CMS Hosts Testing Webinar: Abbott Rapid Tests to be Sent to Some Nursing Homes
Regulation | September 10, 2020 | by Janine Finck-Boyle
CMS held an hour-long conference call for nursing homes, on the evening of September 8th with the following speakers and an open attendee question and answer period:
- Seema Verma, Administrator, Centers for Medicare and Medicaid Services (CMS)
- Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention (CDC)
- Admiral Brett P. Giroir, MD, Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS)
- Lee Fleisher, MD, Chief Medical Officer, CMS
- Jean Moody-Williams and Dr. Shari Ling, CMS
The slide deck was sent out in advance of the call and was reviewed by CMS, focusing on the testing requirements and subsequent regulations of the Interim Final Rule with comment.
Seema Verma and the CMS survey team gave a broad overview of the CMS IFC 3041 - Interim Final Rule, subsequent guidance and the new Infection Control (IC) Training Program. She stressed a call to action to nursing homes for infection control, testing and training to continue to mitigate the spread of COVID. Although in some states cases are trending downward, CMS is still seeing practices and protocol that need to be improved. The Administrator acknowledged that as the rule was rolled out, concerns have emerged in rural areas access to testing and community positivity rates. CMS will be working on these issues in the weeks to come. Please review the CDC coding for counties with small populations that have 10 or less tests in one month. Community positivity rates are on the data.cms.gov website.
The Administrator also discussed the $5 billion Provider Relief Funding sent to nursing homes. As a reminder, $2.5 billion has been sent for testing and other COVID-19 needs. The next $2.0 will be sent on a performance measure program. Without much definition and scope, she did state that this next tranche of dollars will be based on nursing home performance with the number of COVID-19 cases and mortality rates. She ended her opening statement by reviewing the new IC Training Program and emphasizing that it may be used for front-line staff, managers and supervisors as well as other aging services providers other than nursing homes. She called out assisted living and other congregate care settings.
Administrator Verma turned the call over to Admiral Brett P. Giroir, MD, and he began by reporting to date 13,477 testing instruments and 4.7 million test kits have been sent to 13,343 nursing homes. This week, 507 instruments with 192,000 test kits will be sent to nursing homes. This HHS initiative is expected to deliver all nursing homes antigen testing machines and kits by September 30th. He also discussed using the antigen test kits to test residents 1x and staff 2x under this initiative. Once the tests are used – nursing homes are to expend the PRF (funding) to acquire testing kits from the two vendors and their distributors. He stated that there have been reports of testing materials not being available and prices increased way above the cost. A call is scheduled with BD outlets so NHs are prioritized.
Admiral Giroir continued to discuss testing and opened a discussion regarding asymptomatic testing questions that have arisen. He instructed nursing homes to follow the August 24th FDA FAQ, the August 28th CMS statement on using antigen testing on asymptomatic individuals and review the PREP ACT coverage. He continued to stress as a follow up to a call with the Governors, antigen tests are acceptable under FDA and states should accept them as part of the nursing homes testing plan. He followed that with a strong statement, if states do not accept this testing, then they are violating a federal mandate.
NEW ABBOTT BinaxNOW
The big news during the call was HHS purchasing 150 million rapid Abbott BinaxNOW antigen tests on the HHS, in conjunction with the Department of Defense. This Abbott testing card uses nasal swabs and is the size of a credit card. Next week these testing cards will be distributed to nursing homes. Seven hundred and fifty thousand tests will be sent to nursing homes in red/yellow zone counties. Red counties are 2x a week testing mandate. He stated the Abbott testing cards should be used to supplement PCR testing or POC antigen tests to lessen the burden and rotate the type of tests.
The plan is for the Abbott BinaxNOW cards to be supplied approximately mid-November to mid-December. When the cards are available in the marketplace in the future, the cost would be $5-6 per test. Governors are also being sent the cards to have the tests for schools. He believes there will be reserves in states and encourages nursing homes to work with their Governors’ offices to potentially access the tests.
COUNTY POSITIVITY RATES
The next speaker was Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention (CDC) and he began his discussion with the statement that any new case -- one new case -- is an outbreak. CDC has issued new guidance for antigen testing as well as an algorithm with scenarios to help guide nursing homes with their testing plan. Dr. Redfield then outlined the formula for county positivity rates. He stated that the CDC takes the total number of tests and total number of positives to calculate the rate. He then went on to confirm that if a state has newer data than CDC that data may be used by a nursing home as their county positivity rate. If that decision is made, the nursing home MUST document that it is testing on this data source. DOCUMENT is the key word!
The call did allow for questions as the speakers presented and then there was time before the close. One caller asked for specifics on the testing of contractors or consultants, staff that are not frequent workers or those who have a set weekly schedule in the nursing home. It was stated throughout each answer, that yes, these individuals need to be tested. The nursing home may place the individual into the organization testing plan frequency, however, if the individual was tested in another outside nursing home the day or two before, that test result can be documented. The key to this type of contractor or consultant category for testing is their contact with residents, staff and entry into the nursing home. An organization can place the individual into the testing plan the next time they are expected to come into the facility. That gives a bit of room for the nursing home when planning for consultants and contractors.
Although there were questions asked, not all had direct answers. We will continue to ask questions and ask for specific guidelines and definitions. The call was recorded and can be listened to here: https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-toolkit