Effective May 10, 2021
Updates to AIM Specialty Health® Clinical Appropriateness Guidelines
Effective for dates of service on and after May 10, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Molecular Testing of Solid and Hematologic Tumors and Malignancies
Updates by section:
Conditions for which testing may be medically necessary (Table 1)
The following solid tumor markers were added:
- Cholangiocarcinoma: FGFR2 and FoundationOne® CDx
- Colorectal cancer: Praxis Extended RAS panel
- Neuroblastoma: chromosomal microarray analysis (CMA), MYCN, ALK
- Non-small cell lung cancer (NSCLC): Oncomine Dx Target Test
- Ovarian cancer: myChoice® CDx
- Prostate cancer (Suspected): SelectMDx
- Prostate cancer: FoundationOne® CDx
- Tumor agnostic/all solid tumors: microsatellite instability (MSI) and FoundationOne® CDx
Breast Cancer Gene Expression Classifiers
- Criteria were clarified to confirm the patient has undergone surgery and full pathological staging
- Additional statement added explaining testing is not medically necessary to guide decision making for extended endocrine therapy
- OncotypeDx Recurrence Score test: the definition of unfavorable histological features was clarified
Minimal Residual Disease (MRD)
- Testing criteria were revised to require testing performed on bone marrow
Targeted Molecular Testing for NTRK Fusions
Prostate Cancer (symptomatic cancer screening)
- Added criteria for SelectMDx (81479)
- Criteria for PCA3 (81313), ExomeDx (0005U) and ConfirmMDx (81551) were revised
Effective May 6, 2021
Hereditary Angioedema, 5.01.587
Medical necessity criteria updated
- Berinert® (pdC1-INH)
- Added coverage for acquired angioedema
- Cinryze® (pdC1-INH)
- Added patient age, limits to danazol use, and acute HAE frequency requirements
- Firazyr® (icatibant)
- Requires use of generic icatibant first
- Haegarda® (pdC1-INH)
- Added limits to danazol use and acute HAE frequency requirements
- Ruconest® (rhC1-INH)
- Age criteria revised to patients 13 and older
- Takhzyro® (lanadelumab-flyo)
- Added limits to danazol use, acute HAE frequency requirements, and quantity limit
Effective April 7, 2021
Immune Globulin Therapy, 8.01.503
Site of service review added
Miscellaneous Oncology Drugs, 5.01.540
New drug added to policy
- Jelmyto™ (mitomycin)
- Treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC)
Site of Service Infusion Drugs and Biologic Agents, 11.01.523
Site of service review added
Effective March 14, 2021
Updates to AIM Specialty Health® Clinical Appropriateness Guidelines
Effective for dates of service on and after March 14, 2021
The following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Advanced Imaging
Updates by section:
Brain ImagingAtaxia, congenital or hereditary
- Combined with congenital cerebral anomalies to create one section
Acoustic neuroma
- More frequent imaging for a watch and wait or incomplete resection
- New indication for neurofibromatosis type 2 (NF 2)
- More frequent imaging when MRI shows findings suspicious for recurrence
- Single post-operative MRI following gross total resection
- Included pediatrics with known acoustics (rare but NF 2)
Tumor – not otherwise specified
- Repurposed for surveillance imaging of low-grade neoplasms
Seizure disorder and epilepsy
- Limited imaging for the management of established generalized epilepsy
- Required optimal medical management (aligning adult and pediatric language) prior to imaging for management in epilepsy
Headache
- Removed response to treatment as a primary headache red flag
- Included pregnancy as a red flag risk factor
Mental status change and encephalopathy
- Added requirement for initial clinical and lab evaluation to assess for a more specific cause
Brain Imaging and Head and Neck Imaging
Hearing loss
- Added CT temporal bone for evaluation of sensorineural hearing loss in any pediatric patients or in adults for whom MRI is nondiagnostic or unable to be performed
- Higher allowed threshold for consecutive frequencies to establish SNHL
- Removed CT brain as an alternative to evaluating hearing loss based on ACR guidance
Tinnitus
- Removed sudden onset symmetric tinnitus as an indication for advanced imaging
Chest Imaging and Head and Neck Imaging
Hoarseness, dysphonia, and vocal cord weakness/paralysis – primary voice complaint
- Required laryngoscopy for the initial evaluation of all patients with primary voice complaint
Head and Neck Imaging
Sinusitis/rhinosinusitis
- Added more flexibility for the method of conservative treatment in chronic sinusitis
- Required conservative management prior to repeat imaging for patients with prior sinus CT
Temporomandibular joint dysfunction
- Removed requirement for radiographs/ultrasound
Cerebrospinal fluid (CSF) leak of the skull base
- Added scenario for management of known leak with change in clinical condition
Oncologic Imaging
General content changes to align with current oncology recommendations
- Removed indications/parameters not addressed by NCCN
- Average risk inclusion criteria added for CT colonography
- New allowances added for MRI abdomen and/or MRI pelvis by tumor type, liver metastatic disease
- New indications added for acute leukemia (CT, PET/CT), multiple myeloma (MRI, PET/CT), ovarian cancer surveillance (CT), bone sarcoma (PET/CT)
- Updated standard imaging pre-requisites prior to PET/CT for bladder/renal pelvis/ureter, colorectal, esophageal/GE junction, gastric and non-small cell lung cancers
- Additional PET/CT management scenarios added for cervical cancer, Hodgkin lymphoma
Cancer screening
- New indication added for pancreatic cancer screening
Breast cancer
- New PET/CT indication added for restaging/treatment response for bone-only metastatic disease and limitation of post-treatment breast MRI after breast conserving therapy or unilateral mastectomy
Prostate Cancer
- MRI pelvis: removed TRUS biopsy requirement, allowance if persistent/unexplained elevation in PSA or suspicious DRE
Axumin PET/CT
- Updated inclusion criteria (removed general MRI pelvis requirement, additional allowance for rising PSA with non-diagnostic mpMRI)
Effective for dates of service on and after March 14, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Advanced Imaging of the Heart
Updates by section:
Evaluation of patients with cardiac arrhythmias
- Updated repeat TTE criteria
- Added restrictions for patients whose initial echocardiogram shows no evidence of structural heart disease, and follow-up echocardiography is not appropriate for ongoing management of arrhythmia
Evaluation of signs, symptoms, or abnormal testing
- Added restrictions for TTE in evaluation of palpitation and lightheadedness based on literature
Effective for dates of service on and after March 14, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Radiation Oncology
Updates by section:
Special Treatment Procedure
- Removed IV requirement for chemotherapy
CNS cancer: IMRT for glioblastomas, other gliomas, brain metastases
- Eliminated the plan comparison requirement based on feedback from reviewers that essentially all cases were able to meet criteria - same change for high-grade and low-grade gliomas
- Added new indication for hippocampal sparing whole brain radiotherapy
Lung cancer: IMRT and SBRT for non-small cell, SBRT for small cell; fractionation for non-small cell
- Eliminated the plan comparison requirement for IMRT to treat stage III non-small cell lung cancer
- Removed “due to a medical contraindication” language
- Added new indication as an alternative to surgical resection when certain conditions apply
- Adjusted fractions of thoracic radiotherapy for non-small cell lung cancer
Proton Beam Therapy
- Added new indication for hepatocellular carcinoma and intrahepatic cholangiocarcinoma