Medical Policy Update for August 15, 2023

Updated When Covered section, #4 to read as follows: “4. Basic Life Support (BLS) ambulance or medical transport services are considered eligible for coverage if the patient is legally pronounced dead after the ambulance was called, but before pickup, or enroute to the hospital. Medical director review 6/2023.

Reviewed by Avalon 2^nd Quarter 2023 CAB. When Covered section edited to include addition of frequency to 1.b., now allowing lipid panel screening on an annual basis for those with increased risk of dyslipidemia. Addition of “i) Obesity or metabolic syndrome” as a risk factor for annual lipid screening. Changed from Lp(a) screening only for those with risk factors to allowing once per lifetime screening of Lp(a): “3) For individuals 18 years of age or older, reimbursement is allowed for measurement of lipoprotein a (Lp(a)) once per lifetime." Addition of frequency for hs-CRP measurement, now reads: “4) Reimbursement is allowed for individuals for whom a risk-based treatment decision is uncertain (after quantitative risk assessment using ACC/AHA PCEs to calculate 10-year risk of CVD events [see Note 2]), testing for C-reactive protein with the high-sensitivity method (hs-CRP) at the following frequency: a) For initial screening, two measurements at least two weeks apart. b) If the initial screen was abnormal, follow-up screening is allowed up to once per year.” Not Covered section edited for clarity. New Note added to define a simple lipid panel. Description, Policy Guidelines and References updated. Billing/Coding section updated to add CPT code 86140 and remove CPT code 84512. Medical Director review 7/2023.

Reviewed by Avalon 2^nd Quarter 2023 CAB. Related policies added. Description, policy guidelines, and references updated. When Covered section updated for clarity. Medical director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Added related policies. Added the following statement to Benefits Application: “This policy only addresses testing for the purpose of medical decision making in the outpatient setting. This policy does not address work, school, state, or federally mandated SARS-CoV-2 testing”. Removed the following from when covered section: “For asymptomatic individuals prior to undergoing immunosuppressive or aerosol-producing procedures.” As new guidelines specify that asymptomatic screening for those without a known exposure is not supported, even if they are going to undergo these types of procedures. Added “Reimbursement is not allowed for SARS-CoV-2 genotyping in the outpatient setting.” to not covered section. Remaining coverage criteria updated for clarity and consistency. Added CPT code 87913 and removed CPT codes 87797, 87799, G2023, G2024, U0003, U0004 and U0005. Medical Director Review 7/2023.

Added code 0330U to Billing/Coding section.

Policy archived with Avalon Q2 2023 CAB. See M2145-General Genetic Testing, Germline Disorders.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description and policy guidelines. Added references. Added the following statement to When Not Covered section: “Reimbursement is not allowed folate receptor autoantibody testing for all situations.”  Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Background, Policy Guidelines and References updated. Edited When Covered and Not Covered sections for clarity, no change to policy statement. Note 1 removed. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description, Policy Guidelines and References. Not Covered section edited for clarity: previous coverage criteria 1, 2, and 4 combined into new coverage criteria 2 with subcriteria and now reads “To assess an individual’s risk of developing cardiovascular disease, the following tests are considered investigational: a. Gene expression profiling. b. Genotyping for 9p21 single nucleotide polymorphisms. c. Panels that incorporate genetic risk factors with nongenetic biomarkers.” No change to policy intent. Medical Director review 7/2023.

Policy archived with Avalon Q2 2023 CAB.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated the background, guidelines and recommendations, and evidence-based scientific references. Genetic counseling recommendation moved from When Covered to the Policy Description. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description, Policy Guidelines, and   References. The following edits were made to the When Covered section: removed former coverage criteria 1 and 2, which addressed carrier and fetal testing. All CF carrier screening and fetal screening is addressed by AHS-M2179 Prenatal Screening (Genetic). Statement added to Description section to see M2179 for prenatal and preconception screening. Removed previous coverage criteria 8 regarding recommendation for genetic counseling. Recommendation was moved to the policy Description section. Note 1 edited to provide clarity and consistency within all of the coverage criteria which address the note (1, 2, 3, 5). Comprehensive gene sequencing has been added to coverage criteria 1, 2, and 3 as an allowed test type. Not Covered section edited for clarity. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description, Policy Guidelines, and References. The following updates were made to the When Covered section: Former coverage criteria 2 split and expanded into new coverage criteria 1 and 2 for full clarity regarding which genes should be ordered first based on prevalence of cause. Recommendation for genetic counseling removed as coverage criteria and moved into the Policy Description. Removed former coverage criteria 4 (prenatal screening addressed in M2179) and coverage criteria 5 regarding peripheral nerve biopsy. previous Note 1 removed and replaced with new Note 1. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB.  Description, Policy Guidelines, Federal Regulations, and References updated. When Covered and Not Covered sections edited for clarity. No change to policy statement.  Medical Director review 7/2023.

