Does the Varying Rate of Failed Colonoscopy by Provider Create Additional Charges to the Patient? Matthew Nguyen A thesis submitted in partial fulfillment of the requirements for the degree of Master in Public Health University of Washington 2012 Program Authorized to Offer Degree: School of Public Health – Health Services University of Washington Abstract Does the Varying Rate of Failed Colonoscopy by Provider Create Additional Charges to the Patient? Matthew Nguyen Chair of the Supervisory Committee: Research Professor, Charles Maynard, PhD, Clinical Faculty, Otto Lin, MD Health Services Background: The failure of an endoscopist to thoroughly visualize the colon during a colonoscopy will often result in a repeat procedure to ensure proper screening, surveillance, and/or treatment. We believe that the rates of failed colonoscopies and subsequent follow-up procedures will vary by individual endoscopist and contribute extra charges to the patient. Out study has two objectives: 1) To determine if endoscopists have varying rates of failed colonoscopies, 2) To determine if endoscopists have varying rates of early repeat follow-up procedures after failed colonoscopies. Methods: We retrospectively reviewed 6,000 colonoscopies performed from 2009 – 2011 at Virginia Mason Medical Center. Based on the abstracted information, we determined whether each procedure was a success or failure. For failed procedures, we determined whether a repeat procedure was recommended and how soon after the failed procedure was the repeat procedure recommended. Of failed colonoscopies with a recommended early follow-up procedure, we determined those that contributed extra charges to the patient. Results: We found one endoscopist with high odds of performing failed colonoscopies, but he or she did not have high odds of recommending a follow-up interval that would contribute to extra charges. We also found one endoscopist with high odds of recommending a followup interval that would contribute extra charges, but he or she did not have high odds of performing a failed colonoscopy. Conclusions: Our results indicate no one individual provider could be held responsible for extra charges assigned to the patient due to failed colonoscopies. While the total burden of extra charges as a result of failed colonoscopies may be deemed excessive by some, any measures aimed to decrease those excess charges should be addressed more broadly to all physicians and patients. LIST OF TABLES Table Number Page 1. Patient Characteristics……………………………………….... 13 2. Classification of Patients by Clinical Indication or Findings……. 14 3. Odds ratios and 95% confidence intervals of failure type and recommendation for repeat procedure by endoscopist……………………………. 15 Page I 1 Does the Varying Rate of Failed Colonoscopy by Provider Create Additional Charges to the Patient? Introduction To address the rapidly increasing cost of healthcare, many healthcare spending reforms have been centered on minimizing unnecessary medical procedures. These reforms have been aimed towards some of the more prolific medical procedures. One of the most prolific medical procedures in the United States is the colonoscopy (1). The colonoscopy is one of the primary procedures used by gastroenterologists in the United States for screening, surveying, and providing therapeutic services for colonic diseases and anomalies – including colorectal cancer, inflammatory bowel disease, and polyps. With more than 14 million colonoscopies performed annually in the United States and expectations that usage rates will only increase, attention should focus on limiting those colonoscopy procedures which are clinically unnecessary (1). We hypothesize that the rate of failed colonoscopies differs by individual endoscopists. We predict that this variance will result in higher rates of follow-up procedures that result in unnecessary charges to the patient. We therefore performed a retrospective chart review study to determine whether failed colonoscopies rates differ between providers and, if so, whether they contribute extra fiscal charges for the patient. Background One aspect of a successful colonoscopy is cecal intubation – the visualization of the cecum -- in the proximal colon by the endoscopist. Previous studies have found that a 2 significant percentage of colonic lesions do appear near and/or within the cecum, thus failure to reach that area will often require additional screening methods such as a CT colonoscopy or a repeat colonoscopy (2). The U.S. Multi-Society Task Force recommends that cecal intubation be achieved in more than 90% of all colonoscopy procedures (3). Failure to visualize the cecum can occur for a variety of reasons, including