Medical Policy and Coding Updates

Effective November 15, 2026

Effective for dates of service on and after November 15, 2026, the following updates will apply to the Carelon Medical Benefits Management, Inc. Clinical Appropriateness Guidelines for Radiation Oncology. 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.

Radiation Oncology

• Established a new guideline for radiation therapy in select non-malignant conditions, including vascular, inflammatory, fibrotic, and neurologic disorders.
• Added criteria specifying that radiation therapy is considered not medically necessary for select conditions, including osteoarthritis, neovascular age-related macular degeneration, and refractory ventricular tachycardia.

Effective for dates of service on and after November 15, 2026, 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.

Multiple guidelines (Genetic Liquid Biopsy and Somatic Tumor Testing)

• General Criteria:
  • Revised criteria to require demonstration of clinical utility for all test components.

Genetic Liquid Biopsy in the Management of Cancer and Cancer Surveillance

• General Information:
  • Defined circulating tumor-tissue-modified viral HPV DNA (ctHPV DNA).
• General Criteria for Genetic Liquid Biopsy Testing
  • Added criteria specifying that RNA fusion, expression, and whole transcriptome analysis using ctRNA are not medically necessary.
  • Clarified that reflex tissue biopsy is permitted following liquid biopsy when no actionable variant is detected or results are uninformative.
• Breast Carcinoma
  • Expanded coverage criteria to include recurrent and locally advanced breast cancer, including American Journal if Critical Care stage IIB, IIIA, IIIB, and IIIC disease, in addition to metastatic disease.
  • Added imlunestrant to the list of therapies for which ESR1 mutation testing is considered medically necessary.
• Prostate Carcinoma
  • Expanded the list of therapies for which testing is considered medically necessary to include niraparib.
• ctDNA for Molecular Residual Disease (MRD) or Therapy Response
  • Clarified the use of ctDNA to assess therapy response, specified common indications for which MRD testing is considered not medically necessary, and added test examples.
• ctHPV DNA Testing for Recurrence, Surveillance, Post-Treatment Molecular Residual Disease or Therapy Response
  • Revised criteria to state that ctHPV DNA testing in oropharyngeal carcinoma is considered not medically necessary.
• Individuals without Malignancy for whom Liquid Biopsy is Used for Screening
  • Expanded the list of test examples to include CancerGuard.

Somatic Tumor Testing (Solid Tumors)

