Medicare’s policy to withhold payment for “never events” – the first effort to use the payment system to promote patient safety – remains intriguing and controversial. To date, most of the discussion has focused on the policy itself at a macro level (including two articles by yours truly, here and here).
In the past month, experts on two of the adverse events on the “no pay” list – hospital falls and catheter-associated urinary tract infections – have chimed in. Interestingly, while agreeing that the overall policy has upsides and risks, they came to strikingly different conclusions about the wisdom of including their pet peril on the list.
Let’s begin with UTIs. Last month’s Annals of Internal Medicine article by Michigan’s Sanjay Saint and colleagues begins, quite cleverly, with a quote from Ben Franklin: “By failing to prepare, you are preparing to fail.” Turns out that among Franklin’s many inventions was the flexible urinary catheter (so who the hell was Foley?). The piece nicely reviews the “no pay” policy and describes the epidemiology of catheter-associated UTI (CAUTI).
The central assumption of the “no pay” policy is that the adverse events in question can be prevented through assiduous application of evidence-base strategies. In the case of CAUTI, such strategies include: restricting which clinical units are allowed to place catheters, implementing systems to remind docs of the presence of catheters (Sanjay once studied housestaff and attendings and found that nearly 30% of residents and 40% of attendings were unaware that their patient had a Foley catheter, a phenomenon he dubbed “immaculate catheterization”), requiring automatic stop orders for catheters after 3-5 days, and providing feedback to providers about their organization’s or unit’s catheter-associated infection rates. When such “multimodal strategies” are implemented, 25-75% of CAUTIs can be prevented.
The authors warn of unanticipated consequences, many of which relate to the “present on admission” designation. You remember the deal – if a UTI was present on admission (POA), the hospital still gets paid its extra fee for the “complicating condition.” But if the infection’s first documented appearance is on day 2 of the hospitalization, Medicare assumes that the hospital caused it and cuts the payment. Because of the zeal to prove that the UTI was POA, write the authors,
“hospitals may encourage urinalysis and urine cultures at the time of hospital admissions… [thereby increasing] the likelihood of more positive urine culture results, which in turn leads to an increased use of antibiotics for treating patients with asymptomatic bacteriuria.”
These antibiotics, by the way, are unnecessary and do these patients absolutely no good. Despite this risk, the authors conclude…
“that [the new policy] may end up doing more good than harm, because hospitals are likely to redouble their efforts to prevent CAUTIs…”
My colleagues and I have raised concerns about the fairness of a policy that dings hospitals for infections that are, on average, preventable only half the time, but Saint and colleagues apparently feel that the overall benefit will counterbalance any potential injustice. Perhaps so.
In this month’s New England Journal of Medicine, Harvard’s Sharon Inouye (like Sanjay Saint, a former UCSF resident and good buddy of mine) and colleagues are less charitable in discussing the new policy as it relates to falls occurring in hospitalized patients. Noting that falls are common in both hospitals and community settings, the authors write that
“there is no evidence that hospital falls ‘can be consistently and effectively prevented through the application of evidence-based guidelines.’” [this is CMS’s standard for preventability]
They cite one systematic review that found that, at best, approximately one-in-five hospital falls are preventable. More concerning, there is no evidence that any intervention (including hip protectors, lowering the bed, or padding the floor surface) can prevent serious injury from falls.
But, while they are concerned about the justice of withholding payment for injuries that we don’t know how to prevent, they are even more lathered about the patient safety implications of not paying for in-hospital falls. They write,
“Unintended consequences are likely to include a decrease in mobility and a resurgence in the use of physical restraints in a misguided effort to prevent fall-related injuries… As a first step, the CMS should recognize that the goal is ensuring safe mobility, not merely preventing falls, and thus explicitly acknowledge the inherent tradeoff between safety and mobility.”
Sharon is a polite, sweet, and soft-spoken geriatrician, but she doesn’t shirk in her criticism of the CMS policy on falls:
“The inclusion of hospital falls in the new Medicare initiative appears to be premature, at best; at worst, it may be harmful to the very patients it is intended to protect and may ultimately increase the costs of Medicare beneficiaries because of its unintended consequences.”
