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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Labcorp Continues Its Outreach Labs Buying Spree
While the overall M&A market has been slow in 2022, Labcorp has been on a bit of an acquisitions binge.
Amazon Ends Telehealth Services, but Forges Ahead with Healthcare Disruption
In a surprise move, the e-retail giant announced it will close down its Amazon Care Primary Health Services for employees at the end of 2022.
FY 2022 Q2 Earnings Trend Down, but Much Less than Predicted
While not nearly as robust as a year ago, diagnostic companies’ revenues held up surprisingly well in Q2 2022.
Getting Paid: How to Complete the ABN Form
Completing the Advance Beneficiary Notice of Noncoverage form can be extremely complex; this guide helps simplify the process.
Inform Diagnostics Pays $16M to Settle False Billing Allegations
In this Labs in Court monthly roundup, the Texas-based pathology lab was accused of falsely billing Medicare for unnecessary tests on biopsy specimens.
Do Whistleblowers Get a Share of What’s Recovered in Related Criminal Actions?
How much, if any, should a whistleblower get of what the government recovers in criminal or related legal actions resulting from a qui tam suit?
How Labs Can Avoid Problems When It Comes to Standing Orders
New CMS guidance includes information on how labs can avoid Medicare claims denials and documentation violations related to standing orders.
Advance Beneficiary Notice of Noncoverage (ABN) Form (Spanish Version)
Here’s the Advance Beneficiary Notice of Non-Coverage that you should present to patients who speak Spanish, starting August 31, 2022.
Advance Beneficiary Notice of Noncoverage (ABN) Form (English Version)
Here’s the Advance Beneficiary Notice of Non-Coverage that you should present to patients, starting August 31, 2022.
Federal Enforcers Crack Down on Telehealth Genetic Testing Scams
After the DOJ announced a massive National Health Care Fraud Enforcement Action on July 20 targeting telehealth and telemarketing scams, labs need to be extremely wary, especially if they provide genetic testing.
