Medical Policy and Coding Updates

Effective January 3, 2025

Advanced Therapies for Pharmacological Treatment of Pulmonary Arterial Hypertension, 5.01.522  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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 to 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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
Drugs added
Site of service review added

• The following will be reviewed for site of service when requested in the inpatient setting:
  • Cosentyx (secukinumab) IV
  • Tofidence (tocilizumab-bavi) IV

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  Individual | Group
Drugs added
Site of service review added

• The following will be reviewed for site of service when requested in the inpatient setting:
  • Tyruko (natalizumab-sztn)

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  Individual | Group
Drugs added
Site of service review added

• The following will be reviewed for site of service when requested in the inpatient setting:
  • Tofidence (tocilizumab-bavi) IV

Services Reviewed Using InterQual Criteria, 10.01.530  Individual | Group
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

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  Individual | Group
Drugs added
Site of service review added

• The following will be reviewed for site of service when requested in the 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  Individual | Group
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  Individual | Group
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, 7.01.592  Individual | Group
New policy

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

New medical policies
Effective October 1, 2024

Surgical Treatment of Sleep Apnea, 7.01.554   Individual | Group
Policy renumbered from 7.01.101 (see Deleted policies)
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  Individual | Group
Investigational criteria updated

• Added RevitalVision to the list of devices considered investigational

Transcatheter Mitral Valve Repair or Replacement, 2.02.30  Individual | Group
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
Effective October 1, 2024

No updates this month.

Revised pharmacy policies
Effective October 1, 2024

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

• Added Restasis (cyclosporine ophthalmic emulsion) and coverage criteria for treatment of the signs and 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  Individual | Group
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

Surgical Treatment of Sleep Apnea, 7.01.101
Policy renumbered. See Surgical Treatment of Sleep Apnea, 7.01.554  Individual | Group

Added codes
Effective October 1, 2024

Amniotic Membrane and Amniotic Fluid, 7.01.583  Individual | Group
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  Individual | Group
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  Individual | Group
Now requires review for investigational.

A4543, E0721

Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  Individual | Group
Now requires review for investigational.

0479U, 0503U

Immune Checkpoint Inhibitors, 5.01.591  Individual | Group
Now requires review for medical necessity and prior authorization.

J9329

Laboratory Testing Investigational Services, 2.04.520  Individual | Group
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  Individual | Group
Now requires review for investigational.

0482U

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

C9170

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

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

Pharmacologic Treatment of Bladder Cancer, 5.01.632  Individual | Group
Now requires review for medical necessity and prior authorization.

C9169

Pharmacologic Treatment of Hemophilia, 5.01.581  Individual | Group
Now requires review for medical necessity and prior authorization.

C9172

Pharmacologic Treatment of Interstitial Lung Disease, 5.01.555  Individual | Group
Now requires review for medical necessity and prior authorization.

Q5135

Preventive Care Services, 10.01.523  Individual | Group
Now covered as part of the standard benefit.

0502U

Transcatheter Mitral Valve Repair and Replacement, 2.02.30  Individual | Group
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  Individual | Group
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  Individual | Group
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  Individual | Group
No longer requires review.

T1505

Synthetic Cartilage Implants for Joint Pain, 7.01.160  Individual | Group
No longer requires review.

L8641, L8642, 28291

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.

Effective December 5, 2024

Services Reviewed Using InterQual Criteria, 10.01.530  Individual
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.

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  Individual
Now requires review for medical necessity and prior authorization.

90901, 90912, 90913

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

A4606, E0445

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

58353, 58356, 58563

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

G0166

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

92132

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

92250

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

66174, 66175, 66183

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

46601, 46607

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

93792, 93793, G0248, G0249, G0250

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

31513, 31570, 31571, 31573, 31574

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

76981, 76982, 76983

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

64566

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

66982, 66983, 66984, V2630, V2631, V2632

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

90375, 90376, 90377, 90675, 90676

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

93668

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

E0691, E0692, E0693, E0694

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

95930