Medicare is presently thinking about adding several new adverse events to the list, including ventilator-associated pneumonia, Clostridium dificile-associated disease, and hospital-onset delirium. Before they add any more conditions, CMS should rapidly commission studies of unintended consequences of the existing ones. It would be easy enough to study the frequency of antibiotic use for “UTIs” picked up at the time of hospital admission (an uptick over the last year would probably represent clinically inappropriate treatment for asymptomatic bacteriuria discovered during the POA inventory). Ditto a bump in the frequency of use of hospital restraints (applied in a misguided effort to prevent falls). If studies show that these unintended consequences are occurring and CMS can’t figure out a strategy to mitigate the harm, these adverse events should be removed from the list. Personally, after reading the Inouye article, I’d remove falls today, and only add it back if studies demonstrate that it is doing more good than harm.
I remain enthusiastic about “no pay for preventable adverse events” as a clever way to use payment policy to goose the system into focusing on patient safety prevention practices. But for “no pay…” to make a difference, there must be evidence-based prevention strategies to implement. If there aren’t – and, while there are some strategies for CAUTIs, there really aren’t for falls – then “no pay for errors” is just cost-reduction cloaked in the garb of patient safety.
Even scarier, when one factors in the impact of these unintended consequences on targets like falls, the policy might well hurt more patients than it helps.
From the CMS perspective, “primum non nocere” isn’t “the phrase that pays”
“Never events” should be limited to just that–events that we cannot imagine happening if that was your grandma in front of you–e. g. cutting off the wrong leg, giving 100 times the normal dose of med, etc. Toddlers fall, and grandmas fall–that is how they learn to me independent in an unfamiliar body. Foleys run the risk of complications, but so do all procedures and treatments given in a medical setting. That is why we have rules and policies.
Bob,
Your blog is timely for many a reason.
As attention is shifted from the patient to the computer because of poor device usability and altered work flows, that such neglect results in a higher incidence of patient falls and other never events (not necessarily on the CMS list) has been covered up by the recently disclosed HIT vendor demanded contractual gag clauses.
It would appear that low boy beds and floor pads will become the norm. But how about those never event lower back pains in the health professionals, and the lack of Trandelenberg function in such beds?
Best regards,
Menoalittle
(so who the hell was Foley?)
Source Wikipedia
Frederic Foley was born in St. Cloud, Minnesota in 1891. He studied languages at Yale University, receiving a bachelor’s degree in 1914, and then trained in medicine at the Johns Hopkins School of Medicine until his graduation in 1918. He subsequently worked with William Halsted and Harvey Cushing, and worked at the Peter Brigham Hospital, Boston on the junior surgical staff. Although there is no record of his training in urology, he was certified by the American Board of Urology in 1937. Foley worked as a urologist in Boston, Massachusetts, and died in 1966 of lung cancer
(so who the hell was Foley?)
Source Wikipedia
Frederic Foley was born in St. Cloud, Minnesota in 1891. He studied languages at Yale University, receiving a bachelor’s degree in 1914, and then trained in medicine at the Johns Hopkins School of Medicine until his graduation in 1918. He subsequently worked with William Halsted and Harvey Cushing, and worked at the Peter Brigham Hospital, Boston on the junior surgical staff. Although there is no record of his training in urology, he was certified by the American Board of Urology in 1937. Foley worked as a urologist in Boston, Massachusetts, and died in 1966 of lung cancer
In the community hospitals we are very afraid that this will relegate our medical patients to second-class citizen status.
Dr. Wachter has used the phrase “a medical patient is a little better than an empty bed.” Hospitals know that my (hospitalist group’s) patients are not going to earn them any money, and they tolerate us because our patients come to ER and are too sick to go home; besides, they have relatives who need surgery and get pregnant…
We are worried that the performance measures may have the opposite effect – we know that some of our patients will fall, develop C diff, get pneumonia on the vent, or develop a UTI. If the system simply considers these patients “lost causes” and focuses all its energy on the post-op patients (and other patients that help earn a profit) by diverting staff, resources and support, then my patients are doomed.
We are seeing an increase in palliative care consults (which are probably appropriate). How soon until hospital administrators start going to the ER to talk to patients about hospice not because of the medical needs, but because the hospital won’t get paid for their long, complicated hospital stay (OK – exagerated to make a point).
Many of the patients that have a HAC also have other major complications or co-morbidities that keep the MS-DRG at the same level so the payment stays the same. You only need one “CC” or MCC” to keep payment the same in the DRG group that it affects. Some DRGs are not affected by CCs or MCCs so the payment would stay the same whether or not they had a HAC. Also, what if the patient falls off the guerney in the ER and breaks his leg and then is admitted? That will not count because the fracture was POA. It seems that the government is spending alot of money on this new program and really did not think it thoroughly out if they really wanted to reduce payments when HACs occur.
