2022 Atlanta Board of Trustees Meeting

Rules of Order Policy Board Approved September 2017

Rules of Order for Board Meetings

Quorum: Our bylaws state that a quorum is present if the majority of the board is present.

Order of the day: Each meeting will have an agenda which will include points to discuss, old business and new business. The leader of the meeting is referred to as the “Chair.” This may be the chairman of the board, the president, or the highest-ranking officer present at the meeting. Items to discuss: All board members may submit items to discuss. These items must be submitted at least 2 weeks prior to the scheduled meeting. Items must be submitted electronically as editable Microsoft word documents. Items must include: the person (or persons, committee, etc.) introducing the item and the date of submission. Items should be marked as informational items (board updates), discussion items (not asking for action), or action items. For action items, the specific action being requested by the board should be clearly indicated. Late items: From time to time, items of critical importance may need to be introduced within 2 weeks of the board meeting. These items will be marked in the board book as “Late” and will only be discussed after a majority vote of the board to discuss the item. 1) The chair may call on the person responsible for the next order of business. Or, when no one else has the floor, a board member may address the chair by proper title. After recognition by the chair, the board member may make a motion. 2) To make a motion, state, “I move that…,” and state your motion. For example, “I move that we discuss item #4 regarding updating our travel policy…” Regarding the above items of business, the person who introduced the item o f business and who’s name appears on the item of business should introduce the motion. 3) Another member may second your motion. A second simply means that the motion should be discussed. If the motion is not seconded, it is not up for discussion. It is not lost, as there has been no vote. 4) Only if there is a second, the chair states “It has been moved and seconded that…” (state the motion). “Is there any discussion?” 5) Only one main motion may be on the floor at a time. Discussing a motion 1) All speaking points should be limited to 3 minutes. This will be enforced with a timer, and an OMA staff person will be designated to monitor the timer. A different time limit (or no time limit) may also be used if requested by a majority of the quorum, either for a single item of business, or for the entire meeting. 2) The member who made the motion is entitled to speak to it first. 3) Every member may speak to the motion. Only the motion at hand should be spoken either for or against. Each member should clearly state whether they are speaking for or against the motion. 4) A person may not speak against their own motion (however, they can vote against their own motion). 5) All discussion should be directed towards the motion. Avoid using a person’s name during the de bate. 6) All questions should be directed to the chair. 7) Each member may only speak to the motion twice; however, asking a question or a brief suggestion does not count as that person’s debate. Motions: Introducing a main motion

Rules of Order Policy Board Approved September 2017

8) A person may only speak a third time with the chair’s permission. 9) Only the person who introduced the motion may speak again at the end (even if this is a third time).

Voting on a motion 1) Before a vote is taken, the Chair puts the question to a vote by saying “Those in favor of the motion that… (repeat the motion) … say ‘Aye.’ Those opposed say ‘No.’” 2) Wait, then say “The motion is carried,” or “The motion is lost.” 3) If a member is in doubt about the result, he or she may call for “division.” A division is a demand for a standing vote count. This may be show of hands or ballot. 4) A majority is MORE than ½ of the votes cast by persons entitled to vote (a tie does NOT carry because it is not a majority). 5) A confidential written vote may be requested by any member of the board during in-person meetings. This would not require a second. Amending a motion a. Any main motion or resolution may be amended by: adding at the end, striking out or inserting words, substitution. b. To amend a motion, during discussion, a member may say “I move to amend the motion by…” Another member must second this amendment. c. The chair asks “Is there any discussion on the amendment? [repeat amendment].” At this point, only the amendment is discussed. d. When discussion ceases, the Chair says “Those in favor of the amendment [repeat amendment] s ay ‘Aye.’ Those opposed say ‘Nay.’ e. At this point, the motion carries or not. The main motion (amended or not) can now be voted on, discussion can continue, or the motion may be amended again (by another motion). f. Note, even if an amendment is passed, the main motion has still not been voted on – a separate vote is required. 2. Postpone definitely / indefinitely a. When the assembly does not want to take a position on the main question at all (indefinitely) b. When the assembly wants to delay to a certain time (definitely) 3. Motion to substitute a. When the assembly wishes to substitute a new motion for the original motion. 4. Refer a. Sends a pending motion to a committee, etc. 5. Limit debate / Extend debate 6. Lay the motion on the table (tabling the motion) a. This is used to lay the pending question aside and move on with other business. This may be appropriate when there is a more urgent question at hand, scheduling issue (people invited to speak to the board), etc. Privileged Motions 1. Call for order of the day – a member can interrupt a speaker to call for sticking with the agenda. 2. Recess – used to request an intermission (does not end the meeting) Subsidiary Motions 1.

Rules of Order Policy Board Approved September 2017

3.

Adjourn – used to end the meeting.

4. Fix the time to Which to Adjourn – sets the time at which the meeting will adjourn; any unfinished business is moved to the next meeting.