• General Criteria:
  • Revised criteria to require demonstration of clinical utility for all test components.
  • Expanded coverage criteria to permit targeted RNA-based fusion analysis using next-generation sequencing when specified in the applicable cancer-specific criteria.
  • Added an exception permitting reflex tissue biopsy following liquid biopsy when no actionable variant is detected or results are uninformative.
• Tissue-agnostic Testing for Patients with Advanced Solid Tumors
  • Expanded coverage criteria to permit HER2 testing.
  • Removed criteria related to FGFR1/2/3 fusions and pathogenic or likely pathogenic (P/LP) variants.
• Biliary Tract Cancer (including Cholangiocarcinoma and Gallbladder Cancer)
  • Clarified that comprehensive molecular testing must include the genes specified in the criteria.
• Bladder Cancer (Urothelial Carcinoma, including the Upper Tract)
  • Expanded eligibility to include individuals with unresectable or metastatic bladder cancer at initial diagnosis.
• Brain Cancer (Malignant Glioma)
  • Expanded testing criteria to include pathogenic and likely pathogenic (P/LP) H3 K27M variants following FDA approval of doranidazole (Modeyso™) for individuals with diffuse midline glioma.
  • Expanded testing criteria to include BRAF fusions and rearrangements following FDA approval of tovorafenib (Ojemda™) for individuals with pediatric low-grade glioma.
  • Added criteria for use of MGMT promoter methylation testing.
• Breast Cancer, localized invasive, early adjuvant setting (split criteria by lymph node status)
  • Expanded eligibility for Oncotype DX testing to include premenopausal individuals or those younger than age 50 with lymph node-negative, omitted, or micrometastatic disease.
  • Clarified testing eligibility for postmenopausal individuals or those age 50 and older with lymph node-negative, omitted, or micrometastatic disease.
  • Expanded testing criteria to include EndoPredict for individuals with 1 to 3 positive axillary lymph nodes.
  • Expanded testing eligibility for individuals older than age 50 with axillary lymph node-positive disease and incorporated clinical nodal status into pathologic nodal status criteria.
  • Added criteria specifying that testing in breast cancer recurrence is considered not medically necessary.
• Breast Cancer, localized; extended adjuvant setting
  • Clarified that testing for breast cancer recurrence is considered not medically necessary.
• Breast Cancer, metastatic and/or locally advanced
  • Revised criteria to include imlunestrant among therapies eligible for molecular testing.
• Colorectal Cancer, localized
  • Added PIK3CA testing as a predictive biomarker.
• Colorectal Cancer, metastatic
  • Expanded extended RAS testing criteria to include the KRAS p.G12C variant for therapy selection.
• Non-small Cell Lung Cancer, advanced (stage IIIB, IIIC, or IV metastatic)
  • Expanded indications for rebiopsy following disease progression on targeted therapies, including therapies directed at ALK, ROS1, RET, MET, BRAF, HER2, KRAS G12C, and NTRK alterations.
• Ovarian (Epithelial) Cancer
  • Expanded the scope of the criteria to include fallopian tube and primary peritoneal cancers.
  • Added a maintenance therapy indication for homologous recombination deficiency testing.
• Pancreatic Adenocarcinoma
  • Removed stage-specific requirements for testing.
• Prostate Cancer, metastatic
  • Expanded criteria from metastatic adenocarcinoma to metastatic prostate cancer.
  • Expanded testing eligibility to all metastatic prostate cancer indications by removing the requirement for metastatic castrate-sensitive adenocarcinoma with high-volume disease.
  • Expanded the list of poly ADP ribose polymerase inhibitor therapies to include niraparib and talazoparib.
  • Expanded multigene panel testing criteria to include additional genes.
• Sarcoma (including soft tissue sarcoma, bone sarcoma, gastrointestinal stromal tumor, uterine sarcoma)
  • Expanded indications for resistance mutation testing in the setting of clinical progression on targeted therapy.
• Thyroid Neoplasm, noninvasive follicular with papillary-like nuclear features (NIFTP)
  • Clarified that somatic testing of NIFTP is considered not medically necessary.
• Thyroid Cancer, recurrent or persistent locoregional medullary cancer
  • Added criteria supporting testing in medullary thyroid cancer.
• Thyroid Cancer, metastatic, locally advanced, recurrent, progressive, symptomatic
  • Added positive coverage criteria for testing in locally advanced, recurrent, progressive, and symptomatic thyroid cancer.
  • Removed restrictions on the number of genes included in testing.
  • Expanded testing criteria to include additional genes and tumor mutational burden (TMB) testing.
• Thyroid Cancer, anaplastic thyroid cancer
  • Expanded testing criteria to include additional genes and TMB testing that may be considered in clinical decision making.
• Unknown Primary Site Cancer
  • Added positive coverage criteria for microsatellite instability testing in cancers of unknown primary origin.
  • Added positive coverage criteria for multigene panel testing in cancers of unknown primary origin.
  • Added a list of genes recommended for testing.
• Whole Exome (WES), Whole Genome (WGS), and Whole Transcriptome Analysis (WTA)
  • Added criteria specifying that WES, WGS, and WTA are considered not medically necessary.

Hematologic Malignancies

• Tissue, Bone Marrow, or Blood-Agnostic Testing for Patients with Hematological Cancers
  • Added criteria permitting targeted RNA fusion analysis when specified in the applicable cancer-specific criteria.
• Acute Lymphoblastic Leukemia and Pediatric B-cell Precursor Lymphoblastic Lymphoma
  • Established gene-specific criteria for multigene panels containing 50 or fewer genes.
• B-cell Lymphomas
  • Expanded testing criteria to permit testing on lymph node tissue.
  • Expanded testing indications to include risk stratification and identification of actionable therapeutic targets.
• Chronic Lymphocytic Leukemia
  • Added a requirement that multigene panels include testing of the TP53 gene.
• Myeloproliferative Neoplasms
  • Expanded molecular testing criteria to include select non-hematologic abnormalities in the absence of hematologic abnormalities, including unexplained splanchnic, cerebral, or arterial thrombosis.
• Myelodysplastic Syndrome
  • Broadened multigene panel testing criteria to include additional gene targets.
• Multiple Myeloma
  • Added positive coverage criteria for NGS and molecular testing in multiple myeloma.
  • Added criteria specifying when NGS and molecular testing are not indicated in multiple myeloma.
• Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
  • Added positive coverage criteria for molecular testing in Waldenström macroglobulinemia/lymphoplasmacytic lymphoma.
  • Clarified that gene expression testing is considered not medically necessary.

