02/16/04 Doctors Say Medicare Underestimates Costs

[Poster]

Physicians want a better formula for determining their actual costs to prevent a severe loss of income when the Medicare reforms go into effect.

"The current measure is based on the gross domestic product, which measures growth in the overall economy and does not take into calculation the aging Medicare population, technological innovations or changes in the practice of medicine. The medical needs of our Medicare patients do not wane when the economy slows."

"Congress must act to fix this problem," he said. "Otherwise, Medicare will suffer a decline in access and quality that will be difficult to reverse."

Some physicians groups suggest using a yearly updated system to calculate what percentage update they are entitled to.

To read more go to: http://www.ama-assn.org/amednews/2003/12/22/gvl11222.htm

[gdpawel]

Chemotherapy Drug Concession

Oncologists long avoided cuts forced on other specialists because the government allowed them to bill Medicare for cancer drugs in amounts that often far exceeded their actual costs. Even the American Society of Clinical Oncologists say, "we did not like the old system, even the perception that it set up inappropriate incentives we did not support." Some studies suggest that American oncologists overuse cancer drugs, particularly in the last months of patients' lives after the patients have failed to respond to treatment. Advocates for cancer patients say that Medicare's reimbursement system encouraged overtreatment.

On average, oncologists in private practice made $310,371 in 2002, according to surveys by the Denver-based Medical Group Management Association. Where does the bulk of a private oncologist's income come from? The Journal of the National Cancer Institute (JNCI) commented that office-based oncology practices typically derive two-thirds of their income from selling chemotherapy" (JNCI 2001;93:491). The practices are compensated both for delivering the drugs and for the drugs themselves.

The new (MMA) system still has major flaws, in that it continues to provide incentives to administer chemotherapy, in the same way that surgeons have a financial incentive to recommend surgery. Additionally, it is a certainty that there will be large differences between the profit margins of administering different drugs, providing continuing incentives to base drug selection on profit margin. However, the new system is clearly an improvement from the standpoint of cancer patients, taxpayers, and advocates of basing drug selection on individual tumor biology, rather than on a least common denominator approach which invites conflict-of-interest medical decision-making."

What this shows is that simply reducing reimbursement for drugs isn't the answer to the biggest problems, which are financial incentives for infusion therapy over oral therapy or non-chemotherapy, and financial incentives for choosing some drugs over others. One example, oncologists will just not give gemcitabine and /or irinotecan, but instead will choose drugs which are profitable.

Oncologists should simply submit copies of their drug invoices and get paid the exact cost of the drugs, plus only a small markup for administrative expenses. They should get reimbursed for the costs of actually adminsitering the drugs, plus a small markup which is not enough of an incentive to treat with infusion therapy, rather than just writing a prescription for drugs which would be filled at a pharmacy.

Office-based oncology practices derive most of their revenues from treating patients with chemotherapy. The practices are compensated both for delivering the drugs and for the drugs themselves. The Journal of the National Cancer Institute (JNCI) states that private-practice oncologists typically derive two-thirds of their income from selling chemotherapy.

Reimbursement of any kind is often lacking with oral-dose drugs because the patient purchases them directly. The oncologist simply writes a prescription and the patient goes to a pharmacy and obtains the product. There are no administration fees for office-based oncology practices unless they also dispense the drugs, because there is no involvement in their purchase.

The practice will realize almost no revenue from those patients who are treated entirely with oral-dose agents. The core activity in medical oncology is the provision of infusional chemotherapy. The entire structure of office-based practices revolves around this activity and is what distinguishes medical oncology from most other specialties.

Oral-dose chemotherapeutic agents are easy to use and offer the promise of less frequent visits to the physician's office and their infusion rooms. This promise is not trivial, especially as we have come to realize that many forms of cancer may be managed with these drugs, especially when they offer the equivalent outcome as intravenous drugs.

The fact that medical oncologists receive no reimbursement for providing oral-dose therapy to patients had been the principal barrier to the availability of oral-dose protocol. The advent of oral agents ultimately means that medical oncology will need to change its identity, prior to the chemotherapy drug concession.

Under the new Medicare Bill (MMA) medical oncologists will be reimbursed 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.

Because oral-dose drugs ultimately deliver on their promise of combining equally efficacious therapy with better adverse event profiles and easier administration, they will rightfully gain their appropriate share of the marketplace, again.

What needed to be done is to remove the profit incentive from the choice of cancer treatments. Patients should receive what is best for them and not what is best for their oncologists. Then, perhaps we can stop giving patients needless chemotherapy that spreads cancer cells, rather then telling cancer patients that the cancer came back or is spreading on it's own.

