Medical Policy and Coding Updates

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  • Updates for both non-individual and individual plans

  • 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

    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 PBC | Premera HMO
    New policy

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

    Effective August 2, 2024

    C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
    Medical necessity criteria updated

    • Confirmed granulocyte clone size updated to ≥ 15% for Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), and Empaveli (pegcetacoplan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)

    Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  PBC | Premera HMO
    Investigational criteria added

    • Measurement of biochemical markers of Alzheimer’s disease is considered investigational

    New medical policies

    No updates this month.

    Revised medical policies
    Effective August 1, 2024

    Spravato (esketimine) Nasal Spray, 5.01.609  PBC | Premera HMO
    Additional information updated

    • Medication trial and failure requirements clarified to allow for independent or concomitant medication use; separate trials are no longer required

    Transcranial Magnetic Stimulation as a Treatment of Depression and other Psychiatric and Neurologic Disorders, 2.01.526 PBC | Premera HMO
    Medical necessity criteria updated

    • Clarified that the medical necessity criteria for transcranial magnetic stimulation (TMS) to treat bipolar disorder, OCD, and major depressive disorder apply only to the first course of treatment
    • Medication trial and failure requirements clarified to allow for independent or concomitant medication use; separate trials are no longer required

    Medical necessity criteria added

    • TMS may be considered medically necessary as a maintenance therapy while the individual awaits vagus nerve stimulation treatment to take effect

    Vagus Nerve Stimulation, 7.01.20  PBC | Premera HMO
    Medical necessity criteria updated

    • Clarified application to refractory seizures

    Medical necessity criteria added

    • Vagus nerve stimulation (VNS) may be considered medically necessary to treat major depressive disorder in individuals aged 18 years and older  when criteria are met
    • VNS may be considered medically necessary to treat major depressive disorder, in conjunction with TMS, for up to 3 months while VNS takes full effect, with the potential for up to 12 months if results are gained from VNS treatment during this time frame
    • All other concomitant uses of VNS are considered not medically necessary

    Contraindications added

    • A history of left vagotomy or bilateral vagotomy
    • Current or planned therapeutic shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy

    Investigational criteria added

    • All concomitant uses of VNS with ketamines or other psychedelic drugs are investigational

    Investigational indications updated

    • Depression removed
    • Psychiatric conditions (other than major depressive disorder) added
    • Substance use disorders added

    New pharmacy policies

    Gene Therapies for Rare Diseases, 5.01.642  PBC | Premera HMO
    Drug added
    Medical necessity criteria added
    Lenmeldy

    • Lenmeldy may be considered medically necessary to treat metachromatic leukodystrophy (MLD) when criteria are met

    Revised pharmacy policies
    Effective August 1, 2024

    Advanced Therapies for Pharmacological Treatment of Pulmonary Arterial Hypertension, 5.01.522  PBC | Premera HMO
    Drugs added
    Opsynvi (macitentan-tadalafil)

    • Opsynvi may be considered medically necessary for treatment of adults with pulmonary arterial hypertension WHO group 1 with signs and symptoms of WHO functional class II and III.

    Winrevair (sotatercept-csrk)

    • Winrevair may be considered medically necessary for treatment of adults with pulmonary arterial hypertension WHO group 1 with signs and symptoms of WHO functional class II and III when criteria are met

    ALK Tyrosine Kinase Inhibitors, 5.01.538  PBC | Premera HMO
    Medical necessity criteria added

    • Coverage of Alecensa (alectinib) expanded to include individuals with non-small cell lung cancer who require adjuvant treatment following tumor resection with tumors ≥ 4 cm or node positive

    Drugs for Rare Diseases, 5.01.576  PBC | Premera HMO
    Drug added
    Medical necessity criteria added

    • Voydeya (danicopan oral) may be considered medically necessary to treat extravascular hemolysis in individuals with paroxysmal nocturnal hemoglobinuria who are aged 18 tears and over when criteria are met
    • Xolremdi may be considered medically necessary to increase the number of circulating neutrophils and lymphocytes in individuals aged 12 years and older with warts, hypogammaglobulinemia, infections, and myelokathexis when criteria are met

    Herceptin (trastuzumab) and other HER2 Inhibitors, 5.01.514  PBC | Premera HMO
    Drug added

    • Added second-line agent Hercessi (trastuzumab strf)

    Medical necessity criteria added

    • Enhertu may be considered medically necessary for treatment of HER2 positive solid tumors in adults when criteria are met

    Immune Globulin Therapy, 8.01.503  PBC | Premera HMO
    Medical necessity criteria updated

