Testing Nursing Home Residents for COVID-19

 

All people with COVID-19 may be contagious while asymptomatic. Nursing home residents infected with COVID-19 may not have the symptoms that are typical of coronavirus in younger people (elevated temperature, coughs, respiratory symptoms); they may appear asymptomatic.[1] Nursing home staff have been the primary source of COVID-19 infections in nursing facilities because families, ombudsmen, and most surveyors have generally been barred from facilities since March. These facts have made testing issues critical: who should be tested, when, and with what kinds of tests?  On September 2, the federal government, for the first time during the pandemic, required nursing facilities to test residents and staff, although the interim final rule with comment does not specify the types of tests that facilities should use.[2] 

There are two types of tests for the coronavirus: antigen tests, which are intended for people with symptoms, and polymerase chain reaction (PCR) tests.[3] Antigen tests are cheaper, less accurate for asymptomatic people, and can be done quickly at nursing facilities; PCR tests are more accurate but more expensive and they must be processed by laboratories, with results often taking days. 

As discussed below, the Centers for Medicare & Medicaid Services (CMS) announced in July that it is sending all nursing facilities an initial supply of test machines and tests that are intended for symptomatic people. Facilities must pay for additional tests, as needed. The president of the New Hampshire Health Care Association said, “‘Basically you’re giving some lousy tests for nursing homes and you’re making them pay for them. I don’t see that as a win; I see that as a risk.’”[4]  

On July 14, 2020 CMS announced that it would send skilled nursing facilities (SNFs) a diagnostic test instrument and an estimated 400 antigen tests (a “target” of a six weeks’ supply) so that facilities could conduct point-of-care testing for COVID-19.[5] Nursing facilities need to purchase subsequent tests for about $25 each, through a “‘special concierge service’” with the two companies that sell the instruments and tests, Quidel and Becton, Dickinson (BD). Assistant HHS Secretary for Health Admiral Brett P. Giroir, M.D. acknowledged that the antigen tests have a higher risk for false negatives than the gold standard PCR tests that third-party laboratories conduct. BD says its antigen tests have a 15% false negative rate and should not be used with asymptomatic people.[6] According to Giroir, facilities should, therefore, use PCR tests to confirm negative test results and to treat the negative results as “presumptive.”

On July 29, 2020 LeadingAge, the trade association of not-for-profit nursing facilities, wrote to Giroir about CMS’s testing initiative, expressing concerns with the high rate of false negatives with antigen testing and the need to retest using the PCR test; the high cost of testing and retesting; many, if not most, states’ not accepting antigen testing results because of the high rate of false negatives; the low speed of testing; coverage for testing; and details about the rollout of the CMS plan to send instruments and tests to facilities.[7]

On August 25, 2020 CMS released an interim final rule with comment, adding a new section (g) to the existing infection control regulations, 42 C.F.R. §483.80), to require testing of residents and staff. The rules became effective when they were published in the Federal Register on September 2, 2020.[8] 

The detailed rule requires facilities to test residents and staff according to parameters identified by the Secretary, §483.80(g)(1); conduct testing in accordance with standards of practice, §483.80(g)(2); document each test and its results, §483.80(g)(3); take actions to prevent the transmission of COVID when a resident or staff member tests positive, §483.80(g)(4); have procedures for residents, staff, and volunteers who refuse testing, §483.80(g)(5); and “When necessary, such as in emergencies due to testing supply shortages, contact state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results,” §483.80(h)(6). The interim final rule does not prescribe the types of tests that facilities should use. CMS writes, “facilities have the flexibility and discretion to select the test that best suits their needs so long as the tests are conducted in accordance with nationally recognized standards and meet the response time for test results specified by the Secretary.”[9] 

On August 26, 2020 CMS issued surveyor guidance[10] on interim final rules with comment that require testing residents and staff, which it released on August 25 and published in the Federal Register on September 2, 2020. CMS’s guidance adds to the regulatory language and explanation in the preamble and says, “Routine testing of asymptomatic residents is not recommended unless prompted by a change in circumstances, such as the identification of a confirmed COVID-19 case in the facility.” A problem with this guidance is that many residents may have COVID-19 but be asymptomatic.

