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« A different kind of gift.... #RochMN | Main | Mayo Clinic doc says colorectal cancer drug improves survival.... #RochMN »

01/09/2012

Picking on Mayo Clinic: Waste or Foresight?

The New York Times recently published an opinion piece by two physicians, one an oncologist and one a general internist, who decry Mayo Clinic's current cancer proton-therapy construction projects. One each in Arizona and Rochester, Minnesota will cost $180 million apiece.

Dr. Robert Foote, who is at the forefront of Mayo Clinic's proton therapy development, said neither Dr. Ezekiel J. Emanuel of the University of Pennsylvania nor Dr. Steven D. Pearson of Massachusetts General Hospital called him to ask about Mayo's motivation.

According to their opinion piece, "if you want to know what is wrong with American health care today, exhibit A might be the two new proton beam treatment facilities the Mayo Clinic has begun building, one in Minnesota, the other in Arizona, at a cost of more than $180 million dollars each. They are part of a medical arms race for proton beam machines, which could cost taxpayers billions of dollars for a treatment that, in many cases, appears to be no better than cheaper alternatives."

To read the opinion piece in full, click here  (http://opinionator.blogs.nytimes.com/2012/01/02/it-costs-more-but-is-it-worth-more/).

Reactions to the controversial piece were varied, with a mix of pointed criticism and head-nodding agreement (particularly about the need for a different type of Medicare reimbursement).

Both the University of Pennsylvania and Massachusetts General said their physicians were expressing their own opinions, not speaking on behalf of the institutions.

Both Penn. and Mass. General have proton therapy centers. Mass. Geneneral's proton center director was not available, a public relations spokeswoman said.

Mayo's CEO, Dr. John Noseworthy, wrote to the Times, saying, "Mayo Clinic is resolute in its commitment to advance new, superior treatments that best serve patients based on clinical evidence. Our intent is not profit, nor is it to contribute to the medical arms race. In fact, we chose not to build a proton beam center on our Florida campus. That area was served by another center."

Jeff Bauer, a Chicago health futurist and medical economist with "40+ years of full-time experience in health care, including 17 years as a professor at two state medical schools, 4 years as health policy advisor to Colorado Governor Richard D. Lamm, and 20 years as a consultant and writer" had the following written responses to a Post-Bulletin inquiry:

Enough evide to support construction of proton centersThe authors' argument is internally inconsistent.  On the one hand, they want to deny payment for proton beam therapy due to a lack of research on its effectiveness.  On the other hand, they criticize one of the world's best research institutions for wanting to acquire equipment to conduct the needed studies.  I would put Mayo at or near the top of the list of health care systems that ought to have a therapeutic proton beam accelerator because it is a world-class research organization.  

• How proton technology fits in context with MRI, CTs, etc.I was serving as Health Policy Advisor to Colorado Governor Richard D. Lamm when CT and MRI were in the early stages of development for clinical applications (i.e., where proton beam therapy is today).  Like Drs. Emanuel and Pearson, he initially argued that government policies were needed to prevent excessive spending on new, unproven technologies.  I think I helped Gov. Lamm see the value of good research to develop both technologies and expect that he would now be glad he did not forever push a political position comparable to the one published in the Sunday Times.  CT and MRI have been among the most beneficial medical technologies ever developed, more than justifying the costs of research and development.  The issue of the cost of the proton beam procedure, the $50,000 fee that Medicare will presumably pay for the procedure, is a completely different economic issue from the cost of R&D, and I share Drs. Emanuel's and Pearson's concern with the per-procedure charge (see below).  I've long argued that indefensible fees are charged for fully-defensible technologies.  Many medical procedures cost way too much because the technologies are used inefficiently, not because the technologies themselves are too expensive.  For example, CT and MRI tests would cost a whole lot less if hospitals used the machines more intensively.  A typical 500 bed hospital in the US would have three CT scanners and 2 MRIs that are basically operated from 8 to 5; one of each device could provide just as many tests at a much lower cost if it were operated at least 16+ hours a day, as is the case in some very good 500 bed European hospitals.  The high costs of many health care procedures in the US result from poor utilization, not the expense of the device needed to perform them, as shown by the history of CT and MRI.  The $50,000 Medicare reimbursement is a red herring.

