Medical Policy and Coding Updates

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

Updates to Carelon Medical Benefits Management Clinical Appropriateness Guidelines (formerly AIM Specialty Health).

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

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. Genetic Testing 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

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 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

Effective March 5, 2025

Surgical Treatments for Lymphedema and Lipedema, 7.01.567  Individual | Group
Medical necessity criteria added

• Evidence of cuff phenomenon (sparing of feet if lower extremities are affected, or sparing of hands if upper extremities are affected) is present, body mass index (BMI) less than or equal to 35 kg/m², the requested surgical intervention will be performed by a plastic surgeon
• Staged liposuction procedures may be considered medically necessary when there is a large total volume of aspirate (i.e. 5000 cc) during the initial procedure, and they are completed within a 12-month period

Investigational criteria added

• Liposuction or lipectomy for the treatment of lipedema in the trunk or back is considered investigational
• Retreatment of a previously treated area using the same procedure is considered investigational

New medical policies

No updates this month.

Revised medical policies

No updates this month.

New pharmacy policies
Effective March 1, 2025

Pharmacologic Treatment of Parkinson's Disease, 5.01.651  Individual | Group
New policy

• Parkinson’s disease drugs moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Parkinson's Disease, 5.01.651

Pharmacologic Treatment of Seizures, 5.01.649  Individual | Group
New policy

• Seizures drugs moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Seizures, 5.01.649

Medical necessity criteria updated

• Vimpat (lacosamide) criteria for the treatment of partial-onset seizures updated from 4 years and older to 1 month and older

Drugs removed

• Zonisamide (zonisamide oral suspension) removed as product is not available
• Peganone (ethotoin) removed as the product has been discontinued

Revised pharmacy policies
Effective March 1, 2025

Amyotrophic Lateral Sclerosis (ALS) Medications, 5.01.578  Individual | Group
Medical necessity criteria removed

• Exservan (riluzole) removed from policy as product has been discontinued
• Disease duration requirement (two years or less) removed from Qalsody (tofersen) criteria

Medical necessity criteria added

• Generic edaravone IV added for the treatment of ALS when criteria are met

Investigational criteria added

• Clarified that the medications listed in this policy are subject to the product's Food and Drug Administration (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

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

• Bosulif (bosutinib) criteria updated to specify the individual has had resistance or intolerance to prior therapy with generic imatinib
• Sprycel (dasatinib) and Phyrago (dasatinib) criteria updated to require the individual has resistance or intolerance to prior therapy with generic dasatinib

Medical necessity criteria added

• Danziten (nilotinib) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)
• Generic dasatinib for the treatment of Ph+ CML, and gastrointestinal stromal tumor
• Imkeldi (imatinib oral solution) for the treatment of Ph+ CML in chronic phase, accelerated phase or blast crisis
• Scemblix (asciminib) for the treatment of newly diagnosed Ph+ CML in chronic phase
• Documentation Requirements table added

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

Bruton’s Kinase Inhibitors, 5.01.590  Individual | Group
Medical necessity criteria added

• New indication added to Calquence (acalabrutinib) for the initial treatment of mantle cell lymphoma

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

CGRP Inhibitors for Migraine Prophylaxis, 5.01.584  Individual | Group
Investigational criteria added

• Use of drugs in this policy for the prevention or treatment of hemiplegic migraines and vestibular migraines is considered investigational
• 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

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63  Individual | Group
Medical necessity criteria added

• Aucatzyl (obecabtagene autoleucel) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia

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

Epidermal Growth Factor Receptor (EGFR) Inhibitors, 5.01.603  Individual | Group
Medical necessity criteria updated

• Tagrisso (osimertinib) criteria updated to include treatment of stage III NSCLC
• Erbitux (cetuximab) criteria updated to include treatment of metastatic colorectal cancer in combination with Braftovi (encorafenib) or Krazati (adagrasib)
• Updated Vectibix (panitumumab) coverage criteria to include treatment of certain adults with colorectal cancer in combination with Lumakras (sotorasib).

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

Folate Antimetabolites, 5.01.617  Individual | Group
Medical necessity criteria updated

• Criteria updated per the prescribing information for Axtle (pemetrexed), pemetrexed (Avyxa- unbranded), brand pemetrexed (Accord- unbranded), brand pemetrexed (BluePoint Laboratories- unbranded), brand pemetrexed (Sandoz- unbranded), brand pemetrexed (Teva- unbranded), and brand pemetrexed ditromethamine

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

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

• Kebilidi (eladocagene exuparvovec-tneq) for the treatment of aromatic L-amino acid decarboxylase deficiency

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

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

• Voquezna (vonoprazan) for the treatment of erosive esophagitis and GERD to limit the prescribed quantity to one tablet per day
• Moved from pharmacy benefit drug section to medical benefit drug section
  • Brand cantharidin
  • Ycanth (cantharidin)
  • Nexobrid (anacaulase-bcdb)
• Generic bismuth subcitrate potassium-metronidazole-tetracycline, Omeclamox-Pak, Pylera, Talicia, Voquezna Dual Pak, and Voquezna Triple Pak criteria updated to limit the quantity prescribed to one 14-day treatment course and added a separate quantity limit of two treatment courses every 365 days
• Quantity limit of two bottles per two days added to Suflave

Medical necessity criteria added

• Generic lofexidine for the treatment of acute opioid withdrawal symptoms
• Carbinoxamine extended-release suspension added to Antihistamines, Oral
• Fenortho (fenoprofen) added to Brand Oral NSAIDs

Medical necessity criteria removed

• Moved the seizures drugs from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Seizures, 5.01.649
• Moved Inpefa (sotagliflozin) from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to SGLT2 Inhibitors, 5.01.646
• Parkinson’s disease drugs moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Parkinson's Disease, 5.01.651
• Age requirement removed from Nexobrid (anacaulase-bcdb)
• Helidac removed as the product has been discontinued
• Avar, Dapsone, and Neuac removed from Brand Topical Acne or Rosacea Products as these products are now classified as generic medications
• Moved Nexobrid (anacaulase-bcdb) moved from pharmacy benefit drug section to medical benefit drug section and removed age requirement

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

• Ibrance (palbociclib) criteria updated to include treatment of breast cancer in combination with Itovebi (inavolisib)
• Kisqali (ribociclib) and Kisqali Femara Co-Pack (ribociclib-letrozole) criteria updated to include treatment of stage II or III early breast cancer
• Retevmo (selpercatinib) criteria updated:
  • Indication changed from treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) to adult individuals with locally advanced or metastatic NSCLC with a RET gene fusion
  • Age requirement for treatment of medullary thyroid cancer and advanced or metastatic thyroid cancer changed from 12 years and older to 2 years and older.
  • Age requirement for treatment of solid tumors changed from 18 years and older to 2 years and older
• Voranigo (vorasidenib) criteria updated with prescriber requirement and quantity limit
• Krazati (adagrasib) criteria updated to include treatment of locally advanced or metastatic colorectal cancer
• Lumakras (sotorasib) criteria updated to include treatment of KRAS G12C-mutated metastatic colorectal cancer
• Blincyto (blinatumomab) criteria updated to include:
  • Age requirement of one month and older
  • Clarification that the disease should be CD19-positive and include treatment of Philadelphia chromosome-negative acute lymphoblastic leukemia
• Sarclisa (isatuximab-irfc) criteria updated to include treatment of newly diagnosed multiple myeloma

Drug/medical necessity criteria added

• Xeloda (capecitabine) for the treatment of certain cancers
• Rytelo (Imetelstat) for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia
• Tecelra (afamitresgene autoleucel) for the treatment of unresectable or metastatic synovial sarcoma
• Tepylute (thiotepa) for the treatment of adenocarcinoma of the breast or ovary
• Vyloy (zolbetuximab-clzb) for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma

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 Hemophilia, 5.01.581  Individual | Group
Drug/medical necessity criteria added

• Hympavzi (marstacimab-hncq) for the treatment of hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency)

Re-authorization criteria updated

• Re-authorization duration for Hemlibra (emicizumab-kxwh) updated to a maximum of 12 months

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 Prevention and Treatment of HIV/AIDS, 5.01.588  Individual | Group
Medical necessity criteria removed

• Removed step therapy requirement from HIV PrEP criteria:
  • Apretude (cabotegravir extended-release injectable suspension)
  • Descovy (emtricitabine and tenofovir alafenamide)

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 High Cholesterol, 5.01.558  Individual | Group
Medical necessity criteria added

• Tryngolza (olezarsen) added for the treatment of familial chylomicronemia syndrome

Medical necessity criteria removed

• Lescol (fluvastatin) removed from policy as product has been discontinued.

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

Pharmacotherapy of Cushing’s Disease and Acromegaly, 5.01.548  Individual | Group
Medical necessity criteria added

• Generic long-acting octreotide depot for the treatment of acromegaly

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

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

• Ryoncil (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease

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

• Itovebi (inavolisib) for the treatment of endocrine-resistant PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer

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

SGLT2 Inhibitors, 5.01.646  Individual | Group
Medical necessity criteria removed

• eGFR requirement removed from Farxiga (dapagliflozin) and Jardiance (empagliflozin) chronic heart failure coverage criteria

Medical necessity criteria updated

• Brand dapagliflozin criteria updated to include treatment of heart failure or chronic kidney disease (CKD)
• Inpefa (sotagliflozin) criteria updated to clarify that Inpefa is considered medically necessary for the treatment of heart failure in individuals with type 2 diabetes, CKD and other cardiovascular risk factors

Length of approval criteria added

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

Spravato (esketamine) Nasal Spray, 5.01.609  Individual | Group
Medical necessity criteria removed

• Requirement that an oral antidepressant must be used in conjunction with Spravato removed

Topical Drugs for Actinic Keratosis and Other Dermatologic Conditions, 5.01.623  Individual | Group
Drugs/medical necessity criteria removed

• Aldara (imiquimod 5%) and brand imiquimod 3.75% removed as products have been discontinued

Drug/medical necessity criteria added

• Imiquimod 3.75%, generic added for the treatment of actinic keratosis and external genital and perianal warts

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

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

• Zarxio (filgrastim-sndz) criteria updated to include coverage for individuals acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)

Investigational criteria added/updated

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

Effective March 1, 2025

SARS-CoV-2 Serology (Antibody) Testing, 2.04.518

• Policy archived due to low utilization

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 March 5, 2025

Non-covered Experimental/Investigational Services, 10.01.533  Individual | Group
Now requires review for investigational.

92972

Revised codes

No updates this month.

Removed codes
Effective March 1, 2025

Non-covered Experimental/Investigational Services, 10.01.533  Individual | Group
No longer requires review.

25448

SARS-CoV-2 Serology (Antibody) Testing, 2.04.518  Individual | Group
No longer requires review.

0224U, 86328, 86413, 86769

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