Constipation is among the most common digestive problems. Use of Health Care Resources and Cost of Care for Adults With Constipation

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1 CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2007;5: Use of Health Care Resources and Cost of Care for Adults With Constipation GURKIRPAL SINGH,* VIJAYABHARATHI LINGALA, HUIJIAN WANG, SHWETA VADHAVKAR, KRISTIJAN H. KAHLER, ALKA MITHAL, and GEORGE TRIADAFILOPOULOS* *Division of Gastroenterology and Hepatology, Stanford University School of Medicine; Institute of Clinical Outcomes Research and Education, Palo Alto, California; US Clinical Development and Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey See Halder SLS et al on page 799 for companion article in the September 2007 issue of Gastroenterology. Background & Aims: Constipation is a multisymptom disorder that frequently compromises quality of life and leads patients to seek medical advice. To evaluate the clinical and fiscal effects of constipation, we assessed health care resource use by patients with constipation enrolled in a large state Medicaid program. Methods: We identified 105,130 patients older than age 18 who saw a physician at least once for constipation and were enrolled in the California Medicaid program (Medi-Cal). We then studied health care resource use and costs (reimbursed by Medi- Cal) in 76,854 patients without supplementary insurance. The 15-month analysis period encompassed 3 months before and 12 months after the first visit. The prevalence of comorbid conditions was assessed in the sample of 105,130 patients. Results: During the study period, 106,555 physician visits were for constipation; the total associated cost was $3,016,017 ($39/patient). The total cost for gastrointestinal procedures and laboratory testing was $14,052,503 ($183/patient). There were 41,723 over-the-counter and 1665 prescription drug purchases; the total cost was $388,780 ($5/patient). Approximately 0.6% of patients (n 479) were admitted to the hospital for constipation; the total cost was $1,433,708 ($2993/admission). The total direct health care costs for patients with constipation in the Medi-Cal system for the 15-month period was $18,891,008 ($246/patient). Within 12 months of the first physician visit for constipation, 5657 of 105,130 patients had hemorrhoids and 2288 had intestinal impaction or obstruction. Conclusions: Adults seeking treatment for constipation account for significant health care resource use and often have comorbid conditions. The clinical and fiscal burden of constipation in US adults cannot be disregarded or trivialized. Constipation is among the most common digestive problems in North America, with an estimated prevalence between 2% and 27%. 1 Although usually defined by infrequent bowel movements ( 3 per week), constipation often is associated with other symptoms including abdominal bloating, defecatory straining, and the feeling of incomplete evacuation. 2 For many patients, constipation-associated symptoms are chronic and last for several weeks to several years. In a 1997 epidemiologic survey (n 10,018), 45% of female and 30% of male participants reported experiencing constipation-related symptoms that lasted for at least 5 years. 3 Constipation often is sufficiently bothersome to compromise patient quality of life, social functioning, and the ability to perform activities of daily living. 4 7 Poor quality of life has been shown to be an important predictor of constipation-associated health care use and resultant health care costs. 8,9 The cost of evaluating and treating constipation is high. Each year in the United States alone, approximately 2.5 million people consult a physician for constipation, 10 and approximately 92,000 are hospitalized. 11 The average cost of diagnosing constipation is estimated at nearly $ Cathartic agents and laxatives are prescribed to an estimated 2 3 million patients each year by general practitioners or internists, 11 and more than $800 million is spent each year in the United States on over-the-counter (OTC) laxatives. 13 Based on an analysis of 3 national surveys (the 2001 National Ambulatory Medical Care Survey, the 2001 National Hospital Ambulatory Medical Care Survey, and the 2001 National Hospital Discharge Survey), the costs associated with medical care for constipation total $235 million. 14 This estimate does not include the costs of OTC and prescription drugs or the cost of care when constipation was determined to be a complication or a comorbid condition. The full economic impact of evaluating and treating patients with constipation is unknown. There are no reliable estimates of the degree to which Medicaid patients with constipation seek medical advice and use health care resources (including purchasing OTC medications). To help fill this void, we conducted a study to assess the costs associated with medical care, including prescription and OTC medications, for patients with constipation enrolled in the California Medicaid (Medi-Cal) program. It should be noted that Medicaid (and, thus, Medi-Cal) beneficiaries incur relatively small average expenditures per person each year. Medicaid expenditures accounted for only 16% of the total national health expenditure ($1.7 trillion, or $5743 per person) in During fiscal year , the total Medicaid spending per beneficiary was $4027, and the total Medi- Cal spending per beneficiary was $ Abbreviations used in this paper: ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification; Medi-Cal, California Medicaid program; OTC, over-the-counter; PMPY, per member per year by the AGA Institute /07/$32.00 doi: /j.cgh

