2020-12-15 OMA Agenda - Board of Trustees

Board of Trustees Meeting December 15, 2020 4:00 pm – 5:30pm

Mountain Daylight Time (MDT) Via computer, tablet, or smartphone https://obesitymedicine-org.zoom.us/j/96851390432?pwd=dVNzQU9hYnlMYkcwNHIwdDJ3QW4rQT09 Presiding: Craig Primack, MD, FACP, FAAP, FOMA, President Time Topic Lead Action Doc# 4:00 Call to Order and Opening Remarks Craig Primack Order 4:02 Approval of the Agenda Craig Primack Decision 4:05 Conflict of Interest Disclosures Lydia Alexander Declarations 4:10 2021 Proposed Budget Lydia Alexander Katrina Crist Decision 1 5:00 Telehealth Paper Harold Bays Decision 2 5:20 Consent Agenda/Class II Documents • October 29, 2020 Minutes • Global Obesity Forum Manifesto • OAC – Stop Weight Bias Champion Craig Primack Decision 3 4 5 5:25 New Business Craig Primack Introduction 5:30 Call to Adjourn and Closing Remarks Craig Primack Adjourn Board of Trustees - Briefing Documents for December 15 , 2020 Meeting Class III Documents – Materials to be thoroughly reviewed in advance of the board meeting in preparation of introducing motions for deliberation and decision-making. 1. 2021 Proposed Budget 2. Telehealth Paper Class II Documents – Materials to be reviewed in advance of board meeting. These requests and documents are considered non-controversial or not needing board discussion, however, they do require formal approval or adoption by the Board of Trustees. Therefore, they are presented as part of a “consent agenda” which means they will be voted on as one motion to approve. If there is an issue/document you believe should be pulled for discussion/deliberation, please notify the President at craigprimack@gmail.com and the Executive Director at katrina@obesitymedicine.org 24 hours in advance of the meeting. Please include your reason for requesting discussion/deliberation on the issue. 3. October 29, 2020 Board of Trustee Meeting Minutes 4. Global Obesity Forum (GOF) Manifesto 5. OAC – Stop Weight Bias Campaign – Champion Prospectus Class I Documents – Provided for your information to keep you updated and in the loop of communication on items as needed. None

2021 OMA Budget Worksheet

2020 Actuals through early November

Revenue

Product Line:

Budget Line Items

2019 Actuals

2021 Budget Draft

2021 Notes:

Membership & Related Sales

Membership Dues

$ $ $

991,691 26,250

$ $ $

984,921 130,000

$ $ $

1,235,000 100,000 1,335,000

This is based on a 15% increase in projected total 2020 accrued revenue.

Corporate Advisory Council

Total

1,017,941

1,114,921

Affliated Networking Groups

Dues

$ $ $ $ $

- - - - -

$ $ $ $ $

- - - - -

$ $ $ $ $

- - - - -

Education

Sponsorships & Advertisement

Exhibits

Total

Journal - JOMA

$

10,000

Editorial support from publisher

Education Products & Services

Merchandise  Book Sales

jackets, water bottles, rx pads, infographics

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

81,197 37,926 591,742 23,559

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

36,835 17,995 517,354 30,175 7,350 52,491 29,320

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

35,000 20,400 589,050 29,800 8,400 56,338 31,975

Digital CME (Academy)

Avg $40k-58K/month, plus 5% growth Includes sales and collection of shipping charges

Syllabus Sales

Proficiency Badge and Certification Fees

7,700

SAP

- - -

sales will slow since launch. New SAP slated for mid 2021

Algorithm Sales Webinars & Podcasts

launched peds Algo in 2020 only launch of new 2021 algorith with 5% increase Webinars are free product for members. Have very little non-member sales. Podcasts free

144

90

Total

742,124

691,664

771,053

Spring Conference

Education Grants

15,000

2,500

20,000

Misc

232

-

-

Advertisements Sponsorships

8,650 54,600 115,600 518,505

1,050

3,300 11,700 60,000 381,750

-

Additional Sponsorship revenue in Direct Public Support. $45k

Exhibits

4,200

Registrations

284,266

120 paid in person @ $775 / 550 virtual @ $525, this includes 3 precons (1 fundamentals, 1

Livestream Attendees

4,030

-

-

Total

716,617

292,016

476,750

Fall Conference

Educational Grants

$ $ $ $ $ $ $ $ $ $ $ $ $

20,000

$ $ $ $ $ $ $ $ $ $ $ $ $

8,000 9,794 5,250 93,270 136,750 815,632

$ $ $ $ $ $ $ $ $ $ $ $ $

-

Misc..

900

-

Program Ads Sponsorships

3,480 15,135 19,655 347,368

5,500 17,600 90,000 643,750

Additional Sponsorship revenue in Direct Public Support. $45k

Exhibits

Registrations

450 paid in person @ $875 / 400 virtual @ $625

Livestream Attendees

6,686

-

-

Total

1,075,382

386,538

776,850

Publications

Ads- Newsletter

50,208 14,250

14,500 9,430 17,500 3,000 44,430

19,900 11,400 27,000 5,000 63,300

Ads - Website/Social/Directory

Ads- Education Ads- Career Center

- -

Total

64,458

Fundamentals Courses

Educational Grant Fundamentals Online

$ $ $ $ $ $ $ $ $

50,000

$ $ $ $ $ $ $ $ $

75,000 10,072 60,354 17,405 162,831

$ $ $ $ $ $ $ $ $

30,000

Industy grants - actual for 2020 may go down as grant reconcilliation is showing expenses di

-

-

Registrations

60,168 34,300 144,468

50,400 29,100 109,500

Rolling all regitrations here - aver reg 80 per course - $210 fee for 3 virtual courses We won't have virtual exhibits but sponsorship opportunities to make up for the revenue.