Incidental Motions 1. Point of order – used when member feels rules are being violated. Member may interrupt a speaker to raise a point of order. 2. Appeal – used to challenge the chair’s ruling. 3. Suspend the rules – example – suspend the time limit, allow other discussions, etc. 4. Withdraw – permits the maker of the motion to withdraw it. 5. Point of information – requests to the chair to provide information relevant to business at hand. A point of information must be in the form of a question. 6. Objection to consideration of a question – suppresses business that is irrelevant or inappropriate and undesirable to be discussed. Other Main Motions 1. Take from the table – resumes consideration of a motion laid on the table earlier. 2. Reconsider – reopens a motion to debate that has already been voted upon in the same session. 3. Rescind or amend – something previously adopted Carefully review the complete board manual before the board meeting. 2. Communicate prior to the meeting – Many items can be resolved before the meeting, saving valuable time. Or, big ticket items can be identified and proper time allocated. 3. Freedom of movement – Board members are welcome to stand, sit, or use the facilities as needed. 4. Freedom of opinion – Board members are free to express their opinions, without fear of stigmatization or personal attack by other board members. 5. Respect – Board members are expected to treat each other respectfully. 6. Attention – Board members are expected to pay attention. This requires turning off cell phones and other distracting electronic devices. Board members are expected not to be texting, emailing or making personal calls (barring emergency or urgent situations) during meetings. 7. Conflict of interest – If a real or perceived conflict exists, a board member must disclose this. Depending on the conflict, if the other board members feel the conflict is not germane to the item being discussed, the member may be allowed to discuss and vote. Other options – member may be allowed to discuss but not vote. Member may be not allowed to discuss or vote. Or, member may be asked to leave the board room for the discussion. The board should determine the level of conflict and appropriate level of involvement by the conflicted member on the issue at hand. Other Rules of Conduct: 1. Be prepared –

Board of Trustees Meeting April 27, 2022 1:00--5:00 PM ET Hyatt Regency Atlanta, GA Room 1731

Via computer, tablet, or smartphone https://obesitymedicine-org.zoom.us/j/83352938136?pwd=RVdJdVZ2alZCUG5uWkR1MTZuSmRpQT09 Meeting ID: 833 5293 8136 Passcode: 708646 Please note that OMA will not be providing printed copies of the materials at the board meeting. Presiding Officer: Ethan Lazarus, MD, FOMA, President Time Topics Lead Action

Doc #

1:00 PM

Call to Order, Opening Remarks, Rules of Order for Board Meetings

Lazarus

Order

1

1:05 PM 1:08 PM 1:10 PM

Roll Call

Bays

Approval of the Agenda

Lazarus

Decision

2

Conflict of Interest Disclosures

Bays

Declarations

Consent Agenda

3 4 - 10

Vote

• Minutes 1/13/22 • Other Class II Documents

1:15 PM

Lazarus

1:20 PM

Recognition of Dr. William McCarthy, OMA Clinical Education Director Treasurer's Report • Budget Summary for FY2021 & 1 st Quarter FY2022 • Stifel Investment Policy • Finance Committee (appointment of two board members for committee) Bi-Annual versus Annual Meeting(s) Proposal

Lazarus

Discussion

1:30 PM

Fraker Bays

Discussion Vote Appoint

11 12 13

1:45 PM

Discussion and Vote

Fraker

Bylaws Review and Discussion • Board leadership terms

14-17

Discussion and Vote

Fraker, Wilson

2:30 PM

Ethics Presentation

Knopke

Discussion

18-2 1

3:00 PM

General Information

Discussion

2 2

• Fall 2022 Conference Pricing • Certificate of Advanced Training in Obesity Medicine for Allied Health Professionals (RDs, RNs, PharmD, etc.) • Strategic Planning Updates

Fraker

2 3

Obesity Pillars Updates

Bays

Discussion

3:15 PM

3:25 PM

Future Direction of the Obesity Algorithm

Lazarus Primack Fraker

Discussion Appoint

3:40 PM

AMA Updates

Lazarus Auriemma

Discussion

2 4

3:50 PM

Nominating Committee Slate for 2022 Elections

Fitch

Discussion Vote Discussion Discussion Vote

2 5

4:05 PM

Quality Measure Development (National Quality Forum/NQF)

Fitch

2 6

2 7

4:20 PM

The Network for Excellence in Health Innovation Participation (NEHI) for OMA

Fitch

4:30 PM

NP/PA Bylaws Change Proposal

Lazarus

Discussion

2 8

4:45 PM

New Business

Lazarus

Discussion

5:00 PM

Call to Adjourn and Closing Remarks

Lazarus

Adjourn

Board of Trustees Meeting Minutes--January 13, 2022 Call to Order: The Board meeting was called to order at 6:02 PM (MT) Roll Call: Dr. Harold Bays, Secretary/Treasurer

Attendees : Drs . Craig Primack, Ethan Lazarus, Marisa Censani, Lydia Alexander, Ms. Sandra Christensen, Drs. Michelle Freshwater, Larry Richardson, Angela Fitch, Harold Bays, Anthony Auriemma, Suzanne Cuda, Bharti Shetye, and Carolynn Francavilla Brown. Teresa Fraker (OMA Executive Director and Ms. Dana Wicklund-Stifter (Operations and Governance Manager). Dean West and Nikki Haton Shanks (Association Laboratories) joined the call during their presentation. Conflict of Interest Disclosures : Dr. Ethan Lazarus addressed Conflict of Interest Disclosures and asked that once updated, the BOT are to send to the Executive Director. New disclosures should be revealed at the beginning of future meetings. Meeting Agenda and Consent Agenda Consent agenda included minutes from Board of Trustees meeting from 9/13/2021. Motion to accept Meeting and Consent Agenda Motion by: Dr. Harold Bays Second: Dr. Lydia Alexander Approval of Meeting and Consent Agenda: No Objections Rules of Order for Board Meeting Dr. Lazarus discussed the Rules of Order for Board Meetings, that was attached to the materials distributed to board prior to meeting. No further discussion or questions. Code of Conduct Dr. Lazarus provided background on the Code of Conduct for both Board and Members. The Codes of Conduct are being presented to the board with boilerplate language, board input is being requested during this discussion. Motion to amend the preamble of the Board Code of Conduct from, “individualized approach comprised of nutrition, physical activity, behavior therapy, and medication to help patients lose weight”, to “individualized evidence based-treatment to help patients lose

