Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

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New Research Report Doesn't Tell The Whole Story

by Dr. Len February 08, 2010

An article published today in the journal Cancer claims that Medicare “incentivized” urologists to do more surgery in their office, and the net result was a significant increase in medical costs for doing the procedures, compared to doing them in hospital facilities.

 

But, just as in all research, it’s important to get the data and the facts correct.  And when you do that for this article, you may just not come to the same conclusions.  In fact, the conclusions may be so different that one might ask whether the authors need to go back to the drawing board and update their report.

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Filed Under:

Cancer Care | Medicare | Treatment

On To The Next Steps In Health Care Reform

by Dr. Len November 08, 2009

I find myself early on Sunday morning after the House of Representatives passed landmark health care reform legislation last night asking how I really feel about this momentous event.

 

The answer is that I actually feel pretty good. And I must admit that surprised me. 

 

Like you, I have been exposed to many “inputs” that have vied for my attention and have tried to influence my opinions.  I would expect nothing less, especially with something as momentous as health care reform legislation.  After all, this is a bill which inevitably will have a substantial influence on how we receive our medical care, how we provide our medical care, and how we pay for our medical care.

 

Some of those inputs are “pro,” some are “con” and all try to sway us into their camp as part of the political process.  Some of the sources are “distant,” but some are very “up close and personal.”

 

I can start in my own family, where our internal discussions about this legislation have given rise to a considerable amount of disagreement. To put it mildly, not everyone in my household thinks this version of health care reform is such a good idea.

 

I live in an area of the country where opposition to health care reform among physicians and my neighbors and friends runs strong and runs deep. 

 

I work for an organization that supports health care reform.  I belong to other organizations that have been very vocal in their support of the reform legislation, and others which are equally strident in their opposition. 

 

I have been glued to my computer, my Blackberry and the various news shows seeking information and opinions on the reform legislation as it moved through the House.   And I haven’t been disappointed with the variety and number of comments that I found through those outlets.

 

So, with all of that considered--including the personal dilemmas and conflicts--how do I finally come to grips with the realization that this legislation will truly change the landscape in this country for health care for the good and the benefit of many?

 

On a personal level—as reflected in one of my previous blogs where I wrote about what I wanted from health care reform—I believe this legislation will move us forward to address several of those concerns in a positive way.

 

I believe that the concepts embodied in this legislation will result in dramatic, beneficial innovations in health insurance and health care that will considerably improve what is now a very dysfunctional system.  I also am of the opinion that this legislation will support “game changing” advances in processes, administrative simplicity, and customer service that we have seen in other industries.  Competition, after all, is usually a good thing.

 

And then there were the statements of support for the legislation that came from sources that I know and trust.

 

Obviously, I work for the American Cancer Society.  The board of the Society made a commitment several years ago to make improving access to access to health care the leading nationwide initiative for the organization.  Comprehensive health care reform is a major part of the effort to improve access to care, and the Society's advocacy affiliate the American Cancer Society Cancer Action Network (ACS CAN) has led the charge for reform on behalf of cancer patients and survivors across the country.

 

Last week, ACS CAN supported this legislation after carefully analyzing what it would mean to people as viewed “though the cancer lens.”  That evaluation showed that there was much in the legislation that met their expectations and our country’s needs when viewed through this prism.  

 

They weren’t alone.  The AARP, other respected voluntary health organizations, the American Medical Association and numerous medical professional organizations also supported the legislation after their own very detailed examinations led them to conclude that the concepts embodied in this bill were overall good for the country. 

 

I keep hearing the same thing from every one of them: there is much here that conforms to our policies and our expectations.  Every one concluded that—on balance—the legislation is overwhelmingly more favorable than negative.

 

There are significant unknowns about the impact of this legislation, as is always the case with something as far-reaching as health care reform.

 

This is a bill that—if ultimately signed by the President—will be subject to regulatory interpretation.  There will inevitably be “follow-on” legislation over the years to further refine and define what we are trying to accomplish.  And that doesn’t even consider the fact that there is still a long way for this bill to travel before it becomes law, as it moves to the Senate followed by the conference committee followed by reconsideration by the House and the Senate before it is signed by the President.

 

So now we move on.  We are not finished with this process, and there is probably going to be a considerable amount of discussion and drama as we go to the Senate and the conference committee.

 

Maybe we are finally on the cusp of making a real difference in the lives of real people.  Maybe we are on the cusp of getting reforms that will work, and which will expand access to health care for people in this country who have no hope today of getting the health care they need.

 

And just maybe we are on the cusp of fulfilling my own long-held dream of developing a truly American solution to providing adequate, affordable, quality health care to every citizen. 

 

Let’s hope that in the spirit that has made this country great, we will not lose sight of that very elusive goal. 

 

Let’s continue to craft that truly American solution, one which will make many of us proud that we worked towards providing an answer to a fundamental need that will improve the health of our nation and benefit us all.

 

 

 

 

 

 

 

Filed Under:

Cancer Care | Medicare

"Gee Whiz" Cancer Surgery May Not Be Best Surgery

by Dr. Len October 14, 2009

I have a confession to make: I am not a big fan of “gee whiz” medical technology.  At least not until it is proven to really make a difference in the care we provide our patients, or the outcomes of their treatments. 

 

A study in yesterday’s Journal of the American Medical Association comparing the side effects and outcomes of prostate cancer surgery using the robot to more traditional surgery reinforces that notion. 

 

Using the robot to treat prostate cancer surgically may be better in some respects, but not better in others.  And maybe not better enough for you to listen to all of the advertising hype about the robot, and forego treatment from a urologic surgeon who in fact may be more skilled at the operation and not use the robot.

 

The study was reasonably straight forward.  The researchers looked at patient information they obtained from a highly respected national cancer database called SEER and matched those men diagnosed and treated surgically for prostate cancer with another set of data obtained from Medicare fee-for service Part B billing records.

 

Once they matched the men in both sets of records, they looked at factors related to treatment and outcome, such as how long the men stayed in the hospital and what complications they had over the year following their operation.

 

Their goal was to evaluate men who had surgical treatment for their prostate cancer one of two ways: with the robot, which is called “minimally invasive radical prostatectomy”, (MIRP) done with instruments passed through small holes and manipulated by a urologist who is sitting at a special machine, compared to men who had their surgery the more traditional way, called “retropubic radical prostatectomy” (RRP) where the surgeon is standing directly by the patient and operating through a more typical (but still fairly small) incision.

 

Both of these operations remove the cancerous prostate, and--when appropriate—allow the surgeon to remove lymph nodes nearby the prostate.  Both are designed to reduce the risk of impotence, which many years ago was a common problem for men who had prostate cancer surgery before newer types of surgical treatment were developed.

 

The robotic surgery is very new, and has only been used to any significant degree to treat prostate cancer since the early part of this decade.  But it clearly has caught the attention of the public, and hospitals across the country can’t seem to wait to get their hands on one of these machines and advertise that they are a “robotic center” to accommodate the patient demand.

 

The problem is that these machines cost millions of dollars, and the disposable equipment sold for each operation has made the company that supplies these machines a heck of a lot of money.  That in turn means more costs for hospitals, health insurance companies, and ultimately the patients.  It also takes longer to do the robotic operation, according to my colleagues who perform this surgery.

 

So, whether or not these machines are really worth it is a very important question.  Not to mention that the increasing concerns about the value of the PSA test has run head long into the reality that prostate cancer treatment in this country has turned into a huge business for doctors and hospitals—whether or not the treatment is necessary.

 

(That issue was highlighted recently by a hospital in Philadelphia offering PSA screening to men 35 years and older, despite absolutely no proof that this was of any value to men in this age group. As with most community screening fairs run by hospitals, I suspect that one of the major drivers for that campaign was probably to “feed the beast” rather than offer scientifically valid screening to men at risk.)

 

So what did the study find?

 

There has been a huge increase in MIRP from 9.2% of prostate cancer surgeries in 2003 to 43.2% in 2206-2007.  However, if you were poor and/or black or Hispanic and/or less educated, you were less likely to get one of these fancy surgeries. 

 

You were likely to spend one day less in the hospital with the robot (2 vs. 3 days), less likely to have a blood transfusion after surgery, and more likely to do a bit better with regard to surgical complications post-operatively.   But the authors also suggested that the number of days in the hospital may in fact be similar in high volume hospitals, so whether or not this difference is “real” is not certain.

