Effective March 17, 2024
Updates to Carelon Medical Benefits Management Clinical Appropriateness Guidelines
(formerly AIM Specialty Health)
Effective for dates of service on and after March 17, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Genetic Testing Clinical Appropriateness Guidelines
Updates by section
Cell-free DNA Testing (Liquid Biopsy) for the Management of Cancer
- Replaced “contraindicated” with “unsafe or infeasible” for clarification of tissue biopsy
Prenatal Testing using Cell Free DNA
- Clarified required components of genetic counseling
- For viable singleton or twin pregnancy, clarified sex prediction for pregnancies at risk for an X-linked disorder
Somatic Tumor Testing
- Clarification for Food and Drug Administration approved test moved to umbrella criteria
- Expanded BRAF V600E criteria to include RAS variant in localized colorectal cancer
- Removed Afirma standalone assay for testing indeterminate thyroid nodules
- Restricted testing to 50 genes or less for bladder, colorectal, ovarian, acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), chronic myelogenous leukemia, myeloproliferative neoplasms, and myelodyplastic syndromes (MDS)
- Expanded specimen type in tissue-based testing for ALL, AML, and MDS. For ALL, specimen-type, measurable residual disease and BCR-ABL1 monitoring
Effective March 7, 2024
Carelon Medical Benefits Management Clinical Appropriateness Guidelines
(formerly AIM Specialty Health) added services for review.
Effective for dates of service on and after March 7, 2024, the Plan will utilize Carelon Medical Benefits Management to apply clinical appropriateness guidelines and cancer treatment pathways.
Additions by section
Therapeutic Radiopharmaceuticals
- Updated Azedra (iobenguane I 131)
- For the treatment of iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma in individuals who require systemic anticancer therapy
- Removed from policy Therapeutic Radiopharmaceuticals in Oncology, 6.01.525
- Updated Xofigo (radium Ra 223 dichloride)
- For the treatment of castration-resistant prostate cancer with symptomatic bone metastases
- Removed from Therapeutic Radiopharmaceuticals in Oncology, 6.01.525
- Added Zevalin (Ibritumomab tiuxetan)
- For the treatment of certain types of B-cell non-Hodgkin lymphoma
Gene Therapies for Thalassemia, 5.01.42 PBC | Premera HMO
Medical necessity criteria updated
- Updated Zynteglo (betibeglogene autotemcel) criteria including:
- Requirement that the individual does not have an uncorrected bleeding disorder or history of advanced liver disease
- Individual must be 50 years of age or younger
- Individuals 5 years of age or younger must weigh a minimum of 6 kilograms
- Individual must be clinically stable and eligible to undergo a hematopoietic stem cell transplant
Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625 PBC | Premera HMO
Medical necessity criteria updated
- Eligard’s (leuprolide acetate) removed from coverage for the palliative treatment of advanced prostate cancer and added coverage for the treatment of advanced prostate cancer
- Updated initial gender dysphoria criteria to require documentation that the individual has no comorbid psychiatric disorders and that potential adverse effects have been discussed including specifically possible effects on fertility
- Updated initial gender dysphoria criteria to clarify that an individual must be ≥ 14 years of age, Tanner stage 2 or higher puberty onset based on physical examination, or Tanner stage 2 or higher puberty onset based on serum testosterone level in
addition to being less than 23 years of age
- Updated initial gender dysphoria criteria to clarify that the individual has not undergone a gonadectomy
- Added a note that for individuals assigned female at birth, total testosterone of at least 11 ng/dL or 0.36 nmol/L is required to confirm Tanner stage 2
- Added a note that use of these products is also investigational for the treatment of gender dysphoria for individuals who have completed puberty
- Updated gender dysphoria re-authorization criteria to require documented specific rationale for why the individual has not undergone a gonadectomy if the individual ≥ 22 years of age, that suppression of secondary sex characteristics is based on physical
examination, and documentation of annual testing of bone age or bone density
Growth Hormone Therapy, 5.01.500 PBC | Premera HMO
Drug added
- Ngenla (somatrogon-ghla) added as a second-line agent for the treatment of growth hormone deficiency
Pharmacologic Treatment of Hemophilia, 5.01.581 PBC | Premera HMO
Medical necessity criteria updated
- Hemgenix to require:
- Factor IX prophylaxis to be discontinued following administration of Hemgenix
- Assessment by hepatologist if the individual has radiological liver abnormalities or sustained liver enzyme elevations
- Roctavian to require:
