On July 19, 2010, The Department of Health and Human Services issued ‘interim final regulations’ requiring  insurers in the group and individual markets  to include preventive services without any cost sharing as part of the the health care reform law signed by President Obama earlier this year. Preventive services include an important, sleeper provision regarding obesity. Here’s how it works.

The law defines “preventive services” as those with an A or B grade recommendation from the U.S. Preventive Services Task Force (USPSTF). The USPSTF has B grade recommendations for intensive behavioral counseling for adults with obesity and for screening and counseling for children. U.S. Preventive Services Task Force Recommendations

Coverage without cost sharing goes into effect on September 23, 2010. Interestingly, the regulations do not provide any limitations on the frequency, intensity or duration of such coverage. This represents a significant new benefit coverage  affecting millions of Americans. Most of the USPSTF recommendations cover screening tests but counseling is covered for tobacco cessation, sexually transmitted infections, dietary counseling for persons with hyperlipidemia and related cardiovascular risk factors, and promote breast-feeding.

I call this a stealth provision because Congress assumed the USPSTF recommendations were screening tests and probably would have rejected this kind of coverage as a listed benefit.

The regulation background information discusses the low level of obesity counseling presently and the benefits to be expected from broader coverage.

Comments can be received for 60 days from July 14, 2010. The proposed regulation can be accessed at Federal Register Contents, Monday, July 19, 2010

July 16, 2010

I spent three days at the FDA Advisory Committee hearings this week. The first two days were devoted to Avandia for type 2 diabetes. The third day consisted of a review of the anti-0besity medication, Qnexa, made by Vivus Inc.

The committee voted to keep Avandia on the market in spite of long term studies, meta-analyses and observational studies all pointing to an increased risk of heart attacks. And this in a field where there are multiple classes of drugs which enhance glucose control. The evidence was there (in my opinion) but the committee stuck with the drug.

On the other hand, in reviewing Qnexa, the evidence was there that it met the FDA’s requirements for approval. What the committee had was higly speculative fear that it might be approving another phen-fen. (Never mind that Qnexa’s two components – phentermine and topirmate – have been used for decades.) Fear trumped evidence when it comes to obesity products.

Most of the audience at the hearing felt stunned when the vote was announced. Most had expected easy approval as the effectiveness data was very clear and the safety issues were well-addressed, small and mainly speculative. Hopefully, the FDA will look at the company’s two year data in September and approve Qnexa.

Questions and Answers
By Morgan Downey, J.D. 
March 23, 2010
 
With Sunday’s vote in the House of Representatives, the long-awaited health care reform legislation is on track become law. A great deal has been written about health care reform during the past year but little attention has been paid to how reform might affect the obesity epidemic.
Obesity is the most prevalent, fatal, chronic disease in the United States. 68% of American adults are overweight or obese, constituting a majority of the US population. This Q&A is not intended to cover the entire scope of the health care reform legislation but only to explain how it is likely to affect persons with obesity and the future of the obesity epidemic. (N.B. At several points, the legislation incorporates recommendations of the U.S. Preventive Services Task Force (USPSTF) meaning that these recommendations become covered services. The USPSTF has two obesity specific recommendations at level B: one for screening for obesity and the second for intensive behavioral counseling. The intensive behavioral counseling could open the door for extensive new services.)

1.       What does the bill do to help the millions of Americans with obesity?

Briefly:

If you have obesity, have a medical condition and have not had health insurance for six months, you will be able to purchase coverage through a temporary high risk pool. (The pool is ‘temporary’ until the health exchanges are implemented).
If you have obesity and receive Medicare or Medicaid, you will see more preventive services fully covered.         
If you have obesity and employer provided health insurance several provisions may affect you.

A. If you have had claims denied because of a pre-existing condition (either obesity or an obesity-related co-morbid condition), you should have an easier time getting such claims paid starting in 2014. 

B. If you have reached lifetime caps on coverage, within six months of enactment, insurers will be prohibited from placing lifetime limits on the dollar value of coverage and from rescinding coverage, except in the case of fraud. Insurance companies will also be prohibited from canceling policies on people who get sick. (These are called recissions and ‘height and weigh’ is one of the four most common health reasons for a recissions according to a December 2009 report from the National Association of Insurance Commissioners).

C.  Six months after enactment, private, qualified health plans will have to provide, without cost-sharing, preventive services with an A or B recommendation of the U.S. Preventive Services Task Force.
D. More expensive “Cadillac” health plans will start being taxed in 2018. To the extent that these plans may provide coverage of bariatric surgery and related services, they may scale back.

2.     Is it all good?

Briefly, yes and no.
If you have obesity and have employer-paid health insurance, you may be paying more – potentially a lot more-for it. While the new law will ban discrimination on the basis of health status, an exception exists whereby persons in an employee wellness program can be charged up to 50% of the value of their health insurance premium if they do not meet specific health criteria, such as weight.
 Intensive behavioral counseling for obesity will become more available.  Whether insurers will have to provide bariatric surgery or drugs for treating obesity will be decided by a Health Benefits Advisory Board which will make recommendations to the Secretary of Health and Human Services.
Third, the tax deduction for medical expenses will change. Currently, individuals can deduct unreimbursed medical expenses (including physician recommended weight loss costs) to the extent they exceed 7.5% of adjusted gross income. The threshold will rise to 10%. This potentially hurts individuals with multiple chronic conditions and/or high, unreimbursed medical costs. 

