Its not who you know, its your Zip Code for medicare reimbursement

THE EVIDENCE GAP; (Not So) Standard Procedure (December 17, 2008)

Geography Has Role in Medicare Cancer Coverage


Published: December 16, 2008

The medical tool’s catchy name, CyberKnife, evokes digital accuracy. But the way the federal Medicare system treats CyberKnife seems anything but precise.

Ralph Rodriguez undergoing treatment with a CyberKnife machine at Winthrop-University Hospital in Mineola, N.Y.

Joe Pagano, a radiation therapist, readying a CyberKnife device at Winthrop-University Hospital in Mineola. The machines, made by Accuray, a California company, cost $3 million to $5 million.

CyberKnife is a new but fast-growing radiation treatment for prostate cancer, spurred by radio and newspaper ads that stress its convenience and results. The chief selling point is that CyberKnife treatments take five days instead of the eight weeks for conventional prostate cancer radiation, although many experts say they believe that the medical evidence is inconclusive on whether it works as well as those older methods.

But geography may play as big a role as medicine in determining which men diagnosed with prostate cancer are eligible for CyberKnife. As it turns out, Medicare pays for the treatments in 33 states ”” but not in 17 others.

States that do not provide coverage include big ones like California and Texas, but also less populous places like Alaska and South Dakota. Medicare will pay for a man’s CyberKnife treatments in New Hampshire, but not across the border in Vermont.

The disparities result from a policy principle as old as Medicare itself, in which officials in Washington leave many reimbursement decisions to the discretion of 15 regional contractors around the country. A dozen of them willingly pay for CyberKnife treatments among other prostate options. But three of the regional contractors have balked at covering CyberKnife, saying there is not enough evidence of its long-term effectiveness against prostate cancer.

Many health policy experts applaud refusing reimbursement for treatments not supported by medical evidence. But some also point to CyberKnife as emblematic of the inconsistent way that the federal Medicare budget ”” expected to be $477 billion in the current fiscal year ”” is spent, region to region.

“Most policy makers think that, in general, we would want to do more national coverage decisions, partly because there’s a concern that the evidence review in most local regions isn’t very good,” said Dr. Steven D. Pearson. He is president of the Institute for Clinical and Economic Review, an organization partly financed by the insurance industry that is pushing for the use of evidence in medical decisions.

“You can live on one side of the street and get a procedure, but on the other side of the street you can’t,” Dr. Pearson said.

At an average Medicare cost of $29,000, CyberKnife prostate treatment is not cheap. But it can be less expensive than some other radiation methods, which may cost as much as $50,000. And so, if CyberKnife became the standard treatment for prostate cancer, Medicare might save significant money. An estimated 219,000 men in this country are expected to be diagnosed with prostate cancer in the coming year, most of them of Medicare age.

Leo Stutzin, 73, a retired art and theater critic for The Modesto Bee in California, had tentatively chosen CyberKnife treatments for his prostate cancer after doing Internet research a few months ago. But because his doctor told him he would have to pay for the treatments himself, Mr. Stutzin is now undergoing two months of almost daily treatment with a more conventional radiation method that Medicare does cover in California.

“Medicare is a national program,” Mr. Stutzin said. “If it’s available in Connecticut and Virginia, it should be available here.”

Most medical claims to Medicare are paid routinely. But questions frequently arise when it comes to newer treatments and technologies. And over the years, Medicare has resolved only about 300 such questions with blanket national coverage rulings. Meanwhile, thousands of other coverage policies have been ”” and continue to be ”” decided region by region. CyberKnife is among the starker examples of how widely coverage can vary from one region to another.

The principle of local decision-making traces to the creation of Medicare in 1965. Because some doctors and lawmakers had argued that federal meddling in medical decisions would be tantamount to “socialized medicine,” Congress allowed for regional autonomy in reimbursements.

Over the years, there have been complaints about the system, as when a 2003 report by the Government Accountability Office criticized Medicare for regional differences in covering a treatment for Parkinson’s disease tremors. Medicare responded by declaring that it would cover the treatment throughout the nation.

But some experts argue that the regional system is more efficient than having the federal government dictate national coverage in every case. And Medicare officials say the regional contractors ”” generally units of private insurance companies ”” have no financial motive to withhold coverage, because the companies receive the same payment from the government regardless of what treatments are covered.

