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Why Can't We Get It Right?

by Dr. Len December 13, 2005

I recently wrote about the new Medicare program which asks oncologists to provide information about their cancer patients, and whether or not they were following accepted national guidelines in their treatment plans and programs.

 

Shortly afterward, an article and editorial appeared in the Journal of the American Medical Association which highlighted the problems we have as a nation in getting the right treatment to the right patient, and the length of time it takes to get “new” treatments accepted by the medical (and possibly the patient) community.

 

The article discusses a recommendation that was made by a National Cancer Institute consensus conference in 1990 about the treatment of patients with advanced, surgically resectable colon cancer.

 

Basically, based on research that had been completed prior to that conference, experts concluded that the use of a combination chemotherapy program after the surgical removal of advanced, resectable Stage III colon cancer significantly improved survival.  These studies had demonstrated a 40% decrease in the risk the colon cancer would recur in these patients at high risk, and a 33% decrease in the chance these same patients would die from their cancer.

 

In the cancer world, that was very exciting news for a disease that, at the time, was very difficult to treat effectively if it recurred after surgery.

 

One would be right to assume that doctors jumped on the news and immediately began to treat their patients with the new treatment.  The evidence suggests otherwise, and the JAMA article indicates that we could still do a much better job—based on information obtained 13 years after the initial conference.

 

What the authors did was look at information obtained through a program called the National Cancer Database (NCDB).  This program, which is a joint program of the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society, receives information from 1430 hospitals throughout the United States.  These hospitals, which are reviewed regularly by the CoC to assure they meet agreed upon standards for the treatment of cancer, maintain tumor registries in their institutions and transmit the information to a central location for collection and analysis.

 

Although the information may not be obtained as quickly or as in much detail as many of us would like, the fact remains that the NCDB is the largest national source of information on what is happening with the treatment of patients with cancer in this country.  In addition, while many cancers are now diagnosed and treated outside of the hospital setting, surgery for colorectal cancer still has to be done in the hospital, which means that the information is entered into the hospital cancer database, and updates are provided periodically by the physician after the patient’s primary diagnosis and treatment.

 

The JAMA report is based on information obtained from over 85000 patients with colon cancer treated in 560 hospitals from 1990 through 2002.  Some of the hospitals were smaller community institutions; some were large nationally recognized cancer centers.  What they all provided was information that can give us a sense of how patients fare in the community setting, as opposed to clinical trials which are much more selective and controlled in terms of who gets treated and how they get treated. 

 

In other words, the information in this report based on the NCDB data is more “real world” and helps us to understand what is actually going on with medical care as opposed to what may be seen in a research program.

 

So what were some of the findings? 

 

First, some good news: the use of adjuvant chemotherapy in patients with advanced resectable colon cancer increased from 39% in 1991 to 64% in 2002.  Five year survival in these patients at high risk of recurrence increased 16% compared to surgery alone, supporting the initial research findings that adjuvant treatment (preventive therapy given after primary surgery) really does work as predicted from the studies done in the 1980s.  And, adjuvant therapy worked just as well in older folks(80 years of age and over) as it did in younger people (the average patient who gets colon cancer in this country is in their late 60s, which means that a number of people are much older when they are diagnosed).

 

But there was some not-so-good news as well.  Although blacks were treated less frequently in the beginning of the study, they had the same treatment rates at the end of the study.  Despite that, they had less benefit from the treatment for uncertain reasons.  Women were treated less frequently than men, and as mentioned the elderly—who apparently have an excellent response to the treatment—received it less frequently for a number of reasons, including physician bias that the risk of the treatment was greater than the benefit.

 

But in one area in particular, the results of the study were unsettling:  despite a long history of knowing that this treatment works, only about 2 out of every 3 patients who should have received the adjuvant therapy actually got it.  That means about 28,000 people did not receive a treatment with a proven benefit of decreasing their chances of the cancer returning, and did not have the opportunity to improve the odds that their life could be saved.

 

There may well be good and valid reasons why these patients didn’t get the adjuvant therapy.  Perhaps they were truly infirm and in poor health.  Perhaps they didn’t want to go through the chemotherapy because they couldn’t get to the doctor or didn’t want to deal with the side effects.  But one reason that should not be on the list is because their doctor didn’t talk to them about it.

 

The same data base that provided the information for this study also can tell us which hospitals have a high rate of appropriate adjuvant therapy for colon cancer, and which ones don’t.  Maybe it’s time patients asked their doctors what their hospital’s rate is for complying with this recommendation.  Maybe hospitals should voluntarily post their information publicly for all to see.  Maybe we should ask Medicare to ask the doctors specifically when they care for patients with advanced colon cancer whether or not they gave the patient the right treatment, and if they didn’t give the treatment, what valid reason they have for not offering it to their patient.

