The New Jersey Department of Health and Senior Services (DHSS) formed a workgroup a few years ago to determine the best way to respond to concerns over the growth of the surgery, including how to ensure that overutilization is prevented, how to preserve access by patients who could most benefit from the surgery, and how to ensure that the surgery is performed by the most qualified providers.

Unlike procedures such as cardiac catheterization and cardiac bypass, bariatric surgery is not subject to Certificate of Need or other separate state licensure regulations, and individual hospitals continue to have the freedom to decide whether to offer it and how to credential their surgeons for it.

A report released this April by the DHSS, Bariatric Surgery in New Jersey, 2005 – the department’s second report to track bariatric surgery utilization and outcomes in the state – reveals trends that both inspire confidence and cause concern.

The annual volume of bariatric surgeries performed in New Jersey (through 2005 – the most recent data available) has leveled off after years of explosive growth. Almost all cases are performed on morbidly obese individuals, for whom authoritative patient selection criteria say it should be performed, while morbidly obese New Jersey residents far outnumber those who get the surgery. Mortality rates for the surgery are also very low.

The report reveals an alarming trend regarding adverse outcomes, however: the majority of New Jersey providers – both hospitals and surgeons – are performing far fewer annual bariatric surgeries than proficiency volume thresholds recommended by the American Society for Bariatric Surgery (ASBS), and they are seeing much higher complication rates, hospital readmissions and hospital lengths of stay than providers performing at recommended volume levels. Specifically:

· Of the 108 NJ surgeons performing bariatric surgery in 2005, only one-quarter (29) performed the minimum annual volume of 50 recommended by the ASBS.

· Half of NJ surgeons (55) performed fewer than ten that year.

· Patients of those surgeons had 180-day complication rates double and triple that of patients whose surgeons performed at the ASBS proficiency volume, while mortality rates (albeit very small) were on average five times (in-hospital mortality) and three times (30-day mortality) that of patients whose surgeons performed at the ASBS-recommended volume.

· Of the 32 NJ hospitals performing bariatric surgery in 2005, only one-third (10) achieved the ASBS’s minimum annual proficiency volume of 125, yielding a similar correlation between volume and quality outcomes.

· There remains a lack of detailed practice guidelines for bariatric surgery by any national certifying boards, making it difficult to evaluate best practices for the surgery.

The DHSS wants to continue to track these trends before deciding whether regulatory actions should be taken, according to Health Commissioner Fred M. Jacobs, M.D., J.D., who notes that voluntary Centers of Excellence initiatives are beginning to address quality issues in bariatric surgery through minimum annual surgery volume requirements and other quality criteria. Centers of Excellence designations are offered by the ASBS and the American College of Surgeons, while health insurance companies such as Cigna and Horizon Blue Cross Blue Shield of New Jersey have recently begun to offer them as well.

As bariatric surgery continues to evolve in New Jersey, regulatory and the health insurance sectors are monitoring utilization, provider profiles and outcomes before deciding whether to institute mandatory licensure or provider credentialing requirements.

Patient Selection and Utilization Issues

After five years of sharp increases, statewide bariatric surgery volume has leveled off to nearly the same amount during 2003, 2004 and 2005, and overutilization does not appear to be a problem in New Jersey, says Jacobs. Only 0.5 percent of New Jersey’s 4,451 bariatric surgery cases in 2005 were not morbidly obese cases – the prime clinical criterion for the surgery under National Institutes of Health (NIH) guidelines. Morbidly obese persons have a weight-to-height ratio, or body mass index (BMI), of 40 or greater (roughly 100 pounds over ideal body weight), while NIH-approved bariatric surgery candidates also include those with BMI of 35 or greater in association with major medical complications of obesity, such as cardiovascular disease, type 2 diabetes or sleep apnea.

Of New Jersey’s morbidly obese persons, only 25 percent had bariatric surgeries in 2005, offering further evidence that the surgery is not overutilized, the DHSS report indicates.

While surgeons generally agree that patients who meet the NIH-recommended BMI criteria should be eligible for bariatric surgery, Jacobs notes that insurance companies (87 percent of New Jersey’s bariatric surgery patients in 2005 were commercially insured) are unlikely to approve bariatric surgery of patients outside of other NIH patient selection guidelines, which include a well-informed and motivated patient, a strong desire for substantial weight loss, failure of other non-surgical approaches to long-term weight loss, and acceptable operative risks.

