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Lab Compliance Will Change When Public Health Emergency Ends

by | Feb 1, 2023 | News, Open Content

Your current COVID-19 testing arrangements may no longer be compliant on May 11.

On January 30, 2023, the Biden administration notified the Rules Committee of the House of Representatives of its intention to end both the COVID-19 national emergency and public health emergency (PHE) on May 11. Rather than the customary 90 days, the administration’s final renewal would extend the PHE by only 30 days. “This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE,” according to the notification sent to the House committee.

But House Republicans don’t want to wait even that long. They’ve introduced a bill called the Pandemic Is Over Act (H.R. 382) and a resolution (H.J. Res. 7) that would end both emergencies immediately upon passage. The administration opposes the idea, contending that an “abrupt end to the emergency declarations would create wide-ranging chaos and uncertainty throughout the health care system.” Accordingly, the Republican efforts to pull the plug on the PHE now are unlikely come to fruition.

Practical Impact: Labs will have just a bit over three months to transition their compliance programs to business the way it was before the PHE. Of particular concern is the revocation of the blanket waivers issued by the Department of Health and Human Services (HHS) to avoid disruptions to lab testing during the PHE. That includes blanket waivers that temporarily relaxed Anti-Kickback Statute (AKS) and Stark Law restrictions to allowing labs to enter into otherwise problematic arrangements for the purpose of providing COVID-19 testing. Revocation of the waivers will require labs and their compliance officers to step back and take a hard look at COVID-19 testing arrangements based on the relaxed rules, including those involving: 

  • Participation in Accountable Care Organizations (ACOs);
  • Remuneration for services or items at above or below fair market value;
  • Free or below fair market value rent for leased office space or equipment, such as giving physicians free telehealth communications equipment;
  • Hospital medical staff incidental benefits above the usual limits;
  • Nonmonetary compensation above the usual limits;
  • Loans at below fair market value interest or at terms not offered to non-referral sources; and/or
  • Referral by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that doesn’t qualify as a “same building” or “centralized building.” 

Look for a more in-depth version of this article in our March 2023 National Lab Reporter, posted in advance of PDF publication.