Mayo Clinic plans to enter all its patients into research studies. Is that a reasonable answer to critics (who say there's not enough evidence proving proton therapy works better)It is not only a reasonable answer; it is an essential answer, and I am glad that Mayo will be among the institutions able to conduct the research.  Contrary to the implication of the article's statement that there is not a single randomized trial -- the implication being that we only need one center to conduct the research (i.e., sorry Mayo, the door is closed) -- we need several competent research organizations to be pursuing the technology because several research studies are needed to support any conclusions.  Given my background in medical research and statistics, I would not be convinced that proton beam therapy was beneficial on the basis of a single randomized trial, the "gold standard" that is missing according to Drs. Emanual and Pearson.  In other words, I strongly support Mayo being involved in proton beam research so that we can gather enough evidence to learn if it ought to be offered to any patient, regardless of its price.

What should average Americans consider when reading about such topicsI think my answer to the previous question raises a few issues that average Americans should consider (e.g., R&D costs and charges are very important but different issues that ought not to be confused, need for many good research studies to decide whether the procedure has clinical merit independent of its costs).  I also think that typical Americans ought to care more about the totally idiotic way that Medicare pays for care on a fee-for-service basis.  To me, the issue is not whether Medicare can afford another provider charging $50,000 for proton beam therapy, but why Medicare is paying $50,000 to any provider in the first place.  The way the Medicare sets its fees should be added to the list of things nobody would ever want to watch, which so far includes making sausage and passing laws.  

Assessment of Medicare concerns raised by the opinion pieceI wholeheartedly agree with their defense of dynamic pricing and other market mechanisms that would prevent insurance from paying more than the least-cost approach to produce a given outcome.  If proton beam therapy ultimately turns out to be no better than other therapies for a given disease, then no insurance plan should pay more for proton beam therapy (assuming that an economically defensible price is being paid for the least-cost, clinically acceptable alternative).  If the patient wants to pay the difference, that's OK by me, but I do not want to be paying higher insurance premiums for overpriced reimbursement.  On the other hand, proton beam therapy could ultimately justify a relatively higher reimbursement (but probably not $50,000) if it is demonstrably superior to other therapies for a given condition.

Other things to mentionI wish the authors had directly addressed the implicit issue of rationing (the elephant in the room).  ObamaCare, which was certainly based on a lot of input from Drs. Emanuel and Pearson, absolutely prevents Medicare from basing coverage decisions on the results of comparative-effectiveness research.  Curiously, the authors promote dynamic pricing in the article (with my strong support), but they helped pass a law that makes it illegal for Medicare payment determinations to be based on economic factors (a part of the ACA that I strongly oppose).  To Dr. Emanuel's credit, he has actually taken a very defensible position on this issue in some of his other articles, but I think there's a lapse of consistency in this one.  In my opinion, we will not halt the rising prices of health care procedures (a different issue than total expenditures on health care) until we develop a national policy that rations care on the basis of costs and benefits.  The authors may be making this point in their last paragraph where they condemn the "no questions asked" basis of current Medicare reimbursement, but I sure would like to see a strongeer statement about the need to have a public debate about rationing because it's a precondition for creating efficient and effective health care.

Here is a summary of responses from Dr. Andrew Lee, director of the MD Anderson Proton Therapy Center in Houston, Texas:

27PT_proton_therapy_center_building_MDAnderson
[MD Anderson Cancer Center, Proton Therapy Center, Houston, Texas. Photo by Jeff Hansel. Please click to enlarge. Copyright.]

On the New York Times piece:

• "It is an opinion. That's what it is, it's an opinion."

• "Some of the stuff in there's factual. Some of it's maybe an exageration. Some of it's maybe not so factual."

• "It's an opinion piece. It's not meant to be a peer-reviewed article."

• "Everyone's entitled to an opinion."

• "It's meant to be thought-provoking and provocative. It does mean that it's true."

Do medical centers with proton therapy compete, or collaborate

• "I would submit to you that there's almost no current operational proton center that's in operation, or that's being built, where someone from one of those entities has either not come to MD Anderson to actually visit the center and/or spent some time training here and/or have attended one of the conferences that we've provided." Mayo Clinic staff have been to MD Anderson several times for training.

• Loma Linda, Massachusetts General and Indiana have proton therapy.

"We don't need to compete with those three centers. that was not our motivation."

Is there enough demand for proton therapy?

• "Even if there's 20 proton centers operating full blast in the US's, we're maybe going to address 4 to 5 percent of the radiotherapy population, if that."