    • Updated IgG levels from less than 400 to less than 500 for the initial criteria in the policy
    • Clarified that coverage for Guillain-Barre syndrome applies to those aged 18 years and older

    Medical necessity criteria added

    • Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease may be considered medically necessary in individuals who failed to respond to one previous therapy

    Reauthorization criteria updated

    • Added the requirement of an IgG level of 300 mg/dL at the time of reauthorization

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

    • Eohilia (budesonide oral suspension) may be considered medically necessary for treatment of eosinophilic esophagitis in individuals aged 11 years and older when criteria are met
    • Generic mirabergron may be considered medically necessary for treatment of overactive bladder when generic oxybutynin chloride, generic solfenacen, or generic trisodium have been tried and failed

    Drugs added

    • Brand oxybutynin, Vesicare, and Vesicare L5 added to the list of medically necessary agents for treatment of overactive bladder
    • Generic bismith subcitrate potassium-metronidazole tetracycline added to the list of medically necessary agents for treatment of H Pylori

    Drugs removed

    • Removed Beconase AQ, Nasonex, and Veramyst from Intranasal Brand Corticosteroid Products as they have been withdrawn from the market.

    Cosmetic indication updated

    • Removed statement that Scenesse (afamelanotide) for the treatment of vitiligo is not medically necessary as treatment of vitiligo, it is considered a cosmetic exclusion

    Medical necessity criteria added

    • Expand coverage of Rezdiffra to include treatment of stage F2 liver fibrosis (expanding from only F3) as medically necessary when criteria are met
    • Update alcoholic drink limits per week as follows: male, from 21 to 15; and female, from 14 to 10

    Migraine and Cluster Headache Medications, 5.01.503  PBC | Premera HMO
    Drug added/removed
    Brand name triptans

    • Maxalt MLT (rizatriptan oral) added
    • Zolmatriptan nasal spray removed (no longer on the market)

    Generic triptans

    • Ergomar (ergotamine oral) added
    • Trudhesa (dyhydroergotamine nasal spray) added
    • Must include trial and failure of two generic triptan products

    Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
    Miscellaneous Intramuscular/Subcutaneous Agents

    Drug added

    • Brand paciltaxel protein bound particles Teva unbranded added to the list of medically necessary agents

    Drug added
    Medical necessity criteria added

    • Amtagvi (lilifluecel) may be considered medically necessary for treatment of unresectable or metastatic melanoma when criteria are met

    Medical necessity criteria updated
    Gazyva

    • Added coverage for combination therapy in adults with relapsed or refractory follicular lymphoma who have received two or more lines of therapy

    Pharmacotherapy of Arthropathies, 5.01.550  PBC | Premera HMO
    Drugs added
    First-line Janus Kinase Inhibitors

    • Rinvoq and Rinvoq LQ may be considered medically necessary for treatment of polyarticular juvenile idiopathic arthritis
    • Rinvoq LQ may  be considered medically necessary for treatment of active psoriatic arthritis when individual has had an inadequate response to TNF blockers

    Pharmacologic Treatment of Duchenne Muscular Dystrophy, 5.01.570  PBC | Premera HMO
    Drug added
    Medical necessity criteria added

    • Duvyzat may be considered medically necessary for treatment of Duchenne muscular dystrophy when individual is aged 6 years or older and criteria are met

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

    • May be considered medically necessary to reduce reactions to Type 1 allergic reactions for individuals with an IgE mediated food allergy when aged 1 year or older and criteria are met

    Ultrasonographic Measurement of Carotid Intimal-Medial Thickness as an Assessment of Subclinical Atherosclerosis, 2.02.16

    Progenitor Cell Therapy for the Treatment of Damaged Myocardium Due to Ischemia, 2.02.18

    No updates this month.

    Added codes
    Effective August 1, 2024

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

    0346U, 0361U, 0412U, 0393U, 0443U

    Revised codes
    Effective August 1, 2024

    No updates this month.

    Removed codes
    Effective August 1, 2024

    Lumbar Spinal Fusion in Adults, 7.01.542  PBC | Premera HMO
    No longer requires review.

    C1831

  • Updates for only non-individual plans

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

  • No updates this month.

    No updates this month.

    No updates this month.

    Removed codes
    Effective August 1, 2024

    Services Reviewed Using InterQual Criteria, 10.01.530  PBC
    No longer requires review.

    77061, 77062, 77063, 77065, 77066, 77067, G0279

  • Updates for federal employee plans only

  • Effective October 8, 2024

    Surgical Treatment of Femoral Acetabular Impingement, 7.01.592 PBC
    New policy

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

    No updates this month.

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