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The Centers for Medicare and Medicaid Services (CMS) Community-Acquired Pneumonia Core Measures Lead to Unnecessary Antibiotic Administration by Emergency Physicians Bret A. Nicks, MD, David E. Manthey, MD, and Michael T. Fitch, MD, PhD

Abstract Objectives: The objectives were to assess emergency physician (EP) understanding of the Centers for Medicare and Medicaid Services (CMS) core measures for community-acquired pneumonia (CAP) guidelines and to determine their self-reported effect on antibiotic prescribing patterns. Methods: A convenience sample of EPs from five medical centers in North Carolina was anonymously surveyed via a Web-based instrument. Participants indicated their level of understanding of the CMS CAP guidelines and the effects on their prescribing patterns for antibiotics. Results: A total of 121 EPs completed the study instrument (81%). All respondents were aware of the CMS CAP guidelines. Of these, 95% (95% confidence interval [CI] = 92% to 98%) correctly understood the time-based guidelines for antibiotic administration, although 24% (95% CI = 17% to 31%) incorrectly identified the onset of this time period. Nearly all physicians (96%; 95% CI = 93% to 99%) reported institutional commitment to meet these core measures, and 84% (95% CI = 78% to 90%) stated that they had a department-based CAP protocol. More than half of the respondents (55%; 95% CI = 47% to 70%) reported prescribing antibiotics to patients they did not believe had pneumonia in an effort to comply with the CMS guidelines, and 42% (95% CI = 34% to 50%) of these stated that they did so more than three times per month. Only 40% (95% CI = 32% to 48%) of respondents indicated a belief that the guidelines improve patient care. Of those, this was believed to occur by increasing pneumonia awareness (60%; 95% CI = 52% to 68%) and improving hospital processes when pneumonia is suspected (86%; 95% CI = 80% to 92%). Conclusions: Emergency physicians demonstrate awareness of the current CMS CAP guidelines. Most physicians surveyed reported the presence of institutional protocols to increase compliance. More than half of EPs reported that they feel the guidelines led to unnecessary antibiotic usage for patients who are not suspected to have pneumonia. Only 40% of EPs believe that CAP awareness and expedient care resulting from these guidelines has improved overall pneumonia-related patient care. Outcome-based data for non–intensive care unit CAP patients are lacking, and EPs report that they prescribe antibiotics when they may not be necessary to comply with existing guidelines. ACADEMIC EMERGENCY MEDICINE 2009; 16:184–187 ª 2009 by the Society for Academic Emergency Medicine Keywords: community-acquired pneumonia, antibiotics, emergency physicians, core measures

From the Department of Emergency Medicine (BAN, DEM, MTF), Wake Forest University Health Sciences, WinstonSalem, NC. Presented at the American College of Emergency Physicians (ACEP) Scientific Assembly, Chicago, IL, October 2008. Received September 2, 2008; revisions received October 1 and October 15, 2008; accepted October 19, 2008. Address for correspondence and reprints: Bret A. Nicks, MD; e-mail: [email protected].

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group of 20 ‘‘core measures’’ has been developed by The Joint Commission on Accreditation of Hospital Organizations (now ‘‘The Joint Commission’’) as markers of quality health care across the United States.1 Many of these measures have been directly linked with hospital incentive payment plans, especially with the planned expansion of pay-for-performance measures established by the Centers for Medicare and Medicaid Services (CMS).2,3 The underlying premise of these measures is to foster collaboration within the medical community to facilitate transparency within the

ª 2009 by the Society for Academic Emergency Medicine doi: 10.1111/j.1553-2712.2008.00320.x

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health care system and ensure that ‘‘valid quality measures are used’’ to increase uniformity and quality of care.1,2 While these core measures are reportedly based on credible scientific evidence related to patient outcomes, the assertion that sufficient evidence exists to merit adoption of some of these measures has been called into question. As one of the most highly contested core measures, community-acquired pneumonia (CAP), issued in 2002, became reportable in the last quarter of 2004. This core measure includes requirements such as the administration of antibiotics to patients deemed to have CAP within 4 hours of arrival to an emergency department (ED), with blood cultures drawn before administration of such antibiotics.1 Pneumonia is an important and relevant focus for core measures reporting, as it accounts for the acute-care hospitalization of more than 600,000 Medicare recipients annually and is associated with a 12% mortality rate at 30 days.4,5 The core measures established for CAP, however, are based on consensus statements issued by the American Thoracic Society, the Infectious Diseases Society of America, the Canadian Infectious Diseases Society, and the Canadian Thoracic Society, instead of being based upon primary literature regarding measurable patient-based outcomes.4–6 Several articles and studies have subsequently addressed concerns related to the initial CAP core measures. These publications have led to several revisions, but the changes made to this point have inadequately addressed all of these issues.7–12 The increased awareness of CAP core measures, with questionable recommendations on blood cultures and time limits, may have affected the practice of many emergency medicine (EM) practitioners.12,13 In this study, emergency physician (EP) understanding of the CMS core measures for CAP guidelines was assessed. The survey respondents also were asked whether these guidelines had influenced their own antibiotic prescribing patterns related to this patient population.