2 1054 SINGH ET AL CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 5, No. 9 Table 1. Prevalence of Concomitant Medical Conditions Concomitant medical condition ICD-9 code No. of patients (%) Anal fissure 565.0x 30 (0.03) Hemorrhoids 455.xx 5657 (5.38) Fecal impaction 560.3x 1725 (1.64) Intestinal obstruction 563 (0.54) Specified 560.8x Unspecified 560.9x Irritable bowel syndrome (3.42) Inflammatory bowel disease 700 (0.67) Regional enteritis 555.xx Ulcerative colitis 556.xx Intestinal/rectal neoplasms 1755 (1.67) Rectum/anus 154.xx Colon 153.xx Other 159.xx Other intestinal diseases 1245 (1.18) Megacolon, other than Hirschsprung s disease Other specified functional disorders of 564.8x the intestine Unspecified functional disorders of the 564.9x intestine Other specified disorders of the rectum and anus Perforation of intestine (0.07) Stercoral or rectal ulcers 231 (0.22) Anus and rectum Intestine Volvulus 560.2x 8 (0.01) Methods Data Source This study was based on longitudinal data from Medi- Cal. Data for OTC and prescription medications included National Drug Code numbers, dispense dates, quantities of medication dispensed, and number of days for which the medication was supplied. Inpatient medical services contained a primary diagnosis, up to 2 secondary diagnoses in the International Classification of Diseases (Ninth Revision, Clinical Modification; ICD-9-CM) format, and the dates of admission and discharge. Outpatient medical services included the primary diagnosis, current procedural technology codes, and service date. The eligibility file included age, sex, ethnicity, and a monthly history of Medi-Cal eligibility. Data were obtained for the period from 1995 to 2003, and all costs reported were the actual amounts reimbursed by Medi-Cal. For convenience of review, all cost-related data (in the text and tables) have been rounded to the nearest whole dollar. Study Population Data were analyzed from all patients 18 years or older receiving Medi-Cal support who saw a physician at least once for constipation (ICD-9-CM code 564.0x). To ascertain use and cost of health care resources, all cost-related analyses were restricted to patients who did not have supplemental insurance (eg, Medicare). However, data presented for comorbid conditions reflected patients enrolled in the Medi-Cal program who also might have been receiving supplementary insurance. Patients who were selected for the study were required to have been eligible for Medi-Cal for at least 3 months before the index date and for at least 12 months after the index date. Study Design The index date was defined as the first diagnosis of constipation (ICD-9-CM code 564.0x) for each patient starting in Each patient s resource use was assessed over a 15- month period starting 3 months before the index date (to ensure inclusion of diagnostic costs) and ending 12 months after the index date. The prevalence of comorbid conditions was assessed during the 12 months after the initial physician visit for constipation. Outcome Measures Outcome measures for the study included assessments of resource use (ie, physician visits, inpatient hospital stays, procedures, medication costs) for gastrointestinal symptoms and comorbid conditions (Table 1). Results Population and Demographics We identified 105,130 patients who were older than 18 years of age, saw a physician at least once for constipation, and were enrolled in the Medi-Cal program. The mean patient age was 48.5 years (range, y), 65% were women, 31% were white, and 29% were Hispanic (Table 2). Of this group, 76,854 patients had no supplemental health insurance; these patients made up the study population for whom cost-related data were analyzed. Health Care Resource Use and Cost of Care During the 15 months of observation (n 76,854; 115,281 patient-years), there were 106,555 physician visits for constipation (average, 1.4 visits/patient). Medi-Cal reimbursements for physician visits totaled $3,016,017 ($39/patient). The cost of physician outpatient visits alone was $2,186,961 ($28/patient) (Figure 1). The total reimbursement cost for gastrointestinalrelated procedures and laboratory tests was $14,052,503 ($183/ patient). Of this total, $5,758,890 ($75/patient) was spent on laboratory tests alone. Table 3 shows the details of physician visits and selected procedures. Table 2. Patient Demographics Demographic characteristics Patients with 1 code for constipation (564.0x) (N 105,130) Mean age, y (SE) (0.06) Sex, % (n) Female (68,566) Male (36,564) Race, % (n) White (32,916) Hispanic (30,256) Asian (18,114) Black (10,555) Missing response 9.29 (9767) Other 3.02 (3175) American Indian 0.33 (347)

