Knowledge Base Article

This week we highlight key updates spanning from March 16th through 22nd of 2021.

March 15, 2021: FDA Launches COVID-19 Adverse Events Reporting System (FAERS) Public Dashboard

The FDA has launched this dashboard with the intent to make adverse event data publically available. In the Public Dashboard announcement, the FDA does note that there are limitations to the data. “For example, while FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event.”

March 16, 2021: CDC Updates Regarding SARS-CoV-2 Variants

The CDC updated their SARS-CoV-2 Variants webpage. Multiple variants have now been detected and a US government interagency group has developed a Variant Classification scheme to define the three classes of variants:

• Variant of Interest,
• Variant of concern, and
• Variant of High Consequence.

To date, California has seen two variants of concern (B.1.427 and B.1.429). Both of the variants may be about 20 percent more transmissible.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html

Two variants in California are now considered “variants of concern”

March 17, 2021:  American Rescue Plan (ARP) Act of 2021 Funding for COVID-19

President Biden signed the ARP Act into law on March 11, 2021. The following list highlights how some of the $1.9 trillion will be allocated to continue the fight against COVID-19:

• $10 billion will be used to ramp up screening testing to help schools reopen,
• $2.25 billion to scale up testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings, and
• $255 million for the production and delivery of 50 million Abbot BinaxNOW rapid point-of-care antigen tests for COVID-19 to support continued screening testing in long-term care facilities.

You can read more about where funding is being allocated in a March 17, 2021 HHS Press Release. 

March 17, 2021: First SARS-CoV-2 Diagnostic Test Permitted to be Marketed beyond the Public Health Emergency

The FDA announced that the BioFire Respiratory Panel 2.1 (RP2.1) has been granted marketing authorization using the De Novo premarket review pathway. The BioFire Respiratory Panel is “a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.” This test is for use in patients suspected of respiratory tract infections, including COVID-19.

March 18, 2021: CPT Codes Inadvertently Added to Telehealth Services

The 2021 Physician Fee Schedule final rule was issued on December 1, 2020. A related CMS Fact Sheet indicates that CMS finalized a third temporary category of criteria for adding services to the list of Medicare telehealth services. “Category 3 describes services added to the Medicare telehealth list during the public health emergency (PHE)…for the COVID-19 pandemic that will remain on the list through the calendar year in which the PHE ends.”  CMS published final and interim final rule corrections in the March 18, 2021 Federal Register. Specific to the Category 3 list, CMS notes that the following four CPT codes were “inadvertently” added to the services for temporary addition to telehealth services list:

• CPT code 96121: Neurobehavioral Status Examination,
• CPT code 99221: New or established patient initial hospital inpatient care services,
• CPT code 99222: New or established patient initial hospital inpatient care services, and
• CPT code 99223: New or established patient initial hospital inpatient care services.

March 18, 2021: FDA Revises Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products under EUA

The FDA announced revisions to health care provider fact sheets “to include additional information on the susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) treatment of COVID-19.” Specifically, fact sheets for Bamlanivimab, Bamlanivimab and Etesevimab and REGEN_COV (Casirivimab and Imdevimab) has been revised.

March 19, 2021: U.S. House Passes Bill to Extend Halt on Sequestration

The Budget Control Act of 2011 included a 2.00% across-the-board sequestration reduction to Medicare Fee-for-Service claims payments. The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended this payment adjustment from May 1, 2020 through December 31, 2020. Subsequently, the Consolidated Appropriations Act, 2021 that was signed into law on December 27, 2020 extended this suspension to March 31, 2021. Now, as we are closing in on the end of March, the U.S. house has passed House Resolution (HR) 1868 that would extend this extension to December 31, 2021.