Effective September 5, 2025
Medical Necessity Criteria for Pharmacy Edits, 5.01.605 PBC | Premera HMO
Drugs/medical necessity criteria added
- Quzyttir (cetirizine) added to Antihistamines, Injection
- Prialt (ziconotide) added to Chronic Pain Drugs
- Visudyne (verteporfin) added to Photoenhancers, Injection
- Veklury (remdesivir) added to SARS-CoV-2 Inhibitors, Infusion
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 PBC | Premera HMO
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 PBC | Premera HMO
New policy
- Transcatheter radiofrequency ablation or cryoablation to treat atrial fibrillation may be considered medically necessary when criteria are met
- Pulsed field ablation incorporated into all medically necessary statements
Effective July 1, 2025
Pharmacologic Treatment of Psoriasis, 5.01.629 PBC | Premera HMO
Pharmacotherapy of Arthropathies, 5.01.550 PBC | Premera HMO
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563 PBC | Premera HMO
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564 PBC | Premera HMO
Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556 PBC | Premera HMO
Medical necessity criteria added/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 PBC | Premera HMO
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