CMS clarifies when health plans must cover COVID-19 tests; FDA authorizes new at-home test

Mar 01, 2021 - 03:00 PM
COVID19 Testing Web Sized

The Centers for Medicare & Medicaid Services Friday released guidance clarifying federal requirements for health plans to cover certain items and services related to diagnostic testing for COVID-19 without cost-sharing, prior authorization or other medical management requirements.

The guidance also includes information on federal reimbursement for COVID-19-related services provided to the uninsured.

In other news, the Food and Drug Administration today issued an emergency use authorization for the Quidel QuickVue At-Home COVID-19 Test, a prescription antigen test that allows individuals to collect and test a sample at home when their health care provider suspects they have COVID-19 within six days of symptom onset.

The EUA requires Quidel to develop a mobile phone application or website to facilitate results reporting by the user and health care provider. A research team funded by the National Institutes of Health has launched a study to assess the app’s performance and usability.

Related News Articles

Headline
CDC issues reminder on ending of the emergency authorization for COVID-19 in vitro diagnostics tests
The Centers for Disease Control and Prevention issued a reminder Oct. 14 that the declaration supporting the emergency use of COVID-19 in vitro diagnostics…
Headline
HHS seeks feedback on immunization categories in executive order on childhood vaccine schedule
The Department of Health of Human Services Aug. 21 issued a request for information seeking feedback on immunization categories within the Aug. 10 executive…
Headline
CDC reports increase in kindergarten vaccine exemptions
For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year,…
Headline
Study finds COVID-19 can reactivate dormant viruses 
A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study…
Headline
HHS to end emergency authorization for COVID-19 drugs, medical devices 
The Department of Health and Human Services June 30 announced it will terminate emergency use authorization declarations for certain drugs and medical devices…
Headline
CMS Administrator Oz and Deputy Administrator Brillman discuss agency’s focus on innovation, reducing waste
Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat…