Could pay for performance lead to denial of care?

SSI risk classes, surveillance need major revamping

A wicked combination of crude surveillance systems, outdated patient risk assessments and increasing demand for infection rate data could ultimately lead to denial of care for high-risk surgical patients, a leading surgeon warns.

"I think as these public reporting and pay-for-performance initiatives evolve the consequence is going to be that sick patients are not going to get taken care of," Donald Fry, MD, FACS, said recently in La Jolla, CA, at the 26th annual meeting of the Surgical Infection Society. "You're not going to risk your data and your profile to take care of somebody that the 'eyeball test' says right at the beginning is not going to do well."

A professor emeritus of surgery at the University of New Mexico in Albuquerque, Fry gave a characteristically blunt assessment of the current situation while calling for a complete revamping of risk adjustment and surveillance for surgical-site infections (SSIs) to meet the demands for data disclosure.

"The challenges that we are facing in 2006 are different than they have ever been before," he said. "Surgeons are now being held accountable for their infection rates. There is increased demand for public reporting of information. The thing that alarms me is that they don't care whether it is accurate, but they want it reported, by God. I think that is a major, major problem. The risk of SSIs and complications in surgery and medicine is now front page news everyday. I cannot pick up a newspaper in any city without seeing an article on it."

In addition to state laws requiring infection rate reporting, state and federal agencies are pushing "pay-for-performance" initiatives that link outcomes to quality. "Pay for performance is coming," Fry told his fellow surgeons. "If you don't think it is, I have very bad news for you today. It is going to happen. Your reimbursements, your facility, and you personally are going to be linked to it. Public reporting is going to happen. [Health care] is under tremendous pressure to report something, but I would argue that reporting bad data is worse than reporting none at all."

New risk stratification and surveillance strategies for SSIs will be required to generate meaningful data to meet the demands, he said. If not, there could be denial of care for the disadvantaged in the form of surgeons refusing high-risk patients and hospitals closing high-risk programs, he said. Fry is not alone in warning that clinicians may be reluctant to treat high-risk patients because their subsequent infection or death may end up in a public report. For example, a survey of practicing cardiologists published last year found that 83% of respondents felt public reporting may deter surgeons from offering angioplasty to patients who might otherwise benefit.1 Another study found that public reporting may have a chilling effect, with clinicians in states with reporting systems more reluctant to perform high-risk procedures. The study compared angioplasty cases in Michigan with those in New York, which has public reporting for certain health care outcomes. The authors cited "a propensity in New York toward not intervening on higher-risk patients because of fear of public reporting of high mortality rates."2

SSIs lost after discharge

In addition, current SSI surveillance methods produce inaccurate comparative data, primarily because hospitals that do post-discharge surveillance will report many more infections than hospitals that do not. Overall, current surveillance methods likely underestimate the true frequency of SSIs, he said. "I would dare say that our current hospital surveillance processes underestimate [infections] by about 50%," Fry said. "So when you publicly report something that is half what it is and somebody ends up [accurately] reporting twice that rate, then we have set into motion a very difficult problem."

According to the Centers for Disease Control and Prevention, between 12% and 84% of SSIs are detected after patients are discharged from the hospital.3 Most SSIs will be detected 21 days after the operation, but many hospitals do not do sufficient post-discharge follow-up on patients to record subsequent infections.

"The current surveillance is in many respects meaningless in terms of the count," Fry said. "The count is inconsistent between and within hospitals and I think it is dangerous data for hospital public reporting. SSIs are not declared after discharge. They are not captured. They are either missed altogether or underestimated. Outpatient surveillance, particularly if you are in a private hospital, it is virtually impossible. You can't hire enough people to do it."

But reporting systems that focus on accumulating crude numbers will be little better because a draining wound scroma or "stitch sinus" is counted the same as an invasive fascial necrosis, he said. "If you have a simple infection, it counts the same as a disaster," Fry said.

Pressure likely to mount

Nevertheless, the demands by the public and regulatory agencies are not likely to decrease because SSIs are a huge, expensive burden on the health care system. According to CDC estimates, more than 27 million operations are performed annually in the United States, and an estimated 2.6% of them result in an SSI.

