [lamotrigine ER tablets], Mysoline [primidone], brand primidone, Onfi [clobazam tablets], Onfi suspension [clobazam oral suspension], Topamax [topiramate], brand topiramate, Trileptal [oxcarbazepine tablets], Trileptal suspension [oxcarbazepine oral suspension], Zarontin [ethosuximide capsules], Zarontin solution [ethosuximide oral solution], Zonegran [Zonisade capsule]):
  • Trial of the generic equivalent
  • Trial of one additional generic anti-seizure medication
  • Dose limitations based on FDA prescribing info
  • Some drugs include additional criteria for bipolar disorder or migraine prevention

Medical necessity criteria updated

• Zonisade (zonisamide oral suspension) criteria updated from individuals aged 16 years and older to individuals aged 5 years and older

Pharmacotherapy of Cushing’s Disease and Acromegaly, 5.01.548  PBC | Premera HMO
Medical necessity criteria updated

• Diagnostic criteria for Cushing’s disease/syndrome updated for Isturisa (osilodrostat), Recorlev (levoketoconazole), Signifor (pasireotide), and Signifor LAR (pasireotide)
• Isturisa (osilodrostat) covered indications updated to include the treatment of endogenous hypercortisolemia (high cortisol) in individuals with Cushing’s syndrome

Medical necessity criteria added

• Generic lanreotide to policy with the same coverage criteria as Somatuline Depot (lanreotide)

Pharmacotherapy of Spinal Muscular Atrophy (SMA), 5.01.574  PBC | Premera HMO
Medical necessity criteria updated

• Zolgensma (onasemnogene abeparvovec-xioi) criteria updated to require that the prescriber attest to providing clinical outcome information within the appropriate provider portal

Prostate Cancer Targeted Therapies, 5.01.544  PBC | Premera HMO
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)

No updates this month.

Effective August 1, 2025

Site of Service: Select Surgical Procedures, 11.01.524

• This policy is deleted. Criteria for site of service review in the inpatient setting is found within each applicable policy.

Added codes
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  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

92133, 92134, 92137

Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

27700, 27702, 27703

Effective October 3, 2025

Implantable Cardioverter Defibrillator (ICD), 7.01.44  PBC | Premera HMO
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  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J0364

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J1748

Prostatic Urethral Lift, 7.01.598  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
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  PBC | Premera HMO
Now considered investigational.

C1763

Hepatitis C Antiviral Therapy, 5.01.606  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

S0145

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  PBC | Premera HMO
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  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

L6882

Effective August 1, 2025

C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  PBC | Premera HMO
Now requires review for medical necessity, including site of service and prior authorization.

Q5151, Q5152

Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J0893

Revised codes
Effective October 3, 2025

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

J3032

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

J3241

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

J0517, J2182

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

J2351

Pharmacologic Treatment of Osteoporosis, 5.01.596  PBC | Premera HMO
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

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  PBC | Premera HMO
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J2356

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

J2357

Effective August 1, 2025

Hematopoietic Cell Transplantation for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, 8.01.15  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

38230, 38240

Patient Lifts, Seat Lifts and Standing Devices, 1.01.519  PBC | Premera HMO
No longer covered.

E0637

Removed codes
Effective August 1, 2025

Sinus Surgey in Adults, 7.01.559  PBC | Premera HMO
No longer requires review.

31233, 31235, 31240

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.

No updates this month.