Consultant’s Corner: Understanding Bariatric Risk—A Legal, Clinical, and Customer Service Focus

by James W. Saxton, JD; Maggie M. Finkelstein, JD; and Susan Gallagher Camden, RN, MSN, PhD

Patient noncompliance seems to be hitting an all-time high. What is happening and what can I do to increase patient compliance?

Experts: We are hearing similar concerns from bariatric surgeons throughout the country and have researched the issue, including discussing the practical concerns and potential solutions with bariatric surgeons John Baker, MD (President-Elect ASMBS) and Kenneth MacDonald, MD. Patient noncompliance raises more and different issues for bariatric patients than perhaps with other patients. A tension exists among the lifelong care required for bariatric patients and surgeon economics and liability risks.

In most medical specialties, physicians, with a proper process, can discharge patients from their practice for multiple reasons, other than discriminatory ones, including reasons of noncompliance. There is often little issue with a patient’s ability to obtain future care elsewhere. However, with bariatric surgery patients, that may not be the case. Often, bariatric surgery patients have limited access and means to bariatric surgeons. With the need for lifelong care, discharging the bariatric patient from the surgeon’s practice could have additional negative effects on the noncompliant patient from a health standpoint. Many surgeons feel like they are between a rock and a hard place; on the one hand if they discharge the patient—as they would with other noncompliant patients—although one might think that risk is reduced, the fact is that it may be greater. On the other hand, if they keep seeing the noncompliant patient, liability risk exists. It appears to pose a lose-lose for the doctors and the patient, right?

Not so fast. Noncompliant patients take their toll on surgeons, staff members, and economics. You should not have to be at risk when you are doing the right things. Consider patient accountability tools and strategies designed to help.

Patient accountability means placing the ball of responsibility with the patient to adhere to medical advice, to take their medication and vitamins, and to keep their appointments. In other words, maintain compliant behavior. For those patients who are not, consider this process:

Documentation is key. One must realize that cases involving noncompliance focus often on whether or not the patient was aware of the implications of the noncompliance. Too often, noncompliant patients file lawsuits, alleging, for example, had they known they were to take thiamine and had known the consequences of not doing so, they would have taken it. Often, surgeons will say that they did tell the patient, but they have no documentation to support their testimony. Let’s make a change.

When a patient is noncompliant, tell them and discuss the potential consequences of being noncompliant, including discharge from the practice. Document the conversation in the record. Provide a plan for getting care back on track.

For repeat offenders, document the prior and present circumstances in an at-risk letter. Send it by certified mail, return receipt requested. By incorporating an at-risk letter, you are your own process. You can help to prevent the “he said-she said” that so often exists in cases where noncompliance is at issue. Critical elements of such a letter should be split into three paragraphs and clearly stated to include the following:
•    Document prior noncompliance, that had been discussed, including specifics such as dates and circumstances, in a nonjudgmental manner.
•    Document the present noncompliant behavior.
•    Indicate the specific long- and/or short-term risks of noncompliance.
•    Indicate how the patient can get his or her care back on track
•    Clearly state the patient’s specific responsibilities.
•    Provide a timeframe for compliance.
•    Include implications of not getting the care back on track, which may be discharge from the practice.

Working with practices around the country on this issue for the last five years, we have seen the benefit of such letters fall into the following three subgroups: First of all, and most importantly, many patients after receiving such a letter simply comply. Another subgroup are patients who, for whatever reason, have shared this letter intentionally or unintentionally with loved ones who assure compliance. For the group that still does not comply, you have set the record straight as to where the ball of responsibility lies. In some states, where there are laws concerning comparatory negligence, this can have significant positive legal implications for you.
If the patient continues to be noncompliant, follow through with the discharge. However, incorporate some new strategies into your discharge letter. For example, if the issue involves failure to follow up for annual appointments, which is being reported more and more with the economics of today, provide an alternative follow-up process, which involves the family doctor and annual labs/tests. For example, you may discharge the patient and copy the family doctor, providing information on the lifelong care needs and important signs/symptoms they should be on the lookout for in the bariatric patient.

