Is the integration of intensity-modulated radiation therapy (IMRT) services within some community urology practices a “marriage made in heaven” for both urologists and prostate cancer patients, or a turf-grabbing tactic that may ironically mean that more men are being steered to radiation therapy by their urologists for financial rather than medical reasons?
Such was the issue OT began to investigate after being contacted by a San Antonio-based radiation oncologist who was concerned that patients in that city were receiving suboptimal radiation treatment for prostate cancer.
What initially appeared to be a routine information-gathering assignment soon expanded into more and more of a mystery as numerous experts involved in prostate cancer research and treatment, as well as professional society representatives, and those from the business side of medicine, declined to comment despite many saying that the issue was an important one worth covering.
Renowned prostate cancer experts at some of the nation's leading cancer centers said they didn't want themselves or their institutions involved or mentioned in this story, some saying that it was not their issue, others, that it was too controversial.
A spokesperson for the American Society for Therapeutic Radiology and Oncology first agreed that this was an important topic, and then said that the Society would neither comment nor issue what had been a promised statement by its CEO Laura Thevenot, noting “ASTRO can't get involved with this due to antitrust issues.”
The President and CEO of WellMed, a practice-management company that contracts with specialty medical practices in San Antonio, refused to be interviewed; his office said it was an oncology issue, and wouldn't respond to OT's question about whether it was really more about reimbursement.
However, J. Brantley Thrasher, MD, a spokesperson for the American Urological Association, who developed the recent AUA guidelines for the diagnosis and treatment of prostate cancer with Ian Thompson, MD, said during a telephone interview that there was no question that cutbacks in reimbursement in all medical practices had continued to create downward pressure to create new revenue streams.
Dr. Thrasher, who holds the William L. Valk Urological Chair at the University of Kansas Medical Center, said that with so many changes in radiation and surgery for prostate cancer, quality-control issues were a concern in making sure that the same benchmarks were being delivered.
He added that neither surgery nor radiation is right for all men, and that there has also been concern about overtreating prostate cancer.
Since many prostate cancer patients have therapeutic options, it is usually best that they seek medical opinions from both urologists and radiation oncologists, learn the various risks and benefits, and then make an informed medical decision.
Fortunately—or unfortunately—both surgery and radiation have similar outcomes, and there are no solid data to recommend one generally over the other.
A four-year clinical trial evaluating both modalities is under way in the United Kingdom, but could probably never be done in the United States with its current health care system, according to experts.
Different Overviews of Recent Changes in Treatment
Various experts provided different overviews of recent changes in prostate cancer treatment. Some said that radical prostatectomies, especially in community settings, had decreased, while others said there was a resurgence because of robotic procedures. Some cited more men switching to brachytherapy or IMRT, and a few even mentioned watchful waiting.
But what most agreed on were that urologists'—and most medical practitioners'—incomes were declining due to changes in reimbursement.
And steering patients to an approved higher reimbursed modality—especially one that constitutes what has been called the largest investment made by a urology practice—could be an incentive for persuading patients to undergo the less-invasive IMRT.
Patient advocate Katherine Meade, Minority and Underserved Virginia Coordinator for Us TOO International Prostate Cancer Education and Support Network, said that most men faced with a prostate cancer diagnosis want help making a decision. “They want to be told what to do,” she said.
Dr. Thrasher agreed. “Many men look for information on the Internet and elsewhere, and they still come in and ask, ‘Doc, what do you think? I'm still confused.’
“This is exactly the problem. They come to us for guidance, and with the absence of definitive data, there is the potential that guidance can be offered on behalf of economic rather than medical factors. There's been a lot of talk in this field about conflict of interest.”
Urorad Business Model
Radiation oncologist Mark L. Harrison, MD, is Chairman and CEO of McAllen, Texas-based Urorad Healthcare, “the Pioneer of Urology & Radiation Oncology Practice Integration,” according to its tagline.
He is also associated with Urology Associates of South Texas, a six-physician urology practice located in McAllen.
During a telephone interview, Dr. Harrison explained that about three years ago he wanted to start putting IMRT's technique and treatment into the hands of the physicians who had the patients, and founded Urorad.
He sought larger urology practices with a minimum of five urologists and a guaranteed patient base for his turnkey operation that “emulates the precision of the urologist's knife with the gentle touch of the artist's paintbrush.” He said a “healthy center” would need about 120 cases a year, or 10 new patients per month.
