Quest Diagnostics outlines changes to IVD landscape with end in sight for U.S. public health emergency

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When the COVID-19 public health emergency (PHE) in the U.S. ends on May 11, testing will start to become more restricted as some labs, providers, and retailers stop offering testing services, Quest Diagnostics said Monday.

“It is important that providers, patients, and consumers understand that access to, and fees and reimbursement for, COVID-19 testing will change after the PHE expires,” it said in a statement.

Among the changes, Quest noted, private health insurance companies are no longer required to provide free COVID-19 tests. Many insurance companies are including testing as a benefit, but members will be responsible for paying their copay or a deductible based on their benefit plan.

Additionally, some retail testing -- at pharmacies, for example -- may not be available and patient-initiated testing may not be covered, Quest said. Many insurance companies are requiring patients to be symptomatic for testing to be covered as a plan benefit.

Quest added that it will continue to provide a broad suite of tests and services for COVID-19, including observed self-specimen collection services for COVID-19 molecular diagnostic testing. It will also continue to offer a portfolio of COVID-19 molecular diagnostic and serology antibody laboratory services for healthcare providers and consumers. The services include respiratory combination tests, which use a single specimen to test for COVID-19 and other respiratory pathogens.

The U.S. Food and Drug Administration (FDA) recently posted guidance documents for IVD firms and laboratories seeking a transition from tests approved under an emergency use authorization.

On April 26, it held a virtual town hall for test developers to discuss two final guidance documents --  the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).

The documents include the FDA's recommendations for developing a transition implementation plan for in vitro diagnostic tests with an emergency use authorization and applying for an IVD marketing submission.

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