The following is the latest COVID-19 information from the federal government as of 2:30 p.m. on Tuesday, November 10.
Food and Drug Administration
- The FDA has issued emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. In issuing this EUA, the FDA noted that “While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.”
- The FDA has issued an EUA for the first serology test that detects neutralizing antibodies from recent or prior COVID-19 infection.
- The FDA will hold a virtual town hall meeting on COVID-19 test development and validation on November 18 at 12:15 p.m. Go here for more information about the meeting, including sign-in information.
Department of Health and Human Services
- HHS has announced plans to allocate initial doses of the investigational monoclonal antibody therapeutic bamlanivimab. Beginning immediately, weekly allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days based on data hospitals and state health departments enter into the HHS Protect data collection platform. States will then decide on its distribution, with possible locations including hospital outpatient facilities, hospital emergency departments, and alternate care sites set up by hospitals and health departments. These government-purchased doses will be available at no cost to patients, although health care facilities could charge for administering the medicine. Learn more about the allocation and distribution processes here and find the week one allocation dashboard here.
Centers for Medicare & Medicaid Services
- In its online publication MLN Matters, CMS announced that during the COVID-19 public health emergency, non-physician practitioners who are eligible to bill Medicare directly, including registered dietitians and nutrition professionals, may bill for audio-only telephone assessment and management services for CPT codes 98966-98968 for dates of service on or after March 1 until the end of the public health emergency.
CMS COVID-19 Stakeholder Calls
CMS hosts varied recurring stakeholder engagement sessions to share information related to the agency’s response to COVID-19. These sessions are open to members of the health care community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.
CMS COVID-19 Office Hours Call
Tuesday, November 17 at 5:00 – 6:00 PM (eastern)
Toll Free Attendee Dial In: 833-614-0820
Access Passcode: 2491556
Audio Webcast link: go here
Wednesday, November 18 at 4:30 – 5:00 PM (eastern)
Toll Free Attendee Dial-In: 833-614-0820
Access Passcode: 1335116
Audio Webcast link: go here
Centers for Disease Control and Prevention
- The CDC has updated its guidance on COVID-19 point-of-care testing.
- The CDC’s weekly morbidity and mortality report includes new research on characteristics of hospitalized COVID-19 patients who are discharged and later readmitted to the same hospital.
- The CDC has updated its resources for laboratories working on COVID-19 testing.
- The CDC has updated its guidance on maternal, neonatal, and child health services during COVID-19.
National Institutes of Health
- The NIH has issued a news release announcing that a clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with COVID-19 has formally concluded that the drug provides no clinical benefit to hospitalized patients.
Department of Labor
- The Department of Labor has issued guidance alerting employers about frequently cited standards when it conducts COVID-19-related inspections. The department’s announcement includes a brief guide for employers.