Another strategy is that practices have bolstered their upfront education and have even asked patients to verify their willingness to comply, even going so far as to set forth the potential difficulties we know by experience may occur. Consider a patient contract or agreement specifically designed to address and outline the need for long-term, lifelong compliance with follow-up and certain health-promoting behaviors. Many practices have done this successfully. Ask the patient to attest to his or her understanding and agreement by signing the contract. Some practices have taken it a step further and asked the patient’s significant other to attest to his or her understanding that the patient has agreed to engage in compliant behavior postoperatively. The contract, which is signed at the beginning of the care experience, includes a notation of patient understanding of compliance and that failure to do so could result in a discharge from the practice. The patient has been provided with specific expectations and consequences of certain behaviors even before surgery is performed.

This process strikes a balance—putting measures into place to help patients get on track with their care and ensuring lifelong care while decreasing risk for the surgeon. No one situation will be alike and any process you put into place will need to be flexible.
If you are interested in a sample of an at-risk letter, feel free to contact the authors for a copy.

What is the responsibility of the bariatric program in educating couples about the risks inherent in weight and infertility, and later weight and pregnancy? Are there loss control issues?

Experts: Infertility, by definition, is considered the failure to become pregnant after one year of unprotected intercourse, which may be due to the male partner, the female partner, or both. A person who is infertile has a reduced ability to have a child, it usually does not mean a person is sterile—that is, physically unable ever to have a child. Up to 15 percent of all couples are infertile, but only 1 to 2 percent are sterile. Half of couples who seek help can eventually bear a child, either on their own or with medical assistance. Men and women are equally likely to have a fertility problem. In about 1 in 5 infertile couples, both partners have contributing problems, and in about 15 percent of couples, no cause is found after all tests have been done.

With regard to fertility and obesity, obesity may be a risk factor for male infertility. For example, a 2006 epidemiological study found that a 20-pound increase in a man’s weight increased the chance for infertility by about 10 percent,[1] although researchers explain that the reason behind these findings still beg for more investigation. The primary reason for infertility in women is the failure to ovulate, and the leading cause of this condition is polycystic ovarian syndrome, a condition that commonly corresponds with obesity.

Approximately 15 percent of infertility disorders are linked to weight disorders, mainly being the state of overweight and obesity. According to several studies, women whose obesity could be traced back to their childhood have a greater risk of amenorrhea. However, ovulatory disorders are the leading cause of female infertility, resulting in the disruption of hormones, menstrual cycles, and conception. For example, consider there are two sources of estrogen in the body: the ovaries and the adrenal glands. The ovary makes estrogen in phases, providing variations within the normal menstrual cycle. The adrenal glands, among other things, produce androstenedione. These hormones are related to cholesterol, so it is common that hormones are often converted back and forth. In the case of the adrenal androstenedione, fat cells can convert it into an estrogen called estrone. Thus, obesity causes a biochemical threat to normal ovulation by interference of estrone. This occurs when a steady supply of estrogen from the peripheral conversion of androstenedione to estrogen interrupts the cycling function of the ovary, which ultimately interferes with ovulation and can lead to issues of infertility. A secondary concern is the role of excess estrogen, which could lead to precancerous uterine changes. These changes are usually reversible, but nevertheless any woman who is overweight and experiencing menstrual irregularities should be evaluated. Thyroid problems can also cause irregular periods and obesity, so it is plausible that there could be a relationship between thyroid disorders, obesity, and infertility.

