But let me tell you, are we willing to give up that system? Are we willing to have more breast cancer deaths in the United States with this system, to get the 30 million people, which is really means only 18 million people who don’t have coverage. At a $1.8 billion, trillion dollar deficit. That’s the equation we have to ask.

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Rogers, who repeatedly mentioned that he had read the entire House health care bill, argued that the House reform legislation would allow the federal government to use the results of comparative effectiveness research to ration costly treatments.

In reality, the bill authorizes Secretary of Health and Human Services to establish a Center for Comparative Effectiveness Research to “conduct, support, and synthesize research…with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures,” but prohibits the government from applying research findings to coverage decisions. Page 524 of the legislation:

Nothing in this section shall be construed to permit the Commission or the Center to mandate coverage, reimbursement, or other policies for any public or private payer.

Of course, Rogers may have found that part of the bill to be boring. “So if you read this thousand page bill — by the way, which they gave us about 12 hours to do and it got riveting right about page 860. Fantastic! Little plot twist in there,” he joked at the event.

The roadmap for comparative effectiveness research has become much clearer and detailed these past few days with the release of two new reports. One comes from the Institute of Medicine at the National Academies and the other comes from HHS’s Federal Coordinating Committee for Comparative Effectiveness Research. The IOM released a list of 100 health topics for the Obama administration to prioritize as it spends $1.1 billion in stimulus funds dedicated to CER. More importantly, the Federal Coordinating Committee itself has stated in its report to the President and the Congress that CER should “complement the trend in medicine to develop personalized medicine,” and that it will be “an important partner in helping to bring about this new level of medical effectiveness, personalization, and innovation.” This bold vision of personalized medical innovation based on “patient-centered, pragmatic, ‘real world’ research,” clearly dwarfs the feeble criticisms of CER aired by conservatives in last week’s HELP Committee markup of the “Affordable Health Choices Act.”

While the act incorporates CER as part of its health reform agenda, there is another piece of legislation that will establish a dedicated, rigorously-organized federal Institute for CER.

Formerly known as the “Patient-Centered Outcomes Research Institute,” the creation of this federal body depends on the passage of the “Patient-Centered Outcomes Research Act,” (S. 1213) sponsored by Senators Baucus and Conrad. Upon a close reading of the bill, it is evident that the Patient-Centered Outcomes Research Institute will not just be another meaningless chunk of bureaucracy as its critics claim. The Institute’s goal will not be to simply spit out generic guidelines that your doctor must follow “or else.” Rather, the Institute has been designed to ramp up medical innovation for the common good by championing a new era of personalized medicine.

Taking a close look at the bill there is plenty of language about “evaluating and comparing the clinical effectiveness, risks, and benefits” of various tests, treatments, and devices. More importantly, the bill upholds a commitment to doing the best kind of comparative effectiveness research by making it personalized and reaching out to subpopulations. The bill charges the Institute with conducting “research and evidence synthesis that considers variations in patient subpopulations.” The bill builds upon this by later explaining what “subpopulations” means specifically:

“racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular subtypes, or quality of life preferences.” This also means that the institute will “include members of such subpopulations as subjects in the research as feasible and appropriate.”

Even more impressively, the bill kicks biomedical innovation into high gear by explicitly infusing its research with personalized, real-world considerations. The bill stipulates that CER take into account “treatment modalities that may affect research outcomes, such as the phase of the treatment modality in the innovation cycle and the impact of the skill of the operator of the treatment modality.” This basically means that the research will look at how far along a treatment is in the product development process and the skill-level of those administering the treatment. Again, these are real-world considerations that other forms of research like clinical trials often miss.

Additionally, subpopulations will not just be part of the subject pool; they will be part of the implementation process. Their representatives will be incorporated into the advisory group that will set the agenda of the Institute’s primary research. Another advisory group will devise research methodologies by including members who are experts on personalized medicine technologies like biostatisitcs and genomics. The dissemination of research findings will also “discuss findings and other considerations specific to certain subpopulations, risk factors, and comorbidities, as appropriate.”

Finally, for those who might be concerned about the intrusiveness of such an Institute, the bill also stipulates that the dissemination of research findings discuss “limitations of research;” “shall not include practice guidelines, coverage recommendations, or policy recommendations;” and would not “violate the privacy of research participants or violate any confidentiality agreements.” Indeed, far from assuming that scientific data is the infallible final word, the Institute knows its limitations, admits them, and stays within them.

Perhaps one of the most astute and intellectually honest provisions of the bill involves the usage of research findings by the Secretary of Health and Human Services. Many have feared that CER will be used to deny coverage or to tell your doctor what to do. It won’t — this is made explicit multiple times in the bill. Of course, it would not make sense to just let CER research sit there when it comes time for HHS to make Medicare coverage decisions. Thus, there are concerns that CER will be used to justify the enforcement of one-size-fits-all treatments. Once again, it won’t, and the bill states this explicitly by requiring the Secretary of HHS to consider:

“evidence and research that demonstrates or suggests a benefit of coverage with respect to a specific subpopulation of individuals, even if the evidence and findings from the comparative effectiveness research demonstrates or suggests that, on average, with respect to the general population the benefits of coverage do not exceed the harm.”

