Medical Policy and Coding Updates

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  • Updates for both non-individual and individual plans

  • 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

    • Criteria were revised

    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

    • Xembify®

    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

    • Xembify®

    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 Imaging

    Ataxia, 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

    • Interferons

    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

    New medical policies

    Effective February 1, 2021

    Nutrient/Nutritional Panel Testing, 2.04.136

    New policy

    • Nutrient/nutritional panel testing is considered investigational for all indications

    Whole Body Dual X-ray Absorptiometry to Determine Body Composition, 6.01.40

    New policy

    • Dual energy x-ray absorptiometry body composition studies are considered investigational

    Revised medical policies

    Effective February 1, 2021

    Home Nutritional Support, 8.01.502

    Medical necessity criteria added

    • RELiZORB™ immobilized lipase cartridge (B4105) may be considered medically necessary to add digestive enzymes to enteral formula when it is attached to an enteral feeding tube in patients with cystic fibrosis

    Revised pharmacy policies

    Effective February 1, 2021

    Drugs for Rare Diseases, 5.01.576

    New drug added to policy

    • Oxlumo™ (lumasiran)
      • Treatment of primary hyperoxaluria type 1 (PH1)
    • Zokinvy™ (lonafarnib)
      • Treatment of Hutchinson-Gilford progeria syndrome (HGPS) and progeroid laminopathies

    Dupixent® (dupilumab), 5.01.575

    Medical necessity criteria updates

    • Dupixent® (dupilumab)
      • Treatment of chronic rhinosinusitis with nasal polypsosis (CRSwNP)
        • Patient must have tried and failed one intranasal corticosteroid
        • Patient must have used systemic corticosteroids in the last 2 years
        • This drug must be prescribed by or in consultation with an allergist/immunologist or otolaryngologist

    Excessively High Cost Drug Products with Lower Cost, 5.01.560

    Medical necessity criteria updated

    • Generic tavaborole
      • Documented diagnosed of onychomycosis based on lab test and fungal culture
      • Patient must have tried and failed generic ciclopirox (topical) and generic terbinafine or itraconazole
      • Therapy is no longer than 48 weeks
    • Jublia® (efinaconazole)
      • Patient must have tried and failed generic tavaborole
    • Kerydin® (tavaborole)
      • Patient must have tried and failed generic tavaborole

    Removed from policy

    The following topical lidocaine products have been removed:

    • Anastia
    • Astero
    • Kamdoy
    • Lido-K
    • Lidorx
    • Lidotral
    • Lidovex
    • Lidtopic Max
    • Numbonex
    • Suvicort
    • Tranzarel
    • Vexasyn

    Hereditary Angioedema, 5.01.587

    New drug added to policy

    • Orladeyo® (berotralstat)
      • Prevention of acute angioedema attacks in patients 12 years and older

    Immune Checkpoint Inhibitors, 5.01.591

    Drugs with new indications

    • Keytruda® (pembrolizumab)
      • Treatment of patients with inoperable or metastatic triple-negative breast cancer (TNBC)
    • Opdivo® (nivolumab) and Yervoy® (ipilimumab)
      • Treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) when used together and with two cycles of platinum-doublet chemotherapy

    Indication removed

    • Opdivo® (nivolumab)
      • Metastatic small cell lung cancer (SCLC)

    Medical necessity criteria updated

    • Keytruda® (pembrolizumab)
      • Adult patient criteria have been separated from pediatric patients for classical Hodgkin lymphoma (cHL)
      • Prior lines of therapy have been reduced for pediatric patients with classical Hodgkin lymphoma (cHL)

    Medical Necessity Criteria for Pharmacy Edits, 5.01.605

    Anticonvulsants

    New drug added to policy

    • Generic rufinamide
      • Treatment of seizures associated with Lennox-Gastaut syndrome

    New indication added

    • Vimpat® (lacosamide)
      • Treatment of generalized tonic-clonic seizures

    Medical necessity criteria updated

    • Banzel® (rufinamide) oral suspension
      • Patient must have tried generic rufinamide oral suspension

    Brand Oral Antibiotics and Their Generics

    New drug added to policy

    • Helidac® (bismuth subsalicylate, metronidazole, tetracycline)
      • Treatment of Helicobacter pylori infection and duodenal ulcer disease

    Brand Topical Acne or Rosacea Agents

    Removed from policy

    The following drugs have been removed:

    • Adapalene/Benzoyl Peroxide/Clindamycin
    • Adapalene/Benzoyl Peroxide/Niacinamide
    • Benzoyl Peroxide/Clindamycin/Niacinamide
    • Benzoyl Peroxide/Clindamycin/Tretinoin
    • Clindamycin/Niacinamide
    • Clindamycin/Niacinamide/Spironolactone/Tretinoin
    • Dapsone/Niacinamide
    • Dapsone/Niacinamide/Spironolactone
    • Niacinamide/Spironolactone/Tretinoin

    Crohn's Disease Agents

    New policy section

    New drugs added to policy

    • Entocort® EC (budesonide delayed-release capsules)
      • Treatment of Crohn's disease
    • Ortikos™ (budesonide extended-release capsules)
      • Treatment of Crohn's disease

    Corticosteroids, Topical Brand

    Removed from policy

    The following drug has been removed:

    • Tovet®

    Intranasal Brand Corticosteroid Products

    New indication added

    • Nasal polyps for all drugs listed in this section

    Removed from policy

    The following drugs have been removed:

    • Ticanase™
    • Ticaspray®

    Ulcerative Colitis Agents

    New drug added to policy

    • Uceris® (budesonide extended-release tablets)
      • Treatment of ulcerative colitis

