Reduced Survival in Bariatric Surgery Candidates Delayed or Denied by Lack of Insurance Approval

MEDICAL CANDIDACY GUIDELINES for bariatric surgery are well established. The 1991 National Institute of Health (NIH) consensus statement recommended weight-loss surgery for patients with a body mass index (BMI) $ 40 kg/m2 or $ 35 kg/m2 with obesity-related comorbidities, who have failed nonsurgical weight-loss efforts and been screened by a multidisciplinary team.1 Even though these criteria have been substantiated by evidence over the years, referral practices,2 and disparities3 continue to limit access to care.

For those morbidly obese Americans who are evaluated by bariatric providers, insurance coverage still represents a significant and sometimes insurmountable barrier to definitive care. Medical insurance coverage varies between plans and carriers.4 Bariatric insurance precertification requirements are often confusing to patients and providers, in part as a consequence of the rapid shifts in surgical treatment paradigms and ongoing changes related to national health care reform.

Third-party payers often require a certain number and frequency of provider visits to prove sufficient nonsurgical weight-loss effort.5 Some may add other preoperative weight-loss requirements or may cover only certain bariatric operations. In this complex environment, patients and providers sometimes make medical candidacy determinations believing insurance benefits exists for weight-loss surgery, but then precertification is denied. At best, such decisions lead to a delay in effective therapy. At worst, patients who would benefit from bariatric surgery lose momentum and never receive surgical treatment.

Insurance denial is associated with increase in medical comorbidities among morbidly obese patients.6 To date, the impact of insurance denials (and delays) on survival is unknown. As the prevalence of obesity increases, it is important for the medical community to address the possible effects of limited or restricted access to weight-loss surgery. The propensity for obesityrelated comorbidities to continue to progress due to administrative barriers exists and may be associated with a decrease in survival.

Methods

This observational cohort study was conducted with the approval of the University of North Carolina Institutional Review Board.

Using a prospectively maintained database, we identified all patients who applied for weight-loss surgery between August 2003 and December 2008, and who were evaluated and approved as acceptable candidates by our multidisciplinary care team (bariatric provider, nutritionist, and psychologist), and who were then submitted for precertification to a thirdparty insurer. All patients were 18 to 64 years and met the NIH criteria for bariatric surgery candidacy. Patients who were precertified at initial request became the control group for this study. Patients who were denied by their insurance carrier at initial request became the subject cohort. Patients from the subject cohort who eventually went on to receive a weight-loss procedure were kept within the subject cohort to determine the survival effect of any delay in insurance approval.

The Social Security Death Index was used to identify those patients from the subject cohort and the control cohort who were deceased as of January 1, 2013. At least two qualifiers were used to confirm identity from the following: name, date of birth, and Social Security number. Data were analyzed to ensure no duplication of a single patient who had applied to our program more than once.

Descriptive variables were collected, including age, gender, race, and BMI, and then analyzed for variations using the x2 test for categorical data and t test for continuous data, with a P < 0.05 threshold for statistical significance.

Survival was then calculated from the time of insurance approval or denial until January 1, 2013, or the date of death. Kaplan-Meier survival curves were plotted using SPSS Statistics software, version 21.0 (IBM Corp., Chicago, IL). Significance was determined using the logrank test, again using a P < 0.05 level to determine statistical significance.

Results

During the study time frame, 463 prospective bariatric surgery patients completed the bariatric intake process, which involved clearance by our multidisciplinary team (psychology, nutrition, and surgery). Of these, 78 per cent were female, mean age was 45 ± 10 years, and mean BMI was 52.1 ± 9.4 kg/m2. Three hundred and sixty-three patients were approved by their insurance carrier on initial precertification request (85% female, mean age 43 ± 9.7 years, and mean BMI 51.1 ± 9.4 kg/m2), whereas 100 patients (22%) were denied (16% male, mean age 45 ± 9.8 years, mean BMI 52.2 ± 9.5 kg/m2) for various reasons. Of these denied patients, at least nine were later able to receive bariatric surgery, but they were kept in the subject group.

