Health care ii
Health Care II: Quality
TEXT:June 18, 2009 Senate H.E.L.P Committee
SEN. TOM COBURN, R-OK:I think we used – I can’t remember the examples – maybe it was Claritin and Allegra. Let’s say CER comes out and says one is better than the other. What’s going to be the requirement for somebody who’s practicing medicine, and Allegra doesn’t work for their patient but Claritin does?
TEXT:Senator Tom CoburnRepublican from OklahomaOB-GYN Physician
SEN. BARBARA MIKULSKI, D-MD:The doctor decides, with the concurrence of the patient.
TOM COBURN:So does he have to document that he didn’t follow CER guidelines?
BARBARA MIKULSKI:I’m not sure what the rules and regs would be.
TEXT:Senator Barbara MikulskiDemocrat from MarylandAuthor of the Quality section of the H.E.L.P. Committee’s Health Care Reform Bill
BARBARA MIKULSKI:That would be part of what the secretary puts together.
TOM COBURN:That’s my whole problem with this, is what’s the secretary put together? The fact is, I have an amendment, Coburn #9, that I’d like to…
TEXT:A Soomo Publishing productionHealth Care ReformComparative Effectiveness Research and Bureaucracy
BILL WEISSERT, Professor of Political Science, FSU:We really do have a lot of quality problems. We have lower life expectancy than other countries. [1:06]
REP. ALCEE HASTINGS, D-FL:The United States ranks 45th in life expectancy…
BILL WEISSERT:We have very poor infant mortality rates.
ALCEE HASTINGS:And has startlingly high rates of infant mortality, depression, and chronic diseases.
BILL WEISSERT:From city to city and physician to physician and hospital to hospital, there are huge differences in the amount of care given and the outcomes of that care.
BARACK OBAMA:We need to identify the best practices across the country, learn from the successes, and then duplicate those successes everywhere else.
BARBARA MIKULSKI:We’re in the top five of medical expenditures in the world, but we’re in the bottom 37th in terms of health outcomes.
MAN AT MICROPHONE:The WHO says we rank 37th in the world on health care. That’s behind Chile and San Salvador. We deserve better than that.
DR. DAVID GRATZER, Senior Fellow, Manhattan Institute:When you try and do an international comparison, it’s very complicated. I think all too often we tend to be overly simplistic. We look at crude indicators. One finds that Americans smoke too much, they drink too much, and they eat too much, especially compared to their northern neighbors. In fact, and it pains me to say this as a physician, probably one of the less important things is health care in that overall equation.
TEXT:In the Quality sections of all Health Care bills drafted by Congress, a Center would be established to conduct health outcomes, or comparative effectiveness research.
One of the things in the bill that talks about comparative effectiveness studies –information like your age, your diagnosis, gender, et cetera – goes into a national research pool. They collect this data so that when you enter your information onto the computer system, which doctors have to go to this computer system now because the government is mandating it, it collects it and then as this plan goes into place, the computer’s going to kind of pop up and say do this, do that, we have this data, here’s our recommendation. You go with the recommendation, it’s good; you don’t, it’s bad. And the fear is that if you don’t go with what that little government computer is telling you to do, what if you don’t get paid? [3:20]
BILL WEISSERT:The other area that some of these bills would put government into is collecting more data on health care practices, and looking for things that are effective and beginning to develop recommendations and protocols for what should work. We really don’t have a good body of knowledge at this point. We don’t know what works and we don’t know for whom it works and we don’t know how much of it you need. So you have to sort of answer those three questions for a lot of conditions and a lot of treatments, and then you have to keep up with the developments and new treatments. So you’re talking about quite a few years of building up a body of knowledge. And then you have to demonstrate that it’s valid. So people have to see that, when you make these recommendations, you’re not just blowing smoke.
TOM COBURN:[June 18, 2009] What this amendment would require, that the director of the Center for Comparative Effectiveness Research shall not mandate any national standards of clinical practice or quality health standards. Mandate. Doesn’t mean they can’t study and recommend, but it means they won’t mandate it.
BARBARA MIKULSKI:In this legislation, and I’ve given chapter and verse that we do not mandate clinical practice. We do not mandate clinical practice.
TOM COBURN:There is no statement in this legislation that prohibits the mandate. There is no clear language that says we prohibit the mandate of this interfering between a doctor and a patient’s decision for their care.
I want to read you the text: federal and private health plan reports and recommendations shall not be construed as mandates. That’s a big difference than saying they will not be used as mandates.
BARBARA MIKULSKI:Could we come back, though, to quality health standards?
