Medical Policy and Coding Updates October 2024

  • Updates for both non-individual and individual plans

  • Effective January 3, 2025

    Advanced Therapies for Pharmacological Treatment of Pulmonary Arterial Hypertension, 5.01.522  PBC | Premera HMO
    Medical necessity criteria added
    Remodulin (reprostinil injection; for SC or IV infusion)

    • Added coverage criteria for treat pulmonary arterial hypertension in individuals classified as World Health Organization Group 1:
      • Must have tried and had an inadequate response or intolerance to generic trepostinil injection (SC or IV infusion)

    Alpha1-Proteinase Inhibitor, 5.01.624  PBC | Premera HMO
    Drug added
    Medical necessity criteria added
    Glassia (alpha1-proteinase inhibitor [human]) IV

    • Moved from first-line to second-line for treatment of emphysema due to severe hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency) in individuals aged 18 years and older:
      • Must have mutation in the SERPINA1 gene documented by genetic testing
      • Must have serum alpha1-antitrypsin is < 11 micromole/L (approximately 
      • 57 mg/dL by nephelometry)
      • Must have forced expiratory volume in one second (FEV1) ranging from 30-65% of predicted
      • Must be receiving treatment for emphysema with a long acting inhaled bronchodilator and/or corticosteroid
      • Must be a non-smoker or actively enrolled in smoking cessation program
      • Must have had an inadequate response or intolerance to Aralast NP (alpha1-proteinase inhibitor (PI) [human]), Prolastin C (alpha1-PI [human]), or Zemaira (alpha1-PI [human])
      • Must be prescribed by or in consultation with a pulmonologist or geneticist

    Dupixent (dupilumab), 5.01.575  PBC | Premera HMO
    Medical necessity criteria updated
    Moderate to severe asthma

    • Updated criterion to remove “oral corticosteroid dependent asthma” and replaced with additional requirements:
      • Must have had two or more asthma exacerbations in the previous 12 month requiring oral corticosteroids
      OR
      • Must have had one or more asthma exacerbations within the previous 12 months requiring hospitalization, ER, or urgent care visit
      OR
      • Must have forced expiratory volume in 1 second of less than 80% predicted
    • Updated criterion on blood eosinophil count from greater than 150 cells/mcL to greater than 300 cells/mcL

    Herceptin (trastuzumab) and Other HER2 Inhibitors, 5.01.514  PBC | Premera HMO
    Medical necessity criteria updated
    Kanjinti (trastuzumab-anns)
    Trazimera (trastuzumab-qyyp)

    • Moved to first-line and Herceptin (trastuzumab) and Ogivri (trastuzumab-dkst) moved to second-line for treatment of the following conditions:
      • HER2-positive breast cancer, adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease
      • Metastatic gastric cancer or gastroesophageal junction adenocarcinoma

    Herceptin Hylecta

    • Added criterion for treatment of HER2-positive breast cancer, adjuvant therapy, neoadjuvant therapy, and treatment of metastatic disease requiring an inadequate response or intolerance to Kanjinti or Trazimera

    Kanjinti (trastuzumab-anns)
    Trazimera (trastuzumab-qyyp)

    • Moved to first-line and Herceptin (trastuzumab) and Ogivri (trastuzumab-dkst) moved to second-line for treatment of the following conditions:
      • Metastatic gastric cancer or gastroesophageal junction adenocarcinoma
      • Must have had an inadequate response or intolerance to Kanjinti or Trazimera

    IL-5 Inhibitors, 5.01.559  PBC | Premera HMO
    Medical necessity criteria updated
    Nucala (mepolizumab) SC

    • Added additional coverage criteria for labeled-indication of add-on maintenance treatment for severe asthma with an eosinophilic phenotype, in individuals aged 6 years and older:
      • Must use maximum doses of an inhaled corticosteroid
      • Must use an inhaled long-acting beta-agonist
      • Must have one of the following:
        • Two or more asthma exacerbations in the previous 12 month requiring oral corticosteroids
        OR
        • One or more asthma exacerbations within the previous 12 months requiring hospitalization, ER, or urgent care visit
        OR
        • Forced expiratory volume in 1 second of less than 80% predicted
      • Criterion on blood eosinophil count changed from greater than 150 to greater than 300 cells/mcL
      • Must be prescribed by or in consultation with an allergist/immunologist, or pulmonologist
    • Added additional coverage criteria for treatment of eosinophilic granulomatosis with polyangiitis in individuals aged 18 years and older:
      • Must be prescribed by or in consultation with an allergist/immunologist, or pulmonologist

    Medical necessity criteria updated
    Fasenra (benralizumab) SC

    • Added additional coverage criteria for treatment of severe asthma in individuals with an eosinophilic phenotype, who are aged 6 years and older:
      • Must use maximum doses of an inhaled corticosteroid
      • Must use an inhaled long-acting beta-agonist
      • Must have one of the following:
        • Two or more asthma exacerbations in the previous 12 month requiring oral corticosteroids
        OR
        • One or more asthma exacerbations within the previous 12 months requiring hospitalization, ER, or urgent care visit
        OR
        • Forced expiratory volume in 1 second of less than 80% predicted
      • Criterion on blood eosinophil count changed from greater than 150 to greater than 300 cells/mcL
      • Must be prescribed by or in consultation with an allergist/immunologist, or pulmonologist

    Medical necessity criteria updated
    Cinqair (reslizumab) IV

    • Added additional coverage criteria for the labeled indication of add-on maintenance treatment of severe asthma in individuals with an eosinophilic phenotype, who are aged 18 years and older:
      • Must use maximum doses of an inhaled corticosteroid
      • Must use an inhaled long-acting beta-agonist
        • Must have one of the following:
          • Two or more asthma exacerbations in the previous 12 month requiring oral corticosteroids
          OR
          • One or more asthma exacerbations within the previous 12 months requiring hospitalization, ER, or urgent care visit
          OR
          • Forced expiratory volume in 1 second of less than 80% predicted
      • Criterion on blood eosinophil count changed from greater than 150 to greater than 300 cells/mcL
      • Must be prescribed by or in consultation with an allergist/immunologist, or pulmonologist

    Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502  PBC | Premera HMO
    Medical necessity criteria updated
    Ruxience (rituximab-pvvr)

    • Moved to first-line and Rituxan (rituximab) moved to second-line for treatment of the following conditions:
      • Non-Hodgkin’s lymphoma
      • Chronic lymphocytic leukemia
      • Off-label indications

    Rituxan Hycela

    • Added criteria for treatment of the following conditions:
      • Follicular lymphoma
      • Diffuse large B-cell lymphoma
      • Chronic lymphocytic leukemia
      • Off-label indications
      AND
      • Must have had an inadequate response or intolerance to Ruxience or Truxima