 

Another wrinkle to consider in this study was that many of the robotic procedures in this study were performed in Detroit and California, which the authors point out are high volume robotic centers.  This may have contributed to the better outcomes for MIRP, compared to RRP which is done by more surgeons in more locations.  As they say in the weight-loss commercials: “These (robot) results may not represent the typical experience with our product”.  (Detroit, in fact, was one of the “homes” of robotic prostate cancer surgery because of a surgeon there who was nationally renowned for his early work with the robot.)

 

But the robot did not fare better on every measure.

 

You were over twice as likely to have a problem with your urinary tract after the robotic surgery, and have a higher risk of urinary incontinence (controlling your urine flow) compared to the non-robotic technique.  Your risk of having impotence after the robot surgery was about one in four, compared to one in five with the more traditional surgery.

 

Unlike a previous study where the men operated on with the robot were more likely to have an earlier relapse of their prostate cancer and require additional treatment for the spread of prostate cancer compared to men who had traditional surgery, this study showed that both groups did the same.  When it came to the control of prostate cancer, there was no advantage to one type of surgery compared to the other.

 

So what do you do if you are a man diagnosed with prostate cancer who has made an informed decision to have surgery for your disease?

 

I guess for some of you the decision will come down to the old adage “you pay your money and you make your choice.”   You may decide that how long you stay in the hospital is more important than the difference in whether or not you can control your urine flow or are able to have sexual relations.

 

But I think there is a more rational recommendation that actually may surprise you: I suggest you find a surgeon who does either procedure regularly and has done hundreds—if not thousands—of prostate surgeries for cancer.  To me, it is experience that counts not whether the procedure is done with or without the robot.

 

The bottom line is that you can have a great surgeon who doesn’t use the robot, or a lousy surgeon who uses the robot—and vice versa.  The robot does not make an inexperienced surgeon better.  It’s that simple.

 

Take a moment to read this information that was contained in the JAMA paper, and read it carefully.  It is very informative and something that every man considering prostate surgery who has succumbed to the advertising and hype surrounding this robotic procedure needs to know:

 

“For surgeons eager to add robotic-assisted MIRP to their armamentarium, there are few barriers to entry: surgeons must attend a 2-day course before scheduling cases proctored by another surgeon who has performed at least 20 robotic-assisted MIRPs.  Requirements may be less rigorous for attaining hospital privileges for MIRP without robotic assistance*.  Studies estimate the learning curve for either approach is at least 150-250 cases, and greater RRP or MIRP surgical volume is associated with better outcomes.”      

 

(*Note: That means doing the prostate surgery laparoscopically without using the robot)

 

I would suggest that if you need to get surgery for your prostate cancer using either type of surgery, you make certain you are not case #21.  You should be at least case #250, and I would prefer to be case #500 or higher. 

 

Here is what the authors have to say in concluding their report:

 

“In light of the mixed outcomes associated with MIRP, our finding that men of higher socioeconomic status opted for a high-technology alternative despite insufficient data demonstrating superiority over an established gold standard may be a reflection of a society and health care system armored with new technology that increased direct and indirect health care costs but had yet to uniformly realize marketed or potential benefits during early adoption.”

 

In other words, many of us buy the hype and forget the reality that just because it looks fancy doesn’t mean it really gives you a better result.  We are medical consumers run amok, dazzled by ads and unsubstantiated claims rather than by science and documented outcomes.  If we see it on TV or a billboard, it must be better.

 

The science tells me it is the experience of the surgeon that counts, not whether the doctor can play video games. 

 

So, if you decide to get your prostate taken out because you have cancer, go with a surgeon that has done the surgery lots of times, whether or not they use a robot.  You don't have to be uncomfortable if you want to leave the video games to the kids.

 

 

"Euthanasia" Is Taking The Debate Too Far

by Dr. Len August 11, 2009

The debate about euthanasia has gone too far.

 

Someone’s intent to do a good and necessary deed has now been transformed into a hideous misrepresentation that not only affects our humanity and dignity as a nation, but goes to the heart of the physician/patient relationship and the responsibility that physicians have to provide healing and comfort as well as treatment. 

 

That’s our oath, and that’s what we are supposed to do.  Recognizing that imperative is not something that should be punished as an evil act.

 

Perhaps some background would be helpful in framing the issue:

 

Medicare is supposed to only pay for medically necessary and effective care.  It is not allowed to provide other services such as screening or prevention unless specifically authorized by Congress.  End of life counseling falls under the category of non-covered services, but probably gets into the payment mix as part of other billing codes which doctors use to get paid for more routine “evaluation and management” services. 

 

Providing explicit payment for this service will encourage appropriate and needed discussions between physicians and patients on this very important, difficult and humanitarian topic.

 

For years, many of us have been concerned about end-of-life issues, such as living wills, pain management and hospice care.  Counseling our patients as they age about their options—and equally important, understanding what our patients’ wishes may be—is an honored part of the physician/patient relationship, especially for primary care internists, family physicians and oncologists.  The reality is that we have not been as successful as we need to be in encouraging these discussions.

 

We have tried for years to get people to sign living wills and provide durable powers of attorney for health care.  Medical professionals need guidance—preferably in advance of the moment--on what patients want done, either at the time when their lives are coming to an end or when they may not be able to speak for themselves.

 

There is nothing inhumane or inappropriate about that discussion.  It is a discussion that no one wants to have, and one that is never easy.  But it is the right thing to do, and there are plenty of medical and patient organizations who have devoted considerable effort to encourage these discussions.  There is nothing about the discussion that is preordained to limit care.  In fact, some patients and families want “everything done” even when medical professionals find that directive to be against their own ethical instincts.

 

I learned these lessons early in my career as a medical oncologist.  Having discussions about end-of-life is an unfortunate reality in cancer care.

 

What surprised me at the time—when there was less I could do for many patients than is the case today—was the number of patients and families who told me they were more interested in comfort than they were in treatment.  They wanted to be certain someone would be there to care for them through their last days or months and ease their pain and suffering more than they were concerned about getting the next drug which more likely than not would have given them more discomfort that hope and relief from their suffering.

 

Those discussions had an incredible impact on me as a person and a physician, and the experiences remain with me today.

 

I didn’t euthanize anyone, and never, never would such a thought enter my mind.  My patients taught me that having a heart beat and being alive to see the sun rise another day was not living and was not life.  That was their decision, not mine.  I would do what they wanted, but almost always what they wanted was care, compassion and relief from pain. That is what we tried to offer.

 

When I recently heard the gross misrepresentation surrounding the portion of the health care bill that referred to paying health care professionals for these end-of-life discussions, I couldn’t help but be concerned and confused.  When I heard the rhetoric stormed up to a level of “death panels” and “Nazis” I knew we had gone too far.

 

I have stayed out of the politics of health care reform in these blogs, and will continue to do so.  But as I mentioned in my comments the other day, someone has to be an honest broker of what is going on out there, dealing with some of the rhetoric that is coming from both sides and which is designed to inflame rather than inform.

 

If you are a physician who has cared for a patient for years or even decades, you know that person as a friend as well as a patient.  Your goal is to provide the best care you can, but also to provide comfort when cure is no longer the goal.  You counsel your patient and their family on what you think the best path may be at that moment and in the future, whether it be treatment or comfort.  You act as protector for their wishes, the guardian of their health, and at the appropriate time the minister for their comfort.

 

You are not a Nazi.  You are not triaging who will live and who will die.  You are not some thoughtless bureaucrat who is concerned about how much it will cost to keep someone alive.

 

I have stood in the places of remembrance for people who were killed without cause.  I have cried my tears over those who were lost by senseless murders.  I have read the writings of those who survived.  And I will never forget.

 

So please do not dehumanize the memories of those who suffered from terminal illnesses or the ravages of age by suggesting that somehow our great country, our great people, and our great physicians and health professionals are somehow going to become agents of the state and in turn agents of death. 

 

Please understand that dignity in our lives must always be paramount in our thoughts.  Discussing end-of-life wishes is humane and appropriate.  Providing counseling, care, hospice and pain control is in the noblest traditions of our profession and our country.  Listening to our patients and their families is what we do, and what we pledge to do.

 

Continue with the debate and the discussion, make your case and make your points, but do not dishonor those of us who have tried to do the right thing for our patients, families and friends and the memories of those who have died in peace, honor and dignity by make the choices that were best for them.

