Transcript UPDATED_Weight First_Core Slides_08022016x

I N T E R P R O F E S S I O N A L
TRAINING & WORKSHOP
WEDNESDAY, MARCH 30, 9AM-3:30PM
WESTIN, BOSTON WATERFRONT HOTEL
OBJECTIVE
Super Trainers assist Grasstops in the creation of a 45-minute presentation to present at their annual meetings
AGENDA & CURRICULUM
9:00 - 9:05a
INTERPROFESSIONAL
TRAINING & WORKSHOP
Welcome and Introduction
9:05 - 9:25a
The case for putting weight first
State of Obesity Science
Caroline M. Apovian, MD
WED, MARCH 30, 9AM-3:30PM
WESTIN, BOSTON WATERFRONT HOTEL
9:25 - 10:10a
Slide workshop and discussion
10:10 - 10:30a
10:30 - 11:15a
Step 1: Talk to patients about obesity
Motivational interviewing and shared decision-making with patients
Donna H. Ryan, MD
Slide workshop and discussion
11:15 – 12:00p Lunch
12:00 - 12:20p
12:20 - 1:05p
Step 2: Manage obesity with a toolbox of options
Guidelines on Pharmacologic Management of Obesity
Caroline M. Apovian, MD
Slide workshop and discussion
1:05 - 1:25p
Step 3: Get reimbursed
Reimbursement for obesity management
Christopher D. Still, DO
1:25 - 2:10p
Slide workshop and discussion
2:10 - 2:20p
Break
2:20 - 3:20p
Finalizing slides and discussion
3:20p
Adjourn
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
Faculty Disclosures
• Caroline M. Apovian, MD: Advisory Group Member, Enteromedics, Gelesis, Novo Nordisk,
Nutrisystem, Scientific Intake, Zafgen; Advisory Group Member & Investigator, Orexigen; Advisory
Group Member & Speaker Bureau Member, Takeda; Consultant, Science Smart LLC; Investigator,
Aspire Bariatrics, GI Dynamics, MYOS Corporation
• Donna H. Ryan, MD: Consultant, Novo Nordisk, Takeda, Eisai, Pfizer, Jansen, Sanofi Aventis;
Equity interest, Scientific Intake, Gila Therapeutic; Speaker, Novo Nordisk, Takeda, Eisai
• Christopher D. Still, DO: Speaker, Novo Nordisk and Takeda; Primary Investigator (Research
grant), Ethicon-Endosurgery
The case for putting weight first
Caroline M. Apovian, MD
Obesity is a complex and multifactorial disease1-6
Gut microbiota
Fat cells
Genetics/
epigenetics
Expenditure
Intake
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
U.S. adult
population
<18.5
underweight
18.5-24.9
normal
31%
25.0-29.9
overweight
30.0-34.9
obesity I
35.0-39.9
obesity II
>40
obesity III
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
underweight
18.5-24.9
normal
25.0-29.9
overweight
30.0-34.9
obesity I
35.0-39.9
obesity II
>40
obesity III
Waist Circumference: Men > 40 in, Women > 35 in
Disease risk relative to normal weight and waist circumference
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).
Very High
Extremely High
As little as 3% - 5% weight loss reduces the risk of disease
BMI
<18.5
underweight
18.5-24.9
normal
25.0-29.9
overweight
30.0-34.9
obesity I
35.0-39.9
obesity II
>40
obesity III
Waist Circumference: Men > 40 in, Women > 35 in
Disease risk relative to normal weight and waist circumference
High
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity Obes Res. 1998;6(suppl 2).
Very High
Extremely High
Why is losing weight and keeping it off so difficult?
Obesity as an endocrine-related disease
American Medical Association (AMA)
recognizes obesity as a disease:
Under normal conditions, food
intake and energy expenditure
are balanced by a homeostatic
system that maintains stability
of body fat content over time.
• It is a multi-metabolic and hormonal disease state
• It has characteristic signs and symptoms
• Increase in fat mass associated with obesity is
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.
Obesity results through a
perturbation in CNS regulation
of energy homeostasis.