The number of urologists was essential for two reasons: investment in a Urorad facility cost between $2.5 million and $3 million, and a larger practice was necessary “to be compliant with both the federal Stark Law and the Anti-Kickback Amendments. Under Stark regulations, urology practices of two or more physicians are permitted to own their prostate IMRT center,” according to an article by Dr. Harrison in the September 2004 issue of Inside Urology News, the newsletter of International Urology Network, which has, according to its Web site, more than 50% of US urologists as members.
The Urorad business model also circumvents the legal technicalities of the anti-kickback provisions since the IMRT facility is owned by the urology practice and, in most cases, the radiation oncologist is an employee.
Dr. Harrison said that so far Urorad centers haven't had to import any radiation oncologists from outside their geographical areas since they've been able to hire IMRT experts from other local practices. Radiation oncologists working for Urorad never have to worry about where they're going to get their next patient, Dr. Harrison said.
Mack Roach 3d, MD, noted his concern with a Urorad promotional message, saying that it seemed to push the concept of advancing a major financial incentive as a fundamental reason for patient care. IMRT facilities should have board-certified radiation oncologists experienced with the equipment, he said, and wondered about the use of Urorad's “Centers of Excellence” designation.
“Urorad practices can average 50 patients a day. It's an art to push 50 patients through a day, averaging 15 minutes a case. They get very good at it, and learn and utilize all the tricks to maximize patient outcomes.
“It's a match made in heaven. Once I knew IMRT had arrived as an equivalent to surgery, I wanted to make it available to all patients.”
Urorad Develops & Builds the Facility, Helps with Hiring, & Manages the Practice
When a urology practice decides to become part of the “Urorad National Consortium of Prostate IG-IMRT Centers of Excellence,” Urorad develops and builds the facility, helps with hiring, and manages the practice.
Urorad lists its current member centers in McAllen; San Antonio; Dallas; Jeffersonville, Indiana; Overland Park, Kansas.; Independence, Missouri; St. Louis; and Tyler and Laredo, Texas; with another opening in Birmingham, Alabama.
Dr. Harrison said he expects to have about 20 centers operating coast to coast within a year. Urorad has converted many urologists who performed only radical prostatectomies, he said, adding that he has used IMRT to treat one of his urologist partner's prostate cancer.
IMRT is delivered five days a week over nine weeks. The 45-day procedure is approved by Medicare for prostate cancer, and is generally reimbursed at between $36,000 and $41,000, according to the Inside Urology News article.
Dr. Harrison said that radical prostatectomies are usefully reimbursed at between $5,000 and $6,000, but none of the additional cost is passed on to the patient, who pays the same for either procedure.
Part of Clinical Trial
In his practice, he said, “we lay out three options to our patients—seed, IMRT, or radical prostatectomy.” Patients are happy with the continuity of care and reduced side effects of IMRT, he said, noting that Urorad centers were part of a clinical trial led by Anthony V. D'Amico, MD, PhD, in Boston.
Bradley R. Prestidge, MD, a radiation oncologist, is Medical Director of the Texas Cancer Clinic and its Texas Prostate Institute in San Antonio.
Dr. Prestidge had expressed concern to OT that Urorad's delivery of IMRT services might be suboptimal, and claimed that it wasn't possible to do a good job pushing 50 to 60 patients a day through IMRT.
He also said he had spoken with members of ASTRO's regulatory committee who said that what Urorad was doing was not illegal, “although it was possibly unethical.” It was Dr. Prestidge who prompted this article.
During an initial phone interview, Dr. Prestidge was told that it would be especially important to differentiate his concern with quality-of-care issues with that of a competitor losing prostate cancer patients to another practice.
Dr. Prestidge said he was aware of the difference, and pointed OT to several sources for information. That was when call after call to cancer centers, and face-to-face meetings with numerous prostate cancer experts at the annual SPORE Investigator's Workshop in June (OT 7/10/06) netted surprise and alarm about the potential conflict-of-interest problems with the Urorad model, and pleas to be left out of the story.
Integrating RT Services in Urology Practice in General
However, OT was able to find a number of oncologists willing to speak on the record about general issues related to integrating radiation services within a urology practice, although none could comment about specific Urorad self-proclaimed centers of excellence.
Dr. D'Amico is Professor and Chief of Genitourinary Radiation Oncology and MR-Guided Prostate Brachytherapy Programs at Dana-Farber Cancer Institute and Brigham and Women's Hospital.