inadequate patient bowel preparation, endoscopist inexperience, endoscopist low ability level, and colon anatomy (49). Specifically, in regards to patient bowel preparation, the endoscopist evaluates each patient’s bowel preparation on a three-level scale. A successful bowel preparation allows the endoscopist to accurately visualize the entire colon. A mediocre or inadequate bowel preparation will allow the endoscopist to visualize the majority of the colon, but smaller polyps and/or other lesions may be missed. A completely failed colonoscopy due to improper bowel preparation occurs when the endoscopist cannot advance the endoscope towards the cecum in the right colon due to bowel materials blocking the endoscope. Even with these standards, ultimately the judgment of each patient’s bowel preparation is a subjective process determined by the individual provider. A failed colonoscopy will likely be followed with a recommendation for a repeat colonoscopy procedure. There are currently no universally accepted guidelines regarding the recommended length of time between a failed colonoscopy and a subsequent follow-up procedure. Also, very little is known about the financial implications of a failed colonoscopy procedure. Rex et al. concluded that failed colonoscopies due to bowel preparation in 2 medical centers resulted in a 12 – 22% increase in charges over one-year period (10). Extra 3 charges were summed by estimating additional charges associated with a recommendation to have a repeat procedure at an interval shorter than that specified by practice guidelines. This method may overestimate charges, since not all repeat colonoscopies will result in extra charges for the patient and medical facility. A repeat colonoscopy at a quicker interval than the suggested guidelines does not always result in an extra procedure – and charges – over the lifetime of a patient. Methods The institutional Review Board at Virginia Mason Medical Center (VMMC) gave approval for this retrospective chart review study and individual informed consent was not required. Subject Recruitment and Databases VMMC is a health care system located in Seattle, Washington with 14 gastroenterologists performing more than 14,000 colonoscopies annually. Study patients undergoing colonoscopy were identified from the medical center’s financial database (WebFocus, Information Builders, New York, NY) using the following procedure codes from the Current Procedural Terminology): 45386, 45385, 45384, 45382, 45381, 45380, 44388 , 44389 , 44390, 44391, 44392, 44393, 44394, 44397, 45378 , 45379. We extracted colonoscopy procedure data from January 1st, 2010, through July 1st, 2011. Our sample did not include every colonoscopy procedure performed at VMMC during this period. For every 6-month period starting from January 1st, 2010, we identified the first 200 colonoscopies 4 performed by 8 of the 14 gastroenterologists. These 8 gastroenterologists were identified as performing a “significant” number of colonoscopies – on average 200 or more colonoscopies every 6 months. The sample was limited to these 8 gastroenterologists in order to accurately assess the abilities of those providers that regularly performed colonoscopies. Studies have shown that gastroenterologists who perform low volumes of colonoscopies have higher rates of incomplete colonoscopies, a fact that was considered in our conclusions (8 - 9). For each of the colonoscopy procedures, we thoroughly reviewed the electronic medical records at VMMC (Cerner Information Systems, Kansas City, Missouri) -- including clinic notes, procedure notes, pathology reports, history and physicals, and consultations. We personally abstracted data from the medical records into a database. For the purpose of our study, any patient receiving a colonoscopy at VMMC during the study period is an eligible study participant, regardless of indication of the index procedure, gender, age, colonoscopy findings, or any other criteria. Using a standardized data input form, we recorded the following data points: 1) indication for colonoscopy procedure, 2) clinical findings, 3) patient bowel preparation, 4) cecal visualization by the endoscopist, 5) if cecum visualization was not achieved, detailed reasons for this, 6) if cecum visualization was not achieved or if bowel preparation was not adequate, the recommended follow-up procedure, and 7) if cecal visualization was not achieved or if bowel preparation was not adequate, the recommended follow-up time interval for a repeat procedure. Failed colonoscopies were those in which the colonoscopy exam was 5 attempted but cecal visualization by the endoscopist did not occur or those in which the colonoscopy exam was