Perhaps never events can be prevented and we are not looking in the right place for the evidence that they can be. There are some studies that show that some actions by nursing can have a real impact on lowering the incidence of pressure ulcers, falls and CAUTIs. One intervention is the implementation of hourly purposeful rounding as the way that nurses do their work. During these rounds they take the patient to the bathroom and make sure items are in reach.
In any event it doesn’t seem to make sense to say we don’t think we can prevent these events so we are going to go to great efforts to find a way to get paid for them. If we put the same amount of energy into solving the root of the problem we might actually find a way to prevent patients from being harmed by their treatment.
I take issue with bgj 4’s comments on fall reduction….a never event goal is zero not reduction. I work on an Acute Care For Elderly unit in a hospital. We use no foleys no restraints including chemical unless the patient presents a serious danger to himself or staff, utilize low beds, bed and chair alarms and hourly roundings. We work with a team of geriatricians to avoid polypharmacy, identify delirum onset (pretty common after general anesthesia) head to toe assessment of any conditions that could lead to adverse outcome of the hospitlized geriatric patient.Almost all our patients have either some sort of dementia or medical condition that has lead to deconditioning. The root of the problem is that people fall…I’ve fallen, you’ve probably fallen. We rarely have falls but they do occur. Out of negligence..no. Let’s take this conversation out of academia and put in the real world. Hourly rounding? Round and turn your back to leave..they’ve gotten up and fell even after you’ve assesed pain potty and position. Most of them don’t know what a call light is or have the cognition to tell us they have to go to the bathroom or having pain. For the ones who have no cognitive impairment but are weak it is sometimes humiliating for them to have all their independence ripped away while in the hospital…they feel like children. Fall reduction yes..zero falls impossible.
all of this is tinkering around the edges. US medicine requires wholesale regime change. and the public must face rationing and reduced expectations. nothing less will work. end of story.
/mercifully brief rant
//carry on as you were
Completely agree with concerns raised in this post and the NEJM piece. I take call at our nursing home once a year, and attend several times a year on our nursing home based palliative care unit. We try VERY hard to prevent falls, yet are often faced with the challenging trade off between safety and mobility. This issue is often crystallized in our older dying patients, where frailty and cognitive impairment are the norm. After more conservative measures have failed, do we attempt to restrict their mobility, often so important to their quality of life? We do not, but by the proposed regulations, CMS would penalize nursing homes that make similar choices.
Healthcare policy in the US seems to follow only one law: the law of unintended effects (see EMTALA). “No pay for no performance” will most certainly do the same. On the flip side, it may be a good time to invest in oral fluoroquinolones and soft restraints.
Dr. Inouye in her New England Journal of Medicine article mentioned the possibility that in order to prevent falls, for which they would not be reimbursed, hospitals, would resort to the increased use of physical restraints.
What Dr. Inouye didn’t mention, however, is the increased use of chemical restraints, but should have. My elderly mother had a bad fail in April of this year (just one month after the new rules went into effect). Prior to the fall, she had been living independently and was the epitome of what you would think of as a “spry old woman.”
But that all changed in a heatbeat when, after being discharged from the hospital to a nursing home, for what she had been told was a three week stay to recover from her injuries, the nursing home almost immediately started medicating her with a chemical restraint (prescribed only by a nurse, not a physician).
After one month on that antipsychotic medicine (one with anticholinergic properties) my spry old mother had a mini-mental status of 15, and after two months on that medicine, the nursing home was telling us that she would have to be taken care of in such a home for the rest of her life!
Unfortunately, I did not learn about the use of the medicine until she had been on it for three months (when I put a stop to it), but now two months off the medicine, her mini-mental status is up to a 25, and I am hopeful it will keep the upward pace.
But here is the key point, I am sure the reason the nursing home put her on the medicine was to prevent a fall (the nursing notes say as much), a fall for which they could not bill Medicare under the new rules, right? But, look what happened, a three week stay turned into a 5 month stay (so far), all because they went to extreme lengths to avoid the consequence of the new medicare rules!
So, not only did the new rule, in my opinion, result in my mother being turned into a vegetable, almost permanently, but it resulted in increased charges to Medicare anyway (three months in the nursing home, instead of three weeks).