Humana Multianalyte Assays with Algorithmic Analyses for Noncancer Indications Form
Procedure is not covered
Multianalyte assays with algorithmic analyses (MAAAs)
MAAAs are laboratory measurements that use a mathematic formula to analyze multiple markers that may be associated with a particular disease state and are designed to evaluate disease activity or an individual’s risk for disease. The laboratory performs an algorithmic analysis using the results of the assays and sometimes other individual information, such as gender and age and converts the information into a numeric score, which is conveyed on a laboratory report. Generally, MAAAs are exclusive (and/or proprietary) to a single laboratory which owns the algorithm.
Description
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Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 2 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
Proposed indications for the use of MAAA testing include:
- Assess risk
- Diagnose or monitor noncancerous disease activity
Examples include, but may not be limited to, the following:
- Adolescent idiopathic scoliosis (AIS):
ScoliScore is a prognostic test that analyzes genetic markers purportedly associated with spinal curve progression and assigns a numerical value regarding the likelihood of curve progression based on the test results and other clinical information. - Antiviral Drug Susceptibility:
sequence analysis (protease [PR], reverse transcriptase [RT], integrase [INT]) algorithm reported as a prediction of antiviral drug susceptibility that purportedly detects HIV-1 drug resistant mutations. It is for use in an individual with HIV-1 who are about to start or are already taking antiviral therapy to assist in making treatment decisions. - Autism Spectrum Disorder (ASD):
- Clarifi ASD is a test that measures 14 specific microRNAs (miRNAs) in the saliva to purportedly diagnose autism spectrum disorder (ASD) in children 18 months through 6 years of age.
- NPDX ASD ADM Panel 1 is purported to assist with a diagnosis of ASD through identification of 32 amines by LC-MS/MS, using plasma and an algorithm reported as a metabolic signature associated with ASD.
- NPDX ASD Energy Metabolism Test performs quantitative measurements of 6 carbon metabolites (α-ketoglutarate, alanine, lactate, phenylalanine, pyruvate and succinate) by LC-MS/MS, using plasma and an algorithm reported as negative or positive for metabolic subtypes of ASD.
- NPDX ASD Test Panel III uses quantitative measurements of 14 acyl carnitines, microbiome-derived metabolites and LC-MS/MS through plasma to report a negative or positive risk for metabolic subtypes associated with ASD.
- SMASH Genomic Assay is a DNA copy number variation test that utilizes NGS technology and proprietary software to purportedly assist with a diagnosis of ASD.
- StrandDx-ASD uses novel molecular biomarkers developed by proprietary exposome and biological response sequencing platform, utilizing a single strand of hair.
Description Continued
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Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 3 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
The intended use is for determining the likelihood of ASD in children from birth to 18 months old and aid in diagnosis of ASD in individuals 18 months to 21 years of age.
- Diabetes Mellitus:
PreDx Diabetes Risk Score (DRS) is a risk assessment multianalyte serum assay purported to determine an individual’s risk of developing type II diabetes within 5 years. The test measures 7 circulating biomarkers: glucose, insulin, glycosylated hemoglobin A1c (HbA1c), C-reactive protein (CRP), ferritin, interleukin 2 receptor alpha (IL-2Rα) and adiponectin. These measurements are applied to an algorithm, combined with an individual’s age and sex, to determine the individual’s risk of developing diabetes. - Fibromyalgia:
FM/a is a proprietary, multibiomarker-based test to diagnose fibromyalgia by analyzing immune system white blood cell chemokine and cytokine patterns along with a scoring system of 1 to 100. Positive results are reported with a score of 50 or more. - Kawasaki Disease:
HART KD is a 3-assay serum panel consisting of NT-proBNP, C-reactive protein and T-uptake which is used along with machine learning to report an algorithm risk score for predicting the presence of Kawasaki disease.
KawasakiDx is a serum assay that includes interferon alpha-inducible protein 27 (IFI27) and mast cell-expressed membrane protein 1 (MCEMP1) along with RNA and reverse transcription polymerase chain reaction (RT-qPCR) to report a risk score for Kawasaki disease. - Kidney Disease:
Glomerular filtration rate (GFR) measurement by nuclear magnetic resonance (NMR) spectroscopy uses serum and NMR to determine estimated GFR (eGFR) with myo-inositol, valine and creatinine, algorithmically combined with cystatin C (by immunoassay) and demographic data.
