Lawyers Give Their Tips to Spot Clinical Lab Fraud
Medical laboratories should monitor fraud cases across the country and also stay vigilant of suspicious patterns of behavior
National Lab Reporter
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Articles and Reports
Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
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.
CMS Bristles at Criticism It’s Not Recovering Medicare Overpayments
According to a recent OIG report, CMS is not doing a good job collecting the Medicare overpayments OIG auditors are uncovering. However, CMS recently rejected almost all of the recommendations in that report, suggesting all is not well between the two federal agencies.
LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
CMS Proposes CLIA Fee Increases and Nurses Doing High-Complexity Testing
In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here's what lab managers need to know about the proposed rule.
Guidance on HIPAA Abortion Privacy Rights Post-Roe-v-Wade
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.
OIG Calls Out MA Plans for Wrongfully Denying Reimbursement
The new report could be a turning point in the battle to curb payor abuse of preauthorization requirements.
Labs Figure Prominently in New OIG Enforcement Report
While the report’s most significant findings involved labs and lab testing, it wasn’t just the usual finger pointing this time.
Theranos in Court: Jury Finds Balwani Guilty on All 12 Counts
Federal San Jose jury finds ex-Theranos COO guilty of all 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
