The U.S. Department of Health & Human Services (HHS) recently announced plans to supply rapid point-of-care testing instruments and tests to nursing homes throughout the country to aid in identification and mitigation of COVID-19. HHS Assistant Secretary for Health Admiral Brett Giroir began hinting about these plans over the weekend and HHS confirmed on July 14 through a press release and White House Coronavirus Task Force press conference in Baton Rouge, Louisiana. CMS followed up with a national nursing homes call on July 15 to provide more details.

At this time, HHS plans to send rapid point-of-care testing instruments and tests to CMS-certified nursing homes throughout the country. The first allocation of 2,000 testing instruments is scheduled to ship next week to nursing homes that have been prioritized by CMS, with additional allocations being sent over the coming months. HHS will be sending out Quidel Sofia and Sofia 2 and BD Veritor Plus Systems with the associated antigen tests. HHS emphasizes that this is a one-time procurement meant to augment other testing methodologies and strategies employed by nursing homes. Nursing homes will have the option to purchase additional tests directly from the manufacturer and HHS added that these testing instruments can also be used for other rapid point-of-care diagnostic testing, such as flu testing.

This announcement left many questions that were addressed by HHS and CMS as follows below.

HHS has said that the first round of this allocation will go to nursing homes prioritized by CMS. How will nursing homes be prioritized to receive testing instruments and tests, both within the first round and in subsequent allocations?

CMS is utilizing various data to determine how nursing homes should be prioritized, including CDC epidemiology data on hot spots, National Healthcare Safety Network (NHSN) data on reported cases within nursing homes, and NHSN data on testing access within nursing homes. CMS plans to make public the methodology for prioritizing nursing homes as well as information on when a nursing home might expect to receive its allocated instrument and testing supply.

How long will the total distribution process take? If a nursing home is at the bottom of the list, when can it expect to receive its allocation?

HHS states that this will be a “slow roll-out” taking place over several weeks / months. A more precise timeline has not yet been finalized but will be forthcoming.

Will these instruments and tests go to all nursing homes?

Nursing homes must have a CLIA certificate of waiver in order to receive and utilize these instruments and tests. CMS urges nursing homes that do not have a CLIA waiver to begin the application process immediately. Refer to this guidance from CMS for information on how to apply. CMS states that applications are currently being processed within a few days.

This is a new system that many nursing homes will likely not be experienced in using. What kind of training and technical support will be available?

HHS will be working with the manufacturer to ensure that training and technical support is available and widely-utilized.

Understanding that this is a one-time allocation meant to augment current testing capacity, will there be any guidance from CMS or CDC on how to prioritize the use of these tests?

The allocation is meant to provide for the initial, baseline test of residents and staff within the nursing home. Different representatives from within HHS have provided differing information on the amount of tests and supplies a nursing home can expect to receive. LeadingAge was told by HHS and CMS directly that this will be a one-week supply. CMS has stated that they will not direct providers on who to test or how to prioritize, other than to say that providers should use this allocation to meet CMS recommendations and state mandates for testing in nursing homes.

When a nursing home runs out of the HHS-supplied tests, how will they acquire more? What steps will the government take to keep costs reasonable and to prevent scams and “counterfeit tests”?

CMS plans to share information on how to pay for tests as this initiative gets under way. HHS has asked that manufacturers give “concierge services” to nursing home providers to make purchasing additional tests an easy process.

There’s been a lot of buzz about false negatives associated with this test method (antigen testing). Will CMS or CDC issue guidance on steps to take to minimize false negatives or mitigate the implications of a false negative?

CMS will take this recommendation for guidance under consideration. Regarding testing accuracy, HHS states these tests are “somewhere in the neighborhood of 85-90% accurate.” They add that while positive results are 99% accurate, there is a slightly higher chance of a false negative with this type of testing vs. lab-based testing. HHS points out, however, that the value of rapid results outweighs waiting days for test results that have a slightly lower chance of a false negative. HHS says that if a nursing home believes a negative result is inaccurate, such as a negative result for a resident who shows symptoms consistent with COVID-19 or who is the roommate of a resident who has tested positive, the nursing home should follow up with a lab test.

LeadingAge will continue to monitor this situation and provide updates to members as they become available.