Exhibits

Total

New Projects/Innovations

Registrations

- - - -

- - - -

50,000

Exhibits Grants

-

25,000 75,000

Total

Direct Public Support

Corp Contrib for Education

Spring and Fall Sponsored Lunch

$

-

$

90,000

$

90,000

Top Section Revenue total

$

3,760,990

$

2,692,400

$

3,707,453

top sections only - sub total

Total Revenue

3,760,990 $

$

2,692,400

$

3,707,453

Expenses

Membership & Services

Postage/Shipping

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

2,292 4,421 4,377 94,486

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

4,372 1,551 1,914 3,718

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

8,540 9,995 2,500 42,000

Renewal letters, new abom diplomates, Welcome kit, acquisition mailings Renewal letters, brochure, New ABOM diplomates, Welcome Kit

Printing

Certificates/Awards/Pins

CAC, Fall Awards (Pins are included in marketing) List buys, outreach, acqusition efforts, pins, social, google

Marketing

External OMA Membership Dues

-

-

-

Total

105,576

11,555

63,035

Affliated Network Groups

Marketing Seed Money Insurances

- - - - -

- - -

- - - - - - - -

Travel Staff & BOT

276

Accounting and Legal Fees Chapter Formation Agency Fee Education Development

-

12,500

39,500

-

-

Total

12,500

39,776

Education

Merchandise

12,900 5,000 2,000 20,400 20,500 17,000 - 15,000 3,950 3,000 99,750 12,600 2,500 12,000 10,000 37,100 - - -

jackets, water bottles, rx pads, infographics

30,063 15,222

15,595 5,020

eBooks & Course Books

author books, textbooks

Digital CME Algorithm

-

misc costs for course development design work and printing costs

16,557

18,734

Proficiency Badges

71

66

Syllabus

production and shipping costs for external vendor

24,851 21,665 8,000 19,081 4,204 -

Webinars & Podcasts & Student Workshop

average $500 webinar $250 podcast

$

17,850

Salary Calculator

Centers of Excellence & OMEC

$

-

SAP

question writers, editor fees and design fee for new SAP

Shipping

$ $

580

shipping for product and book sales

Trademark Fees

-

- -

Marketing

Social media marketing

Total

$

80,343

117,216

Board Strategic Planning Event

Travel Expenses

$ $

- -

12 board members at 1050 (500 airfare, 300 hotel for 1 nights, 250 ground/meals)

Activities Consultant Facilities

$ $ $ $

2,128 12,211 15,066 29,405

based on 2019 actual based on 2019 actual based on 2019 actual

Total

$

-

Board of Trustees General

12 board members at 2250 (500 airfare, 1500 hotel for 5 nights, 250 ground/meals) x 2

OMA Conference Travel (name change)

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

-

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

-

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

54,000

Other Travel

23,654 2,902 11,043 37,599 3,351 5,522 14,907 1,100 3,802 5,588 7,398 5,294 1,573 -

5,951 2,780

- - -

Meeting Expenses Printing and Postage Leadership Development

238

-

5,000 59,000

Total

8,969

External Professional Meetings

AMA Annual Caucus AMA Interim Caucus

- - - -

5,100 3,050 11,500

1 staff 2 board - booth, onsite materials, travel 1 alternate 1 board - session room, onsite materials, travel 2 staff 2 board - onsite materials, shipping, travel, registration

Obesity Week

Academy of Nutrition and Dietetics

-

AAPA AAFP AANP EASO

5,100 11,000

1,500

2 staff 1 speaker - booth, onsite materials, shipping, travel, speaker

-

- -

1,500

2 staff 1 speaker - booth, onsite materials, shipping, travel, speaker

- $ Virtual in 2021

Blackburn Course Lifestyle Medicine

Virtual - booth and registration

1,405

2,550 10,350 8,000 43,550

2 staff 1 speaker - booth, onsite materials, shipping, travel, speaker Pop up banners, ACPM speaker, ACPM booth and travel

- -

-

Misc. Total

409

48,535

17,914

Certificates

Production Honorarium

-

- - -

- - -

2,500 2,500

Total

Accreditation Cost

AOA

350

325

375

ACCME

9,500

7,500

7,500

APA

450

-

-

AANP/AAPA

5,140 6,555

6,045 2,665

6,250 2,700

AAFP ACPE AAP MISC

- -

- -

- -

ACE Social Work

2,151

450

500 500 220

270

-

CDR Dietician

-

210

Total

24,416

17,195

18,045

Spring Conference

Marketing Printing

41,432 5,963 3,695 2,611 16,381 16,171 300,212 27,673 -

14,908

32,000 5,000 1,500 4,000 1,000 1,000 11,500 75,000 25,000 89,000

Outreach, onsite materials, social, google, LinkedIn,member raffle gft, design

132 184

Onsite Planner, trail map, and materials freight - shipping of materials - local buildouts, signage, clings, furniture

