New CMS Rules Will Require Nursing Homes to Test Staff for COVID-19
On August 26, 2020 by Jonathan Lips
Nursing homes will be required to test staff for COVID-19, and offer testing to residents, under an Interim Final Rule released by CMS August 25. All laboratories conducting COVID-19 testing and reporting patient-specific results
– including nursing homes conducting point-of-care testing – will be required to report test results daily. According to a CMS press release, the new requirements strongly support efforts to boost surveillance of the virus and double down on its commitment to keep nursing home residents safe.
The lengthy Interim Final Rule addresses a number of COVID-19 topics relevant to nursing homes in addition to testing, such as an update on the SNF Value-Based Payment Program. The information below focuses on testing, but this LeadingAge National article summarizes those related topics, and a separate article summarizes yesterday’s CMS stakeholder update call that announced the new rule.
When will the testing requirements be effective? The rules will be effective on the date CMS publishes the Interim Final Rule in the Federal Register. We don’t know when that will happen, but we expect it soon. Even with an immediate effective date, CMS may grant providers some period of time before implementation is required, and we will strongly advocate for them to do that. The rules will be applicable for the duration of the Public Health Emergency for COVID-19.
What are the specific testing requirements? The rule adds the following new section to the infection control requirements in §483.80 (F880):
(h) COVID-19 Testing. The LTC facility must test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19. At a minimum, for all residents and facility staff, including individuals providing services under arrangement and volunteers, the LTC facility must:
(1) Conduct testing based on parameters set forth by the Secretary, including but not limited to: (i) Testing frequency; (ii) The identification of any individual specified in this paragraph diagnosed with COVID-19 in the facility; (iii) The identification of any individual specified in this paragraph with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19; (iv) The criteria for conducting testing of asymptomatic individuals specified in this paragraph, such as the positivity rate of COVID-19 in a county; (v) The response time for test results; and (vi) Other factors specified by the Secretary that help identify and prevent the transmission of COVID-19.
Note: this paragraph is telling us that CMS will issue a memo with interpretive guidance about the new requirements. That guidance will give details about who must be tested, how often, when to test asymptomatic staff or residents, how quickly test results should be returned, and other issues.
(2) Conduct testing in a manner that is consistent with current standards of practice for conducting COVID-19 tests.
(3) For each instance of testing: (i) Document that testing was completed and the results of each staff test; and (ii) Document in the resident records that testing was offered, completed (as appropriate to the resident’s testing status), and the results of each test.
(4) Upon the identification of an individual specified in this paragraph with symptoms consistent with COVID-19, or who tests positive for COVID-19, take actions to prevent the transmission of COVID-19.
(5) Have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse testing or are unable to be tested.
(6) 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.
How does antigen testing figure into this? CMS officials have signaled that providers will have discretion to decide what type of test(s) to administer, but they clearly intend for the point-of-care antigen testing platforms, currently being distributed to nursing homes across the country, to support implementation of the mandate. We can only speculate at this point, but this suggests facilities may not be required to implement the testing requirements until that distribution process is complete.
The CDC (Interim Guidance for Rapid Antigen Testing for SARS-CoV-2) and FDA (FAQs on Testing for SARS-CoV-2) have recently issued updated guidance on use of antigen tests, and the Minnesota Department of Health (MDH) is evaluating those details to inform their own guidance, which we hope they will release soon.
Who will pay for the staff testing? Facilities will bear the cost, but the federal government will provide additional funding to help with the burden. On July 22, 2020, the U.S. Department of Health & Human Services (HHS) announced the release of an additional $5 billion from the Provider Relief Fund to help nursing homes address critical needs, including hiring additional staff, increasing testing, and providing additional services, such as technology so residents can connect with their families if they are not able to visit. CMS officials said yesterday that $2.5 billion of that will be made available soon, possibly as early as this week, but they did not share details about how the dollars will be allocated to nursing homes across the country.
Reporting Test Results: CMS’ new rule also implements a CARES Act requirement that laboratories report COVID-19 test results on a daily basis. Laboratories conducting COVID-19 testing – including nursing homes conducting point-of-care testing under a CLIA Certificate of Waiver – will be required to comply.
We are still working to understand this aspect of the rule, but nursing homes conducting point of care antigen testing may be required to report patient-level test results both (i) to MDH to ensure rapid initiation of case investigations; and (ii) to the CDC’s National Healthcare Safety Network (NHSN) to inform disease surveillance activity.
(i) The CARES Act requires every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 to report the results from each test to HHS, and HHS guidance of June 4, 2020 indicates data should be sent to state or local public health departments to facilitate case investigations. All laboratories must report data for all testing completed, for each individual tested, within 24 hours of results being known.
(ii) Meanwhile, LeadingAge national has informed us that NHSN is hoping to upgrade facilities reporting through NHSN from the expedited enrollment status providers obtained back in May to a “fully-secure enrollment,” that requires what’s called a SAMS grid card (a security feature) to log in and enter data. The reason for this change could be (again, speculation) that CMS intends to require nursing homes to report not only facility-level data but also patient-level data, such as individual test results.
According to LeadingAge, CDC hopes to upgrade all facilities within the next few months. At this time, this enrollment upgrade is optional, and even if members want to upgrade, they do not need to proactively initiate an enrollment upgrade at this time. As the work moves forward, NHSN (CDC) will send out guidance to all reporting providers with instructions on how to start the process. They have also pledged to share this info with the QIOs and with LeadingAge to allow us to help members through this process. Members’ ability to report through NHSN would not be impacted during the upgrade process. Members will still be able to report according to CMS requirements even as they work to complete their enrollment upgrade (a process that may take a week or more). NHSN has already launched a pilot initiative, working with 250 nursing homes over the past 2 weeks and successfully upgrading enrollment for 50 of them.
On a related note: the COVID-19 reporting module for long-term care is scheduled to be updated on Thursday, Aug. 26. Updates will include new questions about access to and use of point-of-care antigen testing, as well as clarifications in the Tables of Instructions related to reinfection and false positives. Those “soft alerts” that pop up any time a provider reports more than once in a week will also go away. The CSV templates for group reporting will be updated on or before Aug. 26 and they hope to send out an alert to group users ahead of the updates, but the ability to do this depends on how quickly that communication gets through internal clearance. Lastly, they plan to release a “version 2” of the Frequently Asked Questions document to include these changes by the end of August. Watch the NHSN webpage for that resource.
How will the testing requirements be enforced? CMS will hold nursing homes accountable for the testing requirement by directing surveyors to inspect nursing homes for adherence to the new testing requirements. Facilities that do not comply with the new requirements will be cited for non-compliance and may face enforcement sanctions based on the severity of the noncompliance, such as civil money penalties in excess of $400 per day, or over $8,000 for an instance of noncompliance.
LeadingAge Minnesota is here to support you!
We know members have many questions about these new requirements: What exactly are we required to do? How soon do we have to implement? What if staff or residents decline to be tested? How feasible will it be to meet the requirements given the many challenges we have already encountered in implementing a testing program?
Please know we will work tirelessly, in partnership with LeadingAge national, to unpack this lengthy new rule, identify gaps where we need more information from CMS and MDH, advocate for a fair and reasonable implementation timeline, and create resources that to help you do what needs to be done.