Chemo Concession Stand

[haroldmac656]

Chemo Concession Stand
Health Sciences Institute e-Alert
By: Jenny Thompson


Imagine sitting down with your doctor to receive the shocking news that you have bone cancer and only a couple of years to live. Even worse, he tells you that your life expectancy will be considerably shorter unless you immediately begin an intensive round of chemotherapy.

Then imagine saying, "No thanks; no chemo for me," and going on to live for well over a decade.

Against the odds, that's what happened to Michael Gearin-Tosh, a don of English literature at Oxford University. In the e-Alert "Land of the Living" (3/11/03) I told you about Mr. Gearin-Tosh's remarkable book, "Living Proof: A Medical Mutiny," in which he describes the rigorous nutritional regimen he used to control his cancer.

"Living Proof" is not an attack on chemotherapy use, but it offers a reminder that the need for chemotherapy should always be questioned because this harsh treatment is sometimes prescribed for cancers that simply don't respond to chemo. Why? The answer to that question uncovers a disturbing business aspect of chemotherapy that few patients ever get a glimpse of.

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Offsetting costs
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Cancer patients often receive chemotherapy drugs in the offices of their oncologists. This procedure, now fairly standard, was established in the early 90's to avoid the high costs of administering the drugs in a hospital. The wrinkle that makes this situation unique is that the oncologists purchase the drugs themselves and bill their patients. And the wrinkle that makes this situation a potential problem is that oncologists typically charge patients far higher amounts than they pay for the drugs. This practice is known as "chemotherapy concession."

The oncologists say they require the additional revenue from selling the drugs to offset the cost of special facilities and staff to administer the drugs. And because chemotherapy has become such a standard treatment, virtually all prescriptions for it are covered by insurance or Medicare, so the markups are generally not paid for by patients.

At face value, this would seem to be reasonable. But I'm sure you won't be surprised to find out there's much more to it than that.

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Everyone pays
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The problem with this "concession" system it that it perpetuates the use of chemotherapy - a problem that can be broken down into three distinct problems.

PROBLEM 1: Taxpayers are footing a large portion of the payout that goes to oncologists.

According to the New York Times, the amount that the government pays may be more than $1 billion per year. That's $1 billion more than the actual cost of the drugs. This amount doesn't include the additional totals paid to doctors by insurance companies - totals for which there are no current estimates, although the chance is very good that the burden carried by insurance companies is at least equal to the amount carried by Medicare. And as we've often seen, when insurance claims rise, our insurance premiums follow.

The Times quotes Dr. Larry Norton, an oncologist and former president of the American society of Clinical Oncology, as saying that he and other doctors are just trying to "break even." Well, things are tough all over, but don't pass the hat just yet to help your local oncologist squeak by, because according the Medical Group Management Association, over the last ten years oncology has become one of the most lucrative fields of medical practice, largely due to the chemotherapy concession. By some estimates, two-thirds of a typical oncologist's total revenue comes from the concession.

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Research suffers
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PROBLEM 2: Because oncologists have a strong monetary incentive to prescribe chemotherapy (after all, they're just "breaking even"), they are less likely to refer patients to clinical research exploring possible cancer cures and less abrasive therapies.

Natural Health Line recently interviewed Nicholas Gonzalez, M.D. - a clinical researcher who has treated cancer with nutrition for many years. When Dr. Gonzalez was recruiting patients for a federally funded study of a cancer treatment based on a nutrition regimen, enrollment in the trial was complicated by the fact that many oncologists were reluctant to refer patients and lose the revenue that the chemotherapy concession would bring.

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Hard to justify
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PROBLEM 3: The most important problem is the way chemotherapy concession affects the treatment of patients.

Two years ago, Ezekiel J. Emanuel, M.D. (an oncologist and bioethicist), presented the results of a study that examined the medical records of almost 8,000 cancer patients. Dr. Emanuel found that in cases where chemotherapy was administered in the final six months of life, ONE-THIRD of the patients suffered from cancers that are known to be unresponsive to chemotherapy!

In Dr. Emanuel's words, "providing chemotherapy to patients with unresponsive cancers is hard to justify."

I'd say that's putting it mildly.

Specific types of cancer that are not responsive to chemotherapy include: pancreatic, melanoma, hepatocellular, renal cell, and gallbladder. If you are diagnosed with one of these cancers and are prescribed chemotherapy, it's time for a second opinion.

[gdpawel]

The shift, almost 20 years ago, from the institution-based, inpatient setting to community-based, ambulatory sites for treating the majority of the nation's cancer patients has prompted in large part additional costs to the government and Medicare beneficiaries. The Chemotherapy Drug Concession gave oncologists the financial incentive to select certain forms of chemotherapy over others because they receive higher reimbursement.

