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cap
What Is CAP’s Role When Lab Has a Serious Medical Error?
IT IS CERTAINLY SIGNIFICANT NEWS FOR THE PATHOLOGY PROFESSION that a respected pathologist—indeed a pathology chair—is alleged to be involved in covering up a misdiagnosis of cancer for a patient who then had a healthy essential organ surgically removed. And the story doesn’t end there. It is …
Cover-Up Charged After Alleged Surgical Pathology Error
CEO SUMMARY: In an explosive civil case, documents show a pathologist erroneously diagnosed a patient as having cancer of an essential body organ and that the organ was removed unnecessarily, stated an attorney for the whistleblower. The patient has not yet been told of the misdiagnosis o…
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
California Lab Company Offers Genetic Tests with Low Prices
ONE BY ONE, A HANDFUL OF PROGRESSIVE LAB COMPANIES is finding financial success with a strategy of pricing genetic tests at levels that are affordable and attractive to the general public. These labs report an added benefit: They find it easier to get health insurers to pay their genetic test claims….
Florida Pathology Group Lost Volume After BeaconLBS Started
CEO SUMMARY: A 22-physician pathology group in Tampa has complied with rules for lab test ordering that UnitedHealthcare and BeaconLBS established, yet has experienced a steep decline in the volume of specimens it receives. Physicians told the pathologists that other labs were not using t…
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
PAMA Final Rule a Threat To Community Lab Survival
CEO SUMMARY: Will implementation of the final PAMA private payment rate reporting rule for labs put smaller, community labs at financial risk? Yes, says the National Independent Laboratory Association (NILA). By deliberately setting a standard to exclude private payer payment data from ho…
Quest to Manage Six Labs at HCA HealthONE Hospitals
CEO SUMMARY: For decades, hospitals were reluctant to allow any outside lab company to run their inpatient lab operations because they preferred to maintain control over quality results and turnaround times. That attitude may be changing as health systems face increasing margin compressio…
Years of Biobank Experience Pay Off for Mayo Clinic Lab
THANKS TO 10 YEARS OF EXPERIENCE, an existing infrastructure for banking patient specimens, and the unique capabilities of its clinical laboratory organization, Mayo Clinic has been awarded a five-year, $142 million grant from the National Institutes of Health. Last…
Genetic Testing Lab Finds Payers Respond To Education on Test Utility
CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utilit…
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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