    Drug added
    Investigational criteria added
    Rituxan Hycela (rituximab and hyaluronidase human)

    • Added to existing criteria for investigational indications:
      • Treatment of lymphoid B-cell malignancies that do not express CD20 antigen (off-label)
      • For indications not listed in this medical policy

    Pharmacologic Treatment in Assisted Reproduction, 5.01.610  PBC | Premera HMO
    Drug added
    Medical necessity criteria added
    Ganirelix SC

    • Added coverage criteria for use in assisted reproduction when the individual has had an inadequate response or intolerance to all the following:
      • Generic cetrorelix or Cetrotide (cetrorelix)
      AND
      • Generic ganirelix or Fyremadel (ganirelix)

    Drug added
    Medical necessity criteria added
    Generic ganirelix SC
    Fryremadel (ganirelix) SC

    • Added coverage criteria for use in assisted reproduction when the individual has had an inadequate response or intolerance to generic cetrorelix or brand Cetrotide (cetrorelix)

    Pharmacological Treatment of Multiple Sclerosis, 5.01.565  PBC | Premera HMO
    NOTE: The following changes ONLY apply to Metallic Plans (INDIVIDUAL, SMALL GROUP and ISHIP Student Insurance members).

    Policy reformatted

    • Added Policy section with navigation to address plan variances:
      • Section 2: Individual/Small Group/Student Insurance ISHIP Metallic Formulary Plans (Rx Plan M1, M2, and M4)

    Drugs added
    Site of service criteria updated

    • Added site of service criteria to apply to Ocrevus (ocrelizumab) and Tysabri (natalizumab)

    Drug added
    Medical necessity criteria added
    Lemtrada (alemtuzumab)

    • Added coverage criteria for treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease, in individuals aged 17 years and older:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have had an inadequate response to two or more disease modifying drugs indicated for the treatment of MS (any two of the following: B-interferon(s), dimethyl fumarate, diroximel fumarate, fingolimod, glatiramer, monomethyl fumarate, natalizumab, ocrelizumab, ofatumumab, ozanimod, ponesimod, siponimod or teriflunomide)
      • Must be prescribed by or in consultation with a neurologist or physician specializing in MS

    Drugs added
    Medical necessity criteria added

    Avonex (interferon-β 1a)
    Betaseron (interferon-β 1b)
    Plegridy (interferon-β 1a)
    Rebif (interferon-β 1a)

    • Added coverage criteria for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have had a documented inadequate response or intolerance to one of the following: generic glatiramer, Glatopa (glatiramer), generic dimethyl fumarate, generic fingolimod, or generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS

    Medical necessity criteria added
    Extavia (interferon-β 1b)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have had a documented inadequate response or intolerance to generic glatiramer or Glatopa (glatiramer)
      • Must have had a documented inadequate response or intolerance to generic dimethyl fumarate
      • Must be prescribed by or in consultation with a neurologist or physician specializing in MS

    Drugs added
    Medical necessity criteria added

    Glatiramer
    Glatopa (glatiramer)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used be concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS

    Drug added
    Medical necessity criteria added
    Copaxone (glatiramer)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have had a documented inadequate response or intolerance to generic glatiramer or Glatopa (glatiramer) of the same strength
      • Must have had a documented inadequate response or intolerance to generic dimethyl fumarate
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS

    Drug added
    Medical necessity criteria added

    Aubagio (teriflunomide)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must have had a documented inadequate response or intolerance to all of the following:
        • Generic teriflunomide
        • Generic glatiramer or Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod
      • Must not be used concurrently with other MS  disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS

    Drug added
    Medical necessity criteria added
    Generic teriflunomide

    • Added coverage criteria for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individual with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS

    Drug added
    Medical necessity criteria added
    Bafiertam (monomethyl fumarate)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have had a documented inadequate response or intolerance to one of the following:
        • Generic glatiramer
        • Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod, or
        • Generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 380 mg per day (190 mg twice a day)

    Drug added
    Medical necessity criteria added
    Generic dimethyl fumarate

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 480 mg per day (240 mg twice a day)

    Drug added
    Medical necessity criteria added
    Tecfidera (dimethyl fumarate)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must have tried generic dimethyl fumarate for 3 months and had an inadequate response or intolerance
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 480 mg per day (240 mg twice a day)

    Drug added
    Medical necessity criteria added
    Vumerity (diroximel fumarate)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must have a documented inadequate response or intolerance to one of the following:
        • Generic glatiramer
        • Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod, or
        • Generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 924 mg per day (462 mg twice a day)

    Drug added
    Medical necessity criteria added
    Generic fingolimod

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals aged 10 years and older:
      • Must have an expanded disability status score of less than 6
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 0.5 mg per day

    Drugs added
    Medical necessity criteria added

    Gilenya (fingolimod)
    Tascenso ODT (fingolimod)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must have tried and had a documented inadequate response or intolerance to all of the following:
        • Generic fingolimod
        • Generic dimethyl fumarate
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 0.5 mg per day

    Drugs added
    Medical necessity criteria added

    Tyruko (natalizumab-sztn)
    Tysabri (natalizumab)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals aged 18 years and older:
      • Must have an expanded disability status score of less than 6
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 0.5 mg per day

    Drug added
    Medical necessity criteria added
    Briumvi (ublituximab-xiiy)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals aged 18 years and older:
      • Must have an expanded disability status score of less than 6
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 0.5 mg per day

    Drug added
    Medical necessity criteria added
    Kesimpta (ofatumumab)

    • Added coverage criteria treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals aged 18 years and older:
      • Must have an expanded disability status score of less than 6
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have tried and had a documented inadequate response or intolerance to all of the following:
        • Generic glatiramer
        • Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod, or
        • Generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS

    Drug added
    Medical necessity criteria added
    Ocrevus (ocrelizumab) IV

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals aged 18 years and older:
      • Must have an expanded disability status score of less than 6
      • Must not be used concurrently with other MS disease modifying drugs
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
    • Added coverage criteria for treatment of primary progressive multiple sclerosis in individuals with an expanded disability status score of less than 7:
      • Must not be used concurrently with other MS disease modifying drugs

    Drug added
    Medical necessity criteria added
    Mavenclad (cladribine) oral

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have tried and had a documented inadequate response or intolerance to two or more disease modifying drugs indicated to treat MS and must include any one of the following:
        • B-interferon(s)
        • Dimethyl fumarate
        • Diroximel fumarate
        • Fingolimod
        • Glatiramer
        • Monomethyl fumarate
        • Natalizumab
        • Ocrelizumab
        • Ofatumumab
        • Ozanimod
        • Ponesimod
        • Piponimod
        • Teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to two courses of treatment

