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Rx For Medical Research

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By David Shaywitz, Stephen Friend and Eric Schadt

Most biomedical research is framed by an outdated view of disease, a linear mind-set that focuses on simple causes rather than complex relationships within dynamic systems. If we are to achieve President Obama’s audacious goal of “a cure for cancer in our time,” we must radically alter the way we think about biology and disease.

Physicians and medical researchers are traditionally taught to consider disease in terms of simple causes and isolated linear pathways. This one-gene-one-disease approach also informs the way most animal models of disease are developed. Technology readily enables researchers to engineer mice with specific molecular defects in one or a small number of genes as an experimental proxy for human disease. While some of these models are informative and reasonably predictive, most are not.

The limitations of animal models are highlighted by results emerging from powerful genomic studies of human diseases ranging from Type 2 diabetes to pancreatic cancer. For these and many other conditions, the cause is not a single defect, or even a handful of defects, but rather, combinations of hundreds of possible defects, each contributing slightly to the overall risk of disease.

Continue reading…

AHLA on the Stark Law and its Revision: a Step Towards Holistic & Ethical Reform

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By KATHLEEN M. BOOZANG

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Health reform that focuses exclusively on health care finance — that
is, how we pay for universal access to insurance coverage — will not
produce successful reform.  Reform must be holistic, with a focus on
the entire system, as well as its component parts, including whether
the system is structured to deliver the right kind of health care
services in the most appropriate setting, whether we have sufficient
quantity and kind of health care professionals and technology
geographically dispersed to provide the health care services that
people will presumably have insurance to access, and whether the system
properly incentivizes health care professionals to make decisions that
are efficient, effective, and in patients’ best interests.  This is a
massive undertaking, with a tremendous risk that important components
will be overlooked precisely because of the size of the undertaking. 
The Stark Law represents the kind of on-the-ground healthcare delivery
problems that healthcare reform must tackle.

The American Health Lawyers Association’s Public Interest Committee today released a Whitepaper entitled: “A Public Policy Discussion: Taking Measure of the Stark Law” analyzing the ” Ethics in Patient Referrals Act” (and its progeny), more commonly known collectively as the “Stark Law“, after its primary sponsor, Congressman Pete Stark,
who now counts himself among the many who believe that while the
problem the law aimed to address is real, the statute and its
multitudinous exceptions have become a nightmare.

Continue reading…

Announcement: Metropolitan College Offers Scholarship to Dana-Farber Cancer Institute Patients and Survivors

Boston University’s Metropolitan College (MET)
recently announced a scholarship for those currently in the care of Dana-Farber
Cancer Institute (DFCI) which will offer patients and survivors an opportunity
to jumpstart their educational initiatives. Starting with the Fall 2009
semester, The Boston University Metropolitan
College Dana-Farber Cancer Institute Scholarship will enable
patients to either begin or continue their undergraduate studies and resume
their interaction with the education community while working toward future
personal and professional goals. The scholarship is offered to any current or
recent (within 18 months) DFCI patient toward any full-time, part-time, or
non-degree MET classroom program at the undergraduate level.

Thus far, MET has raised over $25,000 in scholarship
funds for the program and is working to engage the local community in an effort
to fund the program for years to come.  Donations can be made through the
scholarship website: bu.edu/met/scholarship/dfci/.

And the real reason health reform matters

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By Matthew Holt

And in case you’d forgotten what the health care reform battle is really about, here’s video from Reuters about an open air clinic for the uninsured in Virginia… 

A Practicing Doctor’s Prescription for Health Care Reform

 By JORDAN SHLAIN

Our national healthcare system needs a ‘step-change’, not incremental change. We are facing a vast and complex problem. Let’s use it as an opportunity; rather than blaming our nation’s health problems solely on corporations, providers, insurers, or the government, let’s also think constructively about individual behavior and incentives.