completed but a thorough examination of the majority of the colon was deemed incomplete by the endoscopist due to inadequate bowel preparation by the patient. We did not collect the actual follow-up procedure and interval data since the vast majority of the follow-up procedures were not scheduled to occur until after completion of this study. Instead, we collected data on the recommended interval for follow-up given by the endoscopist after a failed colonoscopy. Colonoscopies were categorized according to indications and clinical findings. Each group of colonoscopies was assigned a recommended follow-up colonoscopy time interval that was based on the existing literature and guidelines set by the major gastroenterology groups: American Society of Gastrointestinal Endoscopy (ASGE), American Gastroenterological Association (AGA) and American College of Gastroenterology (ACG) (11 – 13). The assigned recommended follow-up colonoscopy time interval is initially based on each individual patient’s original indication for receiving a colonoscopy procedure. A more aggressive recommended follow-up colonoscopy time interval would be assigned if a patient had any type of clinical finding during the colonoscopy that would require a quicker follow-up. For example, if a patient -- with no prior personal or family history of polyps and/or colorectal cancer -- came in for a screening colonoscopy, the recommended follow-up colonoscopy time interval – given the absence of any significant clinical findings – would be 10 years. If a different patient with an identical indication received a colonoscopy, but had an 6 adenoma removed during the procedure, the recommended follow-up colonoscopy time interval would be 5 years. Estimation of Charges Colonoscopy charge data were obtained from local Medicare-allowable hospitalbased fees. A standard colonoscopy with biopsy in the Seattle / King County region of Washington State had an average Medicare charge of $783. We used Medicare charge instead of received payments or procedural costs for the following reasons: First, the majority of the recommended follow-up procedures had yet to occur at the time of our study. As a result, we could not collect received payment or procedural cost data. Second, received payments and/or procedural costs at VMMC may not be applicable to other medical facilities. Calculating an estimate using a standardized Medicare charge will permit comparison of our experience with that of other institution. Statistical Methods We utilized multiple logistic regression to determine each endoscopist’s 1) overall rate of failed colonoscopy, 2) rate of failed colonoscopy due to patient bowel preparation, 3) rate of failed colonoscopy due to reasons other than patient bowel preparation, and 3) rate in which a follow-up interval recommendation after a failed colonoscopy was less than or equal to one-half of the recommended follow-up interval for a successful colonoscopy. We controlled for the following potential confounders: patient age, gender, and clinical indication for the colonoscopy. 7 Results Study Population A total of 6,000 unique colonoscopy procedures were identified through the colonoscopy completion rate quality metrics database. The overall mean age was 59 years (range 16-95); 2910 (48%) were male (Table 1).Table 2 details the clinical indications or the findings for each procedure – a patient was grouped into a finding category if the clinical findings for that particular procedure resulted in a follow-up interval that was shorter than it would have been with the original procedural indication. Table 2 also shows the recommended follow-up colonoscopy time interval given a successful procedure. Failed Colonoscopy Rates by Endoscopist According to our study criteria, 550 (9. %) procedures resulted in an incomplete colonoscopy. 48 (0.8%) patients received an incomplete colonoscopy for reasons not involving patient bowel preparation. 481 (8. %) patients were described as having a failed colonoscopy due to mediocre or inadequate bowel preparation -- meaning that the endoscopist was able to visualize the cecum, but due to residual fecal matter in the colon, was not able to thoroughly inspect the entire colon. 27 (0.4%) had a completely inadequate bowel preparation in which the endoscopist could not visualize the cecum due to residual fecal matter completely obstructing visualization or movement of the endoscope. 8 Each of the 550 failed procedures was given a subsequent follow-up interval. 