There were no statistically significant differences in gender, age, race, or BMI between the (denied or delayed) subjects and the (approved) controls (Table 1). When querying the Social Security Death Index for mortality events in the cohorts, six subjects (6%) and seven controls (1.9%) were deceased. Follow-up ranged from 0 to 113 months. Kaplan-Meier survival curves were generated (Fig. 1). Log-rank test demonstrated a statistically significant (P < 0.001) reduction in survival among subjects versus controls.

Discussion

We set out to determine the impact of insurance denial (or delay) on bariatric surgery candidates' cumulative survival. Our results revealed that medically approved patients who were initially denied by the insurance certification process had a mortality rate three times higher than those initially approved on insurance submission.

Obesity Is an Epidemic in the United States

The prevalence of obesity has been increasing over several decades. More than two-thirds of the population is overweight and more than one-third is obese (BMI $ 30 kg/m2). In all, 6.3 per cent of Americans are morbidly obese (BMI $ 40 kg/m2).7 Morbid obesity is associated with increased prevalence of Type II diabetes, hyperlipidemia, arthritis, obstructive sleep apnea, gastroesophageal reflux disease, and certain cancers.8 In 2008, an estimated $147 billion was spent on obesity-associated comorbidities. Each year, it is estimated that over 300,000 Americans die from obesity-related causes.9, 10

Bariatric Surgery Is Safe

Since 1960s, bariatric surgical techniques and perioperative care have been refined to the point where bariatric operations are among the safest elective gastrointestinal procedures. This favorable safety profile may be attributed to the national emergence of advanced laparoscopic procedures in the 1990s and the development of formalized training programs. The combination of effective procedures and a skilled surgical workforce has reduced the 30-day mortality for bariatric operations to 0.17 to 0.28 per cent, which is safer than a colectomy (0.5-2.0%).11

Bariatric Surgery Is Effective

For well-selected patients, bariatric surgery provides the best chance for long-term weight loss and improvement of comorbidities. The most compelling example may be the impact of gastric bypass on Type II diabetes. Gastric bypass is rapidly and durably effective for Type II diabetes and is now recognized by endocrinologists as a legitimate treatment for brittle diabetics.12 Bariatric surgery also allows significant improvement in hypertension, sleep apnea, polycystic ovaries, pseudotumor cerebri, obesity-hypoventilation syndrome, and the incidence of certain cancers.13

Mortality Is Improved in Patients Undergoing Bariatric Surgery

Christou and colleagues performed an observational study comparing two cohorts of morbidly obese individuals: one received bariatric surgery whereas the other did not. Surgery patients had a 0.68 per cent mortality rate compared with 6.17 per cent in controls, corresponding to an overall 89 per cent reduction in the relative risk of death.14 This survival benefit was attributed to reduction in obesity-related comorbidities.

Quality of Life Improves After Bariatric Surgery

Bariatric surgery patients surveyed 10 years out from operation have enhanced health perceptions, social interactions, psychosocial functioning, and less depression.15

Bariatric Surgery Saves Money

The long-standing debate of particular interest to third-party payers involves the cost-effectiveness of bariatric surgery. Recent data show that direct and indirect costs of minimally invasive bariatric surgery for the average patient are offset by reduced health care expenditures after only 2 years.16 Hence, bariatric surgery provides savings for both patients and health care systems.

Access Is Neither Universal nor Guaranteed

Bariatric surgery can improve morbidity and mortality for morbidly obese Americans.17, 18 Given the high expenses associated with surgical therapy, few can afford to cover the attendant medical costs "out of pocket." For those with bariatric surgery insurance benefits, a multidisciplinary medical assessment may be initiated to determine medical candidacy according to evidence-based guidelines. However, even when patients and medical providers determine bariatric surgery is indicated, sometimes the complexities of the insurance approval process delay or restrict access.

