COVID-19 Federal Updates

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Vaccine Updates

Vaccine FAQs: CDC updated their FAQs page about the vaccines. This page answers commonly asked questions about COVID-19 vaccination.

Vaccine Resources: CDC updated their resource page on COVID-19 vaccines. On this page you can find when and where you can receive the vaccine, receive accurate vaccine information, and much more.

Resources on Approved Vaccines: CDC updated their resource page on the different types of vaccines. This web page explains how the body fights infection and how COVID-19 vaccines protect people by producing immunity. It also describes the different types of COVID-19 vaccines that currently are available or are undergoing large-scale (Phase 3) clinical trials in the United States.​

Vaccine Facts and Unknowns for Healthcare Providers: NIH officials highlight COVID-19 vaccine facts, unknowns for healthcare providers. Healthcare providers must be able to explain the latest data supporting the safety and efficacy of vaccines for coronavirus disease 2019 (COVID-19) so they can strongly encourage vaccination when appropriate while acknowledging that uncertainty and unknowns remain.

Ensuring the Safety of Vaccines: CDC updated their page on ensuring vaccine safety. The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is a top priority while federal partners work to make this and other COVID-19 vaccines available.

Toolkits: CDC updated their toolkits, which include audience-specific information for healthcare teams and community administrators. CDC has toolkits for:

Testing

Lessons Learned from COVID-19 Testing: Last week, Secretary Azar delivered remarks at FREOPP on lessons from COVID-19 testing. Azar noted, “What we have done over this past year to develop the world’s largest testing system is not just unprecedented, but a uniquely American achievement—something that we could do because we believed in enlisting every creative corner of society and bringing the public and private sectors together.”

COVID-19 Contact Tracer Tools: CDC released their COVIDTracer and COVIDTracer Advanced which are spreadsheet-based tools that allow state- and local-level public health officials and policy makers to compare the effectiveness, and the resources needed, of three user defined contact tracing and monitoring strategies. Both tools allow you to estimate the potential effectiveness of each of the three strategies, the average number of contacts per case, and the time needed for case interviews and contact tracing follow-up activities.

Healthcare Facilities: CDC has updated their database for healthcare facilities that have implemented COVID-19 electronic case reporting.

Requirement for Proof of Negative COVID-19 Test or Recovery from COVID-19 for All Air Passengers Arriving in the United States: CDC updated their guidance for all people traveling to the US. If you plan to travel internationally, get tested before you travel by air into the United States (US), or be prepared to show proof of a recent positive viral test and a letter from your healthcare provider or a public health official stating that you were cleared to travel. On January 12, 2021, CDC issued an Order requiring all air passengers arriving to the US from a foreign country to get tested no more than 3 days before their flight departs and to present the negative result or documentation of having recovered from COVID-19 to the airline before boarding the flight. This Order will go into effect at 12:01am EST on January 26, 2021.

Proof of Negative COVID-19 Test Required for Passengers Arriving from the UK: CDC updated their guidance for people traveling from the UK to the US. If you travel from the United Kingdom to the United States, make plans to get tested before travel. This Order applies to all air passengers, 2 years of age or older, traveling from the UK to the US, including US citizens and legal permanent residents.

Treatment

Monoclonal Antibody Treatment for High Risk Covid-19 Positive Patients: HHS developed this fact sheet to help providers better understand monoclonal antibody treatment. Monoclonal antibody treatment has been shown to reduce hospitalization and symptom days in high risk COVID-19 patients with mild to moderate symptoms.

Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity:  FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. A critical quality control measure for these products is the development and implementation of a potency assay(s) adequate to ensure that each lot is consistently produced with the potency necessary to achieve clinical efficacy and that such potency is maintained over the shelf life of the product.

Understanding Your COVID-19 Treatment Options: HHS developed this fact sheet to help patients better understand their treatment options.

