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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.
Noridian is also developing a generic policy for donor-derived cfDNA tests that will include several commercially available tests, Natera said.
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.
Palmetto has expanded coverage of the ClonoSeq assay to include monitoring MRD testing for patients with chronic lymphocytic leukemia (CLL.)
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.
A preliminary analysis lends some support to covering NIPS for pregnancies beyond high-risk, and some payors have expanded coverage.
When used together, ThyGeNext and ThyraMir combine next-generation sequencing of an individual's DNA and RNA along with a microRNA classifier.