    Drug added
    Medical necessity criteria added
    Mayzent (siponimod) oral

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 7:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have documented test confirming the individual does NOT have CYP2C9*3/*3 genotype
      • Must have tried and had a documented inadequate response or intolerance to two or more disease modifying drugs indicated to treat MS and must include any one of the following:
        • Generic glatiramer
        • Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod, or
        • Generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 2 mg per day

    Drug added
    Medical necessity criteria added
    Ponvory (ponesimod)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have tried and had a documented inadequate response or intolerance to two or more disease modifying drugs indicated to treat MS and must include any one of the following:
        • Generic glatiramer
        • Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod, or
        • Generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 20 mg per day

    Drug added
    Medical necessity criteria added
    Zeposia (ozanimod)

    • Added coverage criteria for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in individuals with an expanded disability status score of less than 6:
      • Must not be used concurrently with other MS disease modifying drugs
      • Must have tried and had a documented inadequate response or intolerance to two or more disease modifying drugs indicated to treat MS and must include any one of the following:
        • Generic glatiramer
        • Glatopa (glatiramer)
        • Generic dimethyl fumarate
        • Generic fingolimod, or
        • Generic teriflunomide
      • Must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS
      • Dosing is limited to 0.92 mg per day

    Pharmacologic Treatment of Psoriasis, 5.01.629  PBC | Premera HMO
    Medical necessity criteria added
    Plaque psoriasis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]) for in individuals aged 18 years and older:
      • Must have had a diagnosis of chronic plaque psoriasis affecting at least 10% of their body surface area
      • Must have had an inadequate response or intolerance to at least one approved systematic therapy
      • Must have had an inadequate response or intolerance to two of the following:
        • Enbrel (etanerecept)
        • Cyltezo (adalimumab-adbm) or adalimumab-adbm (Cytelzo unbranded) or Adalimumab-adaz (Hyrimoz unbranded) or Simlandi (adalimumab-ryvk) or adalimumab-ryvk (Simlandi unbranded)
        • Otezla (apremilast)
        • Sotyktu (deucravacitinib)
        • Stelara (ustekinumab) SC
        • Taltz (ixekizumab)
        • Tremfya (guselkumab)
        • Skyrizi (risankisumab-rzaa) SC
      • Must be prescribed by or in consultation with a dermatologist

    Medical necessity criteria updated
    Plaque psoriasis

    • Inflectra (infliximab-dyyb) moved to a first-line TNF-α antagonist treatment option for moderate to severe plaque psoriasis
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option for severe plaque psoriasis with existing criteria for Renflixis (infliximab-abda)
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drug removed 
    Plaque psoriasis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Pharmacotherapy of Arthropathies, 5.01.550  PBC | Premera HMO
    Medical necessity criteria updated
    Ankylosing spondylitis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must be prescribed by or in consultation with a rheumatologist
      • Must have had an inadequate response or intolerance to one of the following:
        • Enbrel (etanercept)
        • Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), adalimumab-adaz (Hyrimoz unbranded),adalimumab-adbm (Cytelzo unbranded), or adalimumab-ryvk (Simlandi unbranded)
        • Taltz (ixekizumab)
    • Inflectra (infliximab-dyyb) moved to a first-line TNF-α antagonist treatment option
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drug removed
    Ankylosing spondylitis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Polyarticular, juvenile idiopathic arthritis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must have had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine
        OR
        • Must be starting concurrently with leflunomide, methotrexate, or sulfasalazine
        AND
        • Must have had an inadequate response or intolerance to one of the following:
          • Enbrel (etanercept)
          • Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), adalimumab-adaz (Hyrimoz unbranded),adalimumab-adbm (Cytelzo unbranded), or adalimumab-ryvk (Simlandi unbranded)
          • Taltz (ixekizumab)
      • Must be prescribed by or in consultation with a rheumatologist

    Drug removed
    Polyarticular, juvenile idiopathic arthritis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Rheumatoid arthritis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must have had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine
      • Must have had an inadequate response or intolerance to one of the following:
        • Enbrel (etanercept)
        • Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), adalimumab-adaz (Hyrimoz unbranded),adalimumab-adbm (Cytelzo unbranded), or adalimumab-ryvk (Simlandi unbranded)
        • Taltz (ixekizumab)
      • Must be prescribed by or in consultation with a rheumatologist

    Drug removed
    Rheumatoid arthritis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options

    Medical necessity criteria updated
    Severe rheumatoid arthritis

    • Inflectra (infliximab-dyyb) moved to a first-line TNF-α antagonist treatment option
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drug removed
    Severe rheumatoid arthritis

    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Psoriatic arthritis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must have had an inadequate response or intolerance to one of the following:
        • Enbrel (etanercept)
        • Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), adalimumab-adaz (Hyrimoz unbranded),adalimumab-adbm (Cytelzo unbranded), or adalimumab-ryvk (Simlandi unbranded)
        • Otezla (apremilast)
        • Skyrizi (risankizumab-rzaa) SC
        • Stelara (uteskinumab) SC
        • Taltz (ixekizumab)
        • Temfya (guselkumab)
      • Must be prescribed by or in consultation with a rheumatologist

    Medical necessity criteria updated
    Active psoriatic arthritis

    • Inflectra (infliximab-dyyb) moved to first-line TNF-α antagonist treatment option
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option:
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drug removed
    Active psoriatic arthritis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
    Medical necessity criteria added
    Crohn’s disease

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must have tried or is currently taking a corticosteroid medication (e.g., methylpredinisone, prednisone, prednisolone, dexamethasone, bedesonide, etc.)
        OR
      • Must have tried one other agent (e.g., azathioprine, 6-mercaptopurine, methotrexate, mesalamine extended-release [Pentasa formulation], etc.)
        OR
      • Must have enterocutaneous (perianal or abdominal) or rectovaginal fistulas)
        OR
      • Must have had ileocolonic resection
        AND
      • Must had an inadequate response or intolerance to one of the following:
        • Enbrel (etanercept)
        • Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), adalimumab-adaz (Hyrimoz unbranded),adalimumab-adbm (Cytelzo unbranded), or adalimumab-ryvk (Simlandi unbranded)
        • Skyrizi (risankizumab-rzaa) SC on body injector
        • Stelara (uteskinumab) SC
        • Zymfentra (infliximab-dyyb)
      • Must be prescribed by or in consultation with a gastroenterologist

    Medical necessity criteria updated
    Crohn’s disease

    • Inflectra (infliximab-dyyb) moved to first-line TNF-α antagonist treatment option
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option  with existing criteria for Renflixis (infliximab-abda)
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drugs removed
    Crohn’s disease