Multiple hormonal signals influence hypothalamic neurons and appetite1-3
Stomach
Ghrelin
Increases appetite
Suppresses appetite
Appetite
Fat cells
Leptin
Pancreas
Insulin, Amylin
Gut
GLP-1, CCK, PYY
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
220 pounds
needs 2200 kcal/day
Mr. Jones
200 pounds
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
14% weight loss
reduced:
14% weight loss
increased:
•
•
•
•
•
• Ghrelin
• Pancreatic polypeptide
• Gastric inhibitory polypeptide
Leptin – 65%
Peptide YY
Cholecystokinin
Insulin
Amylin
Measures of appetite
Sumithran P et al. N Engl J Med. 2011;365:1597-1604.
10-week, lifestyle-based weight loss
intervention in healthy overweight and
obese adults (n=34) led to
• sustained elevations in appetite
stimulating hormone(s) and
• decreases in appetite suppressing
hormones
Net result of these hormonal changes
is WEIGHT GAIN!
What are the risks of overweight?
How much weight loss is needed for health benefit?
Obesity and comorbidities
Idiopathic intracranial hypertension
Pulmonary disease
Abnormal function
Obstructive sleep apnea
Hypoventilation syndrome
Nonalcoholic fatty liver disease
Steatosis
Steatohepatitis
Cirrhosis
Gall bladder disease
Stroke
Cataracts
Coronary heart disease
Diabetes
Dyslipidemia
Hypertension
Severe pancreatitis
Gynecologic abnormalities
Abnormal menses
Infertility
Polycystic ovarian syndrome
Cancer
Osteoarthritis
Phlebitis
Breast, uterus, cervix, colon, esophagus,
pancreas, kidney, prostate
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:
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
Reduction in CV events, mortality, remission of T2DM
-5%
-10%
-15%
1. Wing et al. Diabetes Care 2011;34:1481-1486. 2. Lazo et al. Diabetes Care 2010;33:2156–2163. 3. Phelan et al. Urol. 2012;187:939-944.
4. Wing et al. Diab Care 2013;36:2937-2944. 5. Wing et al. Journal of Sexual Medicine 2010 ; 7:156-65. 6. Crosby, Manual for the IWQOL-LITE Measure. 7. Promrat et al.
Hepatology 2010;51:121–129. 8. Foster et al. Arch Intern Med 2009;169:1619–1626
Why is modest weight loss beneficial?
SCAT =
Subcutaneous Adipose Tissue
10% weight loss = 30% VAT Loss
VAT =
Visceral Adipose Tissue
Abdominal obesity,
increased waist
circumference
VAT
Deterioration
Lipid profile
Improvement
Impaired
Insulin sensitivity
Improved

Blood insulin


Blood glucose


Risk markers for
thrombosis


Inflammatory
markers

Impaired
Endothelial
function
Improved
Increased risk
Adapted from: Després J, et al. BMJ. 2001;322:716-720.
Lowered risk
VAT
After weight loss,
reduced waist
circumference
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
STEP 1: Talk to patients about obesity
Motivational interviewing and shared decision-making with patients
Donna H. Ryan, MD
Meet Rosalia: Working mom with a family history of type 2 diabetes
• In for annual visit.
• 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
to lose weight and see her back in a year.
She can improve risk for diabetes, BP, and
lipids with weight loss. This needs to be the
first and central approach.
She can lose weight by just eating a bit less
and exercising a bit more. I will tell her about
healthy lifestyle.
Weight loss requires skills training. The more
intensive the coaching, the greater the
chance of meaningful weight loss.
If she struggles, she just needs more
resolve. She doesn’t need medications.
She can do this on her own.
Some of her medications caused her to gain
weight. She may need help with medications
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 prediabetes. 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
that encourage thoughtprovoking response
• Engage in a 2-way dialogue
• Goal is to understand a
patient’s barriers and
expectations
• Use statements that
recount and clarify the
patient’s statements
• Identify specific points to
act upon
• Recognize and support the
patient’s personal strengths,
successes, and efforts to
change
• Goal is to promote a
collaborative relationship
• Use reflective listening
• Respond thoughtfully by
paraphrasing
• Confirm that the patient
has been heard
• Validate the patient’s
point of view
Talk with Rosalia using OARS motivational interviewing strategy
O
Clinician (you):
Rosalia:
You mentioned 80 pounds, but losing 11-22 pounds and
even as little as 8 pounds can reduce your risk.
How do you feel about that statement?
