Reimbursements Sway Oncologists' Drug Choices

[gdpawel]

The shift in the United States, more than 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 Concession gave oncologists the financial incentive to select certain forms of chemotherapy over others because they receive higher reimbursement.

This was first brought to attention at a Medicare Coverage Advisory Committee meeting in 1999, in Baltimore, Maryland. There was a gastroenterologist in attendance who complained that Medicare had cut his reimbursement for colonoscopies from $400 to $108 and how all the doctors in his large, multi-specialty internal medicine group were hurting, save for two medical oncologists, whom he said were making a killing running their in-office retail pharmacies (1).

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 administered them intravenously to patients in their offices.

Not only do the medical oncologists have complete logistical, administrative, marketing and financial control of the process, they also control the knowledge of the process. The result is that the medical 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.

A joint Michigan/Harvard study entitled, "Does reimbursement influence chemotherapy treatment for cancer patients," (2) confirmed that before the new Medicare reform, medical oncologists are more likely to choose cancer drugs that earn them more money. A survey by Dr. Neil Love, published in "Patterns of Care," showed results that the Medicare reforms have not solved the problem of variations in oncology practice(3).

A patient wants a physician's decision to be based on experience, clinical information, new basic science insights and the like, not on how much money the doctor gets to keep. A patient should know if there are any financial incentives at work in determining what cancer drugs are being prescribed.

It's not that all medical oncologists are bad people. It's just that the system is rotten and still an impossible conflict of interest. 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. Social science research shows that people can be biased by self-interest without being aware of it.(4) There are so many ways for humans to rationalize their behavior.

There is some innate goodness of people who go into oncology. At the time when most oncologists practicing today made the decision to become oncologists, there was no Chemotherapy Concession. Most of them probably had a personal life experience which created the calling to do battle against the great crab. At the time when people make their most important decisions in life, they are in the most idealitstic period of their lives.

The U.S. government wasn't reducing payment for cancer care under the new Medicare Modernization Act (MMA) of 2003. They were simply reducing overpayment for chemotherapy drugs, and paying cancer specialists the same as other physicians. The government can't afford to overpay for drugs, in an era where all these new drugs are being introduced, which are fantastically expensive (5).

Although the new Medicare bill tried to curtail the Chemotherapy Concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Medical oncologists should be taken out of the retail pharmacy business and let them be doctors again.

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). The solution is not to put the doctors in jail; it's to change the system. (6)

1. Verbatim Transcript of Medicare Coverage Advisory Committee (MCAC) Meeting, November 15-16, 1999.

http://weisenthal.org/hcfa_1.htm

http://weisenthal.org/hcfa_2.htm

http://weisenthal.org/hcfa_3.htm

2. Jacobson M, O'Malley AJ, Earle CC, Pakes J, Gaccione P, Newhouse JP. Does reimbursement influence chemotherapy treatment for cancer patients? Health Aff (Millwood). 2006 Mar-Apr;25(2):437-43.

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

3. Love N. Editor's Note: Phase I study of the "gap". Patterns of care in medical oncology. 2005; 2(1)

http://patternsofcare.com/2005/1/editor.htm

4. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003 Jul 9;290(2):252-5

http://jama.ama-assn.org/cgi/content/full/290/2/252

5. http://www.medicare.gov

6. Pawelski GD. Reimbursements Sway Oncologists' Drug Choices. Online Journal of Health Ethics 2006;1(1)

http://ethicsjournal.umc.edu/ojs2/index.php/ojhe/issue/view/4

[fergus51]

How disturbing.

[aimeee, BSN, RN]

Sad

[gdpawel]

Prove that Community Oncologists Put Patients Before Profits

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

[gdpawel]

Cancer Drug Representatives Spelled Out the Way to Profit

"It's clear that physicians stopped making decisions based on what made scientific or clinical sense in lieu of what made better business sense"

Medicare's decision to reform the way it paid for cancer drugs came after a decade in which oncologists collectively made billions of dollars on the drugs they prescribed.

http://www.nytimes.com/2007/06/12/business/12cancerside.html?ref=business

Incentives Limit Any Savings in Treating Cancer

"The system doesn't value the time we spend with patients"

When Medicare cracked down two years ago on profits that doctors made on drugs they administered to patients in their offices, it ended a windfall worth hundreds of thousands of dollars a year for each ...

http://www.nytimes.com/2007/06/12/business/12cancerpay.html?_r=1&ref=health&oref=slogin

It's Still A Chemotherapy Concession

This was first brought to attention at a Medicare Advisory Panel meeting in 1999 in Baltimore. There was a gastroenterologist in attendance who complained that Medicare had cut his reimbursement for colonoscopies from $400 to $108 and how all the doctors in his large, multi-specialty internal medicine group were hurting, save for two medical oncologists, whom he said were making a killing running their in-office retail pharmacies.

