The League appreciates the hard work of those in the HELP and Finance Committees in the Senate and in the House Committees in providing affordable and quality health care for all Americans.

At this moment in history, more Americans than ever before agree that health reform must happen now and can’t be put off for another day. 85% of Americans think the system needs to change, according to a recent New York Times / CBS News poll.  Consumers need access to health care that is high quality and is  centered around their needs.  The places where Americans  live, work, and go to school must be involved, and each must be part of the national goal of living healthier lives.

All of this must be accomplished while keeping health care affordable. Right now, it is not. Sponsored health insurance premiums have nearly doubled in the last decade, rising three times faster than wages.  No longer will health insurance companies be able to discriminate against consumers because of their health status.

NCL also supports a public option, which will give us  transparency and competition between public and private insurers.  If we provide health care coverage to all Americans, we can also save hundreds of billions of dollars previously used to care for the uninsured.

With 75% of health spending going towards care for the chronically ill, we must refocus our system on prevention and health promotion. We can no longer tolerate a system dominated by treating problems; it’s time to provide Americans the necessary resources and tools to attain a healthy lifestyle.

The lack of comprehensive health care coverage is  America’s albatross – it makes our businesses less competitive and our workers less healthy.

Regardless of political ideology or special interest, we need to ensure that the system is reformed.  The cost of doing nothing is unthinkable.

As HHS Secretary Sebelius has said,  it’s the one of the most personal issues to so many Americans.  It is, after all, one of the only pieces of legislation that will truly affect EVERY American.

Yesterday I had the opportunity to moderate a fascinating panel: Drug & Food Safety in the Age of Social Media and Transparency. The panel was part of the Driving the Adoption of Health IT Through Innovations in Social Media conference in Washington DC.

There were three panels in all. Mine was the second panel. After opening remarks by Craig Stoltz, Founder of Web 2.Oh…Really (and Former Editorial Director, Revolution Health and Former Editor of the Washington Post Health section), we heard from experts on H1N1 Influenza: How Social Media Improves Communication & Collaboration For Public Health. After my panel, we heard from experts (including Disruptive Woman’s March Man of the Month, Dr. Ted Eytan of Kaiser Permanente) on Electronic Health Records: Using Social Media To Drive Health IT Adoption.

Drug & Food Safety in the Age of Social Media and Transparency Panel Summary:

Americans have been concerned about drug and food safety over the past several months as they grappled with E. coli, salmonella, flu, and drug safety scares. More and more people are turning to the Internet for information and the Department of Health and Human Services (HHS) has taken notice. Several agencies, including the FDA, are utilizing robust social media tools to help inform the public – health professionals as well as consumers. This panel focused on the general approach HHS is taking in addition to focusing on some of the specific tools the Office of the Secretary and the FDA have incorporated into their websites in order to quickly, accurately, and easily inform the public.

Drug & Food Safety in the Age of Social Media and Transparency Panelists Emphasized:

- efforts under way at the Department and inside FDA to incorporate social media tools—including how they are working, how they are coordinated, the lessons learned, and the challenges that have arisen
- from the health provider’s perspective, what has worked well, where there are gaps, and suggestions for next steps
- issues around the digital divide, health literacy, and how best to evaluate the usefulness of the information.

Disruptive Women is interested in your comments—how can HHS better inform the public about health alerts, public health incidents, food scares, drug/device safety concerns, recalls, when it comes to social media and other forms of communication?

The HHS panelists were very open to seeking our ideas. Let us know what you think and we will pass along your suggestions.

Drug & Food Safety in the Age of Social Media and Transparency Panelists Included:

- Andrew Wilson, Web Manager, Department of Health & Human Services (HHS)
- Sanjay Koyani, Director, Web Communications, Food & Drug Administration (FDA) – presentation
- Val Jones, MD, Medical Blogger and CEO, Better Health LLC – presentation
- Patricia Hinton Walker, PhD, RN, FAAN, Vice President for Nursing Policy & Professor of Nursing, Uniformed Services University of the Health Sciences.

Ola.   Me llamo Meryl.   We were standing in front of 60+ students ages 7 and 8 in a small village school about 2 hours north of Quito, Ecuador.   We were part of a small group (40+) of Americans who had traveled on “vacation”  to Ecuador on a service/humanitarian trip. Some of us were helping “teach” in the schools; others were helping paint the buildings or construct tables and chairs; and the medical team (of doctors and nurses and physician assistants and social workers and nurse practitioners and translators), was working with local health care workers and seeing people at local clinics and from a bus equipped to function as a clinic on wheels.

So as the U.S. stands poised to spend billions of dollars on health care reform and to assure that all Americans have access to the highest quality and most affordable care  and to equip our physician practices and clinics and hospitals with the best electronic health records money can buy;  and funding the most robust and comprehensive research and comparative effectiveness studies……………….. I keep thinking back to the people who didn’t know what it meant to use a tooth brush; or to have soap to wash their bodies or their clothes;  I keep thinking back to the young, wide eyed children seeking a smile and a simple acknowledgement from their American visitors; hugging us hello each morning and hugging us good bye each afternoon; to the countless women washing their family’s clothes in the seemingly polluted rivers along side the cows and sheep and llamas; to the men and women hunched over their knitting needles and yarn for 10-12 hours/day making hats and sweaters and scarves so that they could take their products to market and hopefully support their families; to the dozens of elderly who were blinded by cataracts and unaware of how relatively “simple” surgery could grant them the gift of eyesight again; to the pungent smells from shoeless and toothless “locales” who had probably not bathed in days or weeks or months; to the stories we shared with each other during our “evening debriefs” and how each of us was humbled by the innocence and pride and self sufficiency of the people we met; and how we were inspired by their sincere and genuine and heartfelt friendship; and how I keep thinking about the interrelationships between health and health care and education and clean water and clean air and basic sanitation and plumbing and running water and personal hygiene and poverty and illiteracy……..and I keep thinking about the possibility of returning to Ecuador next summer…….because it was one of the best summer vacations we ever had.

This past week, I ran across a study in Menopause that not only supports this contention but also challenges us to more closely examine the limitations of current investigations into alternative therapies.

ACUFLASH (the Acupuncture on Hot Flashes among Menopausal Women Study) was a randomized, controlled, parallel study comparing the efficacy of weekly acupuncture plus self-care to self-care alone in 277 menopausal women experiencing, on average, 7 or more hot flashes daily. But here’s the rub: unlike previous trials, ACUFLASH actually estimated the effectiveness of acupuncture in practice, meaning that the study was specifically designed to mimic the basic tenets of Eastern philosophy and incorporate the subjective. Consequently, after agreeing upon expected diagnoses and recommended point selection, licensed Traditional Chinese Medicine acupuncturists were free to diagnose, select acupuncture points and individualize treatment for each study participant.

Not only did the mean frequency of hot flashes decline at least 50% in half of women receiving acupuncture plus self-care, but significant improvements were also noted in hot flash intensity and overall quality of life measures. More importantly, by incorporating a larger study group, and eliminating sham needles and “standardized” (compared to individualized) practice, the researchers were better able to preserve the overall quality of acupuncture and what it strives in achieve, while still remaining true to the tenets of evidence-based scientific methodological standards.

Is this study without flaws? Certainly not. Indeed, the investigators acknowledge that the study participants were not treatment naive, and point out that sham acupuncture, which may be necessary for a true comparative analysis, is hardly “physiologically inert.” Nevertheless, I remain hopeful that the study design and its positive results may open the alternative therapy door a bit wider and lend further credence to its role in treating disease.

Some things have not improved—like health insurance coverage. As the years have gone by, coverage for hospital stays and rehabilitation have been shrinking. For example, Medicare has a cap on outpatient rehabilitation that makes no sense—it’s not capped if performed in the more costly hospital outpatient department, but limited to about $1,800 for physical and speech therapy combined, and $1,800 for occupational therapy provided in an office. At current rates, that’s about 45 hours of total therapy, not nearly enough for stroke recovery (to be fair, there is an exceptions process, but it is scheduled to expire at the end of this calendar year).