Typically, doctors give patients prescriptions for drugs that are then filled at pharmacies. But medical oncologists bought chemotherapy drugs themselves, often at prices discounted by drug manufacturers trying to sell more of their products and then administer them intravenously to patients in their offices. Not only does the oncologist have complete logistical, administrative, marketing and financial control of the process, they also control the "knowledge" of the process. The result is that the oncologist selects the product, selects the vendor, decides the markup, conceals details of the transaction to the degree they wish, and delivers the product on their own terms including time, place and modality.

There was a joint Michigan/Harvard study authored by Drs. Joseph Newhouse and Craig C. Earle, entitled "Does reimbursement influence chemotherapy treatment for cancer patients?" It confirmed that medical oncologists choosed cancer chemotherapy based on how much money the chemotherapy earns the medical oncologist.

The authors documented a clear association between reimbursement to oncologists for the chemotherapy and the regimens which oncologists select for their cancer patients. In other words, oncologists tended to base their treatment decisions on which regimen provided the greatest financial remuneration to the oncologist.

The study adds to the 'smoking gun' survey by Dr. Neil Love, entitled "Patterns of Care." One of the results of this survey shows that for first line chemotherapy of metastatic breast cancer, 84-88% of the academic center-based oncologists (who do not derive personal profit from infusion chemotherapy) prescribed an oral dose drug (capecitabine), while only 13% prescribed infusion drugs, and none of them prescribed the expensive, highly remunerative drug docetaxel.

In contrast, among the community-based oncologists (who do derive personal profit from infusion chemotherapy), only 18% prescribed the oral dose drug (capecitabine), while 75% prescribed infusion drugs, and 29% prescribed the expensive, highly remunerative drug docetaxel.

While the Michigan/Harvard study showed results before the new Medicare reform, the Patterns of Care study showed results that the Medicare reforms are still not working. It is still an impossible conflict of interest.

And the existence of this profit motive in drug selection has been one of the major factors working against the individualization of cancer chemotherapy based on testing the cancer biology.

Two scientific studies giving us a dose of reality that once a decision to give chemotherapy is taken, oncologists receiving more-generous Medicare reimbursements used more-costly treatment regimens.

It's not that all oncologists are bad people. It's just that it is still an impossible conflict of interest (i.e. it's the SYSTEM which is rotten). Some oncologists prescribe chemotherapy drugs with equal efficacies and toxicities. I would imagine that some are influenced by the whole state of affairs, possibly without even entirely admitting it. There are so many ways for humans to rationalize their behavior. The solution is not to put the doctors in jail; it's to change the system.

Sources:

http://content.healthaffairs.org/cgi/content/abstract/25/2/437

http://patternsofcare.com/2005/1/editor.htm (figure 37, volume 2, issue 1, 2005)

[gdpawel]

Report: Doctors' $275M Study Questioned

By KEVIN FREKING
The Associated Press
Tuesday, August 29, 2006

http://www.boston.com/yourlife/health/aging/articles/2006/08/29/report_doctors_275m_study_questioned/

In 2005, CMS initiated a one-year demonstration project for cancer patients undergoing chemotherapy. The demonstration focused on measuring patient outcomes in three areas of concern often cited by patients undergoing infusional chemotherapy: controlling pain; minimizing nausea and vomiting; and reducing fatigue. Oncology Practices reporting data on all three factors qualified for an additional payment of $130 per encounter for chemotherapy administration (a financial incentive to use infusional drugs over oral drugs). That included a $26 patient copay.

A Republican, Senate Finance Committee Chairman Chuck Grassley, found out from the Health and Human Services' inspector general's office that the value of the approximately $300 million-a-year demonstration project to report this information was for nothing. Providers were being paid $130 to simply forward the data that was already collected.

While a Michigan/Harvard study (before Medicare reforms) documented a clear association between reimbursement to oncologists for the chemotherapy and the regimens which oncologists select for their cancer patients, a "Pattens of Care" study (after Medicare reforms) showed results that Medicare reforms are still not working. It is still an impossible conflict of interest. Once a decision to give chemotherapy is taken, oncologists receiving more-generous Medicare reimbursements used more-costly treatment regimens.

According to findings in the American Medical Group Association's 2005 Medical Group Compensation & Financial Survey, most specialties saw modest increases in compensation in 2004. The majority of specialties experienced increases at or just above the rate of inflation, and the primary care specialties saw increases of 6% - 8.8%.

