FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval

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Dec 12, 2017

PRODUCT DEVELOPMENT
FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
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		CLFS 2018 Medicare Exclusions: One Week, Two Different Labs Get the Boot From - G2 Compliance Advisor The government agency that runs the Medicare program failed to follow a congressional directive to implement a market-based laboratory payment system… Read More

FALSE CLAIMS
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - Laboratory Industry Report
Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing Medicare and Medicaid for…
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REIMBURSEMENT
CMS Final Fee Schedule Will Impact Patient Access to Laboratories: COLA
From - Diagnostic Testing & Emerging Technologies
The CMS Final Fee Schedule will hurt patient access to clinical laboratories, says the lab accreditation bureau COLA…
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