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CMS Updates County Positivity, Changes Formula. Today, the Centers for Medicare and Medicaid Services (CMS) published an updated county positivity table for routine SNF staff testing. The new table shows Ohio with only two red counties, Butler and Putnam. The explanation can be found in the notes above the table of counties: CMS changed their calculation methodology. The key change reduces counties with positivity rates over 10% from red to yellow if they have relatively low total numbers of tests and tests per 100,000 population in the past 14 days. According to a quote from a CMS email provided by AHCA's Dr. David Gifford, CMS has a new plan for how often they will update county positivity:

Data on county positivity will be release weekly by CMS, which will not always be on the same day.  The will continue to modify and update the method to classify a county as green, yellow or red (facility need to use the color code) or they can also use data on test positivity rate from their state or local health department if its from a time period that is more recent than CMS data.  Members need to have a plan and process to check the CMS data weekly. It does NOT need to be checked more often and changing the frequency of testing only needs to happen when they check not immediately after CMS updates the data. They just need to have a process to check at least every 7 days.  A provider just needs to change testing the next time they have self-scheduled themselves to check, but doesn’t preclude them from checking sooner and changing based on that check.

Under CMS's Quality, Safety, and Oversight letter (QSO) 20-38-NH, a downward change in county color requires SNFs to continue following the routine testing schedule under the previous color for 14 days after the change. If the change is upward, however, SNFs must follow the higher testing frequency immediately.

Assisted Living Testing Webinar Tomorrow Morning. The Department of Aging (ODA) will hold a webinar from 8:30-9:30 a.m. tomorrow (Friday, September 18) on the new state-supported assisted living testing program. MAKO Medical, the state's designated laboratory for this program, also will participate in the webinar. You may register at this page. As we reported yesterday, ODA and MAKO will present a similar webinar later in the day (10:30-11:30 a.m.) on mandated testing for adult day care providers and senior centers. The registration page for that webinar is here.

CMS Issues New SNF Visitation QSO. Also today, CMS released QSO 20-39-NH, which updates the agency's previous guidance on visitation in SNFs. Like the older guidance, the QSO mainly contains recommendations, some of which are consistent with Ohio's visitation policy and some of which are not. The QSO has provisions for both indoor and outdoor visitation. What is different about this QSO is it requires a center to offer visitation if it has no COVID-19 for 14 days and is in a green or yellow county under the CMS system. The guidance specifies that facilities are subject to citation and penalties for failure to comply with this mandate. The QSO also addresses required access for ombudsmen and protection and advocacy agencies (e.g., Disability Rights Ohio). It further points out that:

Health care workers who are not employees of the facility but provide direct care to the facility’s residents, such as hospice workers, Emergency Medical Services (EMS) personnel, dialysis technicians, laboratory technicians, radiology technicians, social workers, clergy etc., must be permitted to come into the facility as long as they are not subject to a work exclusion due to an exposure to COVID-19 or show signs or symptoms of COVID-19 after being screened.

These health care workers are subject to the testing requirements of QSO 20-38. Please review QSO 20-39 in full, as it contains a number of additional points.

Governor's Remarks on SNF Visitation Create Confusion. Members reported that families misconstrued remarks by Governor Mike DeWine during his press conference today to mean that indoor visitation at SNFs and assisted living communities is currently permitted and only the facilities themselves are preventing families from taking advantage. Responding to a reporter's question about possible changes to the Department of Health (ODH) visitation order, as outlined in yesterday's COVID-19 Update, the Governor said that for months, the state’s orders provided for outside visitation. He added that with the advent of colder weather, “we are now working on how visitation can take place inside.” Unfortunately, he went on to say, "[i]f you have a loved one, and you cannot get into a nursing home, that is the nursing home that is stopping you from going in ... it is not the Health Department. ... That is the nursing home that is not letting you in."

To the extent families understood the Governor's words to mean they are permitted to visit indoors now, that is not true. Indoor visitation is not permitted now or until the ODH order is changed. This evening, the Governor's Office issued a summary of the press conference that recast his remarks on visitation to clarify the facts:

In response to media questions, Governor DeWine reminded Ohioans that if they have a loved one living in a nursing home, state health orders permit visitation, under certain health guidelines, including visitation taking place outdoors and the wearing of facial coverings. In the coming weeks, orders will be updated to include health guidelines for indoor visitation in anticipation of the winter months.

Webinar on Reporting Requirements for COVID-19 POC Antigen Testing. At OHCA's request, Bill Storm, Electronic Laboratory Reporting Coordinator for the Department of Health (ODH), will present a webinar on Monday, September 21, from 3:00-4:30 p.m., on the reporting requirements under the Clinical Laboratory Improvement Amendments (CLIA). You may register for this free session at this link. The purpose of the webinar is to explain the reporting requirements that facilities must follow once they start performing COVID-19 testing on the point-of-care (POC) antigen testing devices, including BD Veritor Ag, Quidel Sofia Ag, and Abbott BinaxNOW Ag Card. The agenda will include a brief discussion on case/line-level reporting and aggregate count reporting and a demo on creating the CSV file for electronically submitting POC device results at the line level. There will be a question-and-answer session at the end of the webinar. We highly recommend that everyone who has a POC testing device participate in the webinar to ensure compliance with the CLIA requirements.

AHCA Reviews POC False Positive Data, Urges Continued Use. After reports from members about positive tests from POC antigen testing units, particularly the BD Veritor, that were found to be negative through polymerase chain reaction testing, AHCA together with LeadingAge and the two manufacturers reviewed the matter. This review included a survey completed by 1,100 respondents. From the data, AHCA concluded, "[w]e found that about 20-25 percent of SNFs had a positive antigen test result later found to be incorrect using PCR testing. The vast majority had only 1-3 'potential false positives'; 26 (or 3 percent) had more than 5 potential false positives. While any potential false positive results are concerning, this appears to be consistent with what you would expect to see with widespread testing of many people in communities with relative low rates of COVID-19." In other words, all tests yield some number of false positives, and these results are not outside the norm. Because of this, AHCA advised that, "[m]embers should continue to use these POC antigen tests, but we encourage providers to follow the CDC guidance and algorithm on when to conduct confirmation testing of positive antigen tests." AHCA added that the manufacturers continue to investigate potential causes of false positives and ask that users report these cases. For a full discussion of the findings and next steps, please see AHCA's blog post.

Learn About Abbott BinaxNOW Test. The following message is also from AHCA.

AHCA/NCAL has learned today that this week the Department of Health and Human Services (HHS) will be sending 1 million Abbott BinaxNOW™ test kits to skilled nursing facilities and 540,000 test kits to assisted living communities certified by the Centers for Medicare & Medicaid Services (CMS) with a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver.   

You are invited to a webinar on Friday, September 18 at 12:00 pm ET with HHS and Abbot to get more information on the tests themselves, including training, and use in assisted living facilities. During the webinar, Abbott will demonstrate the training tools available and representatives from the U.S. government will be online to speak about the program. Register now for the webinar. 

Our understanding is that HHS will ship test kits to all ALs with CLIA Certificates of Waiver this week to be used for residents and staff. Kits will also be sent to some SNFs for use with staff. Replenishment of kits will be weekly thereafter with enough kits varying by the county the facility is located in, and based on the CMS ratings for COVID-19 test positivity in that county (red, yellow or green). HHS has also provided a training portal here

ODH Publishes Next Week's SNF Testing Schedule. ODH placed the following notice on the Enhanced Information Dissemination and Collection (EIDC) system today. The notice reflects continuation of the current biweekly state-supported testing schedule while officials determine what changes to make in light of the conflicting CMS testing requirements.

The Nursing Home testing schedule for specimen collection (swabbing) dates 9-21 through 9-27 can be found at this link: https://odh.ohio.gov/static/REGOPS/NH-Staff-Test-Schedule-09-21-to-09-27.xlsx

- Please carefully review the schedule, as a number of DATE and LAB changes have been made. DATE changes are highlighted in column D. LAB changes are highlighted in column H.

 -The schedule for next week can be found on the tab labeled "NEXT WEEK 9-21 to 9-27". Scheduled for previous weeks can be found on the other tabs.

Resource for State Reporting and Questions. With all the reporting requirements to the state, members often ask where to send particular reports. They also need to know where to go to ask questions of state officials responsible for various functions. With information verified by ODH's Rebecca Sandholdt, we put together this handy quick reference guide. You may want to keep the link open so you can check the reference you need with one click.

HHS Provides Additional Detail on SNF Value-Based Purchasing Component. One component of the latest Provider Relief Fund (PRF) Targeted Distribution for SNFs is based on relative performance on to separate measures of COVID-19 activity in each facility. HHS added material to their PRF web page describing how the $2 billion for this program will be allocated. Scroll down to "Allocation for Skilled Nursing Facilities and Nursing Homes," then click the plus sign next to "How is the $2 billion incentive payment to skilled nursing facilities and nursing homes being determined?" HHS divided the $2 billion into 5 $400 million outlays, one for each month through December and one cumulative award. A table on the web page shows the timing of each piece. Eligibility for payments will be based on cases and mortality in each facility. There will be separate awards for each measure, compared to county and national benchmarks, respectively. The first performance month is September, so it is already underway. The web page describes the two measures, but little about how payments will be calculated.

DUNS Number No Longer Required for CRF. Providers applying for payments under the state Coronavirus Relief Fund (CRF) have been frustrated by the requirement to get a Dun and Bradstreet DUNS number and to register for the federal System of Award Management (SAM) to qualify for the money. The Office of Budget and Management (OBM) allowed 30 days after receipt of the payment to secure these items, so many providers may be under the impression that they need to get them. We learned this morning, though, that OBM no longer requires providers to obtain the number and the registration. This change is not reflected on the application portal, but was confirmed by an email from OBM.