3 Steps to Successful Obesity Management Learning objectives

• Review recent findings about the biologic regulation of eating and weight control

• Discuss the clinical recommendations and benefits of sustained weight loss in overweight and obese patients

• Apply principles of motivational interviewing and shared decision-making to improve the clinical management of obesity and promote behavioral changes

• Understand current guidelines for managing obesity, including the role of pharmacological therapy as an adjunct to lifestyle changes in reducing weight gain and promoting weight loss

• Review reimbursement options for intensive behavioral therapy (IBT) in obesity management Disclosures

• Brought to you as a medical education collaboration between the Louisiana Academy of Family Physicians and the Endocrine Society. • Developed by Knighten Health. Supported by an unrestricted educational grant from Novo Nordisk Inc.

• James Campbell, MD: No relevant financial relationships with any commercial interests Challenge #1: Scope of the Obesity Epidemic and Limited Provider Resources

1 in 3 American adults are obese The Obesity Belt: Obesity prevalence > 30%

80 million

Obese (BMI ≥ 30) Not Obese (BMI < 30)

Sources: Behavioral Risk Factor Surveillance System, Source: Prevalence of Self-Reported Obesity Among 2012, CDC; U.S. Census Bureau, 2012 QuickFacts U.S. Adults: “The Obesity Belt” BRFSS, 2013 16,526 obese adults for every Endocrinologist

409 obese adults for every HCP

Based on Endocrine Clinical Workforce: Supply and Demand Projections, Endocrine Society, April 2013. Challenge #2: Health Care Providers Rarely Treat Weight First

Idiopathic intracranial hypertension

Stroke Pulmonary disease Abnormal function Obstructive sleep apnea Cataracts Hypoventilation syndrome

Coronary heart disease Nonalcoholic fatty liver disease Steatosis Diabetes Steatohepatitis Dyslipidemia Cirrhosis Hypertension

Gall bladder disease Severe pancreatitis

Gynecologic abnormalities Abnormal menses Cancer Infertility Breast, uterus, cervix, colon, esophagus, Polycystic ovarian syndrome pancreas, kidney, prostate

Osteoarthritis Phlebitis Venous stasis Skin Gout Challenge #3: Resources needed for obesity management Weight First Initiative Addresses the 3 Challenges

1. Enlist primary care practitioners to fight the obesity epidemic through medical management

2. Use motivational interviewing techniques and multiple therapeutic options to treat weight first

3. Support primary care practitioners with practical information and resources for treating obesity

3 components of the pilot: • Faculty and Primary Care leaders workshop obesity management WA curriculum. Primary Care participants MT ME receive CE credits. ND 1

OR MN ID INTERPROFESSIONAL WI NY SD MI TRAINING & WORKSHOP WY WED, MARCH 30, 9AM-3:30PM CA IA PA NE WESTIN, BOSTON WATERFRONT HOTEL OH NV UT IN IL WV CO VA KS MO KY

NC TN OK AZ Region V NM AR SC pilot region GA MS AL 2 3

TX LA

FL • Primary Care leaders give • www.treatweightfirst.com presentations at state and regional • Enduring materials on association meetings program microsite • CME credit for attendees • CME credit available The case for putting weight first How much body weight does a patient with obesity need to lose to lower his or her risk of health problems and death?

A. 10%

B. 25%

C. 3%

D. 8% Obesity is a complex and multifactorial disease1-6

Gut microbiota

Fat cells

Genetics/ Expenditure Intake epigenetics

Energy balance

Medications

Environment

1. Woods SC et al. Int J Obes Relat Metab Disord. 2002;26(suppl 4):S8-S10. 2. Ludwig DS. JAMA. 2014;311:2167-2168. 3. Speliotes EK et al. Nat Genet. 210;42:937-948. 4. Garvey WT et al. Endocr Pract. 2014;20:977-989. 5. Bray GA, Ryan DH. Ann NY Acad Sci. 2014;1311:1-13. 6. The Obesity Society Infographic Task Force, November 2015. http://www.obesity.org/obesity/resources/facts-about-obesity/infographics. Accessed December 10, 2015. Obesity is “getting worse in this country,” rapidly

BMI <18.5 18.5-24.9 25.0-29.9 30.0-34.9 35.0-39.9 >40 underweight normal overweight obesity I obesity II obesity III

U.S. adult population 31% 34% 20.6% 8.1% 6.4% 35.1% obese 69% overweight and obese More than two-thirds of U.S. adults

Ogden CL, Carroll MD, Flegal KM. JAMA. 2014 Jul;312(2);189-90. Overweight and Obesity Increase Risk of Disease

BMI <18.5 18.5-24.9 25.0-29.9 30.0-34.9 35.0-39.9 >40 underweight normal overweight obesity I obesity II obesity III

Waist Circumference: Men > 40 in, Women > 35 in

Disease risk relative to normal weight and waist circumference

High Very High Extremely High

Ogden CL, Carroll MD, Flegal KM. JAMA. 2014 Jul;312(2);189-90. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity Obes Res. 1998;6(suppl 2). As little as 3% - 5% weight loss reduces the risk of disease

BMI <18.5 18.5-24.9 25.0-29.9 30.0-34.9 35.0-39.9 >40 underweight normal overweight obesity I obesity II obesity III

Waist Circumference: Men > 40 in, Women > 35 in

Disease risk relative to normal weight and waist circumference

High Very High Extremely High

Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity Obes Res. 1998;6(suppl 2). Why is losing weight and keeping it off so difficult? Obesity as an endocrine-related disease Under normal conditions, food intake and energy expenditure are balanced by a homeostatic American Medical Association (AMA) system that maintains stability recognizes obesity as a disease: of body fat content over time. • It is a multi-metabolic and hormonal disease state • It has characteristic signs and symptoms Obesity results through a perturbation in CNS regulation • Increase in fat mass associated with obesity is of energy homeostasis. directly related to comorbidities such as type 2 diabetes mellitus, cardiovascular disease, and some types of cancer • Disease results through a perturbation in the central nervous system (CNS) regulation of energy homeostasis

