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
Effective May 1, 2024

Cardiovascular Risk Panels, 2.04.509  PBC | Premera HMO
New policy

• This policy replaces Cardiovascular Risk Panels, 2.04.100, which is now deleted

Cranial Electrotherapy Stimulation and Auricular Electrostimulation, 8.01.540  PBC | Premera HMO
New policy

• This policy replaces Cranial Electrotherapy Stimulation and Auricular Electrostimulation, 8.01.58, which is now deleted

Revised medical policies
Effective May 1, 2024

Cosmetic and Reconstructive Services, 10.01.514  PBC | Premera HMO
Medical necessity criteria updated

• Letybo added to list of pharmaceutical agents considered cosmetic
• Clarified that Daxxify is considered cosmetic when used for the treatment of wrinkles

Transcatheter Aortic Valve Implantation for Aortic Stenosis, 7.01.132  PBC | Premera HMO
Medical necessity criteria removed

• Removed criterion of left ventricular ejection fraction greater than 20% for transcatheter aortic valve implantation (TAVI) and valve-in valve TAVI

Medical necessity criteria added

• Statement added for consideration of individuals who may be at high risk of open surgery but not demonstrated on Society of Thoracic Surgeons risk score

Upper Gastrointestinal (UGI) Endoscopy for Adults, 2.01.533  PBC | Premera HMO
Medical necessity criteria updated

• UGI is considered medically necessary for family history of gastric, esophageal, or duodenal cancer in a first degree relative
• UGI may be considered medically necessary for the evaluation of the alarm symptom of iron deficiency anemia

New pharmacy policies

No updates this month.

Revised pharmacy policies
Effective May 1, 2024

Amyloid Antibodies for the Treatment of Alzheimer’s Disease, 5.01.626  PBC | Premera HMO
Drug/medical necessity criteria added

• Leqembi (lecanemab-irmb) added for the treatment of Alzheimer’s disease

Amyotrophic Lateral Sclerosis (ALS) Medications, 5.01.578  PBC | Premera HMO
Drug added

• Teglutik (riluzole) added for the treatment of ALS when criteria are met

BCR-ABL Kinase Inhibitors, 5.01.518  PBC | Premera HMO
Drug/medical necessity criteria added

• Phyrago (dasatinib) added for resistance or intolerance to, prior therapy with generic imatinib

Drug/medical necessity criteria removed

• Synribo (omacetaxine) removed as it has been withdrawn from the market

Medical necessity criteria updated

• Clarified that the imatinib step therapy requirement is limited to generic imatinib for Sprycel (dasatinib), Scemblix (asciminib), Tasigna (nilotinib), and Iclusig (ponatinib)
• Iclusig (ponatinib) updated to include treatment of newly diagnosed acute lymphoblastic leukemia

C3 and C5 Complement Inhibitors, 5.01.571  PBC | Premera HMO
Drug/medical necessity criteria added

• Fabhalta (iptacopan) added for the treatment of PNH when criteria are met
• Ultomiris (ravulizumab-cwvz) added for the treatment of neuromyelitis optica spectrum disorder when criteria are met

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

• Hemangeol (propranolol) added for the treatment of proliferating infantile hemangioma when criteria are met

Medical necessity criteria updated

• Livmarli (maralixibat) updated to include the treatment of progressive familial intrahepatic cholestasis when criteria are met
• Lamzede (velmanase alfa-tycv) updated to include the following requirements:
  • Diagnosis of alpha-mannosidosis confirmed by bi-allelic pathogenic variants in the MAN2B1 gene
  • Individual does not have neurological symptoms
  • Individual is able to ambulate without support
  • Individual has not received a hematopoietic stem cell transplant or bone marrow transplant
  • Dose is limited to 1 mg/kg weekly

Dupixent (dupilumab), 5.01.575  PBC | Premera HMO
Medical necessity criteria updated

• Dupixent (dupilumab) age requirement updated from 12 years of age or older to 1 year of age or older for eosinophilic esophagitis

Immune Checkpoint Inhibitors, 5.01.591  PBC | Premera HMO
Medical necessity criteria updated

• Imfinzi (durvalumab) criteria updated to include treatment of metastatic non-small cell lung cancer (NSCLC) in combination with Imjudo (tremelimumab-actl)
• Imjudo (tremelimumab-actl) criteria updated to include treatment of metastatic NSCLC in combination with Imfinzi (durvalumab)
• Keytruda (pembrolizumab) criteria updated to include treatment of metastatic non-squamous NSCLC in combination with Pemfexy (pemetrexed)
• Keytruda (pembrolizumab) criteria updated to include treatment of locally advanced or metastatic urothelial cancer in combination with Padcev (enfortumab vedotin)
• Keytruda (pembrolizumab) criteria updated to include treatment of Stage III-IVA cervical cancer, and HER2-negative gastric or gastroesophageal junction adenocarcinoma
• Opdivo (nivolumab) criteria updated to include treatment of unresectable or metastatic urothelial carcinoma in combination with cisplatin and gemcitabine

Drug/medical necessity criteria added

• Loqtorzi (toripalimab-tpzi) added for the treatment of:
  • Metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine
  • Recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy
• Tevimbra (tislelizumab-jsgr) added for the treatment of unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-L1 inhibitor

Medical necessity criteria removed

• Removed Opdivo (nivolumab) criteria for hepatocellular carcinoma in individuals who have been previously treated with sorafenib as this indication was withdrawn

