The lifetime risk of surgery for pelvic organ prolapse (POP) is 12.6%.1,2 Given the aging population in the United States, Dieter et al estimated that surgery rates for POP are to increase by 48% by 2050.3,4 Conversely, several studies have reported a decrease in POP procedures after the 2008 and 2011 U.S. Food and Drug Administration (FDA) advisories regarding the use of mesh for prolapse.2,5–8 Studies examining POP procedures at a national level have focused on either inpatient or outpatient procedures alone, which may underestimate the true prevalence by failing to account for both settings.9–12 There are limited data assessing trends in utilization of both inpatient and outpatient surgeries for POP that span the time before and after the 2011 FDA safety advisory.
The Health Care Cost Institute is a nonprofit organization that collects inpatient and outpatient claims data from three large commercial insurers across the United States. Our primary aim was to use these data to assess changes in surgical management of prolapse in the inpatient and outpatient settings, with and without mesh, between 2010 and 2013. Our secondary aim was to analyze changes in inpatient and outpatient hospital payments and patient cost share over time. We hypothesize that, during the time of the FDA safety communication on vaginal mesh, procedures for prolapse with mesh decreased, but those without mesh remained stable. As a result of the reduction in procedures with a graft, adjusted payments for these procedures are hypothesized to remain stable or decrease.
MATERIALS AND METHODS
A retrospective cohort study was performed using data from the Health Care Cost Institute between January 1, 2010, and December 31, 2013. The institute includes private payer data from Aetna, Humana, and United Healthcare and is standardized using multiple quality control and validation checks, including an actuarial validation to ensure the data set is consistent with each insurer's claims experience (http://www.healthcostinstitute.org). This study was a secondary data analysis and deemed “not regulated” by the University of Michigan Institutional Review Board (HUM0114432). Patients with employer-based insurance plans and those on the individual market were included. The geographic distribution and market share of these insurance providers by state are provided in Appendix 1, available online at http://links.lww.com/AOG/B66. Inpatient and outpatient claims were analyzed to assess utilization and payment variation within each respective setting. Current Procedural Terminology, 4th Edition and International Statistical Classification of Diseases and Related Health Problems, 9th Revision codes were used to identify procedures performed for prolapse as well as to identify cases involving a graft or prosthesis (ie, “mesh”) (Table 1). All concurrent prolapse repairs on the same day were counted as one procedure. An individual woman may have had more than one surgery on distinct dates during the study period, which would be counted as separate procedures. The primary outcome was to assess the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA safety communication. The secondary outcome was to assess the changes in payments and reimbursements for these procedures.
Number of women enrolled per year, age, procedures of interest, and payment data were all obtained from the database. Inpatient and outpatient utilization was calculated both quarterly and per calendar year and was defined as the number of prolapse procedures performed per 10,000 woman-years. This was obtained by calculating the total number of inpatient, outpatient, and overall prolapse procedures divided by the total number of unique women who have at least 1 month of enrollment for the calendar year. Trends in utilization and payments for procedures in each year were analyzed using generalized mixed models. A multiple-group, single-intervention interrupted time-series analysis using ordinary least squares regression was performed to compare the utilization rates of prolapse procedures with and without mesh before and after the FDA safety communication. P values of <.05 were considered significant.
Payments were analyzed for an episode of care—defined as all claims associated with a patient's medical services between admission and discharge for their surgery. The patient's portion of the payment—referred to as the patient cost share—included coinsurance (amount the patient pays for a specific service as defined by their benefit plan[s]), copayment (a fixed amount the member pays for a service as defined by their benefit plan[s]), and deductible (amount of money applied to the patient's annual deductible if they did not reach the maximum annual amount). The insurance payment is the amount reimbursed to the hospital and health care provider. Total hospital payment is the sum of the patient's and the insurance payments. The average per-case patient cost share and insurance payment to the hospitals were calculated. All payments were adjusted for inflation to 2013 dollars using the Bureau of Labor Statistics Medical Consumer Price Index. Statistical analyses were performed using SAS 9.4.
