TAG:
diagnostic testing
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
GE Healthcare Sells Omnyx to Inspirata
CEO SUMMARY: Now that the FDA has cleared a digital pathology for use in primary diagnosis, interest in DP is building. Inspirata purchased Omnyx and its assets because the Omnyx Dynamyx digital pathology software has strong features that could be integrated into Inspirata’s digital pat…
Lab Executives Declare Concerns about Fee Cuts
CEO SUMMARY: Members of Joint Venture Hospital Laboratories in Michigan anticipate that the 2018 Clinical Laboratory Fee Schedule rates being implemented under PAMA will lower payment from Medicare to less than the cost of running tests, especially for rural and critical access hospitals….
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…
Top 10 Lab Stories of 2017 Dominated by Part B Cuts
CEO SUMMARY: In hindsight, 2017 is likely to be remembered as a milestone year that launched several disruptive developments that will reshape the lab industry moving forward. For the clinical laboratory sector this year, CMS confirmed its intent to slash Part B clinical laboratory test price…
Paths of Hospital Labs, Independent Labs Diverge
CEO SUMMARY: With each passing year, the primary role of hospital and health system labs evolves in a different direction than that of independent lab companies. This trend is a response to the creation of integrated delivery networks paid on value and how they are scored on their ability…
Message to Labs: Improve Outcomes, Get Paid More Money!
CEO SUMMARY: By now, there is widespread recognition among pathologists and clinical lab managers that the era of fee-for-service reimbursement is giving way to new forms of payment that reward value. First-mover lab leaders are in the earliest stages of developing enhanced lab testing se…
Medicare Demands Force PGx Lab into Bankruptcy
CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx …
Another Pharmacogenomic Lab Hit With Audit, Multi-million Dollar Repayment Demand
CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the…
Pharmacogenomic Testing Draws $26 Million Recoupment from Medicare Audit
This is an excerpt from a 1,340-word article in the January 9 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Phar…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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