Why do we stop at a red light? Why do we pay our grocery bill when we check out? Why are we compelled to ‘service’ our car when the red indicator light starts to flash? The simple answer is that if we don’t we know we will incur a penalty. Either we have to pay to get things fixed later, or we pay extra financial fees, or we get nasty looks from our neighbors.

A behavioral sociologist would offer a more complex answer: such contracts form the heart of a civic society. We behave in accordance with laws and a sense of civic duty (we abide traffic signals) because we understand that preserving the community is ultimately self-preserving. We act in ways consistent with financial incentives, or disincentives (we service our cars) because it is immediately self-preserving.Continue reading…

Report Identifies Five Key Challenges to Health Information Exchange

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By SHEERA ROSENFELD

The government’s $19 billion investment
in health information technology is a pivotal catalyst in our pursuit
of a smart, fully interconnected health information system.  However,
as we wait for this investment to take root, there are several immediate
issues the Department of Health and Human Services and the Office of
the National Coordinator of HIT must address.

In a recent paper for the Federation
of American Hospitals, my Avalere colleagues and I distilled the following
five concrete issues that officials must tackle to ensure we create
an HIT infrastructure that fulfills its promise of improved access,
quality, and value.

Continue reading…

Commentology

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Anonymous Reader Murry Ferris writes in:

I am a 65 year old retired ad exec and also an insulin-dependent
diabetic.  I have other medical complications, but taking care of the
diabetes is the big one.

Every day I test my blood glucose
levels as many as ten times.  A box of test strips retails for between
$40-$60 and lasts less than a week…. you do the math.  In case you
were not aware, your glucose levels are in a state of constant flux
depending on your intake of food and exercise.   Bottom line, keep your
levels, "level" and you'll lead a more normal life.

Now with all the
talk about raising taxes to pay for the rising cost of health care I
hear absolutely no discussion about reining in the unjustified
increases of medical supplies and equipment.   Just ten years ago I
could buy test strips for $10.   Now they come in slick PVC canisters,
wrapped in four-color labels and packed in plush slick cardboard boxes
stuffed with layers of "instructions" and phony code strips.   Remember
all you need do is stick your finger an put a drop of blood on the end
of the strip.   How hard is that?

So, for $2,600 a year I get to
stick my finger ten times daily, throw a pile of unread and expensive
packaging in the trash, and pay increasingly higher health care
costs.

Finally, A Reasonable Plan for Certification of EHR Technologies

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By DAVID C. KIBBE and BRIAN KLEPPER

A caution to readers: This post is about methods for certifying Electronic Health Record (EHR) technologies used by physicians, medical practices, and hospitals who hope to qualify for federal incentive payments under the so-called HITECH portion of the American Recovery and Reinvestment Act (ARRA). It may not be as critical as the larger health care reform effort or as entertaining as Sarah Palin, but it WILL matter to hundreds of thousands of physicians, influencing how difficult or easily those in small and medium size practices acquire health IT. And indirectly for the foreseeable future, it could affect millions of American patients, their ability to securely access their medical records, and the safety, quality, and the cost of  medical care.

Three weeks ago, on July 14-15, 2009, the ONC’s Health IT Policy Committee held hearings in DC to review and consider changes to CCHIT’s current certification process. The Policy Committee is one of two panels formed to advise the new National Coordinator for Health IT, David Blumenthal. In a session that was a model of open-mindedness and balance, the Committee heard from all perspectives: vendors, standards organizations, physician groups, and many others.

And then, on July 16, they released their final recommendations on what is now referred to as “HHS Certification.” The effects of their recommendations – these are available online and should be read in their entirety to grasp their extent – are potentially monumental, and could very positively change health IT for the foreseeable future.