Filed Under:

Cancer Care | Medicare | Treatment

What I Want From Health Care Reform

by Dr. Len August 08, 2009

I suspect I am one of many who are not unhappy that Congress has finally taken their August recess.  I suspect I am also one of many who are alarmed and upset by the next act in this play, which is the rancor and near-violence we are seeing on our TV sets every day at the various town hall meetings when health care reform is the topic of discussion.

 

This isn’t what health care reform—or whatever you choose to call it—is supposed to be about.  This is a serious matter for our nation and for many of our fellow citizens. It deserves thoughtful and deliberate discussion.

 

The events of the past several days have left me distressed and concerned.  The anger, the accusations, the lack of decorum and the distortions and occasional “untruths” being promoted by all sides have left me dismayed.  It is even beginning to affect relationships among friends and families.

 

All of this has led me to think about what is important to me, and for my family.  What do I really want from health care reform? 

 

1)      I want to know that I can get health insurance.

 

Sound simple?  It really isn’t. 

 

I have been in a medical practice or otherwise employed most of my adult life.  I have always had health insurance for me and my family.  I have had the opportunity to pick my plan, and pay more to my employer and a bit more in co-pays and deductibles so I could get the coverage I wanted. 

 

But I can not let go of the thought that I am one step away from disaster.

 

If I had to go out into the private market today, I would have difficulty getting insurance.  Why?  I have a couple of fairly common medical problems.  I am older.  Members of my family also have some medical problems.  I suspect we would be “rated” and pay through the nose if we had to purchase our own insurance, if I could even get it. 

 

I have “pre-existing conditions” and despite my efforts to take my medications and exercise regularly to keep those chronic conditions under control, there aren’t many companies who would welcome me with open arms.  I am a “high risk”, despite doing what I am supposed to do to avoid a more serious medical problem. 

 

But what if I had cancer?  What if I had heart disease?  What if I had type 2 insulin dependent diabetes?  Do you honestly think I could get insurance anywhere other than through my employer?  And if I was in a small business—such as a medical practice—can you imagine what my illness would do to the premiums of my company?

 

We know that these scenarios are not unusual or unique.  Listen to the stories, read the studies, talk to the people who have faced the problems.  These are real issues, and these are everyday occurrences for honest, hard working people that are right there in your community.  They are your neighbors, they may be your friends, and they may be your family.  They are not fictional, and they have a very real interest in the outcome of this debate.

 

2) I want to be able to afford insurance.  I want the system to be more effective in terms of quality and less expensive (or at least reasonable) in terms of cost.

 

We are out of control when it comes to spending on health care.  That’s it, plain and simple. 

 

People who want insurance and need care can’t get it; some people who have insurance want everything.  Doctors say that they have to do all the tests they do because of “defensive medicine,” yet we don’t talk seriously about tort reform.  And even if we had tort reform, I don’t believe that it will resolve the issue of over-ordering tests and procedures. 

 

Quality of health care is not top of mind for the medical profession in this debate.  We order too many tests and studies too often without evidence that they make much difference.  We can spend thousands of dollars on scans, but can’t afford dollars for vaccinations or “well care.”  We install imaging machines in offices to make more money, because our physician payment system distorts the incentives substantially in favor of doing more tests.

 

We talk about the “savings” that will come from the widespread use of health information technology, yet we don’t have standards that will allow computers to talk to each other.

 

We pay lots of money for doctors and hospitals to do things.  We pay a pittance for those who try to prevent disease, and we pay relatively even less to those who are charged with trying to coordinate the complex medical care of seriously ill patients. 

 

We need to promote preventive medical services, pay adequately for our necessary (and at the very least) basic medical care including primary care, obstetrics/gynecology, and general surgery.  We are losing doctors in these specialties, and it will take decades to replace them.

 

3) I want to know what I am being charged for when I receive a medical service, what my insurance covers, and what I owe in clear, understandable language. I want to know those fees are reasonable for the service provided.

 

We are charged substantial fees for some medical services, and as ordinary people we have no idea whether or not that fee is reasonable or the service is appropriate. 

 

I recently got a bill for the treatment of a member of my family.  Two 1 centimeter superficial lacerations resulted in a $1700 bill, including a remarkable physician charge which was in fact “upcoded” (that means the doctor “coded” for a service that was a higher level code than appropriate for the service that was performed.  I assume it was an “honest” mistake, because if it wasn’t it would be fraudulent).  The skin glue was charged out at about 9 times the purchase cost available to me on the internet.

 

I get hospital bills that simply say “pay us money”.  No itemized bill. No insurance bill or statement, just pay us the money. 

 

Patients go to doctors, who look at you sideways if you ask in advance what their charges are for their services.  Keeping their fees secret has been a long tradition among my colleagues, and in private conversations they tell me they should be able to charge whatever they want to.

 

Some physicians say that we should individually contract or negotiate the costs of our medical care. The man I cared for a couple of weeks ago on an airplane was in no position to negotiate the costs of his care as the emergency medical technicians wheeled him off the plane on his way to the hospital.

 

Hey, folks, here’s a bulletin: there IS no private market in health care, except for cosmetic and concierge services.  Patients are at an incredible disadvantage in understanding the costs of their services. There is no transparency regarding the costs of medical care and services. The prices are jacked up for those who pay because others can’t—or don’t—pay their bills. 

 

My personal experience confirms that you have to go to incredible lengths to get answers to even simple questions, and I am considered an expert in this stuff.  If you are an “ordinary patient,” I can’t even begin to imagine how you would understand the charges and the payments.

 

4) I want to know what treatments and medicines work, what doesn’t work, and if we know whether or not it works.  I want to know that I am getting appropriate, quality care for my medical problem

 

That is NOT rationing.  It is information.  We need more of it.  We are doing too much of what doesn’t work, too little of what does work, and who knows how much of what may or may not work.

 

It may be a surprise to some of you, but there are many thoughtful physicians and top-tier medical professional organizations who have been clamoring for this type of research.  I have said this publicly and will say it here: It is time to understand that just because a doctor recommends something, doesn’t mean it works or is the right treatment for you.  But you (and too frequently even your doctor) don’t know that, because the research hasn’t been done. Think about hormone replacement therapy, and you will understand what I am saying.

 

Here’s another bulletin: In too many circumstances, you have no way of knowing whether or not you are getting quality medical care. 

 

Too often you as a patient have no way of knowing if you are receiving the right recommendations for your health, whether or not there is a less invasive or less expensive treatment option, or whether the treatment has been shown to effectively treat the condition you have.

 

The medical profession should embrace quality, quality improvement, transparency, and accountability to demonstrate they are providing the best medical service.  Unfortunately, this has not been exactly at the forefront of the discussion about health system reform.  If it was, I would venture that patients and those who foot the bills for these services would greet the effort enthusiastically and reward health care professionals appropriately.

 

5) I want confidence that my insurance will be there when I need it for a serious medical illness.

 

We have too many instances—and too many bankruptcies—where “satisfied” people suddenly found themselves not so “satisfied.”  I am willing to bet that you (and me) have no idea whether or not your insurance will be a facilitator or a barrier to your care if you or someone you love becomes seriously ill with a disease like cancer.  You just don’t know. 

 

So don’t stand there and rail against your Congressman or Senator because you are “happy” with your health insurance.  I wonder how many of you have had a serious, prolonged illness in your family.  If your experiences have been positive, terrific.  But don’t discount that many others have not been so fortunate.

  

I am looking for someone who is a “trusted voice” or “honest broker” who can bring this discussion and debate about health care reform back to the center, who can tell us what is in the bills and what is not.  Too many lies, too many untruths and too many distortions have me feeling there is no such voice being heard in the land today.

 

Then there is the question of what we are really talking about anyway.  There isn’t one bill about health care reform; there are several.  And there is one that hasn’t even made it to the public.  (I find myself hoping against hope that those six senators will have the wisdom to get this close to “right” so we can have something that will ignite the passion of those of us who want something done, yet want it done with balance and the participation of both sides of the aisle.)

 

When this discussion started several years ago, the American Cancer Society had four principles that were core to the Society’s efforts surrounding health care reform.  On reflection, those four principles articulated at that time are consistent with what many of us want today: 

  • Adequate—Timely access to the full range of evidence-based health care, including prevention and early detection.
  • Affordable—Costs are based on the person’s ability to pay.
  • Available—Coverage is available regardless of health status or prior claims.
  • Administratively simple—Processes are easy to understand and navigate.