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

Effective November 6, 2026

Endovascular Stent Grafts for Abdominal Aortic Aneurysms, 7.01.601  Individual | Group
Medical necessity criteria added

• Endovascular aneurysm repair (EVAR) of infra-renal abdominal aortic or aorto-iliac aneurysms using endoprostheses may be considered medically necessary when criteria are met.
• EVAR criteria no longer require an aneurysmal diameter that measures twice the size of the normal infrarenal aorta.

Investigational criteria added

• Bifurcated-bifurcated endoprosthesis repair of aorto-iliac aneurysms for the treatment of abdominal aortic aneurysm is considered investigational.

Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  Individual | Group
Title Change

• Title changed from Evaluation of Biomarkers for Alzheimer Disease to Evaluation of Cerebrospinal Fluid, Urine, and Plasma Tests for Alzheimer Disease.

Medical necessity criteria updated

• Cerebrospinal fluid biomarker tests which may be considered medically necessary are now specifically listed in criteria.

Investigational criteria updated

• Plasma testing of amyloid beta peptides and tau protein using tests that confirm amyloid pathology as part of an evaluation for the initiation of amyloid beta targeting therapy in individuals with mild cognitive impairment or mild dementia due to Alzheimer disease is considered investigational.

Immune Globulin Therapy, 8.01.503  Individual | Group
Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  Individual | Group
Medical necessity criteria updated

• Qivigy (immune globulin) now requires site of service review.

Percutaneous Electrical Nerve Field Stimulation for Irritable Bowel Syndrome, 2.01.106  Individual | Group
Title Change

• Title changed from Percutaneous Electrical Nerve Field Stimulation for Irritable Bowel Syndrome to Percutaneous Electrical Nerve Field Stimulation for Disorders of Gut-Brain Interaction.

Investigational criteria updated

• Investigational criteria expanded to include abdominal pain-related disorders of gut-brain interaction, including irritable bowel syndrome and functional dyspepsia.

Synthetic Cartilage Implants for Joint Pain, 7.01.160  Individual | Group
Title Change

• Title changed from Synthetic Cartilage Implants for Joint Pain to Cartilage Implants for Joint Pain.

Medical necessity criteria updated

• Investigational criteria expanded to include cartilage implants in addition to synthetic cartilage.

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

• Removed criterion for UGI endoscopy for evaluation of gastroesophageal reflux or dyspepsia (heartburn) symptoms after proton pump inhibitor therapy has been discontinued.

Effective October 9, 2026

Psychiatric and Other Specified Evaluations in Inpatient and Residential Behavioral Health Treatment, 3.01.521  Individual | Group
Title changed

• Title changed from Psychiatric and Other Specified Evaluations in Inpatient and Residential Behavioral Health Treatment to Psychiatric and Other Specified Evaluations in Inpatient, Residential, and Partial Hospital Program Behavioral Health Treatment

Medical necessity criteria updated

• Changed the term “detoxification” to “withdrawal management (detoxification)” to align with InterQual and American Society of Addiction Medicine terminology, as well as preferred language within the substance use disorder professional community.

Medical necessity criteria added

• InterQual criteria added for psychiatric evaluations during mental health, eating disorder, and substance use disorder partial hospitalization program (PHP) treatment; for substance use evaluations during substance use disorder PHP; and for nutritional assessments during eating disorder PHP.
• Specified the clinician types authorized to perform each evaluation, ensuring consistency with those designated for the same evaluations in residential treatment settings.

