How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
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
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
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.
Unnecessary Drug and Genetic Tests the Theme in Recent Enforcement Actions
Most healthcare-related enforcement actions from July and August involved urine drug tests and genetic testing.
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.
Above-Market Lease with Landlord Doctors Costs BioReference $9.85 Million
In this month’s Labs in Court roundup, BioReference pays big to settle kickback allegations, among several other kickback-related cases.
Five Changes You Need to Know about New CLIA Proficiency Testing Rules
With the final rule on PT published July 11, here are the five things lab managers need to know to keep their labs compliant.
Federal Court Calls PAMA Rule “Arbitrary,” but Refuses to Strike It Down
D.C. Circuit Court of Appeals agrees with lab industry that CMS got Medicare lab pricing all wrong, but says it’s unable to intervene.
How to Guard Your Lab from Telehealth Liability Risk
The OIG’s new Fraud Alert can help labs and other providers steer clear of potentially suspect arrangements with telemedicine companies.
