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Compliance Lessons for Labs Following Massive Takedown

by | Aug 3, 2022 | News

Here are some steps labs may want to take in the wake of the 2022 National Health Care Fraud Enforcement Action.

After the July 20th U.S. Department of Justice (DOJ) takedown of $1.2 billion in alleged healthcare-related schemes, there are a number of steps labs should take in order ensure compliance, according to Danielle Tangorre, a partner at Robinson+Cole who represents and advises a broad range of healthcare providers, including clinical laboratories. With many of the schemes involving clinical labs, telemedicine, and genetic testing, Tangorre suggests that labs:

  1. Review relationships with marketers and telemedicine services companies.
  2. Review the recent MolDX LCD [local coverage determination] on who can order various types of lab testing and what qualifies as medically necessary.
  3. Revisit compliance plans and do more training as necessary.

To help determine what sort of relationships may be problematic, Tangorre points to the Special Fraud Alert that the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services issued following the DOJ’s enforcement action.

“Compliance plans are meant to be dynamic,” Tangorre said in a recent interview with G2 Intelligence. “The issuance of a Special Fraud Alert, in my opinion, generally calls for revisiting your compliance plan, doing more training, re-examining things, because now the OIG is going to say you’re on notice.”

She adds that labs should also consult with their legal team when considering an arrangement with a telemedicine provider and ensure the proper support for medical necessity exists before submitting tests for payment.

For more insight, read the full Q&A article in the August 2022 issue of Lab Compliance Advisor.


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