LCD and Billing and Coding Articles Updates
Local Coverage Determinations
Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (L33394)
This LCD was released to Final on 5/29/2025 and will be effective 7/13/2025. The Indications of Coverage have been expanded to allow bevacizumab for treating hereditary hemorrhagic telangiectasia (HHT) with arteriovenous malformations. The Summary of Evidence and the Analysis of Evidence sections have been updated.
Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases (L37606)
Updated the tables of genomic biomarkers and their clinical utility in acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN).
Removed the Limitation regarding repeat testing in MDS and added the following bullet to the Indications of coverage under MDS: "Repeat Genomic Sequential Analysis Panel testing is considered reasonable and necessary in MDS after initial diagnosis and risk stratification."
Molecular Pathology Procedures (L35000)
Under Coverage Indications and Limitations section, the indication was corrected to read "JAK2 V617F genotyping is considered medically necessary in the initial diagnostic work-up of BCR-ABL negative, adults with clinical, laboratory, or pathological findings suggesting myeloproliferative neoplasm (MPN) (polycythemia vera (PV), essential thrombocythemia (ET) or primary myelofibrosis (PMF)) or a myelodysplastic syndrome (MDS)."
Billing and Coding Articles
Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases (A56793)
Added the following wording to the Article text: "or DNA analysis, and RNA analysis 51 or greater genes (CPT 81455 or 81456)"
Added the following wording to the CPT/HCPCS codes section-Group 1: "or DNA analysis, and RNA analysis 51 or greater genes CPT code 81455 or 81456"
Molecular Pathology Procedures (A56199)
Effective 7/13/2025, CPT code 81232 DPYD testing has been removed from the Group 3, Tier 1 Non-covered Codes list and has been moved to the Pharmacogenomic Testing Billing and Coding Article, A59915.
Effective 7/13/2025, CPT code 81418 has been removed from the "CPT/HCPCS Code" section-Group 2 (Individual Review) and has been moved to the Pharmacogenomic Testing Billing and Coding Article, A59915.
Bevacizumab and biosimilars (A52370)
This article was released to Final on 5/29/2025 and will be effective 7/13/2025.
New LCDs/Billing and Coding Articles
Pharmacogenomic Testing (L39995) (A59915)
The Proposed LCD for Pharmacogenomics Testing outlines the coverage criteria for genetic tests that evaluate how an individual's genetic makeup affects their response to medications. This LCD aims to enhance patient outcomes by optimizing drug therapy and minimizing adverse events. Pharmacogenomics testing will be considered medically reasonable and necessary if the patient has a condition where clinical evaluation determines the need for a medication with known gene-drug interactions, and if the test results directly impact the drug management of the patient’s condition. Additionally, the test must meet evidence standards for genetic testing as evaluated by a scientific, transparent, peer-reviewed process and demonstrate actionability in clinical decision-making by Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline level A or B, or be listed in the FDA table of known gene-drug interactions. The LCD also specifies that genetic testing where analytical validity, clinical validity, or clinical utility has not been established, and any duplicative germline testing, is not medically reasonable and necessary. This LCD is intended to guide healthcare providers in the appropriate use of pharmacogenomics testing to improve patient care.
Posted 7/14/2025