Morton GJ, Meek TH, Schwartz MW. Nat Rev Neurosci. 2014 Jun;15(6):367-78. Multiple hormonal signals influence hypothalamic neurons and appetite1-3

Stomach Ghrelin

Increases appetite

Suppresses appetite Appetite

Fat cells Gut Leptin GLP-1, CCK, PYY Pancreas Insulin, Amylin

1. Woods SC et al. Int J Obes Relat Metab Disord. 2002;26(suppl 4):S8-S10. 2. Suzuki K et al. Exp Diabetes Res. 2012;2012:824305. 3. Valassi E et al. Nutr Metab Cardiovasc. 2008;18:158-168. Physiology of reduced obese state Metabolic and hormonal changes drive weight regain

The metabolic handicap: reduction in energy expenditure disproportionate to weight reduction.

Mr. Smith Mr. Jones 220 pounds 200 pounds needs 2200 kcal/day needs 2000 kcal/day

Loses weight to 200 pounds Needs 1830 kcal/day ↑ hunger, ↓satiety ≠ Smith Jones Long-term persistence of hormonal adaptations to weight loss

Changes in Weight from Baseline to Week 62

11 lb GAIN

30 lb LOSS

10 week weight-loss program

Sumithran P et al. N Engl J Med. 2011;365:1597-1604. 14% weight loss produced changes in 8 hormones that encourage weight regain

Mean fasting and postprandial levels of some peripheral signals at baseline and 62 weeks 10-week, lifestyle-based weight loss intervention in healthy overweight and 14% weight loss 14% weight loss obese adults (n=34) led to reduced: increased: • sustained elevations in appetite • Leptin – 65% • Ghrelin stimulating hormone(s) and • Peptide YY • Pancreatic polypeptide • decreases in appetite suppressing • Cholecystokinin • Gastric inhibitory polypeptide hormones • Insulin Net result of these hormonal changes • Amylin is WEIGHT GAIN! Measures of appetite

Sumithran P et al. N Engl J Med. 2011;365:1597-1604. What are the risks of overweight? How much weight loss is needed for health benefit? Obesity and comorbidities Idiopathic intracranial hypertension

Stroke Pulmonary disease Abnormal function Obstructive sleep apnea Cataracts Hypoventilation syndrome

Coronary heart disease Nonalcoholic fatty liver disease Steatosis Diabetes Steatohepatitis Dyslipidemia Cirrhosis Hypertension

Gall bladder disease Severe pancreatitis

Gynecologic abnormalities Abnormal menses Cancer Infertility Breast, uterus, cervix, colon, esophagus, Polycystic ovarian syndrome pancreas, kidney, prostate

Osteoarthritis Phlebitis Venous stasis Skin Gout Modest weight loss has benefits, with greater weight loss associated with greater benefit

Measures of glycemia1 Triglycerides1 -3%

HDL cholesterol1 Systolic and diastolic blood pressure Hepatic steatosis measured by MRS2 Measures of feeling and function: -5% Symptoms of urinary stress incontinence3 Measures of sexual function4,5 Quality of life measures(IWQOL)6

NASH Activity Score measured on biopsy7 Apnea-hypopnea index8 -10% Reduction in CV events, mortality, remission of T2DM -15%

See speaker notes for references. Why is modest weight loss beneficial?

SCAT = Subcutaneous Adipose Tissue 10% weight loss = 30% VAT Loss VAT = Visceral Adipose Tissue Deterioration Lipid profile Improvement

Impaired Insulin sensitivity Improved Abdominal obesity, VAT VAT After weight loss, increased waist reduced waist circumference  Blood insulin  circumference

 Blood glucose  Risk markers for  thrombosis  Inflammatory  markers  Endothelial Impaired Improved function Increased risk Lowered risk

Adapted from: Després J, et al. BMJ. 2001;322:716-720. Summary (Risks of overweight & obesity, Benefits of weight modest weight loss)

• Obesity is associated with an increased risk for coronary heart disease, type 2 diabetes, various types of cancer, gallstones, and disability. • Obesity is associated with an increased risk for death, particularly in adults younger than 65 years. • The risk of disease increases with BMI and waist circumference. • Weight loss as little as 3% - 5% in obese individuals is associated with a lower incidence of health problems and death.

Obesity is a disease, but are we talking about it?

USPSTF recommends screening all adults for obesity yet: • A third of patients with a BMI ≥ 30 were never told by their doctors that they have obesity • Rates of physician counseling appear to be decreasing, by as much as 25 percent. Those rates are worse for patients with obesity co-morbidities • Family practitioner–patient conversations about nutrition last an average of 55 seconds • Intensive behavioral counseling can induce clinically meaningful weight loss, but there is little research on primary care practitioners providing such care

Post RE et al. Arch Intern Med. 2011;171(4):316-321 Kraschnewski JL et al. Med Care. 2013;51:186–92. Eaton CB, Am J Prev Med. 2002 Oct;23(3):174-9. Wadden TA et al. JAMA. 2014 Nov 5;312(17):1779-91 How much body weight does a patient with obesity need to lose to lower his or her risk of health problems and death?

A. 10%

B. 25%

C. 3%

D. 8% STEP 1: Talk to patients about obesity Motivational interviewing and shared decision-making with patients What is the first thing you should do when discussing weight with patients?

