The federal agency responsible for oversight of the nation’s 15,500 nursing homes has released proposed rules that would scale back requirements for infection prevention programs and prescribing antipsychotic medications.
The Centers for Medicare and Medicaid Services (CMS), which develops and enforces nursing home standards, describes the potential changes as targeting requirements that are “unnecessary, obsolete or excessively burdensome.”
The rules were heavily influenced by complaints from the nursing home industry. Many of the proposed changes stem from criticism of Obama-era regulations put in place in late 2016, which the nursing home industry told CMS “would be costly and burdensome.”
At times, the rules reveal conflicting loyalties. CMS expresses its support for protecting patients from substandard care, while simultaneously protecting the industry from “burdensome” regulations.
Industry groups say that the new rules would eliminate unnecessary paperwork requirements and increase flexibility for facilities, allowing nursing homes to devote more resources to residents. But elder care advocates doubt that the rollback would lead to stronger nursing home services. Instead, they have expressed concerns that the potential rollbacks could increase risk to nursing home residents’ health and safety.
CMS, an agency nestled within the Department of Health and Human Services, released its revisions as two federal watchdog agencies determined this year that the agency isn’t doing enough to prevent and track elder abuse and neglect.
Robyn Grant, Director of Public Policy and Advocacy for the National Consumer Voice for Quality Long-Term Care, a consumer advocacy organization focused on nursing homes, doesn’t interpret the rules as a benefit to nursing home residents.
“We are concerned that what we see are things that are being eliminated or modified that will, according to CMS, meet the goal of helping providers,” she said, “but we see residents as the ones on the losing end.”
Judith Purdy, a registered nurse and a board member for Kansas Advocates for Better Care, an advocacy organization for nursing home residents in the state, doesn’t see an advantage to rolling back nursing home requirements.
“The oversight that needs to occur in a nursing home is pretty high, because these are our most vulnerable patients,” she said. “Some of them aren’t able to speak for themselves, so there certainly has to be someone there watching and making sure that they are being taken care of and not abused or neglected.”
Purdy, who has 13 years of experience surveying hospitals for CMS requirements, added: “Rolling back regulations looks to me to be more of a cost-saving measure, and especially, you roll back to save money, you roll back on staff, you roll back on quality indicators, and then that’s when you see more problems occur.”
Answering the call for deregulation
In April, CMS administrator Seema Verma wrote in a blog post that “CMS’ approach to oversight of nursing homes is constantly evolving.” She said that she had directed staff to review regulations and guidelines for safety and quality in nursing homes.
In a July opinion piece where she vouched for the idea of “reducing unnecessary regulatory burdens,” Verma said that although nursing home complaints have risen 20 percent since 2013, federal funding for inspections hasn’t gone up since 2015.
Shortly after taking office, President Donald Trump signed an executive order to reduce and eliminate regulations enforced by federal agencies. CMS’s proposed rules deliver on that order, while following a years-long effort to water down enforcement of violations at nursing homes.
The Trump administration suspended penalties for violations of health and safety rules at nursing homes for an 18-month period that ended in May. The administration also stopped fining nursing homes for every day they were out of compliance with health and safety rules, causing the average fine to drop from about $41,000 in 2016 to about $28,000.
Meanwhile, two watchdog agencies were investigating how CMS responds to abuse in nursing homes.
In July, the Government Accountability Office released a report that identified gaps in CMS’s oversight when it comes to abuse and neglect in nursing home facilities. According to the report, although citations for abuse in nursing homes are rare, they more than doubled from 2013 to 2017, with the largest increase in the most severe cases.
The accountability office first recommended CMS do more to protect residents from abuse in 2002.
In June, the Department of Health and Human Services’ inspector general released a report that found skilled nursing homes failed to report many incidents of abuse or neglect to state agencies. The report also found that CMS doesn’t track when incidents of possible abuse or neglect are reported to law enforcement or other agencies.
“Sufficient” oversight of infection prevention
One of the most criticized proposed rule changes relates to a position called an infection preventionist, who oversees a facility’s infection control program. Their responsibilities include monitoring patients who develop infections, identifying the source of infections and ensuring staff follow policies to prevent infections, like handwashing.
Should the rules go into effect, facilities would no longer be required to employ an infection preventionist with a minimum of part-time hours. Instead, the individual filling that role would need to spend a “sufficient” amount of time at the facility to meet the goals of its infection prevention and control program, with nursing homes determining how much time that actually entails.
Holly Harmon, vice president of quality, regulatory and clinical services for the American Health Care Association, a trade group for nursing homes, views eliminating this requirement as “minor in context of the entire rule.” She emphasized that infection preventionists would still be required to spend a “sufficient” amount of time at facilities, adding that infection control programs are part of annual reviews of nursing homes that are required by CMS.
“I think there are definitely safeguards there within the survey process that we feel confident will evaluate that,” Harmon said.
Purdy, on the other hand, said that a part-time infection preventionist would have more of a vested interest in a nursing home than an employee who is involved on a limited basis.
“I would not support that (rule), due to the fact that you really need to have someone who’s on site, viewing the facility, working with the staff to make sure everybody is educated and understands the infection control principles and what they should be doing,” Purdy said.
According to the proposed rules, CMS suggested this change because nursing homes claimed that hiring an infection preventionist was a burden.