Postage/Shipping

Exhibit Services (just name change)

- -

Insurance Supplies

2,224 5,248

Travel

hotel parking, staff meals, staff hotel rooms,

Food & Beverage (name change from facilities)

550

$500pp x 150 ppl

Faculty Travel AV Services Rental Fee Badge Services External Events

-

25 speakers @$1000 each

- - - -

23,835

onsite and streaming av provider, digital recordings, based on hybrid event $14k internet fee

-

- -

5,325 12,898 39,800

if we choose to do offsite party or event based on previous years totals uniforms, trail map gift cards, temp kiosk,

Honoraria

48,000 3,500 1,045 2,909 16,135 13,250 498,977

35,000 8,330 2,000 40,100 -

MISC

23

Consultants Contract Labor

- -

Technology (name change from Digital Recording)

5,277

digital platform, mobile app

Moderator

-

-

Total

110,404

330,430

Fall Conference

Marketing Printing

$ $

32,403 24,497

$ $

7,010

$ $

43,000 8,000

Outreach, onsite materials, social, google, LinkedIn,member raffle gft, design, photographer

-

Planner, trail map, onsite materials

Postage/Shipping

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

9,515

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

49

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

4,000 5,000 2,500 3,000 25,000 250,000 103,000 8,000 30,000 40,000 25,000 3,000 8,000 30,000 587,500 84,000 82,800 15,000 10,000 1,600 5,000 3,000 8,000 - - 1,416,000

freight and shipping of materials to chicago buildouts, signage, exibitor service

Exhibit Services (just name change)

-

350

Insurance Supplies

2,860 13,159 21,756 629,490

1,726

-

Travel

363

staff flights, hotel, meals, etc

Food & Beverage (name change from facilities)

1,100 55,039 8,130 1,920 39,225 -

$500 pp @500ppl

AV Services Rental Fee

- - - -

onsite and streaming av provider, digital recordings, based on hybrid event $18k internet fee

Badge Services External Events Faculty Travel Contract Labor Honoraria

onsite badge printing and kiosks

installation of officers/member appreciation

59,775 28,295 40,550 8,532 16,564 887,396 -

based on previous years speaker travel reim

- - - -

Moderator

Misc

uniforms, trail map gift cards, bags, promo items

Technology (name change from Digital Recording)

digital platform and mobile app

4,277

Total

119,189

Personnel & Benefits

Salaries

1,019,204 76,758 115,099

1,155,133 76,494 117,274

16 staff

Taxes

Benefits & Admin Fees Staff Development Staff Appreciation Professional Dues

4,585 4,916

6,237 3,861

997

995

Temporary Staff

51,328 3,136 17,084

16,743 2,494 4,054 78,735

Payroll Processing Fees

Travel

Recruitment

-

-

Total

1,293,107

1,462,020

1,625,400

Professional Services

Accounting/Audit

89,535 60,000 21,011 194,717 30,992 115,696 120,000

69,354 55,000 16,940 166,012 27,366 91,300 110,000 8,775 1,433 74,440 620,620 99,724 25,647 5,564 4,173 5,748 5,230 -

80,000 60,000 25,000 120,000 30,000 60,000 135,000 2,000 20,000 2,750 66,000 600,750

Advocacy IT Support

Legal

Investment Acct. Services Public Relations & Agency Education Consultants

Reduced retainer to $5k per month

Contract Labor

-

Web Development & Maint.

9,689

Monthly web support of 10 hours plus larger web project for navigation, blog, functionality, et

Web Hosting

822 285

GoDaddy urls, web hosting, ssl certificate

Marketing Vendors

Pico and graphic design

Total

642,747

Office Expenses

Rent

124,835 23,615

72,000 60,000 3,000 5,800

72k for 5 offices at The Village co-share space. 40k annual license fee for LMS, 20k for AMS Includes membership bubble mailers

Database Supplies

9,117 6,851 1,454

Telephone & Internet Office Equipment Office Relocation Cost Equipment Rental

RingCentral (477/mo) for phone system only, no internet it is included in rent

- -

- -

170 623 127

678 250 100

Pittney Bowes postage machine Buisness cards and misc admin Fedex, UPS, Overnight delivery

Printing

476

Postage/Shipping

4,147 8,414 2,727 78,768 12,597 5,748 3,680 13,183 295,612

Insurance

15,651

18,000

D&O, Cyberspace

Maint and Repairs Bank Charges

554

-

57,169

80,000

based on revenue projections similar to 2019 actuals

Constant Contact, Sprout Social, Snapengage, iStock, Marketing adobe licenses, Zoom, Adobe Captivate (LMS), Podcast hosting)

Software Licenses

14,345

11,654

Misc.

