WASHINGTON, D.C. (September 1, 2020)—The Centers for Medicare & Medicaid Services (CMS) released an interim file rule with comment period (IFC) which includes pertinent regulatory revisions for long term care (LTC) facilities in response to the COVID-19 public health emergency. Specifically, facilities are required to test residents and staff—including individuals providing services under arrangement and volunteers—for COVID-19 based on parameters set forth by the Secretary of Health & Human Services (HHS). CMS's Quality, Safety & Oversight (QSO) group then released a memo, QSO -20-38-NH, that provides guidance for the facilities in implementing the new requirements.
This IFC amends the current infection control requirements for LTC facilities at -ß 483.80 by adding a paragraph (h) that requires a facility to test all of its residents and facility staff for COVID-19. Under this requirement, "staff" are considered to be:
- any individuals employed by the facility,
- any individuals that have arrangements to provide services for the facility, and
- any individuals volunteering at the facility.
An example of individuals providing services under arrangement includes a hospice that may have an agreement in accordance with the requirements for the use of outside resources under ¬ß 483.70(g) and (o) to provide hospice care for residents in the facility. It is expected that only those individuals that are physically working on-site at the facility be required to be tested for COVID-19. The facility may have staff, including individuals providing services under arrangement and volunteers, who provide services for the facility from an off-site location that is not physically located within the facility, and such staff would not be required to be tested for COVID-19.
Facilities should have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse testing or are unable to be tested. Neither the IFC nor the memo specifies what these procedures should be. Hospices should discuss this with contracted facilities as the hospice's procedures for addressing such staff and volunteers may be different, and perhaps even contrary, to a facility's procedures. Hospices should expect that staff and volunteers entering facilities would potentially be barred from doing so if they refused to be tested.
CMS acknowledged that the facility may have a provision under its arrangement with a vendor or volunteer that requires them to be tested from another source (e.g., their employer or on their own). However, the facility is still required to obtain documentation that the required testing was completed during the timeframe that corresponds to the facility's testing frequency. Hospices will need to provide this to contracted facilities when requested. Regardless of the frequency of testing being performed or the facility's COVID-19 status, the facility should continue to screen all staff (each shift), each resident (daily), and all persons entering the facility (such as vendors, volunteers, and visitors) for signs and symptoms of COVID-19.
In keeping with current CDC recommendations, staff and residents who have recovered from COVID-19 and are asymptomatic do not need to be retested for COVID-19 within three months after symptom onset. Until more is known, testing should be encouraged again (e.g., in response to an exposure) three months after the date of symptom onset with the prior infection. Facilities should continue to monitor the CDC webpages and FAQs for the latest information.
While not required, facilities may test residents' visitors to help facilitate visitation while also preventing the spread of COVID-19. Facilities should prioritize resident and staff testing and have adequate testing supplies to meet required testing, prior to testing resident visitors.
Facilities can meet the testing requirements through the use of rapid point-of-care (POC) diagnostic testing devices or through an arrangement with an offsite laboratory. Facilities without the ability to conduct COVID-19 POC testing should have arrangements with a laboratory to conduct tests to meet these requirements.
Hospices have been asking how often their staff and volunteers going into facilities should be tested. The QSO memo states that routine testing should be based on the extent of the virus in the community; therefore, facilities should use their county positivity rate in the prior week as the trigger for staff testing frequency.
Surveyors will assess LTC facilities for compliance with the revised regulations. The COVID-19 Focused Survey for Nursing Homes was revised to reflect the new regulations for use on surveys going forward. Hospices having any issues/challenges with accessing facilities when working with the facility under the revised regulation are encouraged to notify the State survey/other applicable state entities. The National Association for Home Care & Hospice (NAHC) continues to monitor this situation and appreciates hearing of any ongoing issues/challenges as well.
The regulatory change is effective through the end of the current COVID-19 emergency. Comments on this IFC are due 60 days after the IFC is published in the Federal Register.