BARBARA MIKULSKI:Because I don’t know what you object there in establishing a standard on quality health care. [5:15]
TOM COBURN:Because all of a sudden we’ve now said there is one right way to do this, and it’s the government’s way, based on iconic professors and doctors of medicine, and it still disregards the patient history, the clinical history, the experience of the physician, and all those combined, which is called the art of medicine.
RICK BAXLEY, Family Practice Physician:The most important aspect of health care is the doctor-patient relationship. It’s a prepared doctor sitting down talking to a patient who needs health care. And the one-on-one relationship has gotten lost in today’s society. I’m Rick Baxley; I’m a family practice physician in Orlando, Florida.
The measured outcome system is another barrier between the doctor-patient relationship. In just a simple example, I have a patient that works the second shift and I hand them a prescription that says that they need to take a pill three times a day, because it’s a generic and it doesn’t cost as much as the one-time-a-day medicine. Well, that’s fine, I’d do that. But I know that that patient’s not going to take them but once or twice a day no matter how many times I put down on that prescription. Because of their lifestyle and the way they work and their timing and that kind of thing, and the kids that they’ve got to pick up after their second shift and all that other stuff, the likelihood of them taking that pill three times a day is almost zero. But the insurance company says that they’re not going to pay the pharmacy for the one-pill-a-day brand. They’ll pay for the three pills a day; whether they get used or not is irrelevant.
So there’s a lot of nuances that the government and the insurance companies have not figured out yet. And I don’t think they’re going to. Because of the economics of the medicine, they’re thinking more of the economics than they are of the art and science of medicine.
TOM COBURN:This is a very important section of this bill. Very important. Medicine is personal. Medicine is individual. It doesn’t fit in a box.
BARBARA MIKULSKI:No, but it does fit practicing guidelines. And you yourself have said that, that national academies of clinicians…
TOM COBURN:Senator, can I finish my point? Guidelines are important, but they’re just that: they’re guidelines. And if in fact you pass this bill out here, with this, you’re going to raise the cost of medicine. Because now what we’re going to do – here’s the guideline that you need to follow as sorted out, and implement it. The people who will implement this will be bureaucrats. And the first rule of a bureaucrat is never do what is best when you can do what is safe for your own job. And that will be the logo under which they operate and administer whatever comes out of CER. [8:42]
BILL WEISSERT:Well, when the law passes, the group that passes it may exist for only a moment in time. It’s a group of people who probably will never assemble again exactly the same way. So who is really able to tell you what the bill meant? Well, the committees, who really wrote it, make an effort at it; they write a report and they say, this is what we mean, this is where we’re trying to go, this is the way you should think about interpreting this. And that’s not the law, but it’s an instruction to the bureaucracy. So the bill goes over to the bureaucracy, to the agency that is responsible for administering that program, and then the report would go to them. And they’re pretty much on the hook to follow that report to the extent that they can. Where they have questions, they can call up the staff of the committee and say, what’d you guys mean here? They can also call up friends they have in the hospital industry and say, you know, we’re thinking about writing some regulations here but we’re not sure this would work. What do you think of this? Do you think this would work?
Another thing that people don’t understand about the bureaucracy is the same person has probably been working on the same issue for a long time, and they are really experts. Now, sometimes they have their own ideas, and so there’s something called bureaucratic drift, which is where the bureaucrat sometimes moves closer to Congress, what Congress wants, but moves away from what the president wants. Or if the bureaucrat sort of favors what the president’s wanting, they might move closer to the president. And so the political scientists have developed a term called the zone of indifference, and that is, the bureaucrat can get away with writing the rules in a way that sort of take a loose
interpretation of the law as long as they don’t do it kind of brashly. If they do it too much, one side or the other – the president or the Congress – is going to notice, and jerk them around. And you want to pay attention to your subcommittee, because that subcommittee very likely also controls your authorizing legislation. And so if you make them mad, they can do subtle things like take away your staff, or they can make a recommendation to the Appropriations Committee that your budget get cut, or that function be cut.
The other place that the bureaucrat gets in a lot of trouble is if it’s a highly salient issue. In the case of effectiveness standards and health care, that’s going to be a salient issue. Every doc, every medical specialty group, is going to be watching that like a hawk, because it’s going to limit the behavior of the physician, it’s going to potentially reduce their income, and so the zone of indifference gets very narrow when the issue is salient. So they write these regulations and they publish them, and then they have to oversee the process of their being implemented. And then of course the people who are doing the implementing make their own interpretations about what the regulations mean.
TOM COBURN:[June 22, 2009] The concerns were raised that if we do this work, with this several-billion-dollar effort, that in fact we couldn’t use the work product to inform and educate and benefit from the work product that is developed. [12:11] And the concerns that were raised were raised essentially that they, under the language that we had written, that it might prohibit this task force and this agency from actually getting that information out. And that’s not our intention at all.
