Archive for December, 2012
December 26th, 2012
Below are my comments about the lack of inclusion of obesity treatments in the definition of essential health benefits under the Affordable Care Act.
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Baltimore, Maryland Re: Standards Related to Essential Health Benefits (EHB)
Thank you for the opportunity to comment on CMS-9980-P, establishing standards related to essential health benefits.
The proposed regulation is a missed opportunity to effectively address one the nation’s major health crises- obesity. There is no need to repeat the well-covered statistics on the nation’s obesity prevalence nor on the extensive impact on personal health caused or made worse by obesity. Suffice it to say that obesity is recognized as a major driver of poor health care, of high utilization of healthcare services and of high, and growing, national health care expenditures.
The proposed regulation establishing standards for essential health benefits (EHB) will have an enormous reach. Non-grandfathered plans in the individual and small group markets, both inside and outside the exchanges, multi-state plans, Medicaid benchmark and bench-mark equivalent, and Basic Health Programs must cover EHB by January 1, 2014. However, the proposed regulation is deficient in its failures to address this national health epidemic.
The proposed regulation fails the test of comprehensiveness
The Affordable Care Act establishes ten categories of ‘essential health benefits’. One of these is “Preventive and wellness services and chronic disease management.” However, the proposed regulation do not define this category in general nor address obesity specifically. Traditionally, these areas have been either ignored or underserved by health insurance programs. Yet, the structure of the EHB regulation relies entirely on already established health insurance programs for its ‘benchmark’ plan.
According to the Obesity Action Coalition, only 22 states have chosen benchmark plans that cover bariatric surgery. Only 5 states have chosen benchmark plans that cover weight loss programs. 28 states have chosen benchmark plans that cover neither bariatric surgery nor weight loss programs. (Source: Obesity Action Coalition http://www.obesityaction.org/wp-content/uploads/1212-OCC-Summary-of-Obesity-Treatment-State-Benchmark-Plan-Coverage.pdf, accessed December 26, 2012)
Few governmental or private health plans provide coverage of Food and Drug Administration approved drugs for the treatment of obesity. Many health insurance plans have explicit exclusions for weight loss. Medicaid coverage is also poor. Eight state Medicaid programs appear to cover all recommended obesity treatment modalities for adults. Only 10 states reimburse for obesity-related treatment in children. In the small group market, 35 states expressly allow obesity to be used for rate adjustments while 10 states allow it in the individual market. Only 5 states provide coverage of one or more treatments in both the small-group and individual markets. (Lee JS, Sheer JL, Lopez N, Rosenbaum S, Coverage of obesity treatment: a state-by-state analysis of Medicaid and state insurance laws, Public Health Rep. 2010 July-August;125 (4): 596-604)
The Medicare program itself is a more positive model. In 2004, Medicare eliminated language in its coverage manual that obesity was not a disease. In February 2006, CMS significantly expanded its national coverage policies to cover more bariatric surgery procedures when performed in designated centers of excellence. In 2011, CMS added intensive behavioral counseling for adult obesity (A grade B recommendation of the U.S. Preventive Services Task Force). As yet, Medicare Part D does not cover drugs for the treatment of obesity.
It is a questionable health policy which covers counseling and surgery for American adults over age 65 when, by this regulation, the same coverage could be extended to younger Americans with obesity for whom the interventions are likely to be more effective in improving health outcomes and reducing the need for expensive treatments of related comorbid conditions. Perpetuating this scattered picture of health insurance coverage makes no sense, especially in the context of implementing the Affordable Care Act.
Further, a companion proposed regulation on employer wellness program would allow overweight or obese employees to be penalized up to 1/3 of the cost of their health insurance plan if they failed to meet employer-determined biometrics, such as weight or Body Mass Index. Yet, under this proposal, their employer’s health plan (or exchange or multi-state plan) would not be providing the employees with the treatments they need to obtain that goal. This is unlike the situation for high blood pressure, high cholesterol or type 2 diabetes where treatments are almost always covered in insurance plans.
Recommendation: The regulation should define EHB to include behavioral, pharmacological and surgical interventions based on the evidence‐based recommendations of the National Institute of Health/National Heart, Lung and Blood Institute. The guidelines for treatment of adult obesity were issued 1998, and are currently being updated, see http://www.nhlbi.nih.gov/guidelines/obesity/obesity2/index.htm Regarding children and adolescents, the American Academy of Pediatrics and 15 national medical societies have adopted guidelines which can be incorporated into the regulation.
The proposed regulation fails the test of non-discrimination
Section 156.125 provides, “An issuer does not provide EHB if its benefit design, or the implementation of its benefit design, discriminates based on an individual’s age, expected length of life, present or predicted disability, degree of medical dependency, quality of life, or other health conditions.”
