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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Articles and Reports
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
CMS Proposes CLIA Fee Increases and Nurses Doing High-Complexity Testing
In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here's what lab managers need to know about the proposed rule.
Guidance on HIPAA Abortion Privacy Rights Post-Roe-v-Wade
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.
OIG Calls Out MA Plans for Wrongfully Denying Reimbursement
The new report could be a turning point in the battle to curb payor abuse of preauthorization requirements.
Labs Figure Prominently in New OIG Enforcement Report
While the report’s most significant findings involved labs and lab testing, it wasn’t just the usual finger pointing this time.
Theranos in Court: Jury Finds Balwani Guilty on All 12 Counts
Federal San Jose jury finds ex-Theranos COO guilty of all 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
Congress Acts to End PAMA Price Cutting Reign of Terror
After years of resistance, the lab industry’s hopes and prayers for relief from the flawed pricing scheme may soon be answered.
Alleged Violation of Medicare’s 14-Day Rule Costs Company $2.8 Million
Caris Life Sciences agrees to pay $2.8 million to settle claims that it purposely delayed submitting lab tests to get around Medicare’s 14-day rule.
CMS Reschedules PAMA Reporting & Adds New PLA Codes
Here are the two key CLFS changes, set to take effect on July 1, 2022, that your billing staff needs to know about.
What the Federal COVID-19 Fraud Crackdown Means for Labs
If your lab received federal relief funds from the US government during the COVID-19 pandemic, you could be at risk of FCA lawsuits.
Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs
The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.