 

As a profession, we can no longer hide behind the skirt of the concept that every doctor does everything right.  Study after study shows this just isn’t the case.  And here we have evidence that despite many, many years of knowledge we aren’t anywhere near where we should be in giving a potentially life saving treatment—even to patients who are over 80 years old.

 

I respect my physician colleagues, and I support them actively in a number of ways including providing extensively of my time and expertise.  But I can no longer accept that we can’t get the right treatment to the right patient at the right time on a consistent basis.  It is particularly disheartening when talking about a treatment that over time has proven it has life saving potential.

 

As a profession, we have an obligation to commit to systems that verify the quality of our care.  We have an obligation that every patient who can and should receive this treatment is able to receive it.  Nothing less is acceptable, and what this study highlights is that we can’t wait another 20 years to make it better.

Filed Under:

Can Medicare Measure Quality Cancer Care?

by Dr. Len December 06, 2005

One of the major questions facing medical practice today is how we measure the quality of care we deliver to our patients.

 

It is not an easy task. 

 

Most doctors’ offices don’t have electronic medical records, so gathering data by hand is a major barrier.  Even those offices with computers don’t have systems in place that can easily gather information (other than for billing purposes), much less analyze it.  And, looking at information as part of an overall quality improvement effort is not part of the doctor’s training or routine practice.

 

Some organizations have made substantial efforts to examine these issues, along with their group practice and individual physician performance.  Large medical groups such as Kaiser Permanente have been looking at their practice information and practice quality for some time.  There are certainly many others throughout the country who do the same thing.  But most doctors don’t practice in such groups, and collecting and analyzing data in a meaningful way is a difficult task for the reasons noted above.

 

For those reasons, a program that Medicare is undertaking on January 1st is worthy of note. It will be interesting to see how it fares.

 

Last year, in response to decreasing reimbursements to oncologists for cancer chemotherapy administration in their offices, Medicare implemented what they called a demonstration project.  In this project, if the doctor (or the staff) asked the patients receiving chemotherapy a couple of questions regarding pain, nausea and fatigue, the doctor received $130.  

 

The intent of the program was to improve the quality of care for the patients and focus attention on the symptoms cancer patients experienced while receiving chemotherapy.  However, it remains unclear what happened to the data from that program and whether or not it had the desired effect of improving the quality of care.  After all, aren’t these questions the doctor should already be paying attention to as part of her/his normal care for the patient?  And shouldn’t those symptoms be addressed as part of that care?

 

One of the questions that continues to confront cancer medicine is whether or not patients are getting appropriate treatment at all stages of their disease.  What constitutes appropriate treatment may differ in the eyes of one doctor vs. another, but there are some organizations out there that have done an excellent job of establishing reasonable guidelines for cancer care based on the consensus of experts in the field.

 

So, as opposed to asking questions about something doctors should already be doing, could Medicare do something to address the more general quality of care issues?

 

In response, this coming year on January 1 Medicare will modify their original program described above, and institute another one that is more focused on the actual overall quality of care provided the patient. 

 

What Medicare has done is establish a program where the oncologist who sees a cancer patient for an office visit can submit a code to Medicare through the billing system, and be reimbursed $23 extra every time they see the patient who has one of 13 cancer diagnoses which are part of this program (see the press release from CMS for more specific details of the program and the diseases being covered).

 

The doctor’s report has to include the code describing the primary focus of the office visit, the patient’s current disease state, and whether the patient’s care adheres to clinical guidelines as provided by that National Comprehensive Cancer Network (NCCN) or the American Society of Clinical Oncology (ASCO).  The doctor can also indicate that the guidelines were not followed, because of patient preferences or because the doctor didn’t agree with the guideline.

 

One of the specific questions on the list is whether the patient’s care is affected by participation in a clinical trial.  Since the doctors are being encouraged to adhere to clinical guidelines, it may not be such a long step to start enrolling patients in clinical trials.  Increased participation in clinical trials is important if we are to continue to quickly improve the treatment of cancer in this country and the world.

 

Medicare says in its press release, “This demonstration also meets the objective of helping us learn to what extent Medicare beneficiaries are being treated in a manner that yields the best outcomes, understand clinical cancer scenarios where there is not a clinical consensus among physicians on the relevance of specific guidelines, and ensure that due emphasis is placed on a multi-disciplinary, comprehensive approach to palliation and end of life care.”

 

That’s a pretty tall order, but if it works it will represent a major step forward in patient care, especially if the data really help meet the objectives noted above.  It is particularly important since cancer for the majority of folks is a disease of aging, so much of the treatment for cancer in this country is paid for by Medicare.

 

I should note that Medicare is not the only health organization that is looking into ways to improve the quality of care patients receive.  There are many initiatives underway in the private sector as well, including efforts by accrediting organizations such as NCQA and JCAHO, insurance companies, and medical associations. 