In a telephone interview he explained that the trial mentioned by Dr. Harrison was an international randomized trial of men with high-risk prostate cancer—with either high Gleason scores or high PSAs—who were randomized to the current standard of care—radiation and hormones, with or without chemotherapy.
He said he had hoped to accrue about 350 men over a two and a half year period, and had so far recruited 25 men during the first few months.
The trial required a multidisciplinary team of urologists to make the diagnosis, radiation oncologists, medical oncologists for chemotherapy or hormone therapy, and a radiologist—the kind of teams now found at facilities such as Urorad centers. Dr. D'Amico added that at this early stage he didn't know whether Urorad would become a player or not.
Not Necessarily a New Thing
Dr. D'Amico commented that Urorad's model of urologists hiring medical oncologists, as well as radiation oncologists to use the IMRT equipment bought by the urologists for the purpose of profit sharing the revenues derived from the procedure was not necessarily a new thing in surgery.
He said similar models exist for both neurosurgeons and orthopedic surgeons, and that urologists are just the latest medical practitioners to pick up on it. He also noted that it was similar to academic models, but pointed out that the model's potential for conflict of interest depended on the degree of collegiality involved.
“If the radiation or medical oncologists are colleagues with the urologists, meaning that they are on equal footing as partners and not employees of the urologists, then as with any other business construct in a medical facility, and from an academic viewpoint, it's fine.
“If they all work as partners, and the radiation oncologist doesn't answer to the surgeon, and the surgeon doesn't answer to the radiation oncologist, and they all go to tumor boards and share the profits, then that kind of model works very well.
“However, if the radiation oncologist is an employee of the urologists, then that's where the sensitivity arises. And if the radiation oncologist is hired to just do what he's told, and there's no good medical discretion on his part, then you could get into a situation where medicine and money conflict.”
In addition, Dr. D'Amico said, treating 50 to 60 men a day on an IMRT machine was not in itself a problem.
He noted that he had just returned from two medical meetings where this specific situation was being discussed—It turned out he had been meeting with other prostate cancer experts who had been recently contacted for this story.
‘At First Thought It Was a Bad Joke’
Mack Roach 3d, MD, Professor of Radiation Oncology and Urology, Director of Clinical Research for the Department of Radiation Oncology, and Interim Chair of Radiation Oncology at the University of California, San Francisco Comprehensive Cancer Center, told OT that he had received a copy of a Urorad marketing e-mail about a year ago from a colleague who was sharing the information with other academic-based radiation oncologists.
“When I first saw it, I thought it was a bad joke,” he said. “And when I realized it was real I felt very uncomfortable with it. My biggest concern was the flavor of the e-mail since it seemed to push advancing a major financial incentive as a fundamental reason for patient care.”
Dr. Roach, who presents a session on treating prostate cancer at the AUA annual meeting with Dr. Thrasher, also said that IMRT facilities should have board-certified radiation oncologists experienced with the equipment, and wondered about the use of Urorad's “Centers of Excellence” designation. He agreed with Dr. D'Amico's assessment that it was feasible to treat 50 patients a day with IMRT.
‘Economic Issues Have Led to Decline in Quality’
David I. Lee, MD, Assistant Professor of Urology in Surgery, and Section Chief of Urology at Presbyterian Hospital, University of Pennsylvania Health System, is a robotics surgery expert who had formerly practiced at a physician-owned hospital outside Dallas.
He said that in his former practice urologists referred patients less often to radiation oncologists because they also offered the option of cryosurgery. He thought there was probably an overall increase in the number of radical prostatectomies and radiation oncology procedures because more prostate cancer cases were being detected.
He also noted that economic issues have led to a decline in the quality of medicine.
“Doctors have to see more patients to make the same amount of money they made several years ago because of reimbursement. Some of them may look for ways to make money by taking an ownership interest in things that they are familiar with, or are related to their practice.
“Today's environment means physicians have to be good at business and look out for these opportunities. What's the downside of that? I don't personally have a problem with it, but it can create the opportunity to do wrong,” he said.
Dr. Lee's colleague, Stephen M. Hahn, MD, Henry K. Pancoast Professor and Chairman of Radiation Oncology at the Abramson Cancer Center at the University of Pennsylvania, said that the individual patient's medical interest should always be the physician's primary concern, not financial interests.
“If medical decisions are being made for financial reasons and what's being recommended is not necessarily best for the patient, then there's a problem regardless of what the Stark Law says.”