[gdpawel]

Neil Love, M.D. reports in a survey of breast cancer oncologists based in academic medical centers and community based, private practice oncologists. The academic center-based oncologists do not derive personal profit from the administration of infusion chemotherapy, the community-based oncologists do derive personal profit from infusion chemotherapy, while deriving no profit from prescribing oral-dosed chemotherapy.

The results of the survey show that for first line chemotherapy of metastatic breast cancer, 84-88% of the academic center-based oncologists prescribed an oral dose drug (capecitabine), while only 13% perscribed infusion drugs, and none of them prescribed the expensive, highly remunerative drug docetaxel.

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

This is not to imply that the academic center-based oncologists are without their fair share of collective guilt. They were misguided in not recognizing that they were trying to mate notoriously heterogeneous diseases into one-size-fits-all treatments. They devoted 100% of their clinical trials resources into trying to identify the best treatment for the average patient, in the face of evidence that this approach was non-productive. However, such unsuccessful experiments will never be viewed as such by the thousands of people whose careers are supported by these experiments.

Henderson, et al, entered 3,100 breast cancer patients in a prospective, randomized study to compare cyclophosphamide/doxorubicin alone versus cyclophosphamide/doxorubicin plus Taxol (in the adjuvant, pre-metastatic setting). The results were microscopically positive, at best, and cannot begin to justify the enormous financial and human resources expended (while making no effort at all to test and improve methods to individualize treatment).

But these results changed the face of the adjuvant chemotherapy of breast cancer. Cyclophosphamide+Doxorubicin+Taxol became standard of care. Taxol recently went off patent. Now the thrust is to identify on-patent therapy which is microscopically better in clinical trials of one-size-fits-all treatment. Already, the community-based oncologists are migrating to Cyclophosphamide+Doxorubicin+Docetaxel (expensive/remunerative) so what was the purpose of doing that 3,100 patient prospective, randomized Henderson study?

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

[gdpawel]

Reimbursements Sway Oncologists' Drug Choices

There was a recent, 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. (Jacobson, M.,O'Malley, A.J., Earle, C.C., et al. Health Affairs 25(2):437-443, 2006).

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. (Patterns of Care: 2005,Vol 2,Issue 1).

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. The two, scientific studies give us a dose of reality. Once a decision to give chemotherapy is taken, oncologists receiving more-generous Medicare reimbursements used more-costly treatment regimens.

Sources:

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

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

[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 ****tails 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

[jacob]

Physicians want a better formula for determining their actual costs to prevent a severe loss of income when the Medicare reforms go into effect.

"The current measure is based on the gross domestic product, which measures growth in the overall economy and does not take into calculation the aging Medicare population, technological innovations or changes in the practice of medicine. The medical needs of our Medicare patients do not wane when the economy slows."

"Congress must act to fix this problem," he said. "Otherwise, Medicare will suffer a decline in access and quality that will be difficult to reverse."

Some physicians groups suggest using a yearly updated system to calculate what percentage update they are entitled to.

To read more go to: http://www.ama-assn.org/amednews/2003/12/22/gvl11222.htm

These factors should not influence that much the overall losses caused by the Medicare reforms. I agree that the medical needs won't change based on economical factors but the medical companies are making too much fuss over these reforms. From the population's point of view, if the local medical conditions are too worst than there are alternatives like online prescription drugs (https://www.planetdrugsdirect.com/).

[great]

These factors should not influence that much the overall losses caused by the Medicare reforms. I agree that the medical needs won't change based on economical factors but the medical companies are making too much fuss over these reforms. From the population's point of view, if the local medical conditions are too worst than there are alternatives like online prescription drugs (https://www.planetdrugsdirect.com/).

That's right. There is this alternative but I don't think that all people will have faith in this kind of prescriptions.

[gdpawel]

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. If pharmaceutical EPO stimulates the bone marrow to make red blood cells, it could feed the growth of tumors in cancer patients.

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!

FDA Sides With CMS in EPO Battle; Labeling Change Next

The FDA current labeling advises that hemoglobin not exceed 12 g/dL. It considers this to be an upper safety limit for EPO dosing, not a target for therapy.

The FDA also says that there is no evidence that pharmaceutical EPO results in improved survival, tumor control, health-related quality of life at any hemoglobin level in cancer patients undergoing chemotherapy. Pharmaceutical EPO was approved based on its effectiveness in reducing the need for red blood cell transfusions.

http://invivoblog.blogspot.com:80/2007/10/fda-sides-with-cms-in-epo-battle.html