373 (6. %) were advised to have a follow-up procedure in a shorter period of time than the recommended follow-up procedure time if the procedure were successful. Altogether, 312 (5%) were given a follow-up interval that was shorter than one-half of the guideline recommended follow-up time interval. We decided to use one-half of the standard follow-up time interval as a benchmark to ensure simplicity and also to prevent overestimating the costs of failed colonoscopies. Even though a provider may have recommended a shorter follow-up interval after a failed colonoscopy, extra procedures – and charges -- may not necessarily have been accrued. For example, a 50 year old patient, who undergoes a failed screening colonoscopy, is advised to have a follow-up procedure in 7 years instead of 10 years as recommended for successful colonoscopies. Will this forward-shifted procedure result in an extra procedure (and charges) over the lifetime of a patient? We argue that it will not. Shorter than recommended intervals will only result in shifting the costs of colonoscopies over a patient’s lifespan forward, rather than adding to the total cost. While we must emphasize that this one-half threshold is an arbitrary benchmark, we feel that it will provide a rough approximation of which failed colonoscopies will result in repeated procedures. Table 3 shows the risk adjusted odds of various types of failed procedures by operator. Regarding the rate of any type of failed colonoscopy, only one endoscopist (Endoscopist “G”) had an odds ratio greater than one that was statistically significant. The 9 odds of Endoscopist “G” performing a failed colonoscopy, after controlling for patient age, gender, and clinical indication, was1.4 times higher than endoscopist I, the reference category. Regarding the rate of recommending a follow-up procedure after a failed colonoscopy at one-half or less of the guideline recommended follow-up interval, only one endoscopist (Endoscopist “H”) had an odds ratio greater than one. The odds of Endoscopist “H” recommending a follow-up procedure after a failed colonoscopy at one-half or less of the guideline recommended follow-up interval was 2.9 times higher than endoscopist I. However, in regards to their rate of performing a failed colonoscopy, Endoscopist “H” had a much lower odds of performing a failed procedure. This rate was statistically significant (p < 0.001). Endoscopist “G”, who had a statistically significant higher odds of performing a failed colonoscopy than operator I, had a lower odds ratio of recommending a follow-up procedure after a failed colonoscopy at one-half or less of the guideline recommended follow-up interval. However, this rate was not statistically significant (p= 0.06). Estimation of Extra Charges due to Failed Colonoscopies Using a standardized Medicare charge ($783) for colonoscopies in the Seattle / King County area, the failed colonoscopies with significantly shorter recommended time intervals contributed an estimated $244,296.00 in extra charges. Discussion In summary, 5% of all the studied colonoscopies were given a recommended followup time interval that resulted in extra procedures and costs. This estimate is much lower 10 when compared to a previous study by Rex et al. who found a 12-22% increase in costs (8). More importantly, we only found one endoscopist with a statistically significant increased likelihood of performing failed colonoscopies. Furthermore this endoscopist did not have high odds of recommending a follow-up procedure that resulted in extra procedures and charges. The only endoscopist that was found to have high odds of recommending extra procedures also had very low odds of performing failed ones. As a result, we argue that this endoscopist also did not contribute extra procedures or charges. Any unnecessary medical procedure presents certain risks and costs to the patient. However, our findings suggest while failed colonoscopies may lead to repeat procedures and consequently, increased charges to the patient, the rate at which they occur cannot be traced to any individual provider. While we found one endoscopist with high odds of performing failed colonoscopies, he or she did not have high odds of recommending a follow-up interval that would contribute to extra charges. Conversely, we found one endoscopist with high odds of recommending a follow-up interval that would contribute extra charges, but he or she did not have high odds of performing a failed colonoscopy. We conclude that efforts within the participating study facility to lower healthcare charges should not be focused on individual provider patterns of failed colonoscopies or on the rates of recommending follow-up colonoscopies that produce extra procedures and charges. Rather efforts should be focused on all providers and all patients. 