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 was clarified to confirm the patient has undergone surgery and full pathological staging
- A statement explaining testing is not medically necessary to guide decision making for extended endocrine therapy was added
- OncotypeDx Recurrence Score test: the definition of unfavorable histological features was clarified
Minimal Residual Disease (MRD)
- Testing criteria was 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
- Removal of indications/parameters not addressed by NCCN
- Average risk inclusion criteria for CT colonography
- New allowances for MRI abdomen and/or MRI pelvis by tumor type, liver metastatic disease
- New indications 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 for cervical cancer, Hodgkin lymphoma
Cancer screening
- New indication for pancreatic cancer screening
Breast cancer
- New PET/CT indication 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: removal of TRUS biopsy requirement, allowance if persistent/unexplained elevation in PSA or suspicious DRE
Axumin PET/CT
- Updated inclusion criteria (removal of 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
Effective March 3, 2021
Medical Necessity Criteria for Pharmacy Edits, 5.01.605
New policy section
New drug added to policy
- Actimmune® (interferon gamma-1b)
- Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD)
- Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO)
Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620
New policy
The following brand drugs have been added and may be considered medically necessary when criteria are met:
- Beovu® (brolucizumab-dbll)
- Treatment of neovascular (wet) age-related macular degeneration (AMD)
- Eylea® (aflibercept)
- Treatment of neovascular (wet) age-related macular degeneration (AMD)
- Treatment of macular edema following retinal vein occlusion (RVO)
- Treatment of diabetic macular edema (DME)
- Treatment of diabetic retinopathy (DR)
- Lucentis® (ranibizumab)
- Treatment of neovascular (wet) age-related macular degeneration (AMD)
- Treatment of macular edema following retinal vein occlusion (RVO)
- Treatment of diabetic macular edema (DME)
- Treatment of diabetic retinopathy (DR)
- Treatment of myopic choroidal neovascularization (mCNV)
- Macugen® (pegaptanib)
- Treatment of neovascular (wet) age-related macular degeneration (AMD)
Effective February 5, 2021
The following policies are being reinstated and used to review medical necessity for dates of service starting February 5, 2021 and after:
Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses, 1.01.11
Artificial Pancreas Device Systems, 1.01.30
Medical necessity criteria updated
- The age for an artificial pancreas device system has been lowered from age 14 to age 6 and older
- The age for a hybrid closed loop insulin delivery system has been lowered from age 7 to age 6 and older
Cochlear Implant, 7.01.05
Medical necessity criteria updated
- The age for bilateral hearing loss has been lowered from 12 months to 9 months or older
Continuous Passive Motion in the Home Setting, 1.01.10
Coronary Angiography for Known or Suspected Coronary Artery Disease, 2.02.507
Deep Brain Stimulation, 7.01.63
Hip Arthroplasty in Adults, 7.01.573
Hospital Beds and Accessories, 1.01.520
Knee Arthroplasty in Adults, 7.01.550
Knee Arthroscopy in Adults, 7.01.549
Medical necessity criteria updated
- Knee arthroscopy for a partial meniscectomy is considered not medically necessary for a degenerative tear(s) that do not result in functional impairment symptoms
Knee Orthoses (Braces), Ankle foot Orthoses and Knee-Ankle-Foot-Orthoses, 1.03.501
Mastectomy for Gynecomastia, 7.01.521
Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions, 1.01.15
Panniculectomy and Excision of Redundant Skin, 7.01.523
Patient Lifts, Seat Lifts, and Standing Devices, 1.01.519
Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation, 2.02.26
Power Operated Vehicle (Scooters) (excluding motorized wheelchairs), 1.01.527
Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers, 1.01.18
Reduction Mammoplasty for Breast-Related Symptoms, 7.01.503
Responsive Neurostimulation for the Treatment of Refractory Focal Epilepsy, 7.01.143
Rhinoplasty, 7.01.558
Semi-Implantable and Fully Implantable Middle Ear Hearing Aids, 7.01.84
Spinal Cord and Dorsal Root Ganglion Stimulation, 7.01.546
Transcatheter Aortic Valve Implantation for Aortic Stenosis, 7.01.132
Treatment of Varicose Veins, 7.01.519
Upper GI Endoscopy, 2.01.533
Medical necessity criteria updated
- Routine preoperative UGI is considered not medically necessary for individuals scheduled for bariatric surgery unless they meet the clinical criteria
Vagus Nerve Stimulation, 7.01.20
Wearable Cardioverter Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement , 2.02.506
Wheelchairs (Manual or Motorized), 1.01.501