1

weight” Motion by: Dr. Anthony Auriemma Second by: Dr. Michelle Freshwaters Motion to amend preamble approved Motion to approve the Board Member Code of Conduct:

Motion: Dr. Ethan Lazarus Second: Dr. Lydia Alexander Motion Approved

As it relates to further discussion on the OMA Member Code of Conduct, Ms. Teresa Fraker will send email out to Board of Trustees for edits and suggestions to rework the language in the Member Code of Conduct. Once completed, an email vote will take place for this item only. When finalized, this document will be included in membership packet, and future committee members will need to abide by the OMA Member Code of Conduct. Strategic Planning Consultant Introduction – Association Laboratory, Inc. Dean West and Nikki Haton Shanks presented the board with information on their company, as well as their approach prepares various boards across the healthcare spectrum. Their plan includes a variety of pre-work involving data collection that will culminate with the BOT’s planned onsite strategic retreat in June 2022 in Chicago, IL. The engagement will include a steering committee to lead these efforts. Self-nominations and recommendations for the steering committee, should be sent to Ms. Fraker by the following Monday, 1/17/2022. As agreed by the board, Dr. Lazarus and Ms. Fraker will make final determination on those who will be appointed to the steering committee. Budget FY2022 Treasurer's Report Ms. Fraker reviewed the 2022 budget and detailed specific line items where adjustments from the previous year’s budget, were made. Dr. Bays reviewed the financials and updated the board on how he will present updates on financials going forward. Motion to approve 2022 Budget Motion: Dr. Harold Bays Second: Dr. Lydia Alexander Motion carries Obesity Pillars Update/Launch Dr. Bays gave an update on the status of the launch of Obesity Pillars , OMA’s journal, the Elsevier website where the open access journal articles are housed, the editorial board, and hiring of Obesity Pillars ’ medical writer, Savannah Logan. "10 Weeks In" Assessment for OMA

2

Ms. Fraker presented to the board details on her observations of OMA as well as how she plans to address a variety of issues both internal and external to the organization that have been presented to her during her initial time at OMA. Old/New Business Dr. Anthony Auriemma brought up the desire for continued discussion around affiliates and state chapters and he inquired as to where the board stands on engaging these. There was discussion amongst board as to how they would like to proceed moving forward with engaging local chapters. After discussion, it was agreed to include these concepts in the strategic plan for the retreat over the course of the next six months to further discuss the logistics and how this might look for OMA. Dr. Lazarus would like any previous documentation on chapters included in the strategic planning documents for the retreat. Dr. Angela Fitch will be sending out an email to all board members, regarding the board’s support in the use of emojis for the weight loss community, including a weight scale. Dr. Fitch is asking that all board members please watch the video she will be sending out and she asks that all members provide feedback and a possible letter of support if the board supports this concept via email.

Dr. Suzanne Cuda discussed the upcoming webinar and podcasts that will be offered by OMA.

Call to Adjourn Motion: Adjourn meeting at 7:59 PM MT Motion: Dr. Harold Bays Second: Dr. Marisa Censani Meeting is adjourned

3

CAMPAIGN FOR EQUITY IN OBESITY CARE

April 13, 2022

VIA EMAIL mary.watanabe@dmhc.ca.gov

Ms. Mary Watanabe Director, Department of Managed Health Care

980 9 th Street, Suite 500 Sacramento, CA 95814

VIA EMAIL publiccomments@dmhc.ca.gov

Social Equity and Health Quality Committee Department of Managed Health Care

980 9th Street, Suite 500 Sacramento, CA 95814

Re:

Health Measures and Obesity

DRAFT

Dear Ms. Watanabe and the DMHC Social Equity and Health Quality Committee:

We write you in your roles supporting California’s effort to advance social equity and health quality under the leadership of Governor Newsom. Consistent with the goals established by the Governor in the Summer of 2021, we urge you to take action now on a critical health equity crisis: The growing number of California adults in underserved communities living with obesity, and who lack access to comprehensive care for this chronic disease. The obesity epidemic is one of the most serious health equity issues impacting our state, affecting 42 percent of Americans. As a top comorbidity for serious cases of COVID-19 and death, obesity disproportionately impacts Black and Latino communities, who are nearly three times as likely to be hospitalized for severe cases of COVID-19 than whites. Obesity is also linked to more than 200 serious health conditions including diabetes, heart disease, high blood pressure, and strokes.

CAMPAIGN FOR EQUITY IN OBESITY CARE 515 S. Flower Street, 18th Floor Los Angeles, California 90071 www.equityobesity.org

California Department of Managed Health Care April 13, 2022 Page 2

Even though obesity is an epidemic that can lead to additional serious health issues, Black and Latino communities, and those from other underserved communities, can’t access the health care needed to treat the disease. A critical first step is the diagnosis of obesity . A formal diagnosis is the first step toward changing provider and patient behaviors in terms of addressing obesity. Furthermore, a diagnosis of obesity is impacted by bias and stigma among healthcare providers directly impacting the ability of those in underserved communities to seek care for and control their weight. The diagnosis of obesity must be included among the developing mandates for changes in health care to achieve the simple goal of improved equity in health outcomes across all underserved communities. Nationally, obesity is associated with nearly $1,900 in excess annual medical costs per person (amounting to over $170 billion in excess medical costs per year). Better access to a range of effective treatment not only could save money but also save lives. Reducing the obesity rate by 25% would have resulted in fewer hospitalizations, fewer ICU admissions, and fewer deaths during the pandemic. Nearly half of those reductions would be among Black people and nearly one quarter would be among Latino people, even though those communities account for 13.4 percent and 18.5 percent of the U.S. population, respectively. The Campaign for Equity in Obesity Care (CEOC) is a public advocacy and public awareness organization founded in 2021. CEOC is exclusively dedicated to advancing covered health care for obesity, together with better access to, and utilization of, that care in underserved communities throughout California. We recognize the extraordinary work that lies ahead and believe an important first step is to ensure that our laws and regulations reflect the latest guidelines and standards of care. To that end, we call on DMHC to take action immediately by requiring all health plans in this state to eliminate the disparities in the diagnosis and treatment of obesity. DRAFT

