Medical Policy and Coding Updates

Effective December 3, 2026

Knee Arthroscopy in Adults, 7.01.549  Individual | Group
Medical necessity criteria added

• Knee arthroscopy for a synovectomy (limited procedure) may be considered medically necessary when criteria are met.

Medical necessity criteria updated

• Under the intra-articular joint pathology indication, symptoms of pathological plica must not have responded to conservative care measures.

Medical necessity criteria removed

• Diagnostic imaging is no longer required within 12 months prior to the requested surgery.

Pharmacotherapy of Spinal Muscular Atrophy (SMA), 5.01.574  Individual | Group
Medical necessity criteria updated

• Itvisma (onasemnogene abeparvovec brve) and Zolgensma (onasemnogene abeparvovec xioi) criteria now define the clinical characteristics that constitute advanced SMA, replacing the previous exclusion criterion that the individual does not have advanced SMA.

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 Carelon’s 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 Carelon’s 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 human papillomavirus (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 Current Procedural Terminology^® (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 Carelon’s 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 Carelon’s 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 is 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 <30 genes
• Thrombophilia testing
  • Added two criteria for individuals with a venous thromboembolism (VTE): Pregnancy or postpartum up to 6 weeks, or estrogen exposure.
  • Added a criterion for individuals with or without a VTE and low activated protein C resistance activity.
  • Edited one criterion for individuals without a VTE contemplating pregnancy and first-degree relative with VTE and high-risk thrombophilia.
  • Added criteria for individuals without a VTE: Pregnant or postpartum and a first-degree relative with a history of VTE and high-risk thrombophilia or cancer receiving chemotherapy at low or intermediate risk of thrombosis and a first-degree relative with a history of VTE.
  • Clarified scenarios considered not medically necessary.
• Biomarker testing for rejection in solid organ transplantation
  • For individuals ≥15 years of age post-cardiac transplantation: Testing is allowed beginning at 2 months post-transplant (reduced from 6 months), with testing frequency permitted at 2-month intervals (reduced from 3 months) between 2 and 12 months after transplant.
  • Clarified additional scenarios and related tests for gene expression profiling, donor-derived cell-free DNA (dd-cfDNA), and MicroRNA testing 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 September 4, 2026

Negative Pressure Wound Therapy (NPWT) Devices in Adults, 1.01.508  Individual | Group
Title change

• Title changed from Negative Pressure Wound Therapy (NPWT) Devices in Adults to Negative Pressure Wound Therapy (NPWT) Devices.

Medical necessity criteria updated

• Eliminated the age restriction limiting the policy to adults aged 19 and older.

Investigational criteria added

• The use of NPWT systems is considered investigational in individuals aged 11 years and younger.

Orthognathic Surgery, 9.02.501  Individual | Group
Medical necessity criteria updated

• Congenital anomalies now include Noonan syndrome and revised Pierre Robin syndrome to Pierre Robin sequence.

Investigational criteria added

• Three-dimensional virtual treatment planning or computer-aided three-dimensional simulation and navigation in orthognathic surgery is considered investigational.

Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence, 1.01.17  Individual | Group
New policy

• Electrical or magnetic stimulation of the pelvic floor muscles as a treatment for urinary or fecal incontinence is considered investigational.

Shoulder Arthrotomy in Adults, 7.01.605  Individual | Group
Medical necessity criteria updated

• Conservative management requirements were modified to include both a medication trial with failure and a trial with failure of physical measures for the indications:
  • Decompression of subacromial space or acromioplasty for rotator cuff tendonitis
  • Full thickness rotator cuff repair
  • Resection of distal clavicle
  • Shoulder dislocation
  • Synovectomy
• Additional testing is now required for the following indications:
  • Decompression of subacromial space or acromioplasty for rotator cuff tendonitis,
  • Full thickness rotator cuff repair
  • Resection of distal clavicle
  • Shoulder dislocation

Medical necessity criteria removed

• Criteria for the following indications no longer included in policy:
  • Acromioclavicular (AC) separation with recent traumatic event
  • Shoulder pain, deformity, partial thickness rotator cuff repair
  • Removal of intra-articular osteochondral lesion or loose body
  • Recurrent shoulder dislocation (greater than two years, less than two years)
  • Initial or recurrent shoulder dislocation with Bankart, Hill-Sachs, or anterior glenoid rim fracture
  • Shoulder fracture repair
  • Shoulder hardware removal

New medical policies
Effective September 1, 2026

Prescription Digital Therapeutics, 3.03.500  Individual | Group
Policy renumbered

• This policy replaces Prescription Digital Therapeutics, 13.01.500.