This criticism was echoed by Janine Finck-Boyle, vice president of regulatory affairs for LeadingAge, an association for nonprofit nursing homes and other organizations that provide aging services. Finck-Boyle, a former nursing home administrator, said that staffing the infection preventionist position part-time was challenging, and eliminating the requirement would allow nursing homes to adjust the position to the scope of their facility. Some organizations might not need a part-time infection preventionist, she said.
“They’re not cookie-cutter, so what one nursing home might need for particular services, equipment and so forth is different from another nursing home,” Finck-Boyle said.
According to CMS, facilities face estimated infection-related costs of $673 million to $2 billion each year. The proposed rules note that infection is the No. 1 cause of death at American nursing homes, with 388,000 deaths caused by infection each year.
“Given those numbers and how it is such an enormous problem, we felt that it needed to be at least part-time, and even that was a concern,” Grant said, adding that requiring the position to involve a “sufficient” amount of time at facilities could allow some nursing homes to dramatically limit hours for the job. “The infection preventionist is key to (the infection prevention and control program’s) success. They’re really over it and guide it, so if they’re not there enough of the time, it just seems like it would be really hard to have a strong program, and it places residents at risk.”
Extending prescriptions for antipsychotics
Another potential change involves as-needed antipsychotic medications, which currently can’t be prescribed beyond two weeks without an evaluation by a physician or prescribing practitioner. As-needed drugs, which also go by the acronym PRN, are taken “as needed” based on a patient’s symptoms, rather than at certain times dictated by a prescription.
The new rule would allow facilities to order as-needed antipsychotics beyond two weeks if a prescriber documents why the medication is warranted and specifies the duration of the prescription.
Grant said the lack of an evaluation at two weeks is one of her organization’s largest concerns with this possible rule revision, because most antipsychotics have a U.S. Food and Drug Administration (FDA) “black box warning,” which discloses the threat of serious or life-threatening side effects.
“So, these medications really need to be closely monitored, and it’s not enough for nursing staff to talk to a doctor on the phone,” she said. “The prescriber needs to see the resident … before it’s prescribed, because we’re looking at serious problems related to misuse of antipsychotic medications.”
Finck-Boyle said that amid a CMS push to reduce prescriptions for antipsychotics, LeadingAge members have actively worked to find alternatives to the medication. She emphasized that the proposed rule applies to as-needed medications that aren’t intended for daily scheduled use.
According to CMS data, antipsychotic prescriptions in nursing homes have dropped during the last decade. In 2011, about 24 percent of long-stay nursing home residents received an antipsychotic, compared with about 15 percent at the end of last year. However, a study published this year in the journal Aging and Mental Health found that nursing homes, particularly for-profit facilities, slightly underreported the number of residents receiving antipsychotics.
According to the proposed rules, medical providers told CMS that the 14-day limit negatively impacts nursing home residents, and rural facilities have limited access to mental health physicians, which affects patient care when the prescriptions expire.
Harmon said the revision “mostly eliminates paperwork that will allow time to be focused on patient care.”
“I would say that a prescribed limit of an X number of days is generally not a clinically sound approach,” she said. “Every individual is different, and so what’s currently in place, … the limit for PRN anti-psychotics or psychotropics, is not an effective measure to reduce unnecessary use of those medications.”
In the proposed rules, CMS acknowledged a Human Rights Watch report from last year that found nursing homes gave antipsychotics to thousands of residents for symptoms that go beyond the drugs’ intended use as approved by the FDA. According to the report, the medication is common among patients with dementia, and antipsychotics were commonly used as “chemical restraints” in nursing homes.
However, the agency ultimately sided with an unidentified, large organization representing mental health professionals, which told CMS that the current rules blocked psychiatrists from appropriate treatment of nursing home residents with mental health and substance abuse disorders. The group called an in-person evaluation at the 14-day mark “unrealistic” and expressed concerns about psychiatrists receiving citations for appropriate prescribing decisions.
CMS concluded that the current rules leave physicians feeling pressured not to prescribe medications, even if they feel they’re appropriate.
In an excerpt demonstrating CMS’s conflicting priorities, CMS stated: “we must ensure that the proposed requirements provide sufficient protections for residents from receiving inappropriate or unnecessary drugs and that medications are prescribed for residents based on their health care needs and not for the convenience of the staff or any other inappropriate reasons.
“However, we must also be mindful not to propose requirements that are overly burdensome to the facilities and health care providers that do not contribute to the quality of care for the residents, especially if they could result in interfering with residents receiving appropriate care for their health care needs.”
Grant said the proposed changes “fly in the face” of CMS’s push to reduce anti-psychotic use in nursing homes.
“PRN means whenever nursing staff thinks it’s needed,” she said. “It’s often used instead of an adequate number of staff. When you have too few staff and staff can’t control them, … often the first place to turn is to get them PRN medication and calm them down, which translates into less work for staff. It’s still being used in that way. This just makes it easier.”
Purdy also has concerns that the rule change could lead to unnecessary use of anti-psychotics.
“There are definitely some behavioral-type things that take place that do benefit from that sort of medication, but probably for far too long, antipsychotics have been used to subdue patients,” she said. “A patient that’s quiet poses no extra work, extra burden or extra requirements if you don’t have enough staff to be taking care of the patients.”
CMS is accepting public comments on the proposed rules until Sept. 16.
Contact Big If True editor Mollie Bryant at 405-990-0988 or bryant@bigiftrue.org. Follow her on Facebook and Twitter.
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