Sincerely,

Campaign for Equity in Obesity Care

Steering Committee Reshape LifeSciences (Chair) National Latino Food Industry Association California Psychological Association California Academy of Nutrition and Dietetics CoachCare MedTech Coalition for Metabolic Health Seca California Life Sciences Octane OC

California Department of Managed Health Care April 13, 2022 Page 3

Coalition Members Community RePower Movement Mujeres de la Tierra Cardenas Markets Northgate Gonzalez Markets Vallarta Supermarkets Walmart The California Endowment Cal-YMCA China Town Service Center Los Angeles Community Clinic Association of Los Angeles County Inland Empire Community Foundation John Wesley Community Health Institute, Inc., A California Health Center Purchaser Business Group on Health

City of Huntington Park, Parks & Recreation Department American Society of Metabolic and Bariatric Surgery Obesity Medicine Association The Obesity Society Gasol Foundation Obesity Action Coalition STOP Obesity Alliance National Kidney Foundation Obesity Care Advocacy Network Endocrine Society Arthur J Gallagher Insurance Brokers, Inc. Intellihealth Black Sports Agents Association (André Farr) United Healthcare Services, Inc. Medtronic Virta Health Corp Pfizer

DRAFT

WW (formerly Weight Watchers) Lockton Insurance Brokers, Inc.

April 15, 2022 On behalf of the Wisconsin State Chapter of the American Society for Metabolic and Bariatric Surgery (ASMBS), Wisconsin Academy of Nutrition and Dietetics (WAND), Obesity Action Coalition (OAC), Obesity Medicine Association (OMA) and The Obesity Society (TOS), we urge the Employee Trust Funds (ETF) and the Group Insurance Board (GIB) to adopt state employee health plan coverage for pharmacotherapy and medical nutrition therapy (aka nutrition counseling) for the treatment of overweight or obesity. Our groups truly appreciate the positive ETF staff recommendation surrounding bariatric surgery in 2019, which led the GIB to approve coverage of “bariatric surgery and required precursor weight management and nutrition services for members with BMI of 35 or greater” beginning in benefit year 2020. To date, numerous state employees have taken advantage of this new benefit and are now healthier and thriving because of the surgery and accompanying counseling services. Since WAND, OAC and the ASMBS Wisconsin State Chapter submitted its January 14 th comments to the GIB, a major coverage announcement regarding obesity treatment has been issued by the federal government. In a February 17, 2022, carrier letter and subsequent technical guidance, the federal Office of Personnel Management (OPM) released specific instructions for health insurance carriers that administer Federal Employee Health Benefit (FEHB) plans -- "clarifying that FEHB carriers are not allowed to exclude anti-obesity medications from coverage based on a benefit exclusion or a carve out…” and that "FEHB Carriers must have adequate coverage of FDA approved anti-obesity medications (AOMs) on the formulary to meet patient needs and must include their exception process within their proposal.” In issuing this new guidance, OPM is quite clear -- emphasizing that "obesity has long been recognized as a disease in the US that impacts children and adults…” and that "obesity is a complex, multifactorial, common, serious, relapsing, and costly chronic disease that serves as a major risk factor for developing conditions such as heart disease, stroke, type 2 diabetes, renal disease, non-alcoholic steatohepatitis, and certain types of cancer.” This new guidance comes eight years after OPM first warned plans that it is not permissible to exclude weight loss drugs from FEHB coverage on the basis that obesity is a “lifestyle” condition and not a medical one or that obesity treatment is “cosmetic.” These definitive statements from OPM should ensure that all federal employees, and their family members, will now have access to comprehensive obesity care. We believe that state employees in Wisconsin deserve the same access and hope that the GIB will support this goal by adopting coverage for pharmacotherapy and medical nutrition therapy (aka nutrition counseling) for the treatment of overweight or obesity. Our growing knowledge regarding the complexity of obesity, the tremendous advances in treatment, and the growing recognition of, and support for treating obesity as the chronic disease that it is, clearly make health plans that continue to exclude coverage for evidence-based treatment avenues out of date and out of touch with the current scientific evidence surrounding obesity care. Should you have any questions or need additional information, please feel free to contact us or Chris Gallagher via email at chris@potomaccurrents.com or telephone at 571-235-6475. Thank you.

