Coronavirus update for Thursday, June 18 as of 3:00 p.m.

CARES Act Provider Relief Fund – Medicaid and SCHIP-Only Distribution Webcasts

On its Provider Relief Fund web page, HHS has posted the following notice:

HHS expects to distribute $15 billion to eligible Medicaid and CHIP providers through the Provider Relief Fund.  Join our webcast to learn more about the application process.  Please pre-register to reserve a spot on your preferred date:

• Tuesday, June 23, 2020 at 2 PM ET
• Thursday, June 25, 2020 at 2 PM ET

Department of Health and Human Services

• HHS has published “Healthcare System Considerations for Resumption of Services During COVID-19,” which highlights interrelated issues for the health care system to consider as systems address their current status, restore services that have been curbed, maintain readiness for potential future waves of COVID-19 patients, and adapt to improve their operations based on lessons learned.
• COVID-19 Clinical Rounds Peer-to-Peer Virtual Communities of Practice are a collaborative effort between HHS’s Assistant Secretary for Preparedness and Response, the National Emerging Special Pathogen Training and Education Center, and Project ECHO. These interactive virtual learning sessions aim to create a peer-to-peer learning network where clinicians from the U.S. and abroad who have experience treating patients with COVID-19 share their challenges and successes; time for participant Q & A is also included.  Three webinar topics are covered every week:
  • EMS: Patient Care and Operations (Mondays, 12:00-1:00 PM ET)
  • Critical Care: Lifesaving Treatment and Clinical Operations (Tuesdays, 12:00-1:00 PM ET)
  • Emergency Department: Patient Care and Clinical Operations (Thursdays, 12:00-1:00 PM ET)

Find previous webinars and sign up to receive information on upcoming webinars.

Centers for Medicare & Medicaid Services

• CMS has updated its COVID-19 FAQ on Medicare fee-for-service billing. Find new questions and answers on pages 18 (two of them), 24, 30, 33 (3), 33-34, 34, 34-35, 35 (5), and 60 (3).
• A new MLN Matters article titled “Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment” includes a section with COVID-19 policy updates and information about past COVID-19 billing-related decisions and practices.
• A new MLN Matters article titled “New Point of Origin Code for Transfer from a Designated Disaster Alternative Care Site” offers information for physicians, hospitals, and other providers who bill Medicare for care delivered to patients who have been served in COVID-19 alternative care sites and other medical settings.
• This week’s MLN Connects includes a brief item explaining that during the COVID-19 public health emergency, teaching hospitals may have until October 1, 2020 (rather than July 1 or June 30, 2020) to submit new or amended Medicare GME affiliation agreements.
• CMS has updated its toolkit on state actions to mitigate the prevalence of COVID-19 in nursing homes.

Food and Drug Administration

• On June 24 from 12:15 pm – 1:15 pm (eastern) the FDA will host a virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19. The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.  Go here to learn more.
• The FDA has published guidance on statistical considerations for clinical trials during the COVID-19 public health emergency.
• The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, that answers questions about adverse event reporting for medical devices distributed under emergency use authorizations (EUAs) or that are the subject of COVID-19-related guidance documents and points out a number of adverse event reporting-related resources.
• The FDA has posted template updates for the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19. This is intended to facilitate the availability of diagnostic tests for asymptomatic testing and sample pooling.  See the FDA’s announcement here.
• The FDA approved an abbreviated new drug application for succinylcholine chloride injection, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to induce skeletal muscle relaxation during surgery or mechanical ventilation.
• The FDA revoked its EUA for the Chembio Diagnostic System, Inc.’s, DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, because of concerns about the accuracy of the test.
• The FDA has issued EUAs for two new diagnostic tests for COVID-19. Find them here and here.
• The FDA has issued an EUA for a new serology test for COVID-19. Find it here.

Centers for Disease Control & Prevention

• The CDC has updated its interim infection prevention and control guidance for dental settings during the COVID-19 emergency.

Federal Funding Opportunities for Hospitals

• NASH has prepared a document that collects and presents in one place the various new federal funding opportunities for hospitals resulting from legislation addressing the COVID-19 public health emergency.  Find that document here.

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