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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…
CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System Under PAMA, ACLA Charges in Suit
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…
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…
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…