Reimbursements Sway Oncologists' Drug Choices

[gpawelski]

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.

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

Ask your oncologist: Why are you prescribing these drugs? What is their published efficacy and toxicity in other patients with the same cancer? Do you have any research or financial interests in prescribing these drugs? Are these drugs a profit center for you in respect to reimbursement? A trusting partnership between doctor and patient that facilitates informed consent is the goal for many proactive patients. Such a partnership, however, may require an understanding of all the factors that lead to a treatment recommendation.

In light of the precious little in the way of guidance from clinical trials with respect to best empiric therapy (where the only thing that has been proven to correlate with treatment decisions is reimbursement to the prescribing oncologist), and the importance of basing cancer treatment at least in part on patient preferences, it is entirely reasonable to support judicious application of laboratory tests which have been well characterized with respect to test accuracy.

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)

[gpawelski]

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/

[gpawelski]

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

[gpawelski]

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 ******** (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 ********* 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 ********. 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

[ceejay2005]

What was interesting about the "Patterns of Care" study was that it is contemporary, after the Medicare reform. It shows that the Medicare reforms haven't solved the problem. It's not that all oncologists are bad people. It's just an impossible conflict of interest, it's the system which is rotten. The solution is to change the system. So far, Medicare reform hasn't achieved that.

Two scientific "evidence-based" studies give a dose of reality. It was very personal situation for me. I didn't need these two scientific "evidence-based" studies to tell me that my wife's oncologists had the incentive to prescribe a $15,000 taxol/carboplatin combination regimen to a patient who was platinum-resistant, instead of a $1,500 alkylating agent regimen the patient had before. Chlorambucil (Leukeran) was the postoperative chemotherapy my wife had for her original ovarian cancer in 1972.

It was the slowest acting and least toxic of the alkylating agents (well tolerated oral drugs). Depression of the immune system was slow and reversible, allowing it to regenerate and contribute to recovery. A malfunctioning immune system can fail to stop the growth of cancer cells. She went twenty-four years before ever experiencing a recurrence in 1996.

The postoperative chemotherapy she received from the oncologists at our so-called community cancer center for her recurrent ovarian cancer was taxol/carboplatin. It is commonplace to give the same treatment to a recurrence (after six months) as was given for the original tumor (in my wife's case, chlorambucil). If it worked the first time, it sure has a very good chance of working again.

Patients who develop recurrent ovarian cancer more than six months after first-line chemotherapy (in my wife's case, 24 years), can experience another remission following treatment with the identical first-line chemotherapy that was previously used (in her case, Chlorambucil). But again, I didn't need two scientific studies to tell me why they did or didn't do. This is just the scientific "proof."

The information is much more important because the "Patterns of Care" shows that the Medicare reforms are still not working. It still is an impossible conflict of interest.

The last time Congress helped cancer doctors, Committee Chairman Senator Chuck Grassley found out that the value of the $300 million-a-year demonstration project for oncology to report on a cancer patient's level of nausea, vomiting, pain and fatigue was for nothing. California Oncologists (http://doctorfinders.com/oncologist.php)

[gpawelski]

The medical oncologist usually serves the traditional role of internist in the multi-disciplinary management of cancer. Whereas the surgical procedure, or even the radiotherapeutic treatment course is of short duration, the medical oncologist has continuing responsibility that may stretch over months or years of therapy, and decades of follow-up, depending on the neoplasm.

There is an understandable but regrettable tendency for every specialty that has interacted with a patient to schedule follow-up appointments, which may entail many more visits and much greater expense than is necessary or prudent. A combined modality follow-up clinic avoids this problem but may not be adaptable to most office practices. Each therapist is entitled to see the results of the particular treatment regimen that has been applied.

The region of prior disease is only a portion of the patient's overall health concerns, however. The search for remediable disease in regional as well as distant areas and a continuing assessment of the impact of the disease and its treatment on the patient as a whole are ordinarily considered medical tasks. A useful approach for medical oncologists is to send the findings at a follow-up visit, including laboratory and radiologic results, to the surgeon and radiation oncologist (or other appropriate specialist) so that what is going on is communicated to all.

