Medical Policy and Coding Updates

Effective July 4, 2024

Pharmacologic Treatment of\Neuropathy, Fibromyalgia, and Seizure Disorders, 5.01.521  PBC | Premera HMO
Medical necessity criteria added

• Qutenza (capsaicin) added for the treatment of postherpetic neuralgia and diabetic peripheral neuropathy

Pharmacotherapy of Multiple Sclerosis, 5.01.565  PBC | Premera HMO
Medical necessity criteria updated

• Briumvi (ublituximab-xiiy) intravenous added to site of service review

Effective June 30, 2024

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

Effective for dates of service on and after June 30, 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

Carrier Screening in the Prenatal Reproductive Setting

• Removed preimplantation testing criteria (transferred to Genetic Testing for Inherited Conditions) and retitled guideline to Carrier Screening in the Reproductive Setting
• Standard carrier screening: expanded testing to include standard hemoglobinopathy screening for all pregnant individuals or an individual considering pregnancy

Genetic Testing for Inherited Conditions

• Preimplantation genetic testing (PGT):
  • Transferred criteria from Carrier Screening guidelines
  • Expanded testing for gamete providers in certain scenarios
  • Clarified the medical necessity of PGT for aneuploidy when there is a clear heritable indication
• Clarified testing considered not medically necessary:
  • MTHFR-gene variant testing for hereditary thrombophilia risk assessment
  • Donor-derived cell-free deoxyribonucleic acid (DNA) testing for use as a biomarker for diagnosis and/or monitoring of cardiac organ transplant rejection

Hereditary Cancer Testing

• Expanded indications for:
  • Li-Fraumeni syndrome
  • Hereditary breast, ovarian, and pancreatic cancer (including multi-gene panel testing)
  • Melanoma
  • Prostate cancer
• Clarified testing is not medically necessary:
  • Serrated polyposis syndrome
  • Hereditary mixed polyposis syndrome (GREM1-associated mixed polyposis)

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 June 7, 2024

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
Medical necessity criteria updated

• Skyrizi (risankizumab-rzaa) intravenous added to site of service review

Effective April 14, 2024

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

Effective for dates of service on and after April 14, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Radiation Therapy 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

• Intensity-modulated radiation therapy (IMRT) for colon cancer
• New indication for adjuvant treatment of locally advanced adenocarcinoma of the cecum
• Stereotactic body radiotherapy for hepatocellular carcinoma
• Modify eligibility criteria to match clinical trial RTOG 1112
• External beam radiation therapy/IMRT for prostate cancer
• Adjust for 2 Gy [gray] fractions. The total allowed dosage is the same with each fraction is a little larger (now 2 Gy) and lower number of fractions.

Effective for dates of service on and after April 14, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Advanced Imaging 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

• Cardiac computed tomography (CT)
  • Cardiomyopathy: Added specificity to establish the basis for the suspicion of arrhythmogenic right ventricular dysplasia to align with cardiac magnetic resonance imaging (MRI) guidelines
• Resting transthoracic echocardiography
• Evaluation of ventricular function
  • New indications for evaluation of patients on mavacamten for treatment of hypertrophic cardiomyopathy

Imaging of the Abdomen and Pelvis

• Biliary tract dilatation or obstruction
  • Added indication for annual surveillance in Caroli disease/syndrome based on a 2022 guideline recommendation
• Diffuse liver disease
  • Removed indication for LiverMultiScan in hemochromatosis as there is insufficient evidence that this provides an advantage over standard MRI for this condition
• Osteomyelitis
  • Added requirement for initial evaluation with radiographs in adult patients based on American College of Radiology (ACR) appropriateness criteria
• Septic arthritis
  • Added requirement for initial radiographs in adult patients based on ACR appropriateness criteria
• Pancreatic mass, indeterminate cystic
  • For enlarging lesions in individuals aged 80 or older, increased surveillance frequency to annually and removed endpoint of 4 years
• Pelvic floor disorders
  • Added indication for MRI (magnetic resonance [MR] defecography preferred) in suspected pelvic organ prolapse based on ACR appropriateness criteria
• Transplant-related imaging
  • Added indication for single CT abdomen or abdomen/pelvis prior to lung, kidney, or stem cell transplant to align with CT chest guidelines

