Pilot Policy for Designated Centers of Excellence: Total Knee or Total Hip Replacement, 7.01.568Total knee or total hip replacement (arthroplasty) for the treatment of osteoarthritis may be considered medically necessary when criteria are met and the surgery is performed in a Designated Center of Excellence. This policy only applies to members whose plan includes the Total Joint Replacement Centers of Excellence Program.
Updates to AIM Specialty Health® Clinical Appropriate Guidelines
Effective for dates of service on and after November 10, 2019, the following updates will apply to the AIM Specialty Health® Advanced Imaging Clinical Appropriateness Guidelines.
Cardiac Imagining Guideline contains updates to the following:Post-cardiac transplantation evaluation when any of the following applies: evaluation of new or worsening cardiac signs, symptoms or new EKG abnormalities; or, surveillance of a stable patient (no new or worsening cardiac signs or symptoms) within the first 6 months of transplant; or, surveillance of a stable patient (no new or worsening cardiac signs or symptoms) at 3-month intervals at 6 to 24 months post-transplant; or, annual surveillance of a stable patient (no new or worsening cardiac signs or symptoms) more than 24 months post-transplant.
Head and Neck Imagining Guideline contains updates to the following: Sinusitis/rhinosinusitis (adult and pediatric): Defined a minimal treatment requirement for uncomplicated sinusitis prior to imaging. Defined indications for preoperative planning for image navigation following a clinical policy statement on appropriate use from the AAO-HNS. Removed CT screening for immunocompromised patients based on lack of evidence. Aligned pediatric and adult sinusitis guidelines and pediatric sinusitis guidelines with ACR and AAO-HNS.
Trauma (adult and pediatric): Radiograph requirement added for suspected mandibular trauma. MRI TMJ in trauma for suspected internal derangement in surgical candidates.
Neck mass: Align adult neck imaging guideline with a high-quality guideline from the American Academy of Otorhinolaryngology – Head and Neck Surgery (AAO-HNS) including mass size and feature requirements for advanced imaging.
Parathyroid adenoma (adult and pediatric): Further defined the patient population that needs evaluation for parathyroid adenomas. Positron CT as a diagnostic test after both ultrasound and parathyroid scintigraphy. Remove MRI as a modality to evaluate for parathyroid adenomas based on lack of evidence for diagnostic accuracy.
Temporomandibular joint dysfunction (adult and pediatric): Added requirement for conservative treatment and planned intervention for suspected osteoarthritis.
Hearing loss: More clearly delineated appropriate modalities based on types of hearing loss in pediatric patients.
Oncologic Imagining Guideline contains updates to the following:Colorectal cancer: Removal of FDG-PET/CT for radiation planning to align AIM Appropriateness Criteria with NCCN: ACR appropriateness level 6 (may be appropriate) only for detection of distant metastases. Not addressed for locoregional staging; Low level evidence to support use of PET-CT imaging for radiation treatment planning; and NCCN states that PET-CT is not indicated for pre-operative staging of rectal cancer. PET-CT can also be considered for potentially curable M1.
Germ cell tumors – testis and ovary: Align AIM Appropriateness Criteria with NCCN for PET-CT, evidence for PET-CT imaging to evaluate residual mass < 3 cm applies to seminoma ONLY. Removed this indication for nonseminoma and malignant ovarian germ cell cancer. Residual nonseminomatous germ cell tumors > 1 cm require surgery.
Hepatobiliary cancer: Align AIM Appropriateness Criteria with NCCN for management, screening and surveillance.
Kidney cancer: Align AIM Appropriateness Criteria with NCCN Kidney Cancer Guidelines and ACR Appropriateness Criteria for use of PET imaging in staging and management of Kidney Cancer/Renal Cell Carcinoma. ACR appropriateness level 3 (usually not appropriate) for use of PET imaging in staging of kidney cancer. NCCN states the value of PET in RCC remains to be determined.
Lung cancer – non-small cell: Use of MRI limited to scenarios where additional imaging would impact management.
Lymphoma – non-Hodgkin: The majority of mucosal melanomas originate from the head and neck. The qualifier added is intended to prevent inappropriate use of MRI head and neck when of other origin besides head and neck.
Prostate cancer: Additional criteria for management to address active surveillance in reaction to NCCN recommending an annual limit on mpMRI for active surveillance.
Suspected metastases not otherwise specified: New criteria for Sodium Fluoride PET.
Vascular Imagining Guideline contains updates to the following:General vascular: Added diagnostic testing strategy for TAVI/TAVR carotid evaluation with initial ultrasound.
