Wednesday, May 20, 2009

Ensuring inclusion of health education and healthy behavior facilitation in the Health Care Reform Bill

The introduction of the upcoming health reform legislation promises to include a strong set of reforms for building a new infrastructure for prevention and healthy lifestyles in the US. As the bill progresses, it will be critical to provide your support to maintain these prevention items in the legislation. Under duress to cut costs of the bill to pass large scale insurance and access reforms, investments in health education and children's wellness may suffer first. But, if we truly want to stem long-term costs by preventing obesity, chronic disease and suffering of the future, advocacy to prevent this, will be critical. There are a number of ways to maintain a focus on prevention and wellness in the legislation. Here, I focus on:

•Health and physical education (at least weekly education on healthy behaviors and understanding of the human body/ self awareness)
•Facilitation of sixty minutes of daily physical activity (recess, gym, sports) and healthy nutrition (breakfast, lunch, snacks)

Unlike previous measures, new legislation should specifically identify standards schools should follow and report on, such as fulfilling the CDC guidelines for physical activity.

------------Specific Language Suggested for the Bill------------------

Health and Physical Education, and Facilitation of Healthy Behaviors

All local educational agencies in a State must have a required, age-appropriate health education curriculum, and physical education curriculum, for all students in elementary schools, middle schools, and secondary schools, that adheres to national guidelines adopted by the Centers for Disease Control and Prevention (CDC) and State standards. This curriculum must provide the full amount of moderate to vigorous aerobic physical activity time recommended by the most current CDC guidelines--at present, sixty (60) minutes per day for children and teens. This can be achieved through a combination of recess, gym class, or participation in an after-school sport. In addition, all children must have access to healthy breakfast, lunch and snack options, where all foods- including competitive foods-- must adhere to Federal and State school nutrition standards. As part of this program, all children and teens must have a fair, equal, and significant opportunity to obtain a high-quality health education and physical education.

In creating such programs, each State must take the following factors into consideration:

(1) Academic and physical assessments, accountability systems, teacher preparation and training, curriculum, and instructional materials must be aligned with Federal and State standards so that students, teachers, parents, and administrators can measure progress against common expectations for student academic and physical achievement;

(2) Programs must meet the educational and physical needs of low-achieving or currently unfit children, particularly in our Nation's highest-poverty schools, obese and overweight children, limited English proficient children, migratory children, children with disabilities, Indian children, neglected or delinquent children, and young children in need of reading assistance;

(3) Programs must close the healthy behaviors knowledge gap between high- and low-performing children, especially the achievement gaps between minority and non-minority students, and between disadvantaged children and their more advantaged peers;

(4) Schools, local educational agencies, and States must provide, at a minimum, weekly education about healthy behaviors and the human body and daily access to and facilitation of healthy nutrition—including water, breakfast, lunch and snacks. Programs must promote schoolwide wellness reform and ensure the access of children to effective, scientifically based instructional strategies and access to and facilitation of healthy nutrition and physical activity according to comprehensive school wellness guidelines;

(5) Professional development opportunities must be made available to staff to elevate the quality of instruction and their own wellness training and opportunities for daily healthy nutrition and physical activity;

(6) All services under this title must be coordinated with each other, with other educational services, and, to the extent feasible, with other agencies providing services to youth, children, and families; and

(7) Programs must involve and train parents in encouraging and supporting a healthy and active lifestyle, including increased physical activity during and outside the school day, and nutritional eating habits in the home and at school.
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In broader terms, additional measures that are pivotal to prevention and wellness reform:

•Tax on high-sugar/ non-nutritional drinks and snack foods. We recommend this also be applied to diet drinks given the latest data suggesting children that consume a high amount of these drinks have similar prevalence of obesity as those that drink sugar-added beverages
•Funding allocation for PE and Health Education teachers, and Health Education curriculum materials
•Increased funding for the Carol M. White PEP grant program to support supplies (activity equipment) and program innovations (SPARK, CATCH, Polar, Hop Sports, Sports 4 Kids, etc.) for Physical Education, Recess and Sports Teams
•Funding for piloting comprehensive in-school health clinics under Medicaid/ S-CHIP
•Improvements in the foods supplied under the free and reduced lunch program and/ or funding to support cooking training and alternative food suppliers, such as Revolution Foods
•A national health behaviors social marketing and incentive program led by CDC and an alliance of social enterprises (information on our Drive 2 Fitness program model is attached, We Can!, and the President's Fitness Challenge are other models)
•Funding allocation for sidewalk, park and playground development (DoT/ States)
•Decrease/ eliminate subsidies for corn used for high fructose corn syrup
•Funding allocation to help schools implement comprehensive school health (Cambridge Health Alliance/ Shape up Somerville/ Alliance for a Healthier Generation/ Fitness Forward School Playbook/ etc.)

Please make you're voice heard now. This will likely be the largest opportunity to revise the nation's approach to health care within the decade.

Cost-effective, complete and personalized care for all: Moving Mountains Beyond Mountains

HIV, AIDS, can be eradicated. Multi-drug resistant Staphylococcus aureus, and tuberculosis, can be overcome. An astronomical obesity rates, and the diabetes, heart disease and cancer it and unhealthy lifestyles bring, can again be reduced to the levels seen in the 1970s—5% nationally. Today, 20% of children are currently obese; among African-American girls, the number is closer to 30%. Like polio, small pox, cervical cancer, or HER2 positive breast cancer, we can begin to prevail over these diseases. We can do so in the US—including the poorest areas, and globally. And, we can expect nothing less of ourselves, where, as Tracy Kidder saw while writing Mountains Beyond Mountains, “Patria Es Humanidad...the only real nation is humanity”.

In this book, protagonist Paul Farmer, and others, personified the altruism of doctoring, and daring of social entrepreneurship. Farmer and Jim Yong Kim have compelled the community to remember that disease can be defeated, even in the poorest areas of Haiti, Peru, Rwanda, Russia, and, Boston. Personalized and complete care can be delivered and new disease can be prevented, while cost-effectiveness analysis is used as a guidepost for which levers of therapy or diagnostic supply and demand need most to be pulled—not as a trap for justifying the status quo. They have compelled us to remember that in doctoring, we must first be Partners in Health (PIH), for each individual, and, community.

The “P's of medicine”-- personalization, prediction, prevention, patient participation and partnership, are all part of the current drive to reform the approach to health care, locally and globally. Over $48.8 billion was allocated in the American Recovery and Reinvestment Act (Stimulus) for health information technology. This is largely to facilitate the complete aggregation of electronic health record (EHR) data required for prediction of clinical outcomes that would enable the prescription of personalized lifestyle and therapy choices necessary to prevent illness. Further, the HIT investment will foster patient-driven self-care and doctor-patient communication through secure 'Health 2.0' technologies such as personal health records and supplemental online video virtual doctor visits. Another $10 B was allocated to the National Institutes of Health (NIH), and much is being dedicated to the development of new genomic technologies, 'theranostics,' and the analytic techniques and computational tools necessary to harness the petabytes (one quadrillion bytes) of data to be collected via EHRs. Another $1 B is being centered on the wellness and healthy lifestyles infrastructure for prevention—an area which has traditionally only accounted for 5% of health spending--in the US--and is reflected in our lower life expectancies, especially in areas where the poor live, like Washington, DC.