On the whole, this bill is a prime example of robust, evidence-based, scientific policymaking. In incorporates the best attributes of the scientific method and the democratic process right into the implementation of public policy. The Institute will constantly update its research in light of new methodologies and treatments, its research will be transparent, it will seek input from the public and a broad range of stakeholders like patient advocates, it will build upon existing research efforts to avoid redundancy, and submit its research to peer review. Most importantly, the Institute will respect the rights of the individual person by taking a personalized approach to CER. As Alan Garber of Stanford and Sean Tunis of the Center for Medical Technology Policy put in a recent NEJM article, “far from impeding personalized medicine, CER offers a way to hasten the discovery of the best approaches to personalization, providing more and better information with which to craft a management strategy for each individual patient.”

We get into this cost. We get into this repetitive word, “rationing”, “rationing.” It goes over very well with focus groups, but it has no rational here. If you go to page 323 of the actual bill, where it says ‘Incorporation.’ We absolutely prohibit that this, anything related to the Center For Health Outcomes, otherwise known as comparative effectiveness, that there “shall not be construed as mandates for payment, coverage, or treatment.” It is in the bill. Page 323, lines 5 through 7.

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Republicans relied on a three-part attack. One, ignore the existing language and offer redundant amendments prohibiting the comparative effectiveness center from mandating that doctors prescribe ‘the best’ treatments. Two — this is a somewhat more coherent strategy — argue that the Center for Medicare and Medicaid Services (CMS) could use the information to make coverage decisions for Medicare. And three, if the government uses the comparative research results to establish best practice guidelines, then doctors who don’t follow the guidelines but rather consider the individual needs of their patients, could be liable for malpractice claims.

But even the last two arguments fall apart on close scrutiny. The government isn’t mandating that doctors adopt the results of CER and it is not rationing care. Each patient has his or her unique needs and the ultimate decision for how to proceed should be left to the doctor and the patient. Currently, approximately one-third of all treatments have never been proven to produce better outcomes; CER would provide doctors with unbiased information about the most effective treatments, help doctors and patients make better informed decisions, and improve the quality of care.

Moreover, far from establishing one-size-fits all medicine or dictating treatments, properly conducted CER will actually promote faster adoption of personalized care. As Alan Garber of Stanford and Sean Tunis of the Center for Medical Technology Policy point out, “far from impeding personalized medicine, CER offers a way to hasten the discovery of the best approaches to personalization, providing more and better information with which to craft a management strategy for each individual patient.” The new CER council and CMS seek to preserve a personalized approach — that is, allow doctors to make decisions based on a patient’s history and individual needs — while eliminating truly ineffective treatments.

CER results are rarely black and white and no one study should serve as a final word on a coverage decision. But given the amount of unnecessary, redundant and ultimately harmful treatments, the government has an interest in informing health care providers about best practices– and this is what the legislation does and our doctors want. More efficient medicine is better medicine, and anyone who wants to prevent the system from wasting money is in the pockets of the medical industrial complex that is getting rich while we get sick.

After all, the “art of medicine,” as Coburn calls it, already relies on certain standards and practice guidelines and physicians often incorporate their knowledge of the patient and clinical experience to offer a patient-centered approach, as such only about half of the recommended guidelines are followed. Ultimately, however, doctors are not superheroes; they should not be ignoring “standard protocols” or attempting to re-enact the heroics of Fox’s HOUSE. They are currently driven by a set of professional standards and procedures, and as patients, it is in our interest to encourage providers to incorporate certain guidelines (derived from CER) into routine practice. After all, “the last thing most Americans want from this wise use of taxpayer funds is more published research gathering dust on library shelves.”

For Kyl, fear mongering about the consequences of government-takeover of health care or medical research is a part time job. He actively rallied against medical research during the stimulus debate, Kathleen Sebelius’ confirmation, and today, he took to the Senate floor to attack Democrats of seeking to “ration care”:

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Pharmaceutical representatives currently instructs doctors on the effectiveness of medications, and the industry opposes research that would lead the government to eschew coverage for ineffective or unnecessary treatments. Fewer prescriptions translate into lower profits and the industry lobbied hard to pare down the cost effectiveness language in the House and Senate versions of the stimulus bill. In fact, the pharmaceutical and biotechnology industries have donated $1,971,968 to Kyl’s career election efforts and ran ads on Kyl’s behalf in 2006. Moreover, according to recently released 2008 personal finance disclosures, Kyl invests heavily in pharmaceutical companies.

His latest effort prohibits the government from using “data obtained from the conduct of comparative effectiveness research…to deny coverage of an item or service under a Federal health care system.” The language compliments the GOP’s larger argument that Obama’s health care reform would usher in the era of European-style socialized-medicine and rationed care, but it ignores the government’s existing ability to make coverage decisions.

As Thomas Scully, the Administrator of the Centers for Medicare and Medicaid Services (CMS) from 2001-2003 pointed out in an interview with ThinkProgress, “you know, Medicare makes decisions on coverage all the time. I made decisions on coverage all the time….You got to do it the right way. But I think – I’ve always been a big fan of comparative effectiveness research if done correctly.”