Survey Content and Administration This survey (Data Supplement S1, available as supporting information in the online version of this paper) was developed and administered after the October 2006 core measure revisions, but prior to any further revisions. Questions were designed, reviewed, and assessed for face validity by four faculty physicians from EM, two faculty physicians from infectious disease, and two hospital-based compliance officers from our institution who are well versed in the CAP guidelines. Participants in the survey indicated their understanding of the CMS CAP guidelines and self-reported effects on their prescribing patterns for antibiotics. The data obtained from the 13 question survey were collected over a 1-month period during which the initial survey and automated weekly reminders were sent until either the survey was completed or the study period ended. All data were collected, compiled, and analyzed anonymously. Results were tabulated related to awareness of the CMS CAP core measures, understanding of the explicit criteria for pneumonia inclusion, timing of antibiotics, institutional support, antibiotic prescribing habits, and perceived effect on patient care. Our study objectives were to identify the current awareness of CMS CAP core measures among board-certified or board-eligible EPs related to pneumonia criteria, timed antibiotics, institutional commitment, and effect on prescribing habits and patient care.

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METHODS Study Design and Population This study was a closed-end categorical Web-based anonymous survey administered to a convenience sample of 150 board-certified or board-eligible EPs and upper-level residents from EM residency training programs in five medical centers throughout North Carolina. The sites invited to participate in this nonincentivized study included academic medical centers in North Carolina with active Accreditation Council on Graduate Medical Education–accredited EM training programs and affiliated community medical centers. The institutions that elected to participate submitted email addresses for their affiliated EM faculty and residents. Inclusion criteria for enrollment in the study included a valid e-mail address for inviting participation in the Web-based survey. One-hundred fifty physicians met this criterion of the approximately 224 EPs at the participating institutions. This study was reviewed and approved by the institutional review board of our medical center.

Data Analysis Descriptive statistics were used to summarize and report results. RESULTS A total of 150 EPs met the enrollment criteria and were invited to participate in the study. A total of 121 (81%) EPs completed the study instrument. All respondents demonstrated awareness of the CMS CAP guidelines and the associated public reporting and potential payfor-performance implications. Of these respondents, 95% (95% confidence interval [CI] = 92% to 98%) appropriately identified the time requirement for the antibiotic period, although 24% (95% CI = 17% to 31%) incorrectly identified the initiation point for this timed measure, believing the criteria did not begin until they had physically examined the patient. Nearly all physicians (96%; 95% CI = 93% to 99%) reported a perception of an institutional commitment to meet these core measures, with 84% (95% CI = 78% to 90%) stating that a department-based CAP protocol exists. In relation to patient care, more than half of the respondents (55%; 95% CI = 47% to 70%) reported prescribing antibiotics to patients they did not believe had pneumonia in an effort to avoid the repercussions of noncompliance with the CMS CAP guidelines. Furthermore, 42% (95% CI = 34% to 50%) of those who reported doing this stated that they did so more than three times per month. When asked about improvements in patient care, only 40% (95% CI = 32% to 48%) of respondents indicated a belief that the guidelines improve patient care

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CMS CORE MEASURES LEAD TO UNNECESSARY ANTIBIOTIC ADMINISTRATION

outcomes. Of those acknowledging potential benefits, improved outcomes were thought to occur by increasing pneumonia awareness (60%; 95% CI = 52% to 68%) and improving hospital processes when pneumonia is suspected (86%; 95% CI = 80% to 92%). DISCUSSION The fact that 100% of the survey respondents were aware of the guidelines is not surprising, as EPs bear a large portion of the responsibility for the primary aspects of the pneumonia core measures and the impact of noncompliance. In addition, as these measures have become publicly reportable with potential financial ramifications, hospital administrations have started to review compliance with these clinically and financially important national benchmarks. The guidelines mandating treatment for CAP within 4 hours of arrival to the ED were based upon controversial data.12–14 One-hundred percent compliance may not be practical to obtain in many circumstances. The determination of whether or not treatment for CAP should have been initiated is not based solely on the initial ED physician’s assessment of the patient. In some cases, if the concern for pneumonia is raised on a radiologic report or admission history and physical, this can be counted as ‘‘noncompliance’’ on the part of the EP, even though there is no concrete evidence or final diagnosis of pneumonia. Fifty-five percent of EPs in this study admit to administering antibiotics to patients without clinical or radiographic evidence of pneumonia in an effort to prevent noncompliance based on future unforeseeable documentation by another service. Nearly half indicate that they have done so several times each month. The consequences of inappropriate administration of antibiotics are considered less important than the consequences of being held in noncompliance with controversial CMS guidelines. The possible increase in the prevalence of multidrug-resistant organisms, increase in patient care costs (antibiotic and delivery costs), allergic reactions, and imprinting of inappropriate behavior on trainees are all negative consequences of such behavior. The guidelines mandating treatment for CAP within 4 hours of arrival to the ED are controversial because they are extrapolated from small patient populations and not based on patient outcomes data.9,13 Being held to consensus-based criteria that have no scientific evidence of improved patient outcome is troubling, especially when inappropriate antibiotic administration in an era of antibiotic resistance is the more common reported outcome, as suggested in this survey.4–6 Since the completion of this study, further modification of the CAP guidelines has occurred and the guidelines have been updated. However, the most recent guidelines continue to lack supportive evidence for antibiotic timing (now extended to 6 hours) and have expanded the inclusion of vague terminology for pneumonia abstraction identification.4,6,12 While EPs are aware of the measures and their potential impact, our survey results suggest that many physicians continue to question the validity of the guidelines and doubt the generalizable benefits to all presenting patients.

