What my prepared talking points for a meeting with my elected officials looked like

[original format: Word document, outline format. Medium doesn’t preserve or portray outline format very well.]

Accompanying material for “Conversation with your elected officials”

Talking Points Regarding Clause Strikeout

Main objective: To improve patients’ access to potentially life-saving medication

I. What Needs to Be Done?

• Strike out item 3 of subdivision 13d part b, chapter 256 which says: “(b) The formulary shall not include: … (3) drugs or active pharmaceutical ingredients used for weight loss, except that medically necessary lipase inhibitors may be covered for a recipient with type II diabetes…”
• [sub-bullet] Link to the statute text:
  https://www.revisor.mn.gov/statutes/?id=256B.0625&year=2012&keyword_type=all&keyword=drug+formulary
• Without this strike out, we cannot explore options to help people who are obese without forcing them to either become sicker first or resort to invasive surgery.

II. Why Now?

• This clause was written far enough in the past that the epidemic had not reached such epic proportions. Obesity’s prevalence has risen to the point that it behooves us to consider all options available to us to treat it, while also strengthening our prevention and education efforts.
• [sub-bullet] We need to be able to at least have a conversation about medication as an option. As written, this clause basically says that everyone who is obese must get sick enough to develop Type II Diabetes before they may receive help, and then only Xenical is an option. Or, they must become so sick that surgery is their only option and bypass this clause.
• Current medication offerings are not the weight loss pills of the Fen-Phen era. Clinical research has changed, these drug formulations have changed, and the standards for safety measures have changed.
• [sub-bullet] For example, not just anyone can have Phentermine. It is a Schedule IV restricted drug (under the Controlled Substances Act) that requires monthly check-ins with a provider, and the patient must have a minimum BMI of 30 as well as the presence of other risk factors such as controlled hypertension, diabetes OR hyperlipidemia. Removing this clause does not suddenly mean anyone and everyone can have weight loss medications, and we have to foot the bill.
• [sub-sub-bullet] Other formulas such as phendimetrazine, diethylpropion and benzphetamine come with stipulations for use and restrictions as well. (Diethylpropion is Schedule IV; phendimetrazine and benzphetamine are Schedule III).
• Other facets of the government recognize that obesity is a large enough problem to warrant changes to policy.
• [sub-bullet] In 2004, Centers for Medicare and Medicaid Services (CMS) deleted language in the official Coverage Issues Manual that had explicitly stated that obesity was not a disease. (http://archive.hhs.gov/news/press/2004pres/20040715.html accessed Sept 2013)
• [sub-bullet] The IRS also recognizes and provides tax breaks for weight loss expenses, to the extent that they are for medical purposes and are not covered by insurance. (http://www.irs.gov/pub/irs-news/ir-02-40.pdf accessed Sept 2013)

III. Why is it a smart decision?

• Other states already have some form of weight loss medication coverage.
• [sub-bullet] 6 states already offer medication coverage for weight loss in addition to MNT and surgery (IA, LA, MI, SC, VA and WI). Other states cover medications with stipulations, but may not cover surgery or MNT.
• [sub-sub-bullet] The Medicaid Fee-For-Service Treatment of Obesity Interventions report provides data on each state. (http://www.stopobesityalliance.org/wp-content/themes/stopobesityalliance/pdfs/Medicaid_Fee-For-Service_Treatment_of_Obesity_Intervention.pdf accessed Sept 2013)
• [sub-sub-bullet] See also The National Institute of Health’s article: “Coverage of Obesity Treatment: A State-by-State Analysis of Medicaid and State Insurance Laws” (cited in the above reference). (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882611/ accessed Sept 2013)
• Bariatric surgery requires attempts at weight loss, usually via MNT and medication, before qualifying for surgery in most cases.
• [sub-bullet] It is safer for patients to have access to rigorously tested medications rather than OTC “diet pills” which have not been reviewed and approved by the FDA. http://www.umphysicians.org/Clinics/weight-loss-surgery-center/FrequentlyAskedQuestionsFAQ/index.htm
• The federal government has already taken action.
• [sub-bullet] Both the Senate and House have introduced bipartisan legislation (6/19/13) to increase Medicare patients’ access to medications and counseling for weight loss, acknowledging that when the policy was originally written there were no viable medication options. Now that there are, this policy needs updating (The Treat and Reduce Obesity Act: http://www.obesityaction.org/treat-and-reduce-obesity-act accessed Sept 2013. Links to the bill language: Senate http://www.obesityaction.org/wp-content/uploads/BILLS-113s1184is.pdf; House http://www.obesityaction.org/wp-content/uploads/BILLS-113hr2415ih.pdf)
• [sub-sub-bullet] The Senate bill status is: Referred to Committee on Finance.
• [sub-sub-bullet] The House bill status is: Referred to Subcommittee on Health.
• [sub-sub-bullet] Stipulations from bills: patient must lose 5% of weight in 12 weeks and are encouraged to participate in intensive behavioral counseling. If weight loss goal cannot be met, product labeling directs that patient be taken off medication.
• [sub-sub-bullet] Note that this bill was introduced PRIOR TO the AMA’s announcement that they view obesity as a disease