11 We did estimate that, within a 3 year period, nearly a quarter-million dollars was charged to our patients due to failed colonoscopies with short recommended follow-up time intervals. Our findings suggest that if efforts are to be made to decrease this estimate in future years, the focus should be pointed towards broad-based methods that encompass all endoscopists and patients. Our study has several limitations. First, our sample may not be representative of all medical systems performing colonoscopies. VMMC performs a high-volume of colonoscopies and the performing endoscopists are highly trained and experienced. Lowvolume medical systems with less experienced endoscopists may have higher rates of failed colonoscopies. Our findings may not be applicable to these situations. Second, in estimating a total charge amount due to failed colonoscopies, our study did not completely capture the cost of a colonoscopy procedure. We decided to use one standardized Medicare charge for a colonoscopy performed in the Seattle/ King County area. Additional charges, such as professional provider charges, supportive nursing charges, administrative charges, etc. were not calculated. Our resulting calculations should not be mistaken for a specific, realistic estimation of the extra charges due to failed colonoscopies. Instead, the primary take-away from this study should be the discrepancies in the rate of inadequate bowel preparations between providers and also the differences between providers in the rate at which they recommended their patients to return for a follow-up colonoscopy. A more complete estimate of the cost of failed colonoscopies may be more persuasive in initiating action to lower the rate of failure. Furthermore, in calculating the rate at which repeat procedures were 12 recommended, we used an arbitrary, conservative threshold that may have underestimated the levels at which unnecessary procedures are recommended. Again, a more liberal threshold may have provided a more persuasive argument to initiate action. We conclude that extra charges associated with failed colonoscopies were not associated with endoscopists’ rates of failure or recommendations for repeat procedures. . We estimated that failed colonoscopies contributed more than $240,000 in extra charges to patients in this single institution. However, further studies comparing estimates of departmental level charges from failed colonoscopies to charges for other costly, unnecessary procedures will be required to inform decision making regarding where limited resources should be given to reduce rates of failed medical procedures. 13 Table 1. Patient characteristics Age (years) Female Male Bowel Preparation Failed Mediocre Not Stated OK 59+12 3090 2910 52 % 48% 27 481 248 5244 0.5% 9% 3% 87% 14 Table 2. Classification of clinical indication or findings. Findings Non-Advanced Adenoma(s) Advanced Adenoma(s) Cancer Hyperplastic Polyp(s) Mass Diagnostic Screening – 1st Degree Family History of Colorectal Cancer Screening – 2nd Degree Family History of Colorectal Cancer Screening - NO Family History Screening – 1st Degree Family History of Polyps Screening – 2nd Degree Family History of Polyps Surveillance - Cancer Surveillance – inflammatory bowel disease Surveillance - Mass Surveillance – Other* Surveillance – Polyps Unknown Patient with Clinical Findings (n=1683) Total % Recommended F/U Interval 727 12.1% 4 (3-5) 478 8.0% 3 41 0.7% 1 408 6.8% 10 29 0.5% 1 Patients with No Clinical Findings (n=4317) Age Dependent (10 for those >= 1126 18.8% 50, or 50 – Age) 318 5.3% 4 (3-5) 77 1.3% 10 1481 24.7% 10 138 2.3% 5 1 95 0.02% 1.6% 10 1 137 12 48 874 2.3% 0.2% 0.8% 14.6% 10 0.2% 3 1 4 (3-5) 4 (3-5) Age Dependent (10 for those >= 50, or 50 – Age) 15 Table 3. Odds ratios and 95% confidence intervals of failure type and recommendation for repeat procedure by endoscopist Endoscopi Failed - Bowel st Prep and Failed A 0.63 (0.44- .90)* (n=600) Failed - Bowel Prep Related Failed - Not Bowel FU @ 1/2 of Prep Related Recommendation 0.62 (0.43 0.89)* 0.96 (0.31 - 2.99) 0.24 (0.10 - 0.57)* 0.26 (0.17 - 0.40)* 0.24 (0.15 0.38)* 0.75 (0.24 - 2.33) 0.72 (0.29 - 1.79) 0.61 (0.42 - 0.89)* 0.52 (0.35 0.77)* 1.89 (0.72 - 4.97) 0.81 (0.38 - 1.71) 0.82 (0.61 - 1.12) 0.83 (0.60 - 1.13) 0.82 (0.28 - 2.41) 1.41 (0.76 - 2.62) 1.15 (0.86 - 1.53) 1.11 (0.82 - 1.50) 1.87 (0.73 - 4.75) 1.67 (0.94 - 2.95) 0.33 (0.21 - 0.50)* 0.3 (0.19 - 0.47)* 0.68 (0.20 - 2.29) 0.97 (0.41 - 2.31) B (n=806) C (n=533) D (n=805) E (n=807) F (n=613) G 1.43 (1.03 - 20)* 1.39 (0.98 - 1.96) 2.16 (0.79 - 5.92) 0.53 (0.27 - 1.03) 0.26 (0.16 - 0.41)* 0.25 (0.15 0.40)* 0.86 (0.25 - 2.90) 2.78 (1.03 - 7.54)* - - - - (n=407) H (n=608) I (reference group) 16 (n=821) P <0.05 1 List of References 1. 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