Effective September 19, 2026

Effective for dates of service on and after September 19, 2026, 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

• Expanded indications for computed tomography (CT) cerebral perfusion

Imaging of the Extremities

• Allowances management without requiring repeat x-ray for osteomyelitis, avascular necrosis
• Specification for triangular fibrocartilage complex instability bypassing requirement for conservative management
• Meniscal tear knee: Added allowances following meniscal repair
• Knee arthroplasty pre-surgical imaging: Expanded allowance when conventional arthroplasty not feasible; specification of deformity criteria

Imaging of the Spine

• Modality specifications for spinal infection and axial spondyloarthropathy
• Spine pain/radiculopathy: Condensed content, added frequency limitation

Nuclear Medicine Imaging

• Condensed content for osseous tumors and established malignancy/neoplasm
• Added content for radioembolization scintigraphy using non-liver specific CPT codes

Vascular Imaging

• Separated content into 2 guidelines: Advanced Imaging for Vascular Indications and Vascular Ultrasound and Physiologic Testing

Advanced Imaging for Vascular Indications

• General
  • Added indication for positron emission tomography (PET)/CT for vasculitis
• Brain, Head and Neck
  • Added allowances for newly added computed tomographic angiography (CTA) Head/Neck code for aneurysm, arteriovenous malformation, dissection, fibromuscular dysplasia, pulsatile tinnitus, procedure related imaging, stenosis or occlusion, and signs/symptoms/abnormal imaging
  • Added duplex ultrasound as a requirement prior to CTA/ magnetic resonance angiography (MRA) for all signs or symptoms of stroke/transient ischemic attack that have been present more than 30 days
  • Removed allowance for advanced vascular imaging for syncope to align with professional society guidelines
  • Added criterion for CTA/MRA for evidence of stroke on brain imaging
  • Added criterion for CTA/MRA for evaluation of subclavian steal syndrome
• Chest
  • Added surveillance intervals following endovascular repair for thoracic aortic dissection
  • Added criteria for surveillance after repair of thoracic aortic aneurysm
• Abdomen and Pelvis
  • Reduced required number of antihypertensive medications from 4 to 3 for renal artery stenosis to treat refractory hypertension to align with the European Society for Vascular Surgery guideline recommendations
  • Added surveillance indication after endovascular revascularization of the aortoiliac vessels
  • Added criterion for imaging of pelvic venous disease
• Upper Extremity
  • Modified post-revascularization imaging intervals in upper extremity peripheral arterial disease to align with lower extremity criteria
• Lower Extremity
  • Aligned the post-revascularization intervals for surgical and endovascular revascularization in peripheral arterial disease

Imaging of the Heart

• Cardiac CT with Quantitative Evaluation of Coronary Calcification
  • When coronary artery calcium is used for go/no go statin decision and score is zero, recommend repeat study in 5-10 years to reevaluate statin question (provided other criteria still met)
• Magnetic resonance imaging (MRI) Cardiac
  • Expansion of criteria for when to allow cardiac MRI for hypertrophic and non-compaction cardiomyopathy
• PET Myocardial Imaging
  • Clarification of language in indications for PET Perfusion Imaging

Effective for dates of service on and after September 19, 2026, the following updates will apply to the Carelon Medical Benefits Management, Inc. Clinical Appropriateness Guidelines for Sleep Disorder Management. 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.

Polysomnography

• Removed respiratory disturbance event definition
• Clarified suspected sleep disorder other than obstructed sleep apnea
• Added criteria to align with best practices for established sleep disorder (obstructed sleep apnea or other) – follow-up laboratory studies
• Added criteria for nocturnal seizures for in-lab (attended) sleep studies in non-adult patients (age 17 years or younger)

Bi-Level Positive Airway Pressure Devices

• Aligned criteria  with recently published American Academy of Sleep Medicine updated clinical practice guideline for treatment of central sleep apnea - Journal of Clinical Sleep Medicine. 2025.

Effective for dates of service on and after September 19, 2026, 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.