A. Recommend a diet.

B. Ask permission to discuss weight.

C. Ask about their exercise routines.

D. Explain a high BMI's health risks. Meet Rosalia: Working mom with a family history of type 2 diabetes

• CC: in for annual visit. • SH: 49-year-old office manager for Blue Cross, recently promoted, divorced, 2 children • Does not smoke or drink • Took paroxetine around time of divorce for depression – continues on it. • Her father has T2DM and is on dialysis; She says “I know this runs in families and I don’t want it to happen to me. • Meds: Has been on paroxetine since her divorce 4 years ago, asymptomatic.

Workup • Height: 5’8”; weight: 223 lbs; BMI: 34 kg/m2 (comments: “I need to lose at least 80 pounds”) • BP: 130/80 mm; pulse: 70 bpm, Resp: WNL • Mammogram report: normal • Lab Chem Survey: glucose 107, A1c 5.8%, otherwise normal. Cholesterol 238, HDL 64, TG 124, LDL 149. CBC & UA normal. TSH 3.91. Pap smear normal. How do you think about your patients’ weight struggles?

What you might think: The reality:

She needs to lose at least 80 pounds. She can greatly reduce her risk for diabetes with loss of just 11 - 22 pounds.

I need to start her on metformin, advise her She can improve risk for diabetes, BP, and to lose weight and see her back in a year. lipids with weight loss. This needs to be the first and central approach.

She can lose weight by just eating a bit less Weight loss requires skills training. The more and exercising a bit more. I will tell her about intensive the coaching, the greater the healthy lifestyle. chance of meaningful weight loss.

If she struggles, she just needs more Some of her medications caused her to gain resolve. She doesn’t need medications. weight. She may need help with medications She can do this on her own. both to lose weight and to address biologic adaptations to weight loss. The 5As of Obesity Management

Ask • Ask for permission to discuss weight • Explore readiness for change Assess • Assess obesity class and stage • Assess for drivers (root cause), complications, and barriers Advise • Advise on obesity risks (related more to obesity stage than BMI) • Explain benefits of modest weight loss focusing on improving health & wellbeing • Explain need for long-term strategy • Discuss treatment options Agree • Agree on realistic weight-loss expectations • Agree on treatment plan Assist • Address drivers and barriers • Provide education and resources • Refer to appropriate provider • Arrange follow-up

Vallis M, et al. Can Fam Physician. 2013;59:27-31;​ Meriwether RA, et al. Am Fam Physician. 2008;77(8):1129-3. Talk to Rosalia using the 5 As of obesity management

Ask: “Let’s talk about your exam. Your mammogram is normal and your exam, and most of your tests are fine. But your blood sugar and A1c are higher than we like to see. This is pre- diabetes. The single best thing you could do for your health would be to make some lifestyle changes that produce some weight loss. Is today a good time to talk about your weight?” Rosalia: “Yes, we can talk about it. I know I need to lose weight – at least 80 pounds. I don’t want to end up like my father.” You: I’m glad to hear you are taking this seriously. We can talk about a goal later, but the good news is that you can improve your diabetes risk with 11-22 pounds loss. Let me ask you a few questions to get started.” What if she says, “No”? Assess: • Comorbidities (sleep apnea symptoms, depression symptoms) • Drivers of weight gain (medications including OTC; sleep deprivation, stress) • Complications and Barriers to weight loss success. • Current lifestyle. • What has worked in the past. • What hasn’t worked in the past.

Motivational interviewing (OARS Strategy)

O A R S Open-ended questions Affirmative statements Reflections Summary statements • Ask open-ended questions • Recognize and support the • Use reflective listening • Use statements that that encourage thought- patient’s personal strengths, • Respond thoughtfully by recount and clarify the provoking response successes, and efforts to paraphrasing patient’s statements • Engage in a 2-way dialogue change • Confirm that the patient • Identify specific points to • Goal is to understand a • Goal is to promote a has been heard act upon collaborative relationship patient’s barriers and • Validate the patient’s expectations point of view Talk with Rosalia using OARS motivational interviewing strategy

Clinician (you): Rosalia: You mentioned 80 pounds, but losing 11-22 pounds and I know I can do it because I have done it O even as little as 8 pounds can reduce your risk. before. With Weight Watchers online once. I How do you feel about that statement? lost 10 pounds in 3 months. I also did Jenny Craig with even more weight loss. I know I Or, “What are some of your thoughts on losing weight?" will never be skinny, but I want to be healthy and be around for my kids.

Health is the right reason to make lifestyle changes. Yes, but I can’t keep it off, so I wasn’t A You CAN decrease your diabetes risk. successful. Open-ended Regaining weight is the result of our bodies’ natural Yes. I don’t think I can do it without help. I Affirmative R defenses. It’s not your fault. It sounds like you are saying might need something. What about you need some help with maintaining lost weight. What medication? Reflections do you think about that? Summary That’s one option we can discuss for our long term OK! S strategy. I’m hearing that you’ve struggled with weight and recognize how it is affecting your health and quality of life. Ok. Now, let’s discuss some strategies to develop a long-term plan to help you address your concerns Talking to patients about weight: Patient-centered communication Keys to Successful Conversations

• Choose words carefully: • “Healthy eating habits” not “diet” • “Physical activity routine” not “exercise” • “Weight” or “healthy weight” not “fat” or “fatness” • Other terms to avoid: “excess fat,” “heaviness,” “large size,” “weight problem”

• Listen actively, with empathy and encouragement

• Be non-judgmental

Preventing Weight Bias. Module 2: Helping Without Harming in Clinical Practice. The Rudd Center for Food Policy and Obesity. Yale University. Summary

Ask  Ask for permission to discuss weight  Explore readiness for change Assess  Assess obesity class and stage  Assess for drivers (root cause), complications, and barriers Advise  Advise on obesity risks (related more to obesity stage than BMI)  Explain benefits of modest weight loss focusing on improving health & wellbeing  Explain need for long-term strategy  Discuss treatment options Agree • Agree on realistic weight-loss expectations • Agree on treatment plan Assist • Address drivers and barriers • Provide education and resources • Refer to appropriate provider • Arrange follow-up

Vallis M, et al. Can Fam Physician. 2013;59:27-31;​ Meriwether RA, et al. Am Fam Physician. 2008;77(8):1129-3.​ What is the first thing you should do when discussing weight with patients?

