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:

Read the rest of this entry »

Today’s guest post by Julie Murchinson, Executive Director, Health 2.0 Accelerator, is the final installment in the Disruptive Women Comparative Effectiveness Research smackdown.

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? Read the rest of this entry »

I don’t think we in health policy really understand how complex our systems are and what manner of challenges – some of which we created – present themselves in clinical care.

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.

Read the rest of this entry »

I’ve been tasked with presenting the genetic and rare disease perspective on comparative effectiveness.

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 simular 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 afore mentioned issues, I think siloing our thinking around disease into these social constructs of abundance of disease misses opportunities that would blossum 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 Top headline of FDA News Device Daily today read, “Comparative Effectiveness Research has Benefits, Risks Experts Say”. Why would Device Daily consider comparative effectiveness to be risky? Many obvious concerns come to mind. There are distinct risks that the process imposed on the device industry may stifle growth. Worries abound related to the direction policy makers may employ such as when studies will be required (e.g., at the early stages of development, or later in the cycle of real-world experience), how studies will be conducted (e.g., by the government or a public/private entity), who will determine the type, scope, design and rationale for conducting such studies, what the studies will be used for (e.g., to restrict coverage, to control access).

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.