 

One collaboration in particular, the Ambulatory Care Quality Alliance, has brought together representatives of all of these groups—including the federal government agencies with an interest in this issue—to develop common measures that can be used by all of the organizations to examine the quality of medical care. 

 

Another organization, the National Quality Forum, has a several year history of collaboration to arrive at valid measures of quality that can be used in the same manner.

 

We are going to see more and more of these types of activities which promote quality medical care.  Consumers, insurers, the government—and, yes, medical professional organizations such as the American Medical Association—all realize that we have to do a much better job of documenting the quality and effectiveness of the care we provide.  There is a huge demand from many sectors that we demonstrate that we are in reality providing the highest quality of medical care in the world to our patients.  It is no longer sufficient to say we are doing it—we have to prove we are doing it.

 

There is nothing wrong with the concept, but it is the approach as to how we get this done that is going to be difficult.

 

If the Medicare project demonstrates real results showing that this method can improve the quality of patient care without being excessively intrusive or costly, then it could be the first real step down a road that has a long way to go.

 

 

 

 

 

Filed Under:

The (High) Costs of Cancer Chemotherapy

by Dr. Len December 01, 2005

There is an article in today’s Wall Street Journal that addresses a problem many cancer patients are going to face: How will we pay for these new, innovative, effective and very expensive medications that treat cancer and other chronic diseases?

 

This is not a new topic. The affordability of drugs have long been a problem for many patients.  Years ago, if you had hypertension, diabetes and heart failure and you had to take medications on a daily basis your drug bill could run to several hundred dollars a month. 

 

If you were insured, that wasn’t much of a problem.  The doctor prescribed the drug, the insurance company created a list of preferred drugs and adjusted the co-pay depending on whether you used a generic, a branded approved drug, or a drug that was not on the formulary, you went to the pharmacy and you got your medications..

 

There were howls from employers, insurers and others about the high and rapidly climbing costs of medications, and there were meetings held to discuss the topic and try to find a solution.  Discussions centered around the value of the drugs, and the impact they had on keeping people out of the hospital (a very expensive place to be) and remaining productive.  The argument was that drugs kept down other costs in the health care system, so to single out their costs as the problem wasn’t the key issue since increased costs in one part (medicines) kept down costs in the other part (the hospital).

 

If you were elderly, on Medicare and not eligible for Medicaid because your social security check was too large (and that wasn’t very much), you scrounged to find the money to pay for your drugs—while trying to keep a roof over your head and having left over to buy groceries.

 

The world of cancer chemotherapy wasn’t much better.  Chemotherapy drugs were expensive in comparison to other medications.  And with the introductions of new drugs and new drug combinations, the costs began to mount.  But they were still much less than is the case for many drug treatment protocols used for cancer treatment today.

 

But nothing—nothing—compares to what we have seen over the past couple of years.

 

I have written previously about the advances we have made in cancer treatment, especially in the area of targeted therapies which take advantage of changes in the cancer cell vulnerable to attack by specifically targeted drugs. 

 

Think of it as rational drug design: define the target and the effect that target has on a cancer cell (such as production of a protein that helps keep the cancer cell alive), and then either search for a compound or develop one that interferes with the target.  The result is that the cell has a serious interruption in its internal operating mechanisms, and if the target is an important part of the cell’s immortal life cycle, then when the target is blocked, and the protein is not produced, the cell dies.  The result is a shrinking tumor or a disappearing white blood cell, as is the case with chronic myelogenous leukemia when treated with Gleevec.

 

There are several of these targeted therapies that have come to market, and many more are in the pipeline.  In fact, probably the majority of cancer drugs currently under investigation or development are of this type.

 

But it became evident a couple of years ago that these drugs were not going to be inexpensive.  Research and development costs were substantial.  The risk of getting a drug through the various clinical and regulatory hurdles raised the barrier to actually getting a drug into standard clinical use.  And, it wasn’t clear how many patients would be able to use the drug.  (The recent example of Iressa takes the case one step further: a drug approved for clinical use is withdrawn after a follow-up study failed to show effectiveness.)

 

When Gleevec first became available, the manufacturer made a special effort to let the American Cancer Society know that patient support for affording the drug would be available.  They had programs in place, and our call center was provided with the phone number.  This was one of the first of the large scale targeted therapies to become generally available, and many of us were a bit taken with the price of the drug. 

 

Taken by mouth, Gleevec was probably covered in some fashion by insurance plans, but oral drugs were not covered by Medicare at the time.

 

From that moment going forward, I was interested in what would happen when people were not able to afford the drug or the co-payments for the drugs.  Certainly this would be a problem for folks on Medicare who had limited resources.  Personally, I anticipated we would be hearing from many people who couldn’t afford the drugs.  I also thought it would quickly become a question on the national agenda.  After all, this wasn’t a problem limited to cancer patients.  As documented in the newspaper article, there are many diseases other than various cancers where the huge costs of medications are a significant issue.

