TAG:
genetic tests
2024: Year of Decision for FDA Regulation of LDTs
By R. Lewis Dark | From the Volume XXX, Number 18 – December 26, 2023 Issue
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Expect More Z-code Requirements for Genetic Tests
By R. Lewis Dark | From the Volume XXX, No. 9 – June 19, 2023 Issue
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…
Getting Payer Coverage for New Tests Continues to Be Difficult
By Robert Michel | From the Volume XXVIII, No. 8 – June 14, 2021 Issue
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 …
Lab Finances to Become More Challenging
By R. Lewis Dark | From the Volume XXVII, No. 14 – October 5, 2020 Issue
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…
Vanderbilt Lab Uses Predictive Medicine to Improve Care
By Joseph Burns | From the Volume XXVII No. 2 – January 27, 2020 Issue
> 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 …
November 25 2019 intelligence late breaking lab news
By Robert Michel | From the Volume XXVI No. 16 – November 25, 2019 Issue
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…
Lab Benefit Managers Want to Help Health Plans
By Joseph Burns
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…
November 4, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 14 – October 14, 2019 Issue
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 …
DOJ Charges 35 Individuals In Genetic Testing Scam
By Joseph Burns | From the Volume XXVI No. 14 – October 14, 2019 Issue
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…
PGx Testing Labs Concerned by FDA’s Statements, Actions
By Mary Van Doren | From the Volume XXVI No. 12 – September 3, 2019 Issue
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…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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