3 September 2007 HEALTH CARE RESOURCE UTILIZATION IN CONSTIPATION 1055 Medications used by the study population included laxatives, enemas, stool softeners, stimulants, preradiograph evacuation agents, and prokinetics. There were a total of 41,723 instances of OTC drug use and 1665 instances of prescription medication use. The total cost of all medications was $388,780 ($5/patient) (Table 4). Approximately 479 patients (0.6% of 76,854) in the cohort required hospital admission for their constipation. The total cost for hospital stays was $1,433,708. The mean duration of stay for these patients was 3.2 days, resulting in a mean cost per hospital admission of $2993. The total health care cost (physician visits, procedures and tests, medications, and hospital admissions) for patients with constipation in the Medi-Cal system for the 15-month period was $18,891,008 ($246/patient) (Figure 2). Figure 1. Cost of constipation-related physician visits (total $3,016,017). Concomitant Medical Conditions Within 12 months of the first physician visit for constipation, of the total Medi-Cal population who saw a physician at least once for constipation (n 105,130), hemorrhoids were diagnosed in 5.4%, irritable bowel syndrome was diagnosed in 3.42%, and fecal impaction or intestinal obstruction was diagnosed in 2.2% (Table 1). It should be noted that the true nature Table 3. Physician Visits and Procedures No. of patients using resource No. of units Mean cost per visit, US$ Total cost, US$ Total no. of patients 76,854 Physician visits Critical care Emergency room 15,300 16, ,009 Physician inpatient ,999 Physician outpatient 61,451 81, ,186,961 Net costs for physician visits 3,016,017 Procedures Anal fissure procedure Appendectomy ,002 Barium enema ,367 Colonoscopy ,051,553 Abdominal/pelvic computerized ,014 tomography Cholecystectomy ,870 Colon resection ,148 Other endoscopic procedures ,512,956 Hemorrhoid procedure ,832 Laboratory studies 59, , ,758,890 Lysis of adhesions ,716 Abdominal/pelvic magnetic ,249 resonance imaging Ovarian cystectomy ,059 Perforation repair Abdominal/pelvic radiology 17,971 32, ,401 Reduction of volvulus, intussusception Sigmoid/proctosigmoid/anoscopy ,311 Diagnostic surgical laparoscopy ,573 Stricturoplasty for intestinal obstruction Total abdominal hysterectomy ,148 Abdominal ultrasound 14,077 22, ,352,461 Net costs for procedures 14,052,503

4 1056 SINGH ET AL CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 5, No. 9 Table 4. Summary of Medication Use and Cost Medications No. of medications used Mean cost per medication, US$ OTC Bulking agents Emollient laxatives 8 26 Enemas 31 9 Stimulant stool softeners Nonstimulant stool softeners 36,991 7 Irritant stimulants Preradiograph evacuants 3 6 Saline laxatives Prescription Polyethylene glycol Nonstimulant stool softeners 2 5 Other laxatives Preradiograph evacuants Prokinetic agents Total cost 388,780 of these conditions as a complication, comorbidity, or cause of constipation was not established. Discussion Our study results show that constipation-related Medi- Cal reimbursement over a 15-month period was $18,891,008, representing a substantial economic burden to the Medicaid system. A recent survey estimated that 2.7 million ambulatory visits (including inpatient care, emergency room visits, physician office visits, and outpatient hospital visits) resulted in a primary diagnosis of constipation, with a resultant total expenditure of $235 million per year in the United States. 14 Although we cannot directly compare our estimated cost of treating constipation in the Medi-Cal population with the estimated cost of treating constipation in the United States, we have shown that adults with constipation make significant and costly use of health care resources, which places a heavy economic burden on patients, employers, and society. This study was based on data from patients enrolled in Medi-Cal, the largest state Medicaid program in the United States, providing health care coverage for more than 7 million low-income and disabled persons who have no other source of health insurance. This data set has been shown to be an accurate representation of costs incurred; the 2004 Medi-Cal Payment Error Study evaluated the accuracy of Medi-Cal payments and found that 96% of total dollars paid were billed appropriately and paid accurately. 17 During the 15-month study period, the largest Medi-Cal reimbursed, constipation-related cost in this patient population was for gastrointestinal procedures and laboratory tests (total, $14,052,503); more than a third of this amount was attributed to laboratory testing alone, a finding consistent with other studies that have reported the high cost associated with diagnosing constipation. 