Aren’t those principles what this is all about?  Can’t we focus on those principles and move this process forward?  Is it really that difficult to get this done?

 

We need some sanity in this discussion.  We need to think as individuals, communities and as a nation about what is important to us when it comes to health care reform and our health care in general.

 

I suspect there is a sense in the country that many of us are willing to “pitch in” if everyone pitches in.  This shouldn’t be about us against them.  This shouldn’t be about “I’ve got mine and you can go to h---.”  We are better than that as people and as a nation.

 

It’s time our public discourse and our political/legislative process should reflect the best of what we are as a nation.  We need to get this done.

 

 

 

Filed Under:

Cancer Care | Medicare | Treatment

The Cost and Value of Health Care

by Dr. Len July 20, 2009

I have been thinking over the past several weeks about a topic that is very near and dear to the hearts of many of us, and that is the cost of health care.

 

Let me put a couple of my longstanding, personal guiding principles on the table for your consideration:

 

1)      We spend way too much on “health care” in this country, and don’t get value for what we spend. 

 

2)      I do believe that there is sufficient money within our current health care spending to provide better care to more people at lower cost.

 

I know I am not alone in those thoughts.  The problem is how we move from the reality of today into the vision of tomorrow, and improve the quality of the care we provide while we create a system where the costs of that care more reasonable and rational so we can extend more care to more people.

 

A couple of weeks ago I was in Washington DC and participated in a panel on health care reform for volunteers attending the annual meeting of the Ovarian Cancer National Alliance.  I showed a slide during that presentation that I have shown many times before.  The slide details the per-person spending for health care in about 30 developed countries and compares it to life expectancy. 

 

When you look at the slide, what you quickly see is that most developed countries in the world spend within a fairly limited range per person per year on health care.  One country stands out however, and that is the United States.  It ain’t even close:  we spend a lot more than other countries per person on medical care.

 

Maybe that wouldn’t be so bad if we had a life expectancy to show for it, but we don’t.  We are actually near the bottom of the pile when it comes to the number of years the average American lives compared to other countries.  We are actually right next to Cuba, who spends almost nothing on providing health care to its citizens.  (By the way, Japan leads the list with about 80.5 years per person.)

 

Usually when I show this slide (which was prepared by my colleague and Chief Medical Officer of the American Cancer Society Dr. Otis Brawley), it gets some attention from the audiences, which are usually made up of people familiar with the subject such as doctors or human resource directors. But this time, there weren’t a lot of doctors in the audience, just committed volunteers committed to their cause. 

 

There was an audible gasp and reaction in the room when I explained the slide.  Clearly it struck a chord.  It is that graphic a representation of where we have failed to get “value” no matter how much we pay for “health”.

 

We have the most expensive health care in the world and we have the most technologically advanced system in the world (at least with respect to machines, but certainly not in relation to health information technology).  But if we tried to measure the quality of the care we provide, the fact remains we would have an impossible task to show that we offer a reasonable quality of care for the money we spend.  There is simply very little accountability built into our processes of providing medical care.

 

Now I don’t want to imply that a lot of doctors don’t care about their patients.  They do, and they are for the most part exceptional, committed people.  But listen carefully to all the discussions surrounding the current health care debate, and most of what you will hear is about money and costs.  No major medical organization—pro or con the larger issue of health reform—is out there waving the quality flag in front of costs and income.  They just aren’t doing it.

 

And yet accountability and quality are really at the heart of the issue.  Getting the right care to the right person in the right place at the right time would take us a long way to getting our arms around the problems we face when it comes to providing affordable, accessible quality health care.

 

It’s not just the doctors who are responsible for this dilemma.  Talk to them and you hear about patients demanding all sorts of treatments, even to the extreme of sending someone to the intensive care unit when they are near death with no reasonable options remaining.  You constantly hear docs talk about defensive medicine, and the fear of being sued for not doing every test possible. 

 

I call this “zero order” medicine.  Zero order meaning nothing is left to chance, and nothing is left to judgment.  It means every test possible is expected, and gets done or risks a malpractice suit.  It is a love affair with technology that implies that if the test is done with fancy equipment, it will work better and tell us more than perhaps doing nothing for the time being.  It means there must be one more medicine available that is going to cure a cancer, or one more stay in an intensive care unit that will allow a lung to breathe on its own once again, after years of damage from smoking.

 

A couple of examples recently have refocused me on this issue. 

 

One example was an article in the New Yorker magazine where a doctor eloquently described the differences between two towns in Texas, and where he tried to figure out why health care was about twice as expensive in one town vs. another while there was no significant difference in health care outcomes by any measurement he could determine.

 

Another was an article in the New York Times recently where the reporter asked if we were getting our money’s worth from very expensive prostate cancer treatments compared to “watchful waiting.” He noted for many men it was not possible to demonstrate that one approach to prostate cancer treatment (depending on the underlying characteristics of a man’s prostate cancer) was necessarily better than the other, while some of the more “advanced” approaches were incredibly more expensive.  (And this is in the face of recently reported research which has shown that it is very difficult to show a real difference in survival as a result of prostate cancer screening.)

 

There are research studies that show prostate cancer is found with about the same frequency in men who are screened vs those who are not (and were biopsied anyway as part of a research study).  That has led some of us start asking the question what difference does PSA testing really make? 

 

And then there is the fallout from a number of prostate cancer survivors (and doctors) who are upset about what we say, since many of them believe—because they have been led to believe—that the PSA test in fact saved their lives. 

 

So where is the honesty that can say to men that maybe the PSA test did save your life, but there are many more men who had the test and debilitating, expensive treatment where it didn’t make a difference because we can’t tell you whether or not your prostate cancer would have been a “bad” one?

 

Here is another example:

 

I returned from vacation to find a letter on my desk—sent certified mail to me and a number of other thought leaders in medical oncology—from a woman who had a strong family history of breast cancer.  She had discovered a lump in her breast and saw her doctors.  She had a mammogram and ultrasound which were inconclusive as to whether or not the lump was a cancer.  One of her doctors—a breast surgeon by specialty—ordered an MRI of the breast. 

 

The bottom line of her letter—with the supporting documents—was that her insurance company had denied the MRI.  The woman thought that was terrible.  She wanted the MRI, her doctor had ordered the MRI, and the insurance company had denied the MRI.  Her argument was that she should have been allowed to have the MRI, which I believe she eventually did get.

 

I read the insurance company letter, and guess what:  I think they were correct.  The mammogram and the ultrasound were inconclusive and cancer could not be ruled out.  They very clearly stated that medically she needed to have a biopsy.  The MRI wouldn’t help make that decision.  

 

They made the exact correct recommendation.  There was nothing about the MRI that should have deterred the physician from proceeding with the biopsy. She needed a biopsy of the mass.  That's what the insurance company said.  Medically, it was the correct recommendation.  From my view, it had nothing to do with cost.  It did have to do with "good medicine."

 

But, you may say, patients aren’t doctors.  They want to do what their doctors say they should do.  They say, “Dr. Lichtenfeld, you are a trained physician.  You have much more knowledge than the average person.”  Yes, that’s correct.  I do.  And so did the doctor who recommended the MRI.  I just hope the MRI wasn’t in the doctor’s office, which I have seen advertised by other “breast specialists” or in a hospital that employed the surgeon who made the recommendation.

 

By the way, I haven’t seen in the correspondence that anyone who saw this lady suggested she have genetic counseling for the BRCA test.  Her history certainly suggested that would be appropriate.

 

In another example, I sat next to a very healthy and admittedly active gentlemen in his mid-30’s on another plane flight.  He was a successful consultant and exercised regularly.  He appeared very fit.  He told me about his back problem, which flared about once a year for a couple of weeks and then resolved.

 

For the past four years, he would see his primary care physician when the problem recurred.  Every time, his primary care doc sent him to a back specialist, who ordered an MRI.  Every year the report came back that they cannot identify the cause of his pain.  The back specialist recommended an over the counter pain medication and told him to call if it didn’t get better. He always got better.

 

Having treated a fair number of patients with low back pain just like his, I asked him if anyone—particularly his primary care physician—ever had a conversation with him suggesting that he didn’t need the MRI or have to see the back specialist if his pain hadn’t changed or resulted in certain neurologic changes?  Or, that even if they found the cause of the pain (something like a bulging disc) most surgeons wouldn’t operate unless there was severe, unremitting pain or a change in his exam?