All Genetic Testing guidelines

• General Requirements:
  • Added statement that testing be performed in a Clinical Laboratory Improvement Amendments certified lab accredited by the College of American Pathologists

Carrier Screening in the Reproductive Setting

• Clarified screening limited to once per lifetime for a given gene instead of for a given condition
• Removed exclusion (clarification): molecular screening for conditions where nonmolecular techniques can be used

Prenatal Screening using Cell-free DNA

• Added medically necessary indications for fetal red blood cell antigen screening using cell-free deoxyribonucleic acid (cfDNA)
• Clarified scenarios on use of cfDNA screening considered not medically necessary, including removal of Rhesus D antigen and/or other fetal red blood cell antigens

Genetic Testing for Inherited Conditions

• General Requirements:
  • Clarified that germline genetic testing is limited to once per lifetime for a given gene except when individual is inadequately tested
  • Allowed testing for an inherited condition per member health plan drug-specific policy requirements
  • Clarified that multigene panel testing is considered not medically necessary when either whole exome or whole genome sequencing is being or has been performed
• Cardiac conditions:
  • Hereditary arrhythmia syndromes: clarifications
  • Hereditary cardiomyopathy syndromes: removed age restriction in symptomatic individuals and allow for genetic testing of either symptomatic or presymptomatic individuals with a family history
  • Hereditary aortopathies: clarifications
• Primary mitochondrial diseases: targeted gene panel expanded from <25 to xtagstartz30 genes

New medical policies
Effective August 1, 2026

Audio-Visual Neuromodulation for Neuropathic Pain, 3.03.07  Individual | Group
New policy

• The use of United States (US) Food and Drug Administration (FDA)-authorized prescription audiovisual digital therapeutics for neuropathic pain is considered investigational.

Immersive Virtual Reality Therapy for Chronic Lower Back Pain, 3.03.06  Individual | Group
New policy

• The use of US FDA-authorized prescription virtual reality digital therapeutics for chronic lower back pain is considered investigational.

Implantable Shock Absorber for Treatment of Knee Osteoarthritis, 7.01.90  Individual | Group
New policy

• The use of implantable shock absorbers as a treatment for knee osteoarthritis is considered investigational.

Permanently Implanted Prostatic Devices for Benign Prostatic Hyperplasia, 7.01.181  Individual | Group
New policy

• The use of permanently implanted prostatic stent devices (e.g., ProVee System, Zenflow Spring Implant) is considered investigational as a treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

Revised medical policies
Effective August 1, 2026

Bioengineered Skin and Soft Tissue Substitutes, 7.01.582  Individual | Group
Medical necessity criteria updated

• Kerecis Omega3 may be considered medically necessary for the treatment of chronic, non-infected, full-thickness diabetic lower-extremity ulcers when criteria are met.

Hematopoietic Cell Transplantation for Autoimmune Diseases, 8.01.25  Individual | Group
Medical necessity criteria added

• Autologous hematopoietic cell transplantation may be considered medically necessary for the treatment of multiple sclerosis when criteria are met.

Prescription Digital Therapeutics, 13.01.500  Individual | Group
Medical necessity criteria removed

• RelieVRx moved to Immersive Virtual Reality Therapy for Chronic Lower Back Pain, 3.03.06.

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

• Removed criterion for UGI endoscopy for evaluation of gastroesophageal reflux or dyspepsia (heartburn) symptoms after proton pump inhibitor therapy has been discontinued.

New pharmacy policies
Effective August 1, 2026

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.544  Individual | Group
Policy renumbered

• This policy replaces Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63

Medical necessity criteria updated

• Breyanzi (lisocabtagene maraleucel) is considered medically necessary for the treatment of relapsed or refractory marginal zone lymphoma when criteria are met.

Medical necessity criteria updated

• Yescarta (axicabtagene ciloleucel) criteria no longer require that the individual does not have primary central nervous system lymphoma.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Revised pharmacy policies
Effective August 1, 2026

Advanced Therapies for Pharmacological Treatment of Pulmonary Arterial Hypertension, 5.01.522  Individual | Group
Medical necessity criteria added

• Macitentan may be considered medical necessary for the treatment of pulmonary arterial hypertension (WHO [World Health Organization] Group 1) when criteria are met.

Medical necessity criteria updated

• Letairis (ambrisentan) criteria now require trial of generic ambrisentan.
• Revatio (sildenafil) tablet criteria now require trial of generic sildenafil 20 mg tablet.
• Opsumit (macitentan) criteria now require trial of generic macitentan.
• Tracleer (bosentan) criteria now require trial of generic bosentan.

Medical necessity criteria removed

• Adcirca (tadalafil) has been discontinued.
• Removed reference to non-formulary exception reviews.