In reaching coverage decisions the Center for Medicare and Medicaid Services relies on an evidence-based process, conducts internal research and consults outside assessments. Upon CMS’s request, fifteen experts on the the Medicare Evidence Development and Coverage Advisory Committee review, evaluate, and collect medical literature and technological assessments and examine the data based on effectiveness and appropriateness. Only then, does the panel of experts issue a coverage decision.

It’s unclear why Kyl and his conservative colleagues would deny Americans the fruits of scientific research. The Food and Drug Administration oversees the safety of food, drugs, and cosmetics and bans the use of harmful products. If the government can ban harmful lipstick, why can’t it deny coverage for a dangerous drug or medical devise and protect access for patients who need experimental treatments? As Peter Orszag pointed out during recent Congressional testimony:

There also are a lot of less extreme ways of guiding medical practice. For example, simply paying more for the things that work than the things that don’t….And so it doesn’t need to be a simple on-off switch.

After all, “there is no reason we cannot set up reasonable procedures, overseen by independent health professionals, to protect patients who can demonstrate a special need for a treatment that is not normally cost-effective.”

But that pay increase my be threatened by the introduction of a new public option — that could negotiate drug prices — and comparative effectiveness research that isn’t guided by an industry hand. As the Wall Street Journal reports, “to help accomplish their goals, the drug makers spent $47.4 million on lobbying in the first quarter, up 36% from a year earlier, according to company-disclosure reports filed with Congress and analyzed by the nonpartisan Center for Responsive Politics. Pfizer Inc. more than doubled its spending on lobbying in the period to $6.1 million”:

The pharmaceutical executives are using their new access to try to steer lawmakers away from measures that could reduce drug margins, pressing instead for cost reductions by hospitals and insurers.

In their meetings at the White House and on Capitol Hill, as well as in speeches and op-ed articles, industry executives and lobbyists have backed such steps as shifting insurance coverage toward prevention, which could increase sales for heart, diabetes and other drugs that patients take long term….Pfizer Inc. Chief Executive Jeffrey Kindler says he backs “comprehensive health-care reform in this country” and is willing to make compromises. But he opposes a public insurance plan except for the poor who otherwise can’t afford insurance, saying it would crowd out private insurers and take “the form of price controls” that fail to reward companies for their expensive and risky investments in drug development.

Indeed, the threat of a robust CER effort and a muscular public option have brought the pharmaceuticals industry to the table and it’s terrified of losing it’s seat. The industry heavily lobbied for input over what’s researched and how, and is now afraid that despite it’s best efforts, some of the CER money will still be spent without its input:

Thornhill, whose firm represents the Partnership to Improve Patient Care–an association funded by BIO and PhRMA and other organizations to lobby on CER–puts the chances of getting the Baucus proposal into health care reform at just 50/50. But even it if is included and signed into law this fall, he notes, a new institute won’t be set up until the end of 2010 at the earliest, with research projects beginning no earlier than 2011.

So “you have this gap between when the [stimulus] funding gets handed out until you have new framework even established,” Thornhill noted. “So its hard for us to go out and lobby to have this Conrad-Baucus entity just control the funding. The pushback is ‘What are we are going to do for two and a half years? Just sit on our hands?’”

The conference call announcing the legislation included Tony Coelho the chairman of the Partnership to Improve Patient Care (PIPC), the lobbying arms of the drug, device and biotechnology industries. The group seeks to “give industry a seat at the table when federal officials decide what to research” and during the call, Coelho emphasized the importance of a patient-centered approach to comparative effectiveness research:

I’m encouraged by inclusion of these safeguards in this bill…my concern is that cost containment will become the main goal [of research] leading to the misuse of comparative effectiveness studies to approve one size fits all polices that prevent patients from getting access to the care they need.

In January, a coalition of groups who accept money from the pharmaceutical industry sent a letter to Capitol Hill demanding “that any agencies conducting comparative effectiveness reviews be run ‘through an open and transparent process that allows for patients, providers and other stakeholders to participate equally in governance and input, starting from the research planning stage.”

The industry is interested in controlling the data, “how it is reviewed, evaluated, and whether the public and government find out about it and use it.” This is why their seat on the 21-member board is so critical. The lawmakers on the call indicated that the Governing Board would consist of 3 members from each interest group. The public, private industry, and health quality researchers would all be represented. But why should pharmaceutics companies “have a the right to veto controversial inquiries and limit the scope of the research that gets done?” As Merrill Goozner asks, “do publicly traded companies have a seat on the governing board of the Securities and Exchange Commission? Should we give Boeing and Airbus the right to determine the scope of the National Transportation Safety Board’s inquiry into airplane crashes? Does the current financial crisis suggest the banks should have more say over how they are regulated?”

Private industry should not be vetoing the decisions of health quality researchers and the government shouldn’t dictate a certain course of treatment. That should be left to the patient and her/his doctor.

But to reduce the waste in our system, the government can and should provide incentives for providers to focus on care quality. This bill, however, specifies that any research the institute produces “cannot be used to define policy guidelines or mandate any particular regiment or treatment.”