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Ulcerative colitis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must had an inadequate response or intolerance to one of the following:
        • Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk), adalimumab-adaz (Hyrimoz unbranded), adalimumab-adbm (Cytelzo unbranded), or adalimumab-ryvk (Simlandi unbranded)
        • Skyrizi (risankizumab-rzaa) SC on body injector
        • Stelara (uteskinumab) SC
        • Zymfentra (infliximab-dyyb)
      • Must be prescribed by or in consultation with a gastroenterologist

    Medical necessity criteria updated
    Ulcerative colitis

    • Inflectra (infliximab-dyyb) moved to a first-line TNF-α antagonist treatment option for ulcerative colitis
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option for ulcerative colitis with existing criteria for Renflixis (infliximab-abda)
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drugs removed
    Ulcerative colitis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Pharmacotherapy of Miscellaneous Autoimmune Disorders, 5.01.564  PBC | Premera HMO
    Medical necessity criteria added
    Hidradenitis suppurativa

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]) for treatment in individuals aged 12 years and older:
      • Must had an inadequate response or intolerance to one of the following:
        • Cyltezo (adalimumab-adbm) or adalimumab-adbm (Cytelzo unbranded)
        • Adalimumab-adaz (Hyrimoz unbranded)
        • Simlandi (adalimumab-ryvk) or adalimumab-ryvk (Simlandi unbranded)
      • Must be prescribed by or in consultation with a dermatologist

    Drug removed
    Hidradenitis suppurativa

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Pyoderma gangrenosum

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must have had an inadequate response to one standard non-biologic therapy
      • Must have had an inadequate response or intolerance to one of the following:
        • Cyltezo (adalimumab-adbm) or adalimumab-adbm (Cytelzo unbranded)
        • Adalimumab-adaz (Hyrimoz unbranded)
        • Simlandi (adalimumab-ryvk) or adalimumab-ryvk (Simlandi unbranded)
      • Must be prescribed by or in consultation with a dermatologist

    Medical necessity criteria updated
    Pyoderma gangrenosum

    • Inflectra (infliximab-dyyb) moved to a first-line TNF-α antagonist treatment option for pyoderma gangrenosum
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option with existing criteria for Renflixis (infliximab-abda)
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drug removed
    Pyoderma gangrenosum

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Uveitis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]) for treatment of  non-infectious intermediate or posterior uveitis and panuveitis in individuals aged 2 years and older:
      • Must have had an inadequate response to periocular, intraocular, or systemic corticosteroids OR immunosuppressives
      • Must have had an inadequate response or intolerance to one of the following:
        • Cyltezo (adalimumab-adbm) or adalimumab-adbm (Cytelzo unbranded)
        • Adalimumab-adaz (Hyrimoz unbranded)
        • Simlandi (adalimumab-ryvk) or adalimumab-ryvk (Simlandi unbranded)
      • Must be prescribed by or in consultation with an ophthalmologist

    Drug removed
    Uveitis

    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from first-line TNF-α antagonist treatment options

    Medical necessity criteria added
    Myasthenia gravis

    • Added additional criterion for Rystiggo (rozanolixizumab-noli) for treatment of AChR antibody positive myasthenia gravis:
      • Must have had an inadequate response or intolerance to at least one of the following:
        • Soliris (eculizumab)
        • Ultomiris (Ravulizumab-cwvz)
        • Vyvgart (efgartigimod alfa-fcab)
        • Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

    Medical necessity criteria added
    Sarcoidosis

    • Added coverage criteria for Humira (adalimumab) (AbbaVie [NDC starting with 00074]):
      • Must have had an inadequate response or intolerance to one corticosteroid AND one immunosuppressive medication
        • Must have had an inadequate response or intolerance to one of the following:
          • Cyltezo (adalimumab-adbm) or adalimumab-adbm (Cytelzo unbranded)
          • Adalimumab-adaz (Hyrimoz unbranded)
          • Simlandi (adalimumab-ryvk) or adalimumab-ryvk (Simlandi unbranded)
      • Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist

    Medical necessity criteria updated
    Sarcoidosis

    • Inflectra (infliximab-dyyb) moved to first-line TNF-α antagonist treatment option
    • Avsola (infliximab-axxq) IV added as a second-line TNF-α antagonist treatment option with existing criteria for Renflixis (infliximab-abda):
      • Must had an inadequate response or intolerance to one of the following:
        • Inflectra (infliximab-dyyb)
        • Infliximab (Janssen – unbranded)
        • Remicade (infliximab)

    Drug removed
    Sarcoidosis

    • Hyrimoz (adalimumab-adaz) (Sandoz) [NDCs starting with 61314] removed from first-line TNF-α antagonist treatment options
    • Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457] removed from second-line TNF-α antagonist treatment options for treatment of sarcoidosis

    Rituxan (rituximab): Non-oncologic and Miscellaneous, 5.01.556  PBC | Premera HMO
    Medical necessity criteria updated
    Ruxience (rituximab-pvvr)

    • Moved to a first-line product and Rituxan (rituximab) and Rituxan Hycela (rituximab and hyaluronidase human) to second-line products for treatment of all indications listed within the policy

    Medical necessity criteria updated
    Hyrimoz (Sandoz) (adalimumab-adaz) [NDCs starting with 61314]

    • Updated from a first-line product to a second-line product

    Medical necessity criteria updated
    Riabni (rituximab-arrx), Rituxan, and Rituxan Hycel]

    • Must have had an adequate response or intolerance to Ruxience or Truxima

    Shoulder Arthroplasty, 7.01.590  PBC | Premera HMO
    New policy
    Medical necessity criteria added
    Total shoulder arthroplasty

    • Added coverage criteria for treatment of joint disease:
      • Must have documented diagnosis of joint disease
      • Must need treatment due to either of the following and lasting 3 months or more: disabling pain OR functional disability that impacts carrying out activities of daily living
      • Must have presence of degenerative joint disease demonstrated through radiographic or imaging done within the past 12 months
      • Must have tried and failed 3 or more months of conservative treatment
      • Must have tried and failed twelve or more weeks of physical measures of treatment
    • Added coverage for:
      • Proximal humorous fracture malunion or non-union
      • Reconstruction after tumor resection of the glenohumeral joint or surrounding tissue
      • Failed hemi-arthroplasty
      • Post-traumatic injury

    Reverse total shoulder arthroplasty

    • Added coverage criteria for when there is an intact deltoid muscle, at least 90 degrees of passive shoulder range of motion, adequate bone stock to support an implant and any of the following:
      • Shoulder fracture that cannot be repaired or reconstructed any other way
      • Reconstruction post tumor resection
      • Failed hemi-arthroplasty
      • Failed total shoulder arthroplasty with non-repairable rotator cuff tear
        OR
      • Presence of advanced joint disease confirmed by radiographic imaging or arthroscopic findings performed within the past 12 months with at least one of the following:
        • Glenohumeral osteoarthritis with irreparable rotator cuff tear
        • Psuedo paralysis from an irreparable rotator cuff tear
        • Massive rotator cuff tear
        • Avascular necrosis or osteonecrosis of the humeral head not involving the glenoid
        AND
      • Must need treatment due to either of the following and lasting 3 months or more: disabling pain OR functional disability that impacts carrying out activities of daily living
      • Must have presence of degenerative joint disease demonstrated through radiographic or imaging done within the past 12 months
      • Must have tried and failed 3 or more months of conservative treatment
      • Must have tried and failed twelve or more weeks of physical measures of treatment