While this is elegant language, it is doubtful that, given insurance practices, it is enough to overcome the inherent prejudice, stigma and discrimination directed at persons with obesity. The insurance industry’s current exclusion of obesity treatments is exactly because of expected length of life, present or predicted disability, degree of medical dependency, quality of life and other health conditions.
Keep in mind that overweight and obese employees already receive a wage penalty because of their weight. A recent study has confirmed that obese employees with employer-provided health insurance are paid less than their peers because of higher health care costs. Stanford University researchers analyzed data from the Bureau of Labor Statistics, the National Longitudinal Survey of Youth and the Medical Expenditure Panel survey. They found that, on average, obese employees with health insurance were paid $1.42 an hour less that non-obese workers. Women had a higher wage penalty than men. Women with obesity whose employers provided health insurance paid a wage penalty of $2.64. (Bhattacharya, J, Bundorf, MK, The incidence of the healthcare costs of obesity, Journal of Health Economics 2009: 28:649-658.)
Recommendation: Section 156.125 should make clear that a plan design which excludes bariatric surgery, FDA approved drugs to treat obesity, intensive behavioral counseling is, ipso facto, discriminating against persons with obesity. Additionally, it is not enough to just have the states monitor and identify discriminatory designs. A federal office needs to be designated where complaints or inquiries can be addressed.
Health reform must address one of the root causes of mortality and morbidity in the country. Without fully including evidence‐based interventions for obesity, it is hard to foresee a net improvement in the health of Americans. The current situation of health insurance, in its avoidance of obesity prevention and treatment, perpetuates a focus on the conditions caused by obesity. Millions of dollars spent on heart disease or type 2 diabetes (not to mention the other ill effects) will only continue.
December 14th, 2012
The Centers for Medicare & Medicaid Services (CMS) has contracted with Mathematica Policy Research (Mathematica) to develop new measures for potential use by eligible professionals (EPs) in the EHR Incentive Program. Mathematica and its subcontractor, the National Committee for Quality Assurance (NCQA), have developed the measures under consideration based on literature reviews of the evidence and reviews by a technical expert panel that includes clinicians, quality experts, EHR vendors, consumers, and other stakeholders.
This measure involves adult obesity screening and counseling as part of the annual wellness visit for Medicare beneficiaries under the Affordable Care Act. Comments must be received by December 17, 2012.
Click here for the proposal.
December 14th, 2012
CNN International is reporting that a ground-breaking study in The Lancet on the Global Burden of Disease indicates that obesity is a greater health crisis than hunger and the leading cause of disabilities worldwide.
December 14th, 2012
The STOP Obesity Alliance has released its “Weight and the States”, a policy research bulletin. The December 2012 edition focuses on key obesity-related trends in 2012 and forecasts those emerging in 2013. Key findings relate to Essential Health Benefits provision of the Affordable Care Act and improving food and physical activity environments.
December 13th, 2012
Obesity has always been known to carry a strong genetic component. At first, there was hope of finding “the gene.” This turned out to be a flawed strategy as many genes were identified which affected body weight and body weight distribution. In a new study, a team using genome-wide association studies (GWAS) studied extreme obesity cases and never-overweight controls as well as families segregating extreme obesity and thinness. They found 16 genome-wide significant signals with the FTO gene being the strongest signal. The second most powerful signal was the MC4R gene. Adding total body weight, waist circumference and waist to hip ration, they found a strong signal for the NRXN3 gene. The researchers state, “The results therefore strongly suggest that FTO and MC4R might be the only two major-effect genes for obesity with common variants in population of European ancestry.” PLOS ONE: Genome-Wide Association Study on Obesity
December 13th, 2012
In a novel study, Jason Fletcher of Yale School of Public Heath, looked at the response to increases in cigarette taxes according to a genetic variation in the nicotinic acetylcholine receptor (CHRNA6). Using NHANES data, he found that one variation in the receptor responded to the taxation while another variation did not respond. Fletcher: Why Have Tobacco Control Policies Stalled?
The research needs to be confirmed of course. However, if it holds up, it may provide a new avenue to evaluate variations in response to anti-obesity public policies.
December 11th, 2012
The Administration also released proposed regulations on employer wellness programs. (See, DHHS press release, November 20, 2012).
Under the Affordable Care Act, insurance companies cannot underwrite a health coverage policy based on health status. However, there is an exception: an authorized corporate wellness program can grant an “incentive” (or a “penalty”) based on an enrollee’s medical condition if certain requirements are met. The incentive/penalty is calculated as a percentage of the employee’s health insurance cost.