If we can’t guide providers towards adopting best policy practices, then what, after all, is the goal of comparative effectiveness research? If we’re really serious about lowering health care costs and enhancing care value, then the first step is comparative effectiveness research. But as the CBO points out, to really generate savings, “we will need legislation to provide incentives on penalties for following or not following where that information leads.” That isn’t health care rationing. It’s just smart medicine and good economic policy.

So when Peter Orszag and I talk about the importance of using comparative-effectiveness studies as a way of reining in costs, that’s not an attempt to micromanage the doctor-patient relationship. It is an attempt to say to patients, you know what, we’ve looked at some objective studies out here, people who know about this stuff, concluding that the blue pill, which costs half as much as the red pill, is just as effective, and you might want to go ahead and get the blue one. And if a provider is pushing the red one on you, then you should at least ask some important questions. [...]

Whether, sort of in the aggregate, society making those decisions to give my grandmother, or everybody else’s aging grandparents or parents, a hip replacement when they’re terminally ill is a sustainable model, is a very difficult question. If somebody told me that my grandmother couldn’t have a hip replacement and she had to lie there in misery in the waning days of her life — that would be pretty upsetting….So that’s where I think you just get into some very difficult moral issues. But that’s also a huge driver of cost, right? I mean, the chronically ill and those toward the end of their lives are accounting for potentially 80 percent of the total health care bill out here. [...]

It is very difficult to imagine the country making those decisions just through the normal political channels. And that’s part of why you have to have some independent group that can give you guidance. It’s not determinative, but I think has to be able to give you some guidance. And that’s part of what I suspect you’ll see emerging out of the various health care conversations that are taking place on the Hill right now.

Obama highlights the anxiety surrounding comparative effectiveness research. We spend too much money on ineffective treatments, but designing a policy that lowers the use of unnecessary/unproven procedures and preserves access to experimental treatments or other unproven procedures is tricky; it’s a source of political concern and contention. Providing doctors with independent analysis about which drugs work and which don’t could save money and countless lives. But that’s the easy part. Almost everyone agrees that telling doctors that that drug X causes more harm than good would encourage providers to switch course and benefit the patient.

What’s more difficult is netting savings from unnecessary medical procedures and discouraging the system from over-treating patients. As the President points out, “the chronically ill and those toward the end of their lives are accounting for potentially 80 percent of the total health care bill out here” and it’s unclear that putting these patients through surgery during the last weeks or months of their lives is best for the patient. America’s medical culture and current payment structure dictates that you have to do everything in your power to extend a person’s life — by hours, days, or weeks — but the patient is rarely consulted. As Dr. Robert Martensen, author of “A Life Worth Living: A Doctor’s Reflections on Illness in a High-Tech Era” and the director of the museum and the office of history at the NIH, recently explained on NPR’s Fresh Air:

What’s different in American hospitals is that advanced technologies, aggressive interventions, keep getting applied to patients and literally applied right up until the body can no longer respond….Nobody stands back and says this patient is dying. Nobody says it to the family. Nobody says it to the patient if the patient is responsive. Things just keep getting done.

And the result is that, I think, we who are doing these treatments are causing great suffering. So there are structural problems in the system, and the result is that the patient who doesn’t want any more aggressive treatment, who just wants comfort care, can feel very frustrated.

This isn’t to say that the government should dictate a certain course of treatment. That should be left to the patient and her/his doctor (a conversation about different treatment options and choices can only improve patient satisfaction). But what the government can do is provide doctors with unbiased information about which treatments work and provide incentives for providers to focus on care quality and not care quantity (i.e. payment reform)

Today a doctor can spend hours talking to a patient like Obama’s grandmother about end-of-life decisions, discussing what matters to them, relevant medical history etc.. but in New York, Medicaid only pays $18 for that service. If however, a doctor is to recommend a complicated procedure, it would be well compensated.

A model that encourages providers to over-prescribe treatments of dubious quality and necessity is unsustainable and a cause of medical inflation. If we’re really serious about lowering health care costs, then the first step is comparative effectiveness research. But to really generate savings, “we will need legislation to provide incentives on penalties for following or not following where that information leads.” That isn’t health care rationing. It’s just smart medicine and good economic policy.

Most conservative dissent circled around Sebelius’ alleged connections to an abortion doctor, but some voted against the nomination because of her views on comparative effectiveness research.

Just before the vote, Sen. Jon Kyl (R-AZ) explained that he could not support Sebelius’ nomination because she did not rule-out using comparative effectiveness to “support the allocation of health resources”:

The acting director said this in a very recent project description, and I quote, cost-effectiveness research will provide accurate and objective information to guide future policy that is support the allocation of health resources for the treatment of acute and chronic conditions, end quote. Allocation of health resources is, of course, a euphemism for denying care based on cost, and yet Governor Sebelius would not agree to pull this project. I believe in the right of every American to choose the doctor, the hospital, the health care plan of his or her choice, and that no Washington bureaucrat should interfere with that right or substitute the government’s judgment for that of a physician. And I will oppose governor Sebelius’ nomination because of her insufficient commitment to these principles.

