Medical Policy and Coding Updates

Effective August 2, 2024

C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
New policy

• 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
New policy

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

Effective July 4, 2024

Pharmacologic Treatment of Neuropathy, Fibromyalgia, and Seizure Disorders, 5.01.521  PBC | Premera HMO
Drug/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
Drug/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

New medical policies

No updates this month.

Revised medical policies
Effective June 1, 2024

Amniotic Membrane and Amniotic Fluid, 7.01.583  PBC | Premera HMO
Medical necessity criteria updated

• AmnioExcel added to the list of medically necessary products for the treatment of nonhealing diabetic lower-extremity ulcers

Islet Transplantation for Chronic Pancreatitis and Donislecel-jujn for Type 1 Diabetes, 7.03.12  PBC | Premera HMO
Title change

• Policy title updated from “Islet Transplantation” to “Islet Transplantation for Chronic Pancreatitis and Donislecel-jujn for Type 1 Diabetes”

Investigational criteria updated

• Islet transplantion cellular therapy product, donislecel-jujn, added to investigational criteria

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

• EpiMonitor, Rejoyn, and MamaLift Plus added to list of Food and Drug Administration (FDA) approved prescription digital therapeutics considered investigational

Treatment of Varicose Veins/Venous Insufficiency, 7.01.519  PBC | Premera HMO
Investigational criteria added

• Endovenous chemical ablation with microfoam sclerotherapy (i.e., Varithena [polidocanol 1%]) of tributary veins is considered investigational

New pharmacy policies

No updates this month.

Revised pharmacy policies
Effective June 1, 2024

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

• Brukinsa (zanubrutinib) may be considered medically necessary for the treatment of follicular lymphoma when criteria are met
• Imbruvica (ibrutinib) age requirement for treatment of treatment of chronic graft versus host disease updated from 18 years of age or older to 1 year or older

Chronic Hepatitis B Antiviral Therapy, 5.01.636  PBC | Premera HMO
Drug/medical necessity criteria removed

• Hepsera (adefovir dipivoxil) removed as it was withdrawn from the market

Medical necessity criteria updated

• Vemlidy (tenofovir alafenamide) age requirement updated from 12 years of age and older to 6 years of age or older
• Treatment with Vemlidy (tenofovir alafenamide) to require trial and failure with generic tenofovir disoproxil fumarate

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

• Rybrevant (amivantamab-vmjw) criteria to include first-line treatment of non-small cell lung cancer in combination with chemotherapy when criteria are met
• Rybrevant (amivantamab-vmjw) criteria to include a quantity limit

Gene Therapies for Thalassemia, 5.01.42  PBC | Premera HMO
Drug/medical necessity criteria added

• Casgevy (exagamglogene autotemcel) added for treatment of transfusion-dependent β-thalassemia when criteria are met

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

• Dymista (azelastine-fluticasone) added to Intranasal Corticosteroid Products, Brands
• Qlosi (pilocarpine) and Vuity (pilocarpine) added to Ophthalmic Cholinergic Agonists

Multiple Receptor Tyrosine Kinase Inhibitors, 5.01.534  PBC | Premera HMO
Medical necessity criteria updated

• Nexavar (sorafenib) is considered medically necessary in adults only per FDA prescribing information
• Indications for treatment of Nexavar (sorafenib) updated to include desmoid tumors
• Treatment with Nexavar (sorafenib) to require trial and failure with generic sorafenib
• Treatment with Sutent (sunitinib) to require trial and failure with the generic sunitinib

Drugs/medical necessity criteria added

• Generic sorafenib and generic sunitinib may be considered medically necessary when criteria are met

Phosphoinositide 3-kinase (PI3K) Inhibitors, 5.01.592  PBC | Premera HMO
Medical necessity criteria updated

• Piqray (alpelisib) coverage criteria to include treatment of breast cancer in certain pre- and peri-menopausal individuals when criteria are met

No updates this month.

No updates this month.

Added codes
Effective June 1, 2024

Microprocessor-Controlled and Powered Prostheses and Orthoses for the Lower Limb, 1.04.503  PBC | Premera HMO
Now requires review for investigational.

L5969

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

C9399

Prescription Digital Therapeutics, 13.01.500  PBC | Premera HMO
Now requires review for investigational.

S9002

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

99459

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523  PBC | Premera HMO
Now requires review for medical necessity, including site of service and prior authorization.

J2327, J2329

Revised codes
Effective June 1, 2024

Leadless Cardiac Pacemaker, 2.02.515  PBC | Premera HMO
Now requires review for investigational and prior authorization.

0795T, 0796T, 0797T, 0801T, 0802T, 0803T

Microprocessor-Controlled and Powered Prostheses and Orthoses for the Lower Limb, 1.04.503  PBC | Premera HMO
No longer requires review for medical necessity and prior authorization. Now requires review for investigational.

L5973

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
Now requires review for site of service. Currently requires review for medical necessity and prior authorization.

J2327

Removed codes
Effective June 1, 2024

Pharmacologic Treatment of Neuropathy, Fibromyalgia, and Seizure Disorders, 5.01.521  PBC | Premera HMO
No longer requires review.

J7336

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.