    Shoulder hemiarthroplasty

    • Added coverage criteria for:
      • Proximal humerus fracture that cannot be corrected by internal fixation
      • Tumor impacting the glenohumeral joint or surrounding soft tissue
        OR
      • Presence of advanced joint disease confirmed by radiographic imaging or arthroscopic findings performed within the past 12 months with at least one of the following
        • Glenohumeral osteoarthritis with irreparable rotator cuss tear
        • Glenoid bone stock is not sufficient to support a prosthesis
        • Osteonecrosis of the humeral head without glenoid involvement
        • Evidence of radiographic or imaging evidence of degenerative joint disease performed within the past 12 months
        AND
      • Must need treatment due to either of the following and lasting 3 months or more: disabling pain OR functional disability that impacts carrying out activities of daily living
      • Must have tried and failed 3 or more months of conservative treatment
      • Must have tried and failed twelve or more weeks of physical measures of treatment

    Revision/replacement shoulder arthroplasty

    • Added coverage criteria for:
      • Aseptic loosening of one or more prosthetic components confirmed by imaging
      • Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction
      • Component instability
      • Displaced periprosthetic fracture
      • Fracture, mechanical failure, or recall of a prosthetic component
      • Migration of the humeral head
      • Periprosthetic infection
      • Recurrent prosthetic dislocation
      • Persistent shoulder pain of unknown etiology unresponsive to non-operative conservative care for 6 months

    Total shoulder arthroplasty
    Reverse total shoulder arthroplasty
    Hemi-arthroplasty

    • Added non-coverage criteria for:
      • When policy criteria are not met
      • Active infection of the joint or active systemic bacteremia
      • Active skin infection or open wound within the planned surgical site
      • Allergy to components of the implant (e.g., cobalt, chromium, stainless steel, titanium, etc.)
      • Deltoid deficiency (e.g., axillary nerve palsy)
      • Inadequate bone stock to support implantation of prosthesis
      • Neuropathic (Charcot) arthropathy of the shoulder
      • Paralytic disorder of the shoulder (e.g., flail shoulder due to irreversible brachial plexus palsy, spinal cord injury)
      • Rapidly progressive neurological disease

    Thymic Stromal Lymphopoietin (TSLP) Inhibitors, 5.01.627  PBC | Premera HMO
    Medical necessity criteria updated
    Tezspire (tezepelumab-ekko)

    • Added additional coverage criteria for add-on maintenance treatment of severe asthma in individuals aged 12 years and older:
      • Must have had one of the following:
        • Two or more asthma exacerbations in the previous 12 months requiring oral corticosteroids
          OR
        • One or more asthma exacerbations within the previous 12 months requiring hospitalization, ER, or urgent care visit
          OR
        • Forced expiratory volume in 1 second of less than 80% predicted
      • Must be prescribed by or in consultation with an allergist/immunologist, or pulmonologist

    Use of Vascular Endothelial Growth Factor Receptor (VEGF) Inhibitors and Other Angiogenesis Inhibitors in Oncology Treatment, 5.01.517  PBC | Premera HMO
    Medical necessity criteria updated
    Mvasi (bevacizumab-awwb)

    • Moved to a first-line agent and Avastin (bevacizumab) moved to second-line for:
      • Use no earlier than 28 days following a major surgery and until surgical wound is fully healed
      • Treatment of metastatic colorectal cancer when used as combination therapy
      • Unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer when used as combination therapy
      • Metastatic renal cell carcinoma when used as combination therapy
      • Persistent, recurrent, or metastatic cervical cancer when used as combination therapy
      • Epithelial ovarian, fallopian tube, or primary peritoneal cancel when used as combination therapy
      • Unresectable or metastatic hepatocellular carcinoma when used as combination therapy

    Medical necessity criteria updated
    Alymsys (bevacizumab-maly)
    Avastin (bevacizumab)
    Avzivi (bevacizumab-tnjn)
    Vegzelma (bevacizumab-adcd)

    • Must have had an inadequate response or intolerance to Mvasi (bevacizumab-awwb) or Zirabev (bevacizumab-bvzr)

    Xolair (omalizumab), 5.01.513  PBC | Premera HMO
    Medical necessity criteria updated

    • Removed requirement for asthma to be a current non-smoker or be enrolled in a smoking cessation program
    • Updated diagnostic criteria to the following:
      • Must have had two or more asthma exacerbations in the previous 12 months requiring use of oral corticosteroids
      • Must have had one or more asthma exacerbations requiring a hospitalization, an emergency department visit, or an urgent care visit in the previous 12 months
      • Must have had forced expiratory volume in 1 second (FEV1) <80% predicted
        OR
      • Must have had a dependence on oral corticosteroids of at least 5 mg per day of prednisone or equivalent

    Effective December 5, 2024

    Pharmacotherapy of Arthropathies, 5.01.550  PBC | Premera HMO
    Drugs added
    Site of service review added

    • Site of service review was added to Cosentyx (secukinumab) IV and Tofidence (tocilizumab-bavi) IV throughout the policy

    Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
    Drug added
    Site of service review added

    • Site of service review was added to Tyruko (natalizumab-sztn) throughout the policy

    Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  PBC | Premera HMO
    Drug added
    Site of service review added

    • Site of service review is added to Tofidence (tocilizumab-bavi) IV throughout the policy

    Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  PBC | Premera HMO
    Drugs added

    • The following will be reviewed for site of service when requested in an inpatient setting:
      • Alyglo (immune globulin intravenous, human-stwk)
      • Cosentyx IV (secukinumab)
      • Spevigo IV (spesolimab-sbzo)
      • Tofidence IV (tocilizumab-bavi)
      • Tyruko (natalizumab-sztn)

    Effective November 1, 2024

    Alpha-1 Proteinase Inhibitors, 5.01.624  PBC | Premera HMO
    Site of service review added

    • The following will be reviewed for site of service when requested in an inpatient setting:
      • Aralast NP
      • Glassia
      • Prolastin-C
      • Zemaira

    Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  PBC | Premera HMO
    Drugs added

    • The following will be reviewed for site of service when requested in an inpatient setting:
      • Aralast NP
      • Glassia
      • Prolastin-C
      • Zemaira

