TAG:
clinical laboratories
Why Labs Operate in a ‘Duality’ during Pandemic
HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”? On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2…
One Genetic Test CPT Code Earns ‘Fraudomatic’ Title
CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…
NorDx Lab Started to Prepare for COVID-19 Testing in 2019
CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…
CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates
CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS). The first letters were sent on Aug. 12 and le…
December 7, 2020 Intelligence: Late-Breaking Lab News
Supply chain issues associated with the SARS-CoV-2 pandemic are about to disrupt testing for other infectious diseases, ranging from strep throat and pneumonia to sexually-transmitted diseases (STDs). That was one important finding from the American Society for Microbiology’s (ASM) November …
COVID-19 or Not, Lab Market Enters ‘Twilight Zone’
Our healthcare system is in a most remarkable state. Even as all providers—including clinical laboratories and anatomic pathology groups—continue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements g…
California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?
CEO SUMMARY: California dropped a bomb on the state’s existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs…
UnitedHealthcare Delays Its New Test Registry Protocol Until April 1
CLINICAL LABORATORIES AND ANATOMIC PATHOLOGY GROUPS working to register their tests with UnitedHealthcare’s (UHC) new Laboratory Test Registry Protocol just got a 90-day reprieve. UHC has delayed the start date to April 1, 2021. …
Palmetto GBA Tells Consultant to Take Down Test Price Data
CEO SUMMARY: Lawyers for Medicare contractor Palmetto GBA sent a cease and desist letter in September to a respected lab consultant, telling him to delete from his health policy blog a document containing Medicare genetic test price and coding data. In the letter, Quinn was directed…
New Twist: HHS Exerts Authority Over FDA on LDTs
CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…
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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