 “Our guidance to them is that if there’s no evidence it works, they shouldn’t pay for it,” said Dr. Steve Phurrough, Medicare’s coverage director in Washington. “The CyberKnife is a good example of a technology where you can review the evidence and come to different conclusions.”

A national coverage decision on CyberKnife is not currently in the works, according to a Medicare spokesman, Donald E. McLeod. It remains to be seen whether a Democratic president will seek changes in the system. Dr. Pearson, of the Institute for Clinical and Economic Review, said that while coverage variations might not yet be a front-burner issue for President-elect Barack Obama, “It would be consistent with your archetype of what a Democratic administration would start to consider as one of its policy options ”” to someday address the inconsistency.”

The three Medicare contractors that have declined to cover CyberKnife for prostate cancer are TrailBlazer Health, Palmetto GBA and Noridian Administrative Services. The affected states are Alaska, Arizona, California, Colorado, Hawaii, Montana, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Texas, Utah, Vermont, Virginia, Washington and Wyoming.

In response to a reporter’s questions, Palmetto, whose Medicare jurisdiction includes California, issued a statement saying that its medical directors had reviewed the evidence about CyberKnife. They concluded that the literature supporting its long-term effects on prostate cancer was sparse and that leading doctor groups believed that treating the disease with CyberKnife remained in the “investigational” stage, Palmetto said in the statement.

“We have all seen the medical problems and complications when pharmaceuticals and therapeutic modalities are released for general use before their effects are fully known,” Palmetto said.

CyberKnife, made by Accuray of Sunnyvale, Calif., was allowed onto the market by the Food and Drug Administration in 1999 as a treatment for brain and spine tumors. Two years later the F.D.A. authorized it for use throughout the body. Accuray, as well as hospitals and clinics that operate the CyberKnife machines, which cost $3 million to $5 million, have been promoting their use on various cancers, including lung and pancreatic cancer ”” and, increasingly, prostate cancer.

According to Accuray, patients can get by on fewer treatments because the machines deliver highly focused beams of radiation at heavier doses than conventional systems. But some leading radiation oncologists worry that the cumulative radiation that CyberKnife delivers over a course of prostate treatments ”” ultimately lower than what patients would receive in standard therapy ”” is not adequate to treat the disease.

“They are basically pushing the envelope,” said Dr. W. Robert Lee, a radiation oncologist at Duke University. “If they’re right, it’s going to be an important advance. If they’re wrong, there’s a potential for a big downside.”

With about 80 patients studied under the regimen in published peer-reviewed research over five years, the results for CyberKnife are promising. Yet, because prostate cancer is frequently slow-growing, Dr. Lee argues that five-year data with so few patients may not be very meaningful. Others raise concerns that high daily doses may increase radiation side effects that can show up years after treatment.

The board of the radiation oncology society, the American Society for Therapeutic Radiology and Oncology, or Astro, has called CyberKnife promising, but raised questions this year about the evidence supporting its use in prostate cancer, saying “there is not sufficient or mature data to demonstrate equivalency to existing standard treatment modalities.” The statement also applied to other brands of the technique, which is known as stereotactic body radiation therapy.

Citing the variety of proven treatments for prostate cancer, one member of the Astro board, Dr. Louis Potters of North Shore-Long Island Jewish Health System, said that advertising CyberKnife directly to consumers could confuse patients, who have to choose the best treatment from an already bewildering array of options.

“Patients are becoming commodities and prostate cancer is the ultimate example,” Dr. Potters said.

Some critics of Astro, though, say the group has its own financial motives in preferring previous forms of external radiation ”” which, because they involve more trips to the doctor, tend to be more profitable for radiation oncologists. CyberKnife’s proponents include Dr. Matthew R. Witten, a doctor in New York State ”” where Medicare pays for the treatment. Dr. Witten, a Long Island physicist, runs the CyberKnife program at Winthrop-University Hospital in Mineola, which actively advertises the treatments.

Dr. Witten said CyberKnife should be viewed in the context of the way radiation oncology has evolved in the past ”” with new methods being developed and pushed into service before long-term clinical data is available.

“The data with CyberKnife are not as mature as with other treatment modalities,” he said. “But from what I see with our patients, anecdotally, they are doing wonderfully.”



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