FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
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.
OCR Doles Out Record Fine for Right of Access Violation
On July 15, the Department of Health & Human Services Office for Civil Rights announced 11 new enforcement actions, including the biggest penalty doled out since the agency began the right of access program back in April 2019—$240,000 against Texas nonprofit Memorial Hermann Health System.
Be Sure to Use New ABN Form, Starting August 31
As of August 31, 2022, labs and other providers must use the new ABN labeled with the appropriate federal OMB Number (0938-0566) and CMS-R-131 to ensure they can bill Medicare beneficiaries for any lab tests or other services that Medicare doesn’t cover.