IV. Concerns I’m aware you may have

• There is no data for the new medications, Belviq and Qsymia, and the current ones do not have data to show effectiveness in long-term use. We know there is data for surgery.
• [sub-bullet] We have data on medication effectiveness that is forthcoming.
• How we define obesity and the faulty nature of BMI as a measurement standard to define conditions for coverage are problematic.
• [sub-bullet] We need to start somewhere. No one thinks BMI calculation is a comprehensive or stand-alone tool. It does, though, provide physicians a legitimate reason to discuss weight with patients in a non-judgmental way.
• [sub-bullet] Waist size and body fat percentage measurements are better ways to assess obesity, but have not yet become standards like BMI has.
• Government intervention should be limited to purely efforts to improve economic efficiency i.e. by correcting market failures, and there is no market failure in this case.
• [sub-bullet] There may not be a market failure in terms of supply meeting demand for weight loss aids, but these products are usually ineffective, FDA un-approved options. Further, they do not assist in promoting sustainable, realistic lifestyle changes that only MNT and medical care can provide.
• There may be other consequences of the AMA’s announcement on obesity’s disease status in other areas of government that will add costs (i.e. increased litigation based on perceived discrimination on basis of weight — www.lexology.com, “ADA suit filed in wake of AMA defining obesity as a disease.”).
• [sub-bullet] Removing the aforementioned clause does not automatically translate into immediately bleeding money to cover medication for an uncontrollable number of people. It allows us to discuss options and carefully decide what makes the most sense given the current situation. Therefore, we should not need to worry about how other areas of government bear costs that are only hypothetical.

V. Policy Solutions

• Instead of a condition for access that uses BMI as a measurement (since it is indeed true that BMI is not 100% accurate, for every person), use body fat percentage and waist size.
• [sub-bullet] These are more accurate indicators of health.
• [sub-sub-bullet] The Whole Body Composition Scan (taken with a DXA machine, which also measures bone density) is how you can most accurately measure body fat percentage. MNCOME is the only facility in the metro area that offers these scans as a regular part of care.
• [sub-bullet] Remember that safe, healthy weight loss takes time. While we should not impose unrealistic timeframes on use, it may be fair to require that a patient lose a certain percentage of body fat or get their waist down to a certain size in 1–2 years in order to qualify for continued access.
• Stick to BMI thresholds since it’s unlikely that a person can have a BMI of 40 or more and not be disproportionately muscle, and increase MNT coverage.
• [sub-bullet] Recommend a schedule of visit or check in frequency based on degree of obesity severity.

VI. Concerns I have

• This isn’t about whether obesity is a disease or not. This is about the fact that there are sick people, whether we like it or not, and they need the option of medical help
• [sub-bullet] In case you want to look into the scientific research of obesity’s disease status:
• [sub-sub-bullet] Scientific American, Sept 2013
• [sub-sub-bullet] Papers on Adiposopathy
• It is much easier to consider other diseases’ relationships to choices when it’s to something we do not need to survive. As the AMA said, cigarette smokers are not condemned when they get lung cancer, even though smoking is a lifestyle choice. People with diabetes are not denied insulin, even though Type II is often the result of lifestyle choices.
• [sub-bullet] The complicated thing is that people need food, so the relationship they have to it and how we view these people is much more difficult to judge and make decisions about than the way we handle alcohol and tobacco addiction interventions.
• Obesity/weight gain in some individuals is not about genetics, biology or habits. It is a side effect of other medications to control psychological issues, without which these people could not be a functioning part of society. Medical assistance is most appropriate for these people, since changing eating and activity habits alone cannot counter a medication’s effects on the body for everyone.
• [sub-bullet] It’s reasonable to investigate whether there is research on psych meds that do not result in weight gain, but that would require delving into the issue of our hostility towards clinical research.