Insurers have become increasingly interested in seeing documented failures of alternative approaches before authorizing payment for the surgery – and stricter coverage requirements may have effected the slowdown in state volume.

Over the past five years, Horizon Blue Cross Blue Shield of New Jersey has made a number of modifications to its bariatric surgery coverage policy as the surgery’s popularity and utilization have grown, according to Stanley E. Harris, M.D., Horizon’s senior medical director. Before approving coverage, Horizon requires documentation from physicians that a patient has tried to lose weight for a minimum of six months through a physician-supervised diet and exercise regimen, as well as documentation that a patient has had a psychological evaluation to demonstrate that they are prepared to deal with a significant lifestyle change after the surgery, Harris notes. Horizon is also carefully scrutinizing clinical findings for bariatric surgery for the super-obese (BMI greater than 60) – whose risk of morbidity and mortality from the surgery is significant, and for adolescents – whose skeletal maturity and comorbidity risks are areas of concern, adds Harris.

Cigna’s coverage policy for bariatric surgery is largely the same as Horizon’s, while Cigna requires candidates to be 18 years or older, according to David Ferriss, M.D., MPH, Cigna’s medical officer for clinical program development.

Some physicians view these additional coverage requirements as barriers to treatment, in an effort to slow down utilization. Robert E. Brolin, M.D., director of bariatric surgery at University Medical Center at Princeton, says private insurers generally relied on NIH’s BMI criteria up until 2003, when the state began to see tremendous proliferation of bariatric surgery and private carriers tried to "slow it down with roadblocks."

Brolin cites research that the risk of illness and premature death of patients who are heavy enough to qualify for bariatric surgery is much higher in those who do not get the surgery, and he notes that the large majority of persons with 40 BMI or greater do not get the surgery. "We are seeing an underutilization of a very successful procedure," says Brolin.

That NIH guidelines identify a population with several diseases caused by their excessive weight, very few of whom can return to their normal weight on their own, makes a compelling case for a surgery that can eliminate three or four of those diseases, says Gus Slotman, M.D., director of bariatric surgery at Our Lady of Lourdes Medical Center.

Even with bariatric surgery’s proven effectiveness in long-term weight loss and elimination of serious comorbidities such as type 2 diabetes, a commercial health insurer’s interest may be to slow down the expense of the surgery, given that the average length of time a patient is with a commercial carrier may be three years – too short for an insurer to reap longer-term cost savings, believes David F. Greenbaum, M.D., of South Jersey Bariatrics, a three-surgeon practice operating at Lourdes.

Complications of the surgery, such as gastrointestinal leaks that are not treated appropriately, can also be very costly for an insurer, Greenbaum adds. The DHSS report shows a statewide bariatric surgery complication rate in 2005 (requiring hospital readmission within 180 days of initial surgery) of 12.42 percent, while nine hospitals had complication rates higher than 20 percent, and four hospitals had rates higher than 40 percent – one with a 57 percent complication rate (out of 14 annual cases) and one with 59 percent (out of 27 annual cases).

Greenbaum says the lengthy documentation interval that insurance companies have required for bariatric surgery candidates has slowed down the overall volume of procedures performed, discouraging some patients from staying the course until ultimately approved. Jacobs says he has personally had gastric bypass surgery and had to wait four to five months before fulfilling the insurer requirements for the surgery to be covered.

Insurers have also dropped coverage for the surgery from some of their products. Under New Jersey law, HMOs cannot exclude bariatric surgery because the HMO statute and regulations require that they provide comprehensive services, including surgery, according to a spokesperson for the New Jersey Department of Banking and Insurance. Non-HMO health plans are not constrained by this law and can exclude bariatric surgery, and offer rider coverage at additional cost. Cigna offers such policies on its non-HMO products, although Ferriss says most employers still choose to purchase the bariatric surgery coverage.

Brolin says his two-surgeon practice’s annual bariatric surgery volume of about 180 is half of what it was since commercial insurers began implementing their documentation requirements and offering health plans that exclude bariatric surgery.

A recent development may cause utilization to grow again. Until recently, gastric bypass has been the primary approach to bariatric surgery, in which portions of the stomach are removed and sections of the small intestine are bypassed, or a small pouch is created from the original stomach and a new connection is created to a section of small intestine.