There is some innate goodness of people who go into oncology. At the time when most oncologists practicing today made the decision to become oncologists, there was no Chemotherapy Concession. Most of them probably had a personal life experience which created the calling to do battle against the great crab. At the time when people make their most important decisions in life, they are in the most idealitstic period of their lives.

The government wasn't reducing payment for cancer care under the new Medicare bill. They were simply reducing overpayment for chemotherapy drugs, and paying cancer specialists the same as other physicians. The government can't afford to overpay for drugs, in an era where all these new drugs are being introduced, which are fantastically expensive.

Although the new Medicare bill tried to curtail the Chemotherapy Concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Medical oncologists should be taken out of the retail pharmacy business and let them be doctors again.

[gdpawel]

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.

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

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.

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." A six-month course of treatment can cost more than $10,000 per patient.

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, said that 44% of those patients had blood work-ups that would indicate they were not anemic.

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

U.S. Oncology takes a hit! Reports first-quarter net loss.

U.S. Oncology said a number of factors impacted the results, including reduced pre-tax income due to lower use of certain supportive care drugs used to treat cancer-induced anemia: and the discontinuation of the Medicare Demonstration Project.

http://www.bizjournals.com/houston/stories/2007/04/30/daily82.html?from_rss=1

The Senate Finance Committee Chairman found that the value of the approximately $300 million-a-year Medicare Demonstration Project to report on a patient's level of nausea, vomiting, pain and fatigue was for nothing.

CMS paid chemotherapy providers $130 per report, per infusional-chemotherapy recipient, on a patient's level of nausea, vomiting, pain and fatigue. However, HHS' inspector general's office found these providers were being paid an extra $130 to simply forward the data that was already collected.

A continuance of the Medicare Demonstration Project would have exacerbated existing economic and clinical problems instead of resolving them by increasing the temptations for physicians to overuse injectable drugs and promise to aggravate the ecnomic problems Congress attempted to fix with the new Medicare law.

U.S. Oncology Under the Gun

U.S. Oncology reports two seeming unrelated bits in their latest SEC Form 10-K. One note say cancer patients are suddenly using a lot less anemia drugs, and as a result U.S. Oncology will bank $8-10 million a year less than expected. The second note says that in 2005 the company was subpoenaed by the U.S. Department of Justice about contracts and relationships with pharmaceutical companies.

Coincidence?

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-03-2007/0004579964&EDATE

Doctors Reap Millions for Anemia Drugs

By ALEX BERENSON and ANDREW POLLACK

New York Times

Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians' offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price.

http://www.nytimes.com/2007/05/09/business/09anemia.html?ex=1185076800&en=6f13d8b41aee804b&ei=5070

Growth Factor of Anemia Drugs

EPO is a natural substance made by the kidney. It stimulates the bone marrow to make red blood cells (it is literally a "growth factor"). Healthy adults are usually at about 15 grams a deciliter. When normal people take it, their blood gets too "thick" and they die of heart attacks and strokes.

But it now looks as if increasing the hemoglobin level above 12 is very risky with pharmaceutical EPO. Pharmaceutical EPO makes sludgy blood.

The anemia drugs, which boosts patients' counts of hemoglobin (a protein that carries oxygen in the blood), raise the danger of heart attacks, strokes and death at "high" doses. The FDA has said there is "serious" cardiovascular risks for patients who took "higher than recommended" doses of these drugs. Also, patients who don't respond well to initial anemia therapy (hyporesponders) are exposed to the highest heart risks.

These anemia drugs are approved to treat patients whose weakness and fatigue is caused by chronic kidney disease or by the side effects of cancer chemotherapy. They stimulate production of oxygen-carrying red blood cells, which can boost patients' energy and strength. The issue is over the drugs' safety on how big a dose to use to boost concentrations of hemoglobin. The FDA-approved level is doses sufficient to increase hemoglobin to a maximum of 12 grams a deciliter.

Blood transfusions are generally needed when patients slip to less than 8 grams. The adage of some physicians was that if some improvement in hemoglobin was good, higher levels of hemoglobin would even be better. However, clinical trials have shown the drugs can reduce the need for blood transfusions and improve the quality of life when used within the "original" dosing range.

New studies have raised questions whether these drugs might be harming patients. Those study results suggest the drugs may make the cancer worse. One such study published in the New England Journal of Medicine found that patients treated aggressively with Procrit had a higher risk of heart problems or death than those treated less aggressively.

As reported in OncoLink, patients and clinicians must understand that no data exists to support claims of improvement in quality of life or fatigue. The manufacturers of these agents frequently used direct consumer marketing to promote these unsupported claims, a fact that concerns many patient advocacy groups.

And now there is emerging evidence that pharmaceutical EPO can feed the growth of tumors in cancer patients (it IS a "growth factor" afterall).