476

500

Other Tax Depreciation

-

-

11,157 246,358

10,000 261,982

Need to confirm with Accounting

Total

Journal - JOMA

$

10,000

Editorial Expense

Fundamentals Courses

Marketing Facilities Staff Travel

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

10,000

Lists/outreach, social, google

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

3,121 19,010 1,512 8,000 3,222 1,219 1,170 12,691 49,953 8

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $

11,205 42,443 21,932 15,211 5,858 4,540 2,417

- - - - - -

Faculty honoraria & Travel

14,000

honoriarum for case study and session moderators - 3 events

Printing Postage Supplies

Faculty Travel

-

AV

Recording of new sessions and reallocated cost of zoom for fundies course

6,500

3,670 27,670

Total

110,106

Development/Innovation

Marketing Facilities Staff Travel

- - - - - - - - -

- - - - - - - - -

5,000

-

3,000 4,000

staff traveling to support event honorarium for potential speakers

Faculty honoraria & travel

Printing Postage Supplies

- -

AV

Total

$

12,000

Faculty/Honorarium

$

4,750

$

-

$

-

Total Expenses

$ $

4,073,569 (312,579)

$ $

2,821,169 (128,769)

$ $

3,776,212

(68,759)

Investment Income

Stifel interest and unrealized gains, etc.

$

639,048

$

102,435

$

-

Below the Line Special Projects: IT Infrastructure Project (below the line) AMS, LMS, Marketing Automation system

$

54,056

$

113,403

Impexium-AMS, Elevate-AMS, Reclassed 20,663 Contract Labor-Professional Srvs for Impe 22 new computers/docks, $1275 each. 15 cuirrent staff, 5 conference A/V, 2 spare for temps 12,000 Abstract Management Software 27,050

$ $ $

$

113,403

39,050

$

54,056

ORIGINAL ARTICLE

Obesity Management via Telehealth A Position Statement from the Obesity Medicine Association Advocacy Committee Working Group [SUBTITLE IS SUBJECT TO APPROVAL BY THE OMA BOT]

Carolynn Francavilla Brown, Bruce A Barker, Laura Davisson, Amanda G. Fontenot, Theresa C. Garcia, Allan L. Hardy, Carl Knopke, Scot B. Kolsin, Vicki March, Michael B. McClurkan, Joynita Nicholson, Bharti Shetye, Catherine Varney, Verlyn Warrington, Susan Wolver, Angela Fitch, Harold E Bays Departments: Carolynn Francavilla Brown, MD- Green Mountain Partners for Health/ Rocky Vista University Bruce Barker, MD -Department of Weight Management, OhioHealth Laura Davisson, MD, MPH-Department of Medicine, West Virginia University School of Medicine Amanda G. Fontenot, MD- Ochsner Medical Center Theresa C. Garcia, MD- GFM Direct Primary Care Allan L. Hardy, MD-Division of Gastroenterology, Augusta Health Carl Knopke, MD-Department of Family Medicine, University of California Riverside Scot B. Kolsin Vicki March, MD-University of Pittsburgh School of Medicine/University of Pittsburgh Medical Center Michael B. McClurkan, MD- St. Bernard's Regional Medical Center Joynita Nicholson, DO- Bon Secours Mercy Health Bharti Shetye, MD- Suncoast Bariatrics Catherine Varney, DO- University of Virginia Physicians Group Verlyn Warrington, MD -Department of Bariatric Medicine, the Guthrie Medical Group

1

Susan Wolver, MD- Department of Internal Medicine, Virginia Commonwealth University Angela Fitch, MD- Department of Medicine, Massachusetts General Hospital/ Harvard University Harold Edward Bays MD, FOMA, FTOS, FACC, FNLA, FASPC Medical Director / President Louisville Metabolic and Atherosclerosis Research Center

3288 Illinois Avenue Louisville KY 40213

P = 502.515.5672 F = 502.214.3999 e = hbaysmd@outlook.com w = www.lmarc.com

Corresponding author contact: Carolynn Francavilla Brown, MD 200 Union Blvd Ste 311 Lakewood, CO 80228 doctorfrancavilla@gmail.com

Funding: No funding was received for this article

Short title: OMA Position Statement on Obesity Management via Telehealth

Conflict of Interests and Disclosures: Dr. Barker reports personal fees from Novo-nordisk, personal fees from Orexigen Dr. Fitch reports personal fees from Novo Nordisk, personal fees from Gelesis, personal fees from Phenomix, personal fees from SetPoint Health, personal fees from MsMedicine. Dr. Harold Bays’ research site has received research grants from, Alon Medtech/Epitomee, Amgen, Boehringer Ingelheim, Eli Lilly, Evidera, NovoNordisk, and Pfizer. The remaining authors have no reportable conflict of interest or disclosures

