By Capitol Associates, Inc.
Congress
- The House and Senate both passed legislation to extend the application deadline for the Paycheck Protection Program (PPP) until August 8 th . The Small Business Administration (SBA) has about $130 billion in unspent PPP funding available. Extending the application deadline gives business more time to apply for the unused PPP funding.
- The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on reopening businesses and schools. The public health officials warned the recent spikes in cases could threaten reopening efforts and reiterated the importance of wearing masks to prevent the spread of the virus.
White House and Federal Agencies
- Department of Health and Human Services (HHS) Secretary Alex Azar is expected to renew the COVID-19 public health emergency (PHE) before it expires in July. The PHE declaration authorizes many of the regulatory flexibilities that have been implemented in response to the pandemic.
- President Trump signed an Executive Order suspending the issuance of certain types of visas through the end of 2020.
- HHS is warning that the coronavirus pandemic is causing a spike in opioid deaths.
- Treasury Secretary Steven Mnuchin said the Treasury Department may consider a second tax filing extension that would push the deadline to file taxes back from July 15th to September 15th.
- The Centers for Medicare and Medicaid Service (CMS) posted additional Frequently Asked Questions (FAQs) to Medicaid.gov, to aid state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their response to the COVID-19 pandemic. They also posted a standalone document containing only the new questions.
- The Federal Communications Commission is redirecting about $200 million in unspent funding from various programs towards its rural broadband infrastructure program.
- US Surgeon General VADM Jerome Adams released a PSA reminding everyone to follow a few simple instructions to help prevent the spread of COVID-19.
Centers for Disease Control and Prevention
- CDC updated information on considerations for health departments and healthcare providers for testing in congregate settings.
- CDC updated its guidance, recommendations, and resources for healthcare systems and facilities during the COVID-19 pandemic. Information reflects the current understanding and ongoing response needs of healthcare systems and facilities.
- CDC updated its clinical care guidance for clinicians caring for patients with confirmed infection with SARS-CoV-2, the virus that causes COVID-19. CDC also published an updated framework for healthcare systems on how to deliver non-COVID-19 health care during the COVID-19 pandemic.
- CDC updated graphs showing new hospitalization forecasts and previous national and state forecasts for hospitalizations due to COVID-19.
- CDC updated a document that describes the procedures for completing the 2019 COVID-19 PUI and CRF for persons under investigation who are being tested or have been tested for the virus that causes COVID-19, and presumptive positive cases, and confirmed cases of COVID-19.
Vaccines, Testing and Reopening
- HHS announced that it secured over 500,000 treatment courses of the COVID-19 treatment remdesivir. HHS will provide the drug at cost to hospitals for about $3,200 per treatment course. HHS secured over 90% of the immediate supply of the drug for the United States.
- The U.S. Food and Drug Administration (FDA) issued guidelines for how it will approve COVID-19 vaccines. National Institute of Allergy and Infectious Disease (NIAID) Director Dr. Anthony Fauci continues to express optimism that a vaccine will be available by the end of the year. However, he also worries that the first vaccines will not be effective enough to produce herd immunity.
- More data has been released about dexamethasone’s effectiveness as a COVID-19 treatment. Dexamethasone is a commonly used steroid that has shown promise as a treatment for severe COVID-19 symptoms in preliminary research. The new data reaffirms optimism that it can be an effective treatment for severe cases however more research is need.
- A vaccine under development by Pfizer that showed promising initial results and could be ready for distribution before the end of the year.
- HHS, the Department of Labor (DOL) and the Department of Homeland Security (DHS) published new guidance for safely resuming air travel.
- The American Medical Association (AMA) created a new CPT code for antigen testing.
- The European Union (EU) left the United States off its list of approved countries for travel to the EU.
Please contact the AHRA Regulatory Affairs Committee with any regulatory questions you may have at regulatory@ahra.org.