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lab test
New Primary Care Providers May Change Who Buys & Who Orders Lab Tests
This is an excerpt of a 2,445-word article in the June 14, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new playe…
MedPAC Advises Congress on Lab-Data Reporting
CEO SUMMARY: For years, the clinical lab industry has sought unsuccessfully to get the federal Centers for Medicare and Medicaid Services to address the inequities in the payment formula CMS adopted after Congress passed the Protecting Access to Medicare Act (PAMA). In April, the la…
New Players May Alter Who Buys & Who Orders Lab Tests
CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new player in healthcare that will transform the lab testing marketplace as we know it today in two ways. First, a new category of primary care providers has the potential to eventu…
Getting Payer Coverage for New Tests Continues to Be Difficult
EVERY YEAR, IT BECOMES TOUGHER FOR CLINICAL LABORATORIES WITH NEW GENETIC AND OTHER TESTS to obtain favorable coverage decisions by government and private payers. Not only does it take longer to get a decision from a payer, but payers today want to see …
Predicting Future Demand for COVID-19 Testing
CEO SUMMARY: After 15 months of the pandemic, the nation’s clinical laboratories are at an interesting crossroads. Is the COVID-19 outbreak diminishing and close to disappearing? Or might it intensify again, particularly when the traditional influenza season arrives next fall? The…
Restitution and Guilty Plea in Two Lab Fraud Cases
CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph…
April 12, 2021 Intelligence: Late-Breaking Lab News
One clinical laboratory company now says it provides COVID-19 testing services to all five of the major men’s professional sports leagues in the United States. On April 1, BioReference Laboratories, Inc. (BRLI), a division of Opko Health, announced a new agreement with Major League…
What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22
CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee…
New Year Brings Three New Clinical Lab Trends
CEO SUMMARY: Since the year began, three trends have affected clinical laboratories and anatomic pathology groups. First is a continuing surge in COVID-19 test volume. Second is inconsistent payment from government and commercial insurers for SARS-CoV-2 test claims. Third is growing…
Pathology Lab Transforms, Runs 1M COVID-19 Tests
CEO SUMMARY: Last spring, a histopathology lab in Illinois began running molecular COVID-19 tests and decided the clinical side of the lab would focus exclusively on PCR testing for COVID-19. The challenge was how to access a reliable source of test kits, reagents, and supplies to o…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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