These approaches, while being augmented by new diagnostics, therapeutics and information technologies, have already been modeled in efforts by doctors, such as Farmer and Kim. The treatment of infectious diseases—such as tuberculosis—has already been personalized through the process of culturing an individual patient's pathogens and assessing their resistance to antimicrobials. But, this had not been readily available to poorer nations. Those that developed multi-drug resistance (MDR) to tuberculosis (TB), were essentially left to die—until Farmer and Kim dared to apply an 'expensive' diagnostic and therapeutic cocktail to save the lives of a handful of daughters, mothers, and brothers, outside Lima, Peru. While participating in World Bank negotiations for loans to Russian prisons to stem TB, Farmer ensured money for better nutrition—a.k.a. vitamins—was also included, to help prevent disease development, and recovery, among prisoners. And, in Haiti, and other communities, he has built schools, where children and parents can learn to participate in the prevention of TB. Kidder asked, “How does one person with great talents come to exert a force on the world?” He also answered: “I think in Farmer's case the answer lies somewhere in the apparent craziness, the sheer impracticality, of half of everything he does...” When tending to an individual human being, when given the opportunity to share in and help protect their life, physicians must first be impractical innovators.

Farmer and Kim have helped save an incredible number of families, by saving patients from MDR TB. But the problem is far from solved. So they, as good doctors, good people, stepped back after their individual encounters, to take an aggregate view, a data-driven view, a public health view, a world view—so that next time they meet a person—or their colleague meets a patient—they are armed with better tools to help.

Indeed, simultaneous with the push for innovations in the P's of medicine, a new era of comparative-effectiveness research (CER) has begun in the United States. Some of the $1.1 billion allocated for CER and the $10 billion allocated to the National Institutes of Health in the Reinvestment & Recovery Act (Stimulus) was already released by the NIH in the form of 69 CER high priority challenge grant topics. Cost-effectiveness analysis--a component of comparative effectiveness research--has long been used in public health, where utilitarian arguments married with data on “Quality Adjusted Life Years (QALYs)” in an attempt to discern which diagnostics, therapies or programs are giving the most bang for their buck. But, the intention of doing such analyses is not to blindly ration care based on the status quo of a fixed pool of constrained health care dollars, fixed costs or fixed effectiveness. Rather, it is to help distributors of medicines and technologies rationally choose the lowest cost item among those that are of the highest efficacy. Further, it is a tool to help set priorities on where it is most critical to invest in innovation to improve efficacy and effectiveness—perhaps through new genomics and health IT, and lower costs—perhaps through increased supply, lower manufacturing costs, or new business models.

One of the Stimulus-related priority NIH Challenge grants called on the research community: “Develop diagnostics and drugs for multiple or extensively drug-resistant tuberculosis.” New personalized diagnostics could help identify MDR TB patients earlier, and more quickly. Some, which utilize genomics and environmental data, might even predict response to therapy and prevent MDR altogether. And new drugs are a necessity, given the dangers of entirely resistant TB, and may help to increase cure rates and further lower costs.

Indeed, Jim Yong Kim and collaborators were able to stimulate new business for generic drug manufacturers that brought down the treatment of MDR TB by nearly 95%. They did not accept the notion that 'limited' economic resources define which human beings are worthy of an investment in their life. Rather, he, Farmer and others have treated people, who have TB and MDR TB, and simultaneously raced to improve effectiveness, lower cost, and shine a light on what 'limited' economic resources actually means. According to Kidder, in considering the costs to overcome TB globally, Farmer estimated $5 billion would be needed; George Soros responded, “Is that all? You only need that?” He, Bill and Melinda Gates, Warren Buffet, Bill Clinton, One.org, Jeffrey Sachs and the Global Fund, the World Bank, WHO and others have responded. And now, so have the Obama Administration and the United States Congress-- more than $140 billion in stimulus funds dedicated to health care, more than $90 billion for education, a $634 billion health care 'initial investment' toward reformed health care for all, and definitive health reform legislation in process. The bulk of funds are focused locally first, but the US has also made a renewed commitment to ending global poverty, though one that can never be fast enough when time is measured by the life of the individual patient.

