Bariatric Surgery: Is this Service Line Right for You?

Obesity in this country has been growing at an alarming rate. Although government guidelines include healthy eating and exercise, few people actually comply. But as the rates of morbid obesity grow, physicians and patients alike are turning to what appears to be the last hope — bariatric surgery.

Primary types of bariatric surgery include laparoscopic and open gastric bypass surgery, laparoscopic adjustable gastric banding and duodenal switch. Currently, gastric bypass surgeries remain hospital-based, while laparoscopic banding is increasing in popularity as an outpatient procedure.

In order to meet the criteria for a bariatric procedure, candidates must have a body mass index (BMI) of 40 or more, or a BMI of 35 or more with an obesity-related disease such as type 2 diabetes, heart disease or sleep apnea. Despite these restrictions, many people still meet the criteria — in fact, in 2007, an estimated 205,000 Americans with morbid obesity will have bariatric surgery, but these are only a drop in the bucket. Overall, approximately 15 million people in the U.S. have morbid obesity, and only 1 percent of the clinically eligible population is being treated through bariatric surgery, according to the American Society for Metabolic and Bariatric Surgery (ASMBS).

Conditioning Staff

When an ambulatory surgery center (ASC) or specialty hospital decides to add bariatric procedures to the mix, a number of unrelated issues come into play. In addition to the traditional monetary considerations — return on investment (ROI), competition, and both — there are more nebulous matters that also require an entrepreneur’s attention.

For example, the bariatric patient cohort is a sensitive one. Many of these clients have been subjected to ridicule and discrimination for much of their lives. It is critical that program directors, surgeons, and other medical staff understand this history and adjust their policies to ensure that patients do not feel marginalized or discriminated against.

There are also comorbidities in most of these patients, and physician-owners should remember to speak to their malpractice insurers to determine if they need additional coverage for these higher-risk patients. The presence of sleep apnea, heart conditions, or diabetes can greatly increase morbidity and mortality related to bariatric surgery, and poor outcomes will not only affect your facility’s reputation, but ultimately will affect the bottom line as well.

Centers of Excellence

Centers planning to focus exclusively on bariatric offerings may wish to be rated as a center of excellence (COE). Following guidelines for becoming a COE will go a long way in guiding new ASC owners toward proper design, product selection, and space assessment.

Occasionally, when a center is applying for COE status, the owner will call the accrediting organization and complain about the high standards required to achieve this ranking, says Gary M. Pratt, CEO of the Surgical Review Corporation. If someone asks why the corporation requires floor-supported toilets, for example, Pratt asks them to consider the bigger picture.

“My response is, ‘Let’s set that aside for a minute. Regardless of COE status, almost any administrator will tell you that more and more patients are morbidly obese, just in general. You may have patients entering your facility after being in a car accident, after having a myocardial infarction, or to have knee surgery. If they go in to use the restroom, and you have a patient who was sitting on a wall-mounted toilet who is now lying spread out on the floor with water gushing over their body, you don’t need to worry about the consequences to your COE designation. Instead, you’ll need to worry about liability from that patient.’ “Society is getting larger, with two-thirds of Americans either overweight or obese. When you’re setting up a bariatric practice, you need to identify that population and accommodate those people,” Pratt says.

The role of the Surgical Review Corporation is to formulate and establish guidelines and criteria for assessing bariatric surgical practices, and to ensure that applicants meet these established standards for recognition as a COE.

Imposing these requirements on applicant facilities is not just a matter of red tape; it is closely tied to patient safety. “If you are seeing patients who weigh as much as 600 pounds, but all of your equipment is rated at 400 pounds, that’s not adequate. You have radiological pieces of equipment, and tunnels for MRIs and CTs not capable of handling these larger patients, so how do you accommodate that population?

Those are the points we would act on if you’re getting ready to build a center — consider your total patient capacity. What happens if you put somebody on a table and they get stuck in a tunnel or the table collapses? At that point, you don’t worry about what it does for your COE designation,” Pratt adds.

“Here’s something else to take into consideration — the impact on the staff. There are issues related to OSHA, due to the fact that there might be injuries to your staff if a patient has fallen and they’re helping them up. Lifting 600 pounds of anything — whether it is a tractor, blocks, or a patient — is still 600 pounds of dead weight. Healthcare workers can throw their backs out trying to help these patients.