Reopening Guidance

Deciding How to Go Back to School: Many parents, caregivers, and guardians face new and difficult choices about how their child will return to school in the fall, such as deciding between in-person and virtual learning. This tool is designed to help parents, caregivers, and guardians weigh the risks and benefits of available educational options to help them make decisions about sending their child back to school. It is organized to provide parents and caregivers with information on COVID-19 and why safely reopening schools is so critical.

Information for Specific Populations

Global COVID-19: CDC updated their resource page for the COVID-19 global pandemic. CDC is working closely with the World Health Organization (WHO) and other partners to assist countries to prepare for and respond to COVID-19. CDC routinely provides technical assistance to ministries of health and subnational and international partners to improve our collective response to infectious disease threats like COVID-19.

Strategy for Global Response to COVID-19: CDC updated their strategy for global response to the COVID-19 pandemic. This strategy provides an overarching framework for the U.S. Centers for Disease Control and Prevention’s global response to the coronavirus (COVID-19) pandemic. The CDC strategy aligns with the U.S. Government (USG) strategy and the U.S. National Security Strategic goals to protect the American people and ensure the U.S. health security by mitigating the spread of infectious disease threats abroad.

COVID-19 At-Risk Medicare Population Dashboard, Related Online Tools to Support Pandemic Response: To aid state, territorial and local health departments in community-level pandemic response efforts such as implementing COVID-19 vaccination plans that meet the needs of Americans ages 65 and older, today we unveiled a suite of online tools built from existing programs and information technology platforms. Read the press release about this dashboard here.

Travel Associated Exposures: CDC updated their public health guidance on travel associated exposures. Individuals who travel may be at risk for exposure to SARS-CoV-2, the virus that causes COVID-19, before, during, or after travel. This could result in travelers’ spreading the virus to others at their destinations or upon returning home.

Cleaner Air Shelters and Cleaner Air Spaces to Protect the Public from Wildfire Smoke: CDC updated their guidance to reduce the risk of introducing and transmitting SARS-CoV-2 in cleaner air shelters and cleaner air spaces. Cleaner air shelters and cleaner air spaces are public spaces where people can seek relief from wildfire smoke.

Dialysis Facilities: CDC updated their resource page for dialysis facilities. This page includes resources on infection control, testing, training and much more.

Animals and COVID-19: CDC updated their resource page on animals and COVID-19. Coronaviruses are a large family of viruses. Some coronaviruses cause cold-like illnesses in people, while others cause illness in certain types of animals, such as cattle, camels, and bats. Some coronaviruses, such as canine and feline coronaviruses, infect only animals and do not infect people.

Workplaces and Businesses: CDC updated their resource page for workplaces and businesses.  This page provides guidance’s and strategies to prevent and reduce COVID-19 transmission in workplaces.

Childcare Programs: CDC updated their toolkit for childcare programs. This toolkit includes posters, fact sheets, guidance and FAQs.

Travel: CDC updated their resource page for travel. This page has information on domestic and international travel, mask recommendations, and more. CDC also updated their travel health notices page, which lists current travel notices and outlines COVID-19 risks in different countries.

COVID-19 Rapid Response Team (RRT) Composition: For COVID-19, RRT activation may occur prior to detection of a COVID-19 case in a particular administrative area. Examples include when there is transmission in a neighboring administrative area or when the emergency response system has already been activated (e.g. Emergency Operations Center (EOC) activation or country-equivalent). Given the high risk of COVID-19 person-to-person transmission, countries can consider prepositioning multidisciplinary RRTs prior to large-scale transmission.

Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: FDA updated their guidance for coagulation systems for measurement of viscoelastic properties. FDA is issuing this guidance to provide a policy to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis, for the duration of the COVID-19 public health emergency.

Protecting Participants in Bioequivalence Studies: FDA updated their guidance for protecting participants in bioequivalence studies during the COVID-19 public health emergency.

Funding

Provider Relief Fund Reporting Update: HHS, through HRSA, will be amending the reporting timeline for the Provider Relief Fund Program (PRF) due to the recent passage of the Coronavirus Response and Relief Supplemental Appropriations Act. HHS has been working to provide updated reporting requirements that comply with this recently passed legislation. Consequently, PRF recipients will now be required to submit their reporting requirements on their use of these funds later than previously announced. PRF recipients may begin registering for gateway access to the Reporting Portal where they will ultimately submit their information in compliance with the new reporting requirements HHS is issuing.