 

The answer was “no,” and the gentleman indicated his frustration that he went through this every year, and all he got was a suggestion to go get and MRI and some NSAIDs.  I asked how he felt about the necessity and costs of the MRI—which probably would be billed at a couple of thousand dollars—and he said that didn’t bother him.  After all, he said, the specialist said he needed it and who was he to argue with a doctor?  As to cost, he only had to pay $100, so why not get it?

 

I could go on and on—including the $1100 bill someone I know very, very well faces for a recent emergency room visit for a daughter who was injured while volunteering as a waiter at a faith-based camp.  The bill was for medical services provided to her when she broke a glass in her hand and had to go to the emergency department for an examination, in an overabundance of caution.  In the ED, she was found to have two minor lacerations with no shattered glass in them, and she had some surgical glue applied to each laceration.

 

The cost?

 

  • $62 for a vial of generic local anesthetic
  • $109 for each of two surgical glue packets
  • $339 for a low intensity emergency room doctor bill
  • $244 for the use of the emergency department.  

 

What would Medicare have allowed for the $339 doctor visit?  The answer: $39.31.

 

That’s right: they charged the young lady almost 9 times what Medicare would have paid for the service.

 

I tend to be an optimist.  Some people might say I believe in the tooth fairy (maybe it’s a carryover from the days when I played tooth fairy for my children).  I have hoped for a long time that one day the folks that are engaged in health care would wake up and develop a sense of rmission and reasonableness when it comes to what they do, how they do it, and what their responsibility is to their patients—both with respect to quality and costs.  Take the best practices and spread them around the country so everyone can benefit.  Demonstrate that as a profession we take quality seriously as a core part of our work.

 

Would it be so hard for someone to say that a test or x-ray may be useful, but in fact it is reasonable NOT to do the study?  Or to say that we really don’t have the evidence to support the usefulness of a test that a patient may want?  Or that we find a way to protect those doctors who make good decisions in line with well thought out recommendations and guidelines, even if the eventual outcome may be that 1 in 10,000 chance of having missed something?  Or that we learn—once again—on how to do a history and physical and advise our patients of their options, and engage them in a learning process together so they don’t go off and spend thousands upon thousands of dollars needlessly and with blind faith that the next test is the best test?

 

Is that asking too much?

 

I suspect it is, and unfortunately I don’t have an easy answer.  There are places in this country that provide high quality, evidence based medical care.  It is part of their core mission.  The amazing thing is that these places are recognized as providing some of the best care in the country, but they frequently do so at substantially lower cost.

 

As a country and its citizens, we desperately need to rethink how we do this.  I would prefer that we do this rationally and voluntarily, and commit ourselves to partnership, shared understanding of risk, quality care, fiduciary responsibility to each other and accountability for the care we provide and the care we receive. 

 

But I fear—after almost 40 years of hoping to the contrary—that we aren’t going to see that day anytime soon. 

 

I guess I will just have to accept the fact that the tooth fairy is a fiction, after all.

 

 

Filed Under:

Cancer Care | Medicare | Treatment

Thank You, Mr. President!

by Dr. Len June 25, 2009

Last night was a special moment for me: I was one of those 164 people representing the “face of America” that was in the East Room of the White House as Charlie Gibson and Dianne Sawyer from ABC News interviewed the President as he answered questions about health care reform.

 

My bottom line conclusion?  This guy knows his stuff.

 

You may have already seen the telecast or snippets on the morning shows (if you can get past the lead story about the Governor from South Carolina).  If so, there isn’t much I can add to what you have already heard.  But what I can say is that—aside from the glamour and imposing “presence” of the room itself—I was overwhelmingly impressed with the President’s grasp of the issues and his ability to respond effectively if not always completely to the questions he was asked.

 

I have been through this before.  I have been “in the room” when political figures address audiences and promote their policies.  And, like you, I watch television from time to time, see the debates, listen to the Sunday morning talk shows, and draw conclusions as to whether I agree or disagree or whether I like or don’t like (or don’t really care) about the person who is the target of an interviewer’s probes.

 

I have over the years become somewhat blasé and perhaps a bit cynical about “the show”.  The answers are frequently scripted and perfunctory, repeating the same sound bites again and again.  They are—in a word—predictable.

 

One could make the argument that the President’s responses last night had some of that same predictability.  But although the interviewers and the questioners had their scripts in hand (it appeared that the people who appeared on camera had been selected after having submitted the questions in advance, since the hosts knew who they were looking for and those people were positioned in certain accessible parts of the room), I don’t believe the President knew what was coming.

 

That’s why I believe his presentation was in fact what I would call a “tour d’ force” on health care reform.  You may not agree with him (I won’t tell you here which parts I thought were right on target and which ones gave me pause), but you can’t fault him for not knowing his topic. 

 

This man sat there for 90 minutes and took on every question he was asked.  And although some of us in discussions after the show recognized where he did a little bobbing and weaving, almost to a person we thought he was masterful in his ability to articulate his position.  And those comments came from some of the most knowledgeable Washington health care “players” that I know.

 

That, my friends, is what I would call “high praise.”

 

It is clear that this President means what he says about advancing health care reform.  Looking at him up close and personal—and I was close if not personal—I can tell you he didn’t flinch, didn’t recoil, and didn’t react adversely to any question (although I did think his answer about basing health care policy decisions on a person’s “spirit” to live put him in a tough spot).

 

So, if I had the opportunity, what questions would I have asked?

 

First and foremost, I would have thanked him on behalf of the Society and the millions of people and their families who are confronting cancer today for making the issue of accessible, affordable, quality health care a priority of this administration, this Congress and this nation.

 

I would have asked how his proposal would have helped the Americans who spend themselves into poverty treating cancer and other chronic diseases. 

 

Our advocacy affiliate, the American Cancer Society Cancer Action Network recently completed a survey that showed 20% of American families spend most or all of their life savings when faced with paying for cancer treatment, and one out of seven families accumulate thousands of dollars of uncompensated debts as a result of a cancer diagnosis. 

 

The diagnosis of cancer not infrequently—and unfortunately—brings with it huge personal financial burdens and all too often outright bankruptcy.  We can’t have people going through their life savings while fighting for their lives.  It’s almost like being in a fight with one hand tied behind your back, although in the case of cancer the consequences are much more serious.

 

I would have asked how we can make certain that everyone has access to preventive services, so we can find cancer early when it is most treatable and offers the best prognosis.  Too many people have to put off or never get recommended screenings for cancer because they simply can’t afford them or don’t have health insurance that covers them.

 

My next question would have been about the portability of insurance coverage, and how to maintain affordable, effective health insurance even if you are too sick to work. 

 

The platitudes about COBRA and how it protects us makes me want to…. (fill in the blank, because I can’t write the words I would like to say here).  I have been out of work in the past, and even 10 years ago the cost of maintaining health insurance for my family was over $12,000.  Without an income and not much savings, that was a very, very large number.  A member of my family recently graduated from college, and the cost to insure her was enormous.  She is now among those 46 or 47 million uninsured they talked about last night.

 

Being sick with cancer and losing your job is bad enough.  Paying through the nose for health insurance after you lose your job makes it worse.  Talking dispassionately about how people can maintain their coverage in those circumstances as though this was a simple mechanism at a reasonable cost just doesn’t cut it with me.  I guess you could say that this particular issue is personal.

 

The final question would have been what protections will be put into place to be certain that people have health insurance that is adequate to meet their needs if they have to be treated for cancer.

 

Too many folks find out too late that their health insurance has a variety of limitations and maximums that simply don’t cut it in today’s expensive treatment environment.  When you have drugs that cost over $100,000 a year each, and scans that cost over $3000 each, you find out that what you thought was a lot of coverage can disappear very, very quickly.  We need to provide assurance to the American people that they have adequate coverage for the prevention, diagnosis and treatment of cancer, from the very first step to the very end of life.  No one—and I mean no one—wants to have cancer.  And no one should be left unable to afford effective, quality based, adequate treatment for their disease.

 

So those were the questions I would have asked the President, and you can decide for yourself whether or not he answered those questions in response to the ones he was asked last night.  And if you didn’t hear the answers, maybe you can ask those same questions yourself and decide whether or not the various plans you are hearing about every day meet the tests outlined above.

