AACC Applauds the Senate for Updating Its Legislation to Ensure that All Patients Have Access to COVID-19 Testing

AACC applauds the U.S. Senate for responding to the concerns of the clinical laboratory community and revising the Coronavirus Aid, Relief, and Economic Security (CARES) Act to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether or not they are performed under an FDA emergency use authorization (EUA).

Read more

AACC Launches Directory of U.S. Labs That Are Performing COVID-19 Testing

To facilitate rapid identification of COVID-19 cases, AACC has launched a directory of U.S. clinical laboratories that are, or will be, performing testing for SARS-CoV-2, the virus that causes COVID-19. This directory is designed to help healthcare providers quickly find laboratories that can diagnose patients suspected to have COVID-19.

Read more

AACC Urges Congress to Ensure That All COVID-19 Tests Are Covered by Insurance Now That FDA Has Released Guidance That Will Expand Testing Access

On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA). AACC commends this decision, which will help speed the expansion of COVID-19 testing at this crucial time. However, the association remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an EUA. AACC urges Congress to rectify this problem before passing the bill so that all patients will have access to coronavirus testing.

Read more

Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests

AACC greatly values the work that the U.S. House of Representatives has done to support American families in the midst of the coronavirus outbreak and is supportive of the goals of H.R. 6201, the Families First Coronavirus Response Act. However, we are concerned that the language as currently drafted does not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA).

Read more

New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing

On March 5, U.S. House and Senate lawmakers introduced the VALID Act, which would give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests—tests that are already regulated by the Centers for Medicare and Medicaid Services (CMS) and are subject to stringent personnel, quality control, and proficiency testing requirements. This bill promotes duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests. AACC urges Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.

Read more