The Kaiser Daily Health Policy Report below announces that the Chairs of the Senate Finance and Senate Budget Committees have introduced a bill to create a Comparative Effectiveness Institute.
The question: Would its decisions guide Medicare’s decisions about what it covers? Clearly Congressional Budget Office Director Peter Orszag thinks the Institute would have some real power: He estimates it “could save up to $700 billion annually in health care spending by identifying treatments that do not produce the best medical outcomes.”
That’s the $1 out of $3 health care dollars that we now waste on unnecessary, unproven, ineffective and often over-priced treatments.
Of course, we wouldn’t save anything close to that amount at the beginning. It will take years to wring the waste out of the system. But putting U.S. healthcare on an evidence-based footing would be a giant step toward the national health reform we need.
I am also encouraged by the fact that the 18 members of the Institute’s panel would be appointed by the Comptroller General. The Comptroller General appoints the members of the Medicare Payment Advisory Commission (MedPac), and they have been producing extremely intelligent reports. They are also widely perceived as apolitical.
But this sentence raises a large question market: “the board’s 18
members… would include representatives from three of the following
entities: private payers; pharmaceutical, device and technology
companies; patients and health care consumers; physicians; and agencies
administering public health programs.”
I count five entities. Which three will be represented on the board?
Pharmaceutical and Device companies should not have a seat at the
table. Their financial self-interest (which would lead them to favor
the most expensive products) creates an immediate conflict of interest.
They should be consulted; but they should not have a vote.
Kaiser Daily Health Policy Report
Capitol Hill Watch | Baucus, Conrad Propose Legislation That Would Create Comparative Effectiveness Institute
[Aug 04, 2008]
Senate Finance Committee Chair Max Baucus (D-Mont.) and Senate Budget
Committee Chair Kent Conrad (D-N.D.) on Friday introduced a bill (S
3408) to create a public-private comparative effectiveness institute,
which health care policy experts say is essential to controlling health
care costs and covering the uninsured, CQ HealthBeat reports. The
institute would function as a not-for-profit private entity, not a
federal agency, governed by a public-private Board of Governors,
according to Baucus. Congressional Budget Office Director Peter Orszag
estimated that the U.S. could save up to $700 billion annually in
health spending by identifying treatments that do not produce the best
medical outcomes.
The Health Care Comparative Effectiveness Research Institute would be
"responsible for setting national priorities" and would contract with
NIH, the Agency for Healthcare Research and Quality and private
entities to provide peer-reviewed research studies that "answer the
most pressing questions about what works in health care," Baucus said.
The institute budget would be $5 million in fiscal year 2009 and
increase to $300 million by FY 2013. By 2011 the institute would become
an "all payer" system, in which the federal treasury would provide $75
million annually from FY 2011 through FY 2018, private insurers would
pay $1 per insured person per year and Medicare trust funds would
provide $1 per beneficiary each year.
The 21 members of the institute’s Board of Governors would include the
secretary of HHS and the directors of AHRQ and NIH. The board’s other
18 members, to be appointed by the Comptroller General, would include
representatives from three of the following entities: private payers;
pharmaceutical, device and technology companies; patients and health
care consumers; physicians; and agencies administering public health
programs.
A Baucus spokesperson said, "we will work to move the bill this year,
but obviously time is very limited," adding, "It is important to start
serious discussion on an issue important to consider in the context of
health reform."
Support
Karen Ignagni, president of America’s Health Insurance Plans, said, "We
very much support this notion of a public-private independent
organization." Ignagni added that the fees health insurers would have
to pay under the bill are "a down payment on the agenda of most
stakeholders, which is to get all Americans covered." Ignagni said that
the findings would be used to "inform coverage decisions" but that
treatments found to be less valuable are likely not to be excluded.
BlueCross and BlueShield Association President Scott Serota said that
the BCBS has "long advocated for such an entity," adding that by
"promoting comparative effectiveness research … we can improve
quality, value and expand coverage for all."
Opposition
According to CQ HealthBeat, "A research agenda that targets the most
costly types of treatments and produces findings that shrinks demand
for those treatments may not sit well with individual drug, device and
medical professionals affected." Pharmaceutical Research and
Manufacturers of America Senior Vice President Ken Johnson said in a
statement that the lobby "supports the development and use of
high-quality evidence … for health care decision-making" but added
that the research should promote timely access to needed therapies "and
avoid denying or delaying patients’ access to beneficial care."