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

• Datroway (datopotamab deruxtecan-dlnk) criteria expanded to include treatment of unresectable or metastatic triple-negative breast cancer in individuals who are not candidates for PD-1/PD-L1 inhibitor therapy.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Antipsychotics, 5.01.659  Individual | Group
Medical necessity criteria added

• Bysanti (milsaperidone) may be considered medically necessary for the treatment of schizophrenia or acute treatment of manic or mixed episodes associated with bipolar 1 disorder when criteria are met.

Medical necessity criteria updated

• Cobenfy (xanomeline and trospium chloride) now includes a quantity limit of 60 capsules per 30 days.

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

• Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), and Zilbrysq (zilucoplan) for the treatment of myasthenia gravis criteria revised to require prescribing by or in consultation with a neurologist.

Gene Therapies for Rare Diseases, 5.01.642  Individual | Group
Medical necessity criteria added

• Kresladi (marnetegragene autotemcel) may be considered medically necessary for the treatment of severe leukocyte adhesion deficiency-I when criteria are met.
• Waskyra (etuvetidigene autotemcel) may be considered medically necessary for the treatment of Wiskott-Aldrich Syndrome when criteria are met.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625  Individual | Group
Medical necessity criteria updated

• Adjuvant treatment of HR-positive, HER2-negative, lymph node-positive, in adult individuals with early breast cancer at high risk of recurrence criteria no longer includes requirement for a Ki-67 score of at least 20%.
• Unfavorable risk stratification criteria revised for Camcevi (leuprolide mesylate), Camcevi ETM (leuprolide mesylate), Firmagon (degarelix), generic leuprolide, brand leuprolide depot, Lupron Depot (leuprolide acetate), Orgovyx (relugolix), Trelstar (triptorelin pamoate), Vabrinity (leuprolide acetate), and Zoladex (goserelin) to include Grade Group 3 histology.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

HER2 Inhibitors, 5.01.514  Individual | Group
Medical necessity criteria added

• Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered medically necessary for:
  • Neoadjuvant treatment of HER2-positive (IHC [Immunohistochemistry] 3+ or ISH [In Situ Hybridization] +) Stage II or III breast cancer when used before taxane, trastuzumab, and pertuzumab; and
  • Adjuvant treatment of HER2-positive breast cancer in individuals with residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based therapy.
• Poherdy (pertuzumab-dpzb) may be considered medically necessary for the treatment of previously untreated HER2-positive breast cancer or recurrent breast cancer when criteria are met.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

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

• Fasenra (benralizumab) may be considered medically necessary for the treatment of hypereosinophilic syndrome in adult and pediatric individuals when criteria are met.

Medical necessity criteria updated

• Nucala (mepolizumab) criteria for the treatment of chronic rhinosinusitis with nasal polyposis revised to specify that diagnosis must be confirmed by physical examination, sinus computed tomography scan, or nasal endoscopy.

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

• Treatment of chronic inflammatory demyelinating polyneuropathy criteria now includes a revised requirement for electrophysiologic findings.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Insulin Therapy, 5.01.648  Individual | Group
Medical necessity criteria updated

• Admelog (lispro), Admelog SoloStar (lispro), Afrezza (human), Apidra (glulisine), Humalog (lispro), insulin lispro, Kirsty (insulin aspart-xjhz), Lyumjev (lispro), and Merilog (insulin aspart-szjj) no longer include insulin aspart as a preferred alternative following product discontinuation.
• Humalog Mix 75/25, Humalog Mix 50/50, and insulin lispro protamine + insulin lispro mix 75/25 no longer include insulin aspart protamine + insulin aspart mix 70/30 as a preferred alternative following product discontinuation.

Medical necessity criteria added

• Langlara (insulin glargine-aldy) may be considered medically necessary for the treatment of type 1 or type 2 diabetes when criteria are met.
• Awiqli (insulin icodec-abae) may be considered medically necessary for the treatment of type 2 diabetes when criteria are met.

Medical necessity criteria removed

• Insulin degludec has been discontinued.

