HEADLINES

• Federal Oversight of State EHB Benchmark Plan Submissions
• FDA Patient Centered Efforts Could Focus on ObesitY
• OCC Promotes MHA-Sponsored Hill Briefing on Mental Health and Obesity

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Editor: Christopher Gallagher, Director of ASMBS Washington Office
October, 2012

Obesity Community Urges Federal Oversight of State EHB
Benchmark Plan Submissions

During early October, ASMBS joined with other leading groups from the
obesity community in sending a strong letter to Department of Health and
Human Services Secretary Kathleen Sebelius — urging HHS to carefully review
each state’s selected benchmark plan to ensure that the product covers all
medically necessary obesity treatment services across the care continuum
The October coalition letter was prompted by the unofficial October 1st
deadline for states to submit benchmark health insurance plans for essential
health benefits that will be the models for individual and small-group insurance
coverage in each state’s health insurance exchange. Over the summer, the
obesity community submitted joint comments to over 12 different states, which
solicited public comment regarding this critical phase of health exchange
development.

FDA Patient-Focused Drug Development Targets Include Obesity

On September 24, 2012, the Food and Drug Administration (FDA) published a
notice in the Federal Register related to Patient-Focused Drug Development, an
initiative designed to provide for a more systematic approach to obtaining the
patient perspective on certain disease areas, including obesity.
Over the next five years, FDA will conduct public meetings for 20 different
disease areas. The meetings will focus on the patient perspective regarding
two key considerations in FDA’s regulatory decision-making — the severity of the
disease and the currently available treatment options. In determining the
disease areas that will be addressed in these meetings, FDA has published a
preliminary list of nominated diseases.
FDA is requesting public comment on the below list through a public docket
and at a public meeting scheduled for October 25, 2012, where FDA will also
provide an overview of Patient-Focused Drug Development.

FDA Nominated Disease Areas:
Pulmonary arterial hypertension. • Heart failure • Primary glomerular
diseases• Narcolepsy• Huntington’s Disease • Depression• Autism•
Peripheral neuropathy • Fibromyalgia • Obesity • Nocturia • Chronic fatigue
syndrome• Irritable bowel syndrome • Inflammatory bowel disease•
Alopecia areata• Diabetic ulcers• Female sexual dysfunction• Interstitial
cystitis/painful bladder syndrome• Fracture healing• Diabetic foot infections•
Hepatitis C• HIV• Patients who have experienced an organ transplant• Sickle
cell disease• Chronic graft versus host disease• Amyloidosis• Aplastic anemia
• Melanoma• Lung cancer• Cancer and young patients• Cancer treatment in
pregnancy • Cancer and sexual dysfunction• Cancer and depression•Clotting
disorders (e.g., hemophilia A (factor VIII deficiency) and von Willebrand
disease)• Thrombotic disorders (e.g., antithrombin deficiency and protein C
deficiency)• Primary humoral immune deficiencies (e.g., common variable
immune deficiency) • Neurologic disorders treated with immune globulins
(e.g., chronic inflammatory demyelinating polyneuropathy)• Hereditary
angioedema• Alpha-1 antitrypsin deficiency

OCC Promotes MHA-Sponsored Hill Briefing on Mental Health and
Obesity

Leaders from the Obesity Care Continuum (OCC) joined with numerous OAC
patient advocates in promoting an October 3rd congressional briefing on
Mental Health Conditions and Obesity. The briefing was sponsored by Mental
Health America (MHA) to promote dialogue on the interconnected challenges
facing the mental health and substance use communities and those with chronic
conditions, including obesity.
The briefing included: Dr. Nora Volkow, Director, National Institute on Drug
Abuse, NIH; Dr. Stephen Bartels, Director, Dartmouth Centers for Health &
Aging and Dr. Ben Druss, Rosalynn Carter Chair in Mental Health at Emory
University. In addition, Jeff O’Neil, MEd, LPCC, Director of Community
Services, Greater Cincinnati Behavioral Health Services joined the panel in
discussing how this intersection of complex health issues is playing out in
various service delivery points (clinical settings, public health venues, etc) in
communities across the country.