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Search Results for: COVID-19

California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?

Clinical Laboratory / By Robert Michel

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 in the Golden State must compete against their state …

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New Twist: HHS Exerts Authority Over FDA on LDTs

Laboratory Compliance / By Robert Michel

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 guidance documents as it previously did, the HHS legal opinion …

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IVD Firms Report Robust Growth In Third Quarter Financial Reports

In Vitro Diagnostics / By Robert Michel

FOR THE BIGGER IN VITRO (IVD) COMPANIES, the third quarter (Q3) ending Sept. 30 was a time when diagnostic sales rose—molecular testing is skyrocketing, actually—while other corporate divisions continued to lag amid the COVID-19 pandemic. Here are recaps of Q3 earnings reports and investor calls from leading companies serving clinical laboratories with instrument platforms, diagnostic …

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Medicare COVID Test Coding May Become a ‘Logistical Nightmare’

Clinical Laboratory Trends, Laboratory Billing, Laboratory Compliance / By Robert Michel

STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests. The federal Centers for Medicare and Medicaid Services (CMS) will pay $100 for COVID-19 test claims if labs can document that the tests were completed within …

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November 16, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

It appears that the onset of the influenza season in North America is bringing with it a sizeable increase in the daily number of new COVID-19 cases. In the second week of November, the United States saw daily new cases push towards 200,000—which is more than double the mid-July peak of about 70,000 cases per …

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Medicare COVID Test Payments to Be Cut Starting Jan. 1

TDR Insider / By Robert Michel

This is an excerpt of a 1,9842-word article in the October 26, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Starting Jan. 1, CMS will lower the Medicare COVID test payment to $75 when labs with “high-throughput systems” report a COVID-19 test result …

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Medicare to Cut Payment for COVID Tests Starting Jan. 1

Laboratory Billing / By Robert Michel

CEO SUMMARY: Starting Jan. 1, CMS will lower the COVID-19 test payment to $75 when labs with “high-throughput systems” report a COVID-19 test result after 48 hours. This is the federal government working at cross purposes, since other federal agencies are diverting COVID-19 testing supplies from labs. This penalizes a lab that accepts COVID-19 specimens believing it has the supplies needed …

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New Clinical Lab Opens on March 23 and Prospers

Laboratory Management / By Robert Michel

CEO SUMMARY: Timing is everything when launching a new clinical laboratory business. The March 23 grand opening of Incyte Pathology’s clinical lab came in the midst of the collapse of daily routine specimen referrals. But once the lab was operational, Incyte had the capability, the expertise, and the facilities to validate and perform COVID-19 testing. Cash flow from SARS-CoV-2 tests …

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Community Lab Ceases after 37 Years of Operation

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: In Pennsylvania, one of the state’s largest independent clinical laboratories, HNL Lab Medicine in Allentown, acquired a lab competitor last month, Northeastern Laboratory Medicine in Hazelton. The deal is a good strategic move for both labs because HNL will continue to serve NLM’s nursing home and at-home patients while adding NLM’s 20 clinical laboratory staff members to its employee …

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$481 Mil Federal COVID Contract Awarded to Young IVD Company

Clinical Laboratory, In Vitro Diagnostics / By Robert Michel

IN THEIR FIGHT AGAINST THE PANDEMIC, federal officials are boosting the fortunes of some little-known or emerging in vitro diagnostics (IVD) companies. One example is the recent award of a $481 million COVID-19 test contract to Cue Health Inc., of San Diego. Earlier this month, the federal Department of Health and Human Services (HHS) and the Department of Defense (DoD) announced a contract that …

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