MP/CG Update/Notice - February 2024 Form

P.O. Box 4330 Woodland Hills, CA 91365 Carelon Medical Benefits Management, Inc. is an independent company providing utilization management services on behalf of the health plan. CarelonRx, Inc. is an independent company providing pharmacy benefit management services on behalf of the health plan.

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc. CABC-CM-050266-24 January 2024

February 1, 2024

Dear Provider:

Anthem Blue Cross (Anthem) is pleased to provide you with the following updates. Please refer to the specific policy for coding, language, rationale updates and changes that are not summarized below.

NEW Medical Policy with prior authorization required effective May 1, 2024

• MED.00146 Gene Therapy for Sickle Cell Disease: This document addresses gene therapy for sickle cell disease (SCD) which is a genetic disease involving variations in the human beta-globin gene (HBB) that reduce an individual’s ability to produce functional hemoglobin leading to a shortage of mature red blood cells and a lack of sufficient oxygen circulation. o Outlines Medically Necessary and Investigation and Not Medically Necessary criteria for exagamglogene autotemcel (Casgevy) or lovotibeglogene autotemcel (Lyfgenia)

Updated Medical Policy effective February 1, 2024

• MED.00140 Gene Therapy for Beta Thalassemia: This document addresses gene therapy for beta thalassemia, a genetic disease that involves mutations in the human beta-globin (HBB) gene. o Title updated (previous titled Lentiviral Gene Therapy for Beta Thalassemia and Sickle Cell Disease) o Removed criteria for treatment of Sickle Cell Disease (moved to MED.00146)

Transition to Carelon Medical Benefits Management, Inc. Genetic Testing Guidelines

Effective May 1, 2024, Anthem Blue Cross will transition to the following Carelon Genetic Testing guidelines to perform medical necessity/clinical appropriateness reviews for select genetic tests. Applicable CPT codes lists are included in each guideline listed below.

• Carrier Screening in the Prenatal Setting and Preimplantation Genetic Testing • Cell-free DNA Testing for the Management of Cancer • Chromosomal Microarray Analysis
• Genetic Testing for Inherited Conditions • Hereditary Cancer Testing
• Pharmacogenomic Testing • Polygenic Risk Scores • Prenatal Testing using cell-free DNA • Somatic Tumor Testing
• Whole Exome Sequencing and Whole Genome Sequencing

Prior authorization requirements remain the same. The requested services received on or after May 1, 2024 will be reviewed with the new clinical criteria.

As a reminder, ordering and servicing providers may submit prior authorization requests to Carelon using Carelon’s ProviderPortalSM directly at providerportal.com. Online access is available 24/7 to process orders in real-time and is the fastest and most convenient way to request authorization.

Please contact Carelon via email at MedicalBenefitsManagement.guidelines@Carelon.com for questions related to guidelines. Additionally, you may access and download a copy of the current and upcoming guidelines at https://guidelines.carelonmedicalbenefitsmanagement.com/current-genetic-testing-guidelines.

Beginning in March 2024, you can submit Behavioral Health prior authorizations through Availity.com

You may already be submitting your prior authorizations through the Availity multi-payer Authorization application — taking advantage of the time savings and speed to care through digital authorization submissions. Beginning in March, you can submit both your physical health and behavioral health prior authorizations through one Authorization application on Availity.com.

You can still access the Interactive Care Reviewer (ICR) to review cases that were submitted through that application. You will also continue to use ICR to submit an appeal or authorization for medical specialty Rx.

Using the Availity Authorization application to submit your behavioral health prior authorizations will not be much different from the process you follow today. You may enjoy more intuitive screens or learn sooner if an authorization is required — but the digital submission process is still the very best way to submit your prior authorization and the fastest way to care for our members.

If you are not already using Availity or If you aren’t already familiar with Availity Authorization, training is available.
Go to https://apps.availity.com/availity/Demos/LP_AP_AnthemAuthorizations/index.html#/ to enroll for an upcoming live webcast or access an on-demand recording.

Accessing the Availity for authorization is easy. Ask your organization’s Availity administrator to ensure you have the Authorization role assignment. Without the role assignment, you will not be able to access the Authorization application. Then, log on to [Availity.com] to access the app through the Patient Registration tab by selecting Authorizations and Referrals.

Specialty Pharmacy updates

Prior authorization clinical review of non-oncology use of specialty pharmacy drugs is managed by Anthem’s medical specialty drug review team. Review of specialty pharmacy drugs for oncology use is managed by Carelon Medical Benefits Management, Inc., a separate company.

Important to note: Currently, your patients may be receiving these medications without prior authorization. As of the effective date below, you may be required to request prior authorization review for your patients’ continued use of these medications.

Inclusion of national drug code (NDC) code on your claim will help expedite claim processing of drugs billed with a not otherwise classified (NOC) code.

Access our Clinical Criteria at anthem.com/ca/ms/pharmacyinformation/clinicalcriteria.html to view the complete information for these prior authorization updates.

Prior authorization updates In the May 2023 provider letter, we announced prior authorization for Adstiladrin (CC-0230) will be effective August

2023. For clarification, review of Adstiladrin is managed by Carelon Medical Benefits Management.

      Effective for dates of service on and after May 1, 2024, the following specialty pharmacy codes from current or new Clinical Criteria will be included in our prior authorization review process.

      Clinical Criteria Drug HCPCS or CPT code(s) CC-0252 Adzynma (ADAMTS13, recombinant-krhn) C9399, J3590 CC-0253 Aphexda (motixafortide) J3490, J3590, J9999 CC-0042 Bimzelx (bimekizumab-bkzx) J3490 CC-0032 Daxxify (daxibotulinumtoxinA-lanm) C9160 CC-0248 Elrexfio (elranatamab-bcmm) C9165, J3490, J3590, J9999
      CC-0050 Omvoh (mirikizumab-mrkz) J3590 CC-0018 Pombiliti (cipaglucosidase alfa-atga) J3490, J3590 CC-0249 Talvey (talquetamab-tgvs) C9163, J3490, J3590, J9999
      CC-0066 Tofidence (tocilizumab-bavi) J3490, J3590 CC-0020 Tyruko (natalizumab-sztn) J3490, J3590 CC-0250 Veopoz (pozelimab-bbfg) C9399, J3590

CC-0251 Ycanth (cantharidin) C9164, J3490 CC-0254 Zilbrysq (zilucoplan) J3490 CC-0062 Zymfentra (infliximab-dyyb) J3590

• Oncology use is managed by Carelon Medical Benefits Management. Note: Prior authorization requests for certain medications may require additional documentation to determine medical necessity.

  Step therapy updates Effective for dates of service on and after May 1, 2024, the following specialty pharmacy codes from current Clinical Criteria will be included in our existing specialty pharmacy medical step therapy review process.

  The preferred product in the Tyruko step therapy is generic dimethyl fumarate.

  Clinical Criteria Status Drug HCPCS or CPT code(s) CC-0020 Non-preferred Tyruko (natalizumab-sztn) J3490, J3590

  Courtesy notice Step therapy criteria for vascular endothelial growth factor (VEGF) inhibitors found in Clinical Criteria CC-0072 has expanded the preferred product list to include Eylea HD. Please refer to Clinical Criteria document for details.

  Quality limit updates Effective for dates of service on and after May 1, 2024, the following specialty pharmacy codes from current or new Clinical Criteria will be included in our quantity limit review process.

  Clinical Criteria Drug HCPCS or CPT code(s) CC-0042 Bimzelx (bimekizumab-bkzx) J3490 CC-0032 Daxxify (daxibotulinumtoxinA-lanm) C9160 CC-0050 Omvoh (mirikizumab-mrkz) J3590 CC-0018 Pombiliti (cipaglucosidase alfa-atga) J3490, J3590 CC-0086 Spravato (esketamine) G2082, G2083, S0013 CC-0066 Tofidence (tocilizumab-bavi) J3490, J3590 CC-0020 Tyruko (natalizumab-sztn) J3490, J3590 CC-0250 Veopoz (pozelimab-bbfg) C9399, J3590 CC-0251 Ycanth (cantharidin) C9164, J3490 CC-0254 Zilbrysq (zilucoplan) J3490 CC-0062 Zymfentra (infliximab-dyyb) J3590

  Carelon Medical Benefits Management, Inc. genetic testing updates

  Updates to Carelon Medical Benefits Management programs apply to local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by Carelon Medical Benefits Management. They do not apply to HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, or Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card.

  Effective for dates of service on and after May 1, 2024, the following codes will require prior authorization through Carelon Medical Benefits Management, Inc.

  CPT code Description 0239U Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, including substitutions, insertions, deletions, select rearrangements, and copy number variations 0306U Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis, cell-free DNA, initial (baseline) assessment to determine a patient-specific panel for future comparisons to evaluate for MRD 0307U Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis of a patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD

0326U Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 83 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden 0356U Oncology (oropharyngeal or anal), evaluation of 17 DNA biomarkers using droplet digital PCR (ddPCR), cell-free DNA, algorithm reported as a prognostic risk score for cancer recurrence 0368U Oncology (colorectal cancer), evaluation for mutations of APC, BRAF, CTNNB1, KRAS, NRAS, PIK3CA, SMAD4, and TP53, and methylation markers (MYO1G, KCNQ5, C9ORF50, FLI1, CLIP4, ZNF132 and TWIST1), multiplex quantitative polymerase chain reaction (qPCR), circulating cell-free DNA (cfDNA), plasma, report of risk score for advanced adenoma or colorectal cancer

We thank you for your continued efforts on behalf of our members and your partnership toward improved access to quality health care for Californians.

Sincerely,

John Yao, MD, MPH, MBA, MPP, FACP Chief Medical Officer