The number of procedures performed for prolapse in 2010 was 31,787 and decreased by 19.6%, to 25,570, in 2013 (P=.026). Utilization rates of prolapse procedures followed a similar trend with a decrease of 21.1% between 2010 and 2013. The number of prolapse procedures both with and without mesh decreased, although the yearly decrease was almost two times as much for mesh procedures (30.7%, P=.05 vs 16.6%, P=.01; Table 2). Analysis of quarterly utilization rates reveals that, before the FDA safety communication (pre-FDA), the use of procedures with mesh was increasing, whereas utilization of procedures without mesh was decreasing (Fig. 1). After the July 2011 FDA safety communication (post-FDA), utilization of procedures with mesh significantly declined (slope pre-FDA=0.024 vs post-FDA=−0.025, P=.002). Utilization rates for procedures without mesh fell more rapidly after the July 2011 FDA safety communication, but this change was not statistically significant (slope pre-FDA=−0.004 vs post-FDA=−0.022, P=.47).
Table 2 is a comparison of yearly enrollment, age of enrollees, and utilization of prolapse procedures over the study period. Overall, utilization of prolapse procedures was highest among patients older than age 65 years, which remained stable, and utilization decreased in all other age groups over time. In evaluating procedure types, combined anterior and posterior repair decreased by 31.3% (P=.008), vaginal and abdominal colpopexy procedures increased by 5.4% (P=.002), and obliterative procedures increased by 1.6% (P=.017). Overall, the number of hysterectomies performed for POP was relatively stable over the time period; however, laparoscopic cases more than doubled (P=.003), whereas those done vaginally decreased by 34% (P=.031). Utilization of inpatient procedures decreased by 52.2% (P=.002) and outpatient procedures increased by 18.5% (P=.132). Length of stay remained unchanged.
Figure 2 shows changes in hospital payments for individual prolapse procedures by year. Patient cost share and insurance payments were higher for inpatient procedures, both with and without mesh. After adjustment to 2013 dollars, mean hospital payment (patient and insurance portion) for individual inpatient procedures increased by 12.0% for inpatient procedures with mesh ($8,315 in 2010 vs $9,315 in 2013, P=.001) and by 15.6% for those without mesh ($7,826 in 2010 vs $9,048 in 2013, P=.005). The majority of this increase was driven by increases in the insurance payment, because patient cost share remained relatively stable ($681–707 for procedures with mesh, $710–772 for procedures without mesh). In the outpatient setting, total hospital payment increased by 40.7% for procedures with mesh ($4,961 in 2010 vs $6,981 in 2013, P=.006) and by 30.2% for procedures without mesh ($3,955 in 2010 vs $5,149 in 2013, P=.004). Outpatient insurance payments increased by 40.8% for procedures with mesh ($4,490 in 2010 vs $6,321 in 2013, P=.011) and by 28.8% for procedures without mesh ($3,511 in 2010 vs $4,522 in 2013, P=.003). Patient cost share increased by 39.9% for procedures with mesh ($471 in 2010 vs $659 in 2013, P=.045) and by 41.2% for those without mesh ($444 in 2010 vs $627 in 2013, P=.016; Fig. 2; Table 3).
Hospital payments were higher for procedures with mesh compared with those without mesh. The relative increase in reimbursement over time for procedures with mesh differed based on inpatient status. The addition of mesh to an outpatient case increased the hospital payment by $1,006 in 2010 and by $1,832 by 2013. Conversely, an inpatient procedure with mesh added $489 to the hospital payment in 2010 and only $267 in 2013 (Fig. 2; Table 3).
Figure 3 and Table 4 show the change in total annual payments for prolapse procedures over time. There was a 13.5% decrease in total annual payments (from $201 million to $174 million) from 2010 to 2013. The largest decrease was seen in inpatient procedures performed with mesh, which saw a 57.3% decrease in number of procedures, whereas inpatient procedures without mesh declined by 48.6%. The downward payment effect is offset by the increasing reimbursements for both inpatient and outpatient procedures described previously.
