View previous medical policies and coding updates
September 5, 2024 – Provider News – LifeWise Washington
Email tease: The Plan will review Cosentyx (secukinumab) IV and Tofidence (tocilizumab-bavi) IV for site of service administration, along with medical necessity review, starting December 5, 2024. See policy Pharmacotherapy of Arthropathies, 5.01.550, in the Special notices section.
Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Radiology Clinical Appropriateness Guidelines.
As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.
Updates by section
Brain Imaging
Added indications for Magnetic Resonance Imaging (MRI) and amyloid beta positron emission tomography (PET) imaging in Alzheimer disease to address patients considering or receiving lecanemab
Spine Imaging
Changed “Perioperative and Periprocedural Imaging” to “Postoperative and Postprocedural Imaging;” pre-procedure requests should be reviewed based on more specific indication
Extremity Imaging
Separated criteria for osteomyelitis and septic arthritis into separate indications
Ultrasound or arthrocentesis as preliminary tests were placed only in the “septic arthritis” indication
Vascular Imaging
Computed tomography angiography (CTA) and magnetic resonance angiography (MRA) Head addition for chronic posterior circulation Stroke/TIA presentations (CTA/MRA neck already allowed, intracranial eval needed for full extent of anatomy)
Lower Extremity peripheral artery disease: Updated physiologic testing parameters and added allowance for ischemic signs/symptoms at presentation, in alignment with American College of Radiology Appropriateness Criteria
Suboptimal imaging option downgrades/removals in Brain, Head and Neck and Abdomen/Pelvis
Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Cardiology Clinical Appropriateness Guidelines.
As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.
Updates by section
Imaging of the Heart
Resting Transthoracic Echocardiography (TTE)
Expanded frequency of echocardiographic evaluation in patients on mavacamten for treatment of hypertrophic obstructive cardiomyopathy
Expanded criteria for echocardiographic evaluation to allow a single screening for cardiac disease in patients undergoing evaluation for solid organ or hematopoietic cell transplant
Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Genetic Testing Clinical Appropriateness Guidelines.
As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.
Updates by section
Chromosomal Microarray Analysis
Clarified recommendations for Genetic Counseling
Clarified requirements for postnatal evaluation of individuals with:
Congenital or early onset epilepsy (before age 3 years) without suspected environmental causes
Autism spectrum disorder, developmental delay, or intellectual disability with no identifiable cause (idiopathic)
Clarified prenatal evaluation of a fetus with a structural fetal anomaly noted on ultrasound
Pharmacogenomic Testing
Added Apolipoprotein E (APOE) testing
Polygenic Risk Scores renamed Predictive and Prognostic Polygenic Testing
Broadened guideline scope to include polygenic expression prognostic testing and multivariable prognostic genetic testing (essentially clarifications)
Moved these tests to exclusions as they are considered not medically necessary
Retitled guideline to Predictive and Prognostic Polygenic Testing to address the change in scope
Somatic Testing of Solid Tumors
Clarified gene expression profiling is to guide adjuvant therapy for localized Breast Cancer
Whole Exome and Whole Genome Sequencing
Expanded whole exome sequencing (WES) criteria to include congenital or early onset epilepsy (before age 3) without suspected environmental etiology and added other clarifications
Clarified well-delineated genetic syndrome in criterion for multiple anomalies
Clarified inclusion criteria of the RTOG 1112 protocol
Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc., Sleep Clinical Appropriateness Guidelines.
As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.
Updates by section
Sleep Disorder Management
Expanded definitions and terminology
Expanded documentation of hypoventilation
Expanded criteria for home and in-lab sleep studies
Added contraindication to automatic positive airway pressure titration for use of supplemental oxygen
Removed home sleep apnea testing as an option in medical necessity of multiple sleep latency test/maintenance of wakefulness test for suspected narcolepsy
Management of obstructive sleep apnea (OSA) using Implanted Hypoglossal Nerve Stimulators (HNS):
Narrowed age range (raised lower limit to 13) for HNS in individuals with Down syndrome and OSA to align with age range suggested by Food and Drug Administration (FDA)
Miscellaneous Devices section added:
Electronic positional therapy and neuromuscular electrical training of the tongue musculature are considered not medically necessary due to lack of high-quality evidence
Surgical treatment of femoral acetabular impingement is considered medically necessary when criteria are met.
Medical policies
New medical policies
Vagus Nerve Stimulation, 7.01.593 Policy renumbered from 7.01.20 (see Deleted policies) Vagus Nerve Stimulation for Major Depression Disorder
Added “not bipolar depression” after “unipolar depression"
Added a new criterion: “No acute or chronic psychotic symptoms”
Added, “or transcranial magnetic stimulation was stopped due to intolerable, incapacitating, or potentially dangerous adverse effects” to the item for a course of transcranial magnetic stimulation.