I know I can do it because I have done it
before. With Weight Watchers online once. I
lost 10 pounds in 3 months. I also did Jenny
Craig with even more weight loss. I know I
will never be skinny, but I want to be healthy
and be around for my kids.
Or, “What are some of your thoughts on losing weight?"
A
R
S
Health is the right reason to make lifestyle changes.
You CAN decrease your diabetes risk.
Yes, but I can’t keep it off, so I wasn’t
successful.
Regaining weight is the result of our bodies’ natural
defenses. It’s not your fault. It sounds like you are saying
you need some help with maintaining lost weight. What
do you think about that?
Yes. I don’t think I can do it without help. I
might need something. What about
medication?
That’s one option we can discuss for our long term
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
OK!
Open-ended
Affirmative
Reflections
Summary
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.​
STEP 2: Manage obesity with a toolbox of options
Guidelines on Pharmacologic Management of Obesity
Caroline M. Apovian, MD
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%
Diet and
Lifestyle1
12%
Lifestyle plus
Obesity
Medications
16%
Gastric Band2
32%
Gastric Bypass
or Sleeve2
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,
but no complications/comorbidities
BMI ≥ 27 with co-morbidity
BMI ≥ 40 or ≥ 35 with co-morbidity
Unsuccessful with therapies that
are less intensive
• Lifestyle modification, healthy eating, and
physical activity
• Self-directed weight loss with reduced
calorie meal plan and physical activity
• Follow patient for development of obesity
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
• Address drivers of weight gain: transition off
drugs for co-morbidities that cause weight gain
and eliminate other drivers of weight gain
• Intensive comprehensive lifestyle intervention
• Consider adding weight loss medications to
lifestyle therapy program
• Consider bariatric surgery
• Discuss bariatric surgery
• Refer for bariatric surgery evaluation
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
Weight Gain Associated With Use
Alternatives
(Weight Reducing in Parentheses)
Diabetes
Insulin, sulfonylureas, TZDs, mitiglinide,
sitagliptin?
(Metformin), (acarbose),
(miglitol), (pramlintide),
(exenatide), (liraglutide), (SGLT-2 inhibitors)
Hypertension medications
α-Blocker?, β-blocker?
ACE inhibitors?, calcium channel blockers?,
angiotensin-2 RAs
Antidepressants and mood
stabilizers
Amytriptyline, doxepin, imipramine,
nortriptyline, trimipramine, mirtazapine,
fluoxetine?, sertraline?, paroxetine,
fluvoxamine
(Bupropion), nefazodone, fluoxetine (short
term), sertraline (< 1 year)
Contraceptives
Progesterone-dominant
Barrier methods, intrauterine devices with
hormones
? 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 healthy eating 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.
• 1*
• 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
FDA approved drugs
Appetite Suppressing Drugs
Hypothalamus
• Naltrexone/Bupropion
• Liraglutide 3 Mg
• Phentermine/ Topiramate
Vagal Blocking Device
Vagus nerve
• Lorcaserin
• Orlistat
LAGB surgery
Stomach
Lipase Inhibitors (Orlistat)
Intestines
Fat Metabolism Drugs
(Beloranib)
Adipose Tissue
Gastric Bypass, BPD
Gastric Sleeve surgeries
Intestines
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
drug
Agent
Action
Approval
Phentermine
• Sympathomimetic agent
Approved, short
term use, 1956
Yes
Orlistat
Xenical®, Alli®
• Pancreatic lipase inhibitor
Approved, 1997
No
Lorcaserin
Belviq®
• 5-HT2C serotonin agonist
• Little affinity for other serotonergic receptors
Approved 2012
Yes
Phentermine/Topiramate ER
Qsymia™
• Sympathomimetic
Approved 2012
• Anticonvulsant (GABA receptor modulator carbonic
anhydrase inhibitor, glutamate antagonist)
Yes
Naltrexone SR/Bupropion SR
Contrave®
• Opioid receptor antagonist
• Dopamine/noradrenaline reuptake inhibitor
Approved 2014
No
Liraglutide 3.0 mg
Saxenda®
• GLP-1 receptor agonist
Approved 2014
No
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;
rare liver failure; multivit advised
Chronic malabsorption; gall bladder
disease
All the symptoms of steatorrhea (fatty
discharge, etc.)