12 The second largest component of Medi- Cal reimbursement was physician visits (total, $3,016,017), followed by hospital admissions (total, $1,433,708), and medications (total, $388,780). Constipation-associated medication costs included more than 40,000 instances of OTC product use and more than 1600 instances of prescription drug use. To bring the results of this study into perspective, we should consider the reported health care costs of treating other disorders in the Medicaid and the privately insured populations. The total direct cost of treating overactive bladder in the California Medicaid population was reported to be approximately $121 per member per year (PMPY); only 15% of the patients were treated pharmacologically. 18 By comparison, an analysis of the annual direct cost of treating overactive bladder among pharmacologically treated patients in managed health care plans was reported to be approximately $8073 $10,523 (depending on the type of treatment). 19 Similarly, the health care costs of treating asthma differ between those reported for the Medicaid population and for a private insurer population. The estimated cost of treating asthma in the North Carolina Medicaid population was reported to be $3346 PMPY ($707 PMPY for prescription medication). 20 The average annual direct cost of treating asthma based on employer health care claims was $6452 per patient, nearly twice the cost of treating asthma in the Medicaid population; the per-patient cost of prescription medication was 3 times what was seen in the Medicaid population ($2127). 21 Estimated average annual direct costs of irritable bowel syndrome in the California and North Carolina Medicaid populations were reported as $2952 and $5908 PMPY, respectively. 22 However, the PMPY cost of prescription medication in both Medicaid populations was the same ( $1400). Results of these studies exemplify the lower expenditures in the California Medicaid population compared with Medicaid expenditures in other states. In addition, they suggest that reduced pharmacologic treatment could be one factor contributing to the lower per-person spending in the California Medicaid population compared with the private insurer population. Although the estimated costs of constipation in the Martin et al 14 study ($235 million) and our study ($19 million) are not directly comparable, they represent important references given the dearth of data on this topic. It should be noted that the key difference between the 2 studies was the populations that were evaluated. Martin et al 14 used national survey data that reflected the total US population (including the US Medicaid popula- Figure 2. Cost of constipation-related use of health care resources (total $18,891,008).

5 September 2007 HEALTH CARE RESOURCE UTILIZATION IN CONSTIPATION 1057 tion), we used data specific for the California Medicaid population. In addition, we excluded children ( 18 y), who make up 39% of the Medi-Cal population, from our analysis. 23 Patients with constipation often experience comorbid conditions, complications, or both. In the current study, the most common condition (among the 105,130 patients who saw a physician at least once for constipation) was hemorrhoids, which occurred in 5657 (5.4%) patients within 1 year of the first visit for constipation. This was followed in frequency by irritable bowel syndrome (3597 [3.42%] patients) and fecal impaction or intestinal obstruction (2288 [2.2%] patients). These additional illnesses further increase the cost of caring for this patient population. It should be noted, however, that we could not establish the relationship between constipation and any of these conditions because of the limited accuracy of claims data in diagnosing concomitant medical conditions. In addition, this study was not designed for that purpose. More studies with well-designed control groups are needed to achieve an understanding of the true nature of the relationship between constipation and each comorbid condition. Many patients have constipation-associated symptoms on a long-term basis 24,25 and regard this disorder as a severe, bothersome medical condition that substantially decreases their quality of life. 25 Because patients enrolled in the current study saw a physician at least once for constipation, it is highly likely that their symptoms were chronic and sufficiently bothersome to affect their daily lives negatively. However, because the duration of constipation-associated symptoms was not documented, the exact percentage of study patients who had chronic constipation is difficult to ascertain. The economic impact of constipation in our study may have been underestimated for several reasons. First, our study reflected only the direct costs of health care resource use and cost of care for constipation. The total economic impact would be considerably greater if indirect costs were considered. In addition, the OTC drug costs reported in this study probably are underestimated because they reflect only those OTC drugs for which patients filed a claim. Another factor that might have affected the total cost is that children were excluded from the analysis. Finally, Medi-Cal spending per person is lower than total Medicaid spending per person. The total Medicaid expenditure for fiscal year 2003 was $233 billion (55 million beneficiaries) for the United States and $26 billion for California (10 million Medi-Cal beneficiaries). 