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Sens. Chuck Grassely (R-IA), Orrin Hatch (R-UT), Jim Bunning (R-KY), Mike Crapo (R-ID), John Ensign (R-NV), Mike Enzi (R-WY), John Cornyn (R-TX) also voted against Sebelius’ nomination.

I had a lot of those fights because the reality is the government should be able to look at what’s the appropriate level for PET scans or MRIs?…You know, Medicare makes decisions on coverage all the time. I made decisions on coverage all the time based on what I thought was not – on comparative effectiveness research. You got to do it the right way. But I think – I’ve always been a big fan of comparative effectiveness research if done correctly.

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Scully dismissed the likes of Sally Pipes and Betsy McCaughey as “just noise” and argued that since Republicans are in the minority, “their job is to hurl attacks,” just as some Democrats did during the debate surrounding Medicare Part D.

Asked if the odds of health reform are better this year, Scully predicted that “the odds are lower” of passing health reform now “because the economy is in such bad shape, I think it’s going to be very difficult to finance this thing.” “I don’t think that the core people that are really in the weeds of health care in the Senate is as big as it was…I don’t think there is a group of 20 guys that really are health care wonks like there was 15 years ago,” Scully explained.

During the panel discussion, however, Scully admitted that the world would have been a better place had Congress passed President Clinton’s health reform plan. “They made a lot of strategic errors back then…but the core issue was trying to fix the commercial insurance option…which is the right thing to do, they probably went too far… but had the plan passed back then, the fundamental concept behind it was regional purchasing cooperatives with a better structured insurance market, which is exactly what we’re talking about right now.”

Transcript:

SCULLY: The government does it anyway. I think there’s got to be limitations, but I think the reality is — look, I had a lot of fights – I’ve had giant fights. I declared the two biggest drugs in Medicare, (inaudible), to be functionally equivalent because they were. I got attacked by the drug companies. I had a lot of those fights because the reality is the government should be able to look at what’s the appropriate level for PET scans or MRIs? I never gave a speech – in four years I haven’t given a speech yet without beating up Nexium. Nexium’s the most bogus drug ever made. Nobody should ever take Nexium. Prilosec’s the same thing. So the government should be out there saying, ‘we’re not paying for Nexium, we’re paying for Prilosec.

THINK PROGRESS: So you, because there’s the controversy over CR obviously is cost and can you use CR research to deny coverage?

SCULLY: Absolutely.

THINK PROGRESS: So you would approve –?

SCULLY: I did it at CMS all the time. People talk about it and say it’s the right thing to do. There’s no question, in my opinion it’s absolutely the right thing to do. There’s a lot of fear from some people that it’s going to stifle innovation of drugs and devices and other things and I just don’t that’s correct. I think the political system is – patients want good drugs, they want good devices, they want good anti-cancer radiation and Medicare denies service every day. I like Senator Kyl, he’s a very big free market guy, he’s got a lot of doctors in Arizona that are very worried about this. And so, like any member of congress he tries to please constituents. He’s one of the nicest people to ever meet. One this one I obviously don’t agree with him. You know, Medicare makes decisions on coverage all the time. I made decisions on coverage all the time based on what I thought was not – (inaudible) research. You got to do it the right way. But I think – I’ve always been a big fan of (inaudible) research if done correctly.

I’m a big fan of Health IT and I wish I would have done more. My problem with Health IT and I don’t blame republicans for this but I spent a lot of time on Medicare forms and trying to fix CMS. I’m a huge fan of Health IT and it can save a lot of money, but you’ve got to have mandates for one platform. I think its crazy for us to spend 25-30 million dollars on Health IT when every hospital and every doctor’s office has something different. We should say look, if you want Health care IT from the federal government, if you want to get paid by Medicare and Medicaid, great – you can use any one of sixty vendors but just like ATMs at banks…

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Sebelius stressed that as insurance commissioner in Kansas, she fought private insurer efforts to ration care:

I can’t tell you that I’m not concerned, ultimately, not with comparative effectiveness research but ultimately reaching a point where in order to control costs there is some effort to ration health care. I frankly, as insurance commissioner where I served for eight years saw it on a regular basis by private insures, who often made decisions overruling suggestions that doctors would make for their patients that they weren’t going to be covered. And a lot of what we did in the office of the Kansas Insurance Department was to go to bat for those patients to make sure that the benefits they had actually paid for were ones that were delivered.

Grassley, a moderate Republican voice who supports both cost-containment measures, encouraged the effort:

I think they ought to hype them right now because people’s attention needs to be brought to it, and that’s the only way you’re going to get their attention. When the dust settles, they won’t have a leg to stand on and we will have and we will have a study and a tool that will be useful for doctors to use but not to dictate medicine.

During the Kaiser Family Foundation event, Grassley also reiterated his opposition for a new public plan, and suggested that insurers should be allowed to sell policies across state lines.

Orszag on why capitalism and Medicare Advantage overpayments are incomparable:

In a rather heated exchange with Sen. Chuck Grassley (R-IA), Orszag defended the Obama administration’s proposal to eliminate the subsidies provided to insurers participating in the Medicare Advantage. “Capitalism is not founded on excessively high subsidies,” he said.