April 15, 2022

On behalf of the Connecticut State Chapter of the American Society for Metabolic and Bariatric Surgery (ASMBS), Obesity Action Coalition (OAC), Obesity Medicine Association (OMA) and The Obesity Society (TOS), we urge the Connecticut General Assembly to support passage of Senate Bill (SB) 282, which would require broader health insurance coverage for bariatric and metabolic surgery and FDA-approved anti-obesity medications (AOMs). Since the Human Services Committee unanimously approved SB 282 on March 17 th , we have learned that a major coverage announcement regarding obesity treatment has been issued by the federal government. In a February 17, 2022, carrier letter and subsequent technical guidance, the federal Office of Personnel Management (OPM) released specific instructions for health insurance carriers that administer Federal Employee Health Benefit (FEHB) plans -- "clarifying that FEHB carriers are not allowed to exclude anti-obesity medications from coverage based on a benefit exclusion or a carve out…” and that "FEHB Car riers must have adequate coverage of FDA approved anti-obesity medications (AOMs) on the formulary to meet patient needs and must include their exception process within their proposal.” In issuing this new guidance, OPM is quite clear -- emphasizing that "obesity has long been recognized as a disease in the US that impacts children and adults…” and that "obesity is a complex, multifactorial, common, serious, relapsing, and costly chronic disease that serves as a major risk factor for developing conditions such as heart disease, stroke, type 2 diabetes, renal disease, non- alcoholic steatohepatitis, and certain types of cancer.” This new guidance comes eight years after OPM first warned plans that it is not permissible to exclude weight loss drugs from FEHB c overage on the basis that obesity is a “lifestyle” condition and not a medical one or that obesity treatment is “cosmetic.” These definitive statements from OPM should ensure that all federal employees, and their family members, will now have access to comprehensive obesity care. We believe that all Connecticut citizens served by the state employee health plan, Medicaid and the state health exchange deserve the same access and hope that the General Assembly will move the state closer toward this goal by passing SB 282. Our growing knowledge regarding the complexity of obesity, the tremendous advances in treatment, and the growing recognition of, and support for treating obesity as the chronic disease that it is, clearly make health plans that continue to exclude coverage for evidence-based treatment avenues out of date and out of touch with the current scientific evidence surrounding obesity care.

Should you have any questions or need additional information, please feel free to contact us or Chris Gallagher via email at chris@potomaccurrents.com or telephone at 571-235-6475. Thank you.

7173 S. Havana St #600-130 Centennial, CO 80112 P: 303.770.2526 | F: 303.779.4834 obesitymedicine.org

03/07/2022 Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-4192-P Mail Stop: C4-26-05,

7500 Security Boulevard, Baltimore, MD 21244-1850

RE: Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Dear Administrator Brooks-LaSure: On behalf of the Obesity Medicine Association, I am writing to bring to your attention a gap in Medicare beneficiary access to important interventions to treat obesity. In 2013, the American Medical Association recognized obesity as a disease state with multiple pathophysiological aspects requiring a range of interventions for treatment and prevention. However, Medicare’s coverage rules for treatment of obesity predate recognition of obesity as a chronic disease and prohibit coverage of FDA-approved anti-obesity medications (AOMs) under a statutory provision excluding drugs used as “weight loss” or “weight gain” agents. This prohibition lumps the treatment of obesity with other cosmetic conditions including hair loss and is not consistent with current science which understands obesity as a deadly, chronic disease with significant consequences. All evidence- based medications that have been approved by the FDA for chronic weight management in people with obesity as measured by body mass index (BMI). Medicare Part D should cover AOMs so that seniors have access to the full continuum of obesity care. Obesity is a highly prevalent and serious chronic disease. • Obesity is a serious chronic disease that is caused by a range of biological, genetic and environmental factors. The American Medical Association has recognized obesity as a disease since 2013. • People living with obesity are at increased risk of morbidity and mortality, and obesity and overweight are major risk factors for a broad range of chronic diseases including diabetes, hypertension, cardiovascular disease, sleep apnea, osteoarthritis, and at least 13 forms of cancers and premature death. • Obesity affects more than 100 million Americans. From 2017 to 2018, the age-adjusted prevalence of obesity in adults was 42.4%. 1

1 Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of obesity and severe obesity among adults: United States, 2017–2018. NCHS Data Brief, no. 360. Hyattsville, MD: National Center for Health Statistics; 2020.

7173 S. Havana St #600-130 Centennial, CO 80112 P: 303.770.2526 | F: 303.779.4834 obesitymedicine.org

• People living with obesity are not only common victims of bias and stigma, but they are perceived as lazy and noncompliant even within our healthcare system. Most are not offered evidence-based treatment, in part because Medicare does not cover these treatments. This absence of coverage perseverates these mis-perceptions. Obesity can be treated, but seniors do not currently have access to all recommended treatment options. • Clinical guidelines recommend treatment with intensive behavioral therapy (IBT), pharmacotherapy, and bariatric and metabolic surgery. However, seniors currently only have limited coverage for IBT and surgery. • Anti-obesity medications are a critical part of the care continuum, particularly for people who are not able to lose weight through lifestyle intervention alone or who have multiple comorbidities. FDA-approved anti-obesity medications are proven to help patients with obesity achieve clinically meaningful weight-loss and can also improve many obesity co-morbidities such as Type II diabetes and hypertension. • A growing number of commercial and Medicaid plans offer coverage for anti-obesity medications. Medicare’s lack of coverage means that many patients lose access to medically necessary care when they turn 65. Access to anti-obesity medications is a health equity issue. • Non-Hispanic blacks had the highest prevalence of obesity at 49.6%, followed by Hispanics at 44.8%, and non-Hispanic whites at 42.2%. 2 African American women have the highest rates of obesity among any demographic group; approximately 4 out of 5 African American women have overweight or obesity. 3 • Given the disproportionate impact of obesity on communities of color – the impacts of this coverage gap are a barrier to better health in racial and ethnic communities that can be remedied. • In response to President Biden’s Executive Order on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, each federal agency must assess whether its programs and policies perpetuate systemic barriers that affect people of color and underserved groups. • To respond to this directive, CMS must update Part D coverage to alleviate this barrier for all Medicare beneficiaries, including communities of color. Obesity increases the risk for severe COVID-19. • The CDC reported that, 78 percent of patients who have been hospitalized needed a ventilator or died from COVID-19 have had obesity or are overweight as a co-morbidity had at least one underlying health condition, many of which were obesity-related diseases. 4