Some like to draw a divide between medical ethics, focused on the individual patient, and utilitarian public health ethics focusing on delivering the best care to populations with limited resources. This divide is artificially induced by our culture's own perceptions. It is in fact, the public health and clinical research fields which are providing the tools enabling the 'new P's'--which support the call of medicine to personalize care, prevent illness and teach the individual to aid in protecting their own health. Ethical public health uses epidemiology and comparative effectiveness research to design a roadmap to allow the good work of medicine to occur; ethical public health does not design blueprints for fences.

The ethic of doctoring, of helping to lift up the destitute, is what will build the roads from that roadmap. Another movement is afoot- a rebirth of service, and social entrepreneurship, as exemplified by Farmer and the now thousands that change the world through Partners in Health. The Stimulus package will help to fund some of the infrastructure, among the poorest areas of the US.

Just over 500 years ago, the world was flat, and America the continent, 'did not exist.' Kidder quoted Farmer as saying, “I have fought for my whole life a long defeat.... Now I actually think sometimes we may win...[but,] I don't care if lose, I'm gonna try to do the right thing.” And in doing so, there will be many victories, like the discovery of America, and many new diseases (like those brought to Native Americans), we cannot immediately defeat, but will, with time. What Farmer, good doctors and good social entrepreneurs share in common is the urgency of now, and the identification with every human being. The confluence of comparative effectiveness research, new approaches for personalized and preventive health, fueled by social entrepreneurship, service and an ethic to heal and keep healthy every person, globally, is unprecedented, and will help us win. As we follow the right ethic of concern for each individual, as we give the poor the tools to lift themselves up, we will continue the long defeat, and accept Farmer's—our own—frustration at the state of illness and poverty in the world. But, we will be rewarded with his freedom from the “self-consuming varieties of psychic pain.” We will win battles every day with the lack of ambivalence of purpose that makes Farmer's life, and so many others, so beautiful.

Saturday, May 16, 2009

Stimulus investment in the new, measured medicines of social entrepreneurs

During the presidential campaign, the Obama team laid out a thoughtful framework to initiate deeper reform of United States health care, promising to make insurance affordable and accessible to all, improve quality of care, lower costs, and promote prevention & public health. Elements of the plan are bold, such as the aim to establish a National Health Insurance Exchange and to “lower health care costs by $2,500 for a typical family by investing in health information technology, prevention and care coordination.” It appears the compromise between the House and Senate on the American Reinvestment and Recovery Plan will provide many of the dollars necessary to fuel a portion of Obama’s health plans, with $19 billion (B) for health information technology, $10B for biomedical research at NIH, $1.1B for comparative-effectiveness research on therapies, $1B for prevention and wellness, federal subsidies for health insurance under COBRA and $87B in additional federal funds for state Medicaid programs. A small portion of the $53.6B State Fiscal Stabilization Fund for education, $8.8B for high priority state needs, $13B for Title I, $12.2B for special education and $5B for state bonus grants for meeting education performance targets could also support health education. So now, as Kathleen Sebelius begins leading as the Secretary of Health and Human Services (HHS) and state governments step in to further guide the investment of these dollars, where will they find the innovative approaches with proven impact to redefine the established health care system? Two sources getting close attention are voices of community innovators and the measured results of social entrepreneurs.

Building on the spirit of the movement that elected Obama as President, his administration fostered the conduct of grassroots local and online Health Care Community Discussions through the end of 2008, asking American citizens to share their ideas on how to simultaneously improve care, reduce the 45 million uninsured and mitigate the 2.6 trillion dollar annual health care spend rate. The process helped the administration garner ideas, and a sense of the popularity of different approaches. But, proven programs are not only creative and popular; they have measured impact, and they are the fruit of those who are not just innovators, but social entrepreneurs.

Social entrepreneurs are social innovators that have brought their new idea to life through curious attention to the pain points of their stakeholders, and details of effective implementation. They have gone on to measure and improve their impact and reach over time. When social entrepreneurship groups like Ashoka and Skoll Foundation highlight organizations, they typically talk about non-profits and their leaders that serve constituents where there are market failures, such as in service, education, job training for the poor, human rights and international health. When people are asked to name a social entrepreneur, they often voice Wendy Kopp and Teach For America or Paul Farmer and Partners in Health. Why don't social entrepreneurs for the health of America immediately come to mind?