A. Recommend a diet.

B. Ask permission to discuss weight.

C. Ask about their exercise routines.

D. Explain a high BMI's health risks. STEP 2: Manage obesity with a toolbox of options Guidelines on Pharmacologic Management of Obesity When should you consider an obesity medication for patients?

A. To help a patient better adhere to a healthy-eating plan

B. To help a patient who has lost weight with healthy eating habits and physical activity keep the lost weight off

C. To help a patient lose more weight than they might lose on their own

D. All of these Weight management intensification options Patients with low risk should have lower intensity, lower risk approaches. Higher risk approaches are justified when patients have more complicated obesity.

Mean Weight Loss 0% 3% 8% 12% 16% 32%

Lifestyle plus Diet and Gastric Bypass Obesity Gastric Band2 Lifestyle1 or Sleeve2 Medications

From LABS3: Perioperative DVT, thromboembolism or death 1% for gastric band 5% for bypass

1. Jensen et al. Circulation 2014;129(25 Suppl 2):S102-38; 2. Courcoulas et al. JAMA 2013;310:2416-2425; 3. LABS consortium. N Engl J Med 2009;361:445-54. Obesity management: A chronic disease requiring life-long care Considerations for patients at different obesity stages

Stage 0 obesity Stage 1 obesity Stage 2 obesity BMI 25-30 or ≥ 30, BMI ≥ 27 with co-morbidity BMI ≥ 40 or ≥ 35 with co-morbidity but no complications/comorbidities • Address drivers of weight gain: transition off Unsuccessful with therapies that • Lifestyle modification, healthy eating, and drugs for co-morbidities that cause weight gain are less intensive physical activity and eliminate other drivers of weight gain • Consider bariatric surgery • Self-directed weight loss with reduced • Intensive comprehensive lifestyle intervention • Discuss bariatric surgery calorie meal plan and physical activity • Consider adding weight loss medications to • Refer for bariatric surgery evaluation • Follow patient for development of obesity lifestyle therapy program associated risks.

Jensen MD, et al. Obesity. 2014;22(S2):S1-S410 Apovian CM et al. J Clin Endocrinol Metab, February 2015, 100(2):34 Pharmacological Management Of Obesity: An Endocrine Society Clinical Practice Guideline

January 15, 2015

Apovian C, Aronne LJ, et al. J Clin Endocrinol Metab. 2015 2015 Feb;100(2):342-62. Common Medications for Chronic Diseases Associated with Weight

Alternatives Weight Gain Associated With Use (Weight Reducing in Parentheses) Diabetes Insulin, sulfonylureas, TZDs, mitiglinide, (Metformin), (acarbose), sitagliptin? (miglitol), (pramlintide), (exenatide), (liraglutide), (SGLT-2 inhibitors) Hypertension medications α-Blocker?, β-blocker? ACE inhibitors?, calcium channel blockers?, angiotensin-2 RAs Antidepressants and mood Amytriptyline, doxepin, imipramine, (Bupropion), nefazodone, fluoxetine (short stabilizers nortriptyline, trimipramine, mirtazapine, term, sertraline, < 1 year) fluoxetine?, sertraline?, paroxetine, fluvoxamine Oral contraceptives Progestational steroids Barrier methods, intrauterine devices

? represents uncertain/under investigation. Apovian CM, et al. J Clin Endocrinol Metab. 2015;100:342-62 Who Qualifies for Obesity Medications?

We need obesity medications to: • help patients better adhere to their dietary plan • help more patients achieve meaningful weight loss • produce more weight loss so that health benefits will be greater • help patients sustain lost weight

Recommendation: Prescribe as an adjunct to diet, exercise and behavior modification for individuals: • with BMI 30+; or 27+ with comorbidity; • who are unable to lose and successfully maintain weight; and • who meet label indications.

Strong recommendation based on High quality evidence

Apovian CM et al. J Clin Endocrinol Metab, February 2015, 100(2):34 Where obesity treatments work: Gut hormone and neuroendocrine targets

Appetite Suppressing Drugs FDA approved drugs Hypothalamus • Naltrexone/Bupropion • Liraglutide 3 Mg • Phentermine/ Topiramate Vagal Blocking Device • Lorcaserin Vagus nerve • Orlistat LAGB surgery Stomach

Lipase Inhibitors (Orlistat) Intestines

Gastric Bypass, BPD Fat Metabolism Drugs Gastric Sleeve surgeries (Beloranib) Intestines Adipose Tissue

Mendieta-Zero´n H, Lo´pez M , Die´guez C. Gen Comp Endocrinol. 2008 Feb 1;155(3):481-95. doi: 10.1016/j.ygcen.2007.11.009. Epub 2007 Nov 21. FDA-approved medications and how they work