Revised medical policies
Effective September 1, 2026

Coronary Angiography for Known or Suspected Coronary Artery Disease in Adults, 2.02.507  Individual | Group
Medical necessity criteria updated

• Stable angina criteria now require optimal medical treatment for each Canadian Cardiovascular Society Class, defined as use of two or more anti-anginal medications from different therapeutic classes, including either a beta-blocker or calcium channel blocker, or both, unless contraindicated.
• Left ventricular enlargement or transient ischemic dilation (TID) criteria now require a TID ratio greater than 1.2.

Revised pharmacy policies
Effective September 1, 2026

Amyloid Antibodies for the Treatment of Alzheimer’s Disease, 5.01.626  Individual | Group
Medical necessity criteria updated

• Leqembi Iqlik (lecanemab-irmb) criteria no longer require 18 months of prior Leqembi IV therapy, now clarify the dose limit, and include a quantity limit per 28 days.

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

• Padcev (enfortumab vedotin-ejfv) criteria for treatment of muscle invasive bladder cancer no longer require ineligibility for cisplatin-containing chemotherapy.

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

• Generic bosutinib may be considered medically necessary for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults with accelerated or blast phase disease resistant or intolerant to prior generic imatinib therapy, and in individuals aged 1 year or older with chronic phase disease when criteria are met.
• Cavhanza (nilotinib) may be considered medically necessary for the treatment of Ph+ CML when criteria are met.

Medical necessity criteria updated

• Bosulif (bosutinib) criteria now require a trial of generic bosutinib.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Bispecific Antibodies, 5.01.650  Individual | Group
Medical necessity criteria added

• Bizengri (zenocutuzumab-zbco) criteria expanded to include treatment of advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

Medical necessity criteria updated

• Blincyto (blinatumomab) criteria for CD19-positive B-cell precursor ALL in the consolidation phase of multiphase chemotherapy no longer references Philadelphia chromosome status.

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

• Imcivree (setmelanotide) may be considered medically necessary for the treatment of acquired hypothalamic obesity when criteria are met.
• Yuviwel (navepegritide) may be considered medically necessary to increase linear growth in individuals with achondroplasia when criteria are met.

Medical necessity criteria updated

• Imcivree (setmelanotide) criteria now include a quantity limit per 30 days.
• Besremi (ropeginterferon alfa-2b-njft) criteria now limit quantity to 2 pens or syringes every 28 days.
• Voxzogo (vosoritide) criteria now require that the medication not be used concurrently with Yuviwel (navepegritide).
• Daybue (trofinetide) and Daybue Stix (trofinetide) criteria now include a quantity limit per 30 days.
• Zycubo (copper histidinate) criteria now require specialist involvement, remove serum copper and ceruloplasmin level requirements from diagnostic criteria, include plasma catecholamine analysis as an acceptable diagnostic option, and provide an initial approval period of 12 months.
• Bylvay, Crenessity, Ctexli, Daybue, Daybue Stix, dichlorphenamide, Enjaymo, Firdapse, Forzinity, Gamifant, Givlaari, Keveyis, Livmarli, Nulibry, Ormalvi, Oxlumo, Pyrukynd, Rivfloza, Ryplazim, Sylvant, and Vykat XR criteria now provide an initial approval period of 12 months.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Drugs for Weight Management, 5.01.621  Individual | Group
Medical necessity criteria added

• Wegovy (semaglutide) injection criteria expanded to include treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH).

Medical necessity criteria updated

• Contrave, Foundayo, liraglutide, phentermine-topiramate ER, Qsymia, Saxenda, Wegovy, Xenical, brand orlistat, and Zepbound criteria for chronic weight management now reference polyendocrine metabolic ovarian syndrome (PMOS) in place of polycystic ovary syndrome (PCOS).
• Foundayo (orforglipron) criteria now provide an initial approval period of 7 months.

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

• Fasenra (benralizumab) criteria for treatment of hypereosinophilic syndrome (HES) now require documentation of HES on two examinations rather than a documented history of HES for at least 6 months, revise the HES flare requirement to require meeting one of the specified criteria and include signs or symptoms indicative of an HES flare, no longer require FIP1L1-PDGFRA (Fip1-like1-Platelet Derived Growth Factor Receptor α) confirmation by fluorescence in situ hybridization (FISH) or reverse transcription polymerase chain reaction (RT-PCR), and require management by a physician experienced in the treatment of HES.
• Nucala (mepolizumab) criteria for treatment of HES no longer require FIP1L1-PDGFRA confirmation by FISH or RT-PCR and require management by a physician experienced in the treatment of HES.

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

• Keytruda and Keytruda Qlex criteria expanded to include use in combination with belzutifan for the adjuvant treatment of ccRCC.
• Keytruda and Keytruda Qlex criteria expanded to include use in combination with sacituzumab govitecan-hziy for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer.
• Imfinzi criteria expanded to include use in combination with Bacillus Calmette-Guérin for the treatment of adult individuals with BCG-naive, high-risk non-muscle-invasive bladder cancer (MIBC).
• Tecentriq and Tecentriq Hybreza criteria expanded to include adjuvant treatment of adult individuals with MIBC after cystectomy who have circulating tumor DNA (ctDNA) MRD.

