Medical Policy and Coding Updates

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
Medical necessity criteria added

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

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Medical necessity criteria added

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

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  Individual | Group
Pharmacologic/biologic agent 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 feature
• 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

Effective February 7, 2025

Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625  Individual | Group
Drug added

• Synarel (nafarelin) to central precocious puberty, endometriosis and gender dysphoria criteria

Medical necessity criteria updated

• Initial gender dysphoria criteria updated to clarify that:
  • Puberty onset at Tanner stage 2 or higher is determined by serum testosterone level, serum estradiol level, serum estrone level, serum luteinizing hormone level, or serum follicle stimulating hormone for individuals assigned female at birth
  • Potential adverse effects have been discussed, including possible effects on fertility, bone mineralization and bone density
  • GnRH agonist is necessary to suppress characteristics of the gender assigned at birth that are not evident by observation or on physical examination in certain individuals aged 23 and older, or after reaching Tanner stage 5, or after irreversible physical/anatomic secondary sexual characteristics are developed
  • Documentation is required demonstrating that cross-sex hormone/gender affirming hormone treatment is not effective when starting a GnRH agonist
• Updated initial gender dysphoria criteria notes to clarify confirmation of Tanner stages due to overlapping values
• Initial authorization duration updated from up to 6 months to up to 12 months
• Re-authorization gender dysphoria criteria updated to clarify that:
  • Documentation of suppression of secondary sex characteristics based on physical examination OR documentation of suppression of characteristics of the gender assigned at birth that are not evident by observation or on physical examination is required
  • Documentation of annual testing of bone age or bone density is required in certain individuals
  • For the first re-authorization request, if the previous coverage was under a non-Company plan, documentation that the initial authorization requirements have also been met is required
• Updated re-authorization gender dysphoria criteria notes to clarify acceptable documentation of suppression of characteristics of the gender assigned at birth

Investigational criteria added

• Use of GnRH analogs that does not meet the age or diagnosis requirements within the Medical Necessity section is considered investigational
• Use of GnRH analogs that meets the age and diagnosis requirements within the Medical Necessity section but does not meet other policy criteria within the Medical Necessity section is considered not medically necessary

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

• CytoGam (cytomegalovirus immune globulin) for the prophylactic treatment of cytomegalovirus (CMV) disease or CMV pneumonitis associated with transplantation in certain individuals

Miscellaneous Oncology Drugs, 5.01.540  Individual | Group
Drugs/medical necessity criteria added

• Brand bendamustine, Belrapzo (bendamustine), Bendeka (bendamustine), and Vivimusta (bendamustine) for the treatment of certain individuals with chronic lymphocytic leukemia or non-Hodgkin lymphoma
• Nipent (pentostatin) for the treatment of certain individuals with hairy cell leukemia
• Oncaspar (pegaspargase) for the treatment of certain individuals with acute lymphoblastic leukemia
• Vyxeos (cyatarabine-daunorubicin) coverage criteria for the treatment of certain individuals with acute myeloid leukemia

New medical policies

No updates this month.

Revised medical policies
Effective February 1, 2025

Hearing Aids (Excludes Implantable Devices), 1.01.528  Individual | Group
Non-covered device added

• Hearing Aid Feature software used with compatible Apple AirPods Pro

Prescription Digital Therapeutics, 13.01.500  Individual | Group
Investigational device added

• DaylightRx added to the list of Food and Drug Administration (FDA) approved prescription digital therapeutics that are considered investigational

New pharmacy policies
Effective February 1, 2025

Gene Therapies for Rare Diseases, 5.01.644  Individual | Group
New policy

• In accordance with Alaska law (HB 226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
• Briumvi, Lemtrada, Ocrevus, Ocrevus Zunovo, Tyruko, and Tysabri moved from Pharmacotherapy of Multiple Sclerosis, 5.01.565 to 5.01.644
• Clarified that the medications listed in this policy are subject to the product’s FDA dosage and administration prescribing information
• Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

