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
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 theCarelon 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
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 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
- 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
- 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
- Zevalin (Ibritumomab tiuxetan)
- For the treatment of certain types of B-cell non-Hodgkin lymphoma
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.
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 criteria for the palliative treatment of advanced prostate cancer and added criteria 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