Imaging of the Brain

• Movement disorders (Adult only)
  • Added indication for head CT for assessment of skull density prior to MR guided focused ultrasound for essential tremor
• Trauma
  • Added a 3-6 week follow-up study in individuals aged 6 or younger with stable or inconclusive exam due to difficulty in accurately assessing for changes in neurologic status
• Acoustic neuroma
  • Added long-term follow-up intervals based on specialty society guidelines

Imaging of the Chest

• Perioperative or periprocedural evaluation, not otherwise specified
  • Added indication for chest CT to be used for planning of biopsy or placement of fiducial markers using navigational bronchoscopy

Imaging of the Head and Neck

• Acoustic neuroma
  • Added long-term follow-up intervals based on specialty society guidelines
• Localized facial pain (including trigeminal neuralgia)
  • Added MRI orbit/face/neck for this indication based on ACR criteria due to some facilities using MRI face rather than brain for this condition

Oncologic Imaging

• Cancer screening
  • Breast cancer screening: Addition of high-risk genetic mutations (National Comprehensive Cancer Network [NCCN] alignment citing absolute risk of 20% or greater)
  • Lung cancer screening: Clarification of asbestos-related lung disease as risk factor independent of smoking, aligned with original intent
  • Pancreatic cancer screening: Alignment with NCCN recommended parameters; changes are overall expansive, except for an older start age (from 45 to 50 years) for certain genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53); and family history alone (relative requirement)
• Breast Cancer
  • Chest CT, abdomen and pelvis CT: Added diagnostic workup allowance when metastatic disease is clinically suspected at presentation
  • MRI Breast: Addition/clarification of surveillance scenarios aligned with NCCN/ACR considerations
  • FDG-PET/CT: Added allowance for radiotherapy (RT) planning locoregional recurrence (e.g., confirmation of regional nodal involvement)
  • 18F-FES-PET/CT: Added that it is not indicated due to uncertain net benefit, low-level evidence, and insufficient data on outcomes
• Cervical Cancer
  • FDG-PET/CT: Update for follow-up of disease treated with either adjuvant RT or chemoradiation (NCCN alignment)
• Hepatocellular and Biliary Tract Cancers
  • FDG-PET/CT: Removed routine preop PET/CT for biliary tract cancers (NCCN alignment)
  • FDG-PET/CT: Added management allowance when standard imaging cannot be done or is nondiagnostic
• Lung Cancer – Non-Small Cell
  • FDG-PET/CT: Added management allowance when recurrence demonstrated by surveillance imaging (NCCN alignment)
• Lung Cancer – Small Cell
  • FDG-PET/CT: Clarification of initial staging allowance (NCCN alignment)
• Lymphoma – Non-Hodgkin and Leukemia
  • FDG-PET/CT: NCCN alignment for interim restaging (allowed for diffuse large B-cell lymphoma stage I-IV with or without bulky disease)
• Melanoma
  • Added surveillance option with MRI abdomen for liver metastases
• Prostate Cancer
  • 18F Fluciclovine-PET/CT, 11C Choline-PET/CT, 68GaProstate-specific membrane antigen PET/CT, or 18F-DCFPyL PET/CT
  • Addition of diagnostic workup/initial staging indication
  • Specification of androgen-receptor pathway inhibitor treatment in alignment with Carelon Radiation Oncology guidelines
• Sarcomas of Bone/Soft Tissue
  • FDG-PET/CT: Added allowance when standard imaging nondiagnostic or contraindicated (bone/soft tissue sarcoma)

For questions related to guidelines, please contact Carelon via email at MedicalBenefitsManagement.guidelines@Carelon.com. Additionally, you may access and download a copy of the current and upcoming guidelines.