 

Let’s finish here on a perhaps more humorous note, which is the “other comment” that I was prepared to make.

 

If you know me, you are aware that I look somewhat like Phil Jackson, the coach of the Los Angeles Lakers who recently won the NBA championship. Knowing that the President is a basketball fan, I was prepared to respond if he made the comment I have heard many times before, namely “Do you know you look like Phil Jackson?”

 

My response to the President would have been, “Sorry, Mr. President, but I’m not Phil.  However, my colleagues at the American Cancer Society, our advocacy affiliate the American Cancer Society Cancer Action Network, and our millions of volunteers across the country would like to bring home a more important championship, which is accessible, affordable, and adequate health care reform for everyone in this country.”

 

That is something all of us could celebrate.

 

Mr. President, thanks for inviting me to your “House.”

Filed Under:

Cancer Care | Medicare | Treatment

CT Colonography and Medicare: Are We The Enemy?

by Dr. Len June 17, 2009

A recent article in the New England Journal of Medicine praising the decision by the Centers for Medicare and Medicaid Services to not cover CT colonography for the prevention and early detection of colon cancer for Medicare patients left me with a great deal of concern—especially since it was written by some of the same people who made the decision in the first place.

 

I consider myself a fairly reasonable, experienced and tolerant person when it comes to the legislative and regulatory decision-making processes.  You win some, you lose some, you reevaluate and generally you move on to the next issue.  But this time, for me at least, it’s different.

 

The article, which was published online on May 27, 2009 in the New England Journal of Medicine, reviewed the basis for the decision denying coverage for CT colonography in the Medicare program, an issue I have covered previously in this blog.

 

Here are the opening paragraphs from that article.  Remember, these are the words of the authors, some of whom had either participated in or wrote the final CMS regulation denying coverage for the test:

 

“In an unprecedented endorsement of evidence-based medicine, the Centers for Medicare and Medicaid Services (CMS) recently decided to deny coverage of computed tomographic (CT) colonography for cancer screening, concluding that ‘the evidence is inadequate.’ The CMS emphasized that the ‘pivotal, overarching concern’ in its decision was the fact that the findings of trials showing a benefit of screening with this method were not necessarily generalizable from the study populations to other groups of patients. In particular, the CMS noted that the mean age of participants in the studies that were cited in support of coverage was significantly lower than that of Medicare beneficiaries. There were no studies evaluating this technology in the elderly, nor were there analyses of subgroups of participants over 65 years of age.

 

“Does the CMS’s strict application of evidence-based analysis herald a shift in its approach to national coverage decisions? We hope so.”

 

My friends, these comments have serious implications.  These are not the words of some outside experts or editorialists who are offering an opinion about how Medicare should make coverage decisions.  These are words of the decision makers themselves.  

 

The key words here are “evidence based analysis.”  Just remember that one person’s conclusion about the results of such “evidence based analysis” may not be the same as someone else’s.  Tweak the data inputs on the models and your evidence-based analysis may go right out the window if you don’t have accurate, up-to-date information.  An analysis is only so good as the quality, validity, and “timeliness” of the data you have to analyze.  Sometimes you have to acknowledge that the data in your model may not be good enough.

 

In the case of CT colonography, I would argue (as I have previously) that the data used in this analysis was, shall we say, a bit dated.  In included studies that looked at old technology, did not consider the new huge costs of treating advanced colorectal cancer with targeted therapies, and didn’t address the question of what happens if more people end up getting effectively screened for colorectal cancer and prevent the disease, as opposed to simplistically concluding that CT colonography vs. traditional colonoscopy is an “either/or” decision.  And, it ignored the fact that you can’t compute the cost of the test if you have not yet determined what the payment will be for that test in the Medicare fee schedule.

 

The authors go on to say that the quality of evidence for many of the treatments we use for Medicare patients is weak.  That is a very true statement, and an unfortunate reality.

 

In fact, I would maintain that if we applied strict evidence criteria to the diagnosis and treatment of Medicare patients today—as suggested by this article—then we could solve the shortfall in the Medicare program tomorrow, because virtually no drug, no test or any procedure would survive this rigorous “evidence based analysis” that was applied to CT colonography.

 

I assure you I am no wild-haired doctor who thinks that the government should pay for anything I want to do for my patients, regardless of cost or other consideration.  It is no secret that I believe we must carefully evaluate what we do for our patients, and that we must move to a paradigm where we provide the right care to the right patient in the right place at the right time.  Simply stated, in the United States we spend way too much money on medical care and don’t get sufficient benefit in return.  I firmly believe that we need to address the overuse of tests and procedures of little or marginal value, if we are going to “bend the curve” of rising Medicare and medical expenditures.

 

But when it comes to saving lives, I think we need to be a bit more careful about the conclusions we draw from the evidence that we have as well as the evidence we don’t have. 

 

When there are significant and substantive disagreements about the evidence and the impact of a particular screening test or treatment that is used in the Medicare population, we need to develop approaches that are designed to resolve those ambiguities before concluding that the test doesn’t work.  We must seek the answers to the questions we must ask.  We can do that through the Medicare program, through the judicious use of a process called “coverage with evidence” or CED.

 

The American Cancer Society and the medical professional organizations that approached CMS about coverage for CT colonography recommended such a CED process be used in this circumstance.  The professional societies agreed to put a rigorous process in place to answer the very questions that CMS was asking.  That wouldn’t result in wide and unfettered use of the test.  Rather, it would continue evaluation of the test while allowing the opportunity to get screened with the test to move forward under very controlled conditions.  They have already done that with other radiology tests, specifically PET scans.

 

CMS denied that request, although they didn’t mention that in their “evidence based” article.  They claimed to us that they couldn’t use CED under their regulatory procedures since—unlike PET scans which are used in to treat of cancer, and which is there is substantially less well done evidence-based research—CT colonography is used to prevent cancer.

 

Other very knowledgeable experts disagreed on their interpretation of the law and their regulations, but the CMS folks were—in my personal opinion—too anxious to “just say no” and prove their point that they could stand up to the “special interests” that were pressuring them to do otherwise.  Their “article” in the NEJM—which appeared surprisingly quickly in a journal that is known for very long lead times for publication of scientific articles--suggests that there may indeed be some foundation to my opinion.

 

Here is another quote from the article:

 

“These findings suggest that many previously approved interventions may lack evidence of benefit in the Medicare population — the group for which U.S. taxpayers are footing the bill. We believe that the CMS’s decision in the CT colonography case, therefore, is a long-overdue step toward meaningful validation of clinical-trial evidence in Medicare beneficiaries.”

 

But here is what I would call the “zinger” paragraph, the one that gave me pause and the greatest concern.  Remember, these authors are in part the “judges” of the decision.  Some of them are or were employees of the agency at the time the decision was under consideration, and had influence on that decision:

 

“Our optimism, however, is cautious. Powerful pressure will inevitably

be applied to the CMS. Indeed, after the agency published its draft decision in February, proponents of CT colonography, in a now-familiar pattern, quickly mobilized. More than 350 comments were submitted to the CMS by interest groups, many with a financial stake in use of the technology. Radiologist groups

and manufacturers of CT equipment, among others, launched a write-in campaign, conducted congressional briefings, and persuaded 56 members of the U.S. House of Representatives to sign letters urging the CMS to reconsider.

Advocates for the medical device industry asserted that the agency lacked the authority to consider data on cost-effectiveness in its decisions. Already at least

one representative, Kay Granger (R-TX), has issued a press release expressing the hope that the CMS will reconsider its decision.”

 

Maybe this is the place where I should be grateful that the authors didn’t offer full discussion of the events that went on prior to the final decision, but here is the fact:  One of those groups who participated “in a now-familiar pattern” was the American Cancer Society.  We submitted comments, we participated in public and private meetings with CMS, and we participated in a congressional briefing where I personally presented a discussion about colon cancer and the potential value of cancer prevention and early detection, which in our opinion includes CT colonography.  But maybe mentioning the American Cancer Society would suggest that not everyone who promoted coverage of this test had a direct financial interest in the outcome.  Maybe we aren’t viewed to be as villainous as the others the regulators singled out in their article.  Whatever the reason, we were there because we have come to the conclusion that this test would save lives from a preventable disease.