• "Even our center, which is pretty big, we probably only can treat 1,200 pts a year."

Research:

• "We're also trying to study it to see how we can make things better. That's what top-flight institutions should be doing."

Medicare

• The authors argue Medicare pays $50,000 for proton therapy, twice the cost of X-ray radiation. But IMRT is the type of conventional radiation therapy used most often, which is much more costly than X-ray.

• "This is misleading."

And a summary of responses from Dr. Foote of Mayo Clinic:

Competition or collaboration?

• "There's not competition. I think if you talk to the academic medical centers that have proton beam therapy, they'd all say that the enemy is cancer and we're all trying to work together to fight this common enemy and help each other develop more-effective and safer treatments."

• "I think they'd all say that the enemy is cancer and that we're all trying to work together to fight the enemy."

• We've done a lot of work with our colleagues at MD Anderson Cancer Center. Their facility is the closest to what ours will be like, as far as the same equipment vendor. And so our physicists and dosimitrists have spent, and will continue to spend, time there at MD Anderson getting training on the treatment planning and treatment delivery process — and they're not charging us any money for this. It's a consumption of their resources. It has a negative impact on their efficiency when you have people there standing around asking questions and slowing down the workflow."

Mayo Clinic also plans to host staff from other health organizations once its own proton centers open.

Evidence about whether proton therapy works better than conventional radiation

• "Our goal is to have every patient that we treat with proton beam therapy on a clinical trial, and we will be collecting, prospectively, outcomes data on all the patients. They're all registered on a patient registry where we study them into the future as long as they live."

Data collected will include:

+ how long do they live?

+ how often do they experience recurrences?

+ what kind of side effects and complications do they develop — and how severe are they?

• That data will be compared to published national benchmarks for people treated with conventional radiation. It could take 10 to 20 years to get long-term results because it takes that long to start seeing long-term complications. Data comparing conventional complications such as nausea, vomiting, diarrhea, burned skin, dry mouth, altered taste, and problems of the bowel and of the bladder should be available quickly.

• "What kind of a monetary value do you put on that and what's that worth?"

• Is medical evidence lacking that proton therapy is unproven? "I think you can make a reasonable argument that's not true." Loma Linda Medical Center has published results on more than 1,000 prostate cancer patients, with long-term followup. Massachusetts General has published results on about 2,000 to 3,000 patients with melanoma of the eye. Mass. General and MD Anderson have published results on hundreds of patients with prostate cancer.

What happens if studies show proton therapy is not as effective as conventional therapy"Then we go with the standard therapies rather than the proton-beam treatments." 

Cost

• The opinion piece focused on initial costs of proton therapy versus initial costs of conventional radiation. But costs such as effects on quality-of-life, time invested, number of trips to the medical center, travel time, lost work time and housing should be considered too.

•  "There's more recurrences with X-rays and more long-term side effects with X-rays than with protons."

Swedish studies showed that "the net analysis in the long-term over time is that the proton initial treatment ends up being less expensive, being the cheaper way to go, looking over the course of the patient's lifetime, by quite a bit."

• "Right now we are reimbursed by the number of treatments we give. The more treatments we give, the more revenue we generate. It's not unusual to have 30, 40, 45 treatments. If we can decrease that down to five treatments, then that's a huge savings. You've reduced the cost to Medicare, to the private insurer, by a lot. And we're very interested in doing that. Mayo wants to be affordable and have the least-expensive care possible.

On proton therapy:

• "I think over the years we'll discover that proton works very well for certain group of patients and diseases and it's not any better in other areas. That's part of the whole process."

• "Our facility is designed for kids. There's a special separate watiting room for the kids. There's a play area for the kids."

Kids will make up about 10 percent of estimated 1,240 patients per year that will get seen for proton therapy in Rochester and the 1,240 that will get seen at Mayo in Arizona.

• "Our facility is geared toward children and we want to treat as many children as we can."

What types of adult patients will be seen at Mayo's Rochester proton center?

 Patients with melanomas of the eye, bone and soft tissue sarcomas involving the base of skull or spine and pelvic area, patients with lung cancer and esophageal cancer, and some women with breast cancer (if it's close to heart or lungs where damage can be spared to those organs. Also, men with lethal prostate cancer that needs to be treated.

• "We are interested in developing a less-expensive treatment with patients, seeing if we can give just 5 treatments instead of the typical 40 or 45."

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the PostBulletin.com, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

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