    Miscellaneous Oncology Drugs, 5.01.540

    New drugs added to policy

    • Danyelza® (naxitamab-gqgk)
      • In combination with GM-CSF for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow
    • Gavreto™ (pralsetinib)
      • Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
      • Treatment of adult and pediatric patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC)
      • Treatment of adult and pediatric patients with advanced or metastatic RET fusion-positive thyroid cancer
    • Onureg® (azacitidine)
      • Treatment of adult patients with acute myeloid leukemia (AML)

    Drug with new indication

    • Xpovio™ (selinexor)
      • Treatment of adult patients with multiple myeloma (MM)

    Medical necessity criteria updated

    • Leukine® (sargramostim)
      • In combination with Danyelza® (naxitamab-gqgk) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow

    Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

    Drug with new indication

    • Benlysta® (belimumab)
      • Treatment of adult patients with active lupus nephritis

    Xolair® (omalizumab), 5.01.513

    New indication

    • Add-on maintenance treatment in adults with nasal polyps

    An archived policy is one that’s no longer active and is not used for reviews.

    Archived policies

    Effective February 1, 2021

    Allergy Testing, 2.01.500

    Added codes

    Effective February 8, 2021

    Effective for dates of service on and after February 8, 2021, the following will apply to the AIM Specialty Health® Clinical Appropriate Guidelines for Genetic Testing

    0017M


    Effective February 5, 2021

    Coronary Angiography for Known or Suspected Coronary Artery Disease, 2.02.507
    Now requires review for medical necessity and prior authorization.

    93460, 93461

    Deep Brain Stimulation, 7.01.63
    Now requires review for medical necessity and prior authorization.

    61868

    Hospital Beds and Accessories, 1.01.520
    Now requires review for medical necessity and prior authorization.

    E0265, E0266, E0296, E0297, E0300, E0912

    Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions, 1.01.15
    Now requires review for medical necessity and prior authorization.

    E0481

    Pharmacotherapy of Spinal Muscular Atrophy (SMA), 5.01.574
    Now requires review for medical necessity and prior authorization.

    E0642, E0985

    Power Operated Vehicle (Scooters) (excluding motorized wheelchairs), 1.01.527
    Now requires review for medical necessity and prior authorization.

    E1230, K0899

    Spinal Cord and Dorsal Root Ganglion Stimulation, 7.01.546
    Now requires review for medical necessity.

    C1767, C1778, C1787, C1820, C1822, C1883, C1897

    Spinal Cord and Dorsal Root Ganglion Stimulation, 7.01.546
    Now requires review for medical necessity and prior authorization as well as site of service.

    63661, 63662, 63664, 63688

    Treatment of Varicose Veins, 7.01.519
    Now requires review for medical necessity and prior authorization.

    0524T, 36482, 36483, 37500, 37700, 37718, 37722, 37735, 37760, 37761, 37765, 37766, 37780, 37785

    Treatment of Varicose Veins, 7.01.519
    Now requires review for investigative.

    36473, 36474

    Wearable Cardioverter Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement, 2.02.506
    Now requires review for medical necessity.

    93292, 93745

    Wheelchairs (Manual or Motorized), 1.01.501
    Now requires review for medical necessity and prior authorization.

    E1012, E1014, E1050, E1060, E1070, E1083, E1084, E1085, E1086, E1087, E1088, E1089, E1090, E1100, E1160, E1170, E1171, E1172, E1180, E1190, E1195, E1200, E1220, E1221, E1223, E1224, E1229, E1240, E1250, E1260, E1270, E1285, E1290, E1295, E2227, E2228, E2230, E2292, E2295, E2300, E2310, E2311, E2331, E2341, E2342, E2343, E2351, E2398, E2610, E2620, E2621, E2622, E2623, K0004, K0009, K0010, K0011, K0012, K0014, K0830, K0831, K0898, K0900

    Added codes

    Effective February 1, 2021

    Diagnosis and Treatment of Sacroiliac Joint Pain, 6.01.23
    Now requires review for investigative.

    64625, G0259, G0260

    Diagnosis and Treatment of Sacroiliac Joint Pain, 6.01.23
    Now requires review for medical necessity and prior authorization.

    27280

    Pharmacologic Treatment of Infertility, 5.01.610
    Now requires review for medical necessity and prior authorization.

    S0128

    Removed codes

    Effective February 5, 2021

    Knee Orthoses (Braces), Ankle foot Orthoses and Knee-Ankle-Foot-Orthoses, 1.03.501
    No longer requires review for medical necessity and prior authorization.

    L1907, L1940, L1950, L1960, L1970, L1980, L1990, L2000, L2005, L2010, L2020, L2030, L2034, L2036, L2037, L2038, L2106, L2108, L2126, L2128


    Effective February 1, 2021

    Effective for dates of service on and after February 1, 2021, the following will no longer apply to AIM Specialty Health® Clinical Appropriateness Guidelines for Radiation Oncology

    20555

    Allergy Testing, 2.01.500

    No longer requires review for medical necessity. Policy archived.

    90506

  • Updates for only non-individual plans

  • Effective February 5, 2021

    InterQual® Criteria: Services Reviewed for Medical Necessity, 10.01.531

    This policy is updated to remove reference to services replaced with individual policies that address medical procedures and durable medical equipment. See the Special notices (above) under the Updates for non-individual and individual plans for the specific policies.

    No updates this month

  • Updates for only individual plans

  • Effective February 5, 2021

    Services Reviewed Using InterQual® Criteria, 10.01.530

    This policy is updated to remove reference to services replaced with individual policies that address medical procedures and durable medical equipment. See the Special notices (above) under the Updates for non-individual and individual plans for the specific policies.

    No updates this month

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