This leads to a more difficult issue in the health reform debate—what exactly should be covered by health insurance? Acute care, annual preventive visits, post-acute, healthy living coaching? Commercial health insurance has many ways to limit its exposure to the costs of long term chronic conditions, like surviving stroke, including caps on therapy. Another way is challenging access through “pre-existing conditions” ineligibility and/or very high premiums. As a result, the physicians and therapists seem to prescribe and set treatment goals that match the insurance plan, often short of the patient’s needs, especially for rehabilitation following stroke. They look to the survivor’s family, particularly the spouse/caregivers, like me, to pick up the torch and carry on.

I am all for patient responsibility, but I am a health policy expert, not a therapist. And as a wife, it strains our relationship for me to drill my husband on therapy exercises or correct his aphasic speech. Over the years, we’ve been creative and resourceful, and sacrificed. We’ve found wonderful rehabilitation professionals who have coached us on our main goal—making my husband as independent as possible. And my husband has a great attitude—he pushes himself to do more. Going back to work full time was one of my husband’s goals that he achieved. As he regained his independence, so have I, giving us a more “normal” family life.

We have been lucky, but there are many families who don’t have our resourcefulness to set goals beyond insurance limits. When a stroke survivor doesn’t reach his full potential for recovery, everyone suffers. Working-aged survivors often lose their jobs, income and benefits; and caregivers are likely to be less productive at work or forced to cut back hours, putting their own benefits at risk.

Health insurance reform needs to provide accessible, affordable ways to make health insurance available, even to people with pre-existing conditions. Health system reform needs to provide pathways for regaining and maintaining health and independence for the patient and the family.

• 18-29 year olds make up just 17% of the population but 30% of the uninsured, and
• Entering adulthood triggers a serious risk of becoming uninsured as the rate almost triples from 11% to 29%.

As we look at this age group, it is critical to hone in on young adults with chronic medical conditions & disabilities (CMCD) since they cannot afford a single day without coverage.

Aware of the need to continue care, they, or their parents, are inclined to seek coverage. However, young adults with CMCD encounter many obstacles:

• Only 54% are able to attend college or work, usual prerequisites for insurance;
• Relying on individual coverage is risky because of pre-existing conditions and inadequate benefits;
• Young adults with CMCD are three times more likely than their healthy peers to earn under $15,000 a year and live in poverty, another risk factor for becoming uninsured; and
• A vicious cycle ensues when 54% of young adults with CMCD lack a usual source of care and two-thirds delay or miss care because of costs. Foregoing treatment hinders their ability to maintain the health status needed to go to college or work.

How can we assess the significance of a specific population without appropriate studies?
We had a logical reason for not studying this population – until now. In the past, children with CMCD did not survive to adulthood. Thanks to advances in medicine paralleled by a rise in chronic conditions, we now face a tidal wave of emerging adults with CMCD:

• Every year, over half a million children with CMCD enter adulthood, and
• Extrapolation of child health data reveals 4.5 million young adults aged 18-24 years have CMCD.

Unprepared, we are unable to build on the systems of support designed for them as children. These young adults with CMCD who struggled as children to be like everyone else and gain independence from their parents fall off a cliff, so to speak, when they turn 19. They age out of support systems, they age out of insurance, but what they are unable to age out of is dependence on their parents.

Even if young adults with CMCD are fortunate to have coverage, they experience another major problem with access: the dearth of adult physicians available, willing, and able to care for their childhood onset conditions. Too often, these young adults remain under the care of their pediatric providers, sometimes forever.

We need to ensure young adults with CMCD are included in health care discussions. What role do they play in issues regarding the uninsured, health care costs and resource utilization, poverty, and social welfare? What impact do they have on the workforce and its productivity? Can we afford to keep them invisible?

Beyond numbers, a moral imperative also presents itself. As a nation committed to promising our children good health and education, are we extending this promise to all of our children and young adults? Shouldn’t our children with CMCD have a fair shot of growing up into educated young adults with the best possible health?

As we embark on one of the greatest changes our health care system has ever seen, will we do the right thing and embrace children & young adults with chronic medical conditions & disabilities – the population that has the most to gain from improved access and quality health care over an entire life’s span – and put their needs at the center of the discussion?

Why aren’t we as health care professionals clamoring for CER? Why shouldn’t we encourage health care policy makers and industries to align themselves to how we make clinical decisions? Perhaps we haven’t taken the time to fully understand the benefits of CER, how it could directly improve our ability to positively affect the lives of our patients, or we see it as something far-off and impossibly complex to implement. If we take a closer look at CER in relation to our needs as caregivers and front-line professionals attuned to the health needs of our patients, we can positively shape the debate on health care reform through CER.

The benefits of CER to healthcare professionals (HCPs), patients and other stakeholders
Efficacy, established within the confined settings of clinical trials using RCT is a necessary but not sufficient standard for deciding on how to treat patients for their conditions. Meta-anlaysis alone is not a sufficient way to address the lack of comparative effectiveness information. Performance, in terms of health outcomes, requires HCPs to make our best guess with limited information about which treatments work best for specific patients’ conditions.

Instead of settling for “siloed” information on health care treatments, what if we had richer information at our fingertips which evaluate treatments “relative” to one another and for specific patient types? By providing that kind of comparative information about treatments, CER gets us closer to the real word of how healthcare professionals practice. Instead of seeing healthcare reform getting between patient and doctor, we might look at CER as a significant step toward healthcare reform providing the necessary conduit between patient and healthcare provider by providing this much needed information to both groups.

Comparative treatment information enables us to choose the best treatments for our patients’ conditions. It helps us get to being closer to “right the first time”, limiting risk of using the “new” or latest treatments – just because they are new. Medical costs can also be reduced by not having to backtrack and consider more interventions based on failures, or adding on therapies and possibly creating even greater risks or problems, for example drug interactions resulting from unnecessary poly-pharmacy. In addition, disparities could be justified based on the results or outcomes substantiated in CER, rather than just being highlighted for their financial impact.

Patients and HCPs are not the only ones who will benefit from a performance-driven approach enabled by CER. Comparative information will save manufacturers’ costs by directing them to develop treatments with the most positive outcomes for the most appropriate patients, and away from me-to products with marginal performance value, directed at the masses. Thus, resources could be directed to developing more data rich and innovative products. Payers will appreciate appropriate costs associated with HCPs prescribing appropriate treatments the first time, resulting in improved patient health and reduced need for treatments or defensive medicine techniques.

CER is not a radical, far-off dream – we can do something now

There are those in the health care field who clearly see and desire the benefits of the performance-driven approach of CER, but are concerned that implementing CER is too daunting in scale and complexity to tackle. Here are three ways to look at addressing these concerns and taking steps towards proceeding with CER:

1- Don’t look at CER as an event
Change required for CER is a greater integration of “performance focus” and practices into ongoing organizational operations. Practitioners need to be more engaged with performance and outcomes, and not enticed and drawn to the newest products and technologies until there is reasonable data to support them versus current options. Industry needs to look at innovation from a standpoint of performance versus current options as the litmus test for moving development projects forward, certainly along with other criteria including e.g., patent protection.