A relatively new technique – Laparoscopic Adjustable Gastric Banding – is far less invasive than gastric bypass and its popularity, aided by aggressive provider marketing, is soaring so quickly that overutilization could become a problem, says Jacobs, particularly if non-morbidly obese individuals opt for the new procedure without an appropriate commitment to diet and exercise, and if patient selection guidelines are not adhered to as scrupulously as for gastric bypass. In the "LAP-BAND" procedure, an adjustable silicone band is placed around the upper stomach to create a small pouch and a restricted outlet, while the diameter of the outlet can be changed by injecting or removing saline through a portal under the skin and, if the procedure is not effective or if serious complications develop, the band can be removed.

The increasing popularity of the LAP-BAND can be seen in the volume trends of individual physician practices. Alexander Onopchenko, M.D., medical director of the Center for Surgical Weight Loss and Wellness at AtlantiCare Regional Medical Center, has recently seen his three-surgeon practice volume grow to 370 bariatric surgeries in 2006, from 283 surgeries in 2005 – with the volume boosted by LAP-BAND procedures. While his practice performed primarily gastric bypass procedures in 2004, LAP-BAND accounted for about one-third of procedures in 2005, and one-half in 2006, says Onopchenko.

Patient selection criteria for the new procedure may expand the eligible population pool as well, as Onopchenko cites recent research strongly suggesting LAP-BAND surgery for individuals with BMI of 30 to 35, with obesity-related comorbidities.

Volume and Quality Issues

The DHSS is not specifically regulating bariatric surgery with licensure or credentialing requirements, as it does for cardiac surgery and cardiac catheterization, both of which are far more resource-intensive and entail regionalization issues as the state seeks to avoid overduplication of expensive services, says Jacobs. Credentialing of surgeons for bariatric procedures in New Jersey remains an individual hospital function, just as it is for thoracic surgery and other complicated abdominal surgeries, he adds.

Jacobs acknowledges that there is a difference in outcome quality with respect to the annual volume of bariatric surgeries performed by providers, but he says that mortality remains quite low, with an average of 0.2 percent statewide in 2005 for in-hospital mortality, and 0.29 percent for 30-day mortality. In fact, he notes that the numbers are too low to serve as reliable quality indicators.

"From a policy standpoint, we are not yet at the point where we think we have to regulate bariatric surgery, given that volume appears to have leveled off, and the professional societies are doing a good job of establishing quality criteria," says Jacobs. With only two annual data sets so far, the DHSS plans on producing a third bariatric surgery report in two years before it is ready to begin discussions on whether regulatory action for bariatric surgery is warranted. "The same questions could be asked about any surgery. Bariatric surgery appears to be handled quite well by hospital credentialing. If they relax the criteria, particularly given the aggressive marketing of the LAP-BAND procedure, we will be watching carefully," says Jacobs.

Jacobs sees the department’s recent bariatric surgery "report card" as a tool to allow patients to scrutinize provider qualifications, as well as a source of quality recommendations for providers to adopt. The department agrees that potential bariatric patients need to carefully evaluate the surgeon they choose and where they will have the surgery performed.

To assist consumers in gathering relevant information, the department’s first report on bariatric surgery, released two years ago, recommended using a checklist of questions, including how many bariatric procedures their surgeon and hospital perform annually, whether their surgeon is board-certified or board-eligible, and whether the anesthesiologist has extensive experience with obese patients.

Although several hospitals have bariatric surgery programs, the department’s first bariatric surgery report noted gaps in the continuum of care for obesity. After the bariatric surgery is completed, patients often lack essential and appropriate follow-up care, as primary care physicians often send bariatric patients with problems or concerns back to surgeons, some of whom are not qualified to deal with the post-surgical issues of bariatric patients.

To address these concerns, as well as quality issues associated with low-volume providers, the department continues to recommend that hospitals performing bariatric surgery voluntarily adopt a "comprehensive approach" to the care of their bariatric surgery patients, using criteria set forth by the ASBS or the American College of Surgeons, rather than simply credential bariatric surgeons to admit patients. The criteria, based largely on ASBS Centers of Excellence hospital requirements, include the following:

· Provide an ongoing, regularly scheduled, in-service education program in bariatric surgery and employ credentialing guidelines for bariatric surgery.

