Lab Economics: Medi-Cal Expands Coverage for Six Whole-Genome Sequencing Tests

Previously, these six codes were covered only for neonatal populations in inpatient settings. While some of the tests now have frequency limits, as well as a treatment authorization request (TAR) requirement, there is no age or place-of-service restriction, according to Clarisa Blattner, Senior Director, Revenue and Payor Optimization for XiFin Inc. (San Diego).

The covered codes are:

• 0340U: Oncology (pan-cancer), analysis of minimal residual disease (MRD) from plasma, with assays personalized to each patient based on prior next gen sequencing of the patient’s tumor and germline DNA; Medicare rate $3,590.
• 81228: Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number variants, comparative genomic hybridization microarray analysis; Medicare rate $900.
• 81229: Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number and single nucleotide polymorphisms (SNP) variants, comparative genomic hybridization microarray analysis; Medicare rate $1,160.
• 81425: Genome (e.g., unexplained constitutional or heritable disorder syndrome); sequence analysis; Medicare rate $5,031.
• 81426: Genome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator genome (eg, parents, siblings); Medicare rate $2,710.
• 81427: Genome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained genome sequence; Medicare rate $2,338.

California was one of the first states in the nation to cover rapid WGS for critically ill infants under Medi-Cal, beginning Jan. 1, 2022. There are 30 states, plus Puerto Rico, with limited coverage for WGS testing under Medicaid, but none is as extensive as California, says Blattner. She believes it is likely that other states will follow California’s example.

Genetic testing labs, especially those that perform neonatal and pediatric testing, are likely to see an increase in testing as a result of the expanded coverage. Because there are no age limitations on the WGS tests now covered by Medi-Cal, the number of tests performed could increase substantially. Southern California, which has the highest concentration of Medi-Cal participants, also includes major genomic hubs, including Rady’s Children’s Hospital, UCLA, Children’s Hospital of Los Angeles and Loma Linda University Medical Center, all of which stand to benefit from the expanded coverage. Independent labs that may benefit include Baylor Genetics, GeneDx and Natera Inc.

According to Blattner, rapid trio WGS is most often used for critically ill infants with unexplained disease while standard WGS in adults is used for rare disease diagnosis, hereditary cancer/cardiac risk assessment and pharmacogenomics.

While Medi-Cal has not yet posted reimbursement rates for the expanded coverage, Blattner notes that Medicare payment ranges from $900 for cytogenomic analysis (CPT 81427) to $10,451 for rapid trio WGS (CPT 81425 & 81426 x2).