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

• Vfend (voriconazole) tablets and oral suspension added to Antifungals
• Verkazia (cyclosporine ophthalmic emulsion) added to Dry Eye Treatments
• Tryvio (aprocitentan) added to Hypertensive Agents, Brand
• Ambien (zolpidem), Lunesta (eszopiclone), Rozerem (ramelteon), Silenor (doxepin), and brand zolpidem tartrate added to Hypnotics
• Xhance (fluticasone proprionate) added for the treatment of chronic rhinosinusitis without nasal polyps to Intranasal Corticosteroid Products, Brands
• Rezdiffra (resmetirom) added to MASH Agents
• Elmiron (pentosan polysulfate sodium) added to Cystitis Agents
• Nascobal (cyanocobalamin nasal spray) and generic cyanocobalamin nasal spray added to Vitamin Agents

Medical necessity criteria updated

• Condylox (podofilox) criteria updated to clarify that step therapy requirement should be limited to the solution version of generic topical podofilox

Miscellaneous Oncology Drugs, 5.01.540  PBC | Premera HMO
Drug/medical necessity criteria added

• Thalomid (thalidomide) added for the treatment of newly diagnosed multiple myeloma when used in combination with dexamethasone, and cutaneous manifestations of moderate to severe erythema nodosum leprosum
• Aphexda (motixafortide) added for the treatment of multiple myeloma when criteria are met

Medical necessity criteria updated

• Ogsiveo (nirogacestat) updated to include a trial and failure of, or intolerance to, generic sorafenib
• Onivyde (irinotecan) updated to clarify that all coverage criteria is limited to adults
• Onivyde (irinotecan) updated to include criteria for the first-line treatment of metastatic pancreatic adenocarcinoma when combined with oxaliplatin, fluorouracil, and leucovorin

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

• Agamree (vamorolone) and Emflaza (deflazacort) criteria updated to include a trial and failure of, or intolerance to, generic deflazacort

Drug/medical necessity criteria added

• Generic deflazacort added for the treatment of Duchenne muscular dystrophy in individuals aged 2 years or older

Pharmacologic Treatment of Psoriasis, 5.01.629  PBC | Premera HMO
Drug/medical necessity criteria added

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] added as a preferred product
• Humira (adalimumab) (Cordavis) [NDCs starting with 83457] added as a non-preferred product
• Spevigo (spesolimab-sbzo) SC injection added to IL-36 Receptor Antagonist

Medical necessity criteria updated

• Spevigo (spesolimab-sbzo) criteria updated from 18 years or older to 12 years or older

Pharmacotherapy of Arthropathies, 5.01.550  PBC | Premera HMO
Drug added

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] added as a preferred product
• Humira (adalimumab) (Cordavis) [NDCs starting with 83457] added as a non-preferred product

Medical necessity criteria added

• Orencia (abatacept) added to include criteria for individuals aged 2 years or older with active psoriatic arthritis

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563  PBC | Premera HMO
Drug/medical necessity criteria added

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] added as a preferred product
• Humira (adalimumab) (Cordavis) [NDCs starting with 83457] added as a non-preferred product

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564  PBC | Premera HMO
Drug/medical necessity criteria added

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] added as a preferred product
• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] added as a preferred product
• Humira (adalimumab) (Cordavis) [NDCs starting with 83457] added as a non-preferred product

Pharmacotherapy of Thrombocytopenia, 5.01.566  PBC | Premera HMO
Drug/medical necessity criteria added

• Alvaiz (eltrombopag choline) added for the treatment of hepatitis C-induced thrombocytopenia chronic immune thrombocytopenia, and severe aplastic anemia when criteria are met
• Nplate (romiplostim) added to for the treatment of chemotherapy-induced thrombocytopenia when criteria are met
• Adzynma (ADAMTS13, recombinant-krhn) added for the treatment of congenital thrombotic thrombocytopenic purpura when criteria are met

Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556  PBC | Premera HMO
Drug/medical necessity criteria added

• Humira (adalimumab) (AbbVie) [NDCs starting with 00074] added as a preferred product
• Humira (adalimumab) (Cordavis) [NDCs starting with 83457] added as a non-preferred product

Effective May 1, 2024

Chelation Therapy, 8.01.535

• Policy archived due to low utilization

Effective May 1, 2024

Cardiovascular Risk Panels, 2.04.100

• This policy is replaced with Cardiovascular Risk Panels, 2.04.509

Cranial Electrotherapy Stimulation and Auricular Electrostimulation, 8.01.58

• This policy is replaced with Cranial Electrotherapy Stimulation and Auricular Electrostimulation, 8.01.540

Added codes
Effective May 1, 2024

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

J2277

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

C9781

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

K1037

Revised codes
Effective May 1, 2024

Amyloid Antibodies for the Treatment of Alzheimer’s Disease, 5.01.626  PBC | Premera HMO
No longer requires review for medical necessity and prior authorization. Now requires review for investigational.

J0172

Removed codes
Effective May 1, 2024

Carelon Management Advanced Imaging
No longer requires review.

75580

Cranial Electrotherapy Stimulation and Auricular Electrostimulation, 8.01.540  PBC | Premera HMO
No longer requires review.

J0172

Evaluation of Biomarkers for Alzheimer Disease, 2.04.521  PBC | Premera HMO
No longer requires review.

0346U, 0358U, 0361U, 0412U

Non-covered Experimental/Investigational Services, 10.01.533  PBC | Premera HMO
No longer requires review.

0445U

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.

No updates this month.