3. Does Medicare coverage of obesity change?
Medicare beneficiaries would receive a comprehensive health risk assessment and a personalized prevention plan. Incentives would be provided to Medicare beneficiaries to compete behavioral modification programs.
Medicare’s current coverage of bariatric surgery does not change.
The ban for drugs to treat obesity under Part D continues in effect.

4.    What about coverage of obesity in Medicaid?

Current state-by-state coverage in Medicaid for bariatric surgery and drugs to treat obesity should not change. (Medicaid may cover drugs for obesity if the state applies for a waiver from a prohibition in the Medicaid statute.)
The Medicaid program will go through its largest expansion since its inception.
If cost-sharing is removed for covered recommendations of the US Preventive Services Task Force (see above), state Medicaid programs will have their federal matching rates increased
The Secretary of Health and Human Services (HHS) is also instructed to develop preventive and obesity-related services for Medicaid enrollees, including obesity screening and counseling for children and adults. Each state is directed to develop a public awareness campaign to educate Medicaid enrollees regarding the “availability and coverage of such services with the goal of reducing incidences of obesity.”
HHS will develop incentives to encourage behavioral change in Medicaid enrollees.
A new state option will be developed for Medicaid, allowing enrollees with multiple chronic conditions to select a medical home.

5.     What does the law do about childhood obesity?

While often overlooked, the expanding coverage includes providing health insurance to millions of children whose parents do not have coverage now. For the increasing numbers of children and adolescents with obesity, their related conditions, like type 2 diabetes and hypertension, will now be covered. Starting in 6 months, children cannot be denied coverage because of pre-existing conditions.

In addition to the coverage components, the law provides funding for a childhood obesity demonstration project.

6.   What about prevention of obesity?

The bill establishes a National Prevention, Health Promotion and Public Health Council to coordinate federal prevention, wellness and public health activities and develop a national strategy to improve the nation’s health. The strategy is due one year after the enactment. A Prevention and Wellness Trust is authorized to carry out the national strategy.
A grant program is developed for 5 years to support the delivery of evidence-based and community based prevention and wellness service aimed at reducing chronic disease rates.
Under Section 4201, the Secretary of HHS shall develop a competitive grant program for states and local governments for “the implementation, evaluation, and dissemination of evidence-based community preventive health activities in order to reduce chronic disease rates, prevent the development of secondary conditions and address health disparities.”                                                          

i.      This includes creating healthier school environments, including increasing healthy food options, physical activity opportunities, promotion of health lifestyle, emotional wellness, and prevention curricula.”

ii.      Also included are “developing and promoting programs targeting a variety of age levels to increase access to nutrition, physical activity;”

iii.      “assessing and implementing worksite wellness programming and incentives; working to highlight healthy options at restaurants and other food venues. 

iv.      Grantees must report changes in weight, nutrition, physical activity.

b.      Section 4202(a) provides a health aging program. Grants are to be provided to states and local governments for the 55 to 64 year old population “to improve nutrition, increase physical activity.” Covered are screenings to identify those with risk factors for cardiovascular disease, cancer, stroke and diabetes.” Those identified with such risk factors are to be referred to clinical services.

c.       Section 4202(b) provides for an evaluation and plan for community-based prevention and wellness programs for Medicare beneficiaries to reduce their risk of disease, disability and injury by making healthy lifestyle choices, including exercise, diet and self-management of chronic diseases.

7.     Does the law affect research on obesity?

a.       The bill establishes a non-profit Patient-Centered Outcomes Research Institute to identify research priorities and conduct research which compares the clinical effectiveness of medical treatments. This is effective on enactment.

b.      Section 4301 provides for research on optimizing the delivery of public health services.

c.       Section 399MM1 provides for studies of worksite health policies and programs. No part of such recommendations, data or assessments can be used to mandate requirements for workplace wellness programs.

d.      Section 4402 also provides for effectiveness research of health and wellness programs for federal employees.

e. Under the reconciliation changes passed by the House of Representatives and on its way for approval by the Senate, the Administrator of the Centers for Medicare and Medicaid will identify the most cost-intensive services for Medicare which shall ‘inform’ research priorities within the Department of Health and Human Service to improve prevention, treatment or cure of such diseases and conditions.
 
