Medical Policy and Coding Updates

Effective August 1, 2025

Effective for dates of service on and after August 1, 2025, the following update will apply to the Carelon Medical Benefits Management (MBM) Genetic Testing Program. The date of service (DOS) will be defined as the sample or collection date. For archival samples, the sample collection or retrieval date will serve as the DOS for review. In the rare circumstance that an exception is needed, providers may reach out to the Carelon MBM genetic testing team at DL-GeneticTestingSolution@carelon.com.

This update is focused on providing clinically appropriate, safe, and affordable health care services. Providers are reminded that they may submit authorization requests through the Carelon provider portal. Portal access is available 24/7 to process requests in real-time and is the fastest, most convenient way to request an authorization.

Effective July 26, 2025

Effective for dates of service on and after July 26, 2025, the following updates will apply to the Carelon MBM, Inc. Clinical Appropriateness Guidelines for Genetic Testing. As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.

Updates by section

Chromosomal Microarray Analysis

• Postnatal/Pediatric evaluation now includes neonatal death as an indication for chromosomal microarray analysis
• Optical Genome Mapping considered not medically necessary; more studies are needed to validate its use for structural variant analysis

Whole Exome Sequencing and Whole Exome Sequencing

• Clarified and restructured criteria for better readability
• Specified that whole exome sequencing is excluded for early neonatal death

Pharmacogenomic Testing

• Genotyping for biomarkers in Table 1 is medically necessary when conditions are met
• Clarified Table 1 title:
  • Therapies and associated biomarkers considered medically necessary for genotyping
• Biomarkers added to Table 1:
  • Donanemab-azbt added for genotyping ApoE ε4 in Neurology for Alzheimer's treatment
  • Deuruxolitinib added for genotyping CYP2C9 in Dermatology for alopecia areata treatment
  • NUDT15 risk allele added to explain thiopurine-related myelosuppression risk in Asians and Hispanics
• Eliglustat's therapeutic area is clarified as hematology, not pediatrics

Predictive and Prognostic Polygenic Testing

• Guideline reaffirmed; Description/Scope and Rationale edited

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

Effective July 3, 2025

Bioengineered Skin and Soft Tissue Substitutes, 7.01.582  Individual | Group
Policy renumbered

• This policy replaces Bioengineered Skin and Soft Tissue Substitutes, 7.01.113, which will be deleted following 90-day provider notification

Investigational device added

• BEAR (bridge-enhanced anterior cruciate ligament repair) implant added to investigational list

Catheter Ablation for Atrial Fibrillation, 2.02.516  Individual | Group
New policy

• Transcatheter radiofrequency ablation or cryoablation to treat atrial fibrillation may be considered medically necessary when criteria are met

Effective July 1, 2025

Pharmacologic Treatment of Psoriasis, 5.01.629  Individual | Group
Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556  Individual | Group
Medical necessity criteria updated

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] updated from a preferred to a non-preferred adalimumab product

Use of Granulocyte Colony-Stimulating Factors (G-CSF), 5.01.551  Individual | Group
Medical necessity criteria updated

• Udenyca (pegfilgrastim-cbqv) and Udenyca Onbody (pegfilgrastim-cbqv) moved from second-line to first-line therapy for individuals younger than 18 years of age
• Udenyca (pegfilgrastim-cbqv) and Udenyca Onbody (pegfilgrastim-cbqv) moved from third-line to second-line therapy for individuals aged 18 years and older
• Nyvepria (pegfilgrastim-apgf) moved from first-line to second-line therapy for individuals younger than 18 years of age
• Nyvepria (pegfilgrastim-apgf) moved from second-line to third-line therapy for individuals aged 18 years and older

Effective June 6, 2025

Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis, 2.04.127  Individual | Group
New policy

• Multitarget polymerase chain reaction testing for the diagnosis of bacterial vaginosis is considered investigational

