Anyone with a vested interest in medical technology probably knows all too well the nightmare stories of worthy products in which their launch was either scrubbed or delayed because payers, particularly Medicare, hesitated on reimbursement. Some of those struggling products include digital mammography and positron emission tomography imaging.
But there are some bright spots in the development of new technologies, and one involves intensity modulated radiation therapy, or IMRT, radiation therapy's heat-seeking missile. The technology allows radiologists to target and attack tumors full-gun while sparing healthy tissue.
Barely five years on the market, IMRT is on the cusp of gaining acceptance at community hospitals across the country, fueled in large part by two new temporary reimbursement codes HCFA approved effective Jan. 1.
"If you had asked me 10 years ago (how significant the reimbursement issue was), I would have said it was not a big deal, but now new technologies don't get adopted without reimbursement," says Richard Levy, president and chief executive officer of Varian Medical Systems. Palo Alto, Calif.-based Varian is one of a handful of companies that have developed or are developing IMRT systems, and Levy points to IMRT as "an emerging success story in the evolution of new technology."
Other companies offering IMRT products include ADAC Laboratories, Computerized Medical Systems, Nomos Corp. and Siemens.
Conventional radiation therapy has evolved considerably since linear accelerators were first introduced in the 1950s. They have gone from analog to digital. The introduction of so-called multileaf collimators to the devices in the early 1990s paved the way for automated three-dimensional conformal radiation therapy (3D-CRT). The collimators enable clinicians to "sculpt" the radiation beams rather than blindly firing away at cancers.
IMRT takes 3D-CRT a step further by adding an even higher-resolution multileaf collimator that shoots pencil-sized radiation beams that also can be modulated. Varian's complete IMRT package also includes inverse treatment software: Rather than calculating where the beams should go, the clinician instead calculates the clinical objective and then lets the software figure out how that objective will be accomplished.
Many experts caution, however, that there is a steep learning curve involved in the treatment planning. Some academic research centers even insist that having a Ph.D. physicist on staff is a must.
The soup-to-nuts package sells for about $1.5 million, but hospitals can sometimes upgrade their linear accelerators for roughly $1 million, says Spencer Sias, a Varian spokesman. However, most of the linear accelerators are going out the door with multileaf collimators if not the software, many of them to community hospitals, Sias adds.
The theory, which is being borne out in a growing body of studies, is that precision- targeting allows radiologists to deliver much higher doses of radiation to cancerous areas, thereby improving outcomes and minimizing complications. For example, in treating prostate cancer, researchers at 437-bed Memorial Sloan-Kettering Cancer Center, New York, reported 90% of the patients treated with megadoses of radiation for their localized tumors were cancer-free three years after treatment, compared with 46% of those treated with the lowest radiation dose. Meanwhile, rectal bleeding complications were reduced to 3%, compared with 17% for 3D-CRT, says Michael Zelefsky, M.D., associate professor of radiation oncology at Sloan-Kettering and lead author of the study.
"If you had that kind of outcome in a pill, it would be a banner headline," Sias says.
In general, under the new payment codes for IMRT, reimbursement for hospital-based radiation oncology departments quadruples to $400 per treatment from roughly $100 per treatment, although freestanding clinics have been left out of the loop. The American Society for Therapeutic Radiology and Oncology, which lobbied hard for the new codes, has set its sights on obtaining higher reimbursement for the clinics, says Paul Wallner, D.O., vice chairman of the department of radiation oncology at the University of Pennsylvania, Philadelphia, and co-chairman of ASTRO's joint economics committee.
"Reimbursement is the silver lining in what was a dark cloud," says Chester Szerlag, executive administrator of radiation and cellular oncology at the University of Chicago. The medical center committed to IMRT two years ago, even knowing it was a money-loser at the old reimbursement rates.
That all changed when ASTRO began lobbying HCFA regarding the meager outpatient rates for the new technology. It only took six months to turn the Medicare administrators around, Szerlag says.
"HCFA has a lot of motivation to make the new ambulatory payment system work well, and the quickest way is to accommodate new technology," Szerlag says. "I give HCFA credit because unlike how they've done things in the past, they are trying to make a system everybody is comfortable with in terms of reimbursement."
Despite the new coding, Szerlag doesn't predict an explosion in use of IMRT, "because people realize it's more than just buying the equipment," he says. Many community hospitals are waiting on the sidelines while academic medical centers such as his work out the complicated practice protocols for various disease sites, he says.
One community hospital that has employed the technology since 1999 is 226-bed Pocono Medical Center, East Stroudsburg, Pa. The hospital's location, equidistant from Philadelphia and New York and surrounded by a large retirement population, drove the early adoption, says Stacy Goetz, director of oncology services at the hospital's cancer center. Goetz said savvy patients are coming in and requesting the therapy after hearing about it in the media or on the Internet.
The department treats 35 to 55 patients per day and up to 40% get IMRT, says Michael Greenberg, M.D., its medical director.
He still considers the technology cutting-edge and believes Pocono will have the IMRT market cornered in his area for at least the next five years.
Zelefsky, the Sloan-Kettering researcher, believes it will take considerably less time for IMRT to take hold.
"I expect this to become more prevalent in many treatment centers over the next couple of years," Zelefsky says.