Look into ergonomics. If somebody does fall, how do you get them back up? Some facilities have to put two beds together to accommodate their patient’s size, and if the patient pushes those beds apart and falls through the middle, how do you get the patient back up?”

Pratt also notes the importance of proper transportation equipment. He points out that the American Disabilities Act covers so many disabilities that it is expensive for employers to become compliant. Although other handicaps have their advocates, no one has yet become a champion for the obese. “Frequently, people make accommodations for physical handicaps, but have not gotten around to accommodating people who are overweight,” he explains. “I call it the last vestige of those who have been discriminated against and haven’t yet found a champion to get that changed. Only then will you see reform.”

Public sidewalks and door widths accommodate wheelchairs; street crossing signals incorporate audible signals for blind pedestrians. Telephones have communication devices for the deaf. But very few accommodations are made for people with overweight.

“One of the payors in Tennessee, before pre-certification for insurance coverage for surgery, required each obese patient to have an IQ test,” Pratt recounts. “That just shows you how arcane some people are when it comes to healthcare for the obese. The attitude is, ‘You did it to yourself; it’s your problem.’ Some payers require five years’ history of morbid obesity before reimbursing for surgery. But obesity is a disease. If somebody gets cancer, try using that logic — what would happen if the insurer said, ‘Show me you’ve had cancer for five years before we’ll pay to treat it’?”

Obese patients may come to the facility for many procedures, not just bariatric surgery. They will have follow-up appointments, or will be seen for other issues such as a plastic surgery procedure after extensive weight loss. It is in the facility’s best interest to treat bariatric patients as valued and continued customers.

Not all of these patients are unhappy with their size, Pratt points out. They may be satisfied with their current weight, but comorbidities such as diabetes or sleep apnea lead them to a gastric bypass or lap-band procedure. Regardless of the patient’s attitude, it is important that staff members be conscious of their own behavior toward their clients.

“We require sensitivity training for the staff, so they don’t say ‘Hand me the oversized cuff.’ Instead, they say, ‘Hand me the orange cuff.’ It implies some sensitivity toward the patient’s needs,” he says. When constructing a new facility or refurbishing an existing building, owners should ensure that doorways can accommodate oversized gurneys and wheelchairs. This may be an issue if an ASC is moving into an existing retail center, rather than building a location specifically designed for healthcare.

Again, Pratt stresses, it is essential to be prepared for the patient population. “Many ASCs are looking at offering the Lap-Band — not just by bariatric surgeons, but by general surgeons, plastics, interventional radiologists, etc. A variety of people are using the adjustable Lap-Band as a therapy, and, as such, are going to see these types of patients at their facilities. Forget about COE status and look at it from a standard of liability,” he says.

Keep in mind, too, that the Surgical Review Corporation also works with payers when establishing a COE and the requirements to become one. If the corporation lowered its standards so they weren’t supported by the literature or weren’t fair or adequate, then payers would not cover procedures at those facilities.

Medicare, for instance, said approximately 18 months ago that it would support the COE program, and that it would reimburse for bariatric services, but only at COEs. “They said, ‘Our Medicare patients are the sickest; they’re disabled and can’t work, so we want only the best care possible.’ So we put program in place for patients, not for surgeons. They recognize that our standards may step on some people’s toes,” Pratt offers.

Getting Certified as a COE

The Surgical Review Corporation implements and administers separate COE programs for hospitals and for freestanding outpatient centers, called the Bariatric Surgery Centers of Excellence (BSCOE) program, in concert with the ASMBS. “In considering the parameters of the program, SRC’s Bariatric Surgery Review Committee recognized that patients treated in a freestanding outpatient Bariatric Surgery Center of Excellence (BSCOE) should carry surgical risk levels appropriate to the outpatient setting,” according to the organization’s Web site.

The BSCOE covers patients, who are defined as less than 60 years of age, with a BMI of less than 55, weight less than 425 pounds, and a classification of 4 by the American Society of Anesthesiologists. In addition, these patients should have no prior history of deep venous thrombosis or pulmonary embolism. The center must perform at least 100 procedures each year, and there must be a formal transfer agreement with a tertiary care facility.

Outpatient procedures cannot include stapling or division of the gastrointestinal tract — so these procedures preclude the Roux-en-Y gastric bypass. A surgical hospital, on the other hand, might function under the hospital-based COE program.