A "growth factor" is about twenty small proteins that attach to specific receptors on the surface of stem cells in bone marrow and promote differentiation and maturation of these cells into morphotic constituents of blood. And blood is a circulating tissue composed of fluid plasma and cells (red blood cells, white blood cells, platelets). Problems with blood composition or circulation can lead to downstream tissue (which is made up of cells) dysfunction.

The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for. Take medical oncologists out of the retail pharmacy business and force them to be cancer "doctors" again!

[nj1grlcrus]

Scary, too bad we can't take the $ factor out of the equation. can't we just treat each person individually to get the best outcome possible? is that too much to ask?

[me5115]

oncologist choice for treatment is based on standards of care. Cancer is an expensive illness to treat, but as is diabetes and heart disease ect.

[KellNY, RN]

oncologist choice for treatment is based on standards of care. Cancer is an expensive illness to treat, but as is diabetes and heart disease ect.

I really have to wonder if you read any of the above posts... Granted, they were long, but here's a snippet for you.

The authors documented a clear association between reimbursement to oncologists for the chemotherapy andthe 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.

[gdpawel]

A recent article published by the National Institute of Health concluded that "about one fourth of abstracts at American Society of Clinical Oncology (ASCO) Annual Meetings have an author with a personal financial interest." Since many of these abstracts are about the results of clinical studies, this means that the study results are being penned by authors that may have a "personal financial interest" in the outcome.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17704409&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17687154&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

These two articles touch on a critical subject - when an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor's training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities. In short, a patient and their family must be their own best advocate and get at the heart as to why a specific treatment regimen is being suggested. Don't be afraid to ask questions to make informed treatment decisions!

Cancer treatments 'excessive'

Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need, medical oncologist Dr. Ian Haines reported in the Journal of Clinical Oncology. Emerging evidence shows that many of the highly expensive "targeted" cancer drugs (Herceptin, Avastin and Rituximab) may be just as effective and produce fewer side effects if taken over shorter periods and in lower doses.

He stated in the Journal that "it would seem that pharmaceutical companies are attracted to studies looking at the maximum tolerated dose of any treatments." He suggested the we make the search for minimum effective doses of these treatments one of the key goals of cancer research.

He gave as an example, Avastin, used to fight colon and lung cancers, the dose being tested is 15 milligrams per kilogram of body weight, despite other research showing it may work with 3 milligrams per kilogram.

A study published in the journal of the American Cancer Society, led by Jeffrey Peppercorn of the University of North Carolina Lineberger Cancer Center, along with three researchers at the Dana-Farber Cancer Institute, found that 84% of trials with pharmaceutical-company involvement showed positive results, compared to 54% for trials without industry backing. Another previous study in oncology, looking at multiple myeloma, found that pharmaceutical studies reported positive results in 74% of trials compared to 47% of non-industry-sponsored trials.

An increasing number of drug studies are developed through collaborations between academic medical centers and drug companies. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. It is important to understand the influence that industry involvement may have on the nature and direction of cancer research. Studies backed by pharmaceutical companies were significantly more likely to report positive results.

As the Haines study suggests more must be spent on analyzing drug data, we also need larger and more detailed studies to figure out why there is an association between pharmaceutical involvement and positive results. Some of the connection between industry and positive results may be because industry focuses on drug development and they do it well.

However, drugmakers are going directly to the consumer at a time when their products are indeed at the margins of evidence-based medicine. On one hand, pharmaceuticals advertise extensively and the advertising is manipulative in the extreme. On the other hand, even NCI-designated cancer centers do this sort of direct to consumer, hard sell advertising. And in cancer medicine, the media advertising is no more misleading than the one-on-one communication which often goes on between a chemotherapy candidate and an oncologist.

A Karolinska Institute in Sweden study showed that U.S. health care system is good at delivering expensive drugs, but that our health care system is not so good at simple medicine like preventive care. Our pharmaceutical-based health care system is very good at creating new health care products that will make a lot of money, but it it's something that has no chance of profit, forget it.

It doesn't take a rocket scientist to figure out that the United States does a good job of developing and delivering new and expensive drugs to cancer patients, because that is the only thing we're good at. But it'll take a rocket scientist to figure out how this makes for a better health care system.

http://jco.ascopubs.org/cgi/content/full/25/25/e31

Cancer Industry Fights To Keep Obscene Profits

The cancer industry derives most of its profits from chemotherapy. Both the drug companies and the treatment providers profit from the chemotherapy drugs and the medications used to combat the side effects. The obscene profits made off chemotherapy override any incentive to find a cure or better treatments.

Doctors administer chemotherapy in their offices, buy the drugs at a lower cost than what insurance companies and public health care programs pay and pocket the difference. This system provides an incentive to overuse chemotherapy and the most expensive medications.

http://www.lawyersandsettlements.com/articles/01828/anemia-overuse.html