COVID-19 UPDATE #79
September 14, 2020
AHCA/NCAL INVESTIGATES REPORTED FALSE POSITIVES IN COVID-19 TESTING: SURVEY AND RESOURCES
Late last week, AHCA/NCAL received a handful of reports of BD Analyzers producing COVID-19 false positives with staff and residents. AHCA/NCAL is working closely with LeadingAge, the Department of Health and Human Services, and BD Veritor leadership to investigate these preliminary reports, determine the extent of the issue, and understand the cause(s).

We wanted to share an update of developments to date and what we are doing jointly.
  • Please complete this short survey by AHCA about your use of the BD and Quidel point of antigen tests by midnight tomorrow, Tuesday, September 15. This will help provide a better understanding of the issues surrounding these tests.
  • Please continue to share reports with AHCA/NCAL of false positive antigen POC tests (with either BD or Quidel) as soon as you get them. 
  • BD has set up dedicated resources for providers experiencing false positives.
  • Providers who experience multiple false positives ONLY can call Sara Lewis at (207) 522-7563. Please note that this number will likely change in the next few days. 
  • You can also email BD at Technical_Services@bd.com.
  • BD offers a microsite and training webinars, which members are encouraged to review if they are having concerns with accuracy to make sure they are properly following all instructions. 

Members should continue to use these POC tests but are encouraged to follow the CDC guidance and algorithm with details about when to conduct confirmation testing of positive antigen tests. 

You are also encouraged to conduct confirmation testing with PCR tests in other situations not covered by CDC guidance where asymptomatic residents or staff test positive with the antigen tests, given the recent reports of false positives. If asymptomatic residents test positive with a POC antigen test, they should be placed into TBC and single room if possible but not moved to a COVID-19 (+) or cohorted with a known positive resident until confirmation testing with PCR is obtained. 
RESIDENTIAL CARE SERVICES ISSUES DEAR ADMINISTRATOR LETTER REGARDING SKILLED NURSING CMS TESTING REQUIREMENTS
The Dear Administrator letter dated September 10, 2020, reiterates a synopsis of the Centers for Medicare & Medicaid Services (CMS) requirements outlined in QSO Memos 20-37 and 20-38. Of particular importance, RCS gives direct guidance to facilities regarding the need to report point of care COVID-19 antigen testing results.

The rule was effective September 2, 2020, but CMS provided a three-week grace period for the reporting requirement. SNFs that have received their equipment from CMS and are using the point of care COVID-19 testing devices under their Department of Health Medical Testing Site (MTS) License/ CLIA Certificate of Waiver are required to report test results under this CLIA regulation. (Facilities contracting with a laboratory instead of performing tests themselves are not responsible for reporting; the laboratory must complete the reporting.)

Under the new regulation, specific data elements are required to be reported daily for point of care COVID-19 antigen testing being conducted in the SNF. According to the guidance, reporting can be done to the state Department of Health (DOH) or local health jurisdiction, or a reporting platform. In Washington State, the reporting mechanisms have not been sufficiently developed to accept reporting.

The Dear Administrator letter directs Washington SNFs that until the reporting mechanisms are in place, Residential Care Services (RCS) and DOH recommend keeping a log of all testing that includes the required elements, beginning September 2, 2020. Keeping a log or spreadsheet will document your effort to report and enable you to report when the reporting mechanism is operational.

Once reporting mechanisms are in place, failure to report COVID-19 test results will result in a condition level violation of the CLIA regulation and may result in the imposition of a CMP. The CMP will be $1,000 for the first day of noncompliance and $500 for each subsequent day of noncompliance. CLIA, not RCS, will review and regulate the reporting requirement. However, Washington State has “exempt” status with CLIA and CMS, which means our state has enacted laws relating to the laboratory requirements that are equal to or more stringent than CLIA/CMS requirements. Under the exempt status, the state laboratory licensure program, which resides with DOH, is approved to conduct oversight of laboratory programs instead of CLIA. Therefore, DOH will be responsible to monitor the new reporting requirements and will issue citations and enforcement penalties if needed. If you have questions, please email Elena Madrid or call her at (800) 562-6170, extension 105.
APPLICATION DEADLINE FOR PRIVATE PAY ASSISTED LIVING FUNDING EXTENDED TO SEPTEMBER 21
Last week the US Department of Health and Human Services (HHS) announced that private-pay assisted living/memory care providers will be eligible to apply for CARES Act Provider Relief Funds. ALFs that may have been previously ineligible to apply for Phase 2 General Distribution funding may now apply for relief. ALF Medicaid providers that previously were eligible for relief and received a payment may also apply, and may receive a payment if their previous relief was less than two percent of 2019 revenue.  HHS is encouraging ALFs to apply for funding to help minimize the financial hardships of these increased expenses caused by COVID-19.

Today, AHCA announced a one week extension. ALF providers will have until September 21, 2020, to apply. If you have not yet begun an application, please visit the Provider Relief Fund web page which includes previously-recorded Phase 2 application webinars, frequently asked questions, and other information on how to apply through the recently-simplified application process. AHCA/NCAL and Argentum are both pursuing conversations with HHS to provide specific details to help with your potential applications. Click here for an informational communication from Argentum. We will continue to keep you informed.
UPDATE ON ASSISTED LIVING TESTING EFFORTS
Last week, Argentum and NCAL representatives spoke with staff from the office of Admiral Brett Giroir, M.D., the assistant secretary for health at HHS, seeking clarification on the strategy for the distribution of point of care COVID-19 antigen tests to assisted living providers. HHS confirmed that 150 million rapid point of care tests had been purchased for long term care facilities including assisted living, and that distribution will begin in the next two to three weeks. Argentum and NCAL will be sharing with HHS the number of tests needed and suggestions for distribution and administration of the tests.

One particular point discussed on the call was the need for CLIA certificates of waiver to administer the tests (as some, but not all, senior living providers have the waiver). HHS discussed the possibility that an umbrella waiver for consultant pharmacists could potentially be applied in assisted living where a consultant pharmacist relationship exists. HHS also informed Argentum/NCAL that they recently extended coverage under the PREP Act to licensed health care practitioners prescribing or administering point of care COVID-19 testing in congregate facilities. Argentum and NCAL will continue discussions with HHS over the next week and we will continue to keep you informed.
ADDITIONAL RESOURCES
WHCA continues to post resources and information as it becomes available on our website. If you have questions or need additional information, please call the WHCA office at (800) 562-6170.