Scheduled Agent Action Approval drug Phentermine • Sympathomimetic agent Approved, short Yes term use, 1956 Orlistat • Pancreatic lipase inhibitor Approved, 1997 No Xenical®, Alli® Lorcaserin • 5-HT2C serotonin agonist Approved 2012 Yes Belviq® • Little affinity for other serotonergic receptors Phentermine/Topiramate ER • Sympathomimetic Approved 2012 Yes Qsymia™ • Anticonvulsant (GABA receptor modulator carbonic anhydrase inhibitor, glutamate antagonist) Naltrexone SR/Bupropion SR • Opioid receptor antagonist Approved 2014 No Contrave® • Dopamine/noradrenaline reuptake inhibitor Liraglutide 3.0 mg • GLP-1 receptor agonist Approved 2014 No Saxenda®

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Medications approved for chronic weight management – safety and tolerability Agent Safety Contraindications Tolerability Orlistat Warning: ↑cyclosporine exposure; Chronic malabsorption; gall bladder All the symptoms of steatorrhea (fatty rare liver failure; multivit advised disease discharge, etc.) Lorcaserin Warnings: serotonin syndrome; Do not use with MAOIs. Headache, dizziness, fatigue valvular heart disease; cognitive Use with “extreme caution” with impairment; depression; serotonergic drugs (SSRIs, SNRIs); hypoglycemia; priapism Pregnancy Phentermine/ Warning: fetal toxicity; Glaucoma; hyperthyroidism; MAOIs; Paresthesias, dysgeusia; dizziness, Topiramate ER acute myopia; cognitive dysfunction; Pregnancy dry mouth metabolic acidosis; hypoglycemia Naltrexone SR/ Boxed warning: suicidality; Seizure disorder; uncontrolled HTN; Nausea, vomiting, headache, Bupropion SR Warning: BP, HR; ↑ seizure risk; chronic opioid use; MAOIs; dizziness, insomnia glaucoma; hepatotoxicity Pregnancy Liraglutide 3 mg Boxed warning: rodent thyroid c-cell Patients with a personal or family Nausea, vomiting, diarrhea, tumors. Warnings: acute pancreatitis, history of medullary thyroid carcinoma constipation, dyspepsia, abdominal

acute gallbladder disease, or Multiple Endocrine Neoplasia.; pain. hypoglycemia, heart rate increase; Pregnancy renal impairment; suicidal behavior

All data from product label Weight loss effects and effects independent of weight loss

Weight loss independent – Weight loss independent – Agent Weight loss-related positive negative Orlistat Expected Independent effect on ↓ LDL Reduction in fat soluble vitamin cholesterol levels Lorcaserin Expected ? Independent effect on glycemia -

Phentermine/ Expected - - Topiramate ER Naltrexone SR/ Expected; Except less than - Less than expected decrease in Bupropion SR expected reduction in pulse, BP BP and pulse Liraglutide 3 mg Expected; Except increased Independent effect on glycemia Increase in lipase, uncertain pulse significance

SNRI, serotonin–norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; MAOI monoamine reuptake inhibitor; BP blood pressure HR heart rate; http://www.accessdata.fda.gov/scripts/cder/drugsatfda/http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Placebo-subtracted weight loss in patients with and without T2DM NOTE: These are not head-to-head comparisons; populations differ across studies and lifestyle intervention differs across studies. Orlistat1,2 Lorcaserin5,6 Liraglutide7,8 Naltrexone/bupropion3,4 PHEN/TPM9,10 120 mg TID 10 mg BID 3.0 mg QD 32/360 mg ER QD 7.5/46 mg ER QD 52 weeks 52 weeks 56 weeks 56 weeks 56 weeks 0

-1

-2

-3 -3.2 -3.2 -4 -3.5 -3.6 -4.0 -3.9 -5 -4.9 -5.2 -5.4

Percent weight loss atloss one year weight Percent -6 T2D Non-T2D -7 -6.6

Values are placebo-subtracted and approximated from kg weight reductions where applicable 1. Torgerson et al. Diabetes Care 2004;27:155–61; 2. Berne et al. Diabet Med 2005;22:612–8; 3. Smith et al. N Engl J Med 2010;363:245–56; 4. O’Neil et al. Obesity 2012;20:1426–36; 5. Apovian et al. Obesity (Silver Spring) 2013;21:935–43; 6. Hollander et al. Diabetes Care 2013;36:4022–9; 7. Pi-Sunyer et al. Diabetologia 2014;57:73-OR; 8. Davies et al. Diabetologia 2014;57:39-OR; 9. Gadde et al. Lancet 2011;377:1341–52; 10. Garvey et al. Diabetes Care online September, 2014 Weight loss: Individual variation

McCullough PA, et al. Poster AANP 2013. Proportion (%) achieving 5% weight loss after 52 weeks at top dose NOTE: These are not head-to-head comparisons; patient populations differ across studies and lifestyle interventions differ across studies.

Placebo Medication 80 72.8 73 70 62 60 57

47.5 50 45.1 42 43 40

30 28 20.3 21

Percentage (%) 20 17

10

0 Orlistat1 Lorcaserin2 Liraglutide3 Naltrexone/bupropion4 Naltrexone/bupropion5 PHEN/TPM6 120 mg TID 10 mg BID 3.0 mg QD 32/360 mg QD 32/360 mg - BMOD 7.5/46 mg ER QD

1. Torgerson et al. Diabetes Care 2004;27:155–61; 2. Smith et al. N Engl J Med 2010;363:245–56; 3. Astrup, et al. Lancet 2009; 1606-1616. 4. Greenway, et al. Lancet 2010; 595-605. 5. Wadden , et al. Obesity (2011) 19, 110–120. 6. Gadde et al. Lancet 2011;377:1341–52 Proportion (%) achieving 10% weight loss after 52 weeks at top dose NOTE: These are not head-to-head comparisons; patient populations differ across studies and lifestyle interventions differ across studies.

