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 early and across the spectrum of care delivery...

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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 Uninsured Relief Fund stopped accepting new claims for...

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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 regulatory status. Perhaps most tellingly, the safety...

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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 lawsuit in the U.S. District Court for the Eastern...

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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, effective April 16, 2022, the January 31, 2020,...

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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 available beginning April 11. HRSA also provided...

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CDRH’s Shuren Expects Center to Return to Normal This Year despite Ongoing COVID Work

  • May 11, 2022

The director said during the April 29 event that even with ongoing COVID-19 priorities, the “goal is to get most of the center back to normal operations by the end of this year.” Shuren also discussed the FDA’s proposed budget for devices and explained key projects built into the request, such as cybersecurity and supply chain programs. In the 2023 budget proposal, the FDA is asking for $5.5...

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OIG Report Reignites Lawmakers’ Push for Action on Medicare Advantage Prior Authorization

  • May 11, 2022

Lawmakers are engaging in a new push to adopt electronic prior authorization in the wake of a major report of certain Medicare Advantage plans denying requests. The Department of Health and Human Services’ Office of Inspector General (OIG) issued a report late last week that showed MA plans at times delayed or denied beneficiary access to services that meet Medicare’s coverage requirements....

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