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Unless the public intervenes, new rule makes patients sick

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Balancing the Budget on the Backs of Cancer Patients?

By Joseph Antos

Tuesday, June 12, 2007

Unless the public intervenes, a new rule will make patients sicker.

Should cancer patients be consigned to an existence of unrelenting fatigue, even though there is a safe and effective treatment that can ease their debilitating condition? The bureaucrats who run Medicare think so.

On May 14, the Centers for Medicare and Medicaid Services (CMS) issued a proposal to cut back sharply on Medicare’s coverage of drugs that treat anemia—a tiring deficit of oxygen in the bloodstream. Patients undergoing chemotherapy, as well as many cancer patients not receiving chemotherapy, often have low red blood cell counts. That causes chronic fatigue that can be so severe that it impairs the patient’s ability to perform even the simplest activities.

Drugs called erythropoiesis stimulating agents or ESAs represent a real breakthrough in the care of cancer patients. Before these drugs, the only recourse was a blood transfusion, which due to its complexity is generally administered in a hospital rather than the doctor’s office. By allowing the doctor to administer effective treatment in the course of a normal office visit, ESAs reduce the challenges of separate appointments for (by definition) fatigued patients, drawing down on a limited blood supply, and increasing exposure to infection when their immune systems are compromised.

The CMS action is breathtaking for its speed and its incursion into the practice of medicine.Offering a better quality of life and lower risk of infection comes at a price, of course. ESAs are, financially, the biggest category of physician-administered drugs paid for by Medicare, amounting to approximately $2 billion annually to treat cancer patients. (ESAs are also used for patients with kidney disease, a use that would not be changed by the CMS proposal.) For that reason alone, it is sensible for CMS to monitor the use of those products and re-evaluate its coverage based on scientific evidence about their appropriate use. But CMS has jumped past science and the Food and Drug Administration (FDA), which is responsible for ensuring the safety of our medicines, in its recent proposal.

ESAs have been used for cancer patients for many years. Procrit, sold by J&J, was approved for oncology patients in 1993, and Aranesp, a second-generation ESA made by Amgen, was approved for oncology patients in 2002. Although that is a very long track record, the performance of innovative biologic drugs is constantly under scrutiny. Several studies began to appear in late 2005 and 2006 that suggested that high dosing levels, above levels recommended on the label, may be associated with an increased risk of death.

Those studies triggered FDA review, leading to a revision of the labels for ESAs. Physicians were advised to use the lowest dose that would work for each patient, resulting in sufficient hemoglobin concentration to avoid transfusions. This decision was announced March 9, 2007.

On May 10, FDA convened a meeting of experts to review the new safety data. At this meeting of the Oncology Drug Advisory Committee (ODAC), the FDA summarized the new studies, but made no new decisions about the appropriate use of ESAs.

The proposed rule would force some very ill patients back to the hospital for transfusions—an outdated treatment that could jeopardize their health.Four days later, on May 14, CMS issued a proposed coverage decision that would severely limit the use of ESAs in cancer patients under Medicare. The 36-page proposal would eliminate payment for ESA use in treating several diseases, including all patients with anemia related to cancer (as opposed to anemia related to chemotherapy treatment) and those with a cancer-like condition of the blood called myelodysplasia. Patients receiving Avastin, Erbitux, or Vectibix—among the most effective new treatments for breast, lung, and colon cancer respectively—would not have access to ESAs. In addition, the proposed decision would restrict payment so that patients could not receive ESAs more than 12 weeks a year, and would require the physician to delay treatment until hemoglobin levels drop to 60 percent of a healthy level.

These are technical provisions, but the message is clear. If the proposed decision is implemented, Medicare would no longer pay for highly effective drugs for every cancer patient who would benefit from them. Patients whose illness and need for treatment fit into the tighter limits of the new policy would receive appropriate treatment. Others who have the wrong disease will no longer have access to ESA treatment that they have previously relied upon to give them a reasonable quality of life. Patients who cannot recover quickly enough from the debilitating effects of chemotherapy are caught in the middle, eligible for relief from their symptoms only according to a bureaucratic schedule rather than medical judgment about their state of health.

The CMS action is breathtaking for its speed and its incursion into the practice of medicine. As a long-time observer of CMS, and as a former official in the agency during the 1980s, I have never seen a proposal with this level of detail emerge from the thicket of clearances in such a short period of time. Perhaps CMS has found some new efficiency that permits it to release rules in record time?

Perhaps not! Similar speed has not been evident for any other Medicare rule, including any of the regulations shaping politically sensitive policies like the new Part D drug benefit or the controversial reductions in Medicare payments to physicians. One need not speculate about motivation to know that this is a highly unusual occurrence from an agency that is celebrated more for its deliberateness than for its ability to react quickly.

More disturbing is the chilling effect on medical discretion that the proposal would have if put into effect. Although medicine is a noble calling, the fact is that money matters. Medicare spends more on ESAs than any other drug covered under Part B. If Medicare eliminates or restricts payment, some patients will not receive the treatment or might not receive enough of the drug over a sufficiently long period of time to alleviate suffering. That will force some very ill patients back to the hospital for transfusions—not the accepted standard of modern medical practice, and for many patients a very bad idea that could jeopardize their health.

The proposed CMS action is all the more dangerous because the FDA process is far from completed. Dosing concerns with ESAs should be investigated—all the evidence is not in yet. Prudence demands that we proceed carefully. The FDA decision to change the drug label is the first step, but a better scientific basis is needed before CMS makes a sweeping change in coverage. Precipitous action by CMS before all the facts are evaluated would raise serious questions about the government’s objectivity in making scientific judgments about the effectiveness of medical treatments when large sums of money are at stake.

The comment period for the proposed decision closes on June 13, and CMS could issue a final ruling between mid-June and August. There is still time for CMS to reconsider its course and make a better decision based on firm scientific evidence and a better understanding of patient needs.

A more nuanced and flexible coverage policy is called for, one that does not take away an option for severely ill patients fighting cancer. Such a policy is within CMS’s grasp, but the proposed coverage decision would remove the flexibility that is already built into the Medicare program. That may save dollars, but it is bad medicine.

Joseph Antos is the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute.

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