The law, prior to the ACA, prohibited group plans from varying premiums based on health status; however, the law, HIPPA, allowed discounts or rebates up to 20% of the cost of the employee’s coverage in a wellness program. The important change is that under HIPPA, “participation” in a wellness program was the nub of the incentive/penalty. Under the ACA, “health outcomes” can now be calculated. Many health groups, especially those representing patients with chronic conditions, were opposed to the change, which also raised the percentage of the employee’s premium from 20% to a possible 50%, claiming that employers would set impossible outcome criteria. As Timothy Jost pointed out in his blog, “Allowing employers to vary the cost to employees of health coverage by as much as 30% because an employee has a high body mass index, blood pressure, or cholesterol seems to simply bring health status underwriting in through the back door. Moreover, wellness program activity requirements are often time consuming and take place on unpaid time. This is a major imposition on lower-income employees who may have to work two jobs to make ends meet or have major family responsibilities.” Tim Jost: Implementing Wellness Programs
Under the proposed regulation, wellness programs based on participation are not affected. For those wellness programs using “incentives/penalties” such as BMI or blood pressure or not smoking, they must meet five standards.
First, once a year, all persons eligible for the program must be given a chance to qualify. Second, the size of the “incentive/penalty” cannot be more than 30% of the total (both the employee and employer share) cost of the health insurance coverage. (How family coverage affects this is still to be worked out.)
The proposed regulation allows the 30% cap to rise to 50% based on the presence of anti-smoking programs.
The third requirement is that health-contingent wellness programs must provide a “reasonable alternative standard” or waiver of the health-contingent standard for individuals who find it unreasonably difficult to meet the otherwise applicable standard because to their medical condition, or for whom it is medically inadvisable to attempt to satisfy the standard. The alternative must be provided on request and cannot be refused simply because the employee has failed at prior attempts. This alternative cannot require the employee to pay the costs of the program. If the alternative is recommended by a company agent, including a health professional, and the worker’s personal physician states that the alternative is not medically appropriate, the worker’s doctor’s view must prevail.
The proposed regulation states, “If the reasonable alternative standard is a diet program, the plan or issurer is not required to pay for the cost of food but must pay any membership or participation fee.”
Health-contingent wellness programs must also be reasonably designed to promote health or prevent disease, not be overly burdensome, not be a subterfuge for health status discrimination, and not use a highly suspect approach. The proposed regulation requests comment on the extent to which such standards should be tightened up, e.g. the proposed regulation states that a plan is not reasonably designed if it requires compliance with a biometric measurement standard (e.g. glucose levels, blood pressure) but does not make available to an individual who cannot meet the measure an alternative means of qualifying for the reward.
Fifth, the program must require plans and insurers to disclose the availability of other means of qualifying for a reward or the possibility of waiver of a standard.
The Department of Health and Human Services and Labor are particularly soliciting comments on whether certain standards, including evidence- or practice- based standards, are needed to ensure that wellness programs are reasonably designed to promote health or prevent disease. “The Departments also welcome comments on best practices guidance regarding evidence- and practice-based strategies in order to increase the likelihood of wellness program success.”
See proposed regulation Here
Comments on the proposed regulation must be submitted by January 25, 2012.
Department of Labor ACA Empolyee Wellness Program Factsheet. Click here
Also released was a study of the workplace wellness market. The report notes, “Diet was another commonly targeted health behavior. Twelve studies evaluated diet, and six (50%) found significant improvements including higher fruit and vegetable consumption and lower fat and energy intake. Programs consisted of group- and individual-level counseling, web-based self-help programs, and access to farmers markets and health expos. Overall, effects were typically small to moderate, such as consumption of an average of 0.2 fewer fast food meals per week, reduction of fat intake by 3 grams (from 51 to 48.1 grams) per day, or an increase of 0.7 servings (from 2.9 to 3.6 servings) of fruits and vegetables per day.” Regarding physiological markers such as BMI, the authors found, “Programs were multifaceted offering virtual support for activity logging, telephone support from health professionals, and health education materials…Six of these studies found beneficial effects in one or more outcomes, including BMI or weight, diastolic blood pressure, and body fat. Three studies found that participants showed a modest decrease in weight of 0.8 kg or BMI of 0.14kg/m2, while nonparticipants showed slight increase in weight of 0.6kg and BMI or 0.42kg/m2. Though the magnitude between the groups is small, wellness programs may help reverse weight gain over time.” (citations omitted) The study noted returns on investment of workplace programs have been declining from around 6 to 1 in a 2005 study to around 3.1 today. “In any case, the expectations of very high cost savings may not materialize.”
Department of Labor Study of Workplace Wellness Market. Click here..