CMS PULLS BACK MEMO RESTRICTING USE OF COVID TESTS
The Centers for Medicare and Medicaid Services (CMS) has rescinded QSO-22-25-CLIA, which barred the use of SARS-CoV-2 tests outside of the FDA test’s instructions for use. This comes after AHCA/NCAL strongly advocated that CMS should rescind this memo because it limited the use of the BinaxNOW COVID-19 Ag Card being sent by the U.S. Department of Health and Human Services (HHS) to symptomatic individuals.
This means that long term care providers can use the BinaxNOW COVID-19 Ag Card the HHS program sends on both asymptomatic and symptomatic individuals.
Specifically, CMS indicates that for the duration of the public health emergency, it will not cite facilities with a CLIA Certificate of Waiver when authorized SARS-CoV-2 molecular or antigen POC tests are performed on asymptomatic individuals outside of the test’s authorization. In addition, CMS will not cite nonwaived facilities when they perform modified authorized, cleared or approved SARS-CoV-2 molecular or antigen POC tests.
CMS UPDATES TESTING AND VISITATION GUIDANCE
CMS released revised QSO memos QSO-20-38-NH (Testing) and QSO-20-29-NH (Visitation) to be consistent with CDC guidance. CMS no longer requires routine testing of asymptomatic staff and it updated recommendations for testing individuals who have recovered from COVID-19. Revisions in the visitation memo include updated guidance for face coverings and masks during visits and the removal of vaccination status as a consideration. Many of these changes reflect the tireless work that AHCA members have devoted to advocating for CDC and CMS to update.
Routine Testing (Staff)
- CMS no longer requires routine testing for staff for SARS-CoV-2.
Outbreak Testing (Residents and Staff)
- When a facility admits a resident with known COVID-19 directly into transmission-based precautions (TBPs), or when a facility admits a resident known to have close contact with someone with COVID-19 directly into TBP and that resident develops COVID-19 before the facility discontinues TBPs, this will not trigger an outbreak investigation.
Reporting Positive Tests
- All facility staff should report a positive viral test, symptoms, or a higher-risk exposure to occupational health or another point of contact designated by the facility so the facility can effectively manage it.
Testing New Admissions
- Facilities are directed to CDC’s Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic guidance under Managing admissions and Residents who leave the facility for information on testing of residents who are newly admitted or readmitted to the facility and those who leave the facility for 24 hours or longer.
- Facilities should test admissions in counties where Community Transmission levels are high upon admission (admission testing at lower levels of Community Transmission is at the discretion of the facility).
- CDC recommends testing at admission and, if negative, again 48 hours after the first negative test and, if negative, again 48 hours after the second negative test.
- Facilities should also advise them to wear source control for the 10 days following their admission.
- Facilities should generally manage a resident who leaves the facility for 24 hours or longer as an admission.
- Testing is not necessary for asymptomatic people who have recovered from SARS-CoV-2 infection in the prior 30 days.
- Facilities should consider testing for those who have recovered in the prior 31-90 days.
- If the facility performs testing, the CDC recommends the use of an antigen test instead of a nucleic acid amplification test (NAAT).
CMS removed references of “up-to-date from the requirements” for outdoor and indoor visitation, removed the requirement to “screen all who enter for visitation exclusions,” and provided the following updates:
- Facilities should provide guidance (e.g., posted signs at entrances) about recommended actions for visitors who have a positive viral test for COVID-19, symptoms of COVID-19, or have had close contact with someone with COVID-19.
- Visitors with confirmed COVID-19 infection or compatible symptoms should defer non-urgent in-person visitation until they meet CDC criteria for health care settings to end isolation.
- For visitors who have had close contact with someone with COVID-19 infection, it is safest to defer non-urgent in-person visitation until 10 days after their close contact if they meet criteria described in CDC healthcare guidance (e.g., cannot wear source control).
- During peak times of visitation and large gatherings (e.g., parties, events) facilities should encourage physical distancing.
CMS included guidance for the use of face coverings and masks during visits as it relates to Community Transmission Level metrics to include:
- If the nursing home’s county COVID-19 community transmission is high, everyone in a healthcare setting should wear face coverings or masks.
- If the nursing home’s county COVID-19 community transmission is not high, the safest practice is for residents and visitors to wear face coverings or masks; however, the facility could choose not to require visitors wear face coverings or masks while in the facility, except during an outbreak.
- The facility’s policies regarding face coverings and masks should be based on recommendations from the CDC, state and local health departments, and individual facility circumstances.
- Regardless of the community transmission level, residents and their visitors when alone in the resident’s room or in a designated visitation area, may choose not to wear face coverings or masks and may choose to have close contact (including touch).
- Facilities should advise residents (or their representatives) and their visitors of the risks of physical contact prior to the visit.
- If a roommate is present during the visit, it is safest for the visitor to wear a face covering or mask.
CMS indicated in most circumstances, it does not recommend quarantine for residents who leave the facility for less than 24 hours (e.g., for medical appointments, community outings with family or friends), except in certain situations described in the CDC’s empiric transmission-based precautions guidance.
UP TO DATE IMPLICATIONS
With the CDC’s recommendation to get the bivalent booster, we understand this may change the definition of up-to-date which has implications for isolation, PPE and testing guidance for residents and staff. AHCA has been in contact with CMS and CDC who are discussing this implication and are setting up some calls for next week. While we wait to hear details back from CMS, this leaves providers to decide how they want to proceed. It appears that immediate action on reclassifying residents and staff's up to date status is not necessary until we hear more from CMS. We would recommend reaching out to your LTC pharmacy to access bivalent vaccine for your residents and staff as soon as feasible.
The recommendations also confirmed that providers may co-administer the bivalent and influenza vaccines without contraindications. Therefore, providers should offer both influenza and COVID-19 vaccines during vaccine clinics if a person is eligible for both.
UPDATED LAB CONTACTS
This updated list of contracting clinical labs for the LTC surveillance testing program includes new contact names & emails for some labs (email addresses appear in blue).
COVID-19 BIVALENT VACCINE BOOSTER APPROVAL
As COVID-19 evolved and created new, more contagious variants of the virus, the Omicron variant emerged quickly becoming the most contagious variant to date. As a result, COVID-19 vaccine manufacturers updated their COVID-19 vaccines with an Omicron-specific component to help restore protection that has waned since previous vaccination. These new “bivalent” vaccines will more effectively fight the Omicron strains of COVID-19.
The FDA has authorized the vaccine and the CDC is recommending both Moderna (for those age 18+) and Pfizer-BioNTech (for those age 12+) bivalent boosters:
Individuals are eligible for a single booster dose if it has been at least two months since they have
- completed primary vaccination, or
- received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
AHCA/NCAL has been meeting with the CDC and LTC pharmacy partners to ensure LTC remains a top priority for access to this booster. Facilities should contact their LTC pharmacies and schedule bivalent booster clinics.
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