Based on the results of Project Baby Bear, Rady Children's Hospital-San Diego hopes the State of California will cover rapid whole-genome sequencing going forward.
The Minneapolis-based firm believes the assay can successfully serve as a clinical indicator for patients at risk of developing high-grade prostate cancer (HGPC), thereby improving prostate cancer management.
The changes include who can order tests for beneficiaries, who can bill CMS for certain testing-related services, and the inclusion of antibody tests as a covered service.
Under the guidance, group health plans and group and individual health insurers must cover diagnostic testing and other "certain related items and services."
A pathologists' group has pointed out that the bill covers only EUA tests, and patients receiving tests with pending regulatory status may receive surprise bills.
The insurer will cover testing at the Rady Children's Institute for Genomic Medicine for children in intensive care with unexplained medical conditions.
Following its IPO in September, the company is expanding its presence with increased product offerings in the pipeline and a renewed focus on reimbursement and R&D.
