CMS Releases SNF Testing Rule. The Centers for Medicare and Medicaid Services (CMS) today proposed a much-anticipated rule that establishes mandatory resident and staff testing as part of the SNF Requirements of Participation. The interim final rule with comment period will take effect upon publication in the Federal Register, but the details of the testing requirements are left to guidelines that have not yet been promulgated. Speculation centers around different testing frequencies based on state positivity levels, but the rule refers to county positivity without giving specific thresholds. The rule establishes penalties for failure to comply with the testing mandate and includes provisions for Medicare coverage of repeated COVID-19 tests when ordered by an appropriate practitioner, along with requirements for laboratories and hospitals. AHCA provided a summary of the proposed rule.
During a national call to announce the rule's release, CMS Administrator Seema Verma and other Department of Health and Human Services (HHS) officials discussed antigen point-of-care (POC) testing devices and N95 respirator distribution. Rear Admiral John Polowczyk explained that HHS, starting Thursday and running through next week, will distribute 1.5 million N95s to SNFs that identified a shortage on their National Healthcare Safety Network reports. Admiral Brett Giroir said HHS had shipped 5,593 POC units and 2 million tests as of yesterday. They expect to provide devices to all SNFs in the country that have Clinical Laboratory Improvement Amendments (CLIA) Certificates of Waiver by the end of September. Administrator Verma pointed to yesterday's revision of the Food and Drug Administration frequently-asked questions (FAQ) document on testing (see 7th item under General FAQs), which like the recent Centers for Disease Control and Prevention (CDC) guidance, now looks favorably on POC testing:
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.
HHS PRF Deadline Extended Once Again. HHS again extended the deadline to apply for the Phase 2 General Distribution from the Provider Relief Fund (PRF). This includes both the Medicaid-only distribution and the re-opened portal for providers who may have received funds from the Medicare General Distribution (Phase 1) earlier this year or that experienced changes of ownership. The new deadline to apply is September 13, 2020.
Here a Training, There a Training, Everywhere a Training. SNF members are understandably baffled about the various training programs the federal government is offering. In addition to the existing trainings, we reported in yesterday's COVID-19 Update three new sessions the federal Agency for Healthcare Research and Quality is offering, starting today. Since these webinars are under the auspices of Project ECHO, the question was whether they are connected with or required to receive funding under a $250 million component of the latest SNF tranche of the PRF. Then today, the Centers for Medicare and Medicaid Services (CMS) got into the act, announcing another training series.
- Today's 1:30 p.m. session revealed that it was in fact the kick-off of the funding-related training, in this case a $6,000 reward for SNFs that participate in 16 90-minute, weekly programs that begin September 15. The sessions today, tomorrow, and next Wednesday are not part of the series required to qualify for the funding, but serve more to introduce the Project ECHO initiative. Please use this link to sign up for one or both of the two upcoming webinars.
- The “CMS Targeted COVID-19 Training for Frontline Nursing Home Staff and Management” is on-demand education focused on infection control, with separate modules for front-line staff and for management. It is free, but not tied to funding. The CMS announcement did not give a date when the training will be available, but stated that it will appear on the CMS Quality, Safety & Education Portal. In addition to the on-demand programming, CMS is offering live question-and-answer sessions every other week starting this Thursday from 4:00–5:00 p.m. Registration is required for these webinars. See the announcement for more information about the programs.
Director McElroy Discusses Saliva Test False Positives. In a meeting today, Director of Aging Ursel McElroy responded to concerns by assisted living providers that the free saliva tests that the Department of Aging is promoting generate false positives. Director McElroy said she and others were working to address these concerns and wanted to get to the facts. She reported that of 11,369 tests, 591 were positive, which is a positivity rate of 5.2%. We pointed out that a significant sample of nasal-swab tests in SNFs had positivity less than 2% and that many assisted living providers had reported false positives confirmed by nasal-swab testing. The Director said she is trying to find out what might have caused the results, including potential problems with specimen collection and transporation, and reminded us of the order that requires testing in assisted living but does not mandate saliva tests. We will have further discussion with Director McElroy early tomorrow morning, but recommend until the situation is clarified that assisted living members pause the screening tests.
More Answers from ODH. We presented questions to the Health Department (ODH) in the same meeting and received a few answers, as follows.
- ODH has not changed its position on KN95 masks or cloth face coverings, following CDC in both cases. Cloth face coverings are allowed in health care if no other masks are available.
- There is no requirement to quarantine residents after they go out to a doctor's appointment, etc. Whether a facility chooses to do so should be based on an analysis of the patient's possible exposure (such as making a side trip elsewhere).
- A person who previously was positive, passes the 12-week mark, and re-tests positive is considered a possible new infection and must be isolated and counted as a current case for reporting.
- OHCA asked for confirmation of the state's position on antigen testing in SNFs. ODH's Rebecca Sandholdt replied that this is a decision to be made by state agency directors, and they have not made one. OHCA responded that members are receiving the POC testing units and need guidance now relative to the mandatory testing program.