TAG:
molecular testing
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
Labs Get High Denial Rates Under New NCCI Rules
CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented …
Nine Lab Groups Say New NCCI Policy Is Inconsistent
CEO SUMMARY: By its name alone, the National Correct Coding Initiative (NCCI) Policy Manual implies that it will be accurate and consistent with other coding initiatives. But nine groups representing various clinical laboratories say NCCI guidelines that the federal Centers for Medicare a…
Sonic to Pay $540 Million to Buy Aurora Diagnostics
CEO SUMMARY: Sonic Healthcare, Ltd., announced that it would pay $540 million—a multiple of 9.2 times EBITDA—to acquire Aurora Diagnostics, the anatomic pathology company based in Palm Beach Gardens, Fla. Sonic will gain 32 pathology practice sites and add 220 pathologists to its netw…
Under Audit, Labs Need Statistics on Their Side
CEO SUMMARY: When commercial and government payers use auditors to review a lab’s claims, they often use statistical sampling and extrapolation to limit the time needed to review claims. But proper sampling and extrapolation require following the rigorous scientific methods to produce a…
Near Real-time Data Helps Lab Save $500K Annually
CEO SUMMARY: After hospital labs and pathology groups implement Lean and process improvement methods to harvest the easiest cost savings and boost quality, they often take the next step of introducing real-time analytics systems. Access to detailed data about workflows, productivity, and …
Key Lab Trends Described At Executive War College
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery…
Medicare Fees Less Than Lab Costs to Serve SNFs?
CEO SUMMARY: Anticipating the negative financial impact of the Medicare 2018 Clinical Laboratory Fee Schedule, a community lab company serving 24 nursing homes on the Jersey Shore stopped offering such services at the end of last year, a lab director told THE DARK REPORT. “The same forc…
Fla. Lab Sells to Labcorp, But Keeps Nursing Homes
CEO SUMMARY: Vista Clinical Diagnostics of Clermont, Fla., is betting big on the nursing home sector just when many labs serving nursing homes are worried about steep Medicare cuts coming Jan. 1. After selling its physician office referral testing, 35 patient service centers, and a mobile…
CURRENT ISSUE
Volume XXXIII, No. 2 – February 9, 2026
Congress has once again delayed cuts to test reimbursement rates under PAMA, this time until Jan. 1, 2027. Laboratory professionals are urged to lobby Congress to pass the RESULTS act to solve the PAMA cuts problem permanently. Also, patient-driven testing is spurring new opportunities.
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