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 Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.
New PLA Codes Billable Under the Medicare CLFS to Be Aware Of
Here’s a quick briefing of the new codes that come into effect on April 1 that your billing staff should know about.
FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
High Billing by Labs Continues to Be Trigger for Audits
As we move further into 2023, COVID-19, add-on, and genetic tests will likely remain targets for federal regulators.
Why Mobile Phlebotomy Companies and Labs Should Be on Alert
Recent fraud case involving phlebotomy company shows why labs need to pay special attention to Medicare specimen collection and travel allowance rules.
Normal Kickback and Billing Rules Return When PHE Ends on May 11
A look at the US end-of-emergency game plan and how it will impact lab compliance.
Lab Sales & Marketing Compliance: The Current State of EKRA
Sales and marketing operations liability risks and the measures labs should and shouldn’t take to manage those risks.
COVID-19, Genetic Tests Wipe Out Medicare Part B Lab Test Savings
Even though PAMA has slashed reimbursement rates for many tests, overall Medicare Part B spending on lab tests continues to increase.
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.
