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genetic tests

2024: Year of Decision for FDA Regulation of LDTs

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…

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Expect More Z-code Requirements for Genetic Tests

GENETIC TESTING COMPANIES ARE STILL REACTING TO LAST MONTH’S NEWS that one of the nation’s largest health insurers—UnitedHealthcare (UHC)—will require Z-codes for molecular test claims submitte…

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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 …

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Lab Finances to Become More Challenging

When you finish reading our story about how Medicare spending for molecular and genetic tests jumped by as much as 700% in certain states during 2019, you’ll be among the first in the nation to understand why a financial crisis is soon to wash over those clinical laboratories and pathology grou…

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Vanderbilt Lab Uses Predictive Medicine to Improve Care

> CEO SUMMARY: The integrative diagnostics lab at the Vanderbilt University Medical Center aims to use sophisticated diagnostics to advance the use of precision medicine testing to improve patient care and to do so at an affordable cost. As part of these efforts, the lab staff …

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November 25 2019 intelligence late breaking lab news

Medicare lab test price cuts mandated by the Protecting Access to Medicare Act (PAMA) are eroding the finances of urology groups that do in-office clinical laboratory testing. In the November issue of Urology Times, urologist Robert A. Dowling, MD, wrote a news story that identified the cut…

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Lab Benefit Managers Want to Help Health Plans

CEO SUMMARY: Laboratory benefit management companies that offer a range of services to health insurers are gaining influence over clinical lab testing in important ways. On behalf of health insurers, LBMs will select labs for a payer’s network, then manage that network. They also manage…

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November 4, 2019 Intelligence: Late Breaking Lab News

Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage …

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DOJ Charges 35 Individuals In Genetic Testing Scam

CEO SUMMARY: Federal prosecutors said those charged illegally lured elderly patients nationwide into giving cheek swabs for fraudulent genetic tests. The indicted individuals allegedly paid kickbacks and bribes to medical professionals working with telemedicine companies in exchange for r…

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PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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