FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
National Lab Reporter
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Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
Genomic Data Sharing: From Utopian Principle to Practical Reality
From - National Intelligence Report
As a principle, it's hard to take issue with Science's recommendation; but as the article itself notes, actually achieving genomic data sharing remains…
Three key items to negotiate for successful payer contracts
By Steve Selbst bio
The purpose of this article is to help you, as a provider, to focus on three key items to look for in payer contracts that will help you to get profitable contracts in place…
Enforcement Trends: CMS Looks to Recover $66.3 Million in Improper Specimen Validity Test Payments
From - National Intelligence Report
The opioid crackdown has made urine drug testing an even greater priority for federal health fraud enforcers. One principle target is specimen validity testing…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
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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…
HHS Proposes Eliminating Drug Rebates to Cut Medicare Prescription Costs
From - National Intelligence Report
On Jan. 31, Department of Health and Human Services Secretary Alex Azar floated a proposed rule to…
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From - National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
Enforcement Trends: Record Breaking Year for HIPAA Fines
From - National Intelligence Report
The federal Office for Civil Rights (OCR) reports that 2018 was a record year for HIPAA enforcement, with 10 settlements and one judgment bringing in…