Placebo Medication 80

70

60

50 41 40 37 35 37

30 21 22.6 21 21

Percentage (%) 20 10 10 7.7 7 7

0 Orlistat1 Lorcaserin2 Liraglutide3 Naltrexone/bupropion4 Naltrexone/bupropion5 PHEN/TPM6 120 mg TID 10 mg BID 3.0 mg QD 32/360 mg QD 32/360 mg - BMOD 7.5/46 mg ER QD

1. Torgerson et al. Diabetes Care 2004;27:155–61; 2. Smith et al. N Engl J Med 2010;363:245–56; 3. Astrup, et al. Lancet 2009; 1606-1616. 4. Greenway, et al. Lancet 2010; 595-605. 5. Wadden , et al. Obesity (2011) 19, 110–120. 6. Gadde et al. Lancet 2011;377:1341–52 Developing a treatment plan for Rosalia

Advising on treatment options • You advised Rosalia that losing at least 5% of weight loss in the next 12 weeks is, for now, a good goal. • You reviewed medications and other drivers of weight gain (acetominophen PM, paroxetine). • Rosalia asked about weight-loss medication and you discussed the available options.

Agreeing on weight goals and treatment plan* • Rosalia will attend weekly Weight Watchers meetings because her office wellness program offers it. • Instead of eating at her desk, Rosalia will join co-workers on lunchtime walks. She sets a goal of 150 minutes per week of brisk walking. • Rosalia will adopt a low-glycemic index diet in the Weight Watchers program after a visit with a dietitian. • Together, you make a decision to taper and discontinue paroxetine and to discontinue acetaminophen PM. • Rosalia will monitor sleep duration on her Fitbit and has engaged in meditation through a smartphone app. • Rosalia begins liraglutide 0.6 mg with a dose escalation planned to 3.0 mg.

Follow-up plan • Refer her to a local dietician you’ve worked with in the past. • Schedule follow-up visits weekly for the next 3 weeks, then monthly for the next 3 months. • Check in at 12 weeks to confirm if she’s lost at least 5% of her weight. • Follow at least every three months thereafter. • After 6 months, renew emphasis on physical activity, trying to push to 250 minutes of moderate activity per week. Continue liraglutide.

Rosalia’s treatment strategy

Ask  Ask for permission to discuss weight  Explore readiness for change Assess  Assess obesity class and stage  Assess for drivers (root cause), complications, and barriers Advise  Advise on obesity risks (related more to obesity stage than BMI)  Explain benefits of modest weight loss focusing on improving health & wellbeing  Explain need for long-term strategy  Discuss treatment options Agree  Agree on realistic weight-loss expectations  Agree on treatment plan Assist  Address drivers and barriers  Provide education and resources  Refer to appropriate provider  Arrange follow-up

Vallis M, et al. Can Fam Physician. 2013;59:27-31;​ Meriwether RA, et al. Am Fam Physician. 2008;77(8):1129-3. Obesity management: A chronic disease requiring life-long care Considerations for patients at different obesity stages

Stage 0 obesity Stage 1 obesity Stage 2 obesity BMI 25-30 or ≥ 30, BMI ≥ 27 with co-morbidity BMI ≥ 40 or ≥ 35 with co-morbidity but no complications/comorbidities • Address drivers of weight gain: transition off Unsuccessful with therapies that • Lifestyle modification, healthy eating and drugs for co-morbidities that cause weight gain are less intensive physical activity and eliminate other drivers of weight gain • Consider bariatric surgery • Self-directed weight loss with reduced • Intensive comprehensive lifestyle intervention • Discuss bariatric surgery calorie meal plan and physical activity • Consider adding weight loss medications to • Refer for bariatric surgery evaluation • Follow patient for development of obesity lifestyle therapy program associated risks.

Jensen MD, et al. Obesity. 2014;22(S2):S1-S410 Apovian CM et al. J Clin Endocrinol Metab, February 2015, 100(2):34 Meet Katherine: Social professional with “metabolically healthy obesity”

Annual Physical Exam • 29-year-old accountant who often works long hours • Lives alone, eats out frequently, drinks wine socially, doesn’t smoke • Meds: • Oxybutynin OTC • Oral contraceptives • Father had T2DM, died of lung cancer. Mother has Parkinson’s disease and is in assisted living

Workup • Height: 5’5”; 195 lbs; BMI: 32.4 kg/m2 • BP: 125/80 mm; pulse: 80 bpm; R 20 • Lab: chem profile, lipid profile, CBC WNL, pap smear normal What is your plan with Katherine?

Use the 5 As of obesity management: • Ask: “Your labs are normal, but I am concerned about your lifestyle and how its affecting your weight over the long term. How do you feel about having a conversation about that today?” • Assess: Determine lifestyle drivers of increasing weight gain. • Poor sleep patterns • Less than ideal dietary pattern • Meds? • Stress? • Family History? • Depression? • Advise: Healthy lifestyle, with or without weight loss

Obesity management: A chronic disease requiring life-long care Considerations for patients at different obesity stages

Stage 0 obesity Stage 1 obesity Stage 2 obesity BMI 25-30 or ≥ 30, BMI ≥ 27 with co-morbidity BMI ≥ 40 or ≥ 35 with co-morbidity but no complications/comorbidities • Address drivers of weight gain: transition off Unsuccessful with therapies that • Lifestyle modification, healthy eating and drugs for co-morbidities that cause weight gain are less intensive physical activity and eliminate other drivers of weight gain • Consider bariatric surgery • Self-directed weight loss with reduced • Intensive comprehensive lifestyle intervention • Discuss bariatric surgery calorie meal plan and physical activity • Consider adding weight loss medications to • Refer for bariatric surgery evaluation • Follow patient for development of obesity lifestyle therapy program associated risks.