8.     What are the other parts of the bill affect obesity?

The Secretary of HHS is mandated to develop, within one month of passage, an education and outreach campaign regarding preventive health services. The campaign must address proper nutrition, regular exercise and obesity reduction. It is mandated that the Secretary develop a website for health care providers and consumers to provide science-based information on guidelines for nutrition, exercise, obesity reduction and specific chronic disease prevention. Another website is to be developed with a “personalized prevention plan tool. This would include determining individual disease risk, based in part on Body Mass Index.

a.      Of particular value for persons with morbid obesity, Section 4203 provides for the removal of barriers to medical devices for individuals with disabilities. Under this provision, standards will be developed to ensure that medical diagnostic equipment used in physician’s offices, clinics, hospitals and other medical settings to ensure that the equipment is accessible to and usable by individuals with accessibility needs to allow independent entry to and use of such equipment.

b.      Restaurants which are part of a chain of 20 or more locations doing business under the same name must disclose for ‘standard menu items’ the nutrient content including calories in the item with the suggested daily caloric intake on the menu as well as a drive-through menu board. Self-service items must also display the calorie information. Restaurants and others, such as vending machine operators, may voluntary register to be part of the program. Regulations must be issued within a year of enactment.

c.       In some studies, breast-feeding has been found to be preventive for the development of obesity in the child. For breast-feeding women, employers with over 50 employees must a reasonable break time to express breast milk for one year after the child’s birth, each time the employee has a need to express the milk and a place, other than a bathroom that is shielded from view and free from intrusion. Employers need not provide compensation for such time.

d. The Secretary of Labor is authorized to set up a grant program for employer wellness programs. Behavioral change is encouraged which provides for altering employee healthy lifestyles through counseling, seminars, on-line programs or self-help materials. Obesity is specifically listed as a focus. Participation cannot be mandated or conditioned on obtaining a health insurance premium discount, rebate or other financial reward.

9. What is not in the bill?

A proposed tax on sugar-sweetened beverages is not in the legislation.

10. What next?

The bill is large and complex. Many issues, especially regarding inclusion of surgery and drugs in health benefit plans, be have to be resolved by regulations from the Department of Health and Human Services. For example, while the USPSTF recommendation for intensive behavioral counseling does not include frequency, intensity and duration. These will need to be specified.

So here is another take on the state of the union:  Increasing health care costs are fueling the country’s economic problems. Obesity is a major driver of the health care costs. The First Lady has launched a campaign against childhood obesity and is promoting gardens and local sources of fresh food. Persons who are overweight or obese get blamed (even the Surgeon General) and are discriminated against.

In the last decade or so, the federal government,  states, counties, cities, joined by major foundations and corporations, supported by numerous non-profit groups have pushed for recognition of obesity and steps to educate the public to its perils.

 So now, two restaurants are fighting each other in court over their themes, like Chili Chest Pain Fries. the Heart Stopper  and the bypass burger, employing décor of heart defibrillators, wheelchairs and dialysis machines  guaranteeing  that their menus will definitely lead to obesity if not outright kill you! Even free food for those over 350 pounds, see Delray Beach restaurant’s food is deadly — will lawsuit kill it? – South Florida Sun-Sentinel.com.

It isn’t just the bizarre, counter-pc approach of these restaurants that is troubling

If someone is fired from their job because their employer doesn’t like their size, there is virtually no recourse.  If you wanted to sue the restaurant or food chain or food company over its portion sizes, calorie content or food composition, you would be ridiculed for not ‘taking personal responsibility.’ The food industry would rush to legislatures to save the world from ‘frivolous’ lawsuits.  If you want to sue your school for what it serves your child, you would be accused on not being a very good parent. If you wanted to sue your insurer for not covering bariatric surgery or FDA approved drugs, you’d be accused of wanting other people to pay for your sins. If you wanted to sue to reduce food marketing to kids, forget about it too…it’s protected by the First Amendment. Yet, the doors of the federal courts are wide open to these restaurants suing each other. Where’s the Tort Reform Chorus? No doubt this will use up some serious judicial resources before it is over. How did we get here? More importantly, how can we move forward if legitimate, if novel, claims cannot even get in the doors of the courthouse?

A CBS New Poll conducted December 17-22, 2009 shows 98% of women and 91% of men consider obesity as a ‘very’ or ‘somewhat’ serious public health problem. But majorities of both men and women give the country a grade of “D” of “F” on making efforts to combat it. 89% believe obesity is something people can control but 60% do not favor a tax on junk food. 55% of Americans say they would like to lose weight, 40% would like to stay at their current weight and only 5% want to gain weight .  (In 1951, 17% wanted to gain weight.) Poll: Most Oppose Tax on Junk Food – Political Hotsheet – CBS News  Another survey has found that the number of people trying to lose weight has jumped from 54% in 1985 to 61% in 2009. The number of Americans who find overweight people less attractive has declined over 20 years from 55% to 24% but whether this is political correctness or a real change in attitude remains disputed. See, Survey: It’s OK To Be Overweight – CBS News . In a third survey, 79% of Americans say they are satisfied with their personal eating habits but 73% say most Americans have an unhealthy relationship with food. BioPortfolio News: GlaxoSmithKline Consumer Healthcare – Eight in 10 Americans Say They're…

Can Smoking Cessation lead to increase in type 2 diabetes? Evidently the answer is yes according to Johns Hopkins researchers who studied a cohort of over 10,000 middle age adults. Smokers at risk for diabetes should engage in smoking cessation coupled with strategies for diabetes prevention. Smoking, smoking cessation, and risk for type 2 di… [Ann Intern Med. 2010] – PubMed result