At the heart of these hearings was the issue of who will define the certification criteria and who will evaluate vendors’ products. Among many others, we have voiced concerns that the Certification Commission for Health Information Technology (CCHIT), the body currently contracted by HHS to perform EHR certification, has been partial to traditional health IT vendors in defining the certification criteria, and in the ways certification is carried out, and thereby able to inhibit innovation in this industry sector. Despite its leaders’ claims that the certification process has been developed using an open framework, CCHT’s obvious ties to the old guard IT vendors have created an overwhelming appearance of conflict of interest. That appearance has not been refuted by CCHIT’s resistance to and delays in implementing interoperability standards, or by its focus on features and functions over safety, security, and standards compliance.

In the hearings that led to the recommendations, longtime IT watchers were treated to some extraordinary commentary, much of which dramatically undermined CCHIT’s position.

“HHS Certification means that a system is able to achieve government requirements for security, privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects…HHS Certification is not intended to be viewed as a ‘seal of approval’ or an indication of the benefits of one system over another.”

In other words, as the definition of Meaningful Use is now tied to specific quality and safety improvements and cost savings that result from health IT — among them e-Prescribing, quality and cost reporting, data exchange for care coordination, and patient access to summary health data — HHS Certification will closely follow. Rather than pertain to an EHR’s long list of features and functions, some of which have nothing to do with Meaningful Use, certification will be focused on each IT system’s ability to enable practices and hospitals to collect, store, and exchange health data securely.

Who Determines the Certification Criteria

The Office of the National Coordinator – not CCHIT – would determine certification criteria, which “should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives.” As regulator, funder for this project, and a major purchaser of health services, the government, not users or vendors, will now determine HHS’ Certification criteria.

A New Emphasis on Interoperability

“Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit.” That is, functions/features criteria will be broadly defined, but there will be a greater focus in the future on the specifics associated with bringing about straightforward data exchange.

Multiple Certifying Organizations

ONC would develop an accreditation process and select an organization to accredit certifying organizations, then allow multiple organizations to perform certification testing. In other words, the Committee recommended that CCHIT’s monopoly end.

Third Party Validation

The “Validation” process would be redefined to prove that an EHR technology properly implemented and used by physician or hospital can perform the requirements of Meaningful Use. Self-attestation, along with reporting and audits performed by a Third Party, could be used to monitor the validation program.

Broader Interpretation of HHS Certification

HHS Certification would be broadly interpreted to include open source, modular, and non-vendor EHR and PHR technologies and their components.

These bold, forward-thinking proposals from the HIT Policy Committee have not been accepted yet. But in our opinion they should be. These measures would encourage new technologies to enter the market for physician medical practices seeking EHR technology, and wrest control away from the legacy health IT vendors that have maintained barriers and delayed adoption, so you can be sure that the old guard players are doing everything possible to have them rejected.

But these are hugely progressive steps in the right direction, toward allowing HIT to enable improvements in care and cost efficiencies that would be in the best interests of users and the public at large. If implemented, the changes recommended by the HIT Policy Committee would create greater choice, more standardization, lower price, less interruption of the practices — as well as a check from CMS or Medicaid each year to help smooth the implementation, starting in 2011.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies. Brian Klepper PhD is a health care market analyst. Their collected collaborative columns may be found here.

The Case for Taxing “Cadillac” Healthcare Coverage

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By CLAYTON MCWHORTERClaytonMcWhorter1

With President Obama’s plan for healthcare reform recently being dealt a tough blow by the Congressional Budget Office over soaring federal deficit projections, I am beginning to wonder if it is time for the President to modify his stance against taxing “Cadillac” healthcare coverage offered by employers.  It’s no secret what Senator Max Baucus, the Democratic Chairman of the Senate Finance Committee and one of the most powerful people in the healthcare reform debate, thinks President Obama should do.  Senator Baucus has been a vocal advocate of taxing healthcare benefits.  He recently told reporters that taxing employer-sponsored benefits is “the best way to raise money for an overhaul of the healthcare system.”  He has also been somewhat critical of President Obama’s decision to not tax healthcare benefits by saying, “Basically, the president is not helping us.”