KidneyIntelX is a multiplex immunoassay that uses algorithms to assess a combination of predictive blood-based biomarkers and an individual’s electronic health record to generate a prognostic risk score for the rapid progression of kidney disease in individuals with type 2 diabetes and existing kidney disease.
NaviDKD Predictive Screening is a biomarker-based blood test (for an individual with type 1 or 2 diabetes) that measures carboxymethyllysine, methylglyoxal hydroimidazolone and carboxyethyl lysine by LC- MS/MS, along with HbA1c and eGFR to provide a risk score which is reported as predictive progression to high-stage kidney disease.
PromarkerD Diabetic Kidney Disease Risk Assessment is a serum panel of 3 biomarkers including, apolipoprotein A4 (ApoA4), CD5 antigen-like (CD5L) and insulin-like growth factor binding protein 3 (IGFBP3) by ELISA algorithm that combines results with high-density lipoprotein (HDL), eGFR and clinical data, which is reported as a risk score for developing diabetic kidney disease. - Pain Index Score / Opioid Use Disorder:
Foundation PISM is a urine analysis of 11 analytes (methylmalonic acid, xanthurenic acid, homocysteine, pyroglutamic acid, vanilmandelate, 5- hydroxyindoleacetic acid, hydroxymethylglutarate, ethylmalonate, 3- hydroxypropyl mercapturic acid [3-HPMA], quinolinic acid, kynurenic acid)
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 4 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 5 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.
Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Using liquid chromatography with tandem mass spectrometry (LC- MS/MS) to produce an algorithm, reported as a pain-index score which assumes a likelihood of atypical biochemical function associated with pain.
- INFINITI Neural Response Panel is a qualitative diagnostic test that uses a buccal swab specimen for the identification of an individual who may be at risk for opioid dependency. The panel is designed to identify 16 genetic mutations involved in the brain reward pathways that are associated with increased risk of opioid use disorder and is intended for use by physicians to aid in prescribing safe and effective pain management.
Systemic Lupus Erythematosus (SLE)
- AVISE CTD tests for SLE by combining a 2-tier, multi-level testing process of cell-bound complement activation products (CB-CAPs) and the proprietary AVISE algorithm, in addition to anti-nuclear antibodies (ANA), double-stranded DNA (dsDNA) and extractable nuclear antigen (ENA) testing.
- AVISE Lupus is a 10-marker analysis of eight IgG autoantibodies and two CB-CAPs using enzyme-linked immunosorbent immunoassay (ELISA), flow cytometry and indirect immunofluorescence of serum, plasma and whole blood which is reported along with an algorithmic SLE-likelihood assessment.
- AVISE SLE Monitor is a multi-biomarker test proposed to monitor disease progression, assess treatment efficacy and identify the risk of lupus nephritis in individuals with SLE.
- AVISE SLE Prognostic is a 10-marker panel developed as an add-on test to AVISE CDT to purportedly assess an individual's potential risk for thrombosis, cardiovascular events, lupus nephritis and neuropsychiatric lupus.
- SLE-Key Rule Out is a molecular diagnostic test developed to rule-out a diagnosis of SLE with classifier algorithm, based on 80 DNA, protein, oligonucleotide, lipid and carbohydrate antigens and detected as IgG and IgM isotypes for a total of 160 antibodies, using indirect ELISA on a protein microarray and serum specimen. Results are expressed as a probability score with classification of SLE ruled out or SLE not ruled out.
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 6 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
For information regarding the proposed use of MAAAs for indications not addressed in this policy, please see the following Medical Coverage Policies:
- Indication: Diagnosis of ASD
- Corresponding Medical Coverage Policy: Autism Spectrum Disorders Diagnosis and Treatment and Genetic Testing for Diagnosis of Noncancer Indications
- Indication: MAAA testing for cancer indications
- Corresponding Medical Coverage Policy: Multianalyte Assays with Algorithmic Analyses for Cancer Indications
Coverage Determination
Humana members may NOT be eligible under the Plan for the following MAAAs including, but not limited to the following:
- AVISE CDT/SLE Monitor/SLE Prognostic (81599, 84999); OR
- AVISE Lupus (0312U); OR
- Clarifi ASD (0170U); OR
- FM/a; OR
- Foundation PISM (0117U); OR
- Glomerular filtration rate (GFR) measurement by nuclear magnetic resonance (NMR) spectroscopy (0259U); OR
- Hart KD (0310U); OR
- INFINITI Neural Response Panel (0078U); OR
- KawasakiDx (0389U); OR
- KidneyIntelX (0105U, 0407U); OR
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 7 of 15
Humana's documents are updated regularly online.