· Maintain a physician medical director for bariatric surgery who is a board-certified bariatric surgeon and who conducts regularly scheduled meetings that involve medical staff, nursing, operating room, administration, and central supply personnel.

· Perform at least 125 bariatric surgical cases per year at the hospital, while each surgeon performs at least 125 total bariatric cases lifetime with at least 50 cases performed in the previous year.

· Have a board-certified bariatric surgeon who spends a significant amount of time in the field of bariatric surgery and who has board-certified coverage for patient care.

· Maintain within 30 minutes of request a full complement of staff required to care for bariatric surgical patients, including the immediate availability of an Advanced Cardiac Life Support (ACLS)-qualified physician on site.

· Designate nurse and/or physician extenders who are dedicated to serving bariatric surgical patients and who take continuing education classes regarding the care of bariatric patients.

· Maintain a full line of equipment and instruments used in caring for bariatric surgical patients, including furniture, wheel chairs, operating room tables, beds, radiologic capabilities, and surgical instruments.

· Use clinical pathways and orders that facilitate the standardization of perioperative care. The surgeon selects which primary operation(s) to perform and such procedures must be done in a standardized manner. Clinical pathway protocols are available for review during site visits.

· Make available organized support groups for all patients who have undergone bariatric surgery at the hospital, and document details regarding the groups, such as locations, meeting times, supervisors, and curriculum.

· Document long-term patient follow-up of at least 75 percent for bariatric procedures at five years, including a HIPAA-compliant monitoring and tracking system for outcomes.

In its recent report, the DHSS released results of a June 2006 survey to assess the progress made by New Jersey hospitals in adopting this comprehensive approach. Of the 32 hospitals completing the survey, five hospitals were designated as a Center of Excellence – an accreditation given to hospitals for adopting the recommended comprehensive approach to bariatric surgery by either ASBS or American College of Surgeons – while 14 hospitals indicated that they had either applied or had plans to apply for the accreditation.

Many hospitals across the country that had "dabbled" in bariatric surgery have stopped performing the procedure as the Centers of Excellence designation has gained popularity, according to Gary Pratt, CEO of the Surgical Review Corporation, which conducts and administers the ASBS Bariatric Surgery Centers of Excellence program. While Pratt says he is unaware of any states that require a Centers of Excellence designation for bariatric surgery licensure or accreditation, he notes that several insurance companies have begun to market the designation.

In New Jersey, Horizon has recently organized a Blue Center for Bariatric Surgery program as part of its Blue Distinction initiative, using criteria largely paralleling that of the ASBS, according to Harris. So far, AtlantiCare Regional Medical Center in Atlantic City is the only New Jersey institution recognized as a Horizon Blue Center for bariatric surgery.

Cigna has its own bariatric surgery Centers of Excellence program, requiring designees to fulfill either the ASBS or American College of Surgeons criteria, as well as to meet certain outcome thresholds, including an overall mortality rate of less than one percent, a 30-day re-operative rate of less than 2.5 percent, and a 30-day readmission rate for severe complications of less than five percent, says Ferriss. Two facilities have thus far fulfilled Cigna’s criteria – AtlantiCare and Lourdes – while Ferriss expects more to be added in the near future.

While a Centers of Excellence designation remains voluntary, and providers and insurers promote them to consumers and other clinicians, using the designation as the basis for preferred networks with the promise of improved reimbursement and referrals is the direction most carriers would like to go, and may be part of the evolution of bariatric surgery coverage, says Harris.

The Centers for Medicare & Medicaid Services began covering bariatric surgery for Medicare patients in 2006, with the requirement that the hospital be designated as a Center of Excellence in bariatric surgery.

Surgeons seeking to meet the 50-procedure annual proficiency volume threshold can ramp-up their bariatric surgery experience in several ways, says Onopchenko. They can pursue a fellowship in bariatric surgery if they are just completing their residency, or they can pursue bariatric surgery training under a preceptor, as Onopchenko did five years ago as an experienced laparoscopic surgeon, jumping from 35 bariatric surgeries the first year to 101 the following year. Computerized surgical simulators are also becoming more sophisticated, allowing surgeons to ramp-up their skills without live patients, he adds.