Using data from three national private insurers, our analysis reveals a 21% decrease in the annual utilization of all procedures for POP from 2010 to 2013. Over the 4 years, the decrease in the utilization of procedures with mesh was twofold greater than those without mesh; however, the utilization of procedures without mesh also significantly declined. Before July 2011, the utilization rate of procedures with mesh was increasing and then sharply declined after the FDA safety communication was released. These findings support prior studies describing an increase in mesh procedures during the years preceding 2011.13–16 Our findings highlight a previously undescribed decrease in surgical management of prolapse, regardless of mesh use, during a time when the need for prolapse surgery on a national level was projected to rise.3,4,17
There are several possible reasons for the decrease in POP procedures. Hospital policies and physician practice may have changed in response to the reports of complications from mesh and the FDA safety communications in 2008 and 2011.2,8 The number of physicians privileged to use mesh may have changed when hospitals reacted to guidelines regarding surgeon privileges, the consent process, and outcomes reporting.18,19 Simultaneously, subspecialty physicians may have become more selective about mesh procedures and changed the procedures they perform. Physicians have reported that after the 2011 FDA safety communication, they were less likely to use mesh in a vaginal repair of recurrent prolapse and more likely to use an abdominal approach for primary prolapse repairs.20 Finally, patients may have become more reluctant to consider surgery for prolapse given the media coverage about mesh-related complications.21,22
Claims data from inpatient and outpatient settings allowed us to identify changes in surgical practice for prolapse. Surgery for prolapse is now more often performed as an outpatient procedure compared with inpatient. Sanses et al reported a 29% decrease in inpatient procedures in the decade before 2011. This change in practice is now occurring at a more rapid pace with a 52.2% decrease in inpatient procedures and a 18.5% increase in outpatient procedures over a 4-year period.10 This outpatient shift may be related to the observed increase in hysterectomies performed laparoscopically. Given the outpatient shift, it will be important for future research to use data sets that include outpatient claims.
Average expenditures for prolapse procedures continue to increase. We found that prolapse surgery became 7.5% more expensive between 2010 and 2013—a surprising development considering the large shift from inpatient to outpatient surgery—and that outpatient procedures were 40% less expensive than inpatient procedures. The majority of the payment increase was seen in the insurance portion, because patient payments remained stable.
There is some evidence to explain why surgery for prolapse became more expensive. First, the proportion of hysterectomies for prolapse performed vaginally, the least expensive and morbid surgical approach, decreased 34%, whereas the utilization of more expensive laparoscopic hysterectomy increased 103%.23 Second, the average outpatient cost of a case involving mesh was $1,823 (40%) higher than a case that did not use mesh. It is possible that a growing proportion of gynecologic surgeons now favor laparoscopic repairs with mesh, which are associated with higher expense, over vaginal surgery. A final factor affecting the changing payments is that hospitals and insurance companies often negotiate payment contracts, which can affect these outcomes, and may be unrelated to clinical factors.
Although the findings among women with private insurance may not apply to women with Medicare, Medicaid, or no insurance, this study's primary strength is its generalizability, because this database provides data for more than 25 million commercially insured women from all 50 states. The use of deidentified claims data is a limitation. We are unable to distinguish between biological and synthetic mesh with current International Statistical Classification of Diseases and Related Health Problems, 9th Revision procedure codes and we are unable to determine whether current coding practices accurately distinguish between conventional and robot-assisted laparoscopy. Therefore, robot-assisted surgeries were considered laparoscopic procedures. Additionally, only one Current Procedural Terminology, 4th Edition code could be recorded per procedure, and as such, we were unable to sufficiently distinguish between vaginal and abdominal colpopexy. Finally, hospital and insurance payments do not necessarily reflect actual cost.
Clinically, the FDA safety communication appears to have led to a change in surgical practice regarding the treatment of POP. Future studies are needed to identify the cause of the declining number of prolapse procedures despite an aging population and a projected increase in need as well as to examine factors that account for the observed rise in hospital payments.
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