Funds to Expand Immunization Information Sharing Collaboration: HHS acting through the Office of the National Coordinator for Health Information Technology (ONC) announced a series of investments to help increase data sharing between health information exchanges (HIEs) and immunization information systems. ONC will award nearly $20 million in funds from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) signed by President Trump on March 27, 2020 to support the nation’s vaccination efforts to fight the COVID-19 pandemic.

CMS Updates

CMS Releases Additional Tools To Help State Medicaid and CHIP Agencies Plan For The Eventual Return To Regular Operations After The COVID-19 Public Health Emergency Ends: CMS released two tools to assist states and territories in their planning efforts to transition back to regular operations and resolve pending Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) eligibility and enrollment actions after the 2019 Novel Coronavirus (COVID-19) public health emergency (PHE) ends.  These tools were announced in the Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency State Health Official Letter that CMS released on December 22, 2020.

CMS Released Preliminary Medicaid COVID-19 Increased FMAP Expenditure Data: On a quarterly basis, states report summarized Medicaid expenditures on the Form CMS-64, which serve as the basis for the amount of FFP paid to states to fund the Medicaid program. CMS released preliminary Medicaid expenditure data that states reported to CMS through the Medicaid Budget and Expenditure System (MBES).   This information is summary level data for Medicaid service expenditures reported by states on the Form CMS-64 in MBES for the period of January 1, 2020 through March 31, 2020 and April 1, 2020 through June 30, 2020.  The data includes a breakout of expenditures associated with the Families First Coronavirus Response Act (FFCRA) section 6004 which provides a 100% Federal match to uninsured individuals eligible under the new “COVID-19 testing” optional Medicaid eligibility group and section 6008 which provides a temporary 6.2 percentage point increase to qualifying states and territory’s Federal Medical Assistance Percentage (FMAP).

Research

Evaluation of Abbott BinaxNow Rapid Antigen Test: CDC released a MMWR on evaluation of Abbott BinaxnNow rapid antigen test for sars-cov-2 infection at two community-based testing sites. Sensitivity of the BinaxNOW antigen test, compared with polymerase chain reaction testing, was lower when used to test specimens from asymptomatic (35.8%) than from symptomatic (64.2%) persons, but specificity was high. Sensitivity was higher for culture-positive specimens (92.6% and 78.6% for those from symptomatic and asymptomatic persons, respectively); however, some antigen test-negative specimens had culturable virus. The high specificity and rapid BinaxNOW antigen test turnaround time facilitate earlier isolation of infectious persons. Antigen tests can be an important tool in an overall community testing strategy to reduce transmission.

Emergence of SARS-CoV-2 B.1.1.7 Lineage: CDC released a MMWR on the emergence of SARS-CoV-2 1.1.7 mutation lineage. Modeling data indicate that B.1.1.7 has the potential to increase the U.S. pandemic trajectory in the coming months. CDC’s system for genomic surveillance and the effort to expand sequencing will increase the availability of timely U.S. genomic surveillance data. The increased transmissibility of the B.1.1.7 variant warrants universal and increased compliance with mitigation strategies, including distancing and masking. Higher vaccination coverage might need to be achieved to protect the public. Genomic sequence analysis through the National SARS-CoV-2 Strain Surveillance program will enable a targeted approach to identifying variants of concern in the United States.

COVID-19 Variants: CDC updated their resource page on emerging SARS-CoV-2 variants and their US cases caused by variants page. There has also been a new variant detected. Multiple SARS-CoV-2 variants are circulating globally. Scientists are working to learn more about these variants to better understand how easily they might be transmitted and the effectiveness of currently authorized vaccines against them. At this time, there is no evidence that these variants cause more severe illness or increased risk of death. New information about the virologic, epidemiologic, and clinical characteristics of these variants is rapidly emerging.