Jensen MD, et al. Obesity. 2014;22(S2):S1-S410 Apovian CM et al. J Clin Endocrinol Metab, February 2015, 100(2):34 Meet Dennis: A CEO with hypertension, OSA, DM, and a history of depression A candidate for bariatric surgery Annual Physical Exam • 55-year-old CEO, divorced, 2 grown children • Lives alone, eats out frequently, snacks in evening • Feels tired all the time and no regular physical activity (was “very athletic” in college) • Gained 50 pounds over the last 10 years • Meds: • Sulfonylurea for DM • propanolol and hydrodiuril for HTN • doxepin for depression • acetominophen PM for sleep • Was prescribed a CPAP machine for his severe OSA but has been non-compliant • Drinks socially; denies tobacco use • Lost and regained ~20 lbs on Atkins a few times over the last 10 years Workup • Height: 5’9”; Hg (treated); weight: 273 lbs; BMI: 40.1 kg/m2 • BP: 132/82 mm; pulse: 64 bpm • Lab findings normal except TGs: 280 mg/dL; FBS: 142 mg/dL, AST/ALT 2x normal, A1C: 8% Weight management intensification options Patients with low risk should have lower intensity, less risk approaches. Higher risk approaches are justified when patients have more complicated obesity.

Mean Weight Loss 0% 3% 8% 12% 16% 32%

Lifestyle plus Diet and Gastric Bypass Obesity Gastric Band2 Lifestyle1 or Sleeve2 Medications

From LABS3: Perioperative DVT, thromboembolism or death 1% for gastric band 5% for bypass

1. Jensen et al. Circulation 2014;129(25 Suppl 2):S102-38; 2. Courcoulas et al. JAMA 2013;310:2416-2425; 3. LABS consortium. N Engl J Med 2009;361:445-54. Bariatric surgery criteria

BMI <18.5 18.5-24.9 25.0-29.9 30.0-34.9 35.0-39.9 >40 underweight normal overweight obesity I obesity II obesity III

With ≥1 severe obesity- associated With no comorbidity comorbidities (e.g., diabetes or OSA) Effectiveness and risks of bariatric surgery and devices: RESULTS An Updated Systematic Review and Meta-analysis, 2003-2012

Bariatric surgery1: • Provides substantial and sustained effects on weight loss • Ameliorates obesity-attributable comorbidities in most patients • Risks of complication, reoperation, and death exist

Gastric Bypass Adjustable Gastric Banding Sleeve Gastrectomy • More effective weight loss • Lower mortality • More effective weight loss • More complications • Lower complication rates than adjustable gastric • Higher reoperation rate banding; comparable with gastric bypass • Less weight loss than gastric bypass

ReShape™ Integrated Dual ORBERA™ Intragastric Balloon System2 Balloon System3 • Two attached balloons placed • Balloon placed into stomach into stomach through mouth through mouth and filled with and inflated saline • 25.44% EWL and 11.27% • 10.2% WL at 6 months TBWL at 12 months

1Change S-H, et al. JAMA Surg. 2014;149(3):275-287; 2ASGE Bariatric Endoscopy Task Force, et al. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5 3www.fda.gov/MedicalDevices Resolution of comorbidities Idiopathic intracranial hypertension

Stroke Pulmonary disease Abnormal function 74-98% resolved Obstructive sleep apnea Cataracts Hypoventilation syndrome

Coronary heart disease 90% reduced Nonalcoholic fatty liver disease Steatosis Diabetes Steatohepatitis Dyslipidemia Cirrhosis Hypertension 69% resolved

Gall bladder disease Severe pancreatitis

Gynecologic abnormalities Abnormal menses Cancer Infertility Breast, uterus, cervix, colon, esophagus, Polycystic ovarian syndrome pancreas, kidney, prostate

41% resolved Osteoarthritis Phlebitis 95% resolved Venous stasis Skin Gout 72% resolved Bariatric surgery – low mortality When performed at a Bariatric Surgery Center of Excellence

Mortality Rate 3.5% 3.30%

3.0%

2.5%

2.0%

1.5%

0.93% 1.0%

0.52% 0.5% 0.13% 0.0% Bariatric Surgery Lap Chole Hip Replacement CABG Putting it all together:

• Obesity is a complex, chronic disease • Risk for obesity is driven by environmental and biologic factors in genetically susceptible individuals • Moderate weight loss can improve health, but response to treatment is highly variable and weight regain is common • When patients struggle, intensification of approach is appropriate • Combinations of approaches (diet, exercise, drugs, devices and surgery) produce more weight loss and health benefit When should you consider an obesity medication for patients?

A. To help a patient better adhere to a healthy-eating plan

B. To help a patient who has lost weight with healthy eating habits and physical activity keep the lost weight off

C. To help a patient lose more weight than they might lose on their own

D. All of these STEP 3: Get reimbursed Reimbursement for Obesity Management What must be documented as part of intensive behavioral therapy for obesity?

A. That the patient lost at least 6.6 pounds after six months.

B. That treatment was consistent with the 5A approach.

C. Up to 22 IBT sessions over 12 months.

D. All of these Reimbursement of IBT for obesity Key Considerations

• Obesity is a disease and should be treated like one. • If you can’t treat it like a disease, treat comorbid conditions, billed using E&M codes. • Medicare Part B allows reimbursement for IBT for obesity w/some restrictions for: • screening for obesity in adults using BMI; • dietary (nutritional) assessment; and, • intensive behavioral counseling and therapy to promote sustained weight loss through high-intensity interventions on diet and exercise. • Medicare coinsurance and Part B deductible are waived. • Private insurance coverage of IBT for obesity remains highly variable However, because Medicare policy exerts a major influence on the commercial health care system, which often adopts its reimbursement and coverage policies..