The survey found that during 2004 three specialties experienced the largest increases in compensation: general surgery (8.89%), pediatrics & adolescent (8.76%), and hematology & oncology ($8.52%). In addition to pediatrics and adolescent, other primary care specialties saw increases: family medicine (6.31%) and internal medicine (7.57%).

Medicare Cancer Project Scrutinized

While doctors profited, patients paid for study about chemotherpy

By Lisa Myers
Senior Investigative Correspondent
NBC News Investigative Unit

http://www.msnbc.msn.com/id/15320188/

[gdpawel]

Superficially, it sounds like a great expose, greedy clinics/doctors trying to make money by pushing drugs. The New York Times article states that the drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because oncologists can make money by using more of the drug. That's not really a new revelation. We've been down that road before without much done to change it.

According to Dr. John Glaspy, director of UCLA's Outpatient Oncology Clinic, one complicating factor, experts say, is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors' decisions. However, patients with anemia, which can cause sluggishness in its early stages and can be fatal in advanced phases, can get blood transfusions, typically every few weeks, instead of using EPO.

Could it be that increased numbers of red cells deliver more oxygen to the tumor cells and thereby increase their activity across the board, including with respect to invasion, proliferation, and metastasis? On one hand they're developing drugs to halt and reverse angiogenesis while on the other hand they're helping the tumor to obtain more oxygen with existing vasculature. And nobody in charge foresaw that? Amazing how they can apply differing standards for proof or benefit when profit is involved.

http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C06EEDB1331F933A25750C0A9619C8B63

In panel discussion that highlighted the 12th annual conference of the National Comprehensive Cancer Network, Lee Newcomer, former chief medical officer and currently an executive with Minneapolis-based United Health Group, pointed out that in reviewing records of patients who were prescribed the drug erythropoietin -- an expensive agent that boosts blood supply in patients with anemia -- said that 44 percent of those patients had blood work-ups that would indicate they were not anemic.

Erythropoietin is a hormone that stimulates red blood cell precursors in the bone marrow. As a therapeutic agent, it is produced by recombinant DNA technology. It is used in treating anemia rsulting from chronic renal failure or from cancer chemotherapy. A six-month course of treatment can cost more than $10,000 per patient.

Len Lichtenfeld, deputy chief medical officer for the Atlanta-based American Cancer Society, told United Press International, "Probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs."

Newcomer said he objected to prescriptions for erythropoietin written for patients with hematocrit higher than 36. Low hematocrit, the ratio of the volume of red cells to the volume of whole blood, is an indication of anemia, Lichtenfeld said.

Normal range for hematocrit is different between the sexes and is approximately 45 percent to 52 percent for men and 37 percent to 48 percent for women. Lichtenfeld said clinicians generally would not treat a hematocrit that was about 36 percent.

Newcomer also stated at the meeting that when he scrutinized prescribing habits for treatment of patients with pancreatic cancer, their were doctors writing prescriptions for 188 different combinations of treatments, yet there are only two drugs that have any activity against that disease.

Newcomer also cited in the meeting last year that the use of the new breast cancer drug tratuzumab, sold as Herceptin, which has been found to be helpful in a group of women with breast cancer that overexpresses a certain gene known as HER2. The drug is ineffective in women with normal levels of HER2, yet about 12 percent of drugs orders -- which costs thousands of dollars per treatment -- were for women who tested negative for HER2 overexpression.

One of the newest biological targeted agents, bevacizumab, sold under the trade name Avastin, which is rapidly being included in numerous drug cocktails because it has been shown to extend survival in diseases such as colon cancer, can cost as much as $47,000 a year for one person.

Newcomer stated, "We know that Avastin improves outcomes in about 20 percent of patients, but we have no idea which cancer patients will benefit from a course of treatment." According to his calculations, it costs $354,000 per year of life extended with Avastin.

http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20070316-20215500-bc-us-cancercosts-analysis.xml

[gdpawel]

The Health Affairs article (1), given play in The New York Times (2), showed that the prescribing behaviors of oncologists caring for Medicare patients between 1995 and 1998 were influenced by the lucrative economics and their drug retailing arrangements. The study's investigative team was comprised of prominent researchers, including a Dana-Farber oncologist. When interviewed, the investigators were emphatic that the study found strong links between oncologists' financial interests and their clinical decisions.

And while the Harvard/Michigan study published in Health Affairs showed results before the new Medicare reform, the Patterns of Care study showed results that the Medicare reforms are still not working (3).

Few healthcare professionals outside the oncology community were surprised. It is common knowledge that most oncologists integrate drug revenues into their practices to bolster their incomes.

