FDA decision to stop quick review of lab developed tests raises payment concerns for labs

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The agency’s decision raises questions around reimbursement and liability protections for those tests moving forward. It could also impact the ability of new lab developed tests to compete in the market. That’s because an EUA, which the new LDTs won’t have, are seen by many clinicians and payors as a mark of quality.

The agency’s decision raises questions around reimbursement and liability protections for those tests moving forward. It could also impact the ability of new lab developed tests to compete in the market. That’s because an EUA, which the new LDTs won’t have, are seen by many clinicians and payors as a mark of quality.

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