There is room to maneuver in the future — as additional types of procedures are approved by the FDA for outpatient surgery, the ASMBS and SRC will adjust their COE programs.

Design Challenges

Whether you are reconditioning an existing space or building a bariatric facility from the ground up, designing the center to accommodate patients is crucial. Hill-Rom, in addition to bariatric products, also offers design services customized to the requirements of the individual facility and its staff. The services include a seminar on “Rooms of the Future,” which include a design seminar, research results, and improvements in technology, environments, and healthcare delivery models. In addition, demonstrations are offered of innovative projects, as well as case studies and results.

The RoomBuilder service offers interactive imaging of patient rooms, assists with equipment placement, and offers both two-dimensional and three-dimensional views. A virtual walk-through can be used, and a Hill-Rom project manager will work with the facility to ensure the proper room design.

The room design is critical to reduce injuries to healthcare providers, who are often responsible for lifting and moving patients.

“If you don’t have a solid program, you’ll be looking at injuries,” says Suzanne Bish, marketing manager for bariatrics for Hill-Rom. “Right after surgery, after a couple hours, doctors want the patient up and walking around, and one of the key areas is trying to get them safely up and walking around within a short period after surgery.”

Hill-Rom offers a bed that transforms into a chair position and assists the patient in getting up; the bed performs most of the lifting, thereby removing the weight from the nurses or other assistants. “Providing solutions to patient lifting, turning and transport can reduce workers’ compensation claims, and can also directly reduce the number of caregivers needed to move a patient,” Bish adds. “The other nice thing is that if the physician wants the patient in a chair, the healthcare providers just push a button and the bed transforms, so they avoid lifting them out of the bed and over to a chair.”

A separate transfer device utilizes an air cushion to move patients from the bed to a gurney, or onto the operating table. Transfer chairs are also available — the chair can be made flat and raised to the bed height, the patient is then transferred, and the device is transformed back into a wheeled chair that can be used for transport. Other products include walkers, wheelchairs, and shower and commode chairs for the bathrooms.

“When it comes to safe patient handling, that’s not just product-based, there’s also the other key factor of the room design itself,” Bish adds. “You can have all the right products, but if you don’t have the space and haven’t designed other aspects into the room, you’ll still be at risk for injuries.”

These design elements include door dimensions and room size, because, she explains, people forget when developing their center that they will have larger furniture in the room. A patient lift may not even be able to open completely, because the room itself is too small. And bathroom elements such as toilets and sinks must be floor-mounted for added strength.

Software Solutions

Other helpful tools for the physician entrepreneur include software that can manage the unique needs of a bariatric program. BariBase™, Bridging Health Options’ patient data management software program, provides administrative, medical record, outcomes analysis needs, and COE and ACS (NYSQIP) reports. Bridging Health Options, a bariatric surgery consulting service, consults on all phases of patient program development and management.

There is also a tool from RemedyMD, which offers a holistic electronic health record (EHR) and patient portal to improve the surgeon’s practice and the patient’s postoperative outcome. The tool is an EHR specific to bariatric surgery, and can assist with patient behavior management, says Emily Bonham, senior director of product management for RemedyMD.

The company’s white paper, The RemedyMD Model for Bariatric-specific EHR Systems, explains how the surgeon entrepreneur and surgical center can better manage both the practice and their patients’ outcomes.

“It is essential to document requirements for certification, credentialing, quality monitoring and improvement. An additional potential benefit is that of building a database of information for future research purposes,” the white paper states. The traditional patient care charting and reporting approach is not enough — instead, providers should look to an integrated solution that can link surgeons, patients, and certification organizations.

The paper notes that there are currently 1,000 to 2,000 surgeons performing bariatric procedures in the United States today; but current electronic medical record (EMR) systems are generic and do not “drill down” specifically enough for bariatrics.

The paper lists market drivers for bariatrics, including tracking outcomes, analyzing trends, and patient behavior management. After surgery, “bariatric practices need to ensure their patients comply with the prescribed behavior modification strategies which typically produce improved outcomes. The more engaged a patient is in his/her healthcare, the more compliant they seem to be. A patient portal — not a standard feature of most EHR systems — offers patients the tools to manage their behavior, improve their compliance, be more engaged, and lose more weight,” the paper says.

“BariEHR™ enables physicians and their staff members to document entire patient visits, record and report on health outcomes, receive clinical decision support, and facilitate better patient involvement in their own healthcare. BariEHR is specifically designed for bariatric surgeons.