The apparent importance of the findings notwithstanding, the Community Oncology Alliance (COA) flatly rejected the news (4). COA released an e-mail bulletin, "The Remarkable Story of Community Oncology," just after the articles broke. The opening sentence called the study's findings "incredibly outrageous and unsubstantiated" and "an unbelievable rehash." Sentence two referred to "incomprehensible statements by government bureaucrats, so-called oncology advocates, well-paid consultants, non-practicing physicians, payers, and specialty pharmacies." In other words, COA cast aside the study, presumably because critics cannot appreciate oncology's complexities and because they are almost certainly misguided or harbor malevolent intent.

Not Acceptable

There are many reasons why this kind of reaction is unacceptable, but the most obvious is that there appears to be a real problem here. The study's investigators are reputable, the journal is credible, and the findings are damning. True, the data were as much as a decade old and from Medicare patients only, but the practice in question - oncologists' prescribing decisions being altered to optimize drug revenues - is still widespread. There is little reason to believe that another analysis with updated data would obtain a different result.

But COA protested too much. It refused to admit that the practice represents a potential conflict. It claimed that community oncologists provide the "highest quality care" but failed to offer data in support of that statement. Ultimately, it avoided the issue entirely, deflecting attention to other, more praiseworthy aspects of oncology practice. And it ridiculed the credibility of the professionals who broached the issue.

To the non-oncologist, such a dismissive response is viewed as self-serving and protectionist. It demeans oncologists' important work and confirms critics' suspicions that an unsavory but hidden practice is ongoing. But worse, it suggests a higher regard for financially rewarding drug arrangements that for patient quality of care. An appropriate response might have soberly acknowledged the findings. It would have then refuted those findings with other data, or committed to addressing the issue.

Getting Serious

There are serious issues that demand serious responses. The American health system is rapidly approaching wholesale collapse due to exploding costs, in large measure because a lack of transparency has created a culture of opportunism and waste exploited by groups throughout the continuum of supply, care, and finance. The Health Affairs article suggest that community oncology is squarely part of the problem.

In the interests of transparency and the reputations of its practitioners, community oncologists should immediately develop a response to the concerns raised by the article. You should release data on:

- the prevalence of the practice of oncologists profiting from the drugs they prescribe;
- the markups involved, and how those revenues translate to income;
- oncologists' adherence rates to evidence-based chemotherapy guidelines; and
- differences in the practice patterns of oncologists who do and do not financially benefit from the drugs they prescribe.

You should follow this information with proposed guidelines to resolve potential conflicts between clinical practice and financial incentives.

Providing Leadership

More than any group, physicians lay claim to a higher purpose and so must also provide the leadership that can help reestablish trust in our doctors and a more effective healthcare system. Community oncologists can and should provide that leadership.

You could advocate for and implement pricing transparency in oncology drug treatment. As Jerry Reeves, MD, urged in a recent interview (5), the charges to patients and other payers should be transparent and open, not hidden. And conflicts of interest should be avoided.

Of course, oncologists should be paid fairly for the services they provide. Continuing to work with Medicare and private payers, you should aim to transition practices away from indirect drug revenues and replace those with higher direct fees for professional services.

As Dawn Holcomb (6) and Linda Bosserman (7) argued last year in this journal, you could lead an effort to develop data on clinical outcomes and cost that can drive future practice and policy change. You could accelerate positive change within your profession by encouraging incentives for patients to choose doctors who have demonstrated care that is safer, more effective, and more efficient.

Anything less will be merely protecting the interests of oncologists over the interests of patients.

References

(1) Jacobson M, O'Malley AJ, Earle CC, Pakes J, Gaccione P, Newhouse JP. Does reimbursement influence chemotherapy treatment for cancer patients? Health Affairs 2005;25:437-443.
(2) Abelson R. Pay method said to sway drug choices of oncologists. The New Your Times March 16, 2006.
(3) Patterns of Care, Volume 2, Issue 1, 2005
(4) Community Oncology Alliance. The remarkable story of community oncology [news-letter].March 16, 2006.
(5) Klepper B. The new focus on accountability [interview with Jerry Reeves, MD]. Commun Oncol 2006;3:241-243.
(6) Holcomb DG. Is oncology compatible with specialty pharmacy? Commun Oncol 2005;2:173-181.
(7) Bosserman L. Specialty pharmacy and MVI:ill-advised systems, wasteful, and harmful [editor's note]. Commun Oncol 2005;2:178-180.

Community Oncology Vol 3/Num 7: Having Your Say July 2006
Center for Practical Health Reform