ORSZAG: I know many people believe that capitalism is founded on private markets, and it is. But I very firmly believe that capitalism is not founded on excessively high subsidies to private firms. That is what this system delivers right now. For every Medicare beneficiary in Medicare advantage, the federal government pays a thousand dollar more than covering the same beneficiary under fee-for-service.

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Orszag’s approach may have come off as smug or arrogant, but he’s probably right on the substance. It’s unclear why Medicare would pay about 13 to 17 percent more for beneficiaries enrolled in MA Plans, if they’re not providing better quality care (and just pocketing the subsidy.)

And as Orszag points out, for every dollar the federal government provides to Medicare Advantage in additional benefits, it spends $1.30 in costs. “We’re all paying a $1.30 in order to deliver a dollar to a subset 20% of Medicare beneficiaries. I don’t think that’s competition, I think that’s an unwarranted subsidy,” he said.

Orszag on the unintended consequences of the health care crisis:

Many progressives have made the argument that the economic crisis demands health care reform. Chairman Max Baucus (D-MT) asked Orszag about the cost of doing nothing. Orszag checked off the usual talking points but then explained why college students should advocate for health care reform:

ORSZAG: Lots of families are experiencing higher tuition at public universities. Research clearly connects rising tuitions to rising costs of health care in state government budgets, which then means they don’t have room to support public education to the degree they did in the past.

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Sen John Kyl (R-AZ) parroted the tired Republican myth that comparative effectiveness research would ration care and limit physician’s freedom.

And while some have argued that the government could — at some point down the road — use the effectiveness data to establish reimbursement rates (why, after all, should we pay for ineffective treatments?), Orszag suggested that the government could lower health care costs by using the data to incentivize best practices.

ORSZAG: At the extreme, if something is shown not to be effective, it could simply not be covered. But there also are a lot of less extreme ways of guiding medical practice. For example, simply paying more for the things that work than the things that don’t. Creating penalties if you have high re-admission rates for example. And so it doesn’t need to be a simple on-off switch.

Listen:

The larger point is that we need much more information on what works and what doesn’t. At this point, most physicians receive their effectiveness information from representatives of the pharmaceutical industry; this research is an effort to provide doctors with unbiased information to ensure that they provide the best quality care to their patients.

Administration wants to have a plan that is deficit neutral in 5 to 10 years:

Orszag hailed the power of compound interest. If we lower health care spending by just 1% every year, we would reduced health care spending by 20% of the GDP in 50 years:

ORSZAG: We believe that health care reform should be deficit neutral even over the medium term [5 to 10 years]…savings will build over time. One of the frustrations is, there has not been enough research done to quantify the things we are talking about…if we can reduce the rate of health care spending growth by 1% a year…the power of compound interest is so strong that after 50 years we would reduce health care spending as share of the economy by 20 percent of GDP. Huge amount.

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Will illegal immigrants be covered under Obama’s proposal?

So this is a common Republican tactic: in trying to obstruct universal health care reform, argue that millions of illegal immigrants would become eligible for free health insurance coverage. This is what Sen. John Ensign (R-NV) tried here and Orszag predicts that “there will be important protections against covering unauthorized immigrants as part of any legislation”:

ORSZAG: The President’s campaign plan does not cover unauthorized immigrants…I would imagine that there will be important protections against covering unauthorized immigrants as part of any legislation.

Listen:

Ensign is really trying to sidetrack a conversation about health care into a debate about immigration. In reality, illegal immigrants obtaining health care coverage isn’t nearly the problem Republicans try to make it out to be.

As the Kaiser Family Foundation points out, while “non-citizens are much more likely to be uninsured than citizens” because of limited access to employer based health care coverage and restrictions for public coverage, citizens still make up “the bulk of the uninsured.”

The majority (76%-80%) of the growth in the number of uninsured from 2000 to 2006 occurred among citizens, not legal and undocumented non-citizens. Moreover, because non-citizens are much less likely than citizens to have a usual source of care, they have significantly lower per capita health care expenditures than citizens and also “generally restricted from enrolling in Medicaid and SCHIP.”

Orszag promises that everything is on the table:

At the end of the hearing, Baucus, who was recently quoted as saying that single-payer is off the table, asked Orszag if every proposal would be considered by the administration. Orszag said yes:

ORSZAG: Everything is on the table.

BAUCUS: It’s a very big table, and stacked pretty high.

Listen:

This probably won’t really mean much for single payer reform. During the health care conference, Obama spoke directly to the single payer community — or liberal bleeding hearts, as he called them — and warned them that we can’t solve this problem without tackling costs. We “have to balance heart and head,” he said.

NELSON: We got some extremist statements that came out from some sectors of the body politic about the stimulus bill, that there were in this comparative effectiveness research that it was going to cause a denial of medical treatments…Why don’t you debunk that theory?

