Research & Development
Policy & Regulation
Trends & Finance
Payor Coverage: Page 2
Immunovia nabs CMS preliminary payment determination
The CMS preliminary payment determination implied a test price of $897.
September 26, 2022
ACLA campaign, letter seek to stop cuts in lab testing payments
ACLA said it is launching a series of digital advertisements as part of its Stop Lab Cuts campaign to urge Congress to pass the Saving Access to Laboratory Services Act.
September 12, 2022
OncoCyte announces evaluation of gene expression test
In a clinical trial, 429 patients diagnosed with metastatic urothelial cancer were treated with atezolizumab (Tecentriq, Genentech), an immune checkpoint inhibitor.
August 24, 2022
Labcorp acquires RWJBarnabas Health outreach services
With the acquisition, physicians and patients will have access to an expanded test menu, Labcorp's network of patient service centers, expanded health plan coverage, and reduced out-of-pocket lab costs, the organizations said, adding that greater support, service, and same day and STAT testing will be available in rural and local communities.
August 23, 2022
Caris Life Sciences to pay almost $2.9M in false claims lawsuit
The Irving, Texas-based company delayed its submission of claims to the Centers for Medicare & Medicaid Services for its predictive biomarker tests, known as Caris Molecular Intelligence and the Adapt Biotargeting System, leading to additional expenses, the DOJ said.
June 1, 2022
AACC lobbies against greater regulation of lab-developed tests
The Verifying Accurate Leading-edge IVCT Development (VALID) Act would limit the availability of laboratory-developed tests, decreasing patient access to these diagnostic tools, the AACC said. Often created when there is no FDA-approved commercial test available, these tests are frequently used to diagnose rare conditions -- such as genetic abnormalities in children -- or to respond to emerging health threats such as COVID-19, according to the association.
May 24, 2022
Lucid promotes new guideline from ACG on esophageal cancer
The new guidelines include a reference to screening for esophageal cancer using Lucid's EsoGuard DNA test on samples collected with its EsoCheck Cell Collection device, it said.
April 3, 2022
PGDx receives updated Medicare rate for Elio test
The Centers for Medicare & Medicaid Services finalized a national reimbursement rate of $2,919.60 for the proprietary laboratory analyses code (0250U) that PGDx obtained for the test, the company reported in a release.
January 27, 2022
COVID-19 tests drove increase in Medicare spending in 2020
The HHS Office of Inspector General (OIG) found that total Medicare Part B spending has increased each year for the past five years. COVID-19 tests accounted for approximately 19% of total Medicare Part B spending on lab tests, while utilization of non-COVID-19 tests as a group decreased 15.9% from 2019. Spending on lab tests other than for COVID-19 in 2020 was the lowest it had been in the past five years (no other year prior to the pandemic had a decrease).
January 3, 2022
LabPulse.com Microbiology Insider
Diagnostic testing is key to controlling the COVID-19 pandemic, and the earlier that SARS-CoV-2 infection can be detected, the better. Researchers from Hong Kong believe they may have found an assay that detects SARS-CoV-2 at a much earlier stage of infection.
October 25, 2020
Report: LDT market to exceed $17B
The findings come from LabPulse.com sister company and IVD research firm Kalorama Information in a new report, "The Market for Clinical LDT Services and LDT Supplies." Kalorama noted that the LDT market is driven by relaxed regulatory activity and the need for improved cancer tests.
October 19, 2020
AACC: LDTs play crucial role in patient care
Furthermore, adding regulation by the U.S. Food and Drug Administration (FDA) would be duplicative, burdensome, and could stymie the ability of labs to respond quickly to new diseases like COVID-19.
October 15, 2020
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