Effective May 6, 2025

Carpal Tunnel Release Surgical Treatments, 7.01.595  Individual | Group
New policy

• Carpal tunnel release surgery is considered medically necessary for individuals with carpal tunnel syndrome who have failed conservative therapy when criteria are met

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

• Aveed (testosterone undecanoate) and Testopel (testosterone pellets) updated to match criteria for all other brand testosterone products

Pharmacologic Treatment of Transthyretin-Mediated Amyloidosis, 5.01.593  Individual | Group
Medical necessity criteria updated

• Amvuttra, Onpattro, and Wainua updated diagnostic criteria

Pharmacotherapy of Arthropathies, 5.01.550  Individual | Group
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  Individual | Group
Medical necessity criteria added

• Tyenne (tocilizumab-aazg) IV added to site of service review

Effective April 20, 2025

Effective for dates of service on and after April 20, 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

Oncologic Imaging

• National Comprehensive Cancer Network alignments for Cancer Screening and tumor-specific indications, largely addressing time intervals of screening or surveillance imaging.
• Added fluorodeoxyglucose positron emission tomography allowances for Colorectal Cancer and Lung Cancer (Small Cell) accounting for nondiagnostic standard imaging.

Imaging of the Abdomen and Pelvis

• Tumor or neoplasm:
  • Added requirement for initial evaluation of testicular masses with ultrasound
• Endometriosis:
  • Removed ultrasound requirement for follow-up of patients with established diagnosis
• Obstetric indications:
  • Specified that fetal magnetic resonance imaging (MRI) is indicated in second or third trimester
• Diffuse liver disease:
  • Removed criteria for LiverMultiScan as an alternative to magnetic resonance elastography
• Abdominal and/or pelvic pain, undifferentiated:
  • Clarified language regarding initial imaging and lab evaluation

Imaging of the Chest

• Added indication for dyspnea

Effective for dates of service on and after April 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

Carrier Screening in the Reproductive Setting

• Standard carrier screening:
  • Removed complete blood count from the list of acceptable prior testing restrictions for hemoglobinopathy screening
• Expanded carrier screening
• Clarified that medical records should attest to adoption or consanguinity
• Expanded criteria to allow for multigene panels to include conditions with less than 1 in 100 carrier frequencies for individuals in a consanguineous partnership
• Removed requirement that alternate biochemical tests are not available, have provided an indeterminate result, or are less accurate than genetic testing

Genetic Testing for Inherited Conditions

• Added expansive criteria to allow confirmatory genetic testing for individuals identified to have a pathogenic or likely pathogenic germline variant in genes with established clinical utility based on results of institutional review board approved clinical research studies
• Cardiac conditions:
  • Expanded genetic testing criteria for hereditary cardiomyopathy syndromes in the pediatric population
  • Added new expansive medical necessity criteria for hereditary aortopathies
• Neurological conditions:
  • Expanded criteria to allow SOD1 genetic testing in individuals with amyotrophic lateral sclerosis when determined to be a candidate for Food and Drug Administration (FDA) approved Qalsody (tofersen) treatment
• Thrombophilia testing:
  • Removed restriction of low bleeding risk in individuals with an unprovoked venous thromboembolism (VTE) who are planning to stop anticoagulation
  • Removed criterion to allow F5 and F2 genetic testing for individuals contemplating estrogen use when they have a first degree relative with VTE and a known hereditary thrombophilia per American Society of Hematology guidance

