CMS has extended the comment period on its nearly 50 percent BRCA testing reimbursement cut to the end of February. But comments from lab and diagnostics groups so far try to underscore the “capriciousness and lack of transparency” that CMS displayed when it made the cut. Experts say the agency is unlikely to change its mind.
CMS extended the comment period on BRCA diagnostic testing reimbursement to Feb. 28, but the consensus among experts is that the agency will not reverse its nearly 50 percent reimbursement cut on sequencing of the BRCA1 and BRCA2 genes for the likelihood of inheriting breast and ovarian cancer.
“Once [CMS has] set something, they won’t change it up or down,” said Charles Root, CEO of Medicare compliance and reimbursement consultancy CodeMap LLC, citing past precedent.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