    Effective October 20, 2024

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

    Effective for dates of service on and after October 20, 2024, 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

    Brain Imaging

    • Added indications for Magnetic Resonance Imaging (MRI) and amyloid beta positron emission tomography (PET) imaging in Alzheimer disease to address patients considering or receiving lecanemab

    Spine Imaging

    • Changed “Perioperative and Periprocedural Imaging” to “Postoperative and Postprocedural Imaging;” pre-procedure requests should be reviewed based on more specific indication

    Extremity Imaging

    • Separated criteria for osteomyelitis and septic arthritis into separate indications
    • Ultrasound or arthrocentesis as preliminary tests were placed only in the “septic arthritis” indication

    Vascular Imaging

    • Computed tomography angiography (CTA) and magnetic resonance angiography (MRA) Head addition for chronic posterior circulation Stroke/TIA presentations (CTA/MRA neck already allowed, intracranial eval needed for full extent of anatomy)
    • Lower Extremity peripheral artery disease: Updated physiologic testing parameters and added allowance for ischemic signs/symptoms at presentation, in alignment with American College of Radiology Appropriateness Criteria
    • Suboptimal imaging option downgrades/removals in Brain, Head and Neck and Abdomen/Pelvis

    Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Cardiology 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

    Imaging of the Heart

    • Resting Transthoracic Echocardiography (TTE)
      • Expanded frequency of echocardiographic evaluation in patients on mavacamten for treatment of hypertrophic obstructive cardiomyopathy
      • Expanded criteria for echocardiographic evaluation to allow a single screening for cardiac disease in patients undergoing evaluation for solid organ or hematopoietic cell transplant

    Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Genetic Testing 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

    Chromosomal Microarray Analysis

    • Clarified recommendations for Genetic Counseling
    • Clarified requirements for postnatal evaluation of individuals with:
      • Congenital or early onset epilepsy (before age 3 years) without suspected environmental causes
      • Autism spectrum disorder, developmental delay, or intellectual disability with no identifiable cause (idiopathic)
    • Clarified prenatal evaluation of a fetus with a structural fetal anomaly noted on ultrasound

    Pharmacogenomic Testing

    • Added Apolipoprotein E (APOE) testing

    Polygenic Risk Scores renamed Predictive and Prognostic Polygenic Testing

    • Broadened guideline scope to include polygenic expression prognostic testing and multivariable prognostic genetic testing (essentially clarifications)
      • Moved these tests to exclusions as they are considered not medically necessary
    • Retitled guideline to Predictive and Prognostic Polygenic Testing to address the change in scope

    Somatic Testing of Solid Tumors

    • Clarified gene expression profiling is to guide adjuvant therapy for localized Breast Cancer

    Whole Exome and Whole Genome Sequencing

    • Expanded whole exome sequencing (WES) criteria to include congenital or early onset epilepsy (before age 3) without suspected environmental etiology and added other clarifications
    • Clarified well-delineated genetic syndrome in criterion for multiple anomalies
    • Clarified Genetic Counseling details for WES

    Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Radiation Oncology 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

    Radiation Therapy (excludes Proton)

    • Removed criteria for hyperthermia
    • Clarified inclusion criteria of the RTOG 1112 protocol

    Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Sleep 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

    Sleep Disorder Management

    • Expanded definitions and terminology
    • Expanded documentation of hypoventilation
    • Expanded criteria for home and in-lab sleep studies
    • Added contraindication to automatic positive airway pressure titration for use of supplemental oxygen
    • Removed home sleep apnea testing as an option in medical necessity of multiple sleep latency test/maintenance of wakefulness test for suspected narcolepsy
    • Management of obstructive sleep apnea (OSA) using Implanted Hypoglossal Nerve Stimulators (HNS):
      • Narrowed age range (raised lower limit to 13) for HNS in individuals with Down syndrome and OSA to align with age range suggested by Food and Drug Administration (FDA)
    • Miscellaneous Devices section added:
      • Electronic positional therapy and neuromuscular electrical training of the tongue musculature are considered not medically necessary due to lack of high-quality evidence

    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 October 8, 2024

    Surgical Treatment of Femoral Acetabular Impingement, 7.01.592PBC | Premera HMO
    New policy

    • Surgical treatment of femoral acetabular impingement is considered medically necessary when criteria are met.

    New medical policies

    Surgical Treatment of Sleep Apnea, 7.01.554  PBC | Premera HMO
    Policy renumbered from 7.01.101

    Medical necessary criteria updated
    Hypoglossal nerve stimulation to treat OSA in adults

    • Updated age band from individuals aged 22 years of age and older to those aged 18 years and older
    • Updated AHI span to include a cap of no more than 100
    • Updated body mass index from at least 40 kg/m2 to at least 35 kg/m2

    Medical necessary criteria updated
    Hypoglossal nerve stimulation to treat OSA in individuals with Down syndrome

    • Updated age band from individuals aged 10 to 21 years of age to those aged 13 to 18 years

    Revised medical policies
    Effective October 1, 2024

    Prescription Drug Therapeutics, 13.01.500  PBC | Premera HMO
    Investigational criteria updated

    • Added RevitalVision to the list of devices considered investigational

    Transcatheter Mitral Valve Repair or Replacement, 2.02.30  PBC | Premera HMO
    Title expanded to include “or Replacement”
    Medical necessity criteria updated

    • Added the Pascal device to the list of devices included for coverage when performing transcatheter mitral valve repair

    Medical necessity criteria added

    • Added coverage criteria for transcatheter mitral valve replacement in individuals with failure of a surgical bioprosthetic mitral value:
      • Must have New York Hearth Association heart failure class II, II, or IV symptoms
        AND
      • Must not an operable candidate for open surgery, as documented by at least 2 cardiovascular specialists
        OR
      • Must be an operable candidate but is considered at increased surgical risk for open surgery due to a history of congenital vascular anomalies, as documented by at least 2 cardiovascular specialists
        OR
      • Must be considered at increased surgical risk for open surgery due to a history of congenital vascular anomalies
        AND/OR
      • Must have a complex intrathoracic surgical history, as documented by at least 2 cardiovascular specialists

    New pharmacy policies

    No updates this month.