Lorcaserin
Warnings: serotonin syndrome;
valvular heart disease; cognitive
impairment; depression;
hypoglycemia; priapism
Do not use with MAOIs.
Use with “extreme caution” with
serotonergic drugs (SSRIs, SNRIs);
Pregnancy
Headache, dizziness, fatigue
Phentermine/
Topiramate ER
Warning: fetal toxicity;
acute myopia; cognitive dysfunction;
metabolic acidosis; hypoglycemia
Glaucoma; hyperthyroidism; MAOIs;
Pregnancy
Paresthesias, dysgeusia; dizziness,
dry mouth
Naltrexone SR/
Bupropion SR
Boxed warning: suicidality;
Warning: BP, HR; ↑ seizure risk;
glaucoma; hepatotoxicity
Seizure disorder; uncontrolled HTN;
chronic opioid use; MAOIs;
Pregnancy
Nausea, vomiting, headache,
dizziness, insomnia
Liraglutide 3 mg
Boxed warning: rodent thyroid c-cell
tumors. Warnings: acute pancreatitis,
acute gallbladder disease,
hypoglycemia, heart rate increase;
renal impairment; suicidal behavior
Patients with a personal or family
Nausea, vomiting, diarrhea,
history of medullary thyroid carcinoma constipation, dyspepsia, abdominal
or Multiple Endocrine Neoplasia.;
pain.
Pregnancy
All data from product label
Weight loss effects and effects independent of weight loss
Weight loss independent – Weight loss independent –
positive
negative
Agent
Weight loss-related
Orlistat
Expected
Independent effect on ↓ LDL
cholesterol
Lorcaserin
Expected
? Independent effect on glycemia
-
Phentermine/
Topiramate ER
Expected
-
-
Naltrexone SR/
Bupropion SR
Expected; Except less than
expected reduction in pulse, BP
-
Liraglutide 3 mg
Expected; Except increased
pulse
Independent effect on glycemia
Reduction in fat soluble vitamin
levels
Less than expected decrease in
BP and pulse
Increase in lipase, uncertain
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
120 mg TID
52 weeks
Lorcaserin5,6
10 mg BID
52 weeks
Liraglutide7,8
3.0 mg QD
56 weeks
Naltrexone/bupropion3,4
32/360 mg ER QD
56 weeks
PHEN/TPM9,10
7.5/46 mg ER QD
56 weeks
Percent weight loss at one year
0
-1
-2
-3
-3.2
-3.5
-4
-3.2
-3.6
-3.9
-4.0
-5
-5.4
-6
T2D
-7
Non-T2D
-5.2
-4.9
-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;57:73OR; 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
80
Medication
73
72.8
70
62
57
Percentage (%)
60
50
47.5
45.1
42
43
40
28
30
21
20.3
17
20
10
0
Orlistat1
120 mg TID
Lorcaserin2
10 mg BID
Liraglutide3
3.0 mg QD
Naltrexone/bupropion4
32/360 mg QD
Naltrexone/bupropion5
32/360 mg - BMOD
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. Int J Obes (Lond) 2012; 843-854.
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
PHEN/TPM6
7.5/46 mg ER QD
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
Percentage (%)
60
50
41
37
40
30
22.6
21
37
35
21
21
20
7.7
10
10
7
7
0
Orlistat1
120 mg TID
Lorcaserin2
10 mg BID
Liraglutide3
3.0 mg QD
Naltrexone/bupropion4
32/360 mg QD
Naltrexone/bupropion5
32/360 mg - BMOD
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. Int J Obes (Lond) 2012; 843-854.