Experts contend that women who are overweight or obese are less likely to respond to fertility drugs because excess weight interferes with the proper absorption of a variety of drugs used in in-vitro fertilization (IVF) treatment.[2] Obese women are far more likely to miscarry after IVF treatment; however, losing even a few pounds could make a significant difference in a successful outcome. Researchers are urging overweight women to change their diets and begin a consistent increase in physical activity prior to fertility treatments. Obese women have long been known to have problems conceiving, and studies have shown that this difficulty is found among women seeking IVF as well. The latest research from Professor Robert Norman’s team at the Reproductive Medicine Unit at the Queen Elizabeth Hospital in Adelaide analyzed the way obesity effected the success of pregnancies among patients who conceived with IVF. The study looked at the progress of a variety of women and compared this with their body mass index (BMI). Women with a BMI between 30 and 35 had a failure rate after fertility treatment of 27 percent. Those with a BMI of more than 35 miscarried in 34 percent of the cases. This equates approximately to 50 percent increased risk among the lower weight group, and a doubled risk among the most obese patients. Norman speculated that as the body’s ability to deal with insulin properly could be affected by carrying excess weight, this could have an impact on the supply of blood to the developing placenta.[3] Others found similar results, reporting that obese women with BMIs of more than 35 had lower success rates compared with overweight (BMI of 25–30), normal weight (BMI of 20–25), or underweight women. Obese women had a lower rate of successful embryo implantation (13% vs. 19% among healthy weight women). They were also less likely to become pregnant after IVF (22% became pregnant vs. more than 30% of normal or underweight women).

Women affected by obesity not only have problems with fertility, but are also at a greater risk for pregnancy complications.[4] Such pregnancy complications include having a Caesarean section, giving birth to a large baby, or developing gestational diabetes.[5] Women who do not treat their obesity before becoming pregnant are also at a greater risk of pregnancy loss.

From the perspective of your bariatric surgery practice, weight loss is weight loss regardless of the source. Therefore, women of childbearing age who have a successful weight loss experience with surgery could very well become pregnant if not practicing reliable birth control methods. This can be problematic if the woman is in the active phase of weight loss, as most experts agree that women should refrain from pregnancy until their weight loss has stabilized or 18 months after weight loss surgery. So, what is the responsibility of your bariatric program in educating couples of the risks inherent in weight and infertility and later weight and pregnancy? We encourage use of patient contacts that clearly establish risks and benefits of the surgery, including the role of vitamin, mineral, and protein supplements, and finally pregnancy and weight loss. Contracts have long been a strategy used by healthcare professionals to develop collaborative, mutually responsive relationships with patients. Roles and responsibilities are clearly described in the contract, which makes good risk management sense. These serve to show further evidence of the bariatric practice’s efforts to educate patients and augment the informed consent process. Contracts encourage accountability on the part of patients as to their commitment to the long-term, postoperative plan of care. As a bariatric program, it is also important to maintain an ongoing relationship with your patient’s primary care provider. NOVUS RRG provides guidelines explaining the rationale for this shared collaborative relationship and offers practical ideas for strengthening the relationship between the primary care provider and bariatric surgeon.

In summary, the science suggests that women who carry extra weight may have difficulty conceiving and carrying the unborn child. Pregnancy and childbirth may be difficult for the larger, heavier woman. Women who lose weight may unexpectedly experience increased fertility, and it is safe to assume that women of childbearing years who have weight loss surgery must use reliable birth control to manage the possibility of pregnancy until it is safe to do so, which is 12 to 18 months after weight loss has stabilized.
The loss control issues must focus on strategies to promote health among the woman, family members, and unborn child. NOVUS RRG is aware of these issues and supports risk management efforts with proper education tools and documentation to attest to this education. Contact Stevens and Lee for a copy of our Pregnancy and Fertility Patient Contract.

References
1.    Sallmén M, Sandler DP, Hoppin JA, et al. Reduced fertility among overweight and obese men. Epidemiology. 2006;17(5):520–523.
2.    Palomba S, Giallauria F, Falbo A, et al. Structured exercise training program versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008;23(3):642–650.
3.    Clark AM, Thornley B, Tomlinson L, et al. Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Hum Reprod. 2006;13:1502–1505.
4.    Dixit A, Girling JC. Obesity and pregnancy. J Obstet Gynaecol. 2008;28(1):14–23.
5.    Cedergren MI. Maternal morbid obesity and the risk of adverse pregnancy outcome. Obstet Gynecol. 2004;103(2):219–224.
6.    Azziz R, Woods KS, Reyna R, et al. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004;89:2745–2749.
7.    Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005;352:1223–1236.

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