BariEHR includes RemedyMD’s patient self-management solution, myHealthManager ™. myHealthManager is a comprehensive patient health and wellness management system that powers patient registration, nutrition, vitals, and exercise journaling and an active weight-loss community. myHealth- Manager includes physician created reminders and secure messaging, as well as online educational resources.”

Facts About Bariatric Surgery

Obesity is very costly; each year, the epidemic costs the nation more than $117 billion in healthcare costs and lost productivity, according to the ASMBS. But treating it surgically can have dramatic results; patients who have bariatric surgery are nine times less likely to die than patients who do not, and after three and a half years, the initial surgery investment is compensated by a reduction in total costs.

In the past 15 years, bariatric procedures have skyrocketed, growing from 16,200 in 1992 to an estimated 205,000 in 2007.

Bariatric surgery is very clearly effective; in fact, a study of 22,000 patients, published in the October 2004 Journal of the American Medical Association (JAMA), showed improvements in the following obesity-related conditions:

• Type 2 diabetes was eliminated in 76.8 percent of patients 
• Hypertension was eliminated in 61.7 percent patients 
• Obstructive sleep apnea or sleep-disordered breathing was eliminated in 85.7 percent of patients 
• High cholesterol levels or hyperlipidemia was decreased in more than 70 percent of patients 
• The average weight loss was 61.2 percent for all patients 

The JAMA study showed 0.1 percent mortality for laparoscopic adjustable gastric band (LAGB) patients, 0.5 percent mortality for gastric bypass patients, and 1 percent mortality for biliopancreatic diversion (BPD) and duodenal switch (DS) patients. And the national inpatient death rate associated with bariatric surgery declined from 0.89 percent to 0.19 percent between 1998 and 2004.

And data about the COE program, which was presented at the June 2006 annual meeting of the ASMBS, demonstrated that more than 55,000 bariatric surgery patients experienced lower mortality rate at COEs compared to the national average for bariatric surgery and for other common operations including hip replacement and coronary artery bypass.

The average 90-day mortality rate was 0.35 percent; the 30-day mortality rate was 0.29 percent, and hospital mortality was 0.14 percent; the national average mortality rate for bariatric surgery is 0.5 percent. Additionally, bariatric procedures performed at COES were comparable to the average mortality rate of hip replacement, which is 0.3 percent, and were lower than the mortality rates for coronary artery bypass (3.5 percent ) and aortic aneurism (3.9 percent).

Currently, 271 hospitals with 493 surgeons have been designated as a COE, and more than 640 hospitals and 1,100 surgeons are in the application process. To view a list of COEs, visit the SRC’s Web site at www.surgicalreview.org. 

To be designated a COE, in addition to other requirements, a hospital must have a dedicated multi-disciplinary bariatric team that includes surgeons, nurses, medical consultants, nutritionists, psychologists and exercise physiologists; it must report long-term outcomes; and must also have an on-site inspection to verify the information, according to the ASMBS.

On Feb. 21, 2006, the Centers for Medicare & Medicaid Services (CMS) announced a national coverage policy for bariatric surgery to help reduce the significant health risks associated with obesity. Qualified Medicare patients are required to go to an ASMBS/(SRC) Center of Excellence or an American College of Surgeons (ACS) Level One Center of Excellence for bariatric surgery.

The new policy applies to all Medicare recipients, including those over 65 and Medicare disabled who are morbidly obese (body mass index or BMI of 35 or greater) with any obesity-related condition or disease, and who have been previously unsuccessful with the medical treatment of obesity. 

The Facts on Sleep Apnea

“Sleep apnea is a substantial risk factor in ASCs and huge risk factor in a bariatric center, where up to 75 percent of some populations may have sleep apnea,” says Stephen A. Burton, PhD, president of Ion Healthcare and a diplomate of the American Board of Sleep Medicine. “Only 20 percent of apnea patients are aware of their condition.”

Ion Healthcare is now singularly focused on managing sleep apnea patients in surgical centers, Burton adds, which, he says, “is what many have described as the hottest topic in surgical centers today.”

Obstructive sleep apnea is a common side effect of obesity. It is characterized by obstruction of the upper airways, and by episodes of apnea during sleep. It also involves hypopnea. Sleep apnea has been linked to irregular heartbeat, high blood pressure, heart attack, and stroke.

Patients often resort to a surgical procedure that addresses the anatomical issues that cause sleep apnea; frequently, these procedures are offered by outpatient centers that already provide bariatric services.

Sleep apnea can lead to problems when sedating patients; according to information from an ongoing clinical trial at Northwestern University, issues with anesthesia include “exquisite sensitivity to all central nervous system depressant drugs and the potential for upper airway obstruction or apnea with even minimal drug doses; difficult mask ventilation; difficult intubation; arterial hypoxemia; arterial hypercarbia; polycythemia; hypertension; pulmonary hypertension and cardiac failure.”¹

As patients cannot always lose sufficient weight to clear up the problem on their own, surgical solutions are becoming more popular. Sleep apnea surgery often lends itself to an outpatient setting — most of the procedures are short and require only local anesthetic.

One surgical solution, Somnoplasty®, is a new, minimally invasive, outpatient procedure that reduces and tightens excess tissue responsible for obstructive sleep apnea, including the base of tongue, which can be difficult to treat.² The procedure, which uses radiofrequency to apply controlled thermal energy, has been shown effective in the treatment of sleep apnea by reducing excess tissue volume. However, more than one treatment is often required. Somnoplasty typically lasts 30 to 40 minutes, and local anesthesia is utilized.

Another treatment utilizes a CO2 laser for laser-assisted uvulopalatoplasty; this procedure also can be done under local anesthesia, and in a study of 46 patients, 40 of them showed at least a 50 percent reduction in the respiratory disturbance index (RDI). Twenty patients had healing of snoring and sleep apnea syndrome. In addition, 20 patients demonstrated a large reduction of length and number of apneas, in addition to improvement in nocturnal oxygen saturation, according to an abstract of the study.³

Specialists at Thomas Jefferson University are currently testing another innovative procedure, Genial Bone Advancement Trephine (GBAT), in which a small portion of the lower jaw attached to the tongue is moved forward, to pull the tongue away from the back of the airway and increase the airway space.

“Even immediately after the procedure, patients have an easier time breathing,” says Maurits Boon, MD, clinical instructor in otolaryngology-head and neck surgery, Jefferson Medical College of Thomas Jefferson University. “We have also observed that in a select group of patients, hypertension drops off.”

This surgical solution is often employed as an adjunct to more conventional surgery and can be very effective at treating obstructive sleep apnea. The procedure is done inside the mouth, with no external incisions or cosmetic changes, and is often done in concert with a uvulopalatopharyngoplasty.

Sleep apnea and related disorders are one of the biggest new trends in surgery centers; in fact, a new Mayo Clinic study indicates that tonsillectomies are increasingly being performed to treat airway obstructions evidenced by snoring and sleep disorders as opposed to tonsil infections. The study was presented Sept. 18 at the American Academy of Otolaryngology - Head and Neck Surgery in Washington, D.C.

“This research shows that obstructive airway problems causing sleep-disordered breathing are now the primary reason children and young adults are having their tonsils and adenoids removed,” says Britt Erickson, the Mayo Clinic medical student leading the team of researchers on this study. “There is an increase in recognition of obstructive airway problems in children and young adults. This could mean that either the problem of sleep disorders is increasing, or that this problem has been here all along and only now is recognized.”

In a review of medical records from 8,106 patients aged 0 to 29 years, the team discovered that surgical removal of tonsils and adenoids occurred more than twice as often in 2000 to 2005 compared to 1970 to 1975. In 1970, nine out of 10 operations were done because of infection, and only one in 10 surgeries was for treatment of upper airway obstruction. In 2005, only about three in 10 surgeries were done exclusively for infection.

There is a difference between occurrence of tonsillectomies and adenotonsillectomies in boys and girls. Overall, girls were more likely to have their tonsils and/or adenoids removed, and women between the ages of 18 to 22 were almost three times more likely than men at this age to have chronic infections leading to tonsillectomy.

The findings suggest that physicians have a better understanding of sleep-disordered breathing and are opting for surgery as their treatment of choice. 

References 

1. http://clinicaltrials.gov/ct/show/NCT00462306;jsessionid=561CAF2CB2B97739E87CF26E8E7CCE48?order=5 

2. www.somnoplasty.com/MDTrack/Introduction/osaintro.html 

3. www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=10172096&dopt=AbstractPlus 

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