FDA Issues Emergency Use Authorization for First At-Home COVID-19 Test
On November 17th, the Food and Drug Administration (FDA) authorized the first prescription at-home COVID-19 test. The test, which was developed by Lucira Health, uses molecular amplification technology for the detection of SARS-CoV-2 RNA in patients with known or suspected COVID-19. It can be used by individuals who are at least 14 years old. The test can also be used by those aged 13 and under when the specimen is collected by a healthcare provider at the point of care in patient care settings.
The FDA’s authorization letter is available here.
HHS Launches Molecular POC COVID-19 Test Pilot Program
On November 19th, the Department of Health and Human Services (HHS) launched a pilot program to use molecular point-of-care (POC) tests for COVID-19. The tests, which were developed by Cue Health, provide results in approximately 20 minutes. The pilot program is distributing test kits and cartridge reader monitoring systems to five pilot states as follows:
- Alaska: 9,000 test kits
- Florida: 4,500 test kits
- Louisiana: 4,500 test kits
- New Jersey: 4,500 test kits
- Texas: 4,500 test kits
One cartridge reader is being supplied for every 45 test kits in the pilot. The program is part of a $481 million Department of Defense (DoD) contract intended to increase domestic production to 100,000 COVID-19 test kits per day by March 2021. The contract includes delivery of 6 million COVID-19 tests and 30,000 cartridge readers to the U.S. government to support the domestic COVID-19 response.
More information is available here.
CMS Releases Nursing Home Holiday Leave Recommendations
On November 18th, the Centers for Medicare and Medicaid Services (CMS) issued an alert for nursing homes, their residents, and their residents’ representatives that provides recommendations for residents who take leave for the Thanksgiving holiday. In general, CMS recommended against residents leaving nursing homes during the COVID-19 public health emergency. However, CMS provided a number of now-familiar recommendations for residents that choose to leave their nursing homes, including, but not limited to:
- Limit close contact, keep gatherings as small as possible, and use technology to engage with others remotely;
- Perform hand hygiene often; and
- Avoid gatherings indoors, crowded areas, and high-risk activities such as singing.
Recommendations for nursing home staff include the advice to consider placing all residents who leave the nursing home for 24 hours on transmission-based precautions. The recommendations are available here.
CMS Updates PRF General Information FAQs
CMS continues to update the Provider Relief Fund (PRF) General Information FAQs. Notable updates include:
- Providers can fully expense capital equipment purchases if they were directly related to prevent, prepare for, and respond to the COVID-19 PHE, such as ventilators, personal protective equipment, and disinfectant supplies.
- Providers can also fully expense capital facilities projects if they were directly related to COVID-19, such as upgrading a heating, ventilation, and air conditioning system to support negative pressure units, retrofitting a COVID-19 unit, and leasing a temporary structure or permanent facility to respond to the pandemic.
- PRF recipients should exclude payments received or made to third parties for care not provided in 2019 or 2020 from the reporting of net patient revenue.
- When calculating expenses attributable to COVID-19 not reimbursed by other sources, the PRF will allow for reimbursement of marginal increased expenses (pre-pandemic average vs. post-pandemic average expenses).
The PRF General Information FAQs are available here.