2

What is already known about this subject? • Whether via obesity medicine specialists, or general clinicians, the management of patients with obesity differs among different medical settings. • Obesity medicine is especially well-suited for telehealth evaluations and interventions due to the prioritization of motivational interviewing, nutrition and physical activity education, and behavior therapy. • Phentermine is a Drug Enforcement Agency controlled substance. Some clinicians do not prescribe controlled substances in general, or phentermine specifically; other clinicians frequently prescribe phentermine for treatment of their patients with obesity. • Phentermine has a Food and Drug Administration indicated use for short-term treatment of obesity and is contraindicated in patients with cardiovascular disease. Obesity is a life-long disease. Among otherwise appropriate patients at low cardiovascular disease risk, phentermine use for longer than 12 weeks is supported by clinical data and supported by expert scientific publications. What are the new findings in your manuscript? • While some clinicians have utilized telehealth for health care delivery for years, the use of telehealth has substantially increased since the Severe Acute Respiratory Syndrome coronavirus (COVID-19) pandemic. • In its 2021 Obesity Algorithm, the Obesity Medicine Association provided guidance on the “ADAPT” Telehealth Obesity Management Model, that includes A ssessment, D iagnosis, A dvice (and Education), P rognosis, and T reatment. • This current manuscript provides guidance as to the safe administration of anti-obesity medications, via telehealth. This expert consensus was drafted by obesity medicine authors having a wide spectrum of clinical experiences, including academia, primary care, and obesity specialty care. • In addition to their shared clinical experiences in obesity medicine and telehealth, these authors are also members of the Obesity Medicine Association Advocacy Committee, who upon multiple meetings, created and edited this manuscript and its revisions. [AFFILIATION WITH OMA IS SUBJECT TO APPROVAL BY THE OMA BOT] How might your results change the direction of research or the focus of clinical practice? • It is likely that beyond the COVID-19 pandemic, telehealth will remain an integral part of obesity management. Clinicians may benefit from a practical telehealth overview originating from the perspective of clinicians experienced in obesity medicine. • Some anti-obesity medications are scheduled medications. Currently, during the COVID-19 pandemic, federal laws allow for some prescribing of controlled substances via telehealth. Adaptation to telehealth requires an understanding of how to safely prescribe anti-obesity medications now, as well as how to safety prescribe anti-obesity medications when/if prescribing laws change in the future.

3

Abstract Obesity medicine heavily relies upon motivational interviewing, nutrition and physical activity education/counseling, and behavior therapy. Hence, obesity medicine is especially well-suited for telehealth evaluations and interventions. This Obesity Medicine Association (OMA) Position Statement on Obesity Management via Telehealth highlights the 2021 OMA Obesity Algorithm “ADAPT” Telehealth Obesity Management Model. Components of this management model include: A ssessment, D iagnosis, A dvice (and Education), P rognosis, and T reatment. Relative to the management of other metabolic diseases (e.g., diabetes mellitus, hypertension, dyslipidemia), the treatment of the metabolic disease of obesity is unique in that some anti-obesity agents are designated controlled substances by the US Drug Enforcement Agency (DEA). Currently, during the COVID-19 pandemic, federal laws allow for prescribing of controlled substances via telehealth. Phentermine is the most prescribed anti-obesity medication and is illustrative of an antiobesity medication that is a controlled substance (DEA Schedule IV drug). Clinicians may benefit from the practical perspective of clinicians actively engaged in obesity management via telehealth during this time of COVID-19, including the prescribing of unscheduled or scheduled anti-obesity medications.

4

Introduction Telehealth can be defined as the use of electronic information and telecommunications to facilitate patient-clinician interactivity towards the goal of safe and effective patient evaluation and delivery of health-related services beyond the traditional clinician “office visit.” Emergence of telehealth presents ethical, legal, and social challenges, as well as opportunities to improve the quality of healthcare. (1) Advantages of telehealth in general include convenience to patients, cost-effectiveness, and extended access to specialty services. Challenges to telehealth include lack of universal availability of required technologies, security of patient data, and limitations in performing some components of the traditional physical exam. (2) While telehealth has been utilized for decades, (3) the use of telehealth has substantially increased since emergence of the Severe Acute Respiratory Syndrome coronavirus (COVID-19) pandemic in early 2020, (4) which is a viral infection that increases morbidity and mortality among patients with obesity. (5) At the time of this writing, it is unclear how long, and how severe the COVID-19 pandemic will persist. Clinicians may benefit from a practical overview of telehealth applicable to obesity care, from the perspective of clinicians representing a spectrum of diverse backgrounds in their clinical practice utilization of telehealth in the management of patients with obesity.

What is the Obesity Medicine Association (OMA) “ADAPT” Telehealth Obesity Management Model?

5

Figure 1 provides an overview of the OMA “ADAPT” Telehealth Obesity Management Model, as included in the 2021 OMA Obesity Algorithm. This obesity management model outlines components of a telehealth encounter, applicable to obesity medicine. Components of the OMA ADAPT Obesity Management Model include assessment, diagnosis, advice (and education), prognosis, and treatment. Table 1 provides a more granular description of each of these components, with an emphasis on how these components specifically apply to the telehealth management of the patient with obesity.

Figure 1. Obesity Medicine Association “ADAPT” Telehealth Obesity Management Model. (6)

6

Table 1. “ADAPT” Telehealth Obesity Management model (Adapted from the Obesity Medicine Association Obesity Algorithm). (6)

A SSESSMENT Platform

Video conferencing via internet cloud-based platforms best for patient and provider, secure, and compliant with the Health Insurance Portability and Accountability Act Concurrent illnesses, body weight pattern, medications, social history, review of systems (e.g., sleep), nutrition and physical activity May include home device weight, pulse, blood pressure, waist circumference, body composition, temperature. Some vital sign metrics can be derived from wearable technologies (pulse, blood pressure, cardiac rhythm strips, temperature). Home device and/or wearable technologies may be able to transmit vital sign data to the clinician for remote monitoring. Skin, cognition, breathing (shortness of breath, wheezing), gait, speech & communication, mobility, eye exam, mental status, mood, behavior Determine which coding is required or applicable for telemedicine payer reimbursement. Proper informed consent process and agreement between patient and provider for virtual visits, explaining potential limitations in some diagnostic abilities with virtual telehealth visits. General nutrition advice (e.g., ultra-processed foods, fiber, fruits, vegetables, fluids), food labels, portions, food energy density, glycemic index/load, and specific nutritional counseling based upon patient food diaries

