CMS Releases New Visitation and Testing Guidance

On March 10, 2022, the Centers for Medicare and Medicaid Services (CMS) issued new visitation and testing memoranda aligning its nursing home requirements with Centers for Disease Control and Prevention (CDC) recommendations. The focus of both documents is the replacement of the term “vaccinated” with “up-to-date with all recommended COVID-19 vaccine doses."

“Up-to-date” means that a person has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible. Members have asked whether a fourth dose is ever required in order to be considered "up-to-date" with vaccinations. The answer is not clear. The CDC recommends a fourth dose for individuals who receive an mRNA vaccine and are moderately or severely immunocompromised – a primary series of three doses of an mRNA COVID-19 vaccine, plus one booster of an mRNA COVID-19 vaccine (fourth dose). Thus, it appears that these individuals must receive four doses in order to be up-to-date. More information about the necessary vaccine doses and timing to qualify as "up-to-date" is available here.

The use of the term "up-to-date" in lieu of "fully vaccinated" has implications for in-room visits with roommates, staff screening testing, and quarantine requirements. The guidance documents indicate that they are effective immediately. However, the State Department of Health (DOH) has told LeadingAge NY via email that it will be issuing new guidance in response to the CMS memoranda.

The following are some highlights of the new CMS guidance. Providers are encouraged to read the documents in their entirety.

Visitation

Highlights: The new CMS visitation guidance:

Clarifies that visitors who have a positive viral test for COVID-19, symptoms of COVID-19, or currently meet the criteria for quarantine should not enter the facility until they meet the criteria used for residents to discontinue transmission-based precautions (quarantine), generally 10 days.
Provides that if a resident’s roommate is not up-to-date with all recommended COVID-19 vaccine doses, or is immunocompromised (regardless of vaccination status), visits should not be conducted in the resident’s room, if possible.
Reinforces the need for masks and physical distancing during indoor visits when around other residents or health care personnel, regardless of vaccination status, and:
- If the nursing home’s county COVID-19 community level of transmission is substantial to high, all residents and visitors, regardless of vaccination status, should wear face coverings or masks and physically distance, at all times.
- In areas of low to moderate transmission, the safest practice is for residents and visitors to wear face coverings or masks and physically distance, particularly if either of them is at increased risk for severe disease or is not up-to-date with all recommended COVID-19 vaccine doses.
- Residents, regardless of vaccination status, can choose not to wear face coverings or masks when other residents are not present and have close contact (including touch) with their visitor.
- Residents (or their representative) and their visitors who are not up-to-date with all recommended COVID-19 vaccine doses should be advised of the risks of physical contact prior to the visit.
Modifies provisions related to residents who leave the nursing home and return. Upon return from an off-site visit:
- If the resident has had close contact with a person who is infected with COVID-19 or exhibits signs or symptoms, test the resident and place them on quarantine if they are not up-to-date with all recommended vaccine doses.
- Facilities may choose to test residents who leave frequently or for prolonged periods, even if they do not have close contact with someone infected with COVID-19.
- Facilities may also consider quarantine for residents who leave the facility and are not up-to-date with all recommended doses based on an assessment of risk of non-compliance with infection prevention measures.
- Facilities should manage residents who leave for prolonged periods as a new admission or readmission. According to CDC guidance, this includes:
  - Placing those who are not up-to-date with their vaccinations on quarantine;
  - Regardless of vaccination status, administering two viral tests for SARS-CoV-2 infection – the first should be conducted immediately, and, if negative, the second should be performed five to seven days after return.
  - In low community transmission counties, facilities may use a risk-based approach to quarantine.