Policy archived with 2023 Avalon Q2 CAB. See policy AHS-M2029 Molecular Testing for Cutaneous Melanoma.

Reviewed by Avalon 2nd Quarter 2023 CAB. Background, policy guidelines and references updated. Changes to When Covered section: Former coverage criteria 1-4 replaced with “1. For individuals who are in a family with a deleterious familial hearing loss gene mutation, reimbursement is allowed for the following genetic testing: a. Testing restricted to the known familial mutation., b. Comprehensive genetic testing using multi-gene panel testing when the specific familial mutation is unknown. 2. Reimbursement is allowed for individuals diagnosed with hearing loss (when hearing loss due to nonhereditary causes [e.g., infection, injury, age-related] has been excluded), multi-gene panel testing (panel must include GJB2 and GJB6).” Recommendation for genetic counseling moved from previous coverage criteria 1 to a note in the description section. Not Covered section edited for clarity. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated the background, guidelines and recommendations, and evidence-based scientific references. When covered section edited for clarity, no changes to policy statement. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description, Policy Guidelines, and References. Not Covered section edited for clarity, no change to policy statement. CPT code 81479 added to Billing/Coding section. Medical Director review 7/2023.

Policy archived with 2023 Avalon Q2 CAB. See M2021-Pharmacogenetic Testing or M2145-General Genetic Testing, Germline Disorders.

Reviewed by Avalon 2nd Quarter CAB. Updated description, background, guidelines, and references.   Minor formatting edits. No change to policy statement. Medical Director Review 7/2023

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Removed AHS-G2138 Evaluation of Dry Eyes from related policies section. Edited and expanded “when covered” section for new medical necessity criteria for individuals with clinical signs of an inherited retinal degeneration, single gene or multi-gene panel testing. Added new Note 1. Updated policy guidelines and references.

Policy review. Reference added. Specialty Matched Consultant Advisory Panel review 11/16/2022

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description, Policy Guidelines and References. Within the table under the When Covered section, row for Candida testing for vaginitis removed (see updates to Table 1 under Not Covered), directive to see M2057 for vaginal Candida moved into policy description, code 87493 for C. diff moved from “Direct Probe” column to “Amplified Probe” column, Hepatitis B removed from the table due to the expansion of G2036 to include Hepatitis B testing. Previous coverage criteria 2 removed (2. "Reimbursement is allowed for PCR testing for any other microorganism without a specific CPT code”). Table 1 under Not Covered section edited to remove references to Candida testing for vaginitis, row now specifies “non-vaginal Candida”. Removed codes 87516, 87517, 87797, 87798, and 87799 from Billing/Coding section. Medical Director review 7/2023.

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Added related policies under description section. Updated policy guidelines and references. Updated table of solid tumors in policy guidelines section to match NCCN guidelines. Added PLA code 0391U to Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated policy guidelines and references. Removed Mutational testing with next generation sequencing to determine targeted treatments for patients diagnosed with cancer of unknown primary origin from when molecular profiling for cancers of unknown primary origin is not covered, this is referenced in policy Microsatellite Instability and Tumor Mutational Burden Testing AHS - M2178. Medical Director review 7/2023.

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Extensive revisions with information and coverage from M2037 Genetic Testing for Familial Cutaneous Malignant Melanoma transferred into this policy. M2029 and M2037 combined into one single policy. Updated description, coverage criteria, policy guidelines, and references. Added CPT codes: 81167, 81216, 81217, 81345, 81404, 81479, 0387U, 0314U to Billing/Coding section. Policy title changed from: Genetic Testing and Genetic Expression Profiling in Patients with Cutaneous Melanoma to Molecular Testing for Cutaneous Melanoma.

Archived this policy per Avalon Q2 2023 CAB. Information and criteria moved to AHS-M2026 Testing for Colorectal Cancer Management.

