COVID-19: CDC, FDA and CMS Guidance

This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.

The Food and Drug Administration updated its FAQs on the emergency use authorization of remdesivir for use on certain hospitalized COVID-19 patients. The document includes information on the changes to Gilead’s fact sheets for health care providers and patient caregivers.
The Centers for Medicare & Medicaid Services added 12 new ICD-10 procedure codes to identify new therapies for COVID-19.
The Centers for Disease Control and Prevention Aug. 4 at 2 p.m. ET will host a Clinician Outreach and Communication Activity webinar on telehealth’s benefits and challenges, based on lessons learned during the COVID-19 pandemic.
The Food and Drug Administration released a new template to help commercial developers submit emergency use authorization requests for COVID-19 diagnostic tests that can be performed in non-laboratory settings and available by prescription or over-the-counter.
The Centers for Medicare & Medicaid Services updated its COVID-19 FAQs to address emerging questions regarding Medicare fee-for-service billing.
Six national organizations representing hospitals, including the AHA, urge the Centers for Medicare & Medicaid Services to delay the start of repayments associated with the Medicare Accelerated and Advance Payment Programs.
The Food and Drug Administration issued emergency use authorizations to Xiamen Biotime Biotechnology Co. and Access Bio Inc. for serology-based tests to detect SARS-CoV-2 antibodies indicating recent or prior infection.
The Centers for Medicare & Medicaid Services released an updated snapshot of the impact of COVID-19 on the Medicare population, which includes COVID-19 cases and hospitalizations through June 20 and the first data for American Indian/Alaskan Native Medicare beneficiaries.
The Food and Drug Administration reissued its emergency use authorization for the LabCorp COVID-19 RT-PCR Test to include authorized use for asymptomatic individuals and for pooled sample testing with up to five individual specimens.
The Food and Drug Administration updated its resource for labs performing authorized COVID-19 tests.