Hereditary Cancer Testing

• Removed requirement that alternate biochemical tests are not available, have provided an indeterminate result, or are less accurate than genetic testing
• Listed specific examples of somatic test findings that, per American Society for Clinical Oncology (ASCO) guideline, should generate consideration of germline testing (clarification)
• Expanded criteria to allow confirmatory genetic testing for individuals identified to have a pathogenic or likely pathogenic germline variant in genes with established clinical utility based on results from direct-to-consumer genetic testing or results from an institutional review board approved clinical research study
• Adenomatous polyp syndromes:
  • Added expansive criteria to include individuals with multifocal or bilateral congenital hypertrophy of retinal pigment epithelium
  • Added expansive criteria to include first-, second-, or third-degree relatives with known pathogenic variant or clinical findings suggestive of an inherited polyposis syndrome
• Juvenile polyposis syndrome:
  • Increased testing requirement for number of juvenile polyps in the colon from three to five (restrictive)
• Cowden syndrome:
  • Expanded minor criteria to include colorectal cancer and lipomas to the list of conditions that may be present
• Lynch syndrome:
  • Personal history criteria expanded to include any Lynch syndrome related cancer: colorectal, endometrial, gastric, ovarian, pancreatic, urothelial, central nervous system glioma, biliary tract, small intestine, sebaceous adenomas or carcinomas, keratoacanthomas, or breast carcinomas with medullary features
• Li-Fraumeni syndrome (LFS):
  • Expanded the personal history criteria to include pediatric hypodiploid acute lymphoblastic leukemia
  • Restricted germline testing criteria for testing as follow-up to TP53 positive somatic tumor test results as per ASCO guideline
  • Restricted germline testing criteria for testing of unaffected first-, second-, or third-degree relatives to individuals whose affected relative meets LFS personal history criteria
• Hereditary Breast Cancer:
  • Expanded BRCA1/2 testing criteria to include all women less than 65 years of age with a personal history of breast cancer
  • All individuals who are candidates for poly ADP-ribose polymerase inhibitor therapy are included in scope for testing
  • Clarified the statement about BRCA risk models, eliminating reference to tools that are not examples of validated risk models
  • Family history criteria for testing related to having a relative with multiple primary breast cancers expanded to first- or second-degree relative
  • Family history criteria for testing related to having a relative with epithelial ovarian, fallopian tube, or primary peritoneal cancer expanded to include first-, second-, or third-degree relatives
  • Family history criteria for testing related to having a relative with breast cancer who is also an individual assigned male sex at birth expanded to include first-, second-, or third-degree relatives
  • Family history criteria for testing related to having a relative less than 50 years of age with breast cancer expanded to be at least one relative who is a first-, second, or third-degree blood relative
• Hereditary epithelial ovarian cancer:
  • Clarified the statement about BRCA risk models, eliminating reference to tools that are not examples of validated risk models
• Hereditary pancreatic ductal adenocarcinoma:
  • Clarified the statement about BRCA risk models, eliminating reference to tools that are not examples of validated risk models
• Multi-gene panel testing for hereditary breast or pancreatic cancer:
  • For pancreatic carcinoma, expanded the multi-gene panel list to include CDK4
  • For breast cancer, removed the following genes from the multi-gene panel list: ATM, BARD1, CHEK2, RAD51C, and RAD51D
• Melanoma:
  • Gene list expanded to 20 genes and can include CDK4 pathogenic variants
• Nevoid basal cell carcinoma syndrome:
  • Expanded threshold for number of basal cell carcinomas from 5 in a lifetime to as low as two (multiple) if this is considered out of proportion to prior skin exposure or skin type
  • Removed age restriction for Lamellar calcification of the falx cerebri (major criterion)
• Endocrine neoplasms:
  • Expanded criteria to include early onset gastrointestinal stromal tumors to account for evaluation for SDHB gene-deficient GIST
• Kidney cancer:
  • Expanded criteria to include individuals with a personal history of various rare kidney tumors (Birt-Hogge-Dubé syndrome, Hereditary leiomyomatosis and renal cell cancer associated renal cell carcinoma, etc.)
  • Expanded criteria to include unaffected individuals with two or more first- or second-degree relatives with renal cell carcinoma
• Prostate Cancer:
  • For individuals with low-risk prostate cancer, criteria expanded to include family history of breast cancer in relatives assigned female at birth and aged 50 years or older; family history of pancreatic, gastric, brain, melanoma, intestinal (colorectal or small bowel), or endometrial cancer diagnosed at aged 50 years or older; family history of upper tract urothelial cancer(s) in first- or second-degree relatives; Ashkenazi Jewish ancestry; intraductal or cribriform histology
  • For individuals with intermediate risk prostate cancer, criteria expanded to include family history of breast cancer in relatives assigned female at birth and aged 50 years or older; family history of pancreatic, gastric, brain, melanoma, intestinal (colorectal or small bowel), or endometrial cancer diagnosed at age ≤50; family history of upper tract urothelial cancer(s) in first- or second-degree relatives
  • Removed CHEK2 or PALB2 from the multi-panel gene list for prostate cancer
  • Expanded family history criteria to first-, second-, or third-degree relatives with multiple primary breast cancers
  • Expanded family history criteria of prostate cancer diagnosed before age 60 to include at least one first- or second-degree relative
  • For individuals unaffected by prostate cancer, criteria are expanded to include 11 additional family history indicators for risk of BRCA1 or BRCA2 pathogenic variants that match the Hereditary breast cancer family history criteria
  • Clarified the statement about BRCA risk models, eliminating reference to tools that are not examples of validated risk models

Effective for dates of service on and after April 20, 2025, the following updates will apply to the Carelon Medical Benefits Management, Inc. Radiation Oncology Appropriateness Guidelines. 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

Radiation therapy

• Special Treatment Procedure and Special Physics Consult:
  • Limited the scenarios where special treatment procedure and special physics consult are indicated, to more closely align with recent American Society for Radiation Oncology guidance.
• Breast cancer:
  • Reduced the minimum age at which patients with invasive disease meet criteria for accelerated partial breast irradiation.
• Head and neck cancer:
  • Removed indication for neutron therapy as it is no longer routinely used.
• Lung cancer:
  • Clarified that the maximum number of fractions for stereotactic body radiation therapy (SBRT) is 5 in both non-small cell lung cancer and small cell lung cancer
• Oligometastatic extracranial disease:
  • Added scenario for oligoprogressive extracranial disease
• Other tumor types:
  • Combined criteria for intensity-modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS), and SBRT
  • Expanded criteria for SRS and SBRT to include any radiosensitive tumor
• Prostate cancer:
  • Modified number of fractions indicated, due to larger dose given in each individual fraction (no change in total dose to be given)
  • Added scenario for salvage treatment after prostatectomy
  • Added max fraction number for salvage radiation therapy

Hydrogel Spacers

• Expanded the use of hydrogel spacers to include them in patients receiving any form of external beam radiation therapy

Proton Beam Therapy

• Added clarifying statement that generic case control plan comparison is insufficient and that patient-specific IMRT isodose comparison is required

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 April 6, 2025

Adjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia, 7.01.596  Individual | Group
Policy renumbered

• This policy replaces Adjunctive Techniques for Screening and Surveillance of Barrett Esophagus and Esophageal Dysplasia, 7.01.167, which is now deleted

Investigational criteria added

• TissueCypher and Esopredict are considered investigational for assessing the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus

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

• Leqembi criteria updated with inclusion of test results that indicate mild cognitive impairment or mild Alzheimer’s Disease (AD) dementia
• Added requirement to Leqembi criteria for testing for ApoE ε4 status and that potential ARIA risks have been discussed

Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  Individual | Group
Investigational criteria added

• Measurement of biochemical markers of Alzheimer’s disease (AD) is considered investigational in individuals with mild cognitive impairment or mild dementia caused by AD in the following instances:
  • Cerebrospinal fluid testing for neural thread proteins to evaluate the need for amyloid beta-targeting therapy
  • Cerebrospinal fluid biomarker testing to support clinical diagnosis
  • Cerebrospinal fluid biomarker testing as part of an evaluation for the continuation of amyloid beta targeting therapy

