The federal government last week cracked down on COVID-19 testing in nursing homes, with a host of new fines exceeding $8,000 per instance, but some industry leaders — and a prominent geriatrician — have raised concerns about whether providers can meet the new benchmarks, or whether the plan will have the intended effects.
“You cannot fine your way out of a pandemic,” Dr. Michael Wasserman, president of the California Association of Long-Term Care Medicine, told SNN. “We continue to need clarity, clear guidance, clear direction, clear plans that actually work.”
Under the new rules, operators must perform routine testing of nursing home staff or risk losing their eligibility to participate in Medicare and Medicaid, with the exact frequency depending on the rate of spread in the surrounding area — the higher the overall case count in the community, the more frequent the testing, up to twice weekly.
Residents must also be tested if they display symptoms, or if there is evidence of a wider outbreak in a facility.
The fines for non-compliance can exceed $8,000 per instance, according to the Centers for Medicare & Medicaid Services (CMS).
Providers can also face an initial fine of $1,000 — with follow-up penalties of $500 per day — for failing to report the results of antigen testing, facilitated by an ambitious Department of Health and Human Services (HHS) effort to ship testing units to most nursing homes across the country.
Both CMS and the Trump administration have pointed to that initiative as a a key source of support for nursing facilities as they work to meet the new requirements.
The point-of-care antigen devices are slated to reach most nursing homes across the country by the end of September, according to HHS officials, with an initial round of about 5,600 units already sent out as of this week, the White House and HHS confirmed this week.
The vast majority of facilities in the country — or more than 14,000 — are authorized to perform the on-site COVID tests under a Clinical Laboratory Improvement Amendment (CLIA) certificate of waiver, which allows health care providers to process diagnostic tests that are normally restricted to dedicated laboratories.
The federal government has been upfront about the fact that the antigen tests are not as accurate as the “gold standard” polymerase chain reaction (PCR) tests. Due to the higher risk of false negatives, officials had previously encouraged nursing homes to double-check all negative results with a follow-up PCR test, though the top HHS official in charge of the program has emphasized the validity of positive results.
“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,” Adm. Brett Giroir said back in July.
HHS went a step further this week, pointing to Food and Drug Administration (FDA) guidance suggesting that repeat tests are only necessary in the event of an outbreak or a resident displaying overt symptoms of COVID-19 — and that routine surveillance testing with a point-of-care machine may be more effective at curbing infections than the slower PCR method.
“It is absolutely not necessary to repeat negative tests during routine screening or surveillance,” Giroir said.
LeadingAge, a trade group that represents non-profit nursing homes and other senior care providers, found concerns and confusion among its members about the question of whether to re-test antigen negatives, and the point-of-care program as a whole.
About 90% of respondents to an August LeadingAge survey indicated that they had received one of the machines, but only about a quarter said they were actively using the units to perform tests. Another quarter of facilities were awaiting more explicit instructions on when to start the antigen testing, while 15% said they had simply set the units aside.
The two companies that HHS has paid to supply the machines — Becton Dickinson (BD) and Quidel — have provided instructions and training materials for nursing homes, according to HHS.
But among those LeadingAge members that have not yet begun using them, the cost of subsequent testing kits remains the largest obstacle. HHS will provide each facility with an initial supply of assays based on facility size — 84% of the survey respondents said they’d received enough to test all staffers once — but operators are on their own to secure refills from BD and Quidel.
Cost considerations aside, those manufacturers are still in the process of ramping up their stockpiles of kits, with Giroir acknowledging that the supplies of assays will remain “tight” through the end of September.
More than half of the providers who have kept their units on the shelf told LeadingAge that they’d be more likely to use them if they were assured easy and affordable refills, and 38% would feel more comfortable with the knowledge that follow-up PCR tests were not required.
Even with a point-of-care testing program up and running, the need to report the data to the government remains another hurdle. Under the new testing rules announced this week, all labs that run point-of-care tests — a category that includes CLIA-waived nursing homes — must report the results within 24 hours.
That mandate comes on top of an existing edict to submit information about weekly COVID-19 infection and death counts to the National Healthcare Safety Network (NHSN), a database maintained by the Centers for Disease Control & Prevention (CDC).
Wasserman, the geriatrician, said he supervised a program to beef up nursing home compliance with NHSN reporting requirements during his work leading a Quality Improvement Organization (QIO), a task that turned out to be “one of the greatest lifts in the history of the QIO system.”
“The database and the system are archaic,” Wasserman said. “It’s like playing video games on an Atari.”
Individual directives aside, Wasserman characterized the most recent CMS regulatory action as emblematic of an overall COVID-19 response that eschewed government collaboration and support for ground-level burdens on staff.
“Everything CMS is putting out, in many ways, leaves it to the individual nursing home to execute,” he said. “During a pandemic, that doesn’t work. Actually, it doesn’t work ever, but during a pandemic, it really doesn’t work.”
The federal government has also faced criticism from the other angle, with resident advocates claiming that enforcement of rules regarding infection control and other key safety metrics — already too lax for years, in their view — has fallen by the wayside during the pandemic.
The Center for Medicare Advocacy, for instance, has repeatedly taken issue with the low numbers of citations issued as part of targeted infection-control surveys; back in July, the independent watchdog group claimed the government’s finding of minimal violations was not credible.
“These data are simply not plausible during the COVID-19 pandemic, especially when infection control deficiencies were the most commonly-cited deficiencies before the pandemic,” the group concluded.
CMS has since responded by touting a total of $15 million in civil monetary penalties (CMPs) issued since the start of the crisis in March, related to both infection control and failure to report COVID-19 data, but multiple independent voices have questioned the efficacy of fines — while still important as an enforcement mechanism — as the way to mitigate the crisis.
Humanitarian organization Doctors Without Borders has asserted that nursing homes need direct on-the-ground support from public health departments and schools of nursing to put federal edicts into practice.
“It’s because a punitive approach is just not the end-all, be-all,” Karin Huster, a Doctors Without Borders leader who helped spearhead nursing home COVID relief efforts in Michigan and Texas, told SNN earlier this month. “Of course, you need to have some form of regulation. It’s important. It plays an important role. But it can’t be the primary tactic to effect true behavior change and improve health outcomes for the residents.”
Harvard University researcher David Grabowski pointed to persistent problems with securing testing kits, and receiving clear guidance from the government, in criticizing this week’s CMS announcement; Grabowski served as a co-author of a new analysis, released last week, that found one in five nursing homes had experienced a “severe” shortage of personal protective equipment (PPE) and staffing as late as July.
“If facilities are refusing to use available tests or report known results, they should be held accountable. However, I do not believe that is the main problem right now,” Grabowski told SNN via e-mail. “This is a testing issue, not a nursing home issue. I believe the federal government should fix the testing issue before turning to fines for nursing homes.”
For Wasserman, formerly the CEO of major California nursing home operator Rockport Healthcare Services, there’s another reason to doubt the efficacy of fines during the pandemic: a feeling that they haven’t worked in the past to bring true reform to the sector.
“The folks who own the real estate could care less about the fines, and fines will not assure good behavior,” Wasserman said. “If they did, this industry would be in a much better place today than it is. If CMPs truly made a difference, we wouldn’t have nearly as many deaths as we have right now.”