The move is precipitated by CMS's decision to grant national coverage to NGS companion diagnostics when they're approved by the FDA.
The partners will conduct an exploratory study to determine how the results of Exagen's lupus test impacts primary care physician practice referral patterns.
Lab, diagnostic and healthcare groups want Congress to enact legislation to modify PAMA and address concerns about the way CMS collected data and established test prices.
Cigna began covering the company's ThyGeNext next-generation sequencing-based test for thyroid cancer risk assessment in 2017.
The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.
The recent OIG report on the implementation of PAMA doesn’t address that CMS has ignored congressional intent in implementing the law, ACLA said.
The coverage decision limits the test mainly to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue testing.
The German Federal Joint Committee (G-BA) plans to decide on reimbursement of breast cancer biomarker tests in Q4.
The report states that using NIPD for trisomy 21 in high-risk women could "probably reduce" the total number of invasive tests though the data is incomplete.
Cigna is the first national private payor to provider coverage for the Decipher tests, which provide a genomic assessment of tumor aggressiveness.
The tests have received coverage decisions from a number of Blue Cross Blue Shield plans this year including ones in California and New Jersey.
The Center for Genomic Interpretation and NSGC want payors to cover confirmatory testing for patients with positive results from 23andMe's FDA-cleared test.
TriCore's new president and CEO reflects on lab industry advancements and discusses new changes on the horizon.
The company said it has produced documents in response to the government's civil investigative demand notice.
Under a collaboration with GeneDx, Boston Children's has rapidly sequenced the exomes of 20 NICU babies and have arrived at a likely diagnosis in around 85 percent.
The coverage decisions follow similar decisions by Blue Shield of California and First Coast Service Options last year.
As payors increase controls over reimbursements for genetic lab testing, labs are increasingly using genetic counselors as middlemen in lab test reimbursements, genetic counselors say.
The lawsuits were filed after the HHS OIG subpoenaed the firm as part of an investigation into how it billed Medicare and Medicaid for the myRisk test.
A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.
Under the draft determination, the test would be covered to help assess which treatments to use in patients with advanced prostate cancer.