On August 19th, the Department of Health and Human Services (HHS) announced that the Food and Drug Administration (FDA) cannot use guidance to set policy regarding laboratory developed tests (LDTs). Instead, the agency must utilize the notice and comment rulemaking process as outlined in the Administrative Procedures Act. AACC has long recommended this approach.
The larger question over whether the FDA should play a part in the regulation of LDTs has been a subject of debate for years. The issue drew renewed attention when the agency barred clinical laboratories from developing LDTs without prior approval after the declaration of the COVID-19 public health emergency. The agency subsequently relaxed these requirements after receiving criticism from AACC and others about how it was hindering the rollout of tests.
The HHS decision means laboratories do not need to submit an emergency use authorization (EUA) to the FDA to develop and perform an LDT for COVID-19. However, there are payment issues associated with this decision. Congress limited federal coverage of COVID-19 tests to those tests reviewed by the FDA or performed in a state that agrees to oversee such testing. Only eight states and Puerto Rico have sought such designation.
While the legislative language appears to give the Department some discretion in this matter, HHS has not publicly stated that it will use it. Clinical laboratories should fully assess how this policy change affects their operations before making any changes based on it. AACC is continuing to seek further clarification on this issue and will report any findings in a future edition of the Lab Advocate.