John Vano, President of ROS, quoted in a DotMed Magazine article on the economics of radiation oncology
By Gus Iversen
View Publication: https://www.dotmed.com/images/magazine/archive/092014.pdf
Nearly a decade ago, the Journal of the National Cancer Institute published a study concluding that hypofractionated radiation therapy for palliation of bone metastases is just as effective as the more drawn out, more expensive standard treatment. De- spite those findings, a study published in the Journal of the American Medical Association found that between 2006 and 2010, only 4 percent of Medicare covered bone metastases cases utilized hypofractionated, (also known as intensity modulated) radiation. Since then, similar studies have emerged recommending hypofractionation for whole breast irradiation and prostate therapy.
Reluctance to embrace new technologies is nothing new in health care. The slow adoption of electronic health records (EHRs), regardless of their numerous benefits over handwritten records, is a well-documented example. In the case of treatment modalities, part of the reason better systems are not implemented is related to the industry’s reimbursement structure. DOTmed HealthCare Business News spoke with Dr. Leslie Botnick, chief medical officer of Vantage Oncology and board certified radiation oncologist, about the adoption of new equipment at Vantage, where they provide a wide variety of linear accelerator (linac) hypofractionated services. “If you’re a free standing facility, you’ve got to be very careful how you spend your capital,” says Botnick. “Over the last generation, the Centers for Medicare and Medicaid Services have cut reimbursement in the freestanding centers close to 20 or 25 percent, while hospital reimbursement has gone up.”
Keeping up with CMS
Dr. Brian Kavanagh, Department of Radiation Oncology at the University of Colorado School of Medicine’s Anschutz Medical Campus and chair of the Health Policy Council for the American Society for Therapeutic Radiation and Oncology (ASTRO), spoke to DOTmed about a three-part plan to improve CMS reimbursement models. The first part is for ASTRO to draft their own accreditation program to provide practitioners with guidelines for what they consider high-quality service.
“The second part is to work with CMS to update some of our treatment delivery codes,” Kavanagh says. “We understand it has been a little hard for CMS to keep up with some of the things that have changed about how radiation oncology is practiced in a modern context,” he says. “So we’re working closely to ensure reimbursement is fair and based on justifiable and realistic costs.”
The third and final part of ASTRO’s plan, according to Kavanagh, is to determine the total cost of care in the interest of better coordinated treatment plans and smarter spending. “We want to design alternative payment models that depart from the traditional fee-for-service system,” he says.
In 2013, CMS cut reimbursement for Gamma Knife brain tumor treatment by more than half while leaving linac coverage unchanged. Decisions like that directly impact patients, and the treatment plans their physicians prescribe. DOTmed spoke to Dr. Constantine Mantz, a board certified radiation oncologist and chief medical officer at 21st Century Oncology about the medical implications of Gamma Knife versus linac for treating brain tumors. He believes either option is suitable in most cases although, “in cases of unusually complex or small tumor anatomy, Gamma Knife holds a technical advantage, given its large number of radio- active sources available for field design.” On the other hand, if the patient cannot tolerate a stereotactic frame attached to their head, Mantz recommends a linac platform. It’s worth mentioning that Gamma Knife is usually a one-time treatment procedure whereas linac brain tumor treatment re- quires multiple visits.
Dean Rosen, a partner with the government relations group, Mehlman Castagnetti Rosen Bingel & Thomas, and a presenter at the upcoming ASTRO conference, spoke to DOTmed about radiation oncology’s relationship with CMS. “Radiation oncology has been very forward leaning and engaged in making sure reimbursement codes are appropriately valued,” says Rosen. “We’ve often had to step in and push back on the administration, and ASTRO has been very successful in working with Congress to pre- vent a lot of those cuts.”
Rosen also emphasizes that reimbursement is about managing money correctly, not trying to get the most possible. He cites a loophole in the physician self-referral law, Section 1877 of the Social Security Act (42 U.S.C. 1395nn), that provides an exception for certain ancillary in-office services. This may create a conflict of interest for radiation oncologists who could earn more money by directing patients to their own practices. “Studies have shown that [this loophole] has led to an increase in cost of care for patients and Medicare,” says Rosen, and ASTRO has been active in pushing Congress to correct it.
Supply and demand of oncologists is out of balance across the globe
A study published by the American Society for Clinical Oncology in 2007 projected a shortage of radiation oncologists in comparison to the projected growth of the treatment’s popularity. Researchers have since returned to that study and found those projections are holding water. Beginning in 2012, 16,347 oncologists and radiation oncologists were active and supplying 15,190 full-time equivalents of patient care. Without consideration of the Affordable Care Act, which may modestly exacerbate the short- age, overall demand for oncologist services is projected to grow 40 percent by 2025, whereas supply may grow only 25 percent. Those projections would indicate a demand for radiation oncologists exceeding the number of qualified practitioners around 2020 and climbing 10 percent higher by 2025. The study concludes that unless oncologist productivity can be enhanced, the anticipated shortage will strain the ability to provide quality cancer care.
