A rule proposed by the U.S. government would change the time an infection preventionist must devote to a facility from part-time to "sufficient" time.
The federal government is considering rolling back infection control requirements in U.S. nursing homes – even as the long-term-care industry's residents and workers are overwhelmed by the coronavirus.
A rule proposed last year by the Centers for Medicare and Medicaid Services (CMS) would modify the amount of time an infection preventionist must devote to a facility from at least part-time to "sufficient time," an undefined term that lets the facility decide how much time should be spent. The regulation has not been finalized, but CMS last week defended its proposal, saying it aims to reduce regulatory burden and strengthen infection control.
Opponents of the change said the rule could leave nursing home residents more vulnerable to infection. They expressed concern, especially given the devastation COVID-19 has caused within long-term care facilities.
"It makes no sense at all – prior to pandemic, but more so now during a pandemic – to roll back any of the necessary infection and control requirements and the federal regulations," said Lindsay Heckler, a supervising attorney at the Center for Elder Law & Justice, a civil legal services agency in Buffalo, New York. "They should be strengthening these infection and control requirements."
CMS has acknowledged that infection is "the leading cause of morbidity and mortality" in the nation's 15,600 nursing homes. In its proposed rule, the agency said 1.6 million to 3.8 million infections occur each year in those facilities, with almost 388,000 deaths attributed to infections.
The coronavirus has put a spotlight on the problem. More than 16,000 long-term-care residents and staff have died of COVID-19, according to a USA TODAY analysis of government data. And nearly 97,000 residents and staff have tested positive for the virus. Those figures are an undercount, because testing has been limited and many states have not released full data.
CMS told USA TODAY its rule would allow facilities to determine for themselves the time needed for infection prevention and go above part-time when warranted.
"This is a person-centered approach to care and would allow CMS to hold facilities accountable by having the infection preventionist onsite full time, especially in times of an outbreak," the agency said in a statement last week.
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The changes were first proposed in July 2019, part of an ongoing effort by the Trump administration to reduce regulations for nursing home providers and suppliers. In addition to modifying the infection preventionist requirement, the proposed rule would also reduce the need for a facility-wide assessment from once a year to every other year and allow certain facilities to disregard a requirement that caps residents at two per room. CMS said the changes would reform "unnecessary, obsolete or excessively burdensome" requirements.
CMS, which has the authority to change regulations on nursing homes without legislation, said the proposal is still under review. There were 1,731 comments on the rule – from nursing home owners to advocates to residents and their family members – when the period for public input closed in September.
Some of the submissions are prescient given what has since occurred with COVID-19.
"Too many people have died and too many have suffered," Alice Hedt, a former director of the National Ombudsman Center, wrote in a comment posted Sept. 24. "Minimizing the requirements of the Infection Preventionist when we know infections can be prevented and addressed will result in even more deaths and suffering. I personally think this person should be full time in every facility until the death rate from infection and unnecessary hospitalizations decline by fifty percent."
Hedt, who spent 30 years as an advocate for long-term care residents, called the proposal "a slap in the face of residents who are more frail than anytime in our long term care history."
Experts say COVID-19’s devastating effect on people in long-term care is the result of a complex mix of factors, including the characteristics of the virus, vulnerability of older adults and those with underlying conditions, staffing levels and national availability of testing and personal protective equipment. For some, the virus' effect on nursing homes has renewed their concerns about the proposed rule.
"That softening of that rule I think, in retrospect, is exactly the wrong thing," said Christopher Laxton, executive director of the Society for Post-Acute and Long-Term Care Medicine.
Laxton, whose association represents about 5,500 medical professionals working in long-term-care settings, last year offered tepid support of the change, writing that his group didn’t object to the new language but that both terms "may be confusing and difficult to define." He wrote that the amount of time spent on infection prevention should be based on real-life factors, such as the facility’s risk assessment, seasonal changes and the presence of outbreaks.
In an interview last week, he said it is “a different world than when we first commented on that proposal.”
"At this point, sufficient time for an infection control preventionist in a building means full time," he said. "And it means dedicated to a single building. And being there every day. That's what sufficient means in this context. It may not mean that outside of a COVID pandemic. But it certainly means it now."‘Sometimes regulation hinders us’
Within the long-term-care industry, some are less convinced that leaving the rule as is, or even strengthening it, would make a meaningful difference in infection control.