Advanced Medical Technology Association CEO Stephen Ubl said that the
bill "reflects a number of AdvaMed principles on comparative
effectiveness," but that the company believes "safeguards should be
included to ensure that the final determination of what treatment
option works best for each patient should be made by individuals and
their physicians." Ubl added that "research should focus on comparative
clinical effectiveness, and not on cost-effectiveness — which could
lead to decision-making that may not be in the best interest of
patients" (CQ HealthBeat, 8/1).
Maggie,
I’m all for objective, unbiased comparative effectiveness research. When it comes to trying to remove wasteful, inappropriate and unnecessary care from the healthcare system, however, consider the following:
While the doctors out there can speak to this much better than I can, I don’t think there are too many cases where doctors would say, gee, now that I have this data from the Comparative Effectiveness Institute, I will no longer order test X, procedure Y or prescribe drug Z. Instead, I think they might often say, while I know this test is probably unnecessary, I think I need to order it to minimize the chance of a lawsuit for a failure to diagnose the patient’s problem. Or, the patient wants an MRI to make sure that his headache is not caused by brain cancer or he wants that new drug that he saw advertised on TV and his insurance will pay for it. Or, the patient is at the end of life and I know the prognosis is poor but the family is insisting that everything possible be done, there is no living will and the patient himself can no longer communicate. They are threatening to sue if we don’t do everything possible to keep mom alive. They tell me that God will decide when death comes, not doctors.
To realize the maximum potential benefit from comparative effectiveness research, we need to incorporate it into payment policy, move to a more sensible litigation environment, especially with respect to claims based on a failure to diagnose, and develop payment models that reward doctors and hospitals for providing cost-effective and appropriate care rather than paying them more just because they did more.
Barry–
I definitely agree–that comparative effectiveness reserach should drive payment policy. It should decide what Medicare does and doesn’t cover.
If that’s the case, then doctors won’t have a problem. Unless the patient wants to pay for the questionable product or procedure out of pocket, doctors are under no obligation to provide something–for free–that Medicare doesn’t cover.
Private insuers will follow Medicare’s lead. I’m told they’ve been begging Medicare to move forward on this, so that they can follow.
Clearly the CBO Director is on board–and that is very important. (Orszag is also very intelligent, honest and understands the problems in our health care system.)
The only thing that concerns me is that Pharma and device makers might end up on the panel. Since they have so consistently lied suppressed evidence(concealing risks and side effects) we really can’t have the fox in the hen-house.
I like the way the U.K. handles this. Manufacturers don’t have a vote but they are consulted. And their rivals are consulted.
Typically, the competiton may well know more than the public (or regulators) about defects in your product.
I nominate Dr. Nortin Hadler to Chair this should it become a reality.
Hadler has written extensively and very intelligently for over a decade on the importance of efficacy- Does it work!
Many others are newcomers to this issue.
Dr. Rick Lippin
Southampton,Pa
ralippin@aol.com
What this comparative institute needs to do is create standards that show ordering a CT angiogram rule out PE in a healthy 23 year old with chest pain but no risk factors for PE and a normal d-dimer is unnecessary and legally protects the doc from failure to diagnose lawsuits when the patient shows up 2 days later with a massive PE. Our legal culture is such that fear drives a lot of what we do as physicians. Fear of the unknown. I know 10000 patients will not have a PE, but it only takes that one patient, outside the box to take you for everything you have. And that’s why the other 9,999 patients get the CT scan as well. If the comparative institute had some teeth to it, it must also come with legal protection for the doc, when following their guidelines ends up not being the right decision for that patient who decides not to follow the recommended course of expected illness.
Sometimes physicians may like to think for themselves. Perhaps they know of cutting-edge technology that has run through the riggers of evidence, but not attached to standards. Sometimes cited literature is often neither the most recent nor the most valid in terms of study design. To give patients confidence in the treatment they are receiving, arriving at conclusions in a fully transparent manner needs to include full disclosure of conflicts of interest. The self-educated physician may not want to submit to the status-quo.
