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
Compliance Tool: HIPAA Compliance Fact Sheet for Lab Marketing Staff
This template helps labs create a fact sheet that highlights the key HIPAA-related do’s and don’ts for marketing staff.
Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business
Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.
October 2023 Labs in Court
Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
OIG Sheds Light on Kickback Implications of Online Healthcare Directories
Recent advisory opinion offers insight on how healthcare providers may want to structure arrangements involving online directories.
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
Medicare Reimbursement: CMS Proposes to Cut Part B Payments to Physicians
The proposed PFS rule also includes other changes that will affect physician, lab, and other reimbursements in 2024 and beyond.
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.
CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
Congress Moves to Require Medicare Coverage of Multi-Cancer Early Detection Tests
Federal lawmakers have renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests.
Whistleblowers: SCOTUS Gives DOJ Wider Authority to Dismiss Meritless Qui Tam Cases
Ruling could spell good news for labs and other healthcare providers targeted by whistleblowers in False Claims Act qui tam lawsuits.