History

Vital signs

Physical exam

D IAGNOSIS Coding

Transparency

A DVICE Nutrition

Physical activity prescription (FITTE)

F requency I ntensity T ime spent T ype E njoyment level

Motivational interviewing and behavior modification (e.g., OARS, SMART)

O pen Ended questions

● S pecific ● M easurable ● A ssignable ● R ealistic ● T ime-related

A ffirmation R eflection S ummary

Review additional treatment options

Potential alterations in management of non-obesity concomitant diseases, review anti-obesity medication options, review bariatric surgery options

P ROGNOSIS Understanding

Educate patient that obesity: is a disease with “sick fat disease” and “fat mass” disease adverse outcomes,

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contributes to the most common adiposopathic metabolic complications encountered in clinical practice, and whose prognosis is enhanced with clarity of treatment plan (e.g., summary of telehealth visit via text, email, posting in electronic health records), and clinical notification of missed referrals or lack of completed medical procedures Establish baseline existing “sick fat disease” metabolic status and establish baseline existing “fat mass disease” status, with an unbiased and realistic determination of what may or may not improve with heathy weight loss Provide the patient unbiased and realistic expectations of weight loss, metabolic health parameters, and fat mass disease adverse consequences of obesity that may or may not improve with healthy weight loss. Provide an unbiased and realistic overview of the challenges of weight regain, after successful weight loss, accompanied by mitigating strategies Simple, attainable, and agreed upon nutritional prescription; instruct patient to keep a dietary diary (written or via electronic app) Give simple, attainable, and agreed upon physical activity prescription; instruct patient to keep a physical activity diary (written or via electronic app) Prescribe anti-obesity medication treatment in accordance with state and federal laws, and as clinically appropriate for telehealth visit. Instruct and provide educational materials regarding possible side effects. If applicable, arrange for outpatient testing (e.g., laboratory assessment, electrocardiogram, vital sign assessment). Potential referral to bariatric surgeon and/or certified bariatric center

Current status

Realistic assessment of outcomes

T REATMENT Nutrition

Physical Activity

Anti-obesity medications

Bariatric surgery

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In the management of patients with obesity, how are telehealth and traditional offices visit similar; how are they different?

Many of the components of the OMA “ADAPT” telehealth obesity management model mirror the traditional obesity medicine face-to-face clinician office visit. These similarities include: A ssessment (e.g., history, vital signs and physical exam); D iagnosis (e.g., determining the etiology and severity of a disease); and A dvice (e.g., education and counseling on nutrition, physical activity, anti-obesity medications, and bariatric surgery – all augmented via motivational interviewing techniques and implementation of behavior modification. This model also includes P rognosis (e.g., create an understanding of the current and future status of obesity as a disease in an individual patient, with realistic assessment of outcomes and T reatment (e.g., nutrition, physical activity, anti-obesity mediations, and bariatric surgery). Where obesity medicine via telehealth may differ from traditional clinician office visits includes need to mutually accessible and effective teleplatforms (e.g., video conferencing or telephone), vital sign measurements (e.g., via home versus office devices), physical exam (e.g., with some limitations via telehealth), and coding for encounters, as well as need to implement an informed consent process wherein the patient agrees to telehealth visits and prescribing of controlled substances. Despite these differences, if implemented via a practical, patient-centered approach, telehealth has the potential to provide obesity management in a way that is not only more convenient and accessible to patients, but perhaps more therapeutically and cost-effective. Table 2 provides practical “tips” on telehealth for obesity management.

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Table 2. General “tips” regarding telehealth for obesity management • Potential advantages of telehealth o More timely, personalized, efficient, and coordinated health care delivery o Safer delivery of health care (i.e., during times of a pandemic wherein office visits might risk exposure to both patient and provider) o Improved communication o More convenience to patient o Greater accessibility to patients with immobility, relative lack of transportation, or located in areas where access to health care is limited o Greater satisfaction of health care to both patient and provider o Potential improved health outcomes o Reasonable cost • Strategies o If approved (or requested) by the patient, consider having a family or friend available on the telehealth encounter, to better understand the patient support system, and better ensure clarity of instructions o Conduct the telehealth encounter in a quiet room, without distractions, and with quality video equipment and adequate lighting o Regarding new patients, patients may be more reassured when providers show them their name on a diploma and scan the telehealth encounter room to confirm privacy o Place the video camera at the top of the screen, so that when the provider is looking at the screen, it will appear the provider is looking at the patient o Login several minutes before the scheduled encounter to address potential technical issues and to prepare for the virtual visit (i.e., review chart) – allowing prioritization of eye contact during the telehealth visit o Be respectful of the patient by being on time. If the provider is to be late, it is preferable to notify the patient so the patient does not believe it is their fault they are not able to connect o Consider use of two screens (or split screen)  Patient encounter screen  Patient charting screen  Split or sharing screen can be used to illustrate concepts or review laboratory o Have a plan when an in office, face-to-face encounters may be preferred:  Older individuals at high cardiovascular disease risk or with multiple concomitant illnesses wherein it may be preferable to have onsite vital signs, electrocardiogram, laboratory and/or a full physical exam  Women who are pregnant o Have a backup device and backup telehealth platform o Plan for priorities before the telehealth encounter