In American health care, insurance and event-based reimbursement has long been the primary mechanism used to address the market failures in caring for the sick. The system has snowballed once socially entrepreneurial hospitals and insurance, pharmaceutical, and device companies into blizzard drifts, now fighting to protect their rooted sources of revenue and financial stakeholders to avoid an avalanche this economic crisis. The work of these institutions is amazing, when you consider their roots, but, it is difficult for them to adapt to address the failures of US health care.

Reimbursement based on disease events, rather than overall outcomes, and consumers lacking price-sensitivity has led to our mountain of health care cost that has also increased the uninsured. It has also led to industries such as health information technology being fragmented and without uniformly adopted standards, and to a lack of long-term attention to prevention. Out of these failures are born a new era of diverse social entrepreneurs for health in the US.

Some of these entrepreneurs start non-profits focusing on children's right to play, be it enabling recess with Sports4Kids or playgrounds for all at KaBOOM!. Now, at the empowerment and suggestion of entrepreneurial health foundations like Robert Wood Johnson and the Clinton Foundation, they have found themselves as new champions for children's health and well-being. Other’s have a focus on health at their core. Peer Health Exchange is among the disciplined nonprofits funded by New Profit Inc., and is filling gaps in health education with rigorously trained college students teaching healthy decision making to teens in Chicago, San Francisco, Oakland, Boston and New York City. Barry Zuckerman, MD, chairman of pediatrics at Boston Medical Center, has long developed and mentored programs that foster child development and a healthy family environment, such as Reach Out and Read and Project Health. He and others have long recognized the tight alignment of child development and health, and these once small programs have blossomed into full-fledged non-profits with large-scale reach, and measurable health impact. But, entrepreneurs don’t have to start in new organizations. Sometimes social entrepreneurs start a new way of sharing health care financial information to empower consumer decision-making at a large Fortune 500 company like Intuit. Sometimes they work at a school of public health and develop, carefully measure and disseminate a health education curriculum for children's health, like Planet Health from Harvard. Sometimes, they come from a government agency like the CDC and develop innovative web tools like Body and Mind- BAM.gov.

Social entrepreneurs don’t need to work for non-profits, either. Ben and Jamie Heywood and Jeff Cole launched Patients Like Me as a for-profit company. Jamie and Ben's brother Stephen developed ALS in 1998. In response, Jamie, Ben and Jeff built an online community to help people with rare and deadly illnesses find medical answers and support from other patients. The early success of the service and promise of impact for other common chronic diseases allowed it to more successfully capitalize and grow as a for-profit- even without insurance reimbursement out of the gate. Patients Like Me is not alone; a whole new generation of Health 2.0 innovators are launching companies, and product lines within existing companies—both for-profit and nonprofit— to provide higher quality care at lower cost via tools for both individual consumers and health care providers (more examples at www.health2con.com). But, not all of these initiatives will substantially change our health care system, and investors, including the government, will need to partner wisely.

Bill Drayton, founder of Ashoka, has said “Social entrepreneurs are not content just to give a fish or teach how to fish. They will not rest until they have revolutionized the fishing industry.” The question for the social innovator on the way to becoming a successful social entrepreneur is how to not only prove, but also efficiently scale their model to eradicate the problem they are fighting.

That may mean an IPO. It may mean government funding. Or, it may mean selling, giving or having the idea copied by another entity which can scale it—all of which can be a good thing when the metric is social impact. The question for the Obama Administration and Congress is, what innovative models to invest in and how to unify and scale them to improve quality, enhance prevention and realize the $2,500 in saving per family they have promised. David Gergen, Harvard's Director of the Center for Public Leadership, has said: “If you could unite the energy, ideals, and innovativeness of social entrepreneurs with the resources of government, you would have a powerhouse.”