Centers for Medicare and Medicaid Services Requirements for Medicare coverage

Eligible Qualified Allowable Allowable primary beneficiaries primary care providers visits care settings • BMI>30kg/m2 • A physician who has a primary • 22 IBT sessions for • Independent clinics specialty designation of family obesity is maximum in a • Competent and • Outpatient clinics practice, general practice, geriatric 12-month period alert when medicine, internal medicine, • Physician’s offices counseling is • 1 face-to-face visit every OB/GYN, or pediatric medicine provided week for first month • State or local public • A qualified non-physician health clinics • Must lose 3kg • 1 face-to-face visit every practitioner who is a certified (6.6lbs) during the other week for months 2-6 clinical nurse specialist, nurse first 6 months for practitioner, or physician assistant • 1 face-to-face visit every continuing month for months 7-12 if coverage • Auxiliary personnel such as beneficiary loses at least registered dieticians working for 3kg (6.6lbs) during first 6 one of the provider specialty types months listed above

U.S. Department of Health and Human Services. Intensive Behavioral Therapy (IBT) for Obesity. Centers for Medicare & Medicaid Services, August 2012

Documentation for IBT for obesity

• Medical records must document all coverage requirements, including the determination of weight loss at the 6- month visit • Must document treatment consistent with the 5A’s approach • Stand Alone Benefit: The IBT for obesity covered by Medicare is a stand alone billable service separate from the initial preventive physical exam (IPPE) or the Annual Wellness Visit (AMV). • Medicare beneficiaries may obtain IBT for obesity services at any time following Medicare Part B enrollment, including during IPPE or AMV encounter. • Note: Obesity counseling is not separately payable with another visit on the same day with the exception initial physical exams, diabetes self-management and medical nutrition therapy services (code 77X), and distinct procedural services claims (modifier 59)

CMS. MLN Matters MM7641. 2012. Billing and coding requirements for IBT

• Submitting Professional Claims • Report the appropriate HCPCS code and the corresponding ICD-10-CM diagnosis code in the X12 837-P (Professional) electronic claim format • Include Place of Service (POS) codes to indicate where service was provided • ASCA requires providers to submit claims to Medicare electronically, with limited exceptions • Submitting Institutional Claims • Report the appropriate HCPCS code, revenue code, and the corresponding ICD-10-CM diagnosis code in the Xl 2 837-1 (Institutional) electronic claim format • Types of Bill (TOBs) Allowed for Institutional Claims: hospital outpatient, rural health clinic (RHC), federally qualitied health center (FQHC), critical access hospital (CAH) • Coding and Diagnosis Information • Use the Healthcare Common Procedure Coding System (HCPCS code) G0447 (face-to-face behavioral counseling for obesity) and relevant ICD- 10-DM Diagnosis Code for BMI 30.0 and over (Z68.30-Z68.39, Z68.41-Z68.45) • Do not use E66.01 or E66.09 • No need to add comorbid diagnoses • Use preventative codes 99401-99404 mandated by ACA for follow-up and management • Covered IBT can be provided “incident to” i.e., by auxiliary staff member such as NP or PA under direct supervision of physician • Can be an efficient and cost-effective way to provide IBT for obesity in a busy practice setting • Physicians of other specialties may be compensated for IBT if they have multiple credentials and bill under approved taxonomy codes – e.g., NP or PA

Centers for Medicare and Medicaid Services Payment information

• Electronic Funds Transfer (EFT) required for payment. • Professional Claims • Medicare pays for IBT for obesity under the Medicare Physician Fee Schedule (MPFS). • As with other MPFS services, non-participating provider reduction and limiting charge provisions apply to all IBT for obesity services • Institutional Claims • Facility type (hospital outpatient, RHC, FQHC, or CAH) determines Medicare payment for IBT for obesity • Facility Payment Methods for IBT for Obesity • Hospital Outpatient: Outpatient Prospective Payment System (OPPS) • RHC: All-Inclusive Payment Rate • FQHC: All-Inclusive Payment Rate • CAH: Method I: 101% of reasonable cost for technical component(s) of services or Method II: 101% of reasonable cost for technical component(s) of services, plus 114% of MPFS non-facility rate for professional component(s) of services • Reasons for Claim Denial may include: • The beneficiary got more than 22 IBT for obesity sessions in the last 12 months. • The beneficiary got IBT for obesity outside of the primary care setting.

U.S. Department of Health and Human Services. Intensive Behavioral Therapy (IBT) for Obesity. Centers for Medicare & Medicaid Services, August 2012 What must be documented as part of intensive behavioral therapy for obesity?

A. That the patient lost at least 6.6 pounds after six months.

B. That treatment was consistent with the 5A approach.

C. Up to 22 IBT sessions over 12 months.

D. All of these Summary: Learning Objectives

• Review recent findings about the biologic regulation of eating and weight control

• Discuss the clinical recommendations and benefits of sustained weight loss in overweight and obese patients

• Apply principles of motivational interviewing and shared decision-making to improve the clinical management of obesity and promote behavioral changes

• Understand current guidelines for managing obesity, including the role of pharmacological therapy as an adjunct to lifestyle changes in reducing weight gain and promoting weight loss

• Review reimbursement options for intensive behavioral therapy (IBT) in obesity management Resources WWW.TREATWEIGHTFIRST.ORG

• On the official Weight First website, you can find: • Links to guidelines, papers, and studies referenced in the presentation • Access to presentation slides • Opportunity for AMA PRA Category 1 CME credit • More information about obesity medical management