The medical oncologist is also most often the conduit to the patient for announcing program change, such as the appearance of metastases, the necessity of more therapy of whatever kind, and sometimes the shift to a palliative approach. The medical oncologist may also superintend the medical activities of the patient that are not addressed by the primary physician, together with general oncologic assessments that are of importance to the surgeon, radiation oncologist, and medical oncologist alike.

When regional concerns arise that are in the purview of the other specialities, the medical oncologist should facilitate early real-time consultation. In circumstances where the patient has not received adjuvant therapy by a medical oncologist and is not undergoing treatment for metastatic disease, the involvement of a medical oncologist is left to the discretion of the primary physician and the other oncological specialists already engaged. The medical oncologist should participate in the decisions concerning choice of therapy, as well as in the clinical staging which may determine operability.

The medical oncologist should be responsible for evaluating the potential for induction (or primary, neoadjuvant) chemotherapy and for the choice of regimen for postoperative chemotherapeutic or immunotherapeutic management. Since our knowledge base is still incomplete, wherever possible, patients should enter research protocols. Data are emerging that emphasize the value of neoadjuvant (primary or induction) chemotherapy in the care of tumors classically considered first for regional surgical or radiotherapeutic approaches. Osteosarcoma and several pediatric tumors, stage III breast cancer, stage III-A non–small cell lung cancer and arguably some other cancers have benefited by chemotherapeutic impact on the presumptive micrometastases and on the primary tumor.

Chemotherapeutic effect on the primary tumor serves as an in vivo bioassay of drug effect, allowing shift to a different regimen, if ineffectual. Complete pathologic regression of primary tumors has been associated with improved results for osteosarcoma, breast cancer, and head and neck cancer. Treatment of the primary neoplasm may be simplified, and lesions once considered inoperable are now potentially curable. This changing pardigm may increase the applicability of radiotherapy, surgery with intent to cure, chemotherapy, and some forms of immunotherapy.

The medical oncologist is most often the physician to reassure the patient when there is no evident cancer. Although the absence of tumor may be tumor in eclipse, the medical oncologist must keep the patient from dwelling incessantly and anxiously on imminent relapse. Reassurance should never involve a lie, just a reasoned basis for hope that relapse will not occur. Osler's admonition to live life in day-tight packages is helpful.

The medical oncologist is the responsible physician when therapeutic options for disease control become progressively restricted as a cancer patient approaches death. Selective interventions by surgical or radiation oncologists or other specialists may be required. The overall responsibility for palliative care, pain control, psychosocial adaption, and coping with the actual aging process of the patient falls on the medical oncologist, however. A competent medical oncologist is expert at palliative care.

Source: Cancer Medicine: Principles of Multidisciplinary Management; 6th Edition

Important Note:

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 had prompted in large part additional costs to the government and Medicare beneficiaries.

The Medicare Modernization Act took issue with the fact that oncologists were often reimbursed too much, sometimes as much as three times what they had paid for the chemotherapy drugs they were giving their patients.

What was needed, was to remove the profit incentive from the choice of cancer treatments, which were financial incentives for infusion therapy over oral therapy or non-chemotherapy, and financial incentives for choosing some drugs over others.

The Medicare Modernization Act changed how CMS paid for doctor-administered drugs to a system based on doctors' costs for the drugs from one based on average ********* price. The government wasn't reducing payment for cancer care, it was simply reducing overpayment for cancer drugs.

Medical oncologists are now reimbursed under Medicare for providing evaluation and management services, making referrals for diagnostic testing, radiation therapy, surgery and other procedures as necessary, and offer any other support needed to reduce patient morbidity and extend patient survival.

While Medicare tried to remove the profit incentive, private payors may still go along with it. The new legislation started the process of providing access to a "full range" of modalities to enhance the quality and standard of treatment for cancer.

[tokmik]

The easiest way to think of it is that they aim an area like a lump in the lung & give the lump a straight shot of radiation at it to kill the cells. The area around the lump is not harmed by the radiation, just the lump. Radiation can only be used for localized cancer, not any that have spread to other areas. Sometimes they will do both radiation with chemo to prevent the tumor spreading.Radiation oncology is the term used for the specialty of treating cancer patients with radiation. Good luck. claremont surgical oncologist. (http://doctorfinders.com/doctor.php?Provider=lvanyo)