"Sometimes regulation hinders us from putting resources where we know they need to be," said Dr. Gregory Johnson, chief medical officer of the Evangelical Lutheran Good Samaritan Society, the largest not-for-profit provider of long-term care and senior services in the United States.
He noted that only a small portion of the facility-wide assessment – which the proposed regulations would require to be conducted every other year rather than annually – focuses on infection control. The amount of work that goes into what can become a 300-page document is "colossal," Johnson said, and there are other regulations that address infection control.
During the pandemic, he said, his organization has "far exceeded" even the part-time requirement. Johnson said they began implementing visitor restrictions and other preventative measures in early March. As of Sunday, the Good Samaritan Society said 26 of its 143 skilled nursing facilities had at least one confirmed case of COVID-19.
Johnson said the organization – which operates in 26 states – grapples with differing local, state and federal regulations and tries to surpass them.
Too often, Johnson said, the public hears only about the nursing homes that are "bad apples."
"There are a whole lot of people out there in this business who are doing it because of a deep care and a deep commitment to mission," he said.
Combined, the CMS regulations serve as the basis for federal inspections that are conducted in U.S. nursing homes. Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living, said that survey process is "broken on many levels" because it measures too many things and is too punitive.
His organization, which represents more than 14,000 long-term-care facilities that collectively provide care to more than 5 million people, said it supports quality infection prevention in facilities but is behind CMS' proposed rule change. The organization said in a statement that "more oversight is not the answer to what has happened during the pandemic – it would reduce critical resources these centers need, or even put them at risk of closing." But it also said facilities can always do more.
"When we get through this, the entire country will need to have a serious discussion and reckoning about our infection control practices in health care settings and throughout society," the statement said.Opposition to proposed rule
People who oppose CMS’ rule change say COVID-19 has proven that strong infection control is paramount.
The Association for Professionals in Infection Control and Epidemiology (APIC) has remained steadfast in its opposition to CMS’ proposed rule. The nonprofit organization said it was disappointed to see CMS acquiesce to the argument that compliance is overly burdensome and expressed concern that the federal government was trying to change the regulations, which have been phased in since late 2016, before their impact has fully been felt.
"The COIVD-19 outbreak has really brought to light the opportunities and vulnerabilities of long-term care and the need for effective infection prevention," said APIC President Connie Steed, who is the director of infection prevention and control at Prisma Health in South Carolina. "And it doesn't matter if it's COVID-19 or influenza or other concerning infections and outbreaks that can occur in these settings. A robust infection prevention control program is really imperative for these types of facilities."
Carol Buckner, a registered nurse who works in telehealth, said she has long had concerns about the quality of care at the nursing home in Rochester, New York, where her brother lives, The Pearl Nursing and Rehabilitation. The center, which until recently was named New Roc Nursing and Rehabilitation Center, is one of 88 nursing homes identified by CMS as a Special Focus Facility, homes that have chronic deficiencies and face additional government oversight.
"There’s not enough staff. They’re not trained. And there’s no direct oversight. I never see a nurse in there unless they’re passing meds," she said. "And then you add COVID into this?"
The facility's administrator did not respond to a request for comment
Last year, Buckner wrote to CMS to object to the proposed rule change by noting that infection control is the "single most protective" measure a facility can provide its residents. She said she knows her brother’s home has an infection preventionist only because she once spotted a staff list on a visit and saw that title listed beside a person’s name. She does not know how many hours the employee devotes to infection control.
She said the facility has not reported any cases of COVID-19, but she still worries.
"I’m still nervous," she said. "I mean I’m hoping they’re doing a stringent job with being masked. But I had asked the facility, 'What can I help you with?' They said if you have any long-sleeved men’s shirts they could put on backwards and wear like gown. So obviously they’re telling me they don’t have enough PPE."
Buckner said CMS needs to impose stricter regulations.
"I’m hopeful things are getting better," she said, "but I don’t know that things will ever improve until full regulations are really strengthened and shored up. They need to be much better than they are."
Marisa Kwiatkowski is a reporter on the USA TODAY investigations team, focusing primarily on children and social services. Contact her at firstname.lastname@example.org, @IndyMarisaK or by phone, Signal or WhatsApp at (317) 207-2855.
Tricia L. Nadolny is a reporter on the USA TODAY investigations team. She can be reached at email@example.com or @TriciaNadolny.
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