Effective November 5, 2021
Allograft Injection for Degenerative Disc Disease, 7.01.166
New policy
- Injecting a tissue graft from a donor into the space between the spinal vertebrae as a treatment of degenerative joint disease is considered investigational
Medical Necessity Criteria for Pharmacy Edits, 5.01.605
Testosterone Replacement Products
New drug added to policy
- Aveed® (testosterone undecanoate)
Miscellaneous Oncology Drugs,
5.01.540
New drugs added to policy
- Abraxane® (paclitaxel protein-bound particles)
- Treatment of metastatic breast cancer
- Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Treatment of metastatic adenocarcinoma of the pancreas
- Arranon® (nelarabine)
- Treatment of T-cell acute lymphoblastic lymphoma (T-ALL)
- Treatment of T-cell lymphoblastic lymphoma (T-LBL)
- Empliciti® (elotuzumab)
- Treatment of multiple myeloma
- Erwinaze® (asparaginase erwinia chrysanthemi)
- As a part of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL)
- Halaven® (eribulin mesylate)
- Treatment of metastatic breast cancer
- Treatment of inoperable or metastatic liposarcoma
- Yondelis® (trabectedin)
- Treatment of inoperable or metastatic liposarcoma or leiomyosarcoma
Non-covered
Experimental/Investigational Services, 10.01.533
New policy
- The safety and/or effectiveness of treatments, procedures, equipment, drugs, drug usage, medical devices, or supplies that have not been supported by a review of published medical and scientific literature are considered experimental/investigational
- This policy lists several services that are considered experimental/investigational
Effective October 1, 2021
Nerve Repair for
Peripheral Nerve Injuries Using Synthetic Conduits or Allografts, 7.01.584
New policy
- Synthetic conduits and nerve allografts are considered investigational for the repair or closure of nerve gaps from peripheral nerve injuries
Effective September 12, 2021
Updates to AIM Specialty Health®
Clinical Appropriateness Guidelines
Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Specialty Health®
Clinical Appropriateness Guidelines for Advanced Imaging
Updates by section
Advanced Imaging of the Spine
Congenital vertebral defects
- Added new requirement for additional evaluation with radiographs
Scoliosis
- Defined presurgical planning criteria
- Added requirement for radiographs and new or progressive symptoms for postsurgical imaging
Spinal dysraphism
Tethered cord
- Revised diagnostic imaging strategy to limit CT use when MRI cannot be performed
- Added new requirement for ultrasound prior to advanced imaging for tethered cord in infants age 5 months or less
Multiple sclerosis
- Added new criteria for imaging in initial diagnosis of MS
Spinal infection
- Aligned new diagnosis and management criteria with Infectious Disease Society of America (IDSA) and University of Michigan guidelines
Axial spondyloarthropathy
- Added definition of inflammatory back pain
- Added diagnostic testing radiography requirements
Cervical injury
- Aligned pediatric cervical trauma criteria with American College of Radiology (ACR) guidelines
Thoracic or lumbar injury
- Revised diagnostic imaging strategy to include radiography and limited use of MRI for a known fracture
- Removed indication for follow-up imaging of progressively worsening pain without fracture or neurologic deficits
Syringomyelia
- Removed surveillance imaging indication
Non-specific low back pain
- Aligned pediatric low back pain criteria with American College of Radiology (ACR) guidelines
Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness
Guidelines for Extremity Imaging
Updates by section
Advanced Imaging of the Extremities
Osteomyelitis
or septic arthritis
Myositis
- Removed CT as a follow-up to nondiagnostic MRI due to lower diagnostic accuracy of CT
Epicondylitis and Tenosynovitis – long head of biceps
- Removed these sections due to lack of evidence supporting imaging for this diagnosis
Plantar fasciitis and fibromatosis
- Removed CT as a follow-up to nondiagnostic MRI due to lower diagnostic accuracy of CT
- Added specific conservative management requirements
Brachial plexus mass
- Added specific requirement for suspicious findings on clinical exam or prior imaging
Morton's neuroma
- Added requirements for focused steroid injection, orthoses, and plan for surgery
Adhesive capsulitis
- Added requirement for planned intervention (manipulation under anesthesia or lysis of adhesions)
Rotator
cuff tear
Labral tear – shoulder
Labral tear – hip
- Defined specific exam findings and updated duration of conservative management
- Updated recurrent labral tear to meet same criteria as an initial tear (shoulder only)
Triangular fibrocartilage complex tear
- Added requirement for radiographs and conservative management for chronic tear
Ligament tear – knee; meniscal tear
- Added requirement for radiographs for specific scenarios
- Increased duration of conservative management for chronic meniscal tears
Ligament and tendon injuries – foot and ankle
- Defined required duration of conservative management
Chronic anterior knee pain including chondromalacia patella and patellofemoral pain
syndrome
- Increased duration of conservative management and specified requirement for chronic anterior knee pain
Intra-articular loose body
- Added requirement for mechanical symptoms
Osteochondral lesion (including osteochondritis dissecans, transient dislocation of patella)
- Added new requirement for radiographs
Entrapment neuropathy
- Excluded carpal and cubital tunnel syndromes
Persistent lower extremity pain
- Defined duration of conservative management