If social entrepreneurs had once been shy about engaging in policy and politics, Congress and Obama seem to have opened the door for a new era of close interaction. In addition to the stimulus package, Obama supported the proposed Serve America Act, which specifically calls for the creation of a social innovation fund to support and scale the efforts of social entrepreneurs, a division of the Corporation for National and Community Service to administer such a fund and a White House office to coordinate interaction between the administration and social entrepreneurs. Obama’s commitment to internal and external collaboration, as evidenced by his hiring of a national Chief Technology Officer and efforts to coordinate activities across the executive departments, such as those between HHS and the Department of Education, will help foster the new synergies needed to realize the $2,500 saving per family on health care he’s promised.

In some ways, health care is already an industry that requires symbiosis between entrepreneurs due to detailed regulation and the large amount of health care dollars that are derived through the Center for Medicare and Medicaid Services, the National Institutes of Health and the Centers for Disease Control. While the prototypically successful “health social entrepreneur” may not be as obvious in this industry, the new era of health social entrepreneurs do have examples they can learn from, who have not only built social enterprises, but have scaled in collaboration with the government. Jeff Palmer, a former Ashoka Fellow, developed the Coordinated Care Network (CCN) to finance and efficiently deliver case management and medications to the uninsured, and semi-insured, in a number of US States. Its methods have generated health outcomes better than national averages. In order to scale the service, CCN participates in the Federal 340B contracted pharmacy program for HHS funding and access to lower cost medication; he has now dispensed 1.1 million medications to over 41,000 patients.

Looking back further in our history, a physician named Sidney Garfield, MD was struggling to get insurers to pay in a timely manner, and to bear the cost of some workers who had no insurance. So, he took the advice of engineer-turned-insurer Harold Hatch to have insurers prepay a fixed amount of funds per each patient up-front to improve his balance sheet and, according to the Kaiser Permanente website, “emphasize maintaining health and safety rather than merely treating illness and injury.” Today, Kaiser Hospitals have among the best health outcomes of any major care provider in the nation, but models like Kaiser still represent a minority of people in the US. Indeed, the federal government under President Nixon used the Kaiser model to spawn employer based insurance coverage. But, there was always a divide between the ideals of the social entrepreneur, Dr. Garfield and his constituents—working-class patients—with the actions of the government and lobby groups that led back to a system of delayed, event-based insurance reimbursement with lack of universal coverage. If Obama, Secretary Sebelius, Congress and the output of bills like the Serve America Act can hold true to their promise of citizen government and collaboration with the measuring social entrepreneurs, then previous mistakes will hopefully not be repeated. Even with the uncertainty of the economy, it is a hopeful time for building a new era of healthful living. If health innovators want to turn their ideas into implemented and measured models, they can turn to organizations like Echoing Green, New Profit, Omidyar Network, DBL Investors and Robert Wood Johnson Foundation for angel investment, social venture capital and evaluation funding. For proven social enterprises, scaling funds for non-profits has been limited to a few organizations like Sea Change, and it is a difficult climate for private equity support or an IPO. Fortunately, health innovation is among the centerpieces of Obama’s economic stimulus plan, with further health care reform legislation still planned, which will bring social entrepreneurs in health to their state capitals and Washington, DC.

And, there waiting for them are generations of social pioneers of policy, hungry for real change. Senator Kennedy, though fighting brain cancer, not only helped author the Serve America Act, he also stepped down from the Judiciary Committee noting: “As Chairman of the Senate Health, Education, Labor and Pensions Committee, I expect to lead a very full agenda in the [the 111th] Congress, including working with President Obama to guarantee affordable health care, at long last, for every American. This is the opportunity of a lifetime, and I intend to make the most of it.” Now, here before social innovators, entrepreneurs for health and policy makers, is the opportunity to change not one but many lifetimes.