Kavanagh is optimistic that productivity can be—and indeed has been—advanced in a way that will mitigate those trends. He cites more active surveillance for low-risk prostate cancer and shorter treatments for certain breast cancer cases as two examples of improved efficiency. Whether or not that will be sufficient to curb the shortage, Kavanagh says, is anybody’s guess.
For aspiring physicians, getting accredited for radiation therapy can be a lengthy process. “For the oncologist who prescribes treatment with [stereotactic] equipment, four years of specialty residency training is required following an internship year,” says 21st Century Oncology’s Mantz, “Some training programs may also offer an additional year of stereotactic radiotherapy training for interested candidates.” In addition to the prescribing oncologist, Mantz says a medical physicist, medical dosimetrist, and radiation therapy technologist are all required to help design and facilitate a treatment plan. Each of those specialists requires post-graduate training to be licensed for their work.
In January, the Toronto Star reported that a shortage of qualified physicians had resulted in more than 5,700 cancer patients in Ontario going without radiation therapy. “We feel the real gap is likely in patients who, toward the end of life, might benefit from radiation treatment to control pain or other issues. However, there are other treatments they can have,” said Dr. Padraig Warde, interim vice president of clinical pro- grams at Cancer Care Ontario. Those other treatments are typically pain medications, which can be disorienting and keep patients from their normal routines. In 2013, 72,000 new patients were diagnosed with cancer in Ontario. At the time of the article, there were only 185 radiation oncologists in the entire province.
Dr. Arkadi Stolpner, president of the Di- agnostic Treatment Center of the International Institute of Biological Systems, told DOTmed about the state of radiation oncology in Russia. He says that 400,000 Russians are diagnosed with cancer every year. He estimates that Russia needs 600 linear accelerators to adequately treat candidates for radiation therapy, but currently only has between 130 and 140 systems. “Many of those radiation oncology systems are old- fashioned cobalt machines,” says Stolpner, “and even then, less than 40 percent of patients receive the treatment.”
The need for better access to treatment is no clearer than in India, where a recent article in Nagpur Today describes an epidemic of 25 million people currently battling cancer. The article states that there are only 2,000 radiation oncologists in the entire country to treat those patients. India’s highest concentration of cancer cases resides in the region of Vidarbha, where there are currently zero linear accelerators. India has one of the highest cancer rates in the world, and according to the International Agency for Research on Cancer, the number of annual diagnoses may double within the next twenty years. Bringing treatment to those patients is a complex and troubling issue.
Meeting demands through re- furbished equipment
The availability of refurbished modalities doesn’t resolve the physician shortage, but it does provide affordable alternatives to end users. DOTmed spoke with three professionals working in the refurbished radiation oncology equipment sector.
Although John Vano, president of Radiation Oncology Solutions, says not all radiation oncology modalities are prominent on the refurbished market, linear accelerators are readily available. He acknowledges the recession as a factor in what he perceives to be diminished modality replacement rates, but believes the trend goes beyond a recovering economy or reimbursement issues. “The newer, more sophisticated technologies allow more efficient targeting of cancer cells,” says Vano, “It’s not uncommon to see four old linear accelerators replaced by two newer systems that can treat the same number of patients just as effectively.” Vano cites the same advantages with hypofractionation, which, by decreasing the number of treatments a patient needs, frees up not only radiation therapists, but high-demand modalities too.
Meanwhile, Jose Rodriguez, president of OncoAmerica Oncology Centers, believes the refurbished industry is growing, but has work to do in gaining consumer trust. “There are a few very good companies servicing parts. In the refurbishing side there is still a long ways to go,” he says, “better service is needed, more knowledgeable companies and more conscientious sellers are needed to better understand the needs of foreign buyers.”
Tony Richardson, vice president of sales and marketing at Acceletronics, mentions India as a country where refurbished modalities could make a significant impact, but importation laws make purchasing them difficult. “There are a number of countries where there is demand, but there are political barriers to pre-owned equipment,” says Richardson.
With regards to a statement indicating that India needs 12,000 more radiation oncology centers, Vano says, “In truth, it probably needs closer to 8,000 to be comparable to the U.S. but in any case, that is 20 times more than exists there today.” Meanwhile, as cancer patients go largely untreated, “the local distributors, local manufacturers, and government officials are the ones that benefit,” he says.
On the domestic end, Vano believes the widespread circulation of refurbished radiation oncology equipment could bring rural communities greater access to advanced cancer therapies. “In reducing reimbursement rates for smaller, freestanding radiation oncology facilities, CMS seems to have forgotten about the toll it takes on some patients and their families to commute long distances for treatment,” he says.
Richardson gives a little back-story on the CMS situation saying, “There was a substantial increase [in reimbursement] when IMRT and IGRT modalities were introduced, but in the last three or four years reimbursement has been coming down.” He says as a consequence, there are fewer new facilities being built, and that trend informs replacement rates. Regardless of that, Richardson expects the number of used