Listen:

Elmendorf explained that comparative effectiveness research is a way to find out which treatments and procedures work, and which don’t. By itself, research “doesn’t change the care that is delivered; it provides the information,” Elmendorf stressed. The separate question is how will doctors and hospitals respond to this information and what incentives are “provided for them.” “The challenge is that information alone is not enough. It’s acting on the information”:

To generate more savings, we will need legislation to provide incentives on penalties for following or not following where that information leads and this particular legislation does not do that… it’s complicated…the studies are not going to say in general this whole type of medicine is completely worthless or this whole type of medicine is completely useful. It will be much more nuanced than that and that’s part of the challenge in creating incentives for providers to do these things that are useful and not.

In the long run, comparative effectiveness research could be used to make health care more cost-effective and government should be able to design policy (by tweaking Medicare reimbursement rules and getting doctors to adopt best practices) that promotes the best practices and lowers health care costs without refusing to pay for popular treatments. So as Elmendorf suggests, the argument isn’t about rationing or denying care; that’s a red herring. The question is: how do we encourage doctors to improve health quality and eliminate the use of wasteful and harmful treatments?

Rep. Charles Boustany Jr. (R-LA), a heart surgeon, opposed the provision because he feared that the government would use the research to deny treatments to Medicare patients because they cost too much. In fact, “when the House Ways and Means Committee debated the stimulus measure, Boustany offered an amendment that would have prevented Medicare from basing coverage decisions on cost alone.”

Once it was defeated, Boustany went on the offensive:

- Federal bureaucrats will misuse this research to ration care, to deny life-saving treatments to seniors and disabled people. [NYT, 2/15/2009]

- Congress should fund research to improve the quality of patients’ medical care, instead of creating new barriers to deprive them of beneficial treatments. [Press Release, 12/12/2009]

Today, in an interview with Congressional Quarterly, Boustany revealed that he hadn’t read the final version of the bill, but would have “voted against the stimulus bill even if the comparative effectiveness provision had been written to his liking“:

While I see some value in doing research to see what’s the best clinical approach, taking into consideration cost and quality, I’m just deeply concerned about cost alone being a factor in making clinical decisions.

Had Boustany read the final language, he would have discovered that the legislation actually addressed his concerns. In fact, the bill states that the research will compare “clinical outcomes effectiveness,” not cost:

That the funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies through efforts that: (1) conduct, support, or synthesize research that compares clinical outcomes effectiveness, appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, and other health conditions...”

The conference report addressed the matter more boldly, “the conferees do not intend for the comparative effectiveness research funding included in the conference agreement to be used to mandate coverage, reimbursement, or other policies for any public or private payer.”

The stimulus legislation established an agency to “conduct and support research that would assess the benefits of competing treatments,” regardless of their cost. As Robert Laszewski points out, “comparative research–which drugs or medical devices work the best–makes a lot of sense. That is especially true in the wake of decades of research that continues to point to wide overuse of technology as the primary cost driver in our health care system.”

In the long run, comparative effectiveness research could be used to make health care more cost-effective. That is, to improve the quality of care, lower health care costs and make insurance more affordable, Medicare could spend health care dollars with “an eye to lifting the quality and reducing the cost of health care” without refusing “to pay for popular treatments that it covers today — unless the research reveals serious risks.”

The study found that patients who received stents stayed in hospitals 1.2 days longer than those who received medication. The average cost of care for stent patients during the first 30 days of treatment was $22,859, compared with $12,683 for those using only medication, according to the study. The cost difference narrowed after two years, but patients using medication alone saved $7,000 on average. According to the study, an estimated 100,000 heart attack patients in the U.S. do not need stents, which could translate to savings of $700 million.

We spend about $700 billion on treatments that just don’t work, and comparative effectiveness research (like this) is just one way to chip away at the waste. As Dr. Sean Tunis of the Center for Medical Technology Policy pointed out a recent AEI event, creating evidence “that allows patients and clinicians and payers to compare risks, benefits, and costs of alternative health care interventions is that that information is essential for informed decision making and informed decision making by consumers is essential for markets to work efficiently.”

When I do something for a patient, I want the scientific research that tells me its the best course for my patient. But the far right, led by people like Rush Limbaugh, hopes to somehow convince Americans that more and better research is a bad thing. Medicine is and should always be science based – not driven by ideology.

A doctor’s perspective has a way of swaying skeptics, and Dean’s testimony goes a ways in unraveling the fear-based arguments of the other side. He pits pragmatism and common sense against the right’s orgy of emotional hysteria.

Dean personalizes this debate — comparative effectiveness can help save patient lives by keeping doctors informed on the latest medical treatments — and couples it with some reasoned debunks. Progressives tend to focus on the latter wonky responses without considering the real-world consequences of CER for individual patients.

As James Fallows suggests, “let’s stop this before it goes any further.” Already, 25 million insured Americans can’t afford our skyrocketing medical costs. Yet we waste approximately one-third of our health care dollars — as much as $700 billion — on duplicated care, unnecessary care, and treatments that just don’t work.

To lower the costs of health care, to make insurance more affordable, and to lay the foundation for a more sustainable system, both Democrats and Republicans have supported the idea of establishing federal standards for electronic medical records and investing federal dollars in sensible medical research.

The idea is this: just like the government established standards for the cell phone industry and then allowed private companies to build on a single network, setting privacy guidelines for electronic health records would establish a framework for vendors to develop a system for securely sharing electronic records and medical data. A Verizon Wireless customer can connect to a T-Mobile cell phone and a primary care physician should be able to transfer medical records and data to a specialist.