 Patients with substantial psychiatric disease  Patients with history of substance abuse  Patients who are unable to afford telehealth visits  Patients unable to utilize required technology for telehealth

• Accompanying technologies that may complement telehealth:

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o Body weight scales  Talking weight scales for patients with obesity who cannot see weight scale number values  Self-body composition scales can initially be compared (validated) with “gold standard” body composition analyses (e.g., dual x-ray absorptiometry), and then followed longitudinally  Body weights are best taken the same time per day  Consider having the patient send a picture of their weight from the scale, with some identifier as to date (and perhaps time) o Self-blood pressure monitoring devices preferably:  Have appropriately sized brachial cuff  Store blood pressure values  Transmit data via telemonitoring  Are listed as a “validated device” according to the American Medical Association US blood pressure validated device listing (VDL TM ), found at https://www.validatebp.org/ o Other home health monitoring devices, such as glucose monitors and smartphone apps for vital signs such as heart rate and sleep patterns, can transmit patient data directly to the provider and sometimes directly into the electronic health records o For all devices that can transmit data, it is best the data be transmitted before the telehealth encounter o Patient should complete electronic health record intake forms (check list and pre-visit questionnaires) prior to the telehealth encounter o Utilize virtual reminders to collect vital signs (e.g., weight, blood pressure, heart rate) prior to the telehealth encounter o Electronic health records can set up alerts or flags for patients at higher risk who would benefit from closer medical and/or psychological follow-up to ensure monitoring of nutrition, physical activity, vital signs, blood testing, and mental/emotional status o Smart watch/phone reminder systems, text messaging, online messaging, and interactive voice calls may enhance uniformity in communication, which may help limit misunderstandings and limit disparities in communication that might otherwise occur. o Video conferencing via internet cloud-based platforms are not only best for patient and provider [provided they are secure, and compliant with the Health Insurance Portability and Accountability Act (Table 1)] but may also allow for group healthcare sessions o Portability of video conferencing (i.e., via smartphone) may allow patient to show real time video of where the patient eats, food in their refrigerator and cabinets, and images of food and supplement labels – all providing insights not available in a traditional office setting. o Patients of providers actively engaged in telehealth and associated technologies benefit from office-provided technology support. o Technologies and systems to improve communication and self-monitoring will have more limited effectiveness among individuals who because of socio-economic status,

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cannot afford, and thus do not have access to smartphones and self-monitoring devices. o Coding requirements for telehealth are rapidly evolving and usually involve general evaluation and management codes with modifiers, with reimbursement for services dependent upon payers.

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What are the practical considerations in prescribing anti-obesity controlled substances (i.e., phentermine), with or without telehealth? Whether DEA controlled medications or not, and whether prescribed via telehealth or clinician office visits, both clinicians and patients should be aware of potential risk and benefits of anti- obesity medications. (6) Additionally, some anti-obesity medications are DEA controlled substances. Phentermine is a DEA schedule IV medication approved in 1959, (7) and often reported to be the most commonly prescribed anti-obesity agent. (8) Phentermine is illustrative of the practicalities of prescribing controlled substances. (Other sympathomimetic amines, such as diethylpropion and phendimetrazine, will not be discussed here). Phentermine may be prescribed alone, or in combination with other anti-obesity agents (e.g., phentermine HCl / topiramate combination agent). (9) Clinicians should prescribe anti-obesity medication treatments in accordance with state and federal laws, and as clinically appropriate for telehealth visit. (Table 1) Phentermine is a sympathomimetic amine that is contraindicated in patients with cardiovascular disease (CVD). (6) The disease of obesity is a major contributor to heart disease. (6) Table 3 lists illustrative cardiovascular diseases and cardiovascular disease (CVD) risk factors to consider in the general management of all patients with obesity. Additionally, according to the prescribing information, phentermine HCl is approved for short-term (12 week) treatment of obesity. (6) From a clinical perspective, the time limitation on indicated use of phentermine may limit potential benefits in patients otherwise at low cardiovascular disease risk having the chronic disease of obesity. (Table 4) From a scientific perspective, the limitation of “short-term”

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indicated use of phentermine has often led to omission from published reviews and meta- analyses of efficacy and safety data. (10)

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Table 3. Illustrative Cardiovascular Disease Risk Factors to Consider When Managing Patients with Obesity* (11) Major ASCVD Events • Recent acute coronary syndrome (ACS within the past 12 months) • History of myocardial infarction (other than recent ACS event listed above) • History of stroke • Symptomatic peripheral arterial disease (history of claudication with ABI <0.85, or previous revascularization or amputation High-Risk Conditions

Age ≥65 y

• •

Heterozygous familial hypercholesterolemia

• History of prior coronary artery bypass surgery or percutaneous coronary intervention • Diabetes mellitus • Uncontrolled hypertension • Chronic Kidney Disease • Current smoking • Persistently elevated low-density lipoprotein cholesterol • History of congestive heart failure Risk-Enhancing Factors