    Revised pharmacy policies
    Effective October 1, 2024

    Medical Necessity Criteria for Pharmacy Edits, 5.01.605  PBC | Premera HMO
    Drug added
    Medical necessity criteria added

    • Added Restasis (cyclosporine ophthalmic emulsion) and coverage criteria for treatment of the sign sand symptoms of dry eye disease in individuals aged 18 years and older:
      • Must have had inadequate response or intolerance to generic cyclosporine ophthalmic emulsion 0.05%
      • Must not be used concurrently with another ophthalmic cyclosporine product

    Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502  PBC | Premera HMO
    Medical necessity criteria added

    • Added coverage criteria for Epkinly (epcoritamab-bysp) for the treatment of relapsed and refractory follicular lymphoma in individuals aged 18 years and older when two or more lines of systemic therapy have been tried and failed

    Effective October 1, 2024

    Allogeneic Hematopoietic Cell Transplantation for Genetic Diseases and Acquired Anemias, 8.01.538

    Effective October 1, 2024

    Surgical Treatment of Sleep Apnea, 7.01.101 Policy renumbered. See Surgical Treatment of Sleep Apnea, 7.01.554 PBC | Premera HMO

    Added codes
    Effective October 1, 2024

    Amniotic Membrane and Amniotic Fluid, 7.01.583  PBC | Premera HMO
    Now requires review for investigational.

    Q4334, Q4335, Q4336, Q4337, Q4338, Q4339, Q4340, Q4341, Q4342, Q4343, Q4344, Q4345

    Bioengineered Skin and Soft Tissue Substitutes, 7.01.113  PBC | Premera HMO
    Now requires review for investigational.

    A2027, A2028, A2029

    Carelon® Medical Benefits Management Clinical Appropriateness Guidelines for Genetic Testing
    Now reviewed by Carelon® Medical Benefits Management for medical necessity and prior authorization.

    0476U, 0477U, 0478U, 0481U, 0485U, 0486U, 0487U, 0488U, 0489U, 0493U, 0494U, 0496U, 0497U, 0498U, 0499U, 0500U, 0506U, 0507U, 0508U, 0509U, 0516U

    Cranial Electrotherapy Stimulation and Auricular Electrostimulation, 8.01.540  PBC | Premera HMO
    Now requires review for investigational.

    A4543, E0721

    Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  PBC | Premera HMO
    Now requires review for investigational.

    0479U, 0503U

    Immune Checkpoint Inhibitors, 5.01.591  PBC | Premera HMO
    Now requires review for medical necessity and prior authorization.

    J9329

    Laboratory Testing Investigational Services, 2.04.520  PBC | Premera HMO
    Now requires review for investigational.

    0490U, 0491U, 0492U, 0495U, 0501U, 0505U, 0510U, 0511U, 0512U, 0513U

    Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes, 2.04.152  PBC | Premera HMO
    Now requires review for investigational.

    0482U

    Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
    Now requires review for medical necessity and prior authorization.

    C9170

    Non-covered Experimental/Investigational Services, 10.01.533  PBC | Premera HMO
    Now requires review for investigational.

    A4544, A4545, A7021, E0469, E0683, E0715, E0716, E0736, E0737, E0743, E0767, E3200, L8720, L8721, P9027

    Non-covered Services and Procedures, 10.01.517  PBC | Premera HMO
    No longer covered.

    0517U, 0518U, 0519U, 0520U, Q0516, Q0517, Q0518, Q0519, Q0520

    Pharmacologic Treatment of Bladder Cancer, 5.01.632  PBC | Premera HMO
    Now requires review for medical necessity and prior authorization.

    C9169

    Pharmacologic Treatment of Hemophilia, 5.01.581  PBC | Premera HMO
    Now requires review for medical necessity and prior authorization.

    C9172

    Pharmacologic Treatment of Interstitial Lung Disease, 5.01.555  PBC | Premera HMO
    Now requires review for medical necessity and prior authorization.

    Q5135

    Preventive Care Services, 10.01.523  PBC | Premera HMO
    Now covered as part of the standard benefit.

    0502U

    Transcatheter Mitral Valve Repair and Replacement, 2.02.30  PBC | Premera HMO 
    Now requires review for medical necessity and prior authorization.

    0483T, 0484T

    Added codes
    Effective October 8, 2024

    Surgical Treatment of Femoroacetabular Impingement, 7.01.592  PBC | Premera HMO
    Now requires review for medical necessity and prior authorization.

    29914, 29915, 29916

    Revised codes
    Effective October 1, 2024

    Hematopoietic Cell Transplantation for Waldenstrom Macroglobulinemia, 8.01.531  PBC | Premera HMO
    No longer requires review for medical necessity and prior authorization. Now requires review for investigational.

    38230, 38240

    Removed codes
    Effective October 1, 2024

    Prescription Digital Therapeutics, 13.01.500  PBC | Premera HMO
    No longer requires review.

    T1505

    Synthetic Cartilage Implants for Joint Pain, 7.01.160  PBC | Premera HMO
    No longer requires review.

    L8641, L8642, 28291

  • Updates for non-individual plans only

  • No updates this month.
    No updates this month.
  • Updates for individual plans only

  • Effective December 5, 2024

    Services Reviewed Using InterQual Criteria, 10.01.530  PBC
    Services added
    Durable Medical Equipment

    • The following modules were added and will be used to review for medical necessity:
    • Continuous glucose monitors, insulin pumps, and automated insulin delivery technology
    • Home mechanical ventilation devices: Invasive, noninvasive, and multifunction

    Procedures

    • The following modules were added and will be used to review for medical necessity:
    • Arthrotomy, shoulder arthroscopy or arthroscopically assisted surgery, shoulder
    • Arthrotomy, shoulder
    • Electrophysiology (EP) testing +/- radiofrequency (RFA) or cryothermal ablation, cardiac
    • Mastectomy, prophylactic, total or simple
    • Osteotomy, proximal, first metatarsal (MT) (Bunionectomy)
    • Prostatectomy, radical
    • Salpingectomy
    • Tendon sheath incision or excision, hand, flexor
    • Video electroencephalographic (EEG) monitoring

    No updates this month.

    No updates this month.

    Added codes
    Effective October 1, 2024

    No updates this month.

    Revised codes
    Effective January 3, 2025

    These codes are currently reviewed retrospectively for medical necessity. For dates of service January 3, 2025, and after, the following will be effective:

    Biofeedback for Incontinence, 2.01.540 PBC
    Now requires review for medical necessity and prior authorization.

    90901, 90912, 90913

    Continuous Home Pulse Oximetry, 1.01.533  PBC
    Now requires review for medical necessity and prior authorization.

    A4606, E0445

    Endometrial Ablation, 7.01.578  PBC
    Now requires review for medical necessity and prior authorization.

    58353, 58356, 58563

    External Counterpulsation Therapy, 2.02.514  PBC
    Now requires review for medical necessity and prior authorization.

    G0166

    Eye-Anterior Segment Optical Coherence Tomography, 9.03.509  PBC
    Now requires review for medical necessity and prior authorization.

    92132

    Fundus Photography, 9.03.507  PBC
    Now requires review for medical necessity and prior authorization.

    92250

    Glaucoma, Invasive Procedures, 9.03.510 PBC
    Now requires review for medical necessity and prior authorization.

    66174, 66175, 66183

    High-Resolution Anoscopy, 2.01.539 PBC
    Now requires review for medical necessity and prior authorization.

