Bass, Berry & Sims attorney Danielle Sloane examined the pros and cons of the recent Department of Health and Human Services (HHS) ruling no longer requiring labs to obtain an emergency use authorization (EUA) from the Food and Drug Administration (FDA) for COVID-19 laboratory-developed tests (LDTs). However, labs that do not obtain an EUA may have trouble getting reimbursed for the tests.
“Absent an EUA—at least until HHS develops a list of qualifying tests or the state applies to review tests—clinical labs that use LDTs for COVID-19 detection have no guarantee that their services will be reimbursed by commercial payers,” Danielle commented. “From a reimbursement standpoint, the easiest path to ensuring payment from commercial payors for COVID-19 LDTs is still to obtain an EUA.”
“Ultimately, it is simply important for clinical laboratories to know and understand the implications of not obtaining an EUA for COVID-19 LDTs, so they can make an informed choice,” Danielle cautioned.
The full article, “Is HHS Ruling on COVID-19 LDTs Negative for Reimbursement?” was published by The Dark Report on September 14 and is available online (subscription required). More information on this topic can be found in our alert issued September 2, available here.