Masking Requirements and Visitation: Many LeadingAge NY members have asked about the scope of masking requirements during visitation and whether residents and families may eat together. The guidance does not provide a clear answer to these questions. Like providers, regulators are trying to walk a fine line between protecting residents' rights and quality of life and preventing transmission of COVID-19. Moreover, November 2021 and January 2022 DOH guidance documents are slightly inconsistent with each other and with CMS documents. The clearest statements about masking and eating during visits are included in CMS Frequently Asked Questions (FAQs), which indicate that:

Residents and visitors may choose not to mask and may choose to eat together, if they are not in a common area.
If a resident and their visitors must be in a common area, they must physically distance from other residents, and the visitors should wear a mask except while eating or drinking.
If the visitor is unable to physically distance from other residents, they should not share a meal with the resident in a common area.
While allowing residents and visitors to remove masks, CMS stresses that residents and visitors should be made aware of the risks of removing masks and close contact.

Although state DOH guidance issued in November 2021 aligned with CMS visitation guidance, the January 2022 DOH guidance, issued in response to the Omicron outbreak, states that all visitors must:

Wear a well-fitting non-surgical paper mask or a mask of higher quality (i.e., surgical mask, KN95, or N95) at all times during any visitation at the facility . . .; and
Physically distance from facility personnel and other patients/residents/visitors who are not directly associated with the specific resident(s) being visited by that individual.

It is unclear whether the January 2022 guidance was intended to overrule the CMS visitation guidance or merely reflected a temporary deviation based on the high transmission rates at the time.

Visitor Testing Requirements: LeadingAge NY members have also asked whether they are still required to verify that visitors have received a negative COVID-19 test result no more than one day prior to visitation (for antigen tests) or no more than two days for PCR tests. This is a state DOH requirement, and it has not yet been lifted. According to CMS FAQs, this type of condition on visitation is permissible:

States can require visitors to be tested prior to entry if the facility is able to provide a rapid antigen test (i.e., the visitor is not responsible for obtaining a test). If the facility cannot provide the rapid antigen test, then the visit must occur without a test being performed if the visitor(s) has not had a positive viral test, does not report COVID-19 symptoms or meet the criteria for quarantine.

Thus, CMS guidance permits the imposition of this requirement as long as the facility makes available rapid tests, and DOH has provided nursing homes with the rapid test kits to enable facilities to comply. LeadingAge NY members that do not have sufficient test kits should contact a member of the LeadingAge NY policy team.

Testing

Like the visitation guidance, the new CMS testing guidance replaces the term “vaccinated” with “up-to-date with all recommended COVID-19 vaccine doses” and deletes the term “unvaccinated.” This affects the scope of routine screening tests of nursing home staff. As a result of this updated guidance, staff who are not "up-to-date" with their vaccinations must be tested routinely based on the community transmission rates in the facility’s county. This would include those who are fully vaccinated and eligible for a booster, but are not boosted; those who are not fully vaccinated; and those who are unvaccinated (i.e., exempt). In most counties, these individuals must be tested twice weekly. Providers are reminded that the routine testing requirement applies to contractors and others providing services "under arrangement," such as hospice personnel.

The updated guidance also clarifies that testing is not necessary for asymptomatic people who have recovered from COVID-19 in the prior 90 days. If testing is performed on people who have recently recovered, an antigen test instead of an NAAT (PCR) test is recommended. Some people may return a positive result with the more sensitive NAAT test, but are not infectious during the 90-day period.

In addition, the guidance clarifies that nursing homes should be testing all staff or residents, regardless of vaccination status, who have been identified as a close contact of someone who tested positive for COVID-19.

LeadingAge NY members have asked whether the at-home tests distributed by government agencies may be used for routine testing of staff either at home or on-site. It is unclear whether off-site use of at-home test kits offers sufficient facility oversight to meet CMS routine screening requirements. However, it appears that these test kits may be used at the facility to conduct routine screening and other types of testing.

To the extent that they are used to meet CMS requirements, and facility oversight is needed (i.e., for purposes other than visitor testing), it is likely that the at-home test kits would be covered by the facility's limited service lab registration certificate. According to DOH's Clinical Laboratory Evaluation Program, the limited service lab registration does not have to be amended to add each point-of-care testing device. If the registration includes COVID-19 antigen tests, and the device used tests only for COVID-19 (i.e., it is not a panel device that tests for other viruses), the registration need not be amended.

We will continue to update members as new guidance becomes available.

Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838