Dr. Rick and Happy Hospitalist–Thanks for your comments
Rick–I too greatly admire Hadler …
Happy Hospitalist– I completely agree.
As I was writing in my comment to Barry (while you were writing this comment) if the Institute’s guidelines determine Medicare coverage, then doctors would be protected.
These days, most insurers cover what Medicare covers.
And if insurance doesn’t cover a CT angiogram for a patient who fits that profile nothing in our legal system would require a doctor to provide it at no charge.
This could significantly reduce malpractice claims. The lack of clear guidelines (for a particular set of patients) leaves our system wide open to unreasonable suits.
Let me stress that the Comparative Effectiveness Institute would provide guidelines for patients fitting a particular profile. This is not one-size-fits-all medicine (as some drug-makers claim).
Gregory–
Usually I agree with you. But here, when you write “The self-educated physician may not want to submit to the status-quo”
I have to disagree.
First, as I’ve indicated before, physicians would not be forced to follow guidelines. These are “guidelines” not “rules.” In individual cases, they could deviate.
But Medicare (and probably most other insurers) would not pay for treatments that were not supported by medical evidence, even if a “self-educated physician” preferred the treatment.
We have too many self-educated doctors in this country–Lone Rangers doing what they think is best, despite what the best evidence shows.
Occasionally they are right. Usually they are wrong. Often they have a financial interest in the procedure they want to do (they may not own any piece of it, but often it’s a very lucrative procedure).
As I’m sure you know, for nearly a decade, oncologists treated breast cancer patients with bone marrow transplants. These transplants were very painful and the side effects afterward -vomiting, diarrhea made it impossible for some these women to say a proper good-bye to their loved ones. The transplants were also very lucrative.
“Indpendent” ncologists just kept on doing them–even as it became apparent that there were no benefits. These women didn’t live longer. They just suffered more.
If a doctor feels strongly that he has a life-saving procedure that just hasn’t made it into the medical literature yet, and his patient can’t afford to pay for it out of pocket, he would be free to provide it at no charge.
And I hope he would do that.
But we can’t risk the lives and health of tens of thousands of patients to support the relatively slim odds that a physician who “likes to think for himself” is right. Too often, these people are simply egomaniacs who pride themselves on going their own way.
Places like the Mayo Clinic have guidelines–and few Lone Rangers. Overall they have much better outcomes
I don’t think an entity which is set up with the ultimate goal of saving money will be best. The stated goal may be “effectiveness” but this is driven by saving money. The criteria should be independent of cost, this means comparing treatment options (or doing nothing) on absolute terms. Then how the total cost gets reined in is treated as a budgetary problem, hopefully with a moral component.
Given all the recent reports on those not getting adequate treatment, it is highly probably that total costs would go up if all those currently under-treated were included in expanded insurance schemes.
The first step is to treat access to adequate health care as a basic human right, as it is in many European countries. Once this is done money can never be used as a criterion.
I’m on a new kick these days, economic discussions need to be replaced by moral ones: this goes for trade policies, tax rates, social welfare programs, etc. The time of cost/benefit needs to end.
Matthew Holt has a nice post up today about NICE, the British system of handling the issue.
http://www.thehealthcareblog.com/the_health_care_blog/2008/08/nice-job-cost-e.html#more
Robert and Chris–
Robert–
This is a ‘Comparative-Effectiveness” institute NOT a “Cost-Effectiveness Instiute.”
I wrote about the difference here http://www.healthbeatblog.org/2008/06/choosing-our-ba.html.
There is so much low-hanging fruit in terms of waste in our system that we don’t need to worry about cost-effectiveness.
There are plenty of less effective or ineffective
treatments that are gobbling up health care dollars.
In any case the Medicare law does not allow Medicare to consider cost-effectiveness. The law would have to be changed, and that would be very, very hard to do. But the law does allow Medicare to look at compative effectiveness and refuse to cover something that is not as effective for a particiular group of patients, regardless of cost.
If it is newer, it is almost always significantly much expensive, so this will save money–but that’s Not the aim.
Chris– thanks for the head’s up. It is an interesting post.