2- We’ve actually been doing this a long time…
Comparative effectiveness is how we, as health care professionals, naturally make health care decisions anyway. A patient performance-driven or outcome-based approach to providing health care is not new. Hospital pharmacists in the late 1970’s, with the advent of the Prospective Payment System, began training medical students and residents in teaching hospitals in order to get more appropriate use of medications, by collecting outcomes data through medical records reviews, data based mining from our DRG data bases, and developing guidelines for interventions. In one case, we looked at coronary artery bypass graft (CABG) patients with nutritional depletion prior to surgery to determine whether they did better post op and through recovery based on intervention with total parenteral nutrition (TPN), an expensive treatment in the hospital setting. We were able to prove that the patients did better on this treatment, and in fact the cost of the TPN was offset by the decreased length of stay and other indicators versus the patients who did not receive TPN. The patients on TPN had better outcomes, and had lower hospital charges overall. Needless to say, the study helped to sell a lot of TPN for CABG patients back then. That was CER – in the early days.

3- We’re just gaining the support of more stakeholders
CER puts all stakeholders on the same page with common goals. In an attempt to socialize the concept of CER better than it is currently, goals for improving HCP decision-making and patient-performance establishes a frame which we can all understand, agree on, and anchor the discussion. Who doesn’t want better health care for themselves, family members or friends? While other goals may be important to CER and health care reform in general, they are often in conflict with other stakeholders’ interest, leading to stifled debate and inaction. Why don’t we let performance be our lens, and ensure that all other goals align with it? I’d like us to try and socialize CER from the healthcare provider and patient performance perspective.

Successful models already exist for performance oriented approaches. I was a practicing hospital pharmacist when Dr. Roy Vagelos was running Merck. To the healthcare provider on the outside, the company culture operated like a huge medical practice. Patient-performance criteria provided the context for product development and marketing, and the foundation on which business goals and objectives aligned. Fully recognizing those were different times back then – we also need to recognize that the business did well back then too! Why not revisit this successful model in our attempts to socialize and progress the discussion on how to implement CER?

We arrive at the dawn of yet-another health reform effort with laws and regulations already in place to protect patients. These arose in past decades when the healer-patient relationship was eroding, presumably at the hands of uncaring clinicians and for-profit medical enterprises.   

The list of those rights was extensive and today’s debates are adding to the mix – guaranteed coverage despite pre-existing conditions comes to mind. The discussion of patient rights has always been politically attractive and I won’t denigrate any one of them. I’m not just writing from a policy perspective, but a personal one as well. I’m a patient, too.

The discussions of patients’ rights, however, has neglected the flip side of rights—responsibilities on the part of patients, and the support that we all need from our communities to be healthy people. Today’s healers are beset with immense responsibilities, yet with few reciprocal rights of their own in their relationships with patients or communities.

As patients, communities and a nation, we all too frequently fail to follow medical advice or practice healthy behaviors, and yet expect that helath care will ‘make it right’ when we become ill or incapacitated.  We smoke, abuse alcohol and drugs, carry guns, drive fast, forget seatbelts, neglect immunizations, shun prenatal care and spread sexually transmitted diseases. We ignore social problems until they create health care consequences—low birth-weight babies, elderly who lack social acceptability, and teens suffering gun-shot wounds. When these risky behaviors result in chronic or high-cost illnesses and disabilities, health-care providers are expected to assure that we get the care we need, insulating us from the cost of our choices by providing whatever we need within a fixed budget. The time has come to broaden all of our health policy and political discussions to encompass the realities that, with rights come responsibilities.

So some questions:

• If managed care has a responsibility to meet all the patients’ needs, do patients have the responsibility to practice healthy lifestyles?
• If patients have the right to sue health-care providers for the failures to meet the patient’s expectations, do health-care providers have a similar right—to sue patients for the costs incurred from their failures to follow medical advice?
• At what point do patients who have rights also become citizens who have responsibilities, particularly as we all—collectively—pay for each other’s health care?
• If the community has a right to call on health-care providers to keep us all productively at work and at school, do communities have a responsibility to do their share as well?
• As the population ages and more health-care costs are attributable to lifestyle, can we afford not to hold patients and communities more responsible for their own health-damaging, cost-increasing behaviors?

What will it take?  Will clinicians, payers and managed care groups be forced to sue patients and communities to get the debates going?

Consider hypertension.

 Health-care providers collectively are asked to:   

• identify patients at-risk from population-based studies,
• call them in for examinations and diagnosis,
• counsel them about diet, exercise, smoking cessation and lifestyle modification,
• prescribe the right medications
• stay current on latest treatment interventions,
• subsidize the cost of those medications,
• place patients in compliance programs to be sure they are taking the medications,
• follow-up to assure the medications are working,
• adjust those medications if they are not as effective as hoped.

 The patient, on the other hand, need do nothing. The patient need not

• stop smoking,
• eat right,
• exercise or
• adhere to the prescription’s directions.

Further, the community need not be supportive, either. Communities need not 

• assure that streets are safe so that people can exercise near their homes,
• that children have healthy food in schools,
• that public policies support healthy lifestyles or
• that those who need help paying for treatments receive that help.

 Yet, years later, if the patient has a heart attack or stroke, the healer must arrive at the emergency room, provide intensive care and help with rehabilitation, all within a negotiated capitated-care rate.

Here’s the current draft: http://www.healthdatarights.org/home

Why not? It’s not a difficult question to answer, but the answer is difficult to share openly.

This is my patienthood we’re talking about here. That has been, historically, a huge compositional element of my personhood in total.

I can’t take this one lightly and start throwing smoke bombs at store windows without thinking it through very carefully.

When I saw the first draft, I immediately began looking at other Bills of Rights, including the US Constitution.

I thought about what Bills of Rights are supposed to do, and what I’d like a Bill of Health Data Rights to accomplish.

Do I think this Bill accomplishes what I’d like to see a revolutionary piece of rousing advocacy achieve? No.

Is it an excellent start? Yes.

Will I sign it as is? No.

Will I support the ongoing initiative with every fiber and dollar I can give? Yes.

Because this bill, and our choice and control over our personal health information, as well as establishing a view from within the system that acknowledges that choice and control, absolutely needs to evolve from this early composition.

I am stepping out on a huge, bowing limb here, fully expecting it to break under the weight of my unreasonably high expectations.

That being said, if I can’t have high expectations about a Bill that is supposed to support my right to my health information, what the hell good are ascribing to principles of any kind?

Again. This is my patienthood we’re talking about here. That has been, historically, a huge compositional element of my personhood in total.

I have not endorsed the first draft of Health Data Rights, despite spending significant time with several composers whom I love and respect and utterly believe have people-who-are-patients best interests at heart.

I must apologize now for the criticisms I am about to offer, which I also offered several times before the bill was made public.

I know many of you who worked tirelessly on this – putting in weekend hours and pooling political, personal, and professional capital to get this done.

I realize I am jeopardizing political, personal, and professional capital by NOT endorsing this draft.

I recognize and applaud your efforts at this early stage. However…

While I wholeheartedly support this initiative, I cannot in good conscience endorse this product.

I feel the results of the first round are problematic for several reasons, namely:

1. The language as is, opaque by necessity in order to get many important signatories (which I understand and accept), is largely not actionable. Terms are so loosely used that it will be very challenging to state with certainty when a ‘right’ to health data has been abused. Example: What does “minimal cost” mean to those who hold my health data in the bowels of their systems?

2. How will we hold organizations (or individuals) accountable if they abuse our rights to health data? There are no suggestions given, in the preamble or media blitz materials.

3. How will we build tools, systems, services, and conversations that help people who have been, will be, and are today patients, navigate these rights? Were they provided in any other language? Are they different for children and adults?

4. Where are the patient advocacy organizations? Where is NAMI and the like? Many employees and volunteers at organizations like this one would have plenty to say on the issue of composing a Bill of Health Data Rights, and useful or not, it would at least help refine the concepts displayed here with more specific and stirring language.

Maybe I expect too much. Maybe I want the impossible. Maybe I would sacrifice several (or all) ‘large’ or ‘famous’ signatories of the Bill in the fight to have the language that I feel is life-saving included.

Maybe I would also fight from within the system to encourage all of the parties who currently hold MY health data that it is, in fact, mine to choose to access (or not), to share (or not), and to control (or not).

