COVID-19 regulatory updates for this week are provided below, including a new visual resource on the Provider Relief Fund timeline from HHS, drug efficacy updates from the FDA, and a PPE Burn Rate calculator from the CDC.
On Friday, June 19, from 12:30 p.m. to 2 p.m., ET, the Centers for Medicare & Medicaid Services (CMS) will host a call with CMS Administrator Seema Verma, Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, and the White House Coronavirus Task Force. Physicians will have an opportunity to ask questions and share their experiences, ideas, strategies, and insights related to your COVID-19 response. Conference lines are limited; consider joining via audio webcast, or by phone at (833) 614-0820; Access Code: 2258722.
The Department of Health and Human Services (HHS) created a new visual resource to track and explain the various payments made to healthcare providers from the Provider Relief Fund to combat the COVID-19 pandemic. The new visual resource is an outline and timeline of the disbursements, how they are calculated, and when they have been distributed. In addition, HHS will host two informational webinars on applying for the Medicaid distribution from the Provider Relief Fund at 2 p.m., ET on June 23 and June 25.
The FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. The agency determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Considering ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. This is the statutory standard for issuance of an EUA.
The FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir.
The Centers for Disease Control and Prevention (CDC) posted a personal protective equipment (PPE) Burn Rate Calculator video on how to use the spreadsheet-based model that will help healthcare facilities plan and optimize the use of PPE for response to COVID-19. Non-healthcare facilities, such as correctional facilities may also find this tool useful. To use the calculator, enter the number of full boxes of each type of PPE in stock (gowns, gloves, surgical masks, respirators, and face shields, for example) and the total number of patients at your facility. The tool will calculate the average consumption rate, also referred to as a “burn rate,” for each type of PPE entered in the spreadsheet. This information can then be used to estimate how long the remaining supply of PPE will last, based on the average consumption rate and help facilities make order projections for future needs.
CMS has issued a new MLN Matters Article MM11814 outlining change for COVID-19, and other payment policies and billing instructions.