Two somewhat unconnected points:
1 – Why wouldn’t CMS use the Institute’s findings to help determine how much to pay, as well as whether to pay anything at all? Even if the Institute isn’t explicitly doing cost-effectiveness analysis, shouldn’t one consideration in payment be value to the patient, which should have to do with effectiveness?
2 – I would suggest that neither pharma, biotech, and device companies, nor private payers should have seats on the board. The former group members have financial incentives towards showing that their products work. The latter group members have financial incentives to show that nothing works. Thus both groups would have conflicts of interest.
Roy–
Good point about private payors. I agree that, in most cases, I wouldn’t want private payors on the board.
Though I can think of a couple of non-profit private payors who would be okay. There might be a need for someone to push back against the patient advocates representing particular diseases who think that we should approve everything that sounds interesting–or might save one life. Of course some (if not many) of those groups are in bed with and financed by Pharma.
If I had my druthers the panel would be made up of physicians, medical ethicists, medical reserachers, knowledgable hospital administrators, and public payors–all of whom would be people who have absolutely no financial interest in outcomes–not one share of stock, no consulting fees, etc.
MedPac has written about using comparative effectiveness reserach to set co-pays–with higher co-pays for procedures and tests that fall into the “grey area” where we think patients may benefit, but we don’t really have solid evidence.
And, I would recommend that there should be no co-pays for treatments that we know are beneficial (Pap smears, mammograms at certain intervals at certain ages, eye exams for diabetics, etc.)
Negotiating for discounts is a separate issue, but I would think that if Medicare begins using its clout to negotiate for discounts, it would use the comparative effectiveness research to decide where it was going to dig in its heels and say “we simply won’t buy it unless we get a much better discount.”
I’m sure the VA uses its medical records to decide what it must have in its formulary and what is optional . ..
Maggie
You presented the treatment of breast cancer patients with bone marrow transplants in the ’90s. It makes my point. We were subjected to bigger guns, more firepower with high dose chemotherapy and stem cell transplant, costing as much as $250,000. This tragedy was a watershed event for many independent (self-educated) oncologists. More is not always better.
Most randomized trials of the therapy were initiated in the 1990s and did not confirm earlier positive findings. Rather, most of these trials showed little or no benefit for women with breast cancer. The therapy’s stature became even more confusing when data from a large randomized positive trial, presented on the plenary session of the 1999 American Society of Clinical Oncology, was later found to be falsified.
The high-dose regimen slightly improved relapse-free survival by about eight months. However, there was no survival benefit for women who received high-dose chemotherapy. It was “academic” oncologists that kept doing them, even as it became apparent that there were not benefits.
According to the Brase’s report, supporters say practice guidelines are needed to contain health care costs, reduce variation in physician practice, and keep physicians up to date with the latest research. However, practice guidelines have overly rigid standards of care, puts restrictions on medical practitioners’ professional freedom and judgement, and imposes a personal agenda by those choosing which research to do, writing the guidelines, as well as administrative bias by those interpreting the guidelines.
Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, and the drug industry works to produce evidence statements that promote use of their brands of drugs. Independent oncologists are not comfortable that many guidelines are unobjective and unbalanced.
While I don’t remember who said it, I’m reminded of the person who had the epiphany that he had been speaking prose all his life. As I’ve mentioned, I usually go into a physician visit with a written set of goals, questions, etc., for the visit, with backup history, tests, etc.
What just struck me, explicitly, is that one reason that I tend to get agreement, or at least focused disagreement, with a course of action is that my per-visit notes, and often followup summary, is about the best protection from liability that a clinician could want: a statement, in the patient’s own words, assessing risks and benefits of proposed diagnostic tests and treatment.
While I wouldn’t expect most patients to say “let’s get an echocardiogram; if the ejection fraction is 50 percent or better, go with this drug, otherwise don’t use it,” I suspect that more intelligent patients, who come in not just with notes for themselves, but a set of questions and concerns that can go into the chart, as well as a possible followup letter of understanding, might be the patients who don’t get so much defensive medicine.
