Tag: Uncategorized

Pharma vs. Devices – FDA, Supreme Court and Liability Whiplash

Whiplash. I don’t know what else to call it when the US Supreme Court does a near 180° reversal on a decision from just a year ago on medical product liability. Consider the following…

On February 20th, 2008, the US Supreme Court ruled in favor of Medtronic in the case Riegel v. Medtronic. The case involved a cardiac catheter, which ruptured during surgery. Medtronic asserted (and the Court agreed) that, because the company had received premarket FDA approval for the device, the company was immune from suit in state courts. The prevailing argument was, in essence, that the rigor of the federal review and approval process trumped the individual’s right to seek judgment using the state courts.

Many supported the notion of keeping federally-regulated medical devices above the reach of state courts, but at the same time questioned whether the FDA was really capable of the safety rigor that the Court attributed to it.

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Op-Ed: Pathway for FOBs Should Balance Need for Competition and Need for Innovation

President Obama's first budget calls for the creation of a regulatory pathway for the creation of follow-on, or biosmiliar, biologics. This is obviously now the most high-profile call yet to move forward with a system that will provide the benefit of biotech drugs to patients who need them the most.

The biotech industry has done an outstanding effort in the last 10 years producing some of the most high-tech but also the most expensive drugs on the market. Some biotech medicines cost hundreds of thousands of dollars each year. Many of these products face no competition, because there is no legal way for a generic version of the product to get on the market. Individual patients as well as the healthcare system generally simply cannot absorb these continually rising costs.

To date, the debate over follow-on biologics has been mostly political posturing between the trade groups that represent the generic drug industry and the pioneering companies. The generic industry wants biotech companies to have only three to five years of market protection after bringing a new drug to market. The industry counters it needs up to 14 years of exclusivity to recapture its investment costs, which can reach over $1 billion for a single product.

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Another Look: The Wal-Mart and E-ClinicalWorks Deal

Portrait2The New York Times reported this week (Wal-Mart Plans to Market Digital Health Records System) that 
the company’s Sam’s Club division will bundle eClinicalWorks
electronic medical record software, Dell computers, installation,
maintenance and training to offer to small physician practices. Pricing
is about $25,000 for the first physician in an office, and $10,000 for
each subsequent physician. Annual maintenance and support costs will be
about $4,000 to $6,500 (though it doesn’t say whether that’s per
physician or per practice).

Wal-Mart says its package deal of hardware, software,
installation, maintenance and training will make the technology more
accessible and affordable, undercutting rival health information
technology suppliers by as much as half…

Dell will be responsible for installation of the computers, while
eClinicalWorks will handle software installation, training and
maintenance. Wal-Mart is using its buying power for discounts on both
the hardware and software.

This program has promise, but it isn’t revolutionary and is by no
means certain to succeed. Interestingly, the Wal-Mart PR people, who
usually send me a heads up about any new Wal-Mart move in health care,
didn’t tell me about this one. It makes me wonder what’s really going
on. There are a couple of very promising aspects of this program:

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Today’s NEJM Hospitalist Study: What’s the News?


A paper in today’s New England Journal
proves what we all know – the hospitalist field is the only thing 
growing faster than the national debt. Even though that’s not news,
this elegant biopsy of the Medicare database offers some new insights
about our field, the fastest growing specialty in medical history.

Briefly, the study used a methodology developed
by Sanjay Saint a decade ago: by examining evaluation and management
(E&M) codes submitted by general internists to Medicare, one can
determine which physicians do virtually all their E&M work in the
hospital, which have traditional general internist practices
(part-inpatient, part-outpatient), and which do virtually no inpatient
work (“ambulists” or “officists” – somebody will ultimately need to
settle on a term).

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Controlling Health Care Costs by Seduction

The past failure of insurers and care providers to control medical costs challenges the Obama health care team to redesign health care to provide broader coverage while managing costs. If the past is any guide, they will fail just as certainly as those who went before. The problem is that those working on the new health care plans do not fully understand why existing plans failed over the past 30 years. The panoply of managed care ideas; HMO’s, rationing, pre-approvals, denial of benefits, denial of service, reduction in fees have all failed to reduce medical costs. If we wish to get past these failures, we need to think about seducing those who control the costs.

