Federal News and Information
FDA Tells Public to Stop Using Certain Innova COVID-19 Antigen Tests
The U.S. Food and Drug Administration is warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The concerns are:
- The performance of the test is not established and presents a health-risk.
- Labeling distributed with certain configurations of the test includes performance claims. These claims did not accurately reflect the performance estimates observed during the clinical studies of the tests.
- The test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the names:
- Innova COVID-19 Self-Test Kit (three tests)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (seven tests)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25 tests).
New OSHA Emergency Temporary Standard to Protect Healthcare Workers
The Federal Register published an interim final rule from the Occupational Safety and Health Administration (OSHA), issuing an emergency temporary standard (ETS) to protect healthcare and healthcare support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present. The final rule can be accessed at: https://www.federalregister.gov/documents/2021/06/21/2021-12428/occupational-exposure-to-covid-19-emergency-temporary-standard. Please note the following areas:
- The ETS applies to all settings where any employee provides healthcare services or performs healthcare support services. This includes hospice.
- Attachment addresses best practices
- CMS Regulations, Hospice Care. The hospice must maintain and document an effective infection control program that protects patients, families, visitors, and hospice personnel by preventing and controlling infections and communicable diseases. The hospice must follow accepted standards of practice to prevent the transmission of infections and communicable diseases, including the use of standard precautions. The hospice must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases. (42 CFR 418.60). In addition, a hospice that provides inpatient care directly must: maintain an infection control program that protects patients, staff and others by preventing and controlling infections and communicable disease as stipulated in 42 CFR 418.60; provide a sanitary environment by following current standards of practice, including nationally recognized infection control precautions; and avoid sources and transmission of infections and communicable diseases. (42 CFR418.110).
FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide
FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic. To access, go to: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-revokes-emergency-use-authorizations-certain-respirators-and-decontamination-systems.
COVID-19 Accelerated and Advance Payments: Updated FAQs
CMS updated FAQs about repayment of COVID-19 accelerated and advance payments. If you got these payments, learn more about how recoupment works and how it affects your Medicare claims payment amounts.
- COVID-19 Accelerated and Advance Payments: https://www.cms.gov/medicare/covid-19-accelerated-and-advance-payments.
- Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021 MLN Matters Article: https://www.cms.gov/files/document/se21004.pdf.
- CMS updated FAQs : https://www.cms.gov/files/document/covid-advance-accelerated-payment-faqs-06-24-21.pdf.
Hospice Aide Services: Enhancing RN Supervision
An Office of Inspector General (OIG) found that Registered Nurses (RNs) didn’t always:
- Visit hospice patients’ homes at least once every 14 days to assess the quality of care and services provided by hospice aides
- Document these visits as required
- Review the Enhancing RN Supervision of Hospice Aide Services fact sheet to learn about roles and documentation at: https://www.cms.gov/files/document/enhancing-rn-supervision-hospice-aide-services.pdf .
You can access the OIG report at: https://oig.hhs.gov/oas/reports/region9/91803022.pdf.
Texas News and Information
Health and Human Services Commission (HHSC)
Emergency Rule Update Regarding Hospital Off-Site Facilities Designation of Licensed Hospital Space in Response to COVID-19
On March 20, 2021, HHSC adopted an emergency rule permitting currently licensed hospitals to apply for approval to temporarily operate an off-site inpatient facility, including hospital space designated by another currently licensed hospital for use as an off-site facility, without obtaining a new license. This emergency rule was adopted to ensure hospitals could treat and house patients in response to the COVID-19 pandemic.
HHSC intends to extend the emergency rule on July 18, 2021, for an additional 60 days, with a new expiration date of September 15, 2021.
Effective September 16, 2021, all licensed hospitals operating off-site facilities must obtain licensure for each off-site hospital location, as required by Texas Administrative Code Title 25, Chapter 133. https://texreg.sos.state.tx.us/public/readtac%24ext.ViewTAC?tac_view=4&ti=25&pt=1&ch=133
For questions or more information, please contact us by emailing [email protected].