Maybe I have. Maybe I am still.

But overall, there is one central tenet missing from the current Bill that, if included in explicit language, would result in me signing, and it is this:

My health data is my own.

End of story. I don’t have to reclaim it. It’s already mine.

Please note – It is a completely different issue for my health data to be tricky or dangerously expensive/time-consuming to obtain or inaccurately kept/updated/shared within the system.

These issues, and these differences, are not even mentioned in the bill or accompanying language, and I fear that is a near fatal diagnosis that will prevent this effort from playing any lasting role in my pursuit of wellness beyond some extra blog hits and sound bytes.

My health data rights already are being abused, and I will stand up against that abuse, personally and for others, and advocate for change. I am utterly committed to doing so.

Here’s where I get myself into real trouble…

That also means I don’t do things in half-measures. If it’s not good enough, it doesn’t go out.

If a Bill of Health Data Rights doesn’t acknowledge vital programs CURRENTLY IN PLACE in hospitals to help make people who are patients aware of our rights, like the JCAHO Speak UP! Program, it fails to connect patients with resources OUT THERE IN THE REAL WORLD more tangible than a Hallmark-card-esque Bill of Rights.

If a Bill of Health Data Rights doesn’t direct me to SOMETHING, SOMEONE to call, or email, or txt, or tweet, or a senator to whom to write a letter or fax a protest, then it has failed me as a patient.

It has failed me because now I’ve got my rights, but what the hell do I do with them?

Perhaps worst of all is the last omission, which I find most aggregious – if a Bill of Health Data rights doesn’t use terminology that ties the ABUSE of those rights to ACTIONABLE CONSEQUENCE then it has failed me.

The failure (conscious or not) to include the term “personal health information” or PHI, that would ‘link’ these rights to actionable, legal consequences under current legislation is a failure of the worst kind. It is either a failure of ignorance or of fear, or of both.

And revolutions, my friends, do not light a bonfire by being afraid of tyranny. Revolutionaries throw firebombs at the doorways. Yes, revolutionaries build barricades. Revolutionaries lay themselves down in protest in the line of fire.

This Bill of Rights does none of those things.

It is the equivalent, at best, of holding up a lighter in protest. Peaceable (not necessarily a bad thing). Lukewarm. Ineffectual.

I must be a radical, and God help me, I’ll probably never work in this town again.

But apparently I’ll have plenty of work to do lobbying for a Bill of Rights that has some sticking power. I hope to do it with those of you who are committed to holding the match, if I haven’t just burned all my connections to cinders.

Here’s the accelerant I’d use to start:

BASIC HUMAN RIGHTS: Health. Life. Liberty. The Pursuit of Happiness.

PREAMBLE

We the people hold these truth(s) to be self-evident:

1. Our health data is our own.
2. Our health data is an asset. It shall be legally described, and protected, as such.
3. Our health data is a part of who we are – it is not the sum and total of our identity.

BILL OF RIGHTS

1. It is my right to know which people and organizations are writing, recording, sending, and receiving my health data.
2. It is my right to have included in my record a listing of who, what, when, where, why and how my information is stored and shared.
3. I have the right share my health data with whom I want, when I want, through any means of communication I choose.

I’d then take the above rights and reword them to demonstrate that people who are patients have the choice and control over personal health information (PHI) to release it only when and where and to whom we choose.

This is my right – to have choice and control over my health data. These rights, more fully explained (but still in very blunt-force-trauma form) look a bit like this:

5. I have the right to choose and control who sees my health information.
6. I have the right to choose and control who shares my health information.
7. I have the right to choose and control who profits from my health information.
8. I have the right to refuse access to my health information.
9. I have the right to correct inaccuracies in my record.
10. I have the right to protest data I view as inaccurate, and to have a record of that contestation included in the record.
11. I have the right to report inaccuracies in my record(s), or abuses of my health data rights, to a HealthDataRights.org, the Better Business Bureau, and my elected representatives.

If I still have a job tomorrow, I’ll see you all ‘online’ then. Where I’ll be working to protect health data rights I already own.

Jen S. McCabe
@jensmccabe

CEO/Founder: Contagion Health
CoFounder: NextHealth (NL)

Consulting/Chief Patient Advocate (social media):
OrganizedWisdom Health

LinkedIn: Jen McCabe
Skype: jenmccabe

iPhone: 301.904.5136
Dutch Mobile: +31655585351

jennifermccabegorman@yahoo.com

This blog post was originally posted here.

The following guest post is penned by Lisa Korin, Graduate Student, Masters of Public Health, Johns Hopkins University Bloomberg School of Public Health.

Barack Obama’s grassroots organization, Organizing for America (OFA), called for a series of health reform kick-off meetings on June 6 (coincidentally my birthday), to brainstorm ideas on the public option notion and plan a healthcare day of service for June 27. I attended a meeting at a stranger’s home that I found on the OFA website.

As the attendees went around the room sharing their healthcare stories, it quickly became apparent that most everyone at the meeting was for a single payor system, in which there is only one public payor for all, and not interested in discussing the Obama plan that was to be the meeting’s purpose. The prevailing belief was that – if insurance companies don’t exist and there is a single payor, it will resolve all of our health woes.

As someone who worked for a private payor at the time, I was not only of a different opinion but also appalled when asked if my company would sponsor a blood pressure screening at the day of health service event we were to plan (at which there would be propaganda promoting a single payor system).

Following the meeting, I wrote the following letter to the event organizer:

Dear Organizer,

Thanks for letting me participate at your meeting Saturday. I found it quite interesting and thought-provoking. I had come to the meeting thinking it would mostly be about promoting the Obama plan, which includes keeping private sponsors of health coverage and adding a public option that may increase health care insurance access and affordability. The group that gathered Saturday seemed to be more in favor of a single, government-based, payor option that is not the Obama plan though.

As I’m not clear what type of literature and promotion would be distributed at the health service event, it would seem to me that it is not strictly in favor of the Obama/Organizing for America ideals. That said, after a few days of digesting some of the dialogue and reading through some of the literature distributed at the meeting, I’m not quite sure the payor I work for would be an appropriate sponsor for the blood pressure screenings at the health service day event. In fact, there seemed to be quite a bit of animosity toward the insurance industry amongst the group – would you agree?

As an account executive in the insurance industry, I appreciated hearing Saturday about some of the troubles people have faced with private insurance and recognize that the current system works well in some ways and lacks in others. At the same time, I couldn’t help but notice the limited understanding of the health insurance industry that perpetuated around the room. As I sat and listened to some opinions that differ from my own – if I may – I wanted to say a few words about the health insurance industry, and, if you feel it’s worthwhile, please share with the group.

The health insurance industry exists as a means to finance health risk, the thought being that a carrier can negotiate more affordable health coverage than an individual or group could pay for or negotiate on their own. Providers need insurance companies to bring members/patients to them (who may not otherwise afford to pay for services), and the insurance companies need health care providers to participate in their networks in order to attract individuals and employer groups to purchase health coverage plans. And yes, like other organizations, a financial margin needs to be produced in order for the insurance company to exist; if there was a 100% dollar for dollar pass through on every insurance premium dollar to pay claims, the insurance company would not exist and therefore, the negotiated discounts, etc. would not exist. (Please note I am oversimplifying this.)

Part of my job has been delivering and explaining annual insurance renewals to employer groups, associations, brokers, consultants, and a number of other types of parties. Having delivered renewals to groups ranging in size from sole proprietor groups of 1 to 500 person companies, I can tell you that 80-90% of every insurance premium dollar goes toward paying claims! Let me say that again: 80-90% OF EVERY INSURANCE PREMIUM DOLLAR GOES TOWARD PAYING CLAIMS!!!