Revised pharmacy policies
Effective February 1, 2025

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

• Adult weight-related comorbid condition criteria updated to include asthma, cardiovascular disease, COPD, coronary artery disease, dyslipidemia, hypertension, knee osteoarthritis, metabolic-dysfunction associated steatotic liver disease/non-alcoholic fatty liver disease, obstructive sleep apnea, polycystic ovarian syndrome, and type 2 diabetes mellitus

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

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

• Dupixent (dupilumab) asthma criteria updated eosinophil count from 300 cells/mcL within the last 12 months to 150 cells/mcL within the last 12 months
• Criteria added for new indication, treatment of chronic obstructive pulmonary disease (COPD) certain individuals when criteria are met
• Age requirement updated from 18 years and older to 12 years and older for the treatment of chronic rhinosinusitis with nasal polyps

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 added/updated

• In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
• Receiving treatment for CRS exception added to site-of-service requirements
• Nucala (mepolizumab), Fasenra (benralizumab), and Cinqair (reslizumab) asthma criteria updated eosinophil count from 300 cells/mcL within the last 12 months to 150 cells/mcL within the last 12 months
• Fasenra (benralizumab) criteria updated to include the treatment of certain individuals with eosinophilic granulomatosis with polyangiitis

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

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

• In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
• Imfinzi (durvalumab) for the treatment of adults with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy and Imfinzi is used as a single agent.
• Keytruda (pembrolizumab) for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma as first-line treatment in adults when used in combination with pemetrexed and platinum chemotherapy
• Opdivo (nivolumab) for the treatment of resectable non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements in the neoadjuvant setting, in combination with platinum-doublet chemotherapy, followed by single-agent nivolumab as adjuvant treatment after surgery
• Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy for the first-line treatment of microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer
• Tevimbra (tislelizumab-jsgr) for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1) when used in combination with platinum and fluoropyrimidine-based chemotherapy

Drug/medical necessity criteria added

• Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), which is a SC dosage form of Tecentriq (atezolizumab), to policy for the treatment of NSCLC, SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma

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
Drug/medical necessity criteria added

• Cobenfy (xanomeline and trospium chloride) and Opipza (aripiprazole oral film) added to Antipsychotics, Second Generation
• Arikayce (amikacin liposome) for the treatment of Mycobacterium avium complex lung disease
• Akynzeo (netupitant and palonosetron), Emend (aprepitant), Sancuso (granisetron transdermal system), and Varubi (rolapitant) added to new section titled ‘Cancer Related Antiemetics’
• Zelapar (selegiline) added to Parkinson’s Disease Agents
• TobraDex ST (tobramycin and dexamethasone ophthalmic suspension) added to Brand Ophthalmic Corticosteroids
• Kyzatrex (testosterone capsules) and Undecatrex (testosterone capsules) added to Testosterone Replacement Products

Drug/medical necessity criteria removed

• Gout drugs brand colchicine, Gloperba (colchicine), Mitigare (colchicine), Uloric (febuxostat), and Zyloprim (allopurinol) moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Gout, 5.01.616
• Rezdiffra (resmetirom) moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases, 5.01.615

Drug/medical necessity criteria updated

• Apokyn (apomorphine) criteria updated to require a trial and inadequate response to generic apomorphine first
• Xadago (safinamide) updated to include selegiline as a qualifying prerequisite drug
• Re-authorization criteria for Xdemvy (lotilaner) updated to allow for retreatment of Demodex blepharitis after greater than or equal to 1 year since completing a prior treatment course
• Testosterone Replacement Products updated to limit use to individuals assigned male at birth or individuals assigned female at birth for the treatment of gender dysphoria
• Zemplar (paricalcitol) criteria updated to require a trial and inadequate response to generic paricalcitol first

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

• Livdelzi (seladelpar) for the treatment of primary biliary cholangitis when criteria are met
• Rezdiffra (resmetirom) moved from Medical Necessity Criteria for Pharmacy Edits 5.01.605 to Policy 5.01.615 Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases

Medical necessity criteria updated

• Iqirvo and Ocaliva criteria updated to exclude combination use with Livdelzi

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 Gout, 5.01.616  Individual | Group
Medical necessity criteria added

• Gout drugs brand colchicine, Gloperba (colchicine), Mitigare (colchicine), Uloric (febuxostat), and Zyloprim (allopurinol) moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Gout, 5.01.616

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

• Vyndamax (tafamidis) and Vyndaqel (tafamidis meglumine) criteria updated for the diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), removed New York Heart Association class IV heart failure as exclusion, updated the assessment of cardiac involvement and history of heart failure, added inclusion of a 6MWT requirement and added quantity limits

Medical necessity criteria added

• Attruby (acoramidis) for the treatment of ATTR-CM when criteria are met

Medical necessity criteria removed

• Tegesdi (inotersen) removed as the product was withdrawn from the market by the manufacturer

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 Arthropathies, 5.01.550  Individual | Group
Medical necessity criteria added/updated

• In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
• Receiving treatment for cytokine release syndrome (CRS) exception added to site-of-service requirements
• Age requirements per prescribing information added to all criteria throughout policy

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 Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Medical necessity criteria added/updated

• In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
• Site of service requirements removed from Stelara (ustekinumab) IV and Skyrizi (risankizumab-rzaa) IV
• Receiving treatment for CRS exception added to site-of-service requirements
• Age requirements per prescribing information added to all criteria throughout policy where age criteria are not already explicitly stated

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
Medical necessity criteria added/updated

• In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
• Receiving treatment for CRS exception added to site-of-service requirements
• Age requirements per prescribing information added to all criteria throughout policy where age criteria are not already explicitly stated
• Actemra (tocilizumab) IV, Tofidence (tocilizumab-bavi) IV, and Tyenne (tocilizumab-aazg) IV CRS criteria to indicate that coverage is medically necessary if CRS is treatment-induced (not limited to CAR-T products) and grade 3 or 4
• Kineret (anakinra) criteria updated to include treatment of CRS in certain individuals
• Niktimvo (axatilimab-csfr) added for the treatment of chronic graft versus host disease after failure of at least two prior lines of systemic therapy when criteria are met
• Fabhalta (iptacopan) added to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgaN) at risk of rapid disease progression when criteria are met
• Clarified the Filspari (sparsentan) is for slowing kidney function decline in adults with primary IgAN who are at risk for disease progression
• Tarpeyo (budesonide) urine protein-to-creatinine ratio updated from ≥1.5 g/g to ≥0.8 g/g or proteinuria ≥1 g/day

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 Multiple Sclerosis, 5.01.565  Individual | Group
Drug removed

• Extavia (interferon-beta 1b) removed throughout policy as it has been withdrawn from the market

Medical necessity criteria added/updated

• Prescriber requirements added to all products throughout policy
• Age requirements per prescribing information added to all criteria throughout policy where age criteria are not already explicitly stated

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 Type I and Type II Diabetes Mellitus, 5.01.569  Individual | Group
Medical necessity criteria updated

• Removed Bydureon as product has been discontinued (Bydureon BCise is still available)
• Sitagliptin added as a non-preferred Dipeptidyl Peptidase IV (DPP-4) Inhibitors
• Sitagliptin-metformin and Zituvimet XR (sitagliptin-metformin extended-release) added as non-preferred DPP-4 and biguanide combinations

Length of approval criteria added

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

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 March 5, 2025

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

92972

Effective February 7, 2025

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

J9034, J9036, J9056, J9153, J9266, J9268

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  Individual | Group
Now requires review for medical necessity and prior authorization.

J0850, J7351, 90291

Revised codes

No updates this month.

Removed codes
Effective February 1, 2025

Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, 8.01.63  Individual | Group
Chimeric Antigen Receptor Therapy for Multiple Myeloma, 8.01.66  Individual | Group
No longer requires review.

38225, 38226, 38227

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