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Precise, but Pricey

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The first time Mark J. Brenner, M.D., saw the CyberKnife, he had an “Oh-my-God!” moment. On display at a radiology oncologists’ convention, the robotic radio-surgery technology seemed like a major advance in treating cancer patients. Driven by a linear accelerator, which delivers a uniform dose of high-energy X-ray to a tumor, the system can target radiation with sub-millimeter precision, taking cancer treatment with radiation to the next level. “The cancer is easy,” says Brenner, chief of radiation oncology at Sinai Hospital of Baltimore. “With a high enough dose you can kill anything. The challenge is sparing the normal tissue.”

Since buying the technology in 2003, Sinai Hospital has treated more than 500 patients, many of whom had few other options. Like other forms of radio-surgery, the CyberKnife can treat brain tumors effectively, Brenner says. But because of its advanced beam guidance system, the technology requires no external frame to be mounted into a patient’s skull.

CyberKnife’s real promise, however, may lie in its ability to treat tumors elsewhere in the body, including on the lung, pancreas and spine. The technology’s ability to track tumors that shift with respiration distinguishes it from other forms of radiation-delivery systems, users say. “It is a hybrid of surgery and radiation,” Brenner says. “It is neither realm entirely.”

The technology may work well, but hospitals must tackle a variety of difficult issues before incorporating it into their clinical operations. For one, CyberKnife is as expensive as it is leading edge. System startup costs—which include building a heavy-duty bunker to house the equipment—can reach $5 million. Beyond the hefty price tag, hospitals also must contend with tricky medical staff relationship issues over which specialists are the technology’s rightful “owners.” Clashes between radiation oncologists and surgeons may surface. Perhaps most critically, health insurers may look at the technology skeptically, declining to reimburse for procedures they consider unproven.

The CyberKnife is so expensive that its vendor, Sunnyvale, Calif.-based Accuray Inc., offers lease and revenue-sharing options to potential hospital customers who are hard-pressed to come up with the cash. The so-called “placement” arrangement was the only way that St. Joseph’s Hospital, a 265-staffed-bed community facility in St. Paul, Minn., could afford to deploy the system, says Chris Laird, associate administrator. Championed by the hospital’s neurosurgeons, the CyberKnife system represented a $5 million outlay that included more than $3 million for the machine plus additional construction and training costs. Unwilling to take that much financial risk, St. Joseph’s agreed to a $25,000 monthly lease and a revenue-sharing arrangement with the vendor that began in 2003. After the economics of running the technology were proven, the hospital bought the machine outright the following fall.

Sinai Hospital struck a similar deal with Accuray, turning to philanthropists to help raise an initial down payment. The technology was emotionally appealing, recalls Brenner, who made the fundraising presentation. “One of the donors got teary-eyed and told everyone how his mother had died of pancreatic cancer. ‘This might have helped her,’ the donor said, and he promptly pledged $500,000. You could have heard a pin drop. Suddenly the other pledges started coming in.”

Surgical turf redefined

Zapping hard-to-reach tumors may be appealing to donors, but Brenner knew the system could cause a rift in the medical staff, pitting surgeons against radiation oncologists. “The issue is ego and money,” Brenner says. “If I had told the surgeons, ‘Hey, I’ve got great news, you do not have to treat this tumor in the OR, you can send the patient to me,’ they would have told me where I could stick my CyberKnife. I knew that would be the death knell.”

Brenner championed a dual-specialty approach in which a surgeon does the initial planning and tumor contouring, but hands off the plan to a radiation oncologist, who determines dosing and frequency of treatments. “I know both the tumor and the risk area,” Brenner says. “The surgeon knows more about cross-sectional anatomy.” Their joint plan is handed off to the physics staff, who create the delivery plan in the CyberKnife system.

Gaining the buy-in of surgeons—especially non-neurosurgeons unaccustomed to radio-surgery—was critical to the acceptance and growth of the technology at Sinai, Brenner says. “This technology is new for surgeons,” he says. Sinai has trained 18 surgeons, including head and neck specialists, to use the CyberKnife. Demand for procedures has taken off, and the hospital is adding a second unit this year in another lease arrangement.

Payors want proof

The newness of the technology underscores another prickly issue. While payors will generally reimburse for CyberKnife treatments of brain tumors, they are more skeptical about using the system on other parts of the body, explains Debra R. Mills, R.N., vice president of clinical coding and reimbursement at Rheinisch Medical Management in Knoxville, Tenn., a consulting group that advises hospitals about high-end technology reimbursement. The Food and Drug Administration approved the technology in 2002, but ongoing clinical trials must be completed to demonstrate the CyberKnife’s clinical effectiveness in treating extracranial tumors, Mills says, for payors to change their policies.

Some payors, such as UnitedHealthcare, officially dismiss the use of CyberKnife for extracranial treatments as “investigational or experimental,” Mills says. “Whatever you call it, it equals nonpayment.” Nevertheless, Mills has helped several hospitals win payment for extracranial procedures, overturning a blanket denial into a case rate for certain types of tumors. The key, Mills says, is for hospitals to discuss their use of the technology with their payors before they begin submitting bills. Medicare has a more liberal payment policy than many private health plans, Mills says, a fact that may sway some private carriers.

For his part, Brenner is convinced of the technology’s utility. Many of the patients Brenner treats with CyberKnife are disqualified from other forms of radiation therapy or invasive surgery due to the complexity of their cases. One patient had a tumor wrapping around her spinal cord, putting her at risk of imminent paralysis. The patient had already undergone extensive radiation therapy and surgery, but to no avail. Brenner put the patient under the CyberKnife, which directed its powerful beam of radiation to the tumor, with the spinal cord only 5 milimeters away. “The radiation hugged the tumor like a glove,” he says.

The tumor slowly regressed, says Brenner. Although the patient died 20 months later, Brenner takes pride in helping prolong her life and avoid paralysis. “We gave her another good year and a half.”

Gary Baldwin is technology editor of HealthLeaders magazine. He can be reached at gbaldwin@healthleadersmedia.com.