As a result, it seems to me that eliminating insurance companies on its own does nothing to make health care more accessible and affordable. The same health care costs exist whether or not the insurance companies exist. In fact, I read an article once that described health care costs in and of themselves as the “cake” and insurance as the “icing”, which I think is a good analogy. The question then becomes what is being done to curb the rising costs of health care – that is, the rising costs of “cake ingredients” (and that is the area I am interested in studying at Johns Hopkins).

Currently, health care comprises 18% of GDP and that number is expected to rise to 30% in the near future if reform is not passed to affect aspects of health care costs such as:

• the chronically unhealthy (I’m sure I don’t need to elaborate on the number of people with Type II diabetes, high cholesterol/blood pressure, etc. or those who smoke, are overweight, do not exercise or maintain a healthy lifestyle, etc.)
• provider malpractice insurance costs/”defensive medicine” (i.e. physicians ordering more tests than may be needed in order to protect themselves from being sued)
• the aging population (people are thankfully living longer, and there are costs associated with this trend)
• health care technology and innovation costs (i.e. the R&D costs pharmaceutical/biotech companies need to recoup when launching a drug/biotech product to market)
• medical errors (technology to help prevent costs billions of dollars to implement on a widespread national scale)
• fraud/abuse (e.g. doctors falsifying diagnosis codes on claim submissions, patient identity theft, etc.)

All of the previously mentioned aspects are the “cake;” insurance is the “icing” that packages and finances all of it. I’m not clear how the single payor system in and of itself would do anything to curb the “cake ingredient” costs. The only difference between the current system and a single payor system that I see is that you and I, employers, etc. would be taxed heavily to continuously support the upward spiral of increasing costs. (Please correct me if I am wrong on that last point.)

Obama’s principles for health reform provide for “what can we do to increase accessibility and affordability?” of health care. I personally am for however greater health care accessibility and affordability can come about.

The Centers for Medicare & Medicaid Services (CMS), the government agency that runs Medicare and Medicaid, and from which a single payor system would be modeled, is hardly staying solvent and is due to run out of money in the coming years. I fear for what would happen if all the health care dollars for the rest of the population were in the hands of the government alone rather than in a free market or private/public payor combination environment. In addition, CMS is already the largest payor in the nation, and as they have reduced reimbursement rates continuously over the years, private payors have followed suit. Nevertheless, private payors’ reimbursements’ remain overall higher than CMS’, thus helping keep a number of health care providers in business. Needless to say, I fear for provider reimbursement rates if a CMS-like entity is the only payor.

By the same token, services private insurance companies deny or require prior authorization for today seemed to be an issue many of the meeting attendees shared. Having a single payor does not mean such services would then be automatically covered. In fact, if the single payor denies health service, there will be nowhere else for that individual to go to get it covered. (i.e. there will be no competitor in which a different policy could be purchased that may cover the service).

Those are a few of my thoughts – hopefully they didn’t come through too harshly but in understandable terms. I have also attached the Economic Case for Health Reform report released by the Obama administration last week as it lends credence to many of the points noted above.

I welcome any responses, rebuttals and/or questions. If not, I understand that as well and enjoyed participating in Saturday’s group.

Sincerely,
Lisa

Stay Tuned: We will be creating and widely distributing a CER e-book.

The HHS Federal Coordinating Council for CER research posted its report to Congress and the President on Monday describing federal activities on CER. Another report with actual priority suggestions is due to Congress by the end of July. On Tuesday, the Institute of Medicine released their sage advice about the top 100 priorities as well as a report on CER. I found one line, in particular, of extreme importance from the report to Congress:

“National Institutes of Health (NIH) diabetes prevention trial demonstrated that lifestyle change was superior to metformin and placebo in preventing onset of type 2 diabetes.”

Although an extremely complex and closely watched effort across the private sector, this line is the crux of the issue of success for such an endeavor. Of the entire IOM report, I found the following meaningful:

“Compare the effectiveness of traditional behavioral interventions versus economic incentives in motivating behavior changes (e.g., weight loss, smoking cessation, avoiding alcohol and substance abuse) in children and adults.”

How do we know how much the patient – their genomic and proteomic make-up, their lifestyle choices, their home environment, the food they eat, the exercise they do, the sangria they drank last night, the choices they make, the levers that influence their behavior – impacts our ability to understand the health outcomes and economic value of clinical interventions such as medications, procedures or clinical delivery system strategies as proposed by comparative effectiveness research? The fact that CER is now being referred to as patient-centered health research or patient-centered outcomes research is definitely half the battle and we are thrilled to see that, but how do we really put our money where our mouth is to ensure that the patient is, in-fact, informing these efforts and the research knowledge base through both their own actions as well as how they inform interactions with the health care delivery system?

A key finding from the Robert Wood Johnson Foundation’s Project HealthDesign work on personal health records was, “collecting ODL (observations of daily living) data through PHRs gives both clinicians and patients insights that are unattainable in records that capture information only from clinical encounters.” How do ODLs play a role in comparative effectiveness research? Well, tracking ODLs can help individuals better understand their own health and well-being status (i.e. pain, mood, sleep patterns, etc.) and/or disease issues. This is, arguably, helpful context to understand who the patient is and how they live their lives and take care of themselves between clinical visits. Put in the right context, individuals can actually visualize trends and relationships in their health data not previously available to them. This alone is helpful, but not likely to impact CER until the information makes its way to a clinician and the health care delivery system. Hence, something about ODL tracking may and should cause individuals to use this information as a “patient” with their clinician. Although this rarely happens today, this phenomenon is on the rise and is playing a critical role with both the clinician in terms of painting a broader picture of the patient sitting in front of them as well as with the patient who is, for the first time in some cases, able to link how they are feeling on multiple levels with a particular experience or clinical indication. This interaction is empowering for both clinician and patient. This interaction has potential repercussions for how the clinician might treat the patient with medical therapies, drugs or other interventions and certainly for how the patient might view their health responsibilities between clinical visits.

So, what does all of this have to do with comparative effectiveness?

Well, if the patient’s tracking can influence the provider’s clinical decision which influences the comparative effectiveness tracking currently being designed by the federal government, doesn’t it make sense to include the patient and enable a technical and operational understanding of their health and health care experiences, decision-making and participation along the way? How can one imagine a clean view of comparative effectiveness without meeting the patient or individual where they are in order to understand how they are potentially influencing comparative effectiveness in their own, personalized way?

It was Dr. Christine Sinsky who enlightened me. She said that just five years ago, a patient with a 143/82 blood pressure, 1.4 creatinine, 128 fasting blood sugar and 189 cholesterol was advised to exercise and lose weight. Today, that same person has hypertension, stage 3 kidney disease, diabetes, hyperlipidemia and is a candidate for four medications and ongoing monitoring.

Citing data from the New England Journal of Medicine, she added that a Medicare patient with diabetes, hypertension and depression with a complaint of headaches is subject to 56 different quality measures.

The complexity of those – and other – clinical situations is something she manages with smart system integration; no doubt you’ve seen her publications on those methods. I can’t help but wonder if CER – not as it is imagined and promised, but as it will be realized – will help or hurt clinicians like her and patients like hers. As a policy maker of longstanding, I have to admit that we generally had the best of intentions, but always created negative unintended effects.

Will we do that again? Have good intentions but negative effects? Only time will tell. Since all of us will soon be walking the territory, I’m offering the beginnings of a map in this blog; a map intended to navigate the territory better. I look forward to the ways others might add to our collective understanding of the landscape. The map is not the territory, as they say, but I believe that the better we explore it now, the better will be the chance that those who traverse it can avoid Donner Pass scenarios.

I currently see 7 components on the CER Map, and each of those has a set of interrelated policy issues. I’m interested if you see the territory differently and if you have components and policy issues that illuminate this endeavor further. As you do, remember Dr. Sinsky and Donner Pass.