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
PHEN/TPM6
7.5/46 mg ER QD
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,
but no complications/comorbidities
BMI ≥ 27 with co-morbidity
BMI ≥ 40 or ≥ 35 with co-morbidity
Unsuccessful with therapies that
are less intensive
• Lifestyle modification, healthy eating and
physical activity
• Self-directed weight loss with reduced
calorie meal plan and physical activity
• Follow patient for development of obesity
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
• Address drivers of weight gain: transition off
drugs for co-morbidities that cause weight gain
and eliminate other drivers of weight gain
• Intensive comprehensive lifestyle intervention
• Consider adding weight loss medications to
lifestyle therapy program
• Consider bariatric surgery
• Discuss bariatric surgery
• Refer for bariatric surgery evaluation
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 eating patterns
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,
but no complications/comorbidities
BMI ≥ 27 with co-morbidity
BMI ≥ 40 or ≥ 35 with co-morbidity
Unsuccessful with therapies that
are less intensive
• Lifestyle modification, healthy eating and
physical activity
• Self-directed weight loss with reduced
calorie meal plan and physical activity
• Follow patient for development of obesity
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
• Address drivers of weight gain: transition off
drugs for co-morbidities that cause weight gain
and eliminate other drivers of weight gain
• Intensive comprehensive lifestyle intervention
• Consider adding weight loss medications to
lifestyle therapy program
• Consider bariatric surgery
• Discuss bariatric surgery
• Refer for bariatric surgery evaluation
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%
Diet and
Lifestyle1
12%
Lifestyle plus
Obesity
Medications
16%
Gastric Band2
32%
Gastric Bypass
or Sleeve2
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
underweight
18.5-24.9
normal
25.0-29.9
overweight
30.0-34.9
obesity I
35.0-39.9
obesity II
With ≥1
severe obesityassociated
comorbidity
(e.g., diabetes
or OSA)
>40
obesity III
With no
comorbidities
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
1Change
Gastric Bypass
• More effective weight loss
• More complications
Adjustable Gastric Banding
• Lower mortality
• Lower complication rates
• Higher reoperation rate
• Less weight loss than gastric
bypass
Sleeve Gastrectomy
• More effective weight loss
than adjustable gastric
banding; comparable with
gastric bypass
ReShape™ Integrated Dual
Balloon System2
• Two attached balloons placed
into stomach through mouth
and inflated
• 25.44% EWL and 11.27%
TBWL at 12 months
ORBERA™ Intragastric
Balloon System3
• Balloon placed into stomach
through mouth and filled with
relevant ICD-9-DM saline
• 10.2% WL at 6 months
Vagal Blocking Therapy
• Pacemaker-like device blocks
the vagus nerve to affect
perception of hunger and
fullness
• 52% achieved ≥20% EWL at
12 months
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
Pulmonary disease
Abnormal function
74-98% resolved Obstructive sleep apnea
Hypoventilation syndrome
90% reduced Nonalcoholic fatty liver disease
Steatosis
Steatohepatitis
Cirrhosis
Gall bladder disease
Stroke
Cataracts
Coronary heart disease
Diabetes
Dyslipidemia
Hypertension 69% resolved
Severe pancreatitis
Gynecologic abnormalities
Abnormal menses
Infertility
Polycystic ovarian syndrome
41% resolved Osteoarthritis
Cancer
Breast, uterus, cervix, colon, esophagus,
pancreas, kidney, prostate
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
STEP 3: Get reimbursed
Reimbursement for Obesity Management
Christopher D. Still, DO
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
beneficiaries
• BMI>30kg/m2
• Competent and
alert when
counseling is
provided
• Must lose 3kg
(6.6lbs) during the
first 6 months for
continuing
coverage
Qualified
primary care providers
• A physician who has a primary
specialty designation of family
practice, general practice, geriatric
medicine, internal medicine,
OB/GYN, or pediatric medicine
• A qualified non-physician
practitioner who is a certified
clinical nurse specialist, nurse
practitioner, or physician assistant
• Auxiliary personnel such as
registered dieticians working for
one of the provider specialty types
listed above
Allowable
visits
• 22 IBT sessions for
obesity is maximum in a
12-month period
• 1 face-to-face visit every
week for first month
• 1 face-to-face visit every
other week for months 2-6
• 1 face-to-face visit every
month for months 7-12 if
beneficiary loses at least
3kg (6.6lbs) during first 6
months
U.S. Department of Health and Human Services. Intensive Behavioral Therapy (IBT) for Obesity. Centers for Medicare & Medicaid Services, August 2012
Allowable primary
care settings
• Independent clinics
• Outpatient clinics
• Physician’s offices
• State or local public
health clinics
Documentation for IBT for obesity
• Medical records must document all coverage requirements, including the determination of weight loss at the 6month visit
• Must document treatment consistent with the 5As 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 ICD10-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
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
• Links to Bariatric Surgery Centers of Excellence
• More information about obesity medical
management