Effective April 4, 2024

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

• Rituxan Hycela (rituximab and hyaluronidase) to require documentation of CD20 antigen expression

Drug/medical necessity criteria added

• Epkinly (epcoritamab-bysp) for the treatment of diffuse large B-cell lymphoma in certain adults

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

• Maintenance transcranial magnetic stimulation (TMS) is considered not medically necessary if the preceding course of intensive TMS was determined to be not medically necessary
• A repeat full intensive course of TMS is considered not medically necessary if the preceding full intensive course of TMS was determined to be not medically necessary
• A short or brief intensive course of TMS is considered not medically necessary if the preceding course of intensive TMS or maintenance TMS was determined to be not medically necessary

New medical policies
Effective April 1, 2024

Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms, 8.01.539  PBC | Premera HMO
New policy/policy renumbered

• This policy replaces Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms, 8.01.21, which is now deleted

Facet Arthroplasty, 7.01.120  PBC | Premera HMO
New policy

• Total facet arthroplasty in individuals with lumbar spinal stenosis undergoing spinal decompression is considered investigational

Fractional Carbon Dioxide (CO₂) Laser Ablation Treatment of Hypertrophic Scars or Keloids for Functional Improvement, 2.01.107  PBC | Premera HMO
New policy

• CO₂ fractional laser ablation treatment for hypertrophic scars and keloids to improve function is considered investigational

Revised medical policies

No updates this month.

New pharmacy policies

No updates this month.

Revised pharmacy policies
Effective April 1, 2024

Antibody-Drug Conjugates, 5.01.582  PBC | Premera HMO
Medical necessity criteria updated

• Padcev (enfortumab vedotin-ejfv) updated to include treatment of locally advanced or metastatic urothelial cancer in combination with pembrolizumab regardless of cisplatin-containing chemotherapy eligibility

BRAF and MEK Inhibitors, 5.01.589  PBC | Premera HMO
Medical necessity criteria added

• Braftovi (encorafenib) added in combination with Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer in adults when criteria are met

Bruton’s Kinase Inhibitors, 5.01.590  PBC | Premera HMO
Medical necessity criteria updated

• Imbruvica (ibrutinib) updated to limit use to adults

Medical necessity criteria added

• Jaypirca (pirtobrutinib) criteria added for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults when criteria are met

Cutaneous T-Cell Lymphomas (CTCL): Systemic Therapies, 5.01.532  PBC | Premera HMO
Drug/medical necessity criteria added

• Generic topical bexarotene added for the topical treatment of cutaneous lesions when criteria are met

Medical necessity criteria updated

• Oral Targretin (bexarotene) updated to require trial and failure with generic bexarotene capsules
• Istodax (romidepsin) and romidepsin injection updated to remove use for the treatment of peripheral T-cell lymphoma as this indication was withdrawn from the prescribing information
• Topical Targretin (bexarotene) updated to require trial and failure with generic topical bexarotene

Epidermal Growth Factor Receptor (EGFR) Inhibitors, 5.01.603  PBC | Premera HMO
Medical necessity criteria added

• Generic gefitinib added for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) when criteria are met

Medical necessity criteria updated

• Iressa (gefitinib) updated to require trial and failure with generic gefitinib
• Tagrisso (osimertinib) updated to include treatment of certain adult individuals with locally advanced or metastatic NSCLC
• Tarceva (erlotinib) updated to require trial and failure with generic erlotinib

Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625  PBC | Premera HMO
Medical necessity criteria updated

• Initial gender dysphoria criteria updated from requiring diagnosis of confirmed gender dysphoria according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria to confirmation of the diagnosis of gender dysphoria, including verification that all diagnostic criteria for gender dysphoria are met as specified in the current version of the DSM

Intravenous Iron Replacement Products, 5.01.630  PBC | Premera HMO
Medical necessity criteria updated

• Injectafer (ferric carboxymaltose) updated to include treatment of chronic heart failure in adults when criteria are met

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

• Zelsuvmi (berdazimer) added to Brand Molluscum Contagiosum Agents
• Zoryve (roflumilast) foam added to Topical Seborrheic Dermatitis Agents, Brand