Pharmacologic Treatment of Epidermolysis Bullosa, 5.01.635  Individual | Group
Medical necessity criteria updated

• Vyjuvek (beremagene geperpavec-svdt) criteria now require that the individual has at least one open wound associated with dystrophic epidermolysis bullosa that is clean in appearance without signs of active infection, and has adequate granulation tissue and vascularization.
• Filsuvez (birch triterpenes) and Vyjuvek (beremagene geperpavec-svdt) initial and ongoing length of approval from 6 months to 12 months.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Pharmacologic Treatment of High Cholesterol, 5.01.558  Individual | Group
Medical necessity criteria added

• Lerochol (lerodalcibep-liga) may be considered medically necessary for the treatment of hypercholesterolemia when criteria are met.
• Redemplo (plozasiran) may be considered medically necessary for the treatment of familial chylomicronemia syndrome when criteria are met.

Medical necessity criteria updated

• Leqvio (inclisiran) for the treatment of heterozygous familial hypercholesterolemia age requirement decreased from 18 years to 12 years or older, and added coverage criteria for treatment of homozygous familial hypercholesterolemia.
• Leqvio (inclisiran), Nexletol (bempedoic acid), Nexlizet (bempedoic acid and ezetimibe), Praluent (alirocumab), and Repatha (evolocumab) for treatment of primary hyperlipidemia revised to treatment of hypercholesterolemia.
• Evkeeza age requirement decreased from 5 years to 1 year or older, and clarified that individuals aged 10 years and older must have tried Repatha (evolocumab) first.
• Tryngolza (olezarsen) criteria revised to clarify prescribing requirements now include that the medication may not be used in combination with Redemplo (plozasiran), and update diagnostic confirmation requirements to include genetic testing or a qualifying clinical diagnosis plus at least one additional criterion.
• Juxtapid (lomitapide) criteria revised to lower the minimum age from 18 years to 2 years, clarify that individuals aged 10 years and older must have tried Repatha (evolocumab) first, added a 30-day quantity limit, and require that the medication be prescribed by or in consultation with a cardiologist, endocrinologist, or physician specializing in cardiovascular risk management and/or lipid disorders.

Medical necessity criteria removed

• Roszet (rosuvastatin/ezetimibe), brand rosuvastatin/ezetimibe, brand simvastatin oral suspension, and Vytorin (simvastatin/ezetimibe).
• Altoprev (lovastatin), Antara (fenofibrate), Fenoglide (fenofibrate), Niaspan (niacin extended-release), Pravachol (pravastatin), Triglide (fenofibrate), and Trilipix (fenofibric acid) have been discontinued.
• Removed reference to non-formulary exception reviews.

Pharmacologic Treatment of Sickle Cell Disease, 5.01.640  Individual | Group
Medical necessity criteria updated

• Casgevy (exagamglogene autotemcel) age requirement lowered from 12 years or older, to 2 years or older.
• Endari (L-glutamine) now includes a quantity limit of 180 packets per 30 days.
• Lyfgenia (lovotibeglogene autotemcel) age requirement expanded from aged between 12 years and 50 years to aged 12 years and older.
• Clarified that all other uses for conditions not outlined in this policy or for a condition not outlined in Gene Therapies for Thalassemia, 5.01.42 are considered investigational.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

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

• Saphnelo (anifrolumab-vnia) subcutaneous criteria now include a quantity limit of 4 pens or syringes per 28 days.
• Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) criteria for chronic inflammatory demyelinating polyneuropathy revised to clarify electrophysiologic findings, require a trial of immune globulin within the past 12 months, and specify that the medication is not used concurrently with immune globulin.
• Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) criteria revised to clarify that a serological test for AChR antibodies has been performed and added a requirement that the medication be prescribed by or in consultation with a neurologist.
• Generalized myasthenia gravis criteria for Imaavy (nipocalimab-aahu), Rystiggo (rozanolixizumab-noli), and Uplizna (inebilizumab-cdon) revised to require that treatment be prescribed by or in consultation with a neurologist.

Medical necessity criteria added

• Adalimumab-bwwd now included in second line adalimumab products.
• Filspari (sparsentan) may be considered medically necessary to reduce proteinuria in individuals with focal segmental glomerulosclerosis without nephrotic syndrome when criteria are met.

SGLT2 Inhibitors, 5.01.646  Individual | Group
Medical necessity criteria added

• Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin-metformin extended-release) may be considered medically necessary for the treatment of type 2 diabetes when criteria are met and are classified as first-line SGLT2 inhibitors.

