LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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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
New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
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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The Newest PAMA Controversy: The GAO Report & Intervention of a Powerful Senator
From - National Intelligence Report
The recent moves by CMS to include certain hospital outreach labs as "applicable laboratories" for purposes of PAMA reporting and…