Reviewed by Avalon 2nd Quarter 2023 CAB. Policy retitled to Oral Cancer Screening and Testing.  Description section, policy guidelines, and references updated. Updated coverage criteria for clarity and consistency. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Updated Description and added references. Added CPT codes 88108, 88112, and 88173 to billing section. CPT code 89240 removed from billing section.  Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Description, Policy Guidelines and References updated. Added policy “General Inflammation Testing AHS-G2155” to Related Policies section. Edited When Covered and Not Covered sections for clarity. Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Background, Policy Guidelines and References updated. When Covered and Not Covered sections edited for clarity, no changes to policy statement. Removed previous Note 1. Removed PLA code 0330U from Billing/Coding section. Medical Director review 7/2023.

Reviewed with Avalon Q2 CAB 2023. Updated description, policy guidelines, and references. Coverage of carrier screening expanded to include all of Tier 1/2/3 screening as recommended by ACMG. Medical Director review 7/2023.

Reviewed by Avalon Q2 CAB 2023, off-cycle review. Proprietary test from Newstar Medical (RiskViewRx) was replaced by CareView360.  No other changes to coverage criteria. Removed PLA codes 0143U, 0144U, 0145U, 0146U, 0147U, 0148U, 0149U, 0150U. Medical Director review 7/2023.

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Changed gender language to individuals throughout policy. Updated description and policy guidelines sections. “When covered” section edited for clarity. No change to policy statement. Added Note: for 5 or more gene tests run on the same platform, please refer to AHS-R2162 Reimbursement Policy.

Reviewed by Avalon 2nd Quarter 2023 CAB. Description, Policy Guidelines, and References updated. CPT Code 83516 added to Billing/Coding section, and CPT code 81479 deleted from Billing/Coding section. When Not Covered section reworded to provide clarity. No change to policy statement. Medical Director review 7/2023. 

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Updated description section, policy guidelines and references. Re-organized “When Covered” section for focus on the cancer and then all appropriate biomarkers. Clarified “When Covered” section. Deleted CPT code 85415 from Billing/Coding section.

Reviewed by Avalon 2nd Quarter 2023 CAB. Description, Policy Guidelines and Reference sections updated. Made the following changes to the When Covered section: combined serum quantification, phenotyping, proteotyping, and genotyping into a single criteria, with the conditions from coverage criteria 1 remaining, results in deletion of previous coverage criteria 3. Added new Notes 1 and 2: “Note 1: AAT phenotyping should be performed using isoelectric focusing. AAT proteotyping (Pi-typing or protease inhibitor typing) for Z and S alleles should be performed using liquid chromatography-tandem mass spectrometry. Initial genetic testing should be restricted to genotyping of SERPINA1 S and Z allele mutations. Note 2: First-degree relatives include parents, full siblings, and children of the individual.” Not Covered section edited for clarity. Medical Director review 7/2023.

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Updated description, policy guidelines and references. Added related policy AHS-M2178. Policy information and criteria from AHS-M2111 Multigene Expression Assay for Predicting Colon Cancer Recurrence was moved into this policy. “When covered and when not covered” sections clarified and edited due to added information from M2111. Added CPT codes 81479, 81525, 81599 to Billing/Coding section. Title changed from: KRAS, NRAS and BRAF Mutation Analysis in Colorectal Cancer to: Testing for Colorectal Cancer Management.

Reviewed by Avalon Q2 2023 CAB. Medical Director review 7/2023. Updated description, policy guidelines and references. Edited “When Covered” section for clarity and consistency. Removed statements testing for BRAF, EGFR, MET, ALK, RET, ROS1 before any systemic therapy initiation in individuals w/NSCLC; NTRK gene fusion for individuals w/NSCLC before 1st line or subsequent therapy due to repetition.

Reviewed per Avalon Q2 2023 CAB. Changed title to Urine Culture Testing for Bacteria to align with Avalon. Description, Policy Guidelines and References updated.  When covered section updated for clarity. Add the following statement to when not covered section: “Reimbursement is not allowed for urine culture testing (with isolate identification and antibiotic susceptibilities if applicable) for all other instances of asymptomatic UTI or asymptomatic bacteriuria not described above.” Medical Director review 7/2023.

Reviewed by Avalon 2nd Quarter 2023 CAB. Description, Policy Guidelines and References updated. Billing/Coding section updated to remove codes 0012U, 0013U, 0014U and 0056U. When Covered and Not Covered sections edited for clarity, no change to policy statement. Medical Director review 7/2023.