TAG:
genetic tests
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…
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 …
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…
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…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
Labs Get High Denial Rates Under New NCCI Rules
CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented …
ACLA: NCCI Guidelines Are a ‘Step Backwards’
CEO SUMMARY: In a letter to the National Correct Coding Initiative, the American Clinical Laboratory Association (ACLA) raised significant concerns about new language in the policy manuals for Medicare and Medicaid. ACLA said the new NCCI guidelines for molecular and other tests requiring…
Nine Lab Groups Say New NCCI Policy Is Inconsistent
CEO SUMMARY: By its name alone, the National Correct Coding Initiative (NCCI) Policy Manual implies that it will be accurate and consistent with other coding initiatives. But nine groups representing various clinical laboratories say NCCI guidelines that the federal Centers for Medicare a…
Useful Lessons for Labs That Report PAMA Data
CEO SUMMARY: Will clinical labs heed the lessons learned from the first PAMA private payer market price reporting cycle that CMS conducted in 2017? One major difference is that the definition of applicable laboratories now includes most hospital labs. This creates the opportunity for a la…
January 14, 2019 Intelligence: Late Breaking Lab News
Up to 10,000 patients will get free genetic testing at Northwell Health, the nation’s largest urban health network. In a deal announced on Jan. 9, Northwell Health and Color, a genetic testing company, will collaborate on a program to offer geneti…
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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