When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
- NaviDKD Predictive Screening (0384U); OR
- NPDX ASD ADM Panel 1 (0063U); OR
- NPDX ASD Energy Metabolism Test (0263U); OR
- NPDX ASD Test Panel III (0322U); OR
- PreDx Diabetes Risk Score (81506); OR
- PromarkerD Diabetic Kidney Disease Risk Assessment (0385U); OR
- ScoliScore (0004M); OR
- Sentosa SQ HIV Genotyping Assay (0219U); OR
- SLE-Key Rule Out (0062U); OR
- SMASH Genomic Assay (0156U); OR
- StrandDx-ASD
These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.
Additional information about conditions addressed in this policy may be found from the following websites:
- Background
- American Academy of Pediatrics
- American College of Rheumatology
- American Diabetes Association
- National Library of Medicine
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 8 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
Medical Alternatives
Alternatives to autoimmune CTD and SLE differential evaluation include:
- Anti-dsDNA and anti-Sm testing and Serum ANA
- CRP, erythrocyte sedimentation rate (ESR) and serum creatinine testing
Alternatives to biomarker testing for fibromyalgia include, but may not be limited to, the following:
- Complete blood count (CBC)
- Cyclic citrullinated peptide antibody test
- ESR
- Rheumatoid factor
- Thyroid function tests (TFTs)
Alternatives to diabetes risk assessment multianalyte assays include, but may not be limited to, the following:
- Fasting plasma glucose test
- Glycosylated hemoglobin A1c (HbA1c) test
- Oral glucose tolerance test
Alternatives to HIV genotyping for HIVDR testing include:
- Sanger sequencing
Alternatives to liquid chromatography-mass spectrometry for the diagnosis of ASD include:
- Evaluation performed by an appropriate certified/licensed health care professional
- For information regarding genetic testing of ASD, please refer to Comparative Genomic Hybridization/Chromosomal Microarray Analysis and Genetic Testing for Diagnosis of Noncancer Indications Medical Coverage Policies)
Alternatives to multi-biomarker risk assessments for end-stage kidney disease include, but may not be limited to, the following:
- Serum measurement of eGFR
- Urine measurement of albumin creatinine ratio (ACR)
Physician consultation is advised to make an informed decision based on an individual's health needs.
Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.
Codes
informational purposes only.
Do not rely on the accuracy and inclusion of specific codes.
Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.
| CPT® Code(s) | Description | Comments |
|---|---|---|
| 81506 | Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbA1c, insulin, hs-CRP, adiponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reporting a risk score | Not Covered Test Obsolete/No Longer Available |
| 81599 | Unlisted multianalyte assay with algorithmic analysis | Not Covered if used to report any MAAA as outlined in Coverage Determination section |
| 84999 | Unlisted chemistry procedure | Not Covered if used to report any MAAA as outlined in Coverage Determination section |
| 0004M | Scoliosis, DNA analysis of 53 single nucleotide polymorphisms (SNPs), using saliva, prognostic algorithm reported as a risk score | Not Covered Test Obsolete/No Longer Available |
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 10 of 15
| 0062U | Autoimmune (systemic lupus erythematosus), IgG and IgM analysis of 80 biomarkers, utilizing serum, algorithm reported with a risk score | Not Covered |
| 0063U | Neurology (autism), 32 amines by LC-MS/MS, using plasma, algorithm reported as metabolic signature associated with autism spectrum disorder | Not Covered |
| 0078U | Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid-use disorder | Not Covered |
| 0105U | Nephrology (chronic kidney disease), multiplex electrochemiluminescent immunoassay (ECLIA) of tumor necrosis factor receptor 1A, receptor superfamily 2 (TNFR1, TNFR2), and kidney injury molecule-1 (KIM-1) combined with longitudinal clinical data, including APOL1 genotype if available, and plasma (isolated fresh or frozen), algorithm reported as probability score for rapid kidney function decline (RKFD) | Not Covered |
| 0117U | Pain management, analysis of 11 endogenous analytes (methylmalonic acid, xanthurenic acid, homocysteine, pyroglutamic acid, vanilmandelate, 5-hydroxyindoleacetic acid, hydroxymethylglutarate, ethylmalonate, 3-hydroxypropyl mercapturic acid (3-HPMA), quinolinic acid, kynurenic acid), LC- MS/MS, urine, algorithm reported as a pain-index score with likelihood of atypical biochemical function associated with pain | Not Covered |
| 0156U | Copy number (eg, intellectual disability, dysmorphology), sequence analysis | Not Covered |
| 0170U | Neurology (autism spectrum disorder [ASD]), RNA, next-generation sequencing, saliva, algorithmic analysis, and results | Not Covered |
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 11 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.
Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
| 0219U | Infectious agent (human immunodeficiency virus), targeted viral next-generation sequence analysis (ie, protease [PR], reverse transcriptase [RT], integrase [INT]), algorithm reported as prediction of antiviral drug susceptibility | Not Covered |
| 0259U | Nephrology (chronic kidney disease), nuclear magnetic resonance spectroscopy measurement of myo-inositol, valine, and creatinine, algorithmically combined with cystatin C (by immunoassay) and demographic data to determine estimated glomerular filtration rate (GFR), serum, quantitative | Not Covered |
| 0263U | Neurology (autism spectrum disorder [ASD]), quantitative measurements of 16 central carbon metabolites (ie, a- ketoglutarate, alanine, lactate, phenylalanine, pyruvate, succinate, carnitine, citrate, fumarate, hypoxanthine, inosine, malate, S-sulfocysteine, taurine, urate, and xanthine), liquid chromatography tandem mass spectrometry (LC-MS/MS), plasma, algorithmic analysis with result reported as negative or positive (with metabolic subtypes of ASD) | Not Covered |
| 0310U | Pediatrics (vasculitis, Kawasaki disease [KD]), analysis of 3 biomarkers (NT- proBNP, C-reactive protein, and T-uptake), plasma, algorithm reported as a risk score for KD | Not Covered |
| 0312U | Autoimmune diseases (eg, systemic lupus erythematosus [SLE]), analysis of 8 IgG autoantibodies and 2 cell-bound complement activation products using enzyme-linked immunosorbent immunoassay (ELISA), flow cytometry and indirect immunofluorescence, serum, or plasma and whole blood, individual components reported along with an algorithmic SLE- likelihood assessment | Not Covered |
| 0322U | Neurology (autism spectrum disorder [ASD]), quantitative measurements of 14 acyl carnitines and microbiome-derived metabolites, liquid chromatography with tandem mass spectrometry (LC-MS/MS), plasma, results reported as negative or positive for risk of metabolic subtypes associated with ASD | Not Covered |
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 12 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
| 0384U | Nephrology (chronic kidney disease), carboxymethyllysine, methylglyoxal hydroimidazolone, and carboxyethyl lysine by liquid chromatography with tandem mass spectrometry (LC- MS/MS) and HbA1c and estimated glomerular filtration rate (GFR), with risk score reported for predictive progression to high-stage kidney disease | Not Covered New Code Effective 04/01/2023 |
|---|---|---|
| 0385U | Nephrology (chronic kidney disease), apolipoprotein A4 (ApoA4), CD5 antigen-like (CD5L), and insulin-like growth factor binding protein 3 (IGFBP3) by enzyme-linked immunoassay (ELISA), plasma, algorithm combining results with HDL, estimated glomerular filtration rate (GFR) and clinical data reported as a risk score for developing diabetic kidney disease | Not Covered. New Code Effective 04/01/2023 |
| 0389U | Pediatric febrile illness (Kawasaki disease [KD]), interferon alpha-inducible protein 27 (IFI27) and mast cell-expressed membrane protein 1 (MCEMP1), RNA, using reverse transcription polymerase chain reaction (RT-qPCR), blood. | Not Covered. New Code Effective 04/01/2023 |
| 0407U | Nephrology (diabetic chronic kidney disease [CKD]), multiplex electrochemiluminescent immunoassay (ECLIA) of soluble tumor necrosis factor receptor 1 (STNFR1), soluble tumor necrosis receptor 2 (STNFR2), and kidney injury molecule 1 (KIM-1) combined with clinical data, plasma, algorithm reported as risk for progressive decline in kidney function | Not Covered New Code Effective 10/01/2023 |
CPT® Category III Code(s)
Description
Description
Comments
No code(s) identified
HCPCS Code(s)
Description
Description
Comments
No code(s) identified
References
- American Academy of Child and Adolescent Psychiatry (AACAP). Practice parameter for the assessment and treatment of psychiatric disorders in children and adolescents with intellectual disability (intellectual developmental disorder). https://www.aacap.org. Published April 2020. Accessed June 4, 2023.