Percutaneous Revascularization Procedures for Lower Extremity Peripheral Arterial Disease, 7.01.594  Individual | Group
New policy

• Percutaneous revascularization procedures are considered medically necessary for the treatment of chronic symptomatic lower extremity peripheral arterial disease (PAD) with guideline-based criteria, chronic limb-threatening ischemia, and acute limb ischemia
• Percutaneous revascularization procedures are considered not medically necessary for the treatment of asymptomatic lower extremity PAD
• Percutaneous revascularization procedures using lithotripsy is considered investigational for the treatment of lower extremity PAD

New medical policies

No updates this month.

Revised medical policies

No updates this month.

New pharmacy policies
Effective April 1, 2025

Pharmacologic Treatment of Vitiligo, 5.01.641  Individual | Group
New policy

• Opzelura (ruxolitinib) for the topical treatment of nonsegmental vitiligo when criteria are met

Revised pharmacy policies
Effective April 1, 2025

ALK Tyrosine Kinase Inhibitors, 5.01.538  Individual | Group
Drug/medical necessity criteria added/updated

• Ensacove (ensartinib) for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

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

• Limitation on the duration of therapy removed from Izervay (avacincaptad pegol) criteria

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

• Asthma criteria updated:
  • Removed time requirement (previous 12 months) to confirm asthma with an eosinophilic phenotype
  • Language modified from ‘using maximum doses of an inhaled corticosteroid’ to ‘using maximum tolerated doses of an inhaled corticosteroid’

HER2 Inhibitors, 5.01.514  Individual | Group
Title change

• Herceptin (trastuzumab) and Other HER2 Inhibitors to HER2 Inhibitors

Medical necessity criteria added

• Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HR-positive HER2-low or HER2-ultralow breast cancer when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

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

• Asthma criteria for Nucala (mepolizumab), Fasenra (benralizumab), and Cinqair (reslizumab) updated:
  • Removed time requirement (previous 12 months) to confirm asthma with an eosinophilic phenotype
  • Language modified from ‘using maximum doses of an inhaled corticosteroid’ to ‘using maximum tolerated doses of an inhaled corticosteroid’

Immune Checkpoint Inhibitors, 5.01.591  Individual | Group
Drugs/medical necessity criteria added

• Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for treatment as monotherapy, monotherapy maintenance following completion of intravenous Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy, or in combination with other therapy for the treatment of renal cell carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
• Unloxcyt (cosibelimab-ipdl) for the treatment of metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma

Insulin Therapy, 5.01.648  Individual | Group
Drug added

• Merilog (insulin aspart-szjj) added to non-preferred insulins

Drug removed

• Levemir removed from policy as it has been withdrawn from the market

Medical Necessity Criteria for Custom Incentive and Open Formularies, 5.01.647  Individual | Group
Medical necessity criteria updated

• Criteria updated to include an age requirements for ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, pyoderma gangrenosum, and sarcoidosis for all of the following drugs: Abrilada (adalimumab-afzb), adalimumab-aacf (Idacio unbranded), adalimumab-aaty (Yuflyma unbranded), adalimumab-fkjp (Hulio unbranded), Amjevita (adalimumab-atto), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Humira (adalimumab) (Cordavis) [NDCs starting with 83457], Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Yuflyma (adalimumab-aaty), Yusimry (adalimumab-aqvh), adalimumab-adaz (Hyrimoz unbranded), adalimumab-adbm (Cyltezo unbranded), adalimumab-ryvk (Simlandi unbranded), Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), and Humira (adalimumab) (AbbVie) [NDCs starting with 00074]

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

• Generic prucalopride for the treatment of chronic idiopathic constipation when criteria are met
• Gabarone (gabapentin) for the treatment of neuropathic pain and seizures when criteria are met
• Nexiclon XR (clonidine extended-release) for the treatment of hypertension when criteria are met
• Ontralfy (tizanidine oral solution) for the treatment of spasticity when criteria are met
• Generic adapalene-benzoyl peroxide 0.3-2.5% for the treatment of acne when criteria are met

