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
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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
Case of the Month: Individual Principles Hit with $114.1 Million Verdict for Role in HDL Blood Test Fraud
From - National Intelligence Report
Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and…
How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
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Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Enforcement Trends: OIG Report Suggests that Urine Drug Testing Is Making Labs a Juicy Target Once Again
From - National Intelligence Report
The Office of Inspector General just published its Semiannual Report to Congress (covering Oct. 1, 2017 through March 31, 2018). Here are the key things labs and lab managers need to…
ACA: DOJ Won’t Defend Individual Mandate in Court—But 16+ States Will
From - National Intelligence Report
One of the DOJ's principal roles is to defend the federal laws in court cases challenging their constitutionality. But the agency has made it known that…
PAMA Reimbursement: CMS Explains How to Get ADLT Status for New Lab Tests
From - National Intelligence Report
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new PAMA Part B payment rules for lab tests remains…
DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings
From - National Intelligence Report
One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs. In fact, the recently published…
Enforcement Trends: Private Insurers Are Cracking Down on the Labs that Scam Them
From - National Intelligence Report
Once the almost exclusive domain of federal law enforcers and inside whistleblowers, the lucrative industry of going after labs for improper billing has…