 

Now for the interesting part: despite keeping my ear to the ground through a variety of organizations and other connections and resources, I didn’t hear the expected outcry.  Reporters interviewed me regularly about the new approaches to the treatment of cancer, and the new drugs.  Together, we marveled at the science and its potential.  We discussed the many new drugs in the pipeline.  We shared our concerns about the cost and the affordability of the drugs.  And then the same question would be asked: have you heard about people not being able to afford the drugs, or insurers not paying for the drugs, and, by the way, are the states paying for these drugs through Medicaid? 

 

I would constantly ask people if they had heard from patients about the problem.   To my continuing surprise, the expected large volume of concern hasn’t occurred. (We have a call center that probably has had some calls on this topic, and we have a pilot program that helps people understand their insurance and can provide some guidance for resources they can pursue to help get payment.  But, as a general policy, the American Cancer Society can’t make grants of the thousands of dollars it would take to help all of the people who are in need.)

 

The article in the Wall Street Journal now offers an explanation as to what may have been the reason there hasn’t been more of a problem.  Although the report in the paper is not a thorough, scientific study of the issue, it does address in a very practical manner how patients and the pharmaceutical companies are working through their difficulties in getting coverage for the drugs.  (The article is well done, and if you are interested in this topic, it is worth reading. The Journal has done several excellent pieces on various aspects of this topic over the past couple of years, including one that reviewed the risks and expenses of developing these new drugs).

 

By establishing support programs, apparently the drug companies are routing money through charitable foundations to help patients.  This is legal, according to the article, and one quote is that this is a win-win for both the companies and the patients.

 

But it is still a critical question, and one that we must face.  I don’t know the right price for a particular drug.  In a sense, we have to rely on the companies to set the price at the appropriate level to provide them the incentives to do the basic and clinical research to develop these new drugs, few of which will get into actual clinical usage.  But we also have to rely on them to not be too extravagant in their pricing, such that no one can afford these medications.

 

Another concern is that as we go forward, we are going to become increasingly more knowledgeable and sophisticated in targeting our therapies to a particular cancer in a particular patient.  That in turn may mean customized treatment programs which may differ from patient to patient, even though they have the same type of cancer.  We are actually seeing the beginning of that today in the treatment of patients with Tarceva and lung cancer, where we have a test which may increase the predictability of response to the drug.

 

When our treatments become more narrow focused, will we still have an economic incentive to develop drugs, and not have each of them cost hundreds of thousands of dollars for a course of treatment each year?

 

What about health insurance maximums?  It used to be that a $1 million lifetime benefit limit was sufficient and almost no one reached it.  Now, it’s nowhere near adequate to see some of us through a serious, chronic illness.  Some companies and plans are even doing away with benefit maximums, although several experts say that such a plan is corporate suicide and is not justifiable from an insurance standpoint.  These experts say that the increase in the cost of insurance would skyrocket if such plans became widespread.

 

Then there is Medicare.  Drugs given in doctors’ offices, up until now, have been covered under Medicare Part B.  The costs of these drugs have had a real impact on the budget neutrality of Part B, and have in turn contributed to the increased premium seniors have to pay.  (Budget neutrality in Medicare Part B means that when costs go up in one part, reimbursements have to go down elsewhere since the amount of money in the program is fixed.  As I write this, reimbursements to doctors for their services are going to decrease 4.4% on January 1, 2006, in part as a result of the increased costs of drugs and technologies paid by the Medicare program.)

 

Finally, there is the 800 pound gorilla that starts on January 1st.  And that is Medicare Part D.  There are many, many seniors who are going to benefit from this program, if they can get the help they need to figure out which plan is best for them.  But, eventually through Plan B and Plan D, looking down the road to the future, the fruits of our research success are going to come knocking at the door of Medicare as more and more of the new drugs become more and more expensive.

 

I don’t have an answer to this dilemma.  As mentioned above, the hue and cry that I expected has never become a prominent issue on the national medical/political radar.  We haven’t started to talk about rationing—yet.  And we haven’t seen a drug insurance co-pay scheme that goes beyond the generic/brand name/formulary approach described at the beginning of this blog. 

 

On the horizon, however, are plans to link co-pays to effectiveness, and when that happens someone is going to be making decisions to have you pay more for very expensive drugs if the insurance company decides that the very expensive drug doesn’t really do much to improve the quality of your life or the length of your days.

 

These are all complicated issues.  We all need to be aware of this issue.  We need to find a way to resolve it, especially to see that those who need these medications are able to get them. 

 

The alternative is going to be a multi-tier health care system, where the wealthy get the medications, and those relying on social security go without.

 

I’m not certain that many of us are yet ready or prepared to allow that to happen.

 

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About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

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