- Excluded hip joint (addressed in other indications)
Upper extremity pain
- Excludes shoulder joint (addressed in other indications)
- Revised diagnostic testing strategy to limit CT use when MRI cannot be performed or is nondiagnostic
Knee arthroplasty, presurgical planning
- Limited to MAKO and robotic assist arthroplasty cases
Perioperative imaging, not otherwise specified
- Require radiographs or ultrasound prior to advanced imaging
Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Specialty Health® Clinical
Appropriateness Guidelines for Vascular Imaging
Updates by section
Vascular Imaging
- Added alternative non-vascular imaging approaches, where applicable
Hemorrhage, Intracranial
- Specified clinical scenario for subarachnoid hemorrhage
- Added pediatric intracerebral hemorrhage indication
Horner's syndrome
Pulsatile tinnitus
Trigeminal neuralgia
- Removed condition management indication for continued vascular evaluation
Stroke/TIA
Stenosis
or occlusion (intracranial/extracranial)
- Added acute and subacute time frames
- Removed carotid/cardiac workup requirement for intracranial vascular evaluation
- Added condition management specifications
- Separated sections into anterior/posterior circulation (carotid artery and vertebral or basilar arteries, respectively)
Pulmonary Embolism
- Added non-diagnostic chest radiograph requirement for all indications
- Added pregnancy-adjusted YEARS algorithm
Peripheral Arterial Disease
- Added new post-revascularization indication to both upper and lower extremity PAD evaluation
Effective September 3, 2021
Alpha1-Proteinase
Inhibitors, 5.01.624
New policy
The following drugs have been added and may be considered medically necessary when criteria are met:
- Aralast® NP (alpha1-proteinase inhibitor (PI) [human])
- Glassia® (alpha1-PI [human])
- Prolastin®-C (alpha1-PI [human])
- Zemaira® (alpha1-PI [human])
- Treatment of adults with emphysema due to hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency)
Drugs for Rare
Diseases, 5.01.576
New drugs added to policy
- Aldurazyme® (laronidase)
- Treatment of mucopolysaccharidosis type I (MPS I), including Hurler, Hurler-Scheie, and Scheie forms, in patients age 6 months and older
- Brineura® (cerliponase alfa)
- Treatment of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) in patients age 3 and older
- Gamifant™ (emapalumab-lzsg)
- Treatment of adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH)
- Kanuma® (sebelipase alfa)
- Treatment of lysosomal acid lipase (LAL) deficiency
- Naglazyme® (galsulfase)
- Treatment of mucopolysaccharidosis type VI (MPS VI, also known as Maroteaux-Lamy syndrome) in patients age 3 months and older
- Sylvant® (siltuximab)
- Treatment of patients with multicentric Castleman's disease (MCD) in patients age 18 and older
Gonadotropin Releasing
Hormone (GnRH) Analogs, 5.01.625
New policy
The following drugs have been added and may be considered medically necessary when criteria are met:
Breast cancer
- Zoladex® (goserelin)
- Palliative treatment of advanced breast cancer in pre- and perimenopausal women
Central precocious puberty
- Fensolvi® (leuprolide acetate)
- Generic leuprolide
- Lupron Depot PED® (leuprolide acetate)
- Supprelin LA® (histrelin implant)
- Triptodur® (triptorelin),
- Vantas® (histrelin implant)
- Treatment of children with abnormally early puberty
Endometriosis
- Generic leuprolide
- Lupaneta Pack® (leuprolide/norethindrone)
- Lupron Depot® (leuprolide acetate)
- Zoladex® (goserelin)
- Management of endometriosis, including pain relief and reduction of endometriotic lesions
- Orilissa® (elagolix)
- Treatment of moderate to severe pain associated with endometriosis
Gender dysphoria
- Fensolvi® (leuprolide acetate)
- Generic leuprolide
- Lupron Depot® (leuprolide acetate)
- Lupron Depot PED® (leuprolide acetate)
- Supprelin LA® (histrelin implant)
- Trelstar® (triptorelin pamoate)
- Triptodur® (triptorelin)
- Vantas® (histrelin implant)
- Treatment of gender dysphoria in adolescents
Prostate cancer
- Eligard® (leuprolide acetate)
- Firmagon® (degarelix)
- Generic leuprolide
- Lupron Depot® (leuprolide acetate)
- Orgovyx® (relugolix)
- Trelstar® (triptorelin pamoate)
- Zoladex® (goserelin)
- Palliative treatment of metastatic prostate cancer
- Zoladex® (goserelin)
- Treatment of locally confined Stage T2b-T4 (Stage B2-C) prostate cancer when used in combination with flutamide
Uterine
fibroids
- Generic leuprolide
- Lupron Depot® (leuprolide acetate)
- Treatment of anemia due to uterine fibroids
- To reduce the size of uterine fibroids prior to surgery
- Oriahnn® (elagolix/estradiol/norethindrone acetate)
- Management of heavy bleeding related to uterine fibroids in premenopausal patients age 18 and older
- Zoladex® (goserelin)
- Use as an endometrial-thinning agent prior to endometrial ablation for abnormal uterine bleeding
Effective August 6, 2021
Pharmacologic Treatment
of Duchenne Muscular Dystrophy, 5.01.570
Site of service review added
Pharmacotherapy of Cushing's Disease and Acromegaly, 5.01.548
New drugs added to policy
- Bynfezia® Pen (octreotide)
- Generic octreotide
- Sandostatin® (octreotide)
- Sandostatin® LAR Depot (octreotide)
- Somatuline® Depot (lanreotide)
- Treatment of acromegaly in adults age 18 and over
- Treatment of adults with inoperable, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
- Treatment of adults with carcinoid syndrome
- Treatment of adults with profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)
Site of Service: Infusion Drugs and
Biologic Agents, 11.01.523
Site of service review added