• Family history of premature atherosclerotic cardiovascular disease (men, age <55 y; women, age <65 y) • Primary hypercholesterolemia • Metabolic syndrome • Chronic kidney disease • Chronic inflammatory conditions (e.g., psoriasis, rheumatoid arthritis, human immunodeficiency virus infection (HIV/AIDS) • Premature menopause (before age 40 y) • Pre-eclampsia • High risk populations (i.e., South Asians) • Persistently elevated triglyceride levels • Elevated high-sensitivity C- reactive protein (≥2.0 mg/L) • Elevated Lipoprotein(a) ( Lp(a) ≥50 mg/dL or ≥125 nmol/L ) • Elevated apolipoprotein B ≥130 mg/dL • Ankle brachial index <0.9

* Not an all-inclusive list

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In absence of prospective, randomized, long-term clinical trials, and omission from meta- analyses, clinicians may reasonably look towards the best available evidence. In an observational study of 13,972 patients at low cardiovascular disease risk, phentermine monotherapy for longer than 3 months was associated with greater weight loss, without an increase in incident cardiovascular disease or death. The conclusion was that: “this study supports the effectiveness and safety of longer-term phentermine use for low (cardiovascular disease) risk individuals.” In a chart review analysis of 300 consequential patients comparing those treated with those not treated with phentermine (with measurements spanning 1 through 104 weeks), the phentermine treated group did have greater weight loss, but did not have increased systolic blood pressure, diastolic blood pressure, or heart rate. In fact, in this comparative analysis, the phentermine treated group had a decrease in categorical blood pressure. (12) In an evaluation of 269 patients treated with phentermine up to 21 years having current or past criteria for the diagnosis of overweight or obesity, no evidence suggested signs or symptoms of psychological dependence (addiction), nor amphetamine-like withdrawal symptoms. (13) Based upon data such as this, some authors believe phentermine has been “ maligned inappropriately ,” with a conclusion that “US physicians will likely continue to use any drug proven useful off-label for this illness (obesity) until such time as more effective drugs are approved.” (7)

In the 2015 Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline, (8) the authors also acknowledged the conundrum wherein phentermine is approved for the treatment of a chronic disease, but does not have an FDA approved indication for long-

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term use. One suggested approach was to implement intermittent therapy. Regarding prescribing phentermine long-term, the authors advised: “ Direction and guidance provided by State Medical Boards and local laws always take precedence. However, in the many locations where these sources have not provided clear advice, clinicians are left to make their own best professional judgments. ” The authors also noted how phentermine was the most widely prescribed weight loss medication (at least partially because it is generic and low cost), and that likely much of this prescribing was “off label.” In this Endocrine Society Clinical Practice Guideline, the authors acknowledged minimal evidence of any serious long-term side effects when phentermine monotherapy was used alone for weight loss. Their conclusion was that it was reasonable for clinicians to prescribe phentermine long term as long as the patient: “1) has no evidence of serious cardiovascular disease; 2) does not have serious psychiatric disease or a history of substance abuse; 3) has been informed about weight loss medications that are FDA approved for long-term use and told that these have been documented to be safe and effective whereas phentermine has not; 4) does not demonstrate a clinically significant increase in pulse or BP when taking phentermine; and 5) demonstrates a significant weight loss while using the medication.” In its Obesity Algorithm, the Obesity Medicine Association has likewise acknowledged that while not studied in a prospective, large, randomized, controlled, clinical outcomes trial, clinicians often prescribe phentermine for longer than 12 weeks. Such clinicians believe this is in the best interest of their patients with obesity, and a style of obesity management supported by existing data and opinion leader recommendations. (6) To the extent that phentermine is to be

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prescribed beyond 12 weeks, it should be done so via a patient’s informed consent, with a patient centered approach, and in a manner that prioritizes safety (Table 4).

Regarding phentermine in fixed combination with topiramate, such a combination can contribute to clinically meaningful weight loss, as well as improvements in blood glucose, blood pressure, and blood lipids. (14) (9) While pulse may increase with phentermine/topiramate, a retrospective cohort study from US insurance billing data suggested no increased risk of major adverse cardiac events among phentermine/topiramate users, although the 95% confidence intervals were large, suggesting wide range of possible values. (15)

What are the practical considerations in prescribing anti-obesity controlled medications (i.e., phentermine) specific to telehealth?

The use of phentermine varies widely in clinical practice, even among obesity medicine specialists. Not everyone prescribes phentermine. Although not required according to its indicated use and prescribing information, some clinicians feel obesity is a major cardiovascular disease risk factor, and thus only prescribe phentermine after a face-to-face clinical encounter and only after an electrocardiogram (although an electrocardiogram is not required according to the prescribing information). Conversely, other clinicians have a low threshold for prescribing phentermine, and routinely do so on a long-term basis. This Position Statement is not intended to advocate how clinicians should treat their patients with obesity. The clinician management of an individual patient is best left to the shared decision making of clinician and patient, using a patient-centered approach. (16) However, it is the intent of this manuscript to highlight issues

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applicable to the telehealth prescribing of phentermine, towards the goal of better ensuring safety irrespective of the style of clinical practice. Table 4 provides some general considerations in prescribing phentermine via telehealth.

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