Fricking Brilliant.via Neil Versel
*This blog post was originally published at Movin' Meat*
Fricking Brilliant.via Neil Versel
*This blog post was originally published at Movin' Meat*
When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.
What Is Comparative Clinical Effectiveness Research?
The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:
“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”
Any mention of “comparative cost effectiveness” or value-based language is notably absent.
How Does It Work?
The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).
The budget for the CCER will be divvied up as follows:
400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ
Here is a quote from the ARRA bill, discussing the mechanics of CCER:
“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”
A Game-Changer For Pharma, Medical Technology, and Biotech
There is no doubt that CCER stands to radically change how industry does business. I anticipate that industry will develop their own internal CCER teams, and begin the process of comparing their new product (to others currently available) as early as phase 3 clinical trials. By and large, that’s probably a good thing – though there are potential unintended consequences that deserve mention.
While it’s appropriate for drug, device, and equipment manufacturers to consider whether or not their new product actually contributes something new/better to our current cadre of treatment options, there will be clear winners and losers in this game. And when companies lose, we lose companies. That’s generally not good for the economy. Manufacturers without diversified product lines are more likely to go out of business – and it will become more difficult for new players to enter the marketplace.
Although comparative clinical effectiveness research is distinct from comparative cost effectiveness research – it is likely that payers will use CCER to build their formularies. This means that even though the government (at this point in time) is not mandating coverage decisions based on CCER, health insurers are going to be using the information liberally to justify coverage preferences and even potential denials of coverage.
There’s also the question of stifling innovation. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.
As Dr. Rich argues in his excellent blog: healthcare rationing is inevitable – but it’s more ethical to do it overtly than covertly. I would also like to suggest that insofar as physicians can be enlisted to translate CCER for patients (rather than being handed down inflexible rules from on high) and help them make the best decision for them – that would be even better. The inflexibility of national decisions about healthcare rationing does make me nervous.
What’s Good For The Geese Isn’t Necessarily Good For The Goose
First of all, most key healthcare stakeholders would like to be able to compare efficacy of one treatment option over another. Informed decision-making is hard to do when head-to-head studies are simply not available for most treatment options.
However, population-based conclusions do not always provide a clear “best choice” for individual patients. Individual genetic differences, allergy profiles, complicated drug regimens, unique constellations of diseases, socioeconomic factors, and psychological issues all influence clinical decision-making.
Dr. Nancy Nielsen recently voiced concern about CCER at the Medicare Policy Summit. She said that the AMA’s position is that CCER is for information purposes, not for coverage decisions. CCER’s goal is to help patients make informed choices, not limit their choices. I’m afraid the horse may have already left the barn on that one – but I agree with Dr. Nielsen’s sentiment. It would be wonderful if CCER could remain in its supportive role for shared physician-patient informed decision-making. My fervent wish is that in doing the right thing by the geese, we don’t kill off the occasional goose. Physicians need the flexibility to make exceptions when necessary for their patients.
A certain degree of hysteria related to CCER has recently wafted up through the hallowed halls of government. Are republicans overreacting to the bill? Maybe – though the bill doesn’t include any provisions for using CCER to mandate coverage decisions or ration care, it seems that Pete Stark has made it clear that he’d like the FCC to “direct medicine” which does kind of send a shiver down my physician spine, and provides some insight into what some democrats are hoping to accomplish with CCER – laying the foundation for future government involvement in the diagnosis and treatment of patients.
Also one particular congressional report is proving helpful in “reading the tea leaves” regarding the democrats’ plan for CCER. In describing the comparative effectiveness provision, the report states that items, procedures, and interventions “that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”
While congressional reports are not binding, they do give an indication of intent.
The bottom line is that though CCER is not supposed to be used for “cost effectiveness” decisions – there’s no policy in place to protect that from happening.
Information about the comparative clinical effectiveness of treatment options is critical for the practice of evidence based medicine. Such information supports informed decision-making, and could be the single most important strategy for reducing the use of wasteful or ineffective therapies in healthcare.
On the other hand, CCER will certainly have some negative consequences, both anticipated and unanticipated. When “cost effectiveness” conclusions are drawn from clinical effectiveness data, rationing ensues, patient choices are limited, people lose their jobs, and some companies go out of business. As a recent article in the New England Journal of Medicine points out, “saying no isn’t nice.” I greet this 1.1 billion dollar initiative with muted enthusiasm.