- Factor VIII prophylaxis to be discontinued following administration of Roctavian
- Documentation demonstrating that the individual received education relating to alcohol abstinence and the use of concomitant medications
Effective February 7, 2024
Botulinum Toxins, 5.01.512 PBC | Premera HMO
Medical necessity criteria updated
- Botox, Dysport, Myobloc, and Xeomin for the treatment of cervical dystonia require the individual does not have acute cervical dystonia caused by exposure to dopamine receptor-blocking drugs
Effective January 1, 2024
Herceptin (trastuzumab) and Other HER2 Inhibitors, 5.01.514 PBC | Premera HMO
Medical necessity criteria updated
- Trazimera (trastuzumab-qyyp)
- Updated to second-line agent
Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502 PBC | Premera HMO
Medical necessity criteria updated
- Ruxience (rituximab-pvvr)
- Updated to a second-line product
Pharmacotherapy of Arthropathies, 5.01.550 PBC | Premera HMO
Medical necessity criteria updated
- Simponi Aria (golimumab) IV
- Updated to a first-line product for all indications
- Avsola (IV)
- Updated to a first-line product for all indications
- Added to a list of preferred infliximab products to be tried and failed prior to trying non-preferred infliximab products
- Inflectra (infliximab-dyyb) IV
- Updated to a second-line product for all indications
- Removed from the list of preferred products to be tried and failed prior to trying non-preferred infliximab products
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563 PBC | Premera HMO
Medical necessity criteria updated
- Avsola (infliximab-axxq) IV
- Updated to a first-line product for all indications
- Added to a list of preferred infliximab products to be tried and failed prior to trying non-preferred infliximab products
- Inflectra (infliximab-dyyb) IV
- Updated to a second-line product for all indications
- Removed from the list of preferred products to be tried and failed prior to trying non-preferred infliximab products
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564 PBC | Premera HMO
Medical necessity criteria updated
- Avsola (infliximab-axxq) IV
- Updated to a first-line product for the treatment of pyoderma gangrenosum
- Added to a list of preferred infliximab products to be tried and failed prior to trying non-preferred infliximab products
- Inflectra (infliximab-dyyb) IV
- Updated to a second-line product for the treatment of pyoderma gangrenosum
- Removed from the list of preferred products to be tried and failed prior to trying non-preferred infliximab products
Pharmacologic Treatment of Psoriasis, 5.01.629 PBC | Premera HMO
Medical necessity criteria updated
- Avsola (infliximab-axxq) IV
- Updated to a first-line product
- Added to a list of preferred infliximab products to be tried and failed prior to trying non-preferred infliximab products
- Inflectra (infliximab-dyyb) IV
- Updated to a second-line product
- Removed from the list of preferred products to be tried and failed prior to trying non-preferred infliximab products
Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556 PBC | Premera HMO
Medical necessity criteria updated
- Ruxience (rituximab-pvvr)
- Updated to a second-line product
Use of Granulocyte Colony-Stimulating Factors (G-CSF), 5.01.551 PBC | Premera HMO
Medical necessity criteria updated
- Fulphila (pegfilgrastim-jmbd) and Nyvepria (pegfilgrastim-apgf)
- Updated to a first-line product for individuals less than 18 years of age
- Updated to a second-line product for individuals 18 years and older
- Udenyca (pegfilgrastim-cbqv) and Ziextenzo (pegfilgrastim-bmez)
- Updated to a second-line product for individuals less than 18 years of age
- Updated to a third-line product for individuals 18 years and older
Effective December 7, 2023
Dry Needling of Myofascial Trigger Points, 2.01.100 PBC | Premera HMO
New policy
- Reinstating previously archived policy
- Dry needling of trigger points for the treatment of myofascial pain is considered investigational
Miscellaneous Oncology Drugs, 5.01.540 PBC | Premera HMO
Drugs added
- Temodar (temozolomide) IV
- For the treatment of newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment, or for refractory anaplastic astrocytoma in adult individuals who have experienced disease progression on a drug regimen containing
nitrosourea and procarbazine
- Unituxin (dinutuximab) IV
- For use in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid, for the treatment of high-risk neuroblastoma in pediatric individuals who achieve at least a partial response to prior first-line
multiagent, multimodality therapy
Site of Service: Infusion Drugs and Biologic Agents, 11.01.523 PBC | Premera HMO
Medical necessity criteria updated
- Monoclonal antibodies for the treatment of lymphoma and Rituximab may be delivered in the inpatient setting when medical necessity criteria for site of service are met