Updates to CLIA Personnel Requirements May Lengthen Hiring Times
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
National Lab Reporter
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Articles and Reports
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
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
Lab Owner Convicted for $463 Million Genetic Testing Fraud
Case is a recent example of the trend toward Medicare schemes involving telehealth, cancer genetic testing, and kickbacks.
Five Key Changes Affecting Labs in the New Spending Bill
While the federal spending bill passed at the end of 2022 will have a large impact on clinical labs, it doesn’t include LDTs reform.
Congress Delays Part B Price Cuts but Nixes Long-Term SALSA Solution
Legislation offering permanent relief from both PAMA price cuts and reporting didn’t make it into the federal spending bill passed Dec. 23.
Massive Caseload Overwhelming No Surprises Act Payment Dispute Resolution System
According to a recent CMS report, the sheer volume of out-of-network payment disputes is overwhelming the system.
New Payment Rules for Lab Specimen Collection & Travel Allowances
Here’s a look at what labs need to know about the new rules that take effect on Jan. 1 as part of the 2023 Medicare Physician Fee Schedule.
Hospital Workplace Violence Prevention to Face Greater Scrutiny
CMS has instructed state surveyors to crack down on hospitals that don’t implement adequate workplace violence protections.
CMS Recognizes 8 New CLIA-Waived Tests
Labs will be able to bill Medicare and Medicaid for these new CLIA-waived tests, starting on April 1, 2023.
FY 2022 OIG Enforcement Rebounds—but Recovery Dollars Don’t Show It
The agency’s latest report to Congress shows that while enforcement activity is returning to pre-pandemic levels, recoveries are still down.
The Year in Lab Compliance: The 6 Biggest Stories of 2022
The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.