The 7 components on the CER map:

1. The types of players who, as stakeholders or vendors, will be involved:

• Public sector; e.g., AHRQ, CMS/QIOs, FDA, NIH, VA/DoD, State Governments
• Private sector, including for-profit groups; e.g., Leapfrog, NBCH, NBGH, NCQA, PBMs, Health plans, insurers, URAC, JACHO, medical centers, producers of products and services (biopharmaceuticals, devices, games), CROs
• Public-Private Joint Groups; e.g., NQF, OHSU Center for Evidence-Based Policy
• Foundations; e.g., RWJ, CHCF
• Academics, professional societies and study groups; e.g., Institute for Clinical and Economic Review (ICER), American College of Physicians (ACP),Drug Effectiveness Review Project (DERP), NY Academy of Medicine Evidence Based Medicine Resource Center, IOM, Rand
• Consumers; e.g., Patient advocates, prescribers, professional societies
• Global Influencers; e.g., NICE.

2. The types of targets that will be deemed important for CER studies:

• Prevention; e.g., primary, secondary, tertiary
• Diagnosis; e.g., pt/caregiver report, lab assessment, imaging
• Condition-related; e.g., all hypertension control methods singly or in combination
• Treatments: e.g., high cost-low volume, high volume-low cost
• Chronic care and maintenance
• Palliative or supportive care; e.g., anti-nausea drugs used with chemotherapy
• Health care delivery system options; e.g., office care vs. telemedicine, physician vs. physician extender.

3. The types of evidence that will be used to conduct studies:

• Economic/claims analyses
• EHR records/data mining
• Clinical guidelines
• Expert opinion
• Registries
• Practical clinical trials
• Predictive modeling.

4. The preferences for types of evidence along the traditional hierarchy:

• Meta-analyses of individual patient data
• Large multi-center RCT
• Meta-analyses of group data
• Small, single-site RTCs
• Prospective cohort studies
• Case control, retrospective cohort or cross-sectional studies
• Poorly controlled studies
• Uncontrolled studies
• Inductive, observational studies.

5. The possible uses of the studies:

• Decision support by clinicians and patients
• Educational for clinicians and patients
• Coverage and payment determinations
• Marketplace entry clearance through product licensure, accreditation or contracting
• Pay for Performance
• Evidence-based clinical guideline updates
• Quality report cards
• Consumer reports.

6. The communication methods by which results will become known:

• Federal agency publications
• Professional society peer-review journals
• Coverage bulletins
• Web-sites
• Lay press.

7. Results implementation and outcome expectations:

• Implementation; e.g., next insurance contract year, first day of next quarter
• Outcome expectations; e.g., price reductions, lower costs of care per episode or course of illness, cost trend decline, patient satisfaction, declines in mortality, improved quality of life

Each of those 7 components has different, but clearly interrelated, policy questions, of which the following are but a sample.

Player-related policy questions:

• Are the players all on equal footing, or are some more important than others?
• Must players who control major segments of the health care market meet different standards of behavior regarding target selection or evidence type because their decisions are more consequential than the role that others might play?
• Are the players who pay for larger shares of the health care budget more important than the players who do not?
• How can the interests of the various stakeholders be accommodated when so many of those are – and will always be – conflicting?
• How will studies account for the reality that stakeholders each defined value in different ways?
• Who will be allowed to conduct useable CER studies? Will credentialing be required of individuals and/or organizations that do CER studies? That is, can anyone with a laptop and data generate a CER, or must they be somehow certified or licensed to do so?
• Can companies do CER studies of their own products in comparison to other modalities (e.g., statin vs. oatmeal)? If so, can these studies be used to change product labels and promotional approaches?
• Can patients opt out of data bases on which CER is conducted? If so, what are the consequences for their care and the validity of the data?
• How will patient outliers be protected? What if patients are harmed by the results? Who is accountable in the chain of those who study, communicate and make decisions based on the results?
• Will there be exceptions or exclusions for rare diseases, and for areas of disease care with considerable unknowns?

Target-related policy questions:

• What aspects of health care might be/should be/are being targeted for CER?
• Should there be a balance for all of the possible targets selected?
• Must there always be ‘cross-target’ comparisons (e.g., between treatments and prevention) or should it be type-type targets (drug-drug)?
• How will the various priorities be set and who will do that? If funders of health care fund the studies, is that evidence of conflict of interest? Likewise, if product or service companies fund the studies, is that evidence of conflict of interest?
• Should ‘hidden costs,’ (e.g., economic and consequences for caregivers) be accounted for in the selection of priorities or are direct medical costs the only interest?

Evidence-type related policy questions:

• Will some types of evidence be preferred over others?
• Should some types of evidence be disallowed?
• Will cross-type comparisons be allowable?
• Since some evidence involves self-report on the part of patients or clinicians, how will accuracy be assured?

Evidence hierarchy-related policy questions:

• Will there be a preferred hierarchy of evidence?
• How much evidence is required? What number of studies and quality of studies is required?
• Must all CER studies account for age, gender, racial, ethnic and health system diversity?
• Since few studies do account for all those distinctions, what provisions will be made for patients who are in those groups if decisions are made as a result?

Use-related policy questions:

• How will the results be used?
• Can results be used to create changes in market entry or payment for products and services?
• If other agencies (e.g., FDA) have approved products and labels, can CER studies be used to create changes in those regulatory rulings?

Communication-method related policy questions:

• How will the results be communicated? By whom? In what timeframe?
• What requirements will there be for updating CER results and for rescinding those published in error, in unclear ways or prematurely?
• What provisions will be made to account for low health literacy levels and diverse cultural and language groups?
• Do communicators have a responsibility to monitor errors in ‘downstream’ communications and misinterpretation of results?
• Does the communicator of the CER study ‘own’ the information? For example, if a professional society is selected as the principal communicator of the evidence in their area of clinical expertise, does it ‘own’ the published information? For areas where more than one professional society serves a field, how would the most appropriate society selection be accomplished?

Implementation- and outcome-related policy questions:

• $1.1B is hardly sufficient to implement CER. How will adequate funds be secured? Will CER-related user fees be imposed on products and services entering the market? Can private plans or payers supplement funding? Will provider types pay user fees?
• What is the reasonable timeframe for implementing the CER results? How long does a patient, clinician, payer, or health system have to adapt to the change?
• Given contract timeframes, if CER evidence results in recommendations for more costly care (e.g., through increasing volume through improved access, or increasing intensity with higher-cost innovations), what is a reasonable timeframe for adaptation for the health system.
• If new evidence leads to a different conclusion later (as sometimes happens) is the decision-maker (e.g., an AHIP member) held harmless or must they restore payments if the patient has purchased OOP care?
• Will there be oversight of the CER process and if so, who will do that?
• What is the relationship of health care CER to other evidence-based policy making (e.g., The Council for Excellence in Government)?
• How and when will CER effectiveness overall be judged? What metrics will determine its success or failure: process measures such as the number of studies or changes in health care practices, or outcome measures such as lowering of rate of disease incidence or health cost increases?
• If CER becomes a condition of coverage for new drugs, imaging or therapeutic devices, does this unfavorably impact those innovations most needed now? Can exclusions be granted if data are not adequate for comparisons, for rare diseases, or for areas of unmet need?

I’ll dispense with ‘rare’ right away.  If by rare, we mean single gene disorders, then perhaps it is a useful designation.

If by rare, we just mean the equivalent of the US definition of orphan disease, i.e., less than 200,000 people in the US, then we should ask a few questions. In the old model of test and drug development, the ‘block buster, body count’, model, rare was a useful designation.  In a system built for BIG, then rare needed a boost.  In the new age of personalized medicine, all conditions are rare. In fact, they are usually an N of 1 after factoring in the myriad of genes involved, epigenetics, environment and so on.  As we enter new ways of dealing with common conditions, they too will be fragmented into dozens, sometimes hundreds, of rare conditions.  Thus rare and common conditions have similar challenges in that realm.  For these reasons, I recommend we lose the word ‘rare’.  I know it has a rich and abundant history in the Orphan Drug Act, but in addition to the aforementioned issues, I think siloing our thinking around disease into these social constructs of abundance of disease misses opportunities that would blossom were we to consider gene families, pathways and targets instead of incidence and prevalence.