So what this amendment simply says – we strike a section that was all the controversy last week, and then we say: are prohibited from being used by any government entity for payment, coverage, or treatment decisions. Nothing in this section shall be construed as preventing the Center from disseminating reports and recommendations to health care providers. So the one argument that was truly raised about our previous language is addressed here, I believe fully, and would not limit in any way, shape, or form the dissemination of that information. If in fact we’re not going to use this to limit care, then what we will be using it for is to improve care.
BARBARA MIKULSKI:I disagree with the senator’s recommendation up there. It is very rigid, it is very stringent, it could absolutely have a draconian impact on the practice of care because it could [inaudible] to even prohibiting them from being able to use – why it says any government entity. If there is in fact information that arises that gives better information about tools and methodologies that are being used, they would, say at the VA, be prohibited from using it.
I’d like to join Senator Mikulski in opposing this. I understand where Senator Coburn is coming from, and I appreciate his desire not to have an interference in the doctor-patient relationship. None of us want that. But I think the effect of this language will be to totally unhinge payment from performance, and to do so in ways that could have far-reaching effects throughout the rest of the system as we try to improve quality.
Let’s just say that it was clearly proven that if you could get somebody who presents at the emergency room with a respiratory infection under the right antibiotic within three hours, that the course of treatment was much improved for that individual, that the costs went down for the hospital and for the system, and that everything was better, if you could do that. So CMS says, okay, well, what we’re going to do is we’re going to do a 5 percent bounty or a 10 percent bounty, an additional reward payment for every hospital that’s able to get people on the right antibiotic at the right time within those three of hours of their presenting. That seems like the kind of thing we want to encourage the health care reimbursement system to do, assuming that the evidence truly supports it.
BILL WEISSERT:So obviously it has to be simply a research enterprise, initially, and then a dissemination effort, and you have to find ways to get it into the hands of physicians who are busy and have lots of demands on their time, and what you’re offering has to be relevant to their particular practice and their setting. And so you overcome all of those problems first, and then I think at some point you say, if you follow these recommendations, or you follow them 80% of the time or 75% of the time or something like that, then we’ll not only pay you but we’ll pay you a bonus. [15:46] If you want the bonus, then you’ve got to follow these recommendations. And if you don’t want to follow the recommendations, you don’t have to, but you don’t get the bonus. And then at some point you say, if you didn’t follow the recommendations and you had a bad outcome, we’re sure as heck not going to pay for you to fix the outcome, it’s on your own, and we may not even pay for you to do that same procedure again; we’re just not going to pay for it.
But you’re talking about years in the future, and of course it’s those years in the future that physicians are worried about, that at some point the recommendations would become mandatory and they might not be right for your patient. And physicians tend to feel that their patients are unique. Now, as somebody who deals with data, nothing’s unique. I mean, it’s all just a distribution, and there’s some people in it and some people aren’t. So I’ve never bought the argument that each patient is unique.
TOM COBURN:Senator Whitehouse’s argument forgets that medicine’s personal. What is the right antibiotic for me? Let’s say it’s a fluoroquinolone, which is great for pneumonias. We talked about a respiratory infection. Fluoroquinolones are absolutely contraindicated most of the times in elderly patients because they cause mental confusion. But there’s no question they’re the best medicine when it comes to treating a large number of respiratory
infections; they’re oral, they work like an IV antibiotic but yet they’re oral. But we’re going to take out that personal knowledge and we’re going to say we’re going to do it.
So if we want the government to make those decisions, to ignore the art of medicine, to ignore the personal nature of medicine, then we’ll defeat this amendment. But if we really want to benefit from this agency, and get the information out there, and then allow the physicians, using their gray hair, using their training, using their experience, and also, most importantly, using the knowledge of the individual patient, not something that’s on a chart that says here’s the best way to cookbook this, but what about the individual patient? Well, could we save money? Yeah. Will we have the same kind of outcomes? No. Will we have the same kind of confidence? No. Will we lead the world in cures? No. So, you know, it’s a big issue. And I understand we’re not going to win this vote. But the political ramifications is you’re going in a direction that most Americans don’t want you to go.
SEN. CHRIS DODD, Committee Chair, D-CT:Senator, thank you very much. And I presume we’d like to record a vote on this now? Look, we’ll call the roll on the Coburn Amendment #9… [votes taken]
UNIDENTIFIED SPEAKER:The voting’s 10 ayes and 13 nays.
CHRIS DODD:The bill is open for further amendment, in Title 2. Senator Coburn?
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