"Infections continue to be a major problem," Fry said. "I don't have to tell the members of this organization that surgical-site infection is something that is the consequence of the confluence of a whole lot of clinical variables, not the least of which are numerous different sources of contamination that occur during the process of a procedure being performed."

Indeed, infection prevention methods are beset by a host of variables from host immunity to timing of antibiotic delivery. "The real 'black box' is our host defense that we are born with," Fry said. "All of us are not the same, and all of these acquired variables end up changing our vulnerability to infection literally on a day-to-day and month-to-month basis."

While causing injury and death, SSIs are among the more expensive adverse outcomes. For example, a $30,000 hospital bill for a total knee replacement can climb to $82,000 if the joint becomes infected, he said.4 However, traditional SSI risk assessments developed by the American College of Surgeons (ACS) and the CDC are no longer adequate to prevent many SSIs, he said. The traditional ACS classification (clean, clean contaminated, contaminated, dirty) uses a crude estimate of contamination as a variable, Fry said. The CDC classifications were created prior to the current laparoscopy/minimally invasive era, lump large variables together, and are not data-driven in powering the variables that are used, he added.

"We have tried to enforce standard infection control policies and we have had an ever increasing dependency on antibiotics to do the job," he said. "We have antibiotics, but we somehow don't manage to use them correctly."

Indeed, a study of more than 30,000 patients found that the antimicrobial dose was administered appropriately within one hour of the surgical incision only 55.7% of the time.5 Antimicrobial prophylaxis was discontinued appropriately within 24 hours after the surgery for only 40.7% of the patients.

Risk severity staging

Calling for a new "risk severity staging" system, Fry said "only a comprehensive prospective analysis of combined clinical and administrative data is going to allow us to structure an appropriate system relative to risk. Risk can't be designed as one size fits all. We are going to have to look at specificity relative to specialty and relative to operations themselves."

Under such a system, infection and patient risk could be more closely matched and given more relative meaning. "I would argue that if you had an incredibly high-risk patient who ended up with a superficial infection, that might actually be a good outcome under the circumstances," Fry said. "We have to make our classification system for the future adjusted to risk severity, and not simply the reporting of crude raw numbers that will mean nothing. Risk severity staging is something I would like to put before this society as something we should seriously consider."

Only serious infections counted

In terms of surveillance, only infections or wound discharge requiring additional hospitalization or antibiotic/health care resource utilization should be counted in the process, he stressed. "That's the important point of combining clinical and administrative data from your facilities and from health plans together," Fry said. "Administrative data allow you to capture who ended up getting antibiotics, who ended up getting wound cultures. It allows you to assess which wound complication required additional hospital resources. It gives us an opportunity to address what the true but significant wound complication rates actually happen to be."

Such a system would permit an appropriate analysis of clinically significant SSIs in the context of the patient's risk of infection, thereby protecting high-risk specialties and high-risk programs (e.g., trauma services) from inappropriate interpretation, he said.

"By doing that I think we can protect our underserved populations, which I think are going to end up bearing the brunt of pay for performance and public reporting because nobody is going to want to take care of them," Fry said.

References

  1. Narins CR, Dozier Am, Ling FS, et al. The influence of public reporting of outcome data on medical decision making by physicians. Arch Intern Med 2005; 165:83-87.
  2. Eagle KA, Share D, Smith D, et al. Public reporting and case selection for percutaneous coronary interventions. J Am Coll Cardiol 2005; 45:1,759-1,765.
  3. Mangram AJ, Horan TC, Pearson ML, et al. Centers for Disease Control and Prevention, The Hospital Infection Control Practices Advisory Committee Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epi 1999 20: 247-278.
  4. Hebert CK, Williams RE, Levy RS, et al. Cost of treating an infected total knee replacement. Clin Orthop 1996; 331: 140-145.
  5. Bratzler DW, Houck PM, Richards C, et al. Use of antimicrobial prophylaxis for major surgery baseline results from the National Surgical Infection Prevention Project. Arch Surg 2005; 140:174-182.