Medical necessity criteria updated

• Ycanth (cantharidin) updated step therapy requirement to include Zelsuvmi (berdazimer)

Oral Iron Chelating Agents, 5.01.613  PBC | Premera HMO
Medical necessity criteria updated

• Ferriprox (deferiprone) updated to require trial with generic deferiprone

Pharmacologic Treatment of Psoriasis, 5.01.629  PBC | Premera HMO
Medical necessity criteria updated

• Brand preferred product step therapy requirement for Sotyktu (deucravacitinib) updated from trial of three agents to one agent

Pharmacotherapy of Cushing’s Disease and Acromegaly, 5.01.548  PBC | Premera HMO
Medical necessity criteria updated

• Tibsovo (ivosidenib) updated to include the treatment of myelodysplastic syndromes
• Welireg (belzutifan) updated to include the treatment of renal cell carcinoma
• Treatment of locally advanced or metastatic urothelial carcinoma with susceptible FGFR2 [fibroblast growth factor receptor] genetic alterations removed from Balversa (erdafitinib) criteria

Pharmacotherapy of Perinatal/Infantile and Juvenile-Onset Hypophosphatasia (HPP), 5.01.573  PBC | Premera HMO
Medical necessity criteria updated

• Strensiq (asfotase alfa) updated to include a prescriber requirement

Prostate Cancer Targeted Therapies, 5.01.544  PBC | Premera HMO
Medical necessity criteria updated

• Xtandi (enzalutamide) updated to include coverage criteria for certain individuals with non-metastatic castration-sensitive prostate cancer

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620  PBC | Premera HMO
Medical necessity criteria updated

• Vabysmo (faricimab-svoa) updated to include treatment of macular edema following retinal vein occlusion

No updates this month.

Effective April 1, 2024

Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms, 8.01.21

• This policy is replaced with Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms, 8.01.539

Added codes
Effective April 1, 2024

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

Q4305, Q4306, Q4307, Q4308, Q4309, Q4310

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

A2026

Botulinum Toxin, 5.01.512  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J0589

C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J2782, J9376

Carelon Management Genetic Testing
Now reviewed by Carelon Medical Benefits Management for medical necessity and prior authorization

0439U, 0440U, 0444U, 0448U, 0449U

Drugs for Rare Diseases, 5.01.576  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

G0138, J1202, J1203

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

0390U, 81382

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J7354

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

J1323, J9248, J3055

Myoelectric Prosthetic and Orthotic Components for the Upper Limb, 1.04.502  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

L7180

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

0441U, 0442U, 0443U, 0445U, 33269, A4593, A4594, E0152, E0738, E0739, H0051

Nonpharmacologic Treatment of Hyperhidrosis, 8.01.519  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

11450, 11451, 69676

Pharmacologic Treatment of Neuropathy, Fibromyalgia, and Seizure Disorders, 5.01.521  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J7336

Pharmacotherapy of Arthropathies, 5.01.550  PBC | Premera HMO
Now requires review for medical necessity.

C9166

Now requires review for medical necessity and prior authorization.

Q5133

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
Now requires review for medical necessity.

C9168

Pharmacotherapy of Multiple Sclerosis, 5.01.565  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

Q5134

Serum Biomarker Panel Testing for Systemic Lupus, 2.04.123  PBC | Premera HMO
Now requires review for investigational.

0446U, 0447U

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620  PBC | Premera HMO
Now requires review for medical necessity and prior authorization.

J0177

Revised codes

No updates this month.

Removed codes
Effective April 1, 2024

Amniotic Membrane and Amniotic Fluid, 7.01.583  PBC | Premera HMO
Code terminated

Q4244

Botulinum Toxin, 5.01.512  PBC | Premera HMO
Code terminated

C9160

C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
Code terminated

C9162

Folate Antimetabolites, 5.01.617  PBC | Premera HMO
No longer requires review.

J9255

Medical Necessity Criteria for Pharmacy Edits, 5.01.605  PBC | Premera HMO
Code terminated

C9164

Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
Code terminated

C9163, C9165

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620  PBC | Premera HMO
Code terminated

C9161

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.