Aneurysm – intracranial: Further define neurological signs and symptoms suggestive of intracranial aneurysm.
Carotid stenosis or occlusion: Advanced imaging as an add on test for problem solving when ultrasound suggests a high-grade stenosis.
Hemorrhage – intracranial or subarachnoid: Define use of vascular imaging as an add on test in patients following intracranial hemorrhage. Sequential diagnostic testing strategy for non-acute stroke or TIA with CTA or MRA as an add on test to change management in select circumstances for unexplained strokes.
Venous thrombosis or compression – extracranial: Added requirement for nondiagnostic venous ultrasound. Further define isolated headache pattern that may require imaging to exclude venous sinus thrombosis. Adopt a sequential diagnostic testing strategy starting with CT or MRI for low risk groups (no risk factors and negative D-dimer).
Aortic aneurysm or dissection: Annual evaluation of stable aneurysms (new for advanced imaging, aligns with echocardiography guidelines). New screening indication for high risk adults, annual screening for pediatrics.
Other vascular indications: New criteria for PAH incorporating a diagnostic testing strategy. Annual evaluation of stable aneurysms (new for advanced vascular imaging) 6-month evaluation of newly diagnosed aneurysms. Further define diagnostic indications for suspected aneurysm for advanced imaging. Align pediatrics with adult guidelines. Added requirement that intra-abdominal bleeding be unexplained for advanced vascular imaging. Remove generalized atherosclerotic disease and follow up based solely on abnormal imaging, requirement for 4 or more antihypertensive medications. More specific clinical indications for CTA/MRA in the diagnosis of suspected stenosis. Duplex ultrasound guideline with CTA/MRA alignment in diagnosis, management, and surveillance for upper extremity. Ultrasound requirement for suspected DVT prior to advanced vascular imaging. Remove Raynaud’s syndrome based on low diagnostic yield and low diagnostic accuracy. Remove CTA/MRA for with ABI less than 0.9 alone for peripheral arterial disease.
Effective for dates of service on and after November 10, 2019, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines: Radiation Oncology.
Proton Beam Therapy Guideline contains updates to the following:Revised proton beam therapy considerations and indications for sinonasal cancer, melanoma of the uveal tract, and pediatric tumors.
Implantable Peripheral Nerve Stimulation for the Treatment of Chronic Pain of Peripheral Nerve Origin, 7.01.574Trial or permanent placement of an implantable peripheral nerve stimulator for the management of chronic pain is considered investigational.
Pharmacologic Treatment of Osteoporosis, 5.01.596Forteo® (teriparatide), Tymlos® (abaloparatide), and Prolia® (denosumab) may be considered medically necessary when criteria are met. They are considered investigational when criteria are not met. The policy is revised to add medical necessity criteria for Evenity™ (romosozumab-aqqg) and update the criteria for Tymlos® (abaloparatide).
Synthetic Cartilage Implants for Joint Pain, 7.01.160Synthetic cartilage implants are considered investigational for the treatment of articular cartilage damage.
Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery, 7.01.140Handheld radiofrequency spectroscopy, i.e. MarginProbe®, for intraoperative assessment of surgical margins during breast-conserving surgery is considered investigational.
Phrenic Nerve Stimulation for Central Sleep Apnea, 2.02.33Phrenic nerve stimulation for central sleep apnea is considered investigational in all situations.
Facet Joint Denervation, 7.01.555Endoscopic radiofrequency denervation (rhizotomy) has been added to the policy and is considered investigational for the treatment of chronic spinal/back pain.
Functional Neuromuscular Electrical Stimulation, 8.03.01Functional electrical stimulation devices for patients with spinal cord injury is considered investigational.
Transcatheter Mitral Valve Repair, 2.02.30Transcatheter mitral valve repair with an FDA-approved device may be considered medically necessary for patients with heart failure when criteria are met.
Treatment of Varicose Veins/Venous Insufficiency, 7.01.519Cyanoacrylate adhesive (VenaSeal™Closure System), previously considered investigational, may now be considered medically necessity for vein ablation when criteria are met.
Cutaneous T-Cell Lymphomas (CTCL): Systemic Therapies, 5.01.532Targretin (bexarotene) topical gel criteria were updated to cover for the topical treatment of cutaneous lesions in patients with cutaneous T-cell lymphoma (Stage IA and IB); considered medically necessary when criteria are met.
