- Testing Nursing Home Residents for COVID-19
- Medicare’s Finances – Challenges and Solutions
- Senators Release Report Concerning Postal Service Problems and Delays in Receipt of Mail-Order Drugs
- CMS Releases Update to Manual for State Payment of Medicare Premiums
- Kaiser Family Foundation Issues Report on Racial Disparities and COVID-19
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.
Medicare’s Finances – Challenges and Solutions
As discussed in a previous CMA Alert, in April 2020, the Medicare and Social Security Trustees released their 2020 annual report, which offers projections concerning the fiscal health of the Medicare and Social Security programs. At that time, the Medicare Trustees estimated that the Part A Trust Fund will be depleted by 2026, unchanged from last year’s projection. The Trustees noted in their report, however, that such projections did not account for the COVID-19 pandemic.
On September 3, 2020, the Kaiser Family Foundation (KFF) posted a policy update entitled “Medicare’s Finances Have Gotten Much Worse in Recent Years, Foreshadowing Tough Choices for November’s Winners” wherein they noted that according to the latest estimates of the Congressional Budget Office (CBO), the Part A Trust Fund “will have insufficient funds to cover all benefit costs beginning in 2024 – just four years from now, and sooner than last year’s projected depletion date of 2026.”
According to KFF, “[t]he outlook for the Medicare HI trust fund has worsened in recent years due to a combination of factors, including the economic impact of COVID-19 on payroll tax revenue and several laws enacted by Congress and signed into law by President Trump that either increased Medicare spending or reduced revenues, including legislation that cut taxes and repealed the Independent Payment Advisory Board, the ACA individual mandate penalty, and the ‘Cadillac tax’.”
As the Center noted in our Alert about the Trustees report, the Trustees’ projection – along with CBO’s more recent projection – should not be used as an excuse to cut Medicare benefits for older and disabled people. As demonstrated by the positive impact the Affordable Care Act had on increasing the life-span of the Trust Fund, the problem is fixable without reducing benefits. Instead, the Administration and Congress should negotiate drug prices for the whole Medicare program, end efforts to repeal and sabotage the Affordable Care Act, and stop wasteful Medicare Advantage overpayments. There’s a way, if there’s the will.
Senators Release Report Concerning Postal Service Problems and Delays in Receipt of Mail-Order Drugs
On September 9, 2020, U.S. Senators Bob Casey and Elizabeth Warren released a report entitled “Rapidly Increasing Postal Service Delivery Delays for Mail-Order.” The report focuses on recent operational changes made at the U.S. Postal Service (USPS) and concludes that “there have been significant delays in USPS deliveries of mail-order prescription drugs in recent months, potentially posing serious health risks to millions of Americans and increasing costs for consumers and taxpayers.”
At the same time that there has been a 20% increase in prescription drugs filled through mail-order during the pandemic, there have been “significant and increasing delays in the delivery of mail-order prescription drugs in the summer of 2020.”
According to the press release accompanying the report,
All four of the largest mail-order pharmacies and pharmacy benefit managers (PBMs) that rely heavily on USPS for deliveries revealed that they were experiencing significant delays in the delivery of mail-order prescription drugs in the summer of 2020, with an increase in average delivery times ranging from 18-32 percent. This means that prescription deliveries that typically took 2-3 days were instead taking closer to 3-4 days. Some delays were much longer, with one mail-order pharmacy reporting “a marked increase in July in the number of patients experiencing shipment delays of seven days or more.” The Senators’ investigation also found that the delays in USPS service are imposing new costs and burdens on health care providers, which could increase costs to the federal government, consumers and taxpayers.
The report cites to several consumer advocacy organizations, including the Center for Medicare Advocacy. According to the Center “[t]he current COVID-19 public health emergency has had a disproportionately harmful impact on older adults, and necessitates minimizing contact with other people. As more people avoid picking up their drugs and supplies at pharmacies and other places of business, older adults and individuals with disabilities are even more dependent upon the Postal Service to provide a bridge to the outside world.”
- Read the Center’s full letter to Senators Casey and Warren at https://medicareadvocacy.org/center-letter-re-impact-of-postal-service-delays-on-medicare-beneficiaries/
CMS Releases Update to Manual for State Payment of Medicare Premiums
On September 8, 2020, the Centers for Medicare & Medicaid Services (CMS) released an updated version of the Manual for State Payment of Medicare Premiums (formerly called “State Buy-in Manual”). The Manual updates information and instructions for states on federal policy, operations, and systems concerning the payment of Medicare Parts A and B premiums (or buy-in) for individuals dually eligible for Medicare and Medicaid. The Manual is part of the CMS Manual System, specifically Pub. 100-24.
- For more information please see: https://www.cms.gov/medicare-medicaid-coordination/medicare-medicaid-coordination-office/state-payment-medicare-premiums
Kaiser Family Foundation Issues Report on Racial Disparities and COVID-19
A recent Kaiser Family Foundation Issue Brief reviewing data and analysis of COVID-19 infections, highlights the disparate impact of infection for people of color.
The Issue Brief, Racial Disparities in COVID-19: Key Findings from Available Data and Analysis, includes the following key findings:
- From March through July 18, 2020, age-adjusted hospitalization rates due to COVID-19 for Black, Hispanic, and American Indian and Alaska Native (AIAN) people were roughly five times higher than that of White people.
- People of color make up a disproportionate share of COVID-19 hospitalizations relative to their share of the population or total hospital visits.
- Nursing homes where a higher share of residents are people of color are more likely to report a COVID-19 case.
- Testing sites in and near predominantly Black and Hispanic neighborhoods are likely to face greater demand than those near predominantly White areas, which could contribute to longer wait times, and the share of people of color in an area is associated with an increase in travel time to a testing site.
The report concludes, “Overall, the findings highlight the importance of considering how COVID-19 relief and response efforts will address inequities, including in decisions related to distribution of treatments and vaccines once they become available. Prioritizing equity will be key for addressing the current gaps in COVID-19 and health care more broadly and preventing widening of disparities in the future.”