Coronavirus update for Wednesday, June 3 as of 12:00 p.m.

Centers for Medicare & Medicaid Services

• CMS has updated its FAQ on Medicare COVID-19 fee-for-service billing.  All of the changes address national coverage determinations and are clearly marked within the document.  Providers should review them carefully.
• In response to COVID-19, CMS is providing new flexibilities and adjustments to current and future CMMI models to address the emergency.  It has released a chart that outlines the models and the new changes.  CMS also has written a blog post describing additional CMMI model flexibilities.
• CMS has released guidance to states supporting implementation of the Optional COVID-19 Testing (XXIII) Group­­­ established by the Families First Coronavirus Response Act (FFCRA) for uninsured individuals for COVID-19 testing and testing-related services.  This guidance identifies the different requirements associated with implementing the new group (including eligibility and enrollment, claiming, and data reporting) and provides guidance on strategies that states may employ to meet these requirements.

Department of Health and Human Services

• HHS has updated its CARES Act Provider Relief Fund FAQ.  See additions on pages 5, 14, and 20.  Providers should review these additions carefully.
• HHS announced that the next deadline for submitting data to inform the agency’s distribution of its supply of remdesivir is Monday, June 8 at 8 p.m. (eastern).  HHS is requesting the same data as last month’s remdesivir request:  the number of currently hospitalized COVID-19 patients, and of those hospitalized, the number requiring placement in ICUs.  Hospitals should submit the data using the HHS TeleTracking web portal. ​
• HHS has provided $250 million to help health care systems treating patients and responding to the COVID-19 pandemic.  According to an HHS news release, the money will support hospitals and other health care entities to train workers, expand telemedicine and the use of virtual health care, procure supplies and equipment, and coordinate across jurisdictions and facilities.  Most of this money is going to state hospital associations for distribution.

Centers for Disease Control and Prevention

• The CDC has established a new web page with a data set of health care entities that have received federal claims reimbursement for COVID-19 testing of uninsured individuals and/or treatment for uninsured individuals with a COVID-19 diagnosis as of May 26, 2020.
• The CDC has updated its interim clinical guidance for managing patients with COVID-19.
• The CDC has updated its FAQ about COVID-19 and children.

Food and Drug Administration

• The FDA has published guidance, titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators, that includes recommendations regarding procedures for single IRB member review.  This is in response to physician requests for a waiver from the requirement for full IRB review.
• The FDA has added a second ventilator to its list of authorized ventilators, ventilator tubing connectors, and ventilator accessories that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. This new ventilator is tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency.
• The FDA has added an emergency resuscitator to its list of authorized ventilators, ventilator tubing connectors, and ventilator accessories.  This commercial resuscitator is a continuous respiratory support system that includes an FDA-cleared manual resuscitator and its design is intended for use in treating patients with COVID-19.
• The FDA and the European Medicines Agency have published procedural assistance for sponsors and applicants that anticipate submitting pediatric product development plans for the treatment and prevention of COVID-19.

Department of Labor

The Department of Labor has issued an alert with information about how to keep stockroom and loading dock workers safe during the COVID-19 pandemic.  See an announcement about the alert and the alert itself.

Federal Funding Opportunities for Hospitals

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

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