Similarly, a serious approach to comparative effectiveness “could not only educate other providers on how to improve, but also inform policymakers on how to design policy that promotes these best practices,” Newt Gingrich explains in a Washington Times editorial. Ultimately, this “fight is over the very concept of evidence-based medicine“:

Health care, we know, is too expensive, and it’s too expensive in part because we pay for lots of treatments that don’t work. But every dollar of medical waste if also a dollar of manufacturer profit. And they — and their allies on the Right — will work very hard to keep those dollars.

Indeed, Big Pharma — which, incidentally, bankrolls Betsy McCaughey’s Hudson Institute — currently instructs doctors on the effectiveness of medications, and opposes research that could persuade physicians to eschew ineffective or unnecessary treatments. Fewer prescriptions translate into lower profits and the industry has lobbied hard to pare down the cost effectiveness language in the House version of the stimulus bill.

The industry has also funded the Partnership to Improve Patient Care, a lobbying group that seeks to “give industry a seat at the table when federal officials decide what to research with the $1.1 billion.”

Ironically, in the interest of protecting their bottom lines, pharmaceutical companies, which so often manufactures life-saving drugs, are undermining research that could save or improve the lives of millions of Americans.

Despite reading two statements to the contrary, the hosts and their guest continued to mischaractarize the provisions as a socialist government takeover of health care that would result in Big Brother watching over Americans’ shoulders. It wasn’t until the program’s 10 o’clock hour that Sen. Ben Cardin (D-MD) set the record straight.

Watch it:

Indeed, the National Coordinator of Health Information Technology would establish minimum privacy standards for technology vendors selling health IT equipment to doctors, but does not grant the federal government access to the confidential documents; nor does it require physicians to follow treatment guidelines. In order to become “meaningful users” of health IT, doctors have to implement an electronic system by 2015, they are not required to change their treatment practices.

Broad implementation of Health IT, which would reduce medical errors, increase efficiency, and create over 200,000 new jobs, has generated broad bipartisan support. Consider this Washington Times article by Newt Gingrich and Sen. Sheldon Whitehouse (D-RI):

Health IT should be what railroad tracks were for transportation 150 years ago: basic infrastructure. A modernized, interconnected health system that electronically links patients, physicians, hospitals, pharmacies, public health agencies, payers and key emergency responders would allow all to share accurate, patient-protected information, and that will undoubtedly save lives and save money…Second, health IT will allow us to capture data and then determine which treatments work and which do not. Today, only about 10 percent of all health care is based on evidence. That means that 90 percent of the care we receive is, basically, informed opinion. We need a rigorous, clear system to measure the costs, benefits and value of a given procedure, technology or drug.

Gingrich and the other lawmakers who believe that Health IT could lay the foundation for comparative effectiveness research aren’t advocating for the rationing of medical care, as Fox News and one absolutely hysterical editorial in today’s Washington Times suggest. The goal here is to provide doctors with information about good treatments, improve medical outcomes, and to stop spending money on procedures that don’t work and harm patients. As Tim Foley explains:

We know there’s a problem here, with a Dartmouth College study approximating at least $700 billion is spent each year on treatments that don’t lead to better health.  But we don’t know the specifics until we analyze the data.  If I was a responsible steward of taxpayer’s money, I’d want to know what we’re spending money on that doesn’t work. 

I am working with Republicans and Democrats in the Senate to try to redirect the major stimulus bill to boost more job creation spending and trim non-stimulative items….This isn’t about pork, but it may be about sacred cows.

But as Merrill Goozner points out, “comparative effectiveness research at this level is nothing more than giving study grants, which would provide an immediate stimulus to the economy.” Currently, only a limited amount of evidence is available about “which treatments work best for which patients and whether the added benefits of more-effective but more-expensive services are sufficient to warrant their added costs.” As a result, the American health care system wastes billions of dollars on unneeded care. Reducing this wasteful spending would go a long way towards lowering overall health care costs and, in turn, making health care more affordable.

So in some ways this is the ideal kind of stimulus. More research funding creates more research jobs, but it also invests in future savings and lays down the groundwork for substantial health care reform.

I’m completely disgusted with the hypocrisy of the libertarian right; those who have screamed for years about the ineffectiveness of government, ranting nonstop about how government can’t do anything right, yet are now screaming even louder as government attempts to make sure they are responsible stewards of the public’s funds.

This is a good way of defending effectiveness research from the onslaught of conservative attack: since over $700 billion is wasted on care that does not contribute to healthy outcomes, figuring out what works and what doesn’t and then throwing resources towards the former is, well, the function of government, conservatives have always told us. So what’s so different this time?

I would add that even the smallest kind of guidance improves health outcomes. As a recently published study in the New England Journal of Medicine concludes, simply using checklists cuts “deaths nearly in half.” So imagine the savings that can be garnered if we actually invest money to figure out what works and what doesn’t. Republicans love saving money and defunding initiatives that don’t produce desirable outcomes. With comparative effectiveness research, we can hold their feet to the fire.