New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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Newly Proposed CMS Hospital Transparency Rules & their Impact on Labs
From - National Intelligence Report
It's an all too common occurrence. You or a loved one require an in-hospital procedure, but you have no idea of what the…
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
From - National Intelligence Report
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against…
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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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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…
Kickbacks: OIG Withdrawal of Old Safe Harbor Proposals Clears Way for Meaningful Reform
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Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play
From - National Intelligence Report
The reimbursement outlook for those who provide next generation sequencing (NGS) testing to early-stage cancer of Medicare patients with…
CMS Says Big Changes Are in Store for Stark Law by End of Year
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