Medical necessity criteria updated

• Keytruda and Keytruda Qlex criteria for treatment of muscle invasive bladder cancer no longer require that the individual be ineligible for cisplatin-containing chemotherapy.

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

• Brand atomoxetine solution added with the same criteria as Atoncy (atomoxetine).
• Dexlyt (dexamethasone) added to brand oral corticosteroids.
• Brand doxycycline hyclate added to brand oral antibiotics and their generics.

Medical necessity criteria updated

• Atmeksi (methocarbamol) criteria now clarify that dosing is limited to 6,000 mg daily for the first 3 days, followed by 4,500 mg daily thereafter.
• Yartemlea (narsoplimab-wuug) criteria no longer require that the individual has not received eculizumab or ravulizumab within the previous 3 months, and updated diagnostic criteria.

Medical necessity criteria removed

• Coverage criteria for albendazole, cinacalcet, and nitazoxanide removed.

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

• Ibrance (palbociclib) criteria expanded to include use in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
• Welireg (belzutifan) criteria expanded to include use in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the adjuvant treatment of clear cell component renal cell carcinoma (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
• Sarclisa Escena (isatuximab-irfc) may be considered medically necessary for the treatment of multiple myeloma when criteria are met.
• Trodelvy (sacituzumab govitecan-hziy) criteria expanded to include first-line treatment of mTNBC as a single agent or in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-mph.

Medical necessity criteria updated

• Tecelra (afamitresgene autoleucel) criteria expanded to include individuals 12 years of age or older.

Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases, 5.01.615  Individual | Group
Medical necessity criteria added

• Lynavoy (linerixibat) may be considered medically necessary for the treatment of cholestatic pruritus associated with primary biliary cholangitis when criteria are met.

Medical necessity criteria updated

• Iqirvo (elafibranor) and Livdelzi (seladelpar) criteria now include a quantity limit per 30 days and provide an initial approval period of 12 months.
• Rezdiffra (resmetirom) criteria now include a quantity limit per 30 days, clarify that fibrosis must be confirmed by liver biopsy, vibration-controlled transient elastography, magnetic resonance elastography, or enhanced liver fibrosis test, replace concomitant condition requirements with one or more metabolic risk factors managed per standard of care, and no longer require additional testing.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Pharmacologic Treatment of Hemophilia, 5.01.581  Individual | Group
Medical necessity criteria updated

• Hympavzi (marstacimab-hncq) criteria expanded to include individuals 6 years of age or older, expanded to include individuals with factor VIII or IX inhibitors, and now includes a quantity limit per 28 days.
• Qfitlia (fitusiran) criteria no longer require a minimum number of bleeding episodes prior to treatment.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

Phosphoinositide 3-kinase (PI3K) Inhibitors, 5.01.592  Individual | Group
Medical necessity criteria updated

• Truqap (capivasertib) criteria expanded to include treatment of metastatic androgen pathway modulation-naïve or sensitive prostate cancer that is PTEN-deficient.

Medical necessity criteria removed

• Aliqopa (copanlisib) has been discontinued.
• Removed reference to non-formulary exception reviews.

Prostate Cancer Targeted Therapy, 5.01.544  Individual | Group
Medical necessity criteria updated

• Abirtega (abiraterone), generic abiraterone, and Zytiga (abiraterone) criteria expanded to include treatment of metastatic androgen pathway modulation-naïve or sensitive prostate cancer that is PTEN (phosphate and tension homolog)-deficient when used in combination with capivasertib.

Medical necessity criteria removed

• Removed reference to non-formulary exception reviews.

No updates this month.

Effective September 1, 2026

Prescription Digital Therapeutics, 13.01.500

• This policy is replaced with Prescription Digital Therapeutics, 3.03.500.

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 September 1, 2026

Drugs for Rare Diseases, 5.01.576  Individual | Group
Now requires review for medical necessity.

J3490, J3590

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

C9399, J3590, J9298, J9999

Removed codes
Effective November 6, 2026

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

28291

Effective September 1, 2026

Implantable Cardioverter Defibrillator (ICD), 7.01.44  Individual | Group
No longer requires review.

C1824, C1882

Miscellaneous Oncology Drugs, 5.01.540  Individual | Group
No longer requires review.

J9285, J0897, J9177, J9321

Phosphoinositide 3-kinase (PI3K) Inhibitors, 5.01.592  Individual | Group
No longer requires review.

J9057

Revised codes
Effective December 3, 2026

Pharmacotherapy of Spinal Muscular Atrophy (SMA), 5.01.574  Individual | Group
Now requires review for medical necessity.

J3399, J3405

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.