16 It should be noted that the results of our study are specific to Medi-Cal and may not be applicable to Medicaid plans in other states or representative of spending in the general population. In conclusion, our study suggests a substantial use of health care resources and a significant economic burden associated with direct medical costs for patients with constipation. Such data reflect the use of medical services and the consumption of prescription and OTC medications, therefore further elucidating the direct use of health care resources in this patient population. References 1. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol 2004;99: Longstreth GF, Thompson WG, Chey WD, et al. Functional bowel disorders. Gastroenterology 2006;130: Stewart WF, Liberman JN, Sandler RS, et al. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol 1999;94: O Keefe EA, Talley NJ, Zinsmeister AR, et al. Bowel disorders impair functional status and quality of life in the elderly: a population-based study. J Gerontol A Biol Sci Med Sci 1995;50: M184 M Chang L. Review article: epidemiology and quality of life in functional gastrointestinal disorders. Aliment Pharmacol Ther 2004; 20(Suppl 7): Irvine EF. Quality of life in inflammatory bowel disease and other chronic diseases. Scand J Gastroenterol 1996;31: Damon H, Dumas P, Mion F. Impact of anal incontinence and chronic constipation on quality of life. Gastroenterol Clin Biol 2004;28: Irvine EJ, Ferrazzi S, Pare P, et al. Health-related quality of life in functional GI disorders: focus on constipation and resource utilization. Am J Gastroenterol 2002;97: Koloski NA, Talley NJ, Boyce PM. The impact of functional gastrointestinal disorders on quality of life. Am J Gastroenterol 2000; 95: Lembo A, Camilleri M. Chronic constipation. N Engl J Med 2003; 349: Sonnenberg A, Koch TR. Epidemiology of constipation in the United States. Dis Colon Rectum 1989;32: Rantis PC Jr, Vernava AM III, Daniel GL, et al. Chronic constipation is the work-up worth the cost? Dis Colon Rectum 1997;40: Rao SS. Constipation: evaluation and treatment. Gastroenterol Clin North Am 2003;32: Martin BC, Barghout V, Cerulli A. Direct medical cost of constipation in the United States. Managed Care Interface 2006;19: US Department of Health and Human Services. National health expenditures by type of service and source of funds: calendar years Available from: NationalHealthExpendData/02_NationalHealthAccountsHistorical.asp#TopOfPage. Accessed: July 18, The Kaiser Commission on Medicaid and the Uninsured. California: Medicaid payments per enrollee, FY2003. Available from: profile& area California&category Medicaid %26 SCHIP&subcategory Medicaid Spending&topic Medicaid Payments per Enrollee% 2c FY2003. Accessed: July 18, State of California Health and Human Services Agency. Medi-Cal payment error study: fee-for-service and dental programs. Sacramento, CA: California Department of Health Services 2004: Singh G, Malla S, Wang H, et al. Adults with overactive bladder have significant health care resource utilization evidence from a large Medicaid population. [Unpublished abstract] Presented at: American Urological Association; May 20 25, 2006; Atlanta, GA. 19. Harris HM, Del Aguila MA, Beaulieu JF, et al. A comparison of total direct medical costs among patients receiving agents used in the pharmacologic management of overactive bladder. Presented at: American Society of Health-System Pharmacists; June 11 15, 2005; Boston, MA. 20. Sapra S, Nielsen K, Martin BC. The net cost of asthma to North Carolina Medicaid and the influence of comorbidities that drive asthma costs. J Asthma 2005;42: Colice G, Wu EQ, Birnbaum H, et al. Healthcare and workloss costs associated with patients with persistent asthma in a privately insured population. J Occup Environ Med 2006; 48: Martin BC, Ganguly R, Pannicker S, et al. Utilization patterns and

6 1058 SINGH ET AL CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 5, No. 9 net direct medical cost to Medicaid of irritable bowel syndrome. Curr Med Res Opin 2003;19: The Kaiser Commission on Medicaid and the Uninsured. Distribution of Medicaid enrollees by enrollment group, FY2003. Available from: compare&category Medicaid %26 SCHIP& subcategory Medicaid Enrollment&topic Distribution by Enrollment Group%2C FY2003. Accessed: July 18, National Digestive Diseases Information Clearinghouse. Constipation. Bethesda, MD: National Institute for Diabetes and Digestive and Kidney Diseases, National Institutes of Health; September NIH Publication No Available from: Accessed: November 16, Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther 2007;25: Address requests for reprints to: Gurkirpal Singh, MD, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Institute of Clinical Outcomes Research and Education, 100 Hamilton Avenue, Suite 225, Palo Alto, California gsingh@ stanford.edu. Presented in part in poster format at the American College of Gastroenterology 69th Annual Scientific Meeting and Postgraduate Course, October 29 to November 3, 2004; Orlando, Florida.