The unusually prescriptive guidance prioritizes testing requirements for staff and residents:

Table 1: Testing Summary

Testing Trigger	Staff	Residents
Symptomatic individual identified	Staff with signs and symptoms must be tested.	Residents with signs and symptoms must be tested.
Outbreak (Any new case arises in facility)	Test all staff that previously tested negative until no new cases are identified.*	Test all residents that previously tested negative until no new cases are identified.*
Routine testing	According to Table 2 below	Not recommended, unless the resident leaves the facility routinely.

*For outbreak testing, all staff and residents should be tested, and all staff and residents that tested negative should be retested every 3 days to 7 days until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result.

The guidance to test all residents whenever there is an outbreak in the facility reflects studies finding that universal testing following an outbreak uncovers many instances of infected residents who are otherwise asymptomatic.[11]

CMS’s August 26 guidance also identifies testing intervals for staff, based on “the extent of the virus in the community.”  Id.

Table 2: Routine Testing Intervals Vary by Community COVID-19 Activity Level

Community COVID-19 Activity	County Positivity Rate in the past week	Minimum Testing Frequency
Low	<5%	Once a month
Medium	5% - 10%	Once a week*
High	>10%	Twice a week*

*This frequency presumes availability of Point of Care testing on-site at the nursing home or where off-site testing turnaround time is <48 hours.

Like the interim final rule with comment, the guidance does not identify the types of tests that facilities should use with testing residents and staff.

On August 31, 2020 Giroir issued guidance on screening tests for residents,[12] quoting guidance from the Food and Drug Administration (FDA) (“repeated use of [off-label] rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times”)[13] and CMS.[14] He concludes by extending coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) “to licensed health-care practitioners prescribing or administering point-of-care COVID-19 tests, using anterior nares specimen collection or self-collection, for screening in congregate facilities across the Nation.” The PREP Act preempts State and local requirements prohibiting health care practitioners from administering FDA-authorized COVID-19 tests to symptomatic or asymptomatic people living in congregate facilities.

On September 8, 2020 Giroir announced in a call[15] that CMS has purchased 750,000 point-of-care antigen tests from Abbott and will begin sending them to nursing facilities, starting next week and continuing through November or December. CMS will initially target facilities in counties that it has designated as red or yellow; these designations require facilities to test all staff weekly or twice per week. After this supply is distributed, facilities will be able to purchase the tests for $5 to $6 per test.[16]

Conclusion

Testing of staff is essential to preventing the introduction or spread of COVID-19 in nursing facilities. Testing of residents is also essential to providing appropriate care to residents, including grouping residents by COVID-19 status (i.e., cohorting). Although the testing equipment and tests that CMS is sending to nursing facilities are not ideal, the PREP Act preempts State and local rules and allows the off-label use of antigen tests for residents and staff.[17]   

