Medical Policy and Coding Updates September 2021

  • Updates for both non-individual and individual plans

  • Effective December 2, 2021

    Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

    New drug added to policy

    • Arcalyst® (rilonacept)
      • Treatment of cryopyrin-associated period syndromes (CAPS) in adults and children age 12 and older
      • Treatment of deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children weighing at least 10 kg
      • Treatment of recurrent pericarditis (RP) in patients age 12 and older

    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

    • Camcevi™ (leuprolide mesylate)
    • 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
    • Myfembree® (relugolix/estradiol/norethindrone acetate)
      • Management of heavy bleeding related to uterine fibroids in premenopausal patients age 18 and older
    • 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

    Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy, 2.01.49

    Investigational criteria updated

    • Transurethral waterjet ablation (aquablation) has been added as an investigational treatment for benign prostatic hyperplasia

    Treatment of Varicose Veins/Venous Insufficiency, 7.01.519

    Policy statements updated

    The following procedures have been removed from the policy:

    • Ligation and stripping
    • Phlebectomy
    • Subfascial endoscopic perferator (SEPS) of incompetent perferator veins
    • Thermal ablation of incompetent perferator veins
    • Ultrasound guidance

    Revised pharmacy policies
    Effective September 1, 2021

    Immune Checkpoint Inhibitors, 5.01.591

    Drug with new indication

    • Keytruda® (pembrolizumab)
      • Treatment of high-risk, early-stage triple negative breast cancer

    Medical necessity criteria updated

    • Keytruda® (pembrolizumab)
      • The indication for cutaneous squamous cell carcinoma (cSCC) now includes locally advanced cutaneous squamous cell carcinoma
    • Opdivo® (nivolumab)
      • Use of this drug as a single agent in patients previously treated with sorafenib has been removed from the hepatocellular carcinoma indication (Opdivo® must be used in combination with Yervoy® [ipilimumab])

    Medical Necessity Criteria for Pharmacy Edits, 5.01.605

    Atopic Dermatitis

    Medical necessity criteria updated

    • Eucrisa® (crisaborole)
      • The exception for the face involvement with topical calcineurin inhibitors has been removed

    Brand Topical Acne or Rosacea Agents

    New drug added to policy

    • Twyneo (tretinoin and benzoyl peroxide)
      • Treatment of acne

    Chronic Kidney Disease Treatment

    New drug added to policy

    • Kerendia (finerenone)
      • Treatment of chronic kidney disease associated with type 2 diabetes

    Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

    Medical necessity criteria updated

    • Ilaris® (canakinumab)
      • This drug must be prescribed by or in consultation with a rheumatologist, geneticist, or dermatologist

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

    No updates this month

    No updates this month.

    Added codes
    Effective September 3, 2021

    Alpha1-Proteinase Inhibitors, 5.01.624

    Now requires review for medical necessity and prior authorization.

    J0256, J0257

    Drugs for Rare Diseases, 5.01.576

    Now requires review for medical necessity and prior authorization.

    J9210, J9131, J1458, J0567, J2860, J2840

    Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625

    Now requires review for medical necessity and prior authorization.

    J1950, J1951, J3315, J3316, J9155, J9202, J9217, J9218, J9225, J9226


    Added codes
    Effective September 1, 2021

    Cutaneous T-Cell Lymphomas (CTCL): Systemic Therapies, 5.01.532

    Now requires review for medical necessity.

    C9065

    Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy, Laminotomy, Laminectomy in Adults, 7.01.551

    Now requires review for medical necessity.

    C9757

    Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

    Now requires review for medical necessity and prior authorization.

    J2793

    Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy, 2.01.49

    Now requires review for investigative and prior authorization.

    0421T

    Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy, 2.01.49

    Now requires review for investigative.

    C2596


    Revised codes
    Effective September 1, 2021

    Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502

    Now requires review for medical necessity and prior authorization.

    J9349

    Removed codes
    Effective September 1, 2021

    Treatment of Varicose Veins/Venous Insufficiency, 7.01.519

    No longer requires review for medical necessity and prior authorization.

    37500, 37700, 37718, 37722, 37735, 37760, 37761, 37765, 37766, 37780, 37785

  • Updates for only non-individual plans

  • No updates this month

    No updates this month

  • Updates for only individual plans

  • Added codes
    Effective September 3, 2021

    The following codes will require review for medical necessity and prior authorization for services on or after September 3, 2021

    American Society of Addiction Medicine (ASAM), 10.01.532

    0362T, 0905, 0912, 97151, 97153, 97154, 97155, 97156, 97158, H0015, H0017, H0035, S9480

    Arthrotomy Hip, InterQual® Criteria, 10.01.530 

    27269

    Specialty Rx Non-Oncology Alpha 1- Proteinase Inhibitor, InterQual® Criteria, 10.01.530

    J0256

    Spinal Orthosis, 1.03.502

    L0622, L0623, L0624

    Surgical Dressings and Wound Care Supplies, 9.01.511

    A6205

    Wound Debridement, InterQual® Criteria, 10.01.530

    11008

    See the Special notices section above.

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