TAG:
ldt
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
New Pricing Formula for Advanced Diagnostic Tests
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
Whole Genome Sequencing Is Poised for Clinical Use
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …
Tricare, DOD Not Paying for MoPath Codes, LDTs
CEO SUMMARY: It turns out that labs serving Tricare patients are going unpaid for certain LDTs, molecular, and genetic tests. The issue of nonpayment began in January 2013 when Tricare stopped paying for these tests that were billed under the new molecular CPT codes that replaced the prev…
CMS Proposes Yet More Cuts for 2014, Beyond
CEO SUMMARY: In July, CMS proposed rules to cut payments under the Hospital Outpatient Prospective Payment System, the Physician Fee Schedule, and the Clinical Laboratory Fee Schedule. Under each program, the proposed payment cuts could have a significant and negative effect on the amount…
July 08, 2013 “Intelligence: Late Breaking Lab News”
In China, independent clinical laboratories are in a fast-growth mode. That’s the conclusion of RnRMarketResearch in a newly-issued survey of the clinical laboratory testing market in China. It estimates this market segment at US$407 million annually. RnR says that three lab companies meet …
Labs Have New Hurdles as Some Payments Start
CEO SUMMARY: Some payments are beginning to flow for claims submitted under the new molecular test CPT codes. But there is a new issue. Medicare contractors, Medicaid programs, and private health insurers are deeming certain molecular tests to be medically unnecessary. Th…
Why One Molecular Diagnostics Company Closed Its Doors
CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding…
Four Labs and Billing Company Pay $140,000 Fine in HIPAA Case
WHEN A BILLING SERVICE company disposes of patients’ lab test records, it should do so in compliance with federal and state privacy rules. That means all protected health information (PHI) should be shredded or incinerated. Four pathology groups in Massachusetts learned this lesson the hard way wh…
Anticipating 2013 Trends in Clinical Lab and Pathology
CEO SUMMARY: Biggest news for 2013 will the impact of significant price cuts for both clinical lab and anatomic pathology testing services. But the bad news doesn’t stop there. Employers and private payers will be more aggressive in taking steps to reduce what they spend on lab testing….
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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