He agreed that an equal relationship between urologists and radiation oncologists was key to avoiding potential conflicts of interest, adding that an employee radiation oncologist was at greater risk of getting fired if he disagreed with his urologist employers about the best treatment modality.
“The best possible situation for a prostate cancer patient would be for him to get an independent evaluation from various practitioners outlining the risks and benefits of their respective treatments and then individualize the decision based on what's best for that person's particular circumstances so he can make an informed decision about treatment,” Dr. Hahn said.
It is also crucial that both urologists and radiation oncologists make independent medical evaluations rather than having a patient seen just by one and referred to the other for treatment, which could give the appearance of a conflict of interest, if not constitute an actual one.
Dr. Hahn mentioned that although he is Scientific Director for ASTRO's Annual Meeting, he was not commenting on behalf of the Society.
He also stressed the importance of obtaining informed consent, and evaluating patients appropriately for IMRT by asking if they had prior radiotherapy, and if so, when it was given, and did patients have any medical conditions that would contraindicate radiation therapy.
Urology San Antonio is a 21-partner, five-office urology practice that was the first outside practice (after Dr. Harrison's McAllen center) to join the Urorad Consortium.
Juan A. Reyna, MD, is President of the practice, which claims to be the largest and most experienced urology group in San Antonio, with some 600 newly diagnosed prostate cancer patients a year, in addition to its other patients.
During a telephone interview, Dr. Reyna told OT that he and his partners had read in the literature that “IMRT was getting rave reviews in comparison to surgery and other results, and we were impressed that it was a good modality, especially when we were having patients ask us about it.
“There were other IMRT units in our city, and we had been referring patients out, until we met Mark Harrison, who helped us figure out economically that we could afford to have our own IMRT unit basically in-house and be able to treat our own patients.”
Dr. Reyna said the practice had to create a formal relationship with a radiation oncologist, whom he described as an employee-slash-partner.
“The unit meant a sizable investment, but other than that, this was kind of where prostate cancer was going. To a large extent the patients were choosing this over the other choices once they were told what their options were.”
Dr. Reyna said Urology San Antonio probably now refers more patients to IMRT, because when the practice started offering the service last year, they were seeing tremendous results, with PSAs dropping.
Very Little to No Morbidity
“We saw our patients getting terrific chemical response to the IMRT, and we're seeing very little to no morbidity with the treatment,” he said. “It's not like the old conventional external-beam radiation treatment when patients would come back to us with radiation-related side effects, and we'd have to treat the problems caused by the radiation.”
Also, Dr. Reyna noted, the practice has urologists who still like to perform radical prostatectomies, and also offered are robotic surgery, radioactive seed implants, and cryotherapy, so patients are provided with various options.
When asked about the potential for a conflict of interest regarding higher reimbursement for IMRT, Dr. Reyna replied: “We tell the patients all the facts, and point out the upsides and downsides to all the potential therapies and let them decide. When they learn that with IMRT they never need an anesthetic, that it's the least invasive of all the things they can have done, and that it's a 15- to 20-minute experience on a daily basis, then it's something that is kind of hard to resist with that as an option versus being put to sleep and having a radical prostatectomy and running a 50 percent risk of serious side effects.
“So, do we steer patients? Well, we try not to; we try to be very objective and offer them various modalities in a very fair way. But the truth is we've been swayed by the success of IMRT, and think it's an unusually great therapy for prostate cancer.”
Dr. Reyna said more and more offices are looking to integrate various services, and that larger practices like his also own CT scanners, do their own pathology, and have surgery centers.
“The historical way of making money off of just bread-and-butter urology is not what it used to be, so you have to go to ancillary sort of ways of boning up your income or really accelerating your revenues, and these are actually very good, creative, and acceptable ways of doing it.”
In the time since Urology San Antonio installed its IMRT unit the practice is doing more marketing, including prostate cancer screening and is “getting more aggressive about looking for guys with prostate cancer than before,” Dr. Reyna said.
“So I think our population of prostate cancer patients has gone up some, but in terms of options, we still offer all the same options we did before.”
He said his practice has no interaction with the other members of the Urorad Consortium, and aside from a five-year management contract with Urorad, the IMRT is really a self-contained operation.
As for the future, Dr. Reyna said his practice was always looking at new technologies to integrate into what they are doing. What's next? Maybe a technology in its early stage of development called high-frequency ultrasound treatment, or HIFU.
“We're always keeping our eyes open,” said Dr. Reyna.
That seems to be sound advice for everyone involved on all sides of prostate cancer treatment.