Medical necessity criteria updated

• Revised the preferred alternative requirements for brand bexagliflozin, Brenzavvy, Invokana, Invokamet, Invokamet XR, Steglatro, and Segluromet to add Farxiga and Xigduo XR as preferred alternatives.

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

• Omlyclo (omalizumab-igec) now requires site of service review.

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

• Tezspire (tezepelumab-ekko) asthma treatment criteria now includes Exdensur (depemokimab-ulaa) in the list of medications that should not be used concurrently.
• Tezspire (tezepelumab-ekko) chronic rhinosinusitis treatment with nasal polyposis criteria now clarify that diagnosis is confirmed by physical examination, sinus computed tomography scan, or nasal endoscopy.

Xolair (omalizumab), 5.01.513  Individual | Group
Title Change

• Title changed from Xolair (omalizumab) to Omalizumab Products.

Medical necessity criteria added/updated (pp. 4-9)

• Incorporated Omlyclo (omalizumab-igec) into the policy using the existing Xolair (omalizumab) criteria.
• Omlyclo (omalizumab-igec) requires site of service review.

No updates this month.

Effective August 1, 2026

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63

• This policy is replaced with Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.544.

Added codes
Effective November 6, 2026

Immune Globulin Therapy, 8.01.503  Individual | Group
Site of Service: Drugs and Biologic Agents, 11.01.523  Individual | Group
Now requires review for site of service, in addition to current review for medical necessity and prior authorization.

J1577

Effective September 4, 2026

Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence, 1.01.17  Individual | Group
Now considered investigational.

E0740

Effective August 1, 2026

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.544  Individual | Group
Now requires review for medical necessity and prior authorization.

36511, 38228, Q2058, Q2041, Q2042, Q2053, Q2054, S2107

Closure Devices for Patent Foramen Ovale and Atrial Septal Defects, 2.02.09  Individual | Group
Now requires review for medical necessity and prior authorization.

C1817

Endovascular Stent Grafts for Abdominal Aortic Aneurysms, 7.01.601  Individual | Group
Now requires review for medical necessity and prior authorization.

34709

Implantable Shock Absorber for Treatment of Knee Osteoarthritis, 7.01.90  Individual | Group
Now requires review for medical necessity.

27599

Permanently Implanted Prostatic Devices for Benign Prostatic Hyperplasia, 7.01.181  Individual | Group
Now requires review for medical necessity.

C1889, 53899

Removed codes
Effective November 6, 2026

Synthetic Cartilage Implants for Joint Pain, 7.01.160  Individual | Group
No longer requires review.

28291

Effective August 1, 2026

Automated Percutaneous and Percutaneous Endoscopic Discectomy, 7.01.18  Individual | Group
No longer requires review.

0274T, 62330, 62331

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63  Individual | Group
No longer requires review.

36511, 38228, Q2058, Q2041, Q2042, Q2053, Q2054, S2107

Electrophysiology EP Studies, 2.02.517  Individual | Group
No longer requires review.

93653, 93654

Endovascular Stent Grafts for Abdominal Aortic Aneurysms, 7.01.601  Individual | Group
No longer requires review.

36200, 36245

Percutaneous Coronary Intervention, Angioplasty, Non-Emergent in Adults, 2.02.508  Individual | Group
No longer requires review.

92941

Revised codes
Effective November 6, 2026

Endovascular Stent Grafts for Abdominal Aortic Aneurysms, 7.01.601  Individual | Group
Now requires review for medical necessity and prior authorization.

34717, 34718

Effective September 4, 2026

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

97605, 97606, 97607, 97608

Effective September 1, 2026

Site of Service Ambulatory Service Center (ASC): Select Surgical Procedures for Adults, 11.01.525  Individual | Group
Upper Gastrointestinal Endoscopy (UGI) in Adults, 2.01.533  Individual | Group
Now requires review for site of service, in addition to current review for medical necessity and prior authorization.

43235, 43238, 43239, 43242

Effective September 4, 2026

Testosterone, 15.01.017  Group
Medical necessity criteria updated

• Correction to measurement of serum free and/or bioavailable testosterone to indicate that testing as a primary test, and for asymptomatic individuals or those with nonspecific symptoms is not reimbursable. These statements were previously listed as reimbursable in error.

No updates this month.

No updates this month.

No updates this month.