In recent days, the Congressional Budget Office (CBO) estimated that the House Democratic legislation would add more than $230 billion to the federal budget deficit.  On the Senate side, Senator Baucus, who has been working with Senate leaders to formulate another plan, has pointed out the difficulties his committee has had with funding reform without some other type of significant revenue.

One way that raises enough revenue to cover well over the $230 billion figure projected by the CBO is through taxing employer-sponsored health benefits.  The nonpartisan Joint Committee on Taxation estimates that taxing employer-sponsored benefits above the value of the Federal Employees Health Benefits Plan (FEHBP), adjusted for inflation, would generate nearly $420 billion over the next 10 years, which would easily fund the difference in the budget gap.  Many other estimates place this number considerably higher.  Furthermore, many experts believe that this policy is a key way to reduce costs, because tax-free benefits encourage more spending on health care.

About 18 months ago, as I worked with a committee that I chaired in Tennessee called the Rolling Hills Group to create a structural model for national healthcare reform, I ran into the same problem that President Obama is facing today.  How do you pay for reform?  After considering several options on how to finance universal insurance, our group kept coming back to the same, single solution – the same one that Senator Baucus is a proponent of, taxing “Cadillac” healthcare benefits.

Under our proposal, we created a basic level of coverage similar to what members of Congress are offered today, known as the FEHBP standard option plan.  This plan is very generous and has been successful in holding down costs compared to other plans.  In order to make sure our plan was budget neutral, we decided we would no longer allow what we consider “Cadillac” coverage benefits to be tax free.  For example, in 2009, under our proposal, any individual policy worth more than $5,871.84 or any family policy worth more than $13,445.64 would be subject to a tax.  Anything less than this amount would be tax free.  For individuals, any amount above the base value of the plan would be considered income.  While for companies, any amount above the base value of the plan would no longer be deductible as a business expense.

We had this idea vetted by the Moran Company, who said that our plan is actuarially sound and budget neutral for the federal government once fully phased in.  Just as a note, in our plan we also derive revenue from Disproportionate Share Payments (DSH) and hold down up front costs by phasing in the reform over a 10 year period.  Disproportionate Share Payments is funding that hospitals receive for treating indigent populations.  Thus, it is reasonable to decrease DSH payments as the uninsured population decreases.

If taxing “Cadillac” coverage raises enough revenue to make healthcare reform budget neutral and encourages less spending on healthcare, why has such an attractive option for reform been pulled off the table amidst the President’s insistence on urgency?  As is usually the case with healthcare reform, the answer may be in the politics.

In recent weeks, several articles have outlined strong opposition by labor unions to the taxation of their healthcare benefits. In the Washington Post, the AFL-CIO stated its opposition to taxing “Cadillac” coverage.  Michael Sullivan, the President of the Sheet Metal Workers Union, has also adamantly stated his opposition to taxing healthcare benefits by saying, “Any bill that taxes health care benefits is dead on arrival.” Understanding these political difficulties, but still seeing the taxing of benefits as a viable way forward, lawmakers have demonstrated that there may be room for compromise.  Senator Baucus himself has hinted that he might consider grandfathering in the taxation of health benefits that are part of a collective-bargaining agreement, which would allow union plans to remain tax-free until new contracts can be negotiated.

Labor unions are not the only ones who have come out against the taxation of “Cadillac” plans, as many large corporations have exhibited significant opposition as well.  However, if healthcare reform is going to happen this year, Congress and President Obama may want to take a harder look at taxing “Cadillac” healthcare benefits as a means of raising revenue and achieving their other healthcare priorities.  I think it is fair to say that if Obama explains to the American people that the Government is only going tax the most lavish of benefits, he might find greater support from the American public for the change in health care that he promised to bring and that this nation so desperately needs.

Clayton McWhorter is a former President and chairman of HCA and current chairman of Clayton Associates and the Rolling Hills Group.  He is the founder of the group SHOUTAmerica, a Nashville based organization that uses social networking and other internet-based technologies to push for change in the healthcare system.

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