Variant classifications (from the CDC): The U.S. government SARS-CoV-2 Interagency Group (SIG) developed a Variant Classification scheme that defines three classes of SARS-CoV-2 variants:
Variant of interest: A variant with specific genetic markers that have been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, reduced efficacy of treatments, potential diagnostic impact, or predicted increase in transmissibility or disease severity.
Variant of concern: A variant for which there is evidence of an increase in transmissibility, more severe disease (e.g., increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.
Variant of high consequence: A variant of high consequence has clear evidence that prevention measures or medical countermeasures (MCMs) have significantly reduced effectiveness relative to previously circulating variants.
Long-term care facilities background
A CMS spokesperson issued the following answers to questions from IowaWatch writer Andy Kopsa reiterating authority of CMS reporting outbreaks, cases and vaccination statistics at long term care facilities and the Iowa Veterans Home. There are 440 CMS certified long-term care facilities in Iowa. The Iowa Veterans Home is also CMS certified. All rules apply.
AK: I understand there is new HHS guidance in a recent rule for state-owned veterans homes bound by states that require them to report COVID cases directly to the CDC. Who has the ultimate authority over civilian and veteran nursing homes when it comes to legal actions if they don’t comply about reporting COVID data?
CMS: CMS only has authority on facilities that are certified as meeting CMS’ federal requirements for long-term care facilities. Some veterans homes meet these requirements, and are therefore subject to CMS’ requirements. However, if a state-owned veterans home has opted to not apply for, and be certified by CMS, then they would not be subject to CMS’ requirements, including the COVID-19 vaccination reporting requirement. Facilities that are certified by CMS are required to report resident and staff COVID-19 vaccination information weekly. Facilities that do not comply with the COVID-19 vaccination reporting requirement are fined for each week they fail to report.
AK: What responsibility does a CMS-certified nursing home have to inform the public regarding COVID, and are there any mandates to do so?
CMS: On May 11, 2021, CMS announced new requirements for long term care (LTC) facilities to submit COVID-19 vaccination information for nursing home residents and staff. On June 10, CMS posted the first set of weekly nursing home COVID-19 vaccination data, which includes vaccination status of both residents and staff, as reported by facilities. The data for the week ending May 30 can be viewed here: Nursing Home Data website. The current data show that approximately 75% of residents and 55% of staff in nursing homes have received a COVID-19 vaccine, which indicates a high level of protection from COVID-19.
The weekly reporting of vaccination data for residents and staff will help ensure that facilities receive support for their COVID-19 vaccination efforts. The data are reported to the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN), the nation’s most widely used healthcare-associated infection tracking system. LTC facilities are already required to report COVID-19 testing, case, and mortality data for residents and staff to the NHSN. The Nursing Home Data website is updated every Thursday with data submitted by the previous Monday.
AK: Are CLIA-certified labs bound by federal mandate reporting laws via CMS as well?
CMS: CMS is committed to taking critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) public health emergency. Under the Clinical Laboratory Improvement Amendments (CLIA) law, labs testing for COVID-19 must have a CLIA certificate to ensure patient health and safety.
In addition, per the Secretary’s guidance, laboratories will need to follow the June 4th Guidance for reporting SARS-CoV-2 test results. However, CLIA will only be assessing whether laboratories have, or have not, reported, or attempted to report, SARS-CoV-2 test results. In order to be in compliance with the CLIA reporting requirements, a laboratory will need to have documentation that it reported SARS-CoV-2 results or at least attempted to report the results.
CMS will continue to work closely with laboratories across the country and other stakeholders to protect patient health and safety during the COVID-19 pandemic.
A CDC spokesperson pointed out the healthcare value of the NHSN network but also the regulatory purpose it serves if a LTC doesn’t comply with federally mandated standards of care including reporting, testing and vaccination requirements for COVID19
“NHSN is a national surveillance system, accessible to registered users through an online, web-based application. Healthcare facility users, including those from LTCFs, report data directly to NHSN”
This allows them to: identify infection prevention problems by facility, state, or specific quality improvement project; benchmark progress of infection prevention efforts; comply with state and federal public reporting mandates, and ultimately; drive national progress toward elimination of healthcare-associated infections.
CMS is serious about compliance for the health and wellbeing of Americans living in long term care facilities:
“CDC has received reports from NHSN users indicating that in some healthcare facilities, some of the decisions about what infections should be reported to NHSN are made by individuals who may choose to disregard CDC’s protocol, definitions, and criteria or who are not thoroughly familiar with the NHSN specifications. While there is no evidence of a widespread problem, CDC and CMS take any deviation from NHSN protocols seriously.”
This link includes information for reporting suspected fraudulent misreporting to the US Department of Health and Human Services Office of Inspector General.
How can you get an at home test free of charge delivered to your door? From the Test Iowa website:
- At-home test kits are available at no cost through the Test Iowa at-home program. To receive a free at-home test kit, request one at testiowa.com. After requesting a test kit, it will be sent to you. You can also pick one up from a nearby location.
- Organizations that would like to become pick up/drop off sites for at home tests in your community visit this link.
So far one facility in Iowa has faced civil penalties for not following critical procedures for screening asymptomatic employees for COVID19.
This from a May 2021 press release from the U.S. Attorney’s office of Northern Iowa:
Care Initiatives, a Texas corporation with a home office in West Des Moines, Iowa, has agreed to repay the United States $214,200 to resolve claims the United States was entitled to restitution for the federal share of Medicaid funds the facility received for an approximately 10 week period while residents at Dubuque Specialty Care, a Care Initiatives facility, were suffering from or testing positive for COVID-19. The United States alleged that repayment of these funds was warranted due to Dubuque Specialty Care’s practices surrounding COVID-19 infections, including the facility’s procedures and criteria for screening symptomatic employees.
“Being a healthcare provider in the Medicare and Medicaid programs is a privilege, not a right. It is incumbent upon these providers to protect the safety of beneficiaries under their care, especially during this pandemic,” said Special Agent in Charge Curt L. Muller of Department of Health and Human Services Office of Inspector General. “Our investigators, working closely with our law enforcement partners, will continue to thoroughly investigate allegations of substandard safety practices.”
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