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September 22, 2020


New Positivity Rates for SNF Testing Out. The Centers for Medicare and Medicaid Services (CMS) this evening published new county-level positivity rates to be used for SNF testing under Quality, Safety, and Oversight letter (QSO) 20-38-NH. The new table shows only one red county - Putnam - and 20 yellow counties, with the remaining 67 green. Remember that according to AHCA through conversations with CMS, SNFs can choose a day of the week on which they will check their county positivity and do not need to take action on changes until that day.

Recording of CLIA Reporting Webinar Now Available. All members who are utilizing either a COVID-19 point-of-care (POC) testing unit (BD Veritor or Quidel Sofia) or plan to utilize the forthcoming Abbott BinaxNOW COVID-19 Ag cards are required to follow all the requirements of being a Clinical Laboratory Improvement Amendments (CLIA) laboratory. Those requirements includes registering the CLIA Certificate of Waiver lab with the Health Department (ODH), performing aggregate daily reporting of results, and taking steps to develop a secure connection with ODH to comply with reporting of line-level data on all POC tests performed. Bill Storm, ELR and eCR Coordinator for ODH, held an informative webinar on COVID-19 CLIA reporting requirements. The webinar was recorded, and we encourage all members to review the recording.

Line-level reporting of COVID-19 tests has been mandatory for all CLIA labs since early June. Per the Department of Health and Human Services' COVID-19 Pandemic Response, Laboratory Data Reporting guidance issued on June 4, there are 18 required data elements that must be reported to state and federal authorities for all COVID-19 tests performed. ODH is very close to having a system in place to meet this requirement. We believe the easiest way for CLIA-waived SNFs and assisted living communities to comply with this requirement is to create a comma-separated value (CSV) file with all the required data elements and to upload it daily to ODH. This CSV file can be pre-populated with many of the required data elements, allowing facilities to copy and paste only the tests performed on a daily basis into a new CVS file for uploading. 

Compliance with this reporting is required under QSO-20-37-CLIA, NH. The QSO also highlights that 5% of Certificate of Waiver labs will receive an on-site survey to ensure their compliance with the reporting requirements. A citation with civil money penalties can be issued for noncompliance. OHCA is committed to helping you with this process, so please review the webinar and reach out to the listed ODH contacts or to OHCA for further assistance.

Additional Guidance on SNF POC Test Billing. As mentioned in last night’s COVID-19 Update, CMS published a flow chart and payer hierarchy for paying for testing in SNFs. After receiving questions from members on this topic, we wanted to provide some additional clarification relative to staff and resident testing:

RESIDENT TESTING

  • If the resident meets one of the conditions below, COVID-19 POC tests are covered under Medicare
    • Resident is not skilled
    • Resident has had suspected exposure OR the facility is in outbreak testing protocols
    • Resident is receiving a baseline test for opening or reopening a facility
    • Resident is being tested to determine if an infection is resolved
  • OHCA is aware that some facilities have chosen also to perform surveillance testing on residents. If the facility is performing surveillance testing not outlined in the examples above for residents, those tests should not be billed to Medicare for reimbursement. 
  • Health insurance issuers and group health plans must cover COVID-19 diagnostic testing (as determined medically appropriate by the individual’s health care provider, consulting Centers for Disease Control and Prevention (CDC) guidelines as appropriate). Health insurance issuers and group health plans are not required to cover non-diagnostic tests (i.e., testing done for public health surveillance purposes) without cost-sharing. 
  • The Department of Medicaid (ODM) has not yet developed a fee schedule to reimburse for this test.  

STAFF TESTING:

  • Some facility staff members, particularly volunteers, may be eligible for Medicare. If the staff member meets one of the criteria outlined above for residents, their testing is also covered.
  • The CMS-mandated routine staff testing for surveillance under QSO 20-38 (not including outbreak testing, testing of symptomatic/exposed staff members, or testing for facility reopening) under the cadence determined by the positivity rate of the facility's county is NOT covered by Medicare. These tests should not be billed to Medicare.
  • Many commercial insurance plans cover testing for asymptomatic members of the general population. It is unclear how each insurance company will handle coverage for surveillance testing. We recommend you speak with your provider contracting representatives regarding their view on medical necessity and coverage limitations for repeat testing of staff. OHCA continues to discuss these issues with the insurance plans and ODM.

