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COVID-19 Federal Responses: Monday, November 16, 2020

COVID-19 Federal Responses: Monday, November 16, 2020
  • The American Medical Association (AMA), in coordination with the Centers for Medicare and Medicaid Services (CMS), announced new CPT codes for COVID-19 immunization.
  • The Department of Health and Human Services (HHS) announced new partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains to provide COVID-19 vaccines. This program covers approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.
  • Both Pfizer and Moderna are expected to submit data to the FDA for an Emergency Use Authorization (EUA) for their respective vaccine candidates in the next few weeks. States are beginning to prepare to distribute vaccines almost immediately upon the FDA issuing an EUA. Johnson & Johnson (J&J) started a new trial for a two-dose regimen of its COVID-19 vaccine candidate. J&J is already conducting a single-dose trial.
  • A new study suggests that rapid COVID-19 tests are less accurate than previously thought.

Congress

On November 17, the Senate Commerce, Science and Transportation Committee holds a hearing on how the COVID-19 pandemic has impacted American manufacturing.

On November 19, the Senate Homeland Security and Government Affairs Committee will hold a hearing on the importance of early outpatient treatment to prevent severe COVID-19 symptoms.

White House and Federal Agencies

The American Medical Association (AMA), in coordination with the Centers for Medicare and Medicaid Services (CMS), announced new CPT codes for COVID-19 immunization.

  • All of the new vaccine-specific CPT codes will be available for use and effective as each new coronavirus vaccine receives Emergency Use Authorization (EUA) or approval from the Food and Drug Administration (FDA).
  • In addition to the long descriptors, short and medium descriptors for the new vaccine-specific CPT codes can be accessed on the AMA website.

The Department of Health and Human Services (HHS) announced new partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains to provide COVID-19 vaccines. This program covers approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.

NIAID Director Dr. Anthony Fauci is urging Americans to “double down” on COVID-19 safety measures during this new surge in cases.

The Assistant Secretary for Preparedness and Response (ASPR) has released guidance and best practices for setting up alternate care sites. Alternate care sites (ACS) can help to alleviate health system stress caused by COVID-19 patient surge events. The following resources and documents are intended to support state, tribal, local, and territorial (STLT) governments in the establishment and operation of ACS.

Centers for Disease Control and Prevention (CDC) Updates

This holiday season, consider how your holiday plans can be modified to reduce the spread of COVID-19 to keep your friends, families, and communities healthy and safe. CDC includes information on celebrating Thanksgiving in a safer manner due to the COVID-19 pandemic. NIH Director Dr. Francis Collins also released a blog post with some ideas on how to find other ways besides family gatherings to make the holidays meaningful in Planning Your Holidays During the COVID-19 Pandemic.

According to the CDC, emergency mental health-related visits for children aged 5–11 and 12–17 years have been 24% and 31% higher this year, respectively, compared to April through October of 2019. This suggests COVID-19 is having a mental health impact on children.

In a CDC Scientific Brief examining community use of cloth masks, the authors found that experimental and epidemiological data support community masking to reduce the spread of SARS-CoV-2. The preventive benefit of masking is derived from the combination of source control and personal protection for the mask wearer.

The FDA hosted a virtual FDA Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve? This presentation provides an overview of the FDA’s research to evaluate the ability of facial coverings to reduce the spread of infection and how the FDA is developing a comprehensive risk-assessment tool to predict the probability of infection with individuals wearing a non-surgical face mask or cloth face covering; given the characteristics of non-surgical face masks, the population, and the pathogen. This presentation discusses how the filtration and leakage performance of cloth face coverings, using both experimental and computational methods, input into a risk assessment model the FDA recently developed and is currently calibrating for COVID-19.

CDC has implemented multi-year studies to learn more about the short- and long-term health effects associated with COVID-19. CDC continues to work to identify how common these symptoms are, who is most likely to get them, and whether these symptoms eventually resolve.

CDC updated information on the late sequelae of COVID-19. In peer-reviewed literature and public discussion, persistent symptoms are being reported among COVID-19 survivors, including individuals who initially experience a mild acute illness. These persistent symptoms pose new challenges to patients, healthcare providers, and public health practitioners. CDC also updated a list of the common long-term effects of COVID-19.

Economy, Vaccines, Testing and Treatment

Moderna reported incredibly strong preliminary data on its COVID-19 vaccine candidate that shows it is 94.5 percent effective in preventing illness. National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci spoke very highly of these preliminary results.

  • Both Pfizer and Moderna are expected to submit data to the FDA for an Emergency Use Authorization (EUA) for their respective vaccine candidates in the next few weeks. States are beginning to prepare to distribute vaccines almost immediately upon the FDA issuing an EUA.

This Op Ed (opposite the editorial page) authored by Dr. Mary I. O’Connor highlights how we can learn from the flu vaccine to improve trust in the COVID-19 vaccine among minority communities.

Johnson & Johnson (J&J) started a new trial for a two-dose regimen of its COVID-19 vaccine candidate. J&J is already conducting a single-dose trial.

A new study suggests that rapid COVID-19 tests are less accurate than previously thought.

COVID-19 treatments for people with early infection are needed urgently, according to a JAMA Viewpoint article by NIAID Director Anthony S. Fauci, M.D., and colleagues. Treating people early in the course of infection with SARS-CoV-2, the virus that causes COVID-19, would speed their recovery, reduce the likelihood they develop severe outcomes and reduce demand on the healthcare system, they write.

COVID-19 test results could be delayed as labs across the country are reaching capacity to deal with the new surge in cases.

New research provides greater insight into why some patients develop more severe COVID-19 symptoms than others.

A new meta-analysis of 50 studies of patients in the U.S. and the U.K. shows how Blacks and Asians have increased COVID-19 infection risk.

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