The federal government is in the midst of an aggressive plan to send point-of-care coronavirus tests to all of the nation’s more than 15,400 nursing homes — but individual state rules may prevent facilities from taking advantage of the program.
“Due to the lower sensitivity and specificity of these test devices, not all state public health departments allow for their use, and many have certain requirements in place for using these tests appropriately,” the American Health Care Association, which represents for-profit nursing facilities across the country, warned in a memo to its members.
AHCA recommended that providers check with their state health departments and epidemiological leaders to ensure that the point-of-care antigen tests comply with state regulations before using the devices.
The Department of Health and Human Services (HHS) has indicated that it will send at least one of two point-of-care testing units — manufactured by BD and Quidel, respectively — to all nursing homes in the country over the coming months, with the exact number of units and testing depending on the size of the individual facility.
Unlike the gold-standard polymerase chain reaction (PCR) test, the antigen method has a higher likelihood of registering false negatives, prompting HHS to advise nursing home operators to treat all negative results as presumptive until a follow-up PCR test can be performed.
That said, a top federal health official indicated that positive antigen tests can largely be trusted as accurate.
“If you get a positive, these are essentially 100% specific. If you have a positive it is positive: You can bet the farm on it. Never 100%, but literally they are operating at about 99-plus percent specificity. If you get a positive, it’s real,” assistant health secretary Admiral Brett Giroir said earlier this month.
Soon after HHS announced the plan, reports surfaced of state rules that specifically prevented the use of antigen tests in nursing facilities: In California, for instance, providers must use methods with at least 95% sensitivity, while the antigen tests only achieve 80%, according to a July 20 report from CalMatters.
Answering a question about a similar hangup in Michigan during a call with nursing home leaders on July 15, Giroir indicated that the antigen method represents the only option for point-of-care testing.
“There will not be another solution, by technology, that is going to be available,” he said. “I am happy to speak with anyone in Michigan, but it would be a death blow to nursing home residents to not be able to use this technology.”
Using the tests also requires each facility to secure a certificate of waiver under CLIA, a law that maintains certain basic standards for laboratory-performed tests; about 10% of facilities do not have such waivers, though officials have indicated that the Centers for Medicare & Medicaid Services (CMS) will expedite applications to meet the need for point-of-care tests.
In addition to the state-level concerns, AHCA advised members to make sure that employees fully take advantage of the promised training materials to ensure CLIA compliance. Under CLIA, facilities must also report the results of all tests to their local or state health departments, a requirement that falls on top of additional case reporting mandates from CMS and the Centers for Disease Control & Prevention (CDC).
“Nursing homes should contact their state/local health departments to identify options to align existing reporting to those agencies with these CARES Act reporting requirements for CLIA laboratories,” the group noted.
HHS this week announced that the initial round of testing units would be increased by about 400, with a particular focus on nursing homes in identified hotspot areas and those without reliable access to testing through other sources.
The entire roll-out will likely not be complete until October, and some providers have already reported that the distribution capacity for the necessary test kits may not be sufficient for six months.