Added, “or electroconvulsive therapy was stopped due to intolerable, incapacitating, or potentially dangerous adverse effects” to the item for a course of electroconvulsive therapy.
Revised medical policies Effective September 1, 2024
Update made within Abnormal Uterine Bleeding – Premenopausal, expanding on criterion for endometrial sampling, indicating it must have been performed within the past 12 months, and adding allowance for when it cannot be performed due to technical
reasons or has been attempted but was unsuccessful
Update made within Uterine Fibroids (leiomyomata), expanding on criterion for endometrial sampling, indicating it must have been performed within the past 12 months, and adding allowance for when it cannot be performed due to technical reasons
or has been attempted but was unsuccessful or dilation and curettage (D&C) in the setting of menometrorrhagia was performed
Related information updated
Definition of menometrorrhagia added
Pharmacy policies
New pharmacy policies Effective September 1, 2024
No updates this month.
Revised pharmacy policies Effective September 1, 2024
Added coverage for treatment of paroxysmal nocturnal hemoglobinuria in individuals aged 13 years or older
Must have completed at least 3 months of therapy with Soliris or Ultomiris
Must have experienced residual anemia (hemoglobin
<10.5 g/dL and lactic acid dehydrogenase level 1.5 times the upper limit) while undergoing treatment on Soliris or Ultomiris
Must have received Streptococcus pneumoniae, Neisseria meningitis, and Hemophilus influenzae at least 2 weeks prior to first does
Drug removed
Removed Ultomiris SC on body injector since it is removed from the market
Added treatment of primary advanced or recurrent endometrial cancer that is mismatch repair deficient when administered as a single agent following combination therapy with carboplatin and paclitaxel
Keytruda (pembrolizumab) IV
Added treatment of hepatocellular carcinoma secondary to hepatitis B in individuals who have received prior systemic therapy other than a PD-1/PD-L1 containing regimen
Added treatment of primary advanced or recurrent endometrial carcinoma when administered as a single agent following combination therapy with carboplatin and paclitaxel
Added treatment of primary generalized tonic-clonic seizures in individuals weighing at least 50 kg
Sirturo (bedaquiline)
Update criterion to indicate diagnosis requirement of pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid
Added coverage for treatment of primary biliary cholangitis (PBC) when used in combination with ursodeoxycholic acid (UDCA) in individuals aged 18 years and older who have had inadequate response to UDCA, or as monotherapy in those unable to tolerate
UDCA
Must have PBC without cirrhosis or PBC with compensated cirrhosis and no evidence of portal hypertension
Must have confirmed diagnosis by consistently elevated alkaline phosphatase for at least 6 months AND positive antimitochondrial (AMA) test OR presence of sp100 or gp210 autoantibodies if AMA-negative OR liver biopsy consistent with PBC
Must not be a diagnosis associated with cholestatic drug reaction, complete biliary obstruction, sarcoidosis, or primary sclerosing cholangitis
Must have tried and had inadequate response to at least 1 year of UDCA therapy or had intolerance to UDCA therapy
Must not be used in combination with Ocaliva (obeticholic acid)
Must be prescribed by or in consultation with a gastroenterologist or hepatologist
Must not exceed 80 mg once daily
Investigational criteria updated
Added Iqirvo (elafibranor) as investigational for all other conditions not outlined in policy
Medical necessity criteria updated Ocaliva (obeticholic acid)
Added requirement that must be prescribed by or in consultation with a gastroenterologist or hepatologist
Must not be used in combination with Iqirvo (elafibranor)
Added coverage for treatment of hemophilia in individuals aged 18 years and older who are assigned male at birth
Must have severe or moderately severe hemophilia B as defined by a plasma Factor IX (FIX) activity level of 2% or less
Must have either current or historical life threatening hemorrhage OR repeated serious spontaneous bleeding episodes OR is currently receiving a FIX prophylaxis that will be discontinued following Beqvez administration
Must not have a history of FIX inhibitors or a positive screen result of 0.6 or greater Bethesda Units
Must have received a liver health assessment including enzyme testing and an hepatic ultrasound and elastography
Must have been assessed by an hepatologist if radiological liver abnormalities or sustained liver enzyme elevations are present
Must be human immunodeficiency virus (HIV) negative or have HIV controlled infection
Must not have an active hepatitis B or hepatitis C infection
Must not have neutralizing antibodies to adeno-association virus serotype Rh74var capsid