In my research for this blog post I came across some interesting quotes. I thought I’d add them here for your consideration:
And before you tell me we need such bills in order to be more scientific, take a minute and ask yourself just how scientific you think the government will be when it applies cost-cutting measures to medicine. The congress is certainly a hot-bed of evidence-based legislation, isn’t it?
When things go wrong, which of course they will, we reach for 2 tools to try to fix them: rules, and incentives. We see this at work in our response to the current financial crisis – but the truth is that neither rules nor incentives are enough to do the job.
When we turn increasingly to rules and incentives, they may make things better in the short run but they create a downward spiral that makes them worse in the long run. Moral skill is chipped away by an over reliance on rules that deprive us of the opportunity to improvise and learn from our improvisations, and moral will is undermined by an incessant appeal to incentives that destroy our desire to do the right thing.
Without intending it, by appealing to rules and incentives we are engaging in a war on wisdom.
Don’t get me wrong, we need rules. Most Jazz musicians need some notes on the page, and we need more rules for the bankers, God knows. But too many rules prevent jazz musicians from improvising and as a result, they lose their gifts – or worse, they stop playing altogether.
We need incentives – people have to make a living. But over-reliance on incentives demoralizes professional activity. It causes people who engage in that activity to lose morale, and it causes the activity itself to lose morality.
Together the Department of Defense and the Department of Veterans Affairs have the largest and most advanced IT infrastructures in US healthcare. As the Obama administration ramps up funding for electronic medical records and other IT initiatives, one might ask what the public and private sectors can learn from the military IT systems (aka AHLTA and VISTA).
I interviewed Dr. Jeff Gruen about the upcoming Military Health Summit at the World Health Care Congress, April 14-16 in Washington, DC. Jeff is Head of the Global Healthcare Practice at PRTM, a management consulting firm and a Chairman of the Military Health Summit.
You may listen to our conversation by clicking the arrow button, or read a summary of our conversation below.
Dr. Val: To set the stage, tell me a little bit about the World Health Care Congress, and what the Military Health Summit hopes to achieve.
Dr. Gruen: This is the 6th annual World Healthcare Congress (WHC), and the first year for the Military Health Summit. We expect 1500 to 2000 participants – the WHC is the premiere event for healthcare services and the healthcare system at large. It brings together people from across all sectors of healthcare and in addition to the general summit events we have this exciting Military Health Summit track.
Dr. Val: What does the healthcare system at large have to learn from the military health system?
Dr. Gruen: Three things: first, we can use the military health system as a case study for IT initiatives, since they’ve already achieved broad adoption of an EMR. It’s not perfect, but it’s used widely and is getting better. The DOD and the VA are working hard to make their systems interoperable. Second, because the military health system is both a payer and a provider, it serves as a wonderful laboratory for inventing new ways of delivering care. Realigning incentives between inpatient and outpatient care or primary and specialty care can be achieved nicely in the military system, which is like a giant, international Kaiser Permanente. Third, the military has developed very advanced battlefield techniques and devices for saving lives – including telemedicine. So it’s fun to hear about these advances.
Dr. Val: How will healthcare reform impact the Military Health System – do you have any predictions based on what you’ve heard on Capitol Hill?
Dr. Gruen: It’s impossible to know exactly, but let me offer a couple of observations. First, there’s a sense of national patriotic commitment to make sure that our service men and women (and their dependents) get the very best care possible. There’s a real desire to apply the best practices from the commercial sector to the military. PRTM feels very passionate about this, especially since one of our own is currently serving in Iraq right now.
There are a few core problems in healthcare, and they all fall under the rubric of “the right care delivered in the right environment by the right provider at the right time.” These problems may be addressed with interventions including providing point of care decision support, tools that would decrease provider practice variation, and connected convergent care – the idea that we have to move from a system that is designed for acute care to one that is very good at managing chronic care. We also need to move to a system where all the data is present in a very transparent way across environments to allow us to apply the same protocols regardless of whether someone’s in the hospital, or at home, or in a nursing home. The military health system could get these systems in place in a faster and broader way than the general healthcare system.
Dr. Val: Who should attend the Military Health Summit? How do they register?
Dr. Gruen: Those who should attend include: 1) People actively involved in the Military Health system because it offers an opportunity to interact with their luminaries. 2) Anyone on the commercial side of healthcare who’d like to do work with the military 3) Anyone who is interested in health reform 4) People with a particular interest in health IT (disease management and telemedicine in particular) 5) Anyone who wants to hear about the coolest new things coming out of battlefield medicine.
To register, one need only go to the World Health Care Congress website and follow the prompts for the Military Health Summit.
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