Billing News May 2022



COVID-19 Add-on CPT Code U0005 Focus of OIG Audits

  • May 27, 2022

The Office of Inspector General (OIG) has announced it will begin auditing add-on payments for high-throughput COVID-19 testing reimbursed by Medicare. In January 2021, to support faster COVID-19 testing, CMS lowered reimbursement for COVID-19 laboratory tests using high-throughput technology to $75 and established a new add-on CPT code U0005 and...

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FDA Sees ‘Appropriate’ Transition Period for COVID-19 Test EUAs When Public Health Emergency Ends

  • May 11, 2022

FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to terminate their authorizations, in anticipation of U.S. public health emergency declarations no longer being in effect. That draft guidance "proposes that there will be at least a 180-day transition period," Lowe said during...

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AMP Offers Recommendations to CMS, HHS to Prepare for Next Pandemic

  • May 11, 2022

The Association for Molecular Pathology released a report on Tuesday with recommendations for the federal government to prepare for future public health emergencies. The main recommendation in the report is that the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services should "engage laboratory stakeholders...

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ACLA, AdvaMed Urge Congress to Immediately Replenish COVID-19 Testing Fund

  • May 11, 2022

The American Clinical Laboratory Association (ACLA) and AdvaMedDx, the medical device lobby’s division representing diagnostics makers, have joined with more than 60 organizations calling on congressional leaders to immediately replenish a fund that enabled uninsured people to access COVID-19 testing. Citing insufficient funds, the COVID-19...

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FDA Issues Safety Communication About Genetic Non-Invasive Prenatal Screening Tests

  • May 11, 2022

The Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or “NIPT”). FDA’s main concern with NIPS appears to be that FDA has not reviewed the performance of most of these tests because of their...

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HHS to Appeal Texas Ruling That Struck Down Key Parts of Surprise Billing Rule

  • May 11, 2022

The Department of Health and Human Services announced in a legal filing late Friday that it is appealing the ruling to the U.S. Court of Appeals for the Fifth Circuit. The decision to appeal the ruling originally issued back in February comes as HHS has other legal fights over the regulation. Last fall the Texas Medical Association filed a...

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Renewal of Determination That A Public Health Emergency Exists

  • May 11, 2022

As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Xavier Becerra, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew,...

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HRSA to Reopen Pandemic Relief Reporting to Providers with ‘Extenuating Circumstances'

  • May 11, 2022

The Health Resources and Services Administration (HRSA) has updated its website with more information on how providers who missed the first reporting period due to "extenuating circumstances" can submit a request to file a late report. Per the website, providers may submit their request from April 11 to April 22 using a form that will be made...

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