 

(By the way, to my knowledge, we have made no direct contact with any legislator about this issue, nor participated in any group which asked Congress to approach CMS on this issue.)

 

After all, we had published a guideline in March 2008 and came to the conclusion that CT colonography was a useful test—in fact, a preferred test—to prevent and detect colorectal cancer. We did so independently.  We don’t make CT scanners, we are not a medical device manufacturer, we have no patents on the technology, and we don’t earn our living from doing the test.  We just represent the ordinary person out there who may want to avoid a fatal disease.

 

One more thing: you should not be singled out as a scoundrel for pleading your case to federal regulators. 

 

Last time I checked, this is a democracy.  You are allowed to let your elected representatives know your position, and you are allowed to submit your comments to regulators about pending regulation and even to speak to them about your concerns.  It is not illegal, unethical, inappropriate, inconsiderate or anything else.  It is part of the way we make decisions in this country.

 

Here’s more from the article:

 

“Indeed, it is worth asking why the CMS has acted differently this time. Perhaps the agency is responding to the current economic reality: with the Medicare hospital insurance trust fund projected to become insolvent by 2017, the CMS no doubt recognizes the need to ensure that we are spending Medicare dollars, first and foremost, on improving the lives of Medicare beneficiaries. With Medicare expenditures increasing at an unsustainable pace, the CMS appropriately —

indeed, necessarily — considered whether the procedure is effective in its beneficiaries.”

 

I don’t want to sound cynical here, but last time I checked Medicare was supposed to provide coverage for reasonable and necessary medical care.  The fiscal issues are nothing to sneeze at.  They are very real, very legitimate and for many of us immediate concerns.  But that is a legislative issue.  The key words for Medicare are “reasonable and necessary.” 

 

I would propose that we need to move forward with CT colonography under a CED process, and answer the legitimate disputed question about cost effectiveness.  The American Cancer Society obviously believes the test is “reasonable and necessary” and in fact considered it “preferred” as a means of finding colorectal polyps before cancer develops and invasive cancers at an early stage.

 

There is no question but that the costs of medical care are a real and pressing concern.  We are in the midst of an intense debate about the financing of health care in this country.  Part of that debate includes a discussion at the political/legislative level about what treatments and medical services we will pay for going forward, and how we will make those decisions.  That is part of the public debate, as it should be.  But now we have the regulators stepping out in front of everyone else in claiming they will solve the problem, even if the premises on which they base their decision may be subject to criticism.

 

What is the problem with their premises?  The technology on which many of the effectiveness studies have been done was old technology.  Assumptions regarding the use of the test may be flawed.  The cost data was from a past era in the treatment of colorectal cancer.

 

Even the President acknowledged in his speech to the American Medical Association the other day that one of the measures that will save us billions of dollars in health care costs over the next decade will be making biologic therapies—read that “targeted therapies” in cancer care—available as generics as soon as possible.

 

What you may not know is that the costs of biologics is rising and rising quickly in the Medicare program.  And these drugs are used to treat advanced colorectal cancer.  And the “cost effective analysis” done by Medicare gave the costs of those drugs no consideration, since it was based on data from earlier in this decade before biologics were even available to treat this disease.

 

So, the President knows this issue.  His regulators obviously do not.  Prevent a colon cancer and you may just save the system a whole lot of money, not to mention someone’s life.

 

As to CMS’ cost effectiveness analysis itself, I heard another presentation at the recent meeting of the American Society of Clinical Oncology that disputed the CMS’ “definitive” conclusion.  Although the presenter acknowledged the issue, he concluded that the data on the newer CT colonography technology is simply insufficient to draw meaningful, firm conclusions.  And, my friends, he is not a gastroenterologist, a radiologist or a medical device manufacturer.   He is a highly respected chairman of a department of internal medicine at a major medical center.

 

Here is the concluding paragraph from the article:

 

“We applaud this landmark decision, and we hope that the agency remains firm

in its evidence-based approach and extends its application as health care reform proceeds.”

 

Given the fact that two of the authors on this article were directly involved in the CMS decision, it sounds more like a pat on the back than applause from the audience.

 

My bottom line concern?  We need to fix this system and this process, but we need to do so in a way that is realistic and not absolutist. 

 

Those of us who tried to work with CMS to get this done the right way (and offered concrete suggestions on how to do that) ended up being vilified in the pages of the world’s leading medical journal.  That is not a comfortable place to be.

 

If this is the attitude that we are going to have to deal with as we move forward in tackling these difficult issues, then that portends real difficulties as all of us try to work together to solve the very real problems we face when it comes to improving the quality and costs of our health care delivery system.

 

Simply stated, there has to be a better way.  Publicly questioning and criticizing the motives of others in the pages of the New England Journal of Medicine is not going to get us where we need to be.

Filed Under:

Colon Cancer | Medicare | Screening

Is Comparative Effectiveness The Answer?

by Dr. Len April 17, 2009

There are two new buzz words that could have significant implications for our health care going forward.  Those words are “comparative effectiveness.”

 

Why is comparative effectiveness so important?  Because depending on your interpretation and definition of the concept, this could be anything from a very much needed way to address some nagging questions about how we treat different diseases or the forerunner of a more aggressive effort to control medical costs.

 

It is no secret that many of us think we spend too much money on health care.  We have a difficult time in this country demonstrating that we get true value for the money we spend.  Our technology in health care is state-of-the-art, unlike any place else on earth.  However, our outcomes are far down the list when we compare ourselves to other countries when we look at some measures of health, such as our average life expectancy.

 

One of the things we have learned over the past couple of decades is that we don’t know as much about the effectiveness of our treatments as we should. 

 

For example, are newer medicines for the treatment of common chronic diseases like diabetes and high blood pressure really better than the older drugs that are substantially less expensive?  In cancer, the question would be whether drugs that doctors use in treating patients—especially at the end of life with third or fourth line therapy for metastatic disease— are really appropriate if there is no evidence that they provide significant benefit under such circumstances?

 

Just look back on our experience with hormone replacement therapy, which took years to develop a sufficient body of evidence to help us understand the true benefits and risks of these commonly used medicines.

 

I could go on, but in my world comparative effectiveness means trying to get to the heart of these issues.  There simply has been very little money available to organize the type of research that needs to be done to answer these fundamental questions.  It would be—in my opinion—a good thing to be able to conduct such studies and get the evidence we need.

 

But there is another side to the comparative effectiveness debate that is beginning to raise some concerns, especially in the context of health care reform.

 

I have personally been troubled about how easily some think we can easily reduce health care costs in the United States. 

 

I have been around for a while, and if someone had the answer to that question (think managed care and Medicare, the former which is supposed to organize networks of care and the latter for the most part intent on driving down payments to the lowest fee) I think we would have seen it already.  We haven’t, and we aren’t going to get there quickly with our current “piece work” payment system.

 

Enter comparative effectiveness definition #2: we should carefully study the evidence supporting our treatments, and if we don’t have evidence, we shouldn’t pay for the treatment.

 

In cancer, it goes to the question of off-label therapy which I addressed in a recent blog discussing articles that appeared in the Annals of Internal Medicine.  No evidence, no treatment was the conclusion of the journal’s articles and editorial.  The problem is that the majority of cancer treatments in this country are in fact off-label based on the opinions of experts who have reviewed the evidence, none of which may be sufficient for a company to go to the FDA and get approval for a specific cancer drug or combination of drugs to treat a specific cancer.

 

Another example might be CT colonography.  The American Cancer Society thinks the evidence is sufficient to recommend this test as a reasonable one to prevent colorectal cancer.  The US Preventive Services Task Force does not.  The Centers for Medicare and Medicaid Services (CMS)—which administers the Medicare program—has issued a preliminary decision not to cover the test.  Their final recommendation is currently under review.  And this is a test where there is published literature to support its value and its use.

 

On the other hand, when I sat on a panel to evaluate the evidence supporting the use of PET scans in cancer, the quality and amount of credible information to support PET scanning in the diagnosis and treatment of cancer was actually very limited.  It was only because we had data from a PET scan registry that had followed some patients on Medicare that we got anywhere near concluding that the science in any way supported the use of PET scans.  And this is for a test that is used routinely and accepted without question by cancer specialists in the United States.

 

In a comparative effectiveness world as envisioned by some, they would use this process to deny payment for “unapproved” treatments under government programs.  That, to me, is not comparative effectiveness.  It may be something else, but it isn’t comparative effectiveness.