2 Centers for Disease Control and Prevention. Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion. Adult Obesity Facts. 2020 [cited 2020 November 24]. Available from: https://www.cdc.gov/obesity/data/adult.html#:~:text=Obesity%20affects%20some%20groups%20more%20than%20others&text=Non%2DHispanic%20blacks%20(49.6%25),%2 DHispanic%20Asians%20(17.4%25). 3 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=25 4 Body Mass Index and Risk for COVID-19–Related Hospitalization, Intensive Care Unit Admission, Invasive Mechanical Ventilation, and Death — United States. (2021, March 11). Retrieved April 29, 2021, from https://www.cdc.gov/mmwr/volumes/70/wr/mm7010e4.htm?s_cid=mm7010e4_w

7173 S. Havana St #600-130 Centennial, CO 80112 P: 303.770.2526 | F: 303.779.4834 obesitymedicine.org

• One study showed that a 25% reduction in the rate of obesity could have led to 7% fewer hospitalizations, 12% fewer ICU admissions, and 12% fewer deaths from COVID-19 by April 2021. 5 CMS can and should update its policy to cover AOMs so that seniors have access to the full continuum of obesity care. • Medicare Part D still prohibits coverage of FDA-approved AOMs under a statutory provision excluding drugs used as “weight loss” or “weight gain” agents. This prohibition was intended to exclude drugs for cosmetic use and predates our understanding of obesity as a chronic disease. However, the Medicare Part D statute does not define “weight loss” and “weight gain” agents and it does not prohibit the treatment of obesity. In fact, the medications are now indicated for “chronic weight management”, not simply for “weight loss”. • CMS’ policy currently interprets the statute to exclude anti-obesity drugs from Part D coverage. CMS adopted this policy in the preamble to a 2008 Part D final rule and can therefore reverse this policy the same way. • CMS took a similar approach when it interpreted the prohibition on agents for weight gain to permit Part D coverage of drugs used to treat AIDS wasting and cachexia. • As our understanding of obesity has evolved, it is important that Medicare no longer exclude AOMs as “weight loss” agents but as important therapies that treat a severe, chronic disease— obesity—and importantly, many of its associated conditions beyond direct weight loss alone, to reduce overall morbidity and mortality. We urge CMS to update its policy in the 2023 Part D Final Rule to ensure coverage for FDA- approved anti-obesity medications. CMS’ policy to exclude AOMs from Part D coverage was adopted in the preamble to a 2008 Part D final rule and can therefore be reversed through similar guidance. We would welcome the opportunity to work with you to ensure that seniors have access to the full continuum of obesity care, including FDA-approved anti-obesity medications. If you have any questions about our comments, please contact me at ethanlazarus@gmail.com. Sincerely,

Ethan Lazarus, MD, FOMA President, Obesity Medicine Association (OMA)

5 Xcenda. The Impact of Obesity on COVID-19 Outcomes of Hospitalizations and Mortality. https://www.xcenda.com/-/media/assets/xcenda/english/content-assets/white- papers-issue-briefs-studies-pdf/xcenda_covid_obesity_update_june2021.pdf

7173 S. Havana St #600-130 Centennial, CO 80112 P: 303.770.2526 | F: 303.779.4834 obesitymedicine.org

3/2/2022

To:

Tracy Johnson, Colorado Medicaid Director

From:

Ethan Lazarus, MD Carolynn Francavilla, MD Rebecca Andrick, DO

Dear Ms. Johnson,

The Obesity Medicine Association (OMA) represents over 5,000 clinicians including physicians, nurse practitioners and physician assistants specializing in the care of patients with the chronic disease of obesity. Obesity is a multi-factorial disease and not adequately addressed with lifestyle changes alone. By the time patients with obesity seek our care, most have attempted weight loss multiple times and often with some success but then nearly always followed by weight regain due to the relapsing nature of the disease. One of the tools we have available to assist these patients with treating this disease are anti-obesity medications. These FDA-approved prescription medications enhance the amount of weight lost, and more importantly, double to triple the odds of sustaining the weight lost. Like medications used for diabetes or high blood pressure, they reduce the burden of the disease for the patient, improve co-morbidities, and improve quality of life. However, unlike medications for hypertension and diabetes, most insurance companies deny coverage for this important class of medications, because they inaccurately classify the disease of obesity as a lifestyle choice. This is not consistent with current views of this important disease. It is no more a lifestyle choice than diabetes, hypertension, or mental illness like depression. Obesity disproportionately affects persons with lower socioeconomic status such as those on Medicaid. Statistics from CDPHE (2014) show Colorado’s adult obesity rate to be 21.3% overall but 26.9% in the Medicaid population. Minority populations are also disproportionately affected with an obesity rate of 30.5% in blacks, 26.5% in Hispanics compared to 19.9% in whites. Obesity also affects women more than men. People with a body mass index above 35 are estimated to have a reduction in lifespan by as much as 8 years. Patients with obesity are a group that has been discriminated against because much bias exists in our health care system and having access to the full spectrum of treatment options for obesity is a matter of health equity. As you know, obesity is the root cause of as many as 236 other diseases such as diabetes, hypertension, hyperlipidemia, and cardiovascular disease. It also increases the risk for 13 types of cancer, is a major cause of degenerative arthritis in joints and obstructive sleep apnea. The pandemic

