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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Stark Law: CMS Plan Would Make It Easier for Labs to Get Advisory Opinions
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FDA Issues Guidance on Submitting NGS Data for Antiviral Drugs
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Inside Washington: What’s Going on with Regulation of LDTs?
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Enforcement Actions: Doctors Pay $1.1 Million to Settle Genetic Test Kickback Claims
From - National Intelligence Report
Kickbacks for genetic test referrals has become a focus of recent federal enforcement action. The most recent case involves…
Texas Scammer Gets 20 Years for Role in $50 Million Lab Test Ripoff
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Medicare Reimbursement: CMS Publishes New CPT Codes
From - National Intelligence Report
CMS recently published new CPT codes taking effect on Oct. 1, 2019. All the codes have a Type of Service (TOS) code of 5, and the codes are…
Lab Management: Billing Company Contract Liability Risks & How to Avoid Them
From - Lab Compliance Advisor
Like many labs, you may outsource your billing and coding to an outside medical billing company. While this…
Texas Health System Fined $431K for Falsely Billing Genetic Tests
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