LIMITATIONS The physician population that was invited to participate in this study was designed to sample the major academic medical centers in North Carolina and included board-certified, board eligible, and upper-level resident physicians in EM training programs and affiliated community-based locations. Our study population used a convenience sample of 150 physicians based on valid e-mail addresses supplied by participating institutions, and by definition this method excluded some faculty and residents who may not have had working e-mail addresses at the time of this study. We also excluded first-year residents, knowing exposure to core measures may not be well established at that point in training. This relatively small sample size included physicians from five academic medical centers and affiliates and presumably would reflect a physician population well educated about current treatment guidelines. This study design does not take into account any regional variances in CMS guideline awareness that may occur in other geographical regions or in smaller medical centers that may have EDs staffed by non– board-certified physicians or midlevel providers. However, as these measures are well-publicized federal guidelines, we believe our study results are generalizable to EDs staffed by EPs. CONCLUSIONS In the locale surveyed, EM-trained physicians and resident physicians in EM training programs are aware of the CMS CAP guidelines, and they report that almost all of their institutions have initiated protocols to increase compliance. More than half of EPs report using antibiotics when they do not believe they are clinically indicated in an effort to comply with these guidelines, and only 40% feel that pneumonia-related patient care is improved by these national guidelines. References 1. Centers for Medicare and Medicaid Services. Evidence-based Care ⁄ Performance Measurement. Available at: http://www.cms.hhs.gov/MedicaidSCHIP QualPrac/03_evidencebasedcare.asp#TopOfPage. Accessed Sep 24, 2008. 2. Centers for Medicare and Medicaid Services. Medicare ‘‘Pay for Performance (P4P)’’ Initiatives. Available at: http://www.cms.hhs.gov/apps/media/ press/release.asp?Counter=1343. Accessed Jun 25, 2008. 3. Centers for Medicare and Medicaid Services. Pay for Performance: Payment Aligned with Quality. Available at: http://www.cms.hhs.gov/MedicaidSCHIPQualPrac/04_P4P.asp. Accessed Sep 24, 2008. 4. Niederman MS, Mandell LA, Anzueto A, et al. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001; 163:1730–54. 5. Barlett JG, Breiman RF, Mandell LA, File TM Jr. Community-acquired pneumonia in adults:

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Guidelines for management. The Infectious Diseases Society of America. Clin Infect Dis. 1998; 26:811–38. Mandell LA, Marrie TJ, Grossman RF, Chow AW, Hyland RH. Canadian guidelines for the initial management of community-acquired pneumonia: an evidence-based update by the Canadian Infectious Diseases Society and the Canadian Thoracic Society. The Canadian Community-Acquired Pneumonia Working Group. Clin Infect Dis. 2000; 31:383–421. Birnbaumer DM. Blood Cultures Aren’t Useful for Managing Immunocompetent CAP Inpatients. J Watch Emerg Med. Available at: http://emer gency-medicine.jwatch.org/cgi/content/full/2004/ 1124/1. Accessed Oct 24, 2008. Corbo J, Friedman B, Bijur P, Gallagher EJ. Limited usefulness of initial blood cultures in community acquired pneumonia. Emerg Med J. 2004; 1:446–8. Walls RM, Resnick JB. The CMS Blood Cultures for CAP Program: The Architects Speak Out. Journal Watch EM Editors Reply. Available at : http://emer gency-medicine.jwatch.org/cgi/content/full/2005/427 /1. Accessed Jun 25, 2008. Waterer GW, Wunderink RG. The influence of severity of community-acquired pneumonia on the usefulness of blood cultures. Respir Med. 2001; 95:78–82.

11. Ramanujam P, Rathlev NK. Blood cultures do not change management in hospitalized patients with community-acquired pneumonia. Acad Emerg Med. 2006; 13:740–5. 12. Welker JA, Huston M, McCue JD. Antibiotic timing and errors in diagnosing pneumonia. Arch Intern Med. 2008; 168:347–8. 13. Kennedy M, Bates DW, Wright SB, Ruiz R, Wolfe RE, Shapiro NI. Do emergency department blood cultures change practice in patients with pneumonia? Ann Emerg Med. 2005; 46:393–400. 14. Wachter RM, Flanders SA, Fee C, Pronovost PJ. Public reporting of antibiotic timing in patients with pneumonia: lessons from a flawed performance measure. Ann Intern Med. 2008; 149:29–32.

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Supporting Information The following supporting information is available in the online version of this paper: Data Supplement S1. Questionnaire. The document is in PDF format. Please note: Wiley Periodicals Inc. is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing material) should be directed to the corresponding author for the article.