7173 S. Havana St #600-130 Centennial, CO 80112 P: 303.770.2526 | F: 303.779.4834 obesitymedicine.org

has shown us the vulnerability of patients with obesity to have more severe illness and death from COVID-19. Medicaid spending on treating these secondary diseases must be substantial. We believe treating the obesity first is the best way to prevent these co-morbidities but also improve them even with as little as 5-10% body weight loss. The newest anti-obesity medications can help patients to lose 16-18% of their body weight. Often with weight reduction, patients can discontinue some of the chronic medications they are on for obesity related co-morbidities and lower health care spending. We understand bariatric surgery is covered by Health First Colorado which is a good option for many patients with more severe obesity, but it is not for everyone. Requirements for surgery include a BMI over 35 with co-morbidity or BMI over 40 without which leaves out a lot of people in the BMI range for obesity of 30-34. These patients may avoid bariatric surgery with medical management with anti- obesity medications earlier in the course of their disease. It is bewildering that we will pay for medications to treat all the diseases caused by obesity but fail to provide coverage for the root cause. We would like to ask you to meet with us to have a conversation about anti-obesity medications and how to advance gaining coverage by Health First Colorado. We appreciate you consideration of this request and look forward to hearing from you.

Thank you,

______________________________________

Ethan Lazarus MD, President, Obesity Medicine Association Owner, Clinical Nutrition Center, Greenwood Village, CO

Carolynn Francavilla MD, Board of Trustees, Obesity Medicine Association Owner, Green Mountain Partners for Health, Lakewood, CO

Rebecca Andrick, DO, Advocacy Committee Chair, Obesity Medicine Association Owner, Weigh to Wellness Denver, Denver CO

2/12/2022

State Medical Board of Ohio

30 E. Broad St., 3 rd Floor Columbus, Ohio 42315 (614) 466-3934 www.med.ohio.gov

Dear members of the Ohio Medical Board :

Thank you for the opportunity to review proposed rule 4731-11-04. In opening, I like medical boards to consider that obesity has been recognized as a chronic disease by our American Medical Association in 2013, to be treated the same as other diseases such as hypertension and type 2 diabetes. I was personally involved in the passing of that resolution, and I was the author of the later resolution calling on the AMA to help remove barriers to treatment so that physicians can practice the current standard of care with regards to the treatment of obesity without fear of reprisal. I appreciate the State ’ s concerns regarding mis-use of older medications due to the fact that they are Schedule IV controlled substances; however, as you review your rules, please consider the following question – would you have the same rule in place for a disease such as diabetes or hypertension? Also, will the rule improve the care the patient receives, or will it be a barrier for them to receive treatment? With that in mind, this proposed rule represents a good step in the right direction. In particular, eliminating the rule to only use medication short-term for a chronic condition is extremely helpful, and allows the current standard of care to be provided for many more Ohio patients living with obesity. That being said, I do have several concerns with the proposed language where I think it is overly prescriptive and will still represent a barrier to care for many patients, particularly with those with difficult to treat obesity. Item B (3) (d) – BMI is intended as a population-based measurement, and should not be strictly enforced with the individual patient. This language could be improved by adding language to the effect that “ or the benefits of weight loss treatment for the patient would significantly outweigh any risks of the medication being used. ” Further, this does not make allowance for on-label use of current or future medications in kids, where it is based on BMI percentile, not BMI (see Saxenda label, for example). You could address this with additional language, “ Or pursuant to guidance from package inserts. ”

5995 Greenwood Plaza Blvd. Ste 150, Greenwood Village, CO 80111 | 303.750.9454 www.ClinicalNutritionCenter.com

Item B (3) (f) This language is very castigatory, blaming the patient for the disease of obesity. It has no place in a medical board rule and should be removed. Past poor performance does not indicate the patient can ’ t do well moving forward. Under this rule, a patient gets one shot at treating their obesity, and if they don ’ t do well, is barred from ever being treated again. Item C (3) While we desire all patients to lose 5% or more body weight within the first 3 months, some of the patients with the most severe obesity do not. Oftentimes we can simply stop weight gain, or are lucky to achieve any weight loss. Even the PI for Qsymia states that it can be continued if at 3 months the patient has lost 3% or more, or that if the response is less than 3%, the medication dose can be increased from 7.5 mg phentermine to 15 mg phentermine. You could add language that in the event 5% weight loss is not achieved within 3 months, the provider document pros and cons of continuing medication to see if 5% can be achieved at 6 months, if there is a compelling reason why the benefits outweigh the risks of continuing treatment, or can change the treatment (phentermine to diethylpropion), augment treatment (add topiramate), raise dose (from 8 or 15 mg to 30 or 37.5 mg), etc. This language is overly prescriptive and will result in the more complex patient not being able to continue on treatment. Item C (4) (b) – this language is not consistent with how the disease of obesity acts. Obesity is a chronic progressive disease. Virtually everybody that successfully loses weight regains it over time. However, they will sustain a percentage weight loss vs. where they would have been untreated. For example, if you treat a patient who is 200 pounds and they lose 10% of their weight in the first 6 months and sustain that for 6 more, they will be 180 pounds at the end of the year. But most slowly gain weight – 1-2 pounds per year. Within 10 years, they will likely be back up to 200 pounds. Conversely, were they not treated, they would gain a similar amount of weight and now be 220 pounds. A requirement to sustain weight loss is not consistent even with the newest medications like Saxenda, where in their 3 year trial patients regained about 1/4 th of the weight that was lost. Even bariatric surgical patients regaine about 1/3 rd of the lost weight. Further, there is no “ goal weight. ” This is a myth that should be retired. I encourage you to strike item C (4) (b) as it will result in all treated patients having their treatment stopped. When treatment is stopped, weight regain is quite rapid posing further risks to the person ’ s health. Item C (5) – Why would you need to stop a weight loss program due to alcohol use? These do not appear related. Further “ Drugs ” is non-specific – I ’ d clarify – “ other stimulants, whether prescription or illicit. ”

Item C (5) (c) – see above. This language should be stricken.