Let’s move then to single gene disorders.  Comparative effectiveness would have to go on unemployment if it depended on single gene disorders for its first tasks.  Most single gene disorders do not have a treatment, let alone several.  And once one is developed, it is hard for a second one to be developed given the lack of financial incentives in the old paradigm.  Perhaps a first step in comparative effectiveness for single gene disorders is creation of ANY treatment for these conditions.

On to genetic conditions.  I think genetic conditions have already been spoken for in all of the preceding posts – because all disease is a mix of genes and environment, and so all of the conditions spoke about, either explicitly or implicitly, are genetic to some extent.  That said, I believe genetic diseases, and genomic signatures of attributes of disease, like tumors, offer ways to quantitatively measure expression thereby offering a new level of scientific scrutiny for disease.  While most genetically and genomically authored tests and treatments are nascent and have not yet been scrutinized, we are seeing some assessments of genetic tests, at least.  These are not complete comparative effectiveness studies, but they use methodology that might offer something to the field of comparative effectiveness.  If the field does use methodologies like those of EGAPP, then it will be important to do a broader assessment of the methodology before wide spread implementation.  From the website, “The project’s goal is to establish and evaluate a systematic, evidence-based process for assessing genetic tests and other applications of genomic technology in transition from research to clinical and public health practice.”  There are those who ask why almost all tests that EGAPP has assessed have failed to meet the requirements to pass into clinical practice, when some of these tests have done so in a variety of ways.  EGAPP is a good example of how hard it will be to do comparative effectiveness, since its assessment (far from comparative effectiveness) is so difficult, resource and time consuming.

However, I look forward to our foray into comparative effectiveness.  I believe it is time for the practice of medicine to move from being a cottage industry.  Comparative effectiveness, coming of age in the genomic/informatics era, while we move toward individualized medicine (commonly known as personalized medicine), will be an effective tool if, in the words of the post by Randel before me:

“A fair, open, cooperative public/private process, if designed properly will enhance the information needs of patients, physicians, and scientists and eliminate wasteful and ineffective medical technologies and procedures. Implemented without a fix of the payment system, however, the fear that this may stifle access and innovation will be realized.”  If we wish to move medicine out of the cottage industry realm, reimbursement has to come too.  There are exciting months ahead of us – let’s not call each other names like rare or common, genetic or infectious, popular or unpopular.  No disease, condition, or disorder should be left standing around the edges of the dance floor while the rest are dancing.

Stay tuned to the collaborative discussion about health reform resulting from the flash mob on June 17, 2009.

Inform Health Reform

http://fastercures.blogspot.com/2009/06/fastercures-joins-healthcare-advocates.html

The medical device industry has legitimate reason to worry from the increasing banter of politicians and inexperienced policy makers suggesting that comparative effectiveness controlled by a new government agency will be the silver bullet to manage unbridled utilization of medical interventions. Those experienced in device trial design and commercialization strategies for devices know that the struggle to move new innovation to the patient already takes years driven by inconsistent and irregular evaluative processes imposed by technology assessment authorities in some 3000 private payer health plans, individual hospital technology assessment groups, state Medicaid coverage entities, and Medicare local and national coverage processes. Adding another evaluative process, an entity to conduct comparative evidence research, rightly gives technology manufacturers who are currently subject to multiple assessments reason to question the true utility of another over-arching authority.

To seriously understand why and how procedures are or a technology is properly used (and is it cost-effective?) one must examine how technology use (or underuse) is linked to the payment process. Few policy makers understand the complicated payment system for medical technology that rewards doctors for the most acute, lengthy, or complex procedures performed in the highest priced site of service. Until we correct the arcane formulas that punish any technological advance that is simpler, more efficient, and delinked from physician time, any “comparative effectiveness” study is irrelevant. To recoup the extraordinary costs of development, manufacturers and physicians often have no choice but to seek fair payment through complicated coding processes that are completely disassociated from the true value of a device or procedure.

Innovators need a crystal ball to commercialize. The investor community, who fuels the pipeline of great new technological advances, has serious concerns about how the new comparative effectiveness entity may affect the future, especially the amount of investment it will take to bring something promising to commercialization. New investors, particularly private equity and hedge funds, are likely to severely curtail device investing due to the uncertainty of the expected increased development costs or delays to market.

So, Is comparative effectiveness a rational approach to managing utilization and costs?

Indeed, in principle, we need more and improved information to ensure we are wisely using resources. Randomized controlled trials (the foundation of comparative effectiveness research) have a role in large target populations, where making the wrong recommendation is high. In addition, it is important to model the risk and potential consequences of making the wrong recommendations. Failure to develop a rigorous, systematic approach to evaluating tests and interventions can lead to mistakes—good tests for instance may fail to be adopted, and bad tests may be the norm. Be wary of the manufacturers that argue RCT’s are not feasible under most circumstances. Nonetheless, we need a new paradigm for evaluation that is transparent, independent, rigorous and scalable.

The era of “trust me” science is over. We must more directly rely on the good science and studies generated by the FDA—the pre-IDE process—the very important and time-tested process – and acknowledged as valuable by all parties. Use new study approaches developed at the FDA to inform decision making and increase the rigor and scalability of these methods and apply to “comparative effectiveness” research.

In the words of Henry Waxman, Chairman of the House Energy and Commerce Committee, “We need to compare whether some of these new ideas are really advances or more costly alternatives to what we know will work”. Medical innovators with products that improve patients’ lives passionately embrace proving their worth.

A fair, open, cooperative public/private process, if designed properly will enhance the information needs of patients, physicians, and scientists and eliminate wasteful and ineffective medical technologies and procedures. Implemented without a fix of the payment system, however, the fear that this may stifle access and innovation will be realized.

The first decision was how to continue care. Should we try to coordinate outpatient care through the hospital, or through independent practitioners? Should we sacrifice our savings by spending a lot of money to extend his inpatient time at the hospital or transfer to another less costly one nearby? Should we sacrifice our time together and support of local family and friends to send him out of town to the state’s only comprehensive rehab facility run by the department of vocational rehabilitation services a few hours away?

In my professional life, and intellectually, I strongly supported community-based care. My gut told me that Paul needed to stay connected in town, and find a way to make it work from home. My heart didn’t want us to be separated. I became Paul’s “case coordinator” and orchestrated his weekly therapy schedule, periodic doctor’s visits, paperwork, prescriptions, equipment, home modifications, a daytime driver/companion/homework helper (since I continued to work full time), vocational rehab assessments, contact with his employer, and many of the chores Paul had handled—taking care of our finances, among others.

This was twenty years ago. At the time, AHRQ’s predecessor agency had the ambitious goal of writing clinical practice guidelines for major conditions affecting Medicare’s budget. Cataract surgery and treatment of benign prostate enlargement were at the top of the list. Post-stroke rehabilitation made it into the mix, and Paul and I testified during a public hearing. We also coordinated testimony by speech and physical therapists to talk about the need to clinically recognize that stroke survivors – like Paul – could continue to make progress many months, indeed years, after their stroke.

These guidelines are in the archives at AHRQ. A few years ago, the Department of Veterans Affairs developed a set of post-stroke rehabilitation guidelines. I have seldom, if ever seen these guidelines provided to survivors and their families.