Insurance Denials and Delays Are High

In our study, 22 per cent of medically approved candidates were denied initially by insurance providers. Tsuda et al.19 reported 47.8 per cent initial denials. One large study from California found that 1 in 10 appeals for insurance denials involved a request for bariatric surgery; although most of these were overturned the study highlights the issue of delays incurred by many morbidly obese patients seeking effective therapy.20 Since insurance companies are able to determine and use their own definitions of "medical necessity" to either deny or approve bariatric claims, approval criteria are often more stringent than those applied by a multidisciplinary bariatric team.21 For instance, many insurance companies require documentation of a period of intensive "assisted" weight loss by either a nutritionist, health care professional, or a dietician. Each visit may be scrutinized for documentation around nutritional and behavioral counseling, weight measurement, treatment of comorbid conditions, etc. Missed appointments during a proscribed series of monthly visits may restart the clock. Some insurers even mandate preoperative weight loss, despite the obvious internal inconsistency in this requirement. Many of these "hurdles" continue despite studies showing they do not positively alter postoperative outcomes or compliance, and are associated with a 50 per cent increase in drop out.22 Insurance mandates, which exist without proven benefit may serve as a source of discouragement and inefficiency for patients and programs.

Delays/Denials Harm Patients

Postponement or restriction of definitive care for morbid obesity may lead to more than just time wasted. In 2010, Al Harakeh et al.6 reportedanincreaseinobesity-related comorbidities shortly after denial in insurance approval for bariatric surgery. These data, in combination with ours which show a survival disadvantage in similar patients, implicate progression of disease states or the development of new medical conditions as the underlying cause of the reduced survival identified in our subjects.

This Present Study Has a Few Limitations

We used an observational, single-center design. Nine patients who were initially denied coverage did successfully appeal and received a bariatric operation. We could not be certain whether other patients denied at our center came to operation outside our system. Therefore, we have been careful to use the primary denial in defining our groups, and have considered denial and delay together in our analysis. In addition, to obtain a reliable mortality calculation, we used the Social Security Death Index. However, this method did not permit identification of cause of death. Our attribution of additional deaths in the subject group to comorbid conditions and obesity is inferential based on the other medical literature cited. Finally, our study population is limited by its size and the regional nature of our patient population. We believe a larger cohort across multiple institutions and practice types will allow generalization of our results and conclusions.

Our Results May Underestimate the Impact of Restricted Access

The subject group in the present study was comprised of patients under the care of primary care providers who were actively managing comorbidities. Certainly, we are equally concerned for those individuals without the means or awareness to reach out or obtain a referral for bariatric evaluation and fear they are an untested subject group at even greater risk for poorer survival. Unfortunately, only 1 per cent of the population that could benefit from surgical therapy for morbid obesity seeks care.23 Our interpretations are easily extended to encompass all those who have limited access to surgical therapy for morbid obesity.

We Need to Simplify and Expand Access to Bariatric Surgery

Our finding of a survival disadvantage for patients restricted in accessing weight-loss surgery calls into question administrative hurdles that limit access unnecessarily. Today, some insurance carriers apply overly stringent criteria for "medical necessity" or overly burdensome requirements to validate comorbid conditions and weight-loss efforts, despite the absence of compelling evidence that such filters improve outcomes or compliance. The onus is on the health care community to enhance access for those Americans who cannot enter the system and to streamline access for those who can. It is time to implement universal guidelines for bariatric benefits.

Conclusion

Obesity is an epidemic associated with enormous medical and personal costs. To date, nonsurgical treatments are unreliable. Bariatric surgery is safe, medically effective, and cost-effective. Nevertheless, coverage is not universal and access is not always easy. Patients and bariatric providers still contend with stringent requirements and documentation mandates that delay or deny access to care even after multidisciplinary medical clearance. In our study, 22 per cent of such patients were initially denied by insurance and this group had 3-fold higher cumulative mortality, presumably by progression of obesityrelated comorbidities.

Acknowledgments

We thank the Foundation for Surgical Fellowships.