Drugs removed

• Fenortho (fenoprofen), Mobic (meloxicam), Voltaren (diclofenac), and Plixda removed as these medications have been discontinued and are no longer available

Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502  Individual | Group
Medical necessity criteria updated

• Adcetris (brentuximab vedotin) for the treatment of relapsed or refractory large B-cell lymphoma when criteria are met

Pharmacologic Treatment of Atopic Dermatitis, 5.01.628  Individual | Group
Drug/medical necessity criteria added

• Vtama (tapinarof) for the treatment of atopic dermatitis when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

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

• Vyalev (foscarbidopa and foslevodopa) for the treatment of motor fluctuations in individuals with advanced Parkinson’s disease when criteria are met

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Drug/medical necessity criteria added

• Bimzelx (bimekizumab-bkzx) for the treatment of hidradenitis suppurativa when criteria are met

Pharmacotherapy of Multiple Sclerosis, 5.01.565  Individual | Group
Medical necessity criteria updated

• Ponvory (ponesimod) criteria updated to require initial treatments with generic fingolimod and generic dimethyl fumarate, and experienced either an inadequate response or intolerance to both medications

Pharmacotherapy of Type 1 and Type 2 Diabetes Mellitus, 5.01.569  Individual | Group
Title change

• Pharmacotherapy of Type I and Type II Diabetes Mellitus to Pharmacotherapy of Type 1 and Type 2 Diabetes Mellitus

Drugs removed

• Bydureon BCise and Byetta removed from policy as they have been withdrawn from the market

Medical necessity criteria updated

• Ozempic, Rybelsus, Mounjaro, Trulicity, Victoza, brand liraglutide, Soliqua, and Xultophy criteria updated to prohibit use with another GLP-1 or GIP/GLP-1 receptor agonist
• Januvia, Tradjenta, Nesina, alogliptin, Onglyza, Oseni, alogliptin-pioglitazone, sitagliptin, Zituvio, Janumet, Janumet XR, Jentadueto, Jentadueto XR, Kazano, Kombiglyze XR, alogliptin-metformin, sitagliptin-metformin, Zituvimet, and Zituvimet XR criteria updated to prohibit use with another DPP-4 inhibitor
• Glyxambi, Qtern, Trijardy XR, and Steglujan criteria updated to prohibit use with another DPP-4 inhibitor or SGLT2 inhibitor

SGLT2 Inhibitors, 5.01.646  Individual | Group
Medical necessity criteria updated

• Farxiga, Jardiance, Brenzavvy, brand bexagliflozin, brand dapagliflozin, brand dapagliflozin-metformin, Invokana, Steglatro, Synjardy, Synjardy XR, Xigduo XR, brand dapagliflozin-metformin, Invokamet, Invokamet XR, Segluromet, and Inpefa criteria updated to require that use will not be in combination with another SGLT2 inhibitor

Medical necessity criteria added

• Supplemental chronic kidney disease diagnostic criteria added to the Related Information section

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

• Severe asthma language modified from ‘using maximum doses of an inhaled corticosteroid’ to ‘using maximum tolerated doses of an inhaled corticosteroid’

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620  Individual | Group
Drug/medical necessity criteria added

• Pavblu (aflibercept-ayyh) for the treatment of certain ocular disorders when criteria are met

Medical necessity criteria added

• Pavblu added to list of drugs not to be used in combination with Beovu, Byooviz, Cimerli, Eylea, Eylea HD, Lucentis, Macugen, Susvimo, and Vabysmo

Medical necessity criteria updated

• Susvimo (ranibizumab) criteria updated to
  • Require that the individual has previously responded to at least two intravitreal injections of a VEGF inhibitor
  • Include criteria for the treatment of diabetic macular edema when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information

Length of approval criteria added

• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

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

• Moderate to severe persistent asthma language modified from ‘using maximum doses of an inhaled corticosteroid’ to ‘using maximum tolerated doses of an inhaled corticosteroid’

No updates this month.