Looking at defensive medicine in general, and Happy Hospitalist’s example of CT angiography to rule out a very unlikely pulmonary embolism. All cost considerations aside, we now know that CTs, especially the more prolonged exposures as in angiography, deliver enough radiation to cause a slight but real increase in cancer risk. Now, would I want an indicated CT? Of course! But I’m still annoyed about the time that while I was uninsured, and had a soft tissue infection where the risk of DVT was minimal, that I was in so much pain that I couldn’t refuse the ultrasound, at least until a few simpler and cheaper tests were done.
I even do notes like this when an inpatient, and give them to the hospitalist (or have the nurse put them in the chart, frequently having to insist, so they are read by the time the hospitalist sees me).
I’m wondering, and I don’t have an answer, if more patients writing more of their own opinions and goals — even if they don’t have detailed analysis — might smooth a lot of patient-physician relationships. Doing so is certainly not a panacea, and one doing so has to have a realistic self-appraisal of their knowledge.
Gregory–
You write: “Independent oncologists are not comfortable that many guidelines are unobjective and unbalanced.”
Here, I complete agree.
This is why guidelines should Not be written by Specialist Societies. Depending on the politics of the particular society, it may be advocating treatments that are not fully proven on the mistaken notion “more and newer is probably better.”
And there is going to be a financial conflict of interest if most of the specialists are working fee-for-service.
That’s why I think guidelines need to be drawn up by boards of physicains, reserachers etc. who a)work on salary, not fee for service b)have no financial interest in what is or isn’t included in the guidelines and c) are fully familiar with the Dartmouth research and other research which has shown that, often, less care is better care, and that too often, we begin using cutting edge procedure and products without knowing enough about them.
In the case of the bone marrow transplants the Breat Cancer Coalition finally had to write an open letter to oncologists pointing out that this is a very lucrative procedure, that there is no evidence that it works, and that oncologists should consider there own financial conflict of interest.
On the other hand, if guidelines (not rules) are written by group that has no financial interest and is up-to-date on why outcomes are often better when medical practice is
more conservative, I think
those guidelines can help doctors.
The point is that they don’t have to follow them.
If a patient wants a particular treatment that is in the guidelines, and a particiular oncologist does not believe in the treatment, the patient can go elsewhere.
(I would think that the doctor would have a duty to tell the patient that ” This is in the guidelines, many doctors would recommend it, I don’t and here’s why. But you should seek a second opinion before deciding. That seems to me the right thing to do and also protects against accusations of malpractice.)
HC Berkowitz–
It strikes me that if well-educated patients are willing to put something in writing about why they are happy not to have a specific treatment, what they understand about risks and benefits, etc.,
that might reduce defensive treatment.
As I’ve mentioned in earlier posts, the state of Washington has passed legislation that makes it very difficult to sue a doctor if he/she took the patient through the whole
“shared decision-making” process (a formal process with pamphlets and videos).
Donald Berry, Ph.D., professor and head of the Division of Quantitative Sciences at M.D. Anderson, presented findings at the 30th Annual San Antonio Cancer Symposium, high-dose chemotherapy and autologous stem cell transplantation has proven not be beneficial as an adjuvant therapy for women with node-positive disease.
http://cancerfocus.net/forum/showthread.php?t=787
I agree with your point that guidelines are not rules. Try telling that to ASCO. Of course, while independent oncologists acknowledge ASCO guidelines are just that, guidelines and not rules, when they know of cutting-edge technology that has run through the riggers of evidence, but not attached to standards, they will not submit to the status-quo.
The China Study. Read it, if you have not already. More publicity about prevention through change in nutrition is crucial. This is real cost savings but the dairy and meat lobbies blockade this solution.
While I’m glad some of you admire Dr. Hadler, doesn’t it bother anyone that Dr. Hadler had set himself up as an expert on diseases on which he does no research and for which he isn’t even a clinician. I would be able to overlook these shortcomings if there were some objective test to prove his assertions, but there isn’t. Theories are great for academia, but this is the real world and I expect competence not knee jerk reactions.
I expect experts to know what they are talking about.
Kelly–
Read Dr. Hadler’s book,
“Worried Sick”
Everthing that he says is backed up, in the appendix, by detailed references to clinical studies published in peer-reviewed medical journals.
No one person could do all of these studies himself.
Dr. Hadler provides a valuable service by putting the evidence together in one place.