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Medicare may Stop Covering Device Used in Prostate, Ovarian Cancer Treatment

by Liz Freeman | | 06.27.2009

NAPLES — Prostate cancer patients willing to try something relatively new a few years ago for faster treatment and reduced side effects came to swear by the CyberKnife technology.

Men were coming to Naples from all over for the robotic system for non-invasive, precision-targeted radiation therapy.

The NCH Healthcare System purchased the system in 2004, investing nearly $5 million for the technology and for remodeling space in its cancer center on Fourth Avenue North.

The Centers for Medicare and Medicaid Services left the reimbursement decision up to its regional Medicare administrators, like it does for some other services. For five years, Medicare in Florida has paid for CyberKnife treatment of prostate cancer.

That’s potentially about to change and Medicare coverage could end this fall, according to a spokesman for First Coast Services Options Inc., the Jacksonville-based Medicare administrator for Florida, Puerto Rico and the U.S. Virgin Islands.

First Coast has drafted a local coverage determination that says stereotactic body radiation therapy, the treatment offered by CyberKnife, will no longer be covered because scientific data doesn’t show it offers an advantage over other treatment options for prostate cancer.

Likewise, Medicare would no longer cover CyberKnife for treating ovarian and uterine cancer, although usage for those cancers is infrequent compared to prostate cancer.

First Coast held a public meeting June 18 in Jacksonville to hear what people had so say. In addition, a public comment period is ongoing until July 15, said Harold Barnett, the company spokesman.

If the decision is made to discontinue Medicare coverage, Florida would join 17 other states, based on coverage decisions of three other regional Medicare administrators.

“If it was pretty definitive that this was the best or only treatment, we wouldn’t come up with a (local coverage determination),” Barnett said. “The literature does not support an outcome advantage over other conventional radiation modalities.”

* * * * *

Dr. Chaundre Cross, a Naples radiation oncologist who specializes in CyberKnife and other therapies, said there has only been one study about CyberKnife that just came out this spring from Stanford University.

That’s where CyberKnife got started by its founder and developer, Dr. John Adler, in the early 1990s.

It gained approval by the U.S. Food and Drug Administration in 1999 for treating tumors in the neck, head and upper spine, and in 2001 for treating tumors anywhere else in the body.

Cross said the study shows outcomes with CyberKnife is equivalent to other radiation approaches. That said, the advantages of CyberKnife are much shorter treatment, usually five days, and reduced side-effects.

“The effectiveness is not the reason why CyberKnife is popular. It was the convenience factor,” said Cross, who has treated about 50 men with CyberKnife in Naples. “When men are presented with that choice, CyberKnife was a very attractive option I have had no failures in two years.”

On the other hand, some men forego it in favor of conventional radiation therapy because there is data on outcomes but none until now on CyberKnife, he said.

When NCH purchased its CyberKnife in 2004, the hospital system was relying on data on short-term outcomes. Last year, NCH signed a deal with 21st Century Oncology to take over its cancer program and radiation therapy, including the CyberKnife.

Even if Medicare stops paying, Cross expects some men will pay for it out of pocket.

Private insurance doesn’t cover CyberKnife treatment for prostate cancer either, he said.

“There is a role for it in prostate cancer, for early stage disease,” he said, adding that he was unaware of the June 18 meeting in Jacksonville.

He likely will submit comments to the Medicare administrator.

Quentin Heim, vice president of patient access for Accuray, the Sunnyvale, Calif., company that makes CyberKnife, said it is more cost-effective than proton therapy and intensity-modulated radiation therapy, which is a computer-assisted radiation approach, for prostate cancer.

Florida’s Medicare administrator is paying for those therapies, he said.

“And there really isn’t any clinic trial or data that proton is effective,” Heim said. “CyberKnife has been used in Florida for hundreds of patients.”

At present, there are 14 CyberKnifes at centers and hospitals in Florida out of 107 in the United States.

He estimated Medicare pays about $20,000 for the treatment, compared with $30,000 for the computer-assisted radiotherapy.

Moreover, he said the federal Agency for Healthcare Research and Quality came to the conclusion last year that no one therapy can be regarded as superior to another.

* * * * *

At the June 18 meeting, Heim said the medical director of First Coast, the Florida Medicare administrator, was receptive to testimony of half a dozen cancer patients who have been treated with CyberKnife, including an ovarian cancer survivor, and to what radiation oncologists reported.

He’s optimistic Medicare coverage will stay intact.

Naples resident Dr. Scott Silver, a retired orthopedic surgeon whose practice was in upstate New York, was diagnosed with prostate cancer in 2006. He researched his options and went with CyberKnife in May of that year. He based his decision on reduced side-effects and lower risk of complications.

He attended the June 18 meeting in Jacksonville and testified in support of continued Medicare coverage.

“It’s a question of choices for patients primarily as a patient and as a physician,” he said. “I don’t understand why our choices should be limited when it offers advantages over other (therapies), in my opinion.”

He also questions why First Coast is considering dropping CyberKnife coverage in favor of proton therapy, which doesn’t have supporting scientific data.

Officials with 21st Century Oncology, one of largest for-profit radiation therapy providers in the U.S., has taken the position that if Medicare coverage for Cyberknife is discontinued, the federal government is creating an unjust access issue, said Andrew Woods, executive vice president for global governmental affairs for 21st Century.

“What’s the difference between a 65-year-old patient in Florida to that of one in California?” Woods said. “We are waiting to see what the decision will be and continue to offer it to all our patients.”

Dr. Mark Perman has treated more than 500 patients with CyberKnife, starting in Miami in 2003 and now in Gainesvile as clinical director of CyberKnife at North Florida Regional Medical Center.

He regards it as complementary therapy for treating certain tumors and isn’t intended to replace conventional radiation therapies.

“Our concern is Medicare beneficiaries in Florida will not have the same level of coverage as other areas of the country, and the tremendous cost savings (that would be lost),” he said. “The data is there. I don’t think we need to prove ourselves any more.”

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