COVID-19 Federal Response Update – Thursday, July 23, 2020

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By Capitol Associates, Inc. 

Congress

Senate Republicans and the White House are still finalizing a Republican COVID-19 relief bill. This legislation is intended to serve a marker for Republicans as they negotiate a bipartisan relief bill with Democrats. Bipartisan negotiations are expected to accelerate after the Republican bill is introduced.

Next week, the House Select Subcommittee on the Coronavirus Crisis will hold a hearing on the federal response to COVID-19.

Sen. Lamar Alexander (R-TN) proposed a $15 billion bill aimed at preparing the U.S. for future pandemics. The bill provides states with funding over 10 years to build stockpiles of Personal Protective Equipment (PPE). It also gives funds to U.S.-based vaccine and testing manufacturing facilities.

White House and Federal Agencies

The Department of Health and Human Services (HHS) has developed a website, HHS Protect, which provides centralized COVID-19 data including: general data, hospital-specific data, and supply chain data.

HHS announced that it will require Provider Relief Fund recipients to report payments exceeding $10,000. Reporting instructions will be released by August 17th. The reporting system will be available to recipients starting October 1st.

Providers have until August 3rd to apply for a $15 billion distribution to Medicaid providers from HHS Provider Relief Fund.

The HHS Office for Civil Rights (OCR) issued guidance reminding healthcare facilities that receive federal financial assistance about their legal obligations to not discriminate against patients based on race and ethnicity.

HHS announced a new program, the National Testing Implementation Forum, which will allow federal officials and private sector stakeholders to share feedback on COVID-19 supply chain issues.

The National Institutes of Health (NIH) is using participant data from a health disparity research project developed in 2018, called “All of Us,” to analyze how social factors like income, family structure, and diet effect COVID-19 infection rates and outcomes in different communities.

The Food and Drug Administration (FDA) published an article on how the FDA is protecting Americans from unproven, illegitimate, and substandard medical products.

The Internal Revenue Service (IRS) is allowing individuals who lost job-based health insurance coverage to sign up for COBRA coverage until 60 days after the COVID-19 public health emergency ends.

Centers for Disease Control and Prevention (CDC) Updates

The CDC updated the list of underlying medical conditions that are more likely to put an individual at risk for a more severe case of COVID-19. The list now includes cancer and pediatric patients.

The CDC released findings from their Household Pulse Survey, a survey aimed at understanding how American’s are experiencing the pandemic in terms of employment, health, access to healthcare, food security, housing, and education.

The CDC updated its guidance for residents, providers, and public health officials from rural communities.

The CDC updated its guidance for communities that are at an increased risk for severe COVID-19 cases, including: older adults, those with underlying conditions, and racial and ethnic minority groups.

The CDC released guidance on how and when to test healthcare personnel for COVID-19.

The CDC updated its recommendations regarding isolation periods and precautions adults should take to mitigate the spread of COVID-19. The CDC also updated its guidance on how to best self-isolate while infected with COVID-19 and when recovered patients can end self-isolation.

The CDC updated its Worker and Safety Support Toolkit which provides guidance to employees on how to return to work safely while protecting customers and coworkers.

Reopening, Vaccine and Treatment

Data on the AstraZeneca/Oxford University COVID-19 candidate was published in The Lancet, a medical journal, which shows that the vaccine is relatively safe and results in the production of neutralizing antibodies.

HHS signed a $2 billion contract with Pfizer that will ensure that the government receives 100 million doses of their COVID-19 vaccine candidate once it is deemed safe and effective by the FDA.

The contract would also allow the U.S. to buy another 500 million doses if they so choose.

The NIH is preparing to launch a numerous late-stage clinical trials for COVID-19 treatments.

The NIH launched the COVID-19 Prevention Trials Network, a website where volunteers can sign up to be a part of COVID-19-related clinical trials, on July 8th. So far, over 107,000 Americans have volunteered.

A study from the New England Journal of Medicine shows that COVID-19 antibody levels, especially in more mild cases, begin to decline just three months after infection. This may leave recovered COVID-19 patients vulnerable to reinfection.

The CDC conducted a survey in 10 U.S. regions looking at the presence of COVID-19 antibodies in that region’s population. Data suggests that the number of actual infections exceed the number of reported cases.

The U.S. alleges that two Chinese citizens participated in a computer hacking campaign that targeted companies studying COVID-19 therapies and vaccines.

Dr. Francis Collins, Direction of the NIH, published a blogpost that discusses findings from a study in Australia that demonstrate how genomic data can help in contact tracing.


Please  contact the AHRA Regulatory Affairs Committee with any regulatory questions you may have at regulatory@ahra.org.

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