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[1] Melissa M. Arons, et al, “Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility,” The New England Journal of Medicine (May 28, 2020), https://www.nejm.org/doi/pdf/10.1056/NEJMoa2008457 (finding that when all the resident at Life Care Center of Kirkland were tested for coronavirus, more than half the residents who tested positive did not have any symptoms); Judith Graham, “Seniors With COVID-19 Show Unusual Symptoms, Doctors Say,” Kaiser Health News (Apr. 24, 2020), https://khn.org/news/seniors-with-covid-19-show-unusual-symptoms-doctors-say/ (finding that older people may be lethargic, sleep more, stop eating, become dizzy, or become disoriented and unable to speak, but may not have the more typical symptoms of COVID-10).
[2] 85 Fed. Reg. 54,820 (Sep. 2, 2020, CMS-3401-IFC, https://www.govinfo.gov/content/pkg/FR-2020-09-02/pdf/2020-19150.pdf.
[3] Rachana Pradham, “Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes – But There’s a Hitch,” Kaiser Health News (Aug. 24, 2020), https://khn.org/news/trump-is-sending-fast-cheap-covid-tests-to-nursing-homes-but-theres-a-hitch/.
[4] Rachana Pradham, “Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes – But There’s a Hitch,” Kaiser Health News (Aug. 24, 2020), https://khn.org/news/trump-is-sending-fast-cheap-covid-tests-to-nursing-homes-but-theres-a-hitch/.
[5] Alex Spanko, “HHS to Provide 400 Tests as Part of Initial Nursing Home Round, with $25/Test Cost Afterwards,” Skilled Nursing News (Jul. 15, 2020), https://skillednursingnews.com/2020/07/hhs-to-provide-400-tests-as-part-of-initial-nursing-home-round-with-25-test-cost-afterwards/.
[6] Rachana Pradham, “Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes – But There’s a Hitch,” Kaiser Health News (Aug. 24, 2020), https://khn.org/news/trump-is-sending-fast-cheap-covid-tests-to-nursing-homes-but-theres-a-hitch/.
[7] Letter, https://www.leadingage.org/sites/default/files/LeadingAge_ADM%20Giroir%20Antigen%20Testing%20Ltr%20072920.pdf. See also LeadingAge’s questions and answers on CMS’s July 14 announcement, https://leadingage.org/sites/default/files/QA%20on%20POC%20antigen%20tests%20and%20reporting%20final.pdf.
[8] 85 Fed. Reg. 54,820 (Sep. 2, 2020).
[9] 85 Fed. Reg., at 54,852.
[10] CMS, “Interim Final Rules (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool,” QSO-20-38-NH (Aug. 26, 2020), https://www.cms.gov/files/document/qso-20-38-nh.pdf.
[11] Benajmin F. Bigelow, Olive Tang, Bryan Barshick, “Outcomes of Universal COVID-19 Testing Following Detection of Incident Cases in 11 Long-term Care Facilities,” Journal of the American Medical Association (Jul 14, 2020 Research Letter), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768377 (finding that more than half the 893 residents at 11 Maryland nursing facilities who were tested for COVID-19, following a case at their facility, tested positive but were asymptomatic; “results underscore the importance of universal testing because symptom-based approaches may miss a substantial number of cases”); Hatfield KM, Reddy SC, Forsberg K, et al. Facility-Wide Testing for SARS-CoV-2 in Nursing Homes — Seven U.S. Jurisdictions, March–June 2020. MMWR Morb Mortal Wkly Rep,  2020;69:1095–1099. DOI: http://dx.doi.org/10.15585/mmwr.mm6932e5external icon, https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6932e5-H.pdf (CDC Weekly Morbidity and Mortality Report (Aug. 14, 2020) finding that “79% of testing events performed in response to a known case identified unrecognized cases”); McMichael TM, Clark S, Pogosjans S, et al. COVID-19 in a Long-Term Care Facility — King County, Washington, February 27–March 9, 2020. MMWR Morb Mortal Wkly Rep 2020;69:339-342. DOI: http://dx.doi.org/10.15585/mmwr.mm6912e1external icon, https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6912e1-H.pdf (CDC Weekly Morbidity and Mortality Report, Mar. 18, 2020),  https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e1.htm#:~:text=On%20February%2028%2C%202020%2C%20a,including%2081%20of%20the%20residents%2C.
[12] HHS Office of the Secretary, “Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term Care Facilities, and other Congregate Facilities” (Aug. 31, 2020), https://www.hhs.gov/sites/default/files/prep-act-coverage-for-screening-in-congregate-settings.pdf.
[13] CDC: “[W] when screening asymptomatic individuals, health care providers should consider using a highly sensitive test, especially if rapid turnaround times are available. If highly sensitive tests are not feasible, or if turnaround times are prolonged, health care providers may consider use of less sensitive point-of-care tests, even if they are not specifically authorized for this indication (commonly referred to as “off-label”). For congregate care settings, like nursing homes or similar settings, repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times.”
[14] In light of the FDA’s Emergency Use Authorization for use of certain antigen tests for people suspected of COVID-19 by their health care providers, CMS “will temporarily exercise enforcement discretion for the duration of the COVID-19 public health emergency . . . [and] will not cite facilities with a CLIA Certificate of Waiver when SARS-CoV-2 POC antigen tests are performed on asymptomatic individuals, as described in the FDA FAQ.”
[15] In connection with the call, CMS issued a slide deck with detailed information about testing and reporting requirements.  CMS, “New COVID 19 Testing and Reporting Requirements” (Sep. 8, 2020), https://www.cms.gov/files/document/covid-ppt-nh-all-call.pdf.
[16] Alex Spanko, “HHS Will Send 750K Abbott Point-of-Care Tests to Nursing Homes Next Week,” Skilled Nursing News (Sep. 8, 2020), https://skillednursingnews.com/2020/09/hhs-will-send-750k-abbott-point-of-care-tests-to-nursing-homes-next-week/.
[17] See LeadingAge, “Point-of-Care Anigen Testing A to Z” (updated Sep. 1, 2020), https://leadingage.org/sites/default/files/tool%20antigen%20testing%20a%20to%20z%2009.01.pdf?_ga=2.263941385.482564749.1599580087-1021098696.1598989890.