Must be prescribed by or in consultation with a physician specializing in hemophilia B or a hematologist
Added Tyenne (tocilizumab-aazg) IV/SC for treatment of polyarticular juvenile idiopathic arthritis with current criteria for Actemra (tocilizumab) IV
Added Tyenne (tocilizumab-aazg) IV/SC for treatment of systemic juvenile idiopathic arthritis with current criteria for Actemra (tocilizumab) IV
Added Tyenne (tocilizumab-aazg) IV/SC for treatment of moderate to severe rheumatoid arthritis with current criteria for Actemra (tocilizumab) IV
Second-line IL-6 Inhibitors
Added Kevzara (sarilumab) SC for treatment of polyarticular juvenile idiopathic arthritis with current criteria for Actemra (tocilizumab) IV
Must have had inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine
Must have had an inadequate response or intolerance to two of the drugs as listed within the policy
Must be prescribed by or in consultation with a rheumatologist
Second-line T-Cell Costimulation Modulators
Orencia (abatacept) IV/SC: Updated list of drugs which individual must have inadequate response or intolerance to include Tyenne and Rinvoq or Rinvoq LQ
Added Tyruko (natalizumab-sztn) for treatment Crohn’s disease with current criteria for Tysabri (natalizumab)
Drug added Medical necessity criteria added
Site of service review is added to Skyrizi (risankizumab-rzaa) IV and Skyrizi (risankizumab-rzaa) SC on-body injector
Added Skyrizi (risankizumab-rzaa) IV for treatment of ulcerative colitis prescribed by or in consultation with a gastroenterologist and used only for induction therapy
Added Skyrizi (risankizumab-rzaa) SC on-body injector for treatment of ulcerative colitis when prescribed by or in consultation with a gastroenterologist and individual has received induction therapy with Skyrizi IV
Added coverage of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in individuals aged 18 and older
Must have experienced progressive or relapsing motor and/or sensory symptoms of more than one limb and hyporeflexia or areflexia in affected limbs for at least 2 months
Must have electrophysiologic findings that meet at least 3 of the 4 American Academy of Neurology criteria indicating demyelinating neuropathy
Must have excluded any other causes of demyelinating neuropathy
Must have result of other testing to support diagnosis, if available, and as outlined in the policy
Must have tried and had an inadequate response or intolerance to intravenous or subcutaneous immune globulin
Must be prescribed by or in consultation with a neurologist
Sarcoidosis First-line agents
Added first-line agents adalimumab-adaz (Hyrimoz unbranded), adalimumab-adbm, (Cyltezo unbranded), adalimumab-ryvk (Simlandi unbranded), Cyltezo (adalimumab-adbm), Humira (adalimumab) (AbbVie) [NDCs starting with 00074], Hyrimoz (adalimumab-adaz),
(Sandoz) [NDCs starting with 61314], and Simlandi (adalimumab-ryvk) for treatment of sarcoidosis when individual has tried and had an inadequate response or intolerance to one corticosteroid
Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
Added first-line TNF-α antagonists Avsola (infliximab-axxq), Infliximab (Janssen-unbranded), and Remicade (infliximab) for treatment of sarcoidosis when individual has tried and had an inadequate response or intolerance to one corticosteroid
Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
Second-line agents
Added second-line TNF-α antagonists Abrilada (adalimumab-afzb), adalimumab-aacf (Idacio unbranded), adalimumab-aaty (Yuflyma unbranded), adalimumab-fkjp (Hulio unbranded), Amjevita (adalimumabatto), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp),
Humira (adalimumab) (Cordavis) [NDCs starting with 83457], Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457], Idacio (adalimumab-aacf), Yuflyma (adalimumabaaty), and Yusimry (adalimumab-aqvh) for treatment of sarcoidosis when individual
has tried and had an inadequate response or intolerance to one corticosteroid
Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
Must have inadequate response or intolerance to all agents as listed within the policy
Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
Added second-line TNF-α antagonists Renflexis (infliximab-abda) and Inflectra (infliximab-dyyb) for treatment of sarcoidosis when individual has tried and had an inadequate response or intolerance to one corticosteroid
Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
Must have inadequate response or intolerance to Avsola (infliximab-axxq), Infliximab (Janssen – unbranded) or Remicade (infliximab)
Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
77061, 77062, 77063, 77065, 77066, 77067, G0279Surgical Dressings and Wound Care Supplies, 9.01.511 No longer requires review.Surgical Dressings and Wound Care Supplies, 9.01.511 No longer requires review.
Surgical Dressings and Wound Care Supplies, 9.01.511 No longer requires review.