CRS: HHS’ LDT Policy Shifts Raise Regulatory, Coverage Issues

By Kelly Lienhard / December 14, 2020 at 1:58 PM
The Congressional Research Service says HHS’ decision to remove laboratory-developed tests from FDA oversight yet still require the agency to review voluntarily submitted emergency use authorization requests raises several regulatory and coverage issues. HHS hasn’t clearly defined LDTs, leaving the scope of its policy unclear; hasn’t clarified whether FDA post-marketing requirements still apply to LDTs that receive EUAs; hasn’t explained how modifications to tests that already received EUAs will be handled; and hasn’t said whether LDTs that lack EUAs or...

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