 

 In the United Kingdom, they have a group called NICE that determines what medical services are paid for by the National Health Service.  I have been interviewed fairly often on the topic of how cancer treatment differs in the United States and Britain, and how our systems differ in advancing new technologies.  Inevitably, the questions come down to which approach to providing health care is best: basically open access to everything, or strict limits which allow more people to be covered?

 

I am not a fan of the concept that every new test, every new drug and every new gadget necessarily improves our health care here in the United States.  But there have been some major examples where a new treatment is available quickly here, such as the use of Herceptin as an adjuvant therapy in HER-2 positive breast cancer, long before Britain decides that  they can pay for it.

 

My concern is that if we adopt a “strict evidence” standard here in the United States, we are going to become much more like Britain.  Maybe that’s a good thing, maybe it’s not.  I can’t make that determination.   That’s something that needs to be discussed and debated.  But it has to be an open and honest discussion, not couched in words that have different meanings to different people.

 

We can’t go on spending the way we have on health care, without expecting some limits of some kind.  We simply can’t afford it as a nation, while millions go without insurance and adequate medical care.  We are going to have to make some decisions at some point on how we can more effectively make our system more rational.  Right care for the right person at the right time is a responsibility for all of us, doctors, medical professionals, patients and families alike.

 

How we address the question of “comparative effectiveness” and what it means and what it is expected to accomplish may seem like a small point that is flying under almost everyone’s radar as we tackle larger issues, but I suspect if we don’t get it right we will live with the consequences for years to come.

 

 

Filed Under:

Cancer Care | Medicare | Treatment

Public Health Meets Policy: Colon Cancer Screening

by Dr. Len March 09, 2009

It’s fitting that during Colorectal Cancer Awareness Month there is an intense discussion in the medical and regulatory communities and elsewhere about whether or not we should offer Medicare patients the option of a new screening test for colorectal cancer (CRC).

 

The test is called CT colonography (CTC), or virtual colonoscopy.  In short, it is a CT scan that can find polyps and cancers in the colon with x-rays.

 

As of now, the odds are against coverage for this test by Medicare.  But there is still time for the Centers for Medicare and Medicaid Services (or CMS, which runs the Medicare program) to review comments from interested parties and perhaps reconsider its recent preliminary “non-coverage” decision.

 

I previously wrote about CTC in 2007 when an article was published in the New England Journal which supported the use of this test as an alternative to traditional colonoscopy for CRC screening.  Another article published more recently in September 2008 reported on the results from a carefully done trial where CTC was compared with traditional colonoscopy as a screening test, and fared well.

 

In March of 2008, the American Cancer Society published new guidelines for the prevention and early detection of colorectal cancer.  The Society was joined by other professional organizations in writing these guidelines.

 

One of the key recommendations in that report was that we should favor tests that can prevent colorectal cancer, primarily through the detection of pre-cancerous polyps which, when removed, do not go on to become cancers.  It was in this vein that CT colonography was recommended as another option to find these pre-cancerous polyps as part of those guidelines. 

 

But despite this recommendation, concerns about CTC have persisted.

 

One key issue surrounding CTC is that if a polyp or lesion suspicious for cancer is found on the x-ray, then the patient still has to undergo a traditional colonoscopy to remove the polyp or biopsy the abnormal lesion.  

 

Some centers can do this immediately “on demand.”  But many cannot, so it means the patient would have to undergo another bowel cleansing and colonoscopy on a different day.  Going through a bowel prep for colonoscopy—whether CTC or traditional—is not anyone’s idea of a fun time.

 

The good news is that with improving technology, CTC has become much more effective at finding polyps that are more commonly associated with a higher risk of becoming cancer.  And that technology continues to improve.

 

Unlike traditional colonoscopy, a CTC does not require anesthesia and has a much lower risk of perforating the bowel, which can happen with the traditional study more often than most people realize.

 

On the other hand, CTC can be an uncomfortable test.  It requires that air be forced into the colon while the patient lies on their stomach.  Some people find that actually painful.  There is also concern about the radiation dose associated with CTC.

 

Looming over all this is the fact that CTC is essentially a CT scan, and CT scans of the abdomen will find other things that may or may not be significant.  That could lead to further diagnostic tests and surgery that might otherwise not have been needed for something that would never have caused a problem for the patient.

 

The American Cancer Society and its collaborators reviewed the evidence and thought that CTC should be an option for patients to consider “on the menu” for colorectal cancer screening, along with testing the stool for blood, routine colonoscopy, barium enema and sigmoidoscopy.

 

Others have reviewed the same evidence and came to different conclusions.  They did not think the evidence was sufficient to support CTC as an alternative for CRC screening.

 

More recently, Medicare was asked to review the evidence on CTC and make a nationwide determination as to whether or not it should be available for people on Medicare.

 

There is a very specific approach called a “national coverage decision” (or NCD) used by CMS to make these determinations.  (Much of Medicare coverage is in fact based on “local” determinations by Medicare carriers, but that is beyond the scope of this discussion.  In this case, the determination was going to be made by the central office in Baltimore).

 

As part of that determination, they reviewed a significant amount of evidence including a recent review and recommendation from the United States Preventive Services Task Force that there was insufficient evidence to support CTC as an effective screening procedure for CRC.

 

The result is a preliminary conclusion from CMS that the test will not be covered.

 

Why is this so important, and why are so many organizations—including the American Cancer Society—working to have this decision reconsidered, or at least subject to further careful ongoing evaluation to answer some of the questions raised by CMS and the USPTF?

 

Colorectal cancer is the second leading cause of cancer death in this country.  It affects both men and women, and overwhelmingly occurs in people age 65 and older.  It increases in frequency the older we get.

 

We know that colorectal cancer—which currently takes the lives of almost 50,000 people a year in the United States—could be prevented in many cases or at least found early if we followed the current recommendations to screen for the disease. 

 

Right now, some estimates are that about one-half of the people age 50 and older are getting screened.  My personal hunch is that number is actually inflated.  But even so, if only 1 in 2 people are taking advantage of screening for colorectal cancer, then we could do much better.

 

“Much better” in this case means that we could save thousands of lives every year when it comes to colorectal cancer if we only applied the knowledge we already have about screening for this disease.  Even if we were perfect, we wouldn’t find every case.  But, we would be a lot better off than we are now.

 

When you look at the age when colorectal cancer is diagnosed in the Medicare population, and realize that it takes 10 years or longer for many polyps to develop and become cancerous, then you wonder how many lives could be saved or at least relieved from the suffering that colorectal cancer brings, even if it occurs near the end of life.

 

It is my opinion and that of my colleagues here at the American Cancer Society that CTC could help reduce the disability and death from this disease.  I suspect it will encourage more people to be screened for this cancer.  Some of those people—especially those in rural America--may not have access to colonoscopy, given the shortage of trained colonoscopists in this country.  CTC would probably assure 60-70% of the people screened with this new “virtual” test that they don’t have a problem and don’t need to go on to routine colonoscopy.

 

Treating colon cancer—especially when it spreads—is becoming more and more expensive, with the newer chemotherapy and targeted therapies that have become available.  Reduce the incidence of CRC by finding a polyp in the colon before it becomes cancer and you not only reduce suffering but you reduce costs as well (by the way, estimates used to look at the cost effectiveness of CTC as part of this process used data from 2003, which was well before the newer expensive drugs became available).

 

So, we find ourselves on the horns of a dilemma. 

 

The American Cancer Society and others say CTC is an effective test and should be available from appropriately trained physicians and centers.  Others look at the same data and conclude the test is not ready for prime time, calling for additional studies.  Still others say we can do those studies while we are providing access to CTC with appropriate quality controls, yet there is no money to do the studies.

 

In the meantime, lives literally hang in the balance.  And the people whose lives are hanging have no idea that they will be victims of colorectal cancer 5, 10 or 15 years down the line.

 

We need to take a careful look at how we spend money for health care in this country.  That is no secret and no surprise.  But here we have an opportunity to do this the right way, while at the same time working together to answer the questions and be certain we do get it right.

 

Maybe CT colonography as a screening test is just the right place to start asking those questions and getting the answers, while saving lives as part of the process.

 

I don’t think from a public health or public policy point of view it gets any better than that.  But first, we need Medicare’s help to get it done.

Filed Under:

Colon Cancer | Medicare | Screening

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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