Effective April 6, 2025

Adjunctive Techniques for Screening and Surveillance of Barrett Esophagus and Esophageal Dysplasia, 7.01.167

• This policy is replaced with Adjunctive Techniques for Screening and Surveillance of Barrett Esophagus and Esophageal Dysplasia, 7.01.596

Added codes
Effective April 6, 2025

Adjunctive Techniques for Screening and Surveillance of Barrett Esophagus and Esophageal Dysplasia, 7.01.596  Individual | Group
Now requires review for investigational.

0108U

Amyloid Antibodies for the Treatment of Alzheimer’s Disease, 5.01.626  Individual | Group
Now requires review for medical necessity and prior authorization.

J0175

Percutaneous Revascularization Procedures for Lower Extremity Peripheral Arterial Disease, 7.01.594  Individual | Group
Now requires review for investigational.

C9764, C9767, C9772-C9775

Now requires review for medical necessity and prior authorization.

37220-37235, 0505T, 0238T

Now requires review for medical necessity.

C7531, C7534, C7535

Effective April 1, 2025

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

A2035, Q4354, Q4355, Q4356, Q4357, Q4358, Q4359, Q4360, Q4361, Q4362, Q4363, Q4364, Q4365, Q4366, Q4367

Bioengineered Skin and Soft Tissue Substitutes, 7.01.113  Individual | Group 
Now requires review for investigational.

A2030, A2031, A2032, A2033, A2034

C3 and C5 Complement Inhibitors, 5.01.571  Individual | Group
Now requires review for medical necessity and prior authorization.

J1299

Carelon Management Genetic Testing
Now requires review for medical necessity and prior authorization.

0532U, 0533U, 0534U, 0536U, 0537U, 0538U, 0539U, 0540U, 0543U, 0544U, 0549U

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

C9301

Cutaneous T-Cell Lymphomas (CTCL): Systemic Therapies, 5.01.532  Individual | Group
Now requires review for medical necessity and prior authorization.

J9161

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

0547U, 0548U 0551U

Now requires review for investigational and prior authorization.

0358U, 0445U, 0459U

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

J9024

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

0531U, 0535U, 0541U, 0546U, 0550U

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

J2351

Microprocessor-Controlled and Powered Prostheses and Orthoses for the Lower Limb, 1.04.503  Individual | Group
Now requires review for investigational.

L5827

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

C9303

Now requires review for medical necessity and prior authorization.

J9054, Q2057

Myoelectric Prosthetic and Orthotic Components for the Upper Limb, 1.04.502  Individual | Group 
Now requires review for investigational.

L6700

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group 
Now requires review for medical necessity and prior authorization.

J9038

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

C9304

Use of Granulocyte Colony-Stimulating Factors (G-CSF), 5.01.551  Individual | Group 
Now requires review for medical necessity and prior authorization.

Q5148

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620  Individual | Group 
Now requires review for medical necessity and prior authorization.

Q5147

Revised codes

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
No longer requires review.

25448

Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers, 1.01.18  Individual | Group
No longer requires review for medical necessity and prior authorization. Now requires review for investigational.

E0656, E0657, E0670

Removed codes
Effective April 1, 2025

Hospital beds and accessories, 1.01.520  Individual | Group
No longer requires review.

E0912

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.

Effective July 3, 2025

Updates to Prior Authorization for Therapy Services

• Prior authorization will be required for physical and occupational therapy services:
  • Applicable to seventh visit onwards
  • The initial six visits do not require review
• These services will continue to be reviewed using InterQual criteria

No updates this month.

No updates this month.

No updates this month.

No updates this month.