- American Association for Clinical Chemistry (AACC). Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. https://www.aacc.org. Published 2011. Accessed June 4, 2023.
- American Diabetes Association (ADA). Standards of medical care in diabetes – 2023. https://www.diabetes.org. Published January 2023. Accessed June 4, 2023.
- ClinicalKey. Clinical Overview. Kawasaki disease. https://www.clinicalkey.com. August 30, 2022. Accessed May 31, 2023.
- ECRI Institute. Genetic Test Assessment. Avise lupus test (Exagen, Inc.) for diagnosing systemic lupus erythematosus. https://www.ecri.org. Published March 2, 2022. Accessed May 29, 2023.
- ECRI Institute. Genetic Test Assessment. KidneyIntelX (Renalytix, Inc.) for assessing risk for progressive kidney function decline. https://www.ecri.org. Published March 9, 2022. Accessed May 29, 2023.
- Hayes, Inc. Genetic Test Evaluation (GTE) Report (ARCHIVED). PreDx Diabetes Risk Score (DRS). https://evidence.hayesinc.com. Published November 8, 2012. Accessed May 30, 2023.
- Hayes, Inc. Genetic Test Evaluation (GTE) Synopsis (ARCHIVED). AVISE CTD (Exagen Diagnostics). https://evidence.hayesinc.com. Published October 27, 2016. Accessed May 29, 2023.
- Hayes, Inc. Precision Medicine Research Brief. NPDX ASD test (NeuroPointDX). https://evidence.hayesinc.com. Published December 27, 2022. Accessed May 29, 2023.
- Merck Manual: Professional Version. Human immunodeficiency virus (HIV) infection. https://www.merckmanuals.com. Updated February 2023. Accessed May 31, 2023.
- UpToDate, Inc. Adolescent idiopathic scoliosis: clinical features, evaluation, and diagnosis. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Adolescent idiopathic scoliosis: management and prognosis. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Approach to the management of chronic non-cancer pain in adults. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 13 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
- UpToDate, Inc. Autism spectrum disorder in children and adolescents: evaluation and diagnosis. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Cardiovascular sequelae of Kawasaki disease: clinical features and evaluation. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Clinical manifestations and diagnosis of fibromyalgia in adults. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Clinical manifestations and diagnosis of systemic lupus erythematosus in adults. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Diabetic kidney disease: pathogenesis and epidemiology. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Genetic testing in patients with a suspected primary immunodeficiency or autoinflammatory syndrome. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
Multianalyte Assays with Algorithmic Analyses for Noncancer Indications
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 06/22/2023
Policy Number: HUM-0509-037
Page: 15 of 15
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
- UpToDate, Inc. Overview of HIV drug resistance testing assays. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Pathogenesis of type 2 diabetes mellitus. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Type 2 diabetes mellitus: prevalence and risk factors. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- UpToDate, Inc. Screening for type 2 diabetes mellitus. https://www.uptodate.com. Updated April 2023. Accessed May 30, 2023.
- US Food & Drug Administration (FDA). De novo decision summary: Sentosa SQ HIV-1 genotyping assay. https://www.fda.gov. Published November 5, 2019. Accessed June 5, 2022.
- Weber J, Volkova I, Sahoo M, et al. Prospective evaluation of the Vela Diagnostics next-generation sequencing platform for HIV-1 genotypic resistance testing. J Mol Diagn. 2019;21(6):961-970. https://www.ncbi.nlm.nih.gov/pmc. Accessed May 30, 2023.