The phenomenology of health care shows that medical costs are a function of fees and utilization. Fees are what we pay for a medical service. Utilization denotes the variety of services available. Almost all medical services are performed or ordered by physicians. The ever spiraling cost of medical care amply demonstrates that coercive methods used by insurers and managed care proponents against physicians have failed to bring about the desired results.

If physicians cannot be coerced into cooperating, perhaps they can be seduced.

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ARRA: A New Era for Health IT, and for CCHIT – Part 1

Mark LeavittWhen President Obama signed the American Recovery and Reinvestment Act (ARRA) into law, health IT
was catapulted into a new era.  I believe this is — and forever will be — the biggest milestone in the history of health IT.  I’d like to share my perspectives on it, but it will take several blog posts to cover such a big topic.  Today, I’ll start with a high level view of the significance of this event, and talk about some of the confusion that has resulted from the injection of so much new money – and with it, some new politics – into the world of health IT.  Then I’ll follow up with posts that delve into the details of how I believe CCHIT will need to evolve in this new environment. 

I’m personally struck by the parallels to a historical event still vivid in my memory: Project Apollo, President Kennedy’s incredible national goal of achieving manned spaceflight to the moon.

Apollo cost $22B (in 1969 dollars, now worth five times that) and took 8 years to achieve the first moonwalk.  NASA, a new government agency, spearheaded the effort, but the technology was developed by private sector contractors.

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The New Landscape of the Health Reform Debate

Bill KramerIn the recent publicity about President Obama’s budget and health reform initiative, an important issue 
has not received enough attention.  Most reporters, analysts, editorial writers and bloggers have focused on the proposed $634 billion reserve fund, the aim for universal coverage, the reduction in Medicare Advantage payments, the tax on families with incomes over $250,000, and other key features.   In the view of many Republicans and others opposed to this approach, the proposal looks like just another version of a “tax and spend” strategy to fix our health care system.  There is something different, however, and the health reform battle is moving into new terrain.

In the past, advocates of health reform focused on need to provide access to care for the uninsured.  This was (and is) a moral issue – “How can the richest nation on earth let millions of people go without access to decent health care?”  To provide universal access, however, required a lot more government spending.  This set up a conflict, because every reform proposal had a big price tag, and few politicians were willing to support a program that dramatically enlarged the federal deficit.   Many advocates believed that expanding coverage was worth it, but it faced very difficult obstacles due to concerns about the rising government debt load.

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Stimulus Modeling and Accountability

Images-1As well all prepare for the work ahead, many in healthcare are
beginning to model the potential payments and design the reporting
systems needed to account for the money spent.

I've promised to share all the Beth Israel work we're doing as it happens, so here's a near real time update.  Our CFO, Steve Fischer used the guidance from the American Hospital Association to compute BIDMC's share. You'll see that we are expecting $6.3 million because we anticipate "meaningful use of EHRs" by all our clinicians in 2011.

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The Role Speech Technology Can Play in Helping to Streamline the EHR Transition

Early adopters – the approximately 15 percent of
doctors who use an electronic health record (EHR) system successfully –
are hitting a major speed bump ahead of their peers: EHRs can slow physicians

Too much emphasis is being placed on EHR
deployment and not enough on utilization.  In the rush to
computerize patient information, per Obama’s five-year goal that all
medical records go digital, it has been assumed that once EHRs are widely
deployed, patient records will automatically be more complete and shareable, administrative
costs will be cut and that universal quality of care will be enhanced.  First,
we have to get doctors to meaningfully use the system…

In a study conducted by Fallon Clinic comparing EHR
technology used as is vs. with speech recognition technology (replacing traditional
transcription and keyboard-only control of the EHR), not only did speech
recognition prove to help doctors capture the patient encounter in more detail;
it helped to save $5,000 per doctor per year in transcription costs and generated
additional reimbursement per encounter.

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