Drugs for Rare Diseases, 5.01.576Firdapse® (amifampridine) medical necessity criteria was updated to include diagnostic testing. Ruzurgi® (amifampridine) may be considered medically necessary for patients under age 18 for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) when criteria are met. Cablivi® (caplacizumab-yhdp) may be considered medically necessary for the treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP) when criteria are met.
Excessively High Cost Drug Products with Lower Cost Alternatives, 5.01.560Exjade® (deferasirox tablet for oral suspension), Jadenu® (deferasirox tablet), and Jadenu® Sprinkle (deferasirox granules) may be considered medically necessary for the treatment of chronic iron overload in patients 2 and older when criteria are met. Bethkis® (tobramycin inhalation solution), Kitabis® Pak (tobramycin inhalation solution), TOBI® (tobramycin inhalation solution) and TOBI® Podhaler™ (tobramycin inhalation powder) may be considered medically necessary for the management of cystic fibrosis when criteria are met.
Herceptin® (trastuzumab) and Other HER2 Inhibitors, 5.01.514Kanjinti™ (trastuzumab-anns) and Ogivri™ (trastuzumab-dkst) may be medically necessary to treat patients with HER2-positive breast cancer, gastric cancer or gastroesophageal junction adenocarcinoma when criteria are met. Kadcyla® may be considered medically necessary for adjuvant treatment of patients with HER2-positive early breast cancer when criteria are met.
Immune Checkpoint Inhibitors, 5.01.591Keytruda® (pembrolizumab) may be considered medically necessary for several newly-approved FDA indications when criteria are met. See policy for details.
Medical Necessity Criteria for Pharmacy Edits, 5.01.605Vraylar® (cariprazine) may be considered medically necessary after trial and failure of a generic second-generation antipsychotic or for the treatment of bipolar depression in adults without trial and failure of a generic second-generation antipsychotic.
Miscellaneous Oncology Drugs, 5.01.540Balversa™ (erdafitinib) was added to the policy and may be considered medically necessary for treatment of adult patients with locally advanced or metastatic urothelial carcinoma when criteria are met. Tibsovo® (ivosidenib) may be considered medical necessary to treat adults with newly diagnosed acute myeloid leukemia (AML) when criteria are met.
Pharmacotherapy of Multiple Sclerosis, 5.01.565Mavenclad® (cladribine) and Mayzent® (siponimod) may be considered medically necessary in the treatment of relapsing forms of multiple sclerosis when criteria are met. See policy for details.
Pharmacotherapy of Thrombocytopenia, 5.01.566Doptelet® (avatrombopag) may be medically necessary for the treatment of chronic immune thrombocytopenia (ITP) when criteria are met.
Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery, 7.01.140Now requires review for Investigational
0546T - Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report
Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502 & Rituxan® (rituximab): Non-oncologic and Miscellaneous Uses, 5.01.556Now requires review for Site of Service as well as Medical Necessity; Currently requires Prior Authorization
Q5115 - Injection, rituximab-abbs, biosimilar, (Truxima), 10 mg
Plasma-based Proteomic Screening in the Management of Pulmonary Nodules, 2.04.515Now requires review for Investigational
0080U - Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors (age, smoking status, nodule diameter, nodule-spiculation status and nodule location), utilizing plasma, algorithm reported as a categorical probability of malignancy
0092U - Oncology (lung), three protein biomarkers, immunoassay using magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancy
Pharmacologic Treatment of Osteoporosis, 5.01.596Now requires review for medical necessity, now requires prior authorization
J0897 - Injection, denosumab, 1 mg
Synthetic Cartilage Implants for Joint Pain, 7.01.160Now requires review for Investigational; Now requires prior authorization
28291 - Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; with implant
L8641 - Metatarsal joint implant
L8642 - Hallux implant>
Functional Neuromuscular Electrical Stimulation, 8.03.01Now requires review for Investigational (previously reviewed for Medical Necessity), no longer requires Prior Authorization
E0770 - Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified
Transcatheter Mitral Valve Repair, 2.02.30No longer requires review for Medical Necessity; no longer requires Prior Authorization
0483T - Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed
0484T - Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical)
AIM Specialty Health®AIM Clinical Appropriateness Guidelines for Genetic Testing
Codes will no longer be reviewed for medical necessity:
G0452 - Molecular pathology procedure; physician interpretation and report
S3620 - Newborn metabolic screening panel, includes test kit, postage and the laboratory tests specified by the state for inclusion in this panel (e.g., galactose; hemoglobin, electrophoresis; hydroxyprogesterone, 17-d; phenylalanine (PKU); and thyroxine, total)
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