ODH Interpretations. In a meeting today with ODH personnel, we received interpretations on several points that may be of interest.

  • A SNF resident does not have to be quarantined under CDC guidance except upon admission or a readmission. Return from a trip outside of the facility is not considered a readmission, provided during the trip, the resident wears a mask, practices social distancing, and does not have any known exposure.
  • OHCA asked about the number of negative polymerase chain reaction (PCR) tests ODH requires to confirm that a positive antigen test is incorrect, given that CDC guidelines suggest one is sufficient. ODH's Rebecca Sandholdt provided the following response from the Bureau of Infectious Disease (BID):

ODH follows CDC guidance for interpretation/response to antigen test results in nursing homes, and would recommend LHDs follow CDC guidance. Attached is a helpful algorithm that can be used. The guidance ODH has been giving about using two negative PCR tests after a positive antigen test is essentially the use of the test-based strategy to discontinue isolation before the symptom/time-based strategy would have released them.

We read this answer as meaning ODH only requires one confirmatory PCR test.

  • Jill Shonk of ODH agreed that QSO 20-38 does not require SNFs to ensure results from PCR tests are returned within 48 hours. Providers simply may document what the actual turn-around time was and that they could not get results within 48 hours.
  • BID gave the following explanation of the difference between a test-based strategy to remove transmission-based precautions and quarantine of admissions and readmissions:

The test based strategy refers to suspected or confirmed cases and when to remove them from isolation.  The recommendation for a 14-day quarantine in any congregate living setting remains 14-days, regardless of testing. 

Quarantine keeps someone who might have been exposed to COVID-19 away from others to prevent transmission (e.g. new admissions/readmissions). With persons with unknown COVID-19 status, you do not know about their exposure prior to admission and/or if they could be in their incubation period, which is why you place them in quarantine and use precautions. Based on existing literature, the incubation period (the time from exposure to development of symptoms) of SARS-CoV-2 ranges from 2–14 days. At this time, studies show that early testing during this time period may not be reliable. The Federal Drug Administration’s Fact Sheet for Healthcare Providers says “A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19”. CDC’s Test for Current Infection webpage says “If you test negative for COVID-19, you probably were not infected at the time your sample was collected. However, that does not mean you will not get sick. The test result only means that you did not have COVID-19 at the time of testing. You may test negative if the sample was collected early in your infection and test positive later during your illness. You could also be exposed to COVID-19 after the test and get infected then. This means you could still spread the virus.”

Satisfaction Surveys Not Likely to Occur. The Department of Aging (ODA) sought our perspective today on family satisfaction surveys this year for both SNFs and assisted living communities. These surveys nominally are required by statute, and for SNFs, the survey results are tied to the current quality incentive program under ODM. The resident survey that ODA started early in 2020 was not completed. Given COVID-19, all of the trade associations in the meeting agreed that ODA should not conduct the family satisfaction survey this year, even with adjustments to account for the pandemic. The results will be heavily influenced by extrinsic factors brought on by COVID-19, families have not been in a position to observe facilities or care, and providers do not need an additional administrative burden. We recommended waiting until next year for the satisfaction survey and potentially doing a different, simpler survey to assess the impact of COVID-19 on families. The ODA representatives seemed to expect this response and said although higher-ups will make the final decision, our views are likely to carry the day. 

Webinar: Ideas to Support Dementia Caregivers in the Global Pandemic. This session will be held on Tuesday, October 6, at 10:30 a.m. The COVID-19 pandemic presents unique challenges for people living with dementia and their caregivers. The webinar will focus on potential issues COVID-19 may have on people living with dementia. The webinar will provide an opportunity for caregivers to enhance their knowledge with tools to support dementia care management in an unprecedented environment. Please use this link to register.