5995 Greenwood Plaza Blvd. Ste 150, Greenwood Village, CO 80111 | 303.750.9454 www.ClinicalNutritionCenter.com

Item C (5) (f) – duplicative – language already included above.

I hope you find these comments helpful, and applaud you for allowing Ohio patients to receive the current standard of care with regards to the treatment of obesity.

Sincerely,

Ethan Lazarus, MD President, Obesity Medicine Association

5995 Greenwood Plaza Blvd. Ste 150, Greenwood Village, CO 80111 | 303.750.9454 www.ClinicalNutritionCenter.com

Medications for Obesity Management Revised Background and Scope March 31, 2022

Background Obesity is a common chronic disease that increases the risk of other diseases such as diabetes, cancer, and heart disease as well as death. 1,2 Individuals who are overweight or those with obesity face considerable social stigma that can make them feel judged, shamed, and ostracized, and can affect interactions with family, friends, and even health professionals. 3 Because obesity often starts in childhood, the stigma can affect social interactions, educational development, relationships, and work throughout life. 4,5 Obesity is defined by the World Health Organization as abnormal or excessive fat accumulation that presents a risk to a person’s health. 6 Body mass index (BMI, weight in kilograms/height in meters 2 ) is commonly used to assess for obesity because it is easy to reliably measure and correlates with body fat measurements. 4,7 More than two-thirds of the United States (US) population is overweight (BMI ≥25) or has obesity (BMI ≥30). The prevalence of obesity among adu lts has increased over time and was 40 - 45% in 2017 - 2018. 8 Among children and adolescents, the prevalence of obesity is almost 20%. 9 The total number of adults who were overweight was estimated at 79 million and those with obesity was estimated at 70 million in 2015 with half of the US population projected to have obesity by 2030. 10 ,11 There are important disparities by race /ethnic status with the prevalence of obesity higher for Hispanic adults and highest among non-Hispanic Black women. 9,12 Given the prevalence of obesity and its impact on health, the direct medical costs of obesity are staggering, estimated to be $260 billion in the US in 2016 . 13 The financial impact of obesity on individuals includes not only direct medical costs but also indirect costs of lower wages and greater work loss and disability. 14,15 T here are many factors that contribute to developing obesity, including increasing recognition of complex genetic factors associated with the body’s mechanisms that control energy balance. 16,17 The goal of therapy for obesity is to broadly prevent, treat, or reverse its complications, including its impact on quality of life. 18 ,19 Treatments to promote weight loss are intended to prevent the health risks associated with obesity (e.g., diabetes, hypertension, heart disease) and ultimately improve quality of life and longevity. 4, 20 Observational studies support an association between weight loss and reductions in mortality. 7 Initial weight loss treatments focus on lifestyle interventions that

variably combine diet, exercise, and behavioral modifications. Though help ful for some, weight loss is usually modest and regaining weight over time occurs in the vast majority of individuals. Earlier generation medications and dietary supplements also had modest effects on weight loss, and some were found to pose significant health risks. The introduction of surgical procedures to pro mote weight loss demonstrated that for severe obesity, significant weight loss was possible and was associated with decreased weight-related complications. 21 For individuals who have not achieved desired weight loss with lifestyle changes, there are multiple pharmacotherapy options that are indicated to promote weight loss and prevent complications of obesity. Pharmacotherapy is often considered first-line before more invasive weight loss techniques are considered (e.g., bariatric surgery). Currently, approved medications by the US Food and Drug Administration (FDA) include the single agents: phentermine (1959), orlistat (Xenical®, H2 Pharma , 2007), liraglutid e (Saxenda®, Novo Nordisk , 2014) , and semaglutide (Wegovy®, Novo Nordisk , June 2021), and the combination drugs : phentermine/topiramate (Qysmia®, Vivus , 2012) and naltrexone/bupropion (Contrave®, Currax Pharmaceuticals, 2014). Liraglutide and semaglutide are glucagon-like peptide-1 (GLP-1) peptides that are approved for diabetes due to their effect in stimulating insulin production. Their weight loss effect is mediated by decreasing appetite. Both are given by injection under the skin with liraglutide administered daily and semaglutide weekly. Semaglutide may promote greater weight loss than other FDA- approved medications and, as a result, has engendered interest among patients and providers. The other FDA-approved medications are administered by mouth and taken daily. Because orlistat results in modest weight loss and causes intestinal side effects, it is less commonly used for initial medication management. Phentermine is approved for short-term use (less than 12 weeks), and is also available in combination with topiramate. The combination of naltrexone and bupropion works in the brain to decrease hunger. Since bupropion, naltrexone, phentermine, and topiramate are available as single agents, clinicians may also use them “off label” alone and in combination for weight loss. Practical issues in using medications for weight loss are potential side effects, durability of treatment effect, and concerns about insurance coverage and pre-authorization. Consequently, there is a need to understand the comparative benefits and costs of the newer branded medications for individuals interested in weight loss after not achieving their goals with initial lifestyle modification. Stakeholder Input This revised scoping document was developed with input from diverse stakeholders, including patients, patient advocacy organizations, consumer advocates, clinicians, researchers, and manufacturers of the agents of focus in this review. ICER looks forward to continued engagement with stakeholders throughout its review.

©Institute for Clinical and Economic Review, 202 2 Revised Scope – Medications for Obesity Management

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