I believe that for comparative effectiveness research (CER) to be successful, meaningful public outreach is needed to get the information into the hands of the patients and their families. CER needs to provide advice for real life decisions in real time. Studies must be designed with the patient in mind. Myrl Weinberg, President of the National Health Council, said it best:

“Comparative effectiveness research should supply us with good evidence and data about what works and what doesn’t. However, it should not be just about one product against another, or treatment process, or combination thereof. We also need to look at how different delivery systems can be compared.” www.nationalhealthcouncil.org

Evidence-based public health and medicine strategies are necessary to decrease variation of service delivery that impacts and rations care to Latinos, especially in our poor neighborhoods. Medical treatment should be based on comparative effectiveness value of treatment strategies that produce the greatest benefit for the Hispanic community at the lowest cost. We recognize that comparative effectiveness research is about value in health care. We also heed the concerns of those who have warned to beware of a “one size fits all” approach that could decrease access to treatments for minority patients. However, NHMA believes that comparative effectiveness research will add to the body of knowledge for reducing health disparities for 1) physicians to use to improve quality care for patients; as well as 2) for administrators to use to improve health systems for delivery in following priority areas:

1. Cultural competence and health literacy research in order to ultimately change behaviors and improve lifestyle in our communities
2. Effective ways of communicating with Hispanic patients and their families
3. Knowledge about health disparities interventions between hospital systems and clinics that have longstanding experience with Hispanic physicians and their patients
4. Innovative research targeted to Hispanic patients and their families
5. Integrated case that is outcomes based – and with mental health and oral health as well as physical health

So what’s the real issue here? Better yet, is there a way to bridge the gap between Western and Eastern philosophies so that the constituent that matters most in this paradigm — the patient — wins?

I believe that when it comes to comparative effectiveness research (CER, i.e. the efficacy/superiority of one drug or modality compared to another), the heart of the West vs. East battle is two-fold and until we find ways to overcome philosophical barriers, never the twain shall meet.

First, we must examine the funding factor. Notably, most Western studies have been and continue to be privately funded and simply fade away with little fanfare if findings are negative or inconclusive. Conversely, a majority of studies that examine “unconventional” or alternative treatments have had the taxpayers footing the bill. Consequently, let’s ask what we can do to engage institutional and pharmaceutical interests so that the funding conundrum is more equitable?

Second, (and more importantly) are Western researchers attempting to fit a square peg into a round hole? Does ‘one size fits all’ work? Eastern research has long been based on an inductive method that relies on direct observation of the individual and his/her relationship to environmental insults. On the other hand, Western research is reductive (or deductive) with general observations evolving into a statistical design that leads to certain conclusions. Although there has been a movement within the Eastern research community to incorporate traditional Western methodologies (e.g. control groups, randomization) one must wonder if by doing so (and thereby eliminating the subjective element that has driven data collection for centuries) the modality under investigation becomes diluted in terms of quality of practice?

Rather than screaming ‘foul” and “nonsense,” shouldn’t we be encouraging innovation in scientific methodology and CER in ways that integrate Eastern inductive approaches into Western reductive strategies so that the researchers can truly measure efficacy? A new paradigm is a win-win for all.

Since it is accepted knowledge that women and minorities were not, and are still not, to the degree they should be, included in clinical trials, there is much we are learning and still do not know about sex and ethnic differences in terms of prevention, diagnosis and treatment. My concern with CER, therefore, is how differences in effectiveness and treatment will be determined. Several genetic, hormonal, environmental factors influence health and disease in particularly different ways in women and men. Because of that, CER must study both men AND women and analyze fully any sex based difference in disease prevalence, treatment options and procedures. Those decisions must correlate to real world experiences.

In January, I sent a letter to Senator Tom Harkin that outlines the Society’s concerns and offers suggestions and recommendations.

CER decisions must be clinically relevant to decisions made by health care professionals and patients and that to achieve this, patients must be provided a voice in the health care decision-making and determination process.

The research results must avoid creating unintended access barriers, coverage denials, or arbitrary dollar thresholds that can arise through centralized cost effectiveness determinations. By focusing on gaps in clinical knowledge the research findings may improve the quality and ultimately, the value of health care.

I am encouraged that most recently there has been attention to this issue and that many of the concerns raised by the Society and other groups are being discussed and in some pieces of legislation are addressed. However, the devil is always in the details and there are several legislative proposals out there and it is not clear which one or which parts will prevail and when and by whom these decisions will ultimately be made.

As an organization whose mission is to improve the health of all women through advocacy, research and education, we will keep a watchful eye on this and other issues that may have negative consequences for women in this health care reform debate.

After years of stops and starts when it comes to healthcare reform, it appears that we are now moving forward at lightning speed. Perhaps so fast that we are trying to change a complex system without the required due diligence needed to make sure that we preserve what works. It has always been the conventional wisdom of most policy makers that true reform needs to be done incrementally, not in one giant overhaul. The growing number of Americans without access to healthcare has increased the urgency to “do something.” Although many are frustrated with what has been perceived as “all talk and no action”, pushing for health reform at ANY cost is not necessarily the answer either. The projected price tag to overhaul the system—$1 to 1.6 trillion dollars—is staggering. And, frankly, the $1 trillion dollar question is no longer “what do we need to change to make it better” but “how are we going to pay for it?” So while we are busy talking about everything we want to add to the system, the strongest undercurrent on the Hill right now is what needs to be taken away in order to pay for everything.

Medical imaging, for example, is one of many “pay-fors” currently on the table. The Obama Administration has proposed that Health and Human Services (HHS) base reimbursements for advanced imaging services in non-hospital settings on the assumption that physicians operate imaging equipment 95% of the time that the office or freestanding imaging center is open . Because of the way the formula is calculated, this proposed change will drastically cut payments for services already significantly impacted by reductions in reimbursements from several regulatory and policy changes, including the Deficit Reduction Act of 2006. The Administration has focused its proposal on one data point in an extraordinarily complex formula and did not consider other factors such as the way CMS maintains the budget neutrality of the Physician Fee Schedule (PFS) and the way it calculates payments for overhead and indirect costs for PFS services. All of these factors, when viewed as a whole, actually undervalue imaging services, instead of overpaying as assumed by the Administration.

As pointed out by the Access to Medical Imaging Coalition, the President’s proposal is similar to past ones advanced by the Medicare Payment Advisory Commission (MedPAC) which were based on a survey that relied on data from only six urban medical imaging centers. Also, according to AMIC, the methodology used by MedPAC to make its utilization assumptions did not account for the health or age of the patient – both important factors accounting for patient preparation time – the single biggest determinant affecting the length of an imaging appointment, and ultimately utilization rates. Denying providers adequate payments for the services they provide may account for some short-term savings to Medicare, but it ultimately could result in access problems for Medicare beneficiaries, especially in rural areas.

There is no argument that there is waste in our current healthcare system. We need to change the way we deliver and pay for healthcare in this country. But cutting payments for valuable services is not the way to fund health reform. We must focus on innovation that increases value by improving care for patients and helps realize substantial savings by enabling healthcare professionals to deliver more efficient, coordinated care. By focusing on patients and care providers, we can work together to advance healthcare and drive for goals like better diagnosis, more appropriate treatment, faster patient recovery and more effective management of long-term health—all of which can help drive down the cost of providing care. Right now we are trying to chip away at an antiquated payment system by cutting payments and containing services, instead of really focusing on how to change that system to better reflect the way healthcare can be delivered today. We have a great opportunity right now to really improve our healthcare system – let’s slow down a bit to make sure we do it right.

• Liz Scherer, Health Reporter & Creator Flashfree blog
• Nancy Singer, JD, President, Compliance-Alliance
• Sally Greenberg, JD, Executive Director, National Consumers League
• Santi Bhagat, MD, Founder, Physician–Parent Caregivers (Focus on chronically ill children and young adults)
• Val Jones, MD, Medical Blogger and CEO, Better Health

To learn more about these dynamic women, check out their bios.