    46601, 46607

    Home Apnea Monitoring, 1.01.534  PBC
    Now requires review for medical necessity and prior authorization.

    94774, 94775, 94776, 94777

    Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring, 1.01.536  PBC
    Now requires review for medical necessity and prior authorization.

    93792, 93793, G0248, G0249, G0250

    Laryngeal Injection for Vocal Cord Augmentation, 2.01.541  PBC
    Now requires review for medical necessity and prior authorization.

    31513, 31570, 31571, 31573, 31574

    Noninvasive Tests for Hepatic Fibrosis, 2.01.536  PBC
    Now requires review for medical necessity and prior authorization.

    76981, 76982, 76983

    Posterior Tibial Nerve Stimulators, 7.01.579  PBC
    Now requires review for medical necessity and prior authorization.

    64566

    Presbyopia Correcting Intraocular Lenses (PIOLs) and Astigmatism Correcting Intraocular Lenses (ACIOLs), 9.03.511  PBC
    Now requires review for medical necessity and prior authorization.

    66982, 66983, 66984, V2630, V2631, V2632

    Rabies Vaccine, Home Setting, 9.01.508 PBC
    Now requires review for medical necessity and prior authorization.

    90375, 90376, 90377, 90675, 90676

    Services Reviewed Using InterQual Criteria, 10.01.530  PBC
    Now requires review for medical necessity and prior authorization.

    34701, 34702, 34703, 34704, 34705, 34706, 34707, 34708, 34709, 34710, 34711, 34712, 34713, 34714, 34715, 34716, 34808, 34812, 34813, 34820, 34833, 34834, 34841, 34842, 34843, 34844, 34845, 34846, 34847, 34848, 58720, 58940, A4633, E0424, E0431, E0433, E0434, E0439, E0441, E0442, E0443, E0444, E1390, E1391, E1392, E1405, E1406, K0378

    Supervised Exercise Therapy for Peripheral Artery Disease, 8.01.537  PBC
    Now requires review for medical necessity and prior authorization.

    93668

    Ultraviolet B Light Therapy in the Home to Treat Skin Conditions, 2.01.542  PBC
    Now requires review for medical necessity and prior authorization.

    E0691, E0692, E0693, E0694

    Visual Evoked Response Test, 9.03.512 PBC
    Now requires review for medical necessity and prior authorization.

    95930

  • Updates for federal employee plans only

  • Effective January 3, 2025

    Shoulder Arthroplasty, 7.01.590  PBC
    New policy
    Medical necessity criteria added
    Total shoulder arthroplasty

    • Added coverage criteria for treatment of joint disease:
      • Must have documented diagnosis of joint disease
      • Must need treatment due to either of the following and lasting 3 months or more: disabling pain OR functional disability that impacts carrying out activities of daily living
      • Must have presence of degenerative joint disease demonstrated through radiographic or imaging done within the past 12 months
      • Must have tried and failed 3 or more months of conservative treatment
      • Must have tried and failed twelve or more weeks of physical measures of treatment
    • Added coverage for:
      • Proximal humorous fracture malunion or non-union
      • Reconstruction after tumor resection of the glenohumeral joint or surrounding tissue
      • Failed hemi-arthroplasty
      • Post-traumatic injury

    Reverse total shoulder arthroplasty

    • Added coverage criteria for when there is an intact deltoid muscle, at least 90 degrees of passive shoulder range of motion, adequate bone stock to support an implant and any of the following:
      • Shoulder fracture that cannot be repaired or reconstructed any other way
      • Reconstruction post tumor resection
      • Failed hemi-arthroplasty
      • Failed total shoulder arthroplasty with non-repairable rotator cuff tear
        OR
      • Presence of advanced joint disease confirmed by radiographic imaging or arthroscopic findings performed within the past 12 months with at least one of the following:
        • Glenohumeral osteoarthritis with irreparable rotator cuff tear
        • Psuedo paralysis from an irreparable rotator cuff tear
        • Massive rotator cuff tear
        • Avascular necrosis or osteonecrosis of the humeral head not involving the glenoid
        AND
      • Must need treatment due to either of the following and lasting 3 months or more: disabling pain OR functional disability that impacts carrying out activities of daily living
      • Must have presence of degenerative joint disease demonstrated through radiographic or imaging done within the past 12 months
      • Must have tried and failed 3 or more months of conservative treatment
      • Must have tried and failed twelve or more weeks of physical measures of treatment

    Shoulder hemiarthroplasty

    • Added coverage criteria for:
      • Proximal humerus fracture that cannot be corrected by internal fixation
      • Tumor impacting the glenohumeral joint or surrounding soft tissue
        OR
      • Presence of advanced joint disease confirmed by radiographic imaging or arthroscopic findings performed within the past 12 months with at least one of the following
        • Glenohumeral osteoarthritis with irreparable rotator cuss tear
        • Glenoid bone stock is not sufficient to support a prosthesis
        • Osteonecrosis of the humeral head without glenoid involvement
        • Evidence of radiographic or imaging evidence of degenerative joint disease performed within the past 12 months
        AND
      • Must need treatment due to either of the following and lasting 3 months or more: disabling pain OR functional disability that impacts carrying out activities of daily living
      • Must have tried and failed 3 or more months of conservative treatment
      • Must have tried and failed twelve or more weeks of physical measures of treatment

    Revision/replacement shoulder arthroplasty

    • Added coverage criteria for:
      • Aseptic loosening of one or more prosthetic components confirmed by imaging
      • Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction
      • Component instability
      • Displaced periprosthetic fracture
      • Fracture, mechanical failure, or recall of a prosthetic component
      • Migration of the humeral head
      • Periprosthetic infection
      • Recurrent prosthetic dislocation
      • Persistent shoulder pain of unknown etiology unresponsive to non-operative conservative care for 6 months

    Total shoulder arthroplasty
    Reverse total shoulder arthroplasty
    Hemi-arthroplasty

    • Added non-coverage criteria for:
      • When policy criteria are not met
      • Active infection of the joint or active systemic bacteremia
      • Active skin infection or open wound within the planned surgical site
      • Allergy to components of the implant (e.g., cobalt, chromium, stainless steel, titanium, etc.)
      • Deltoid deficiency (e.g., axillary nerve palsy)
      • Inadequate bone stock to support implantation of prosthesis
      • Neuropathic (Charcot) arthropathy of the shoulder
      • Paralytic disorder of the shoulder (e.g., flail shoulder due to irreversible brachial plexus palsy, spinal cord injury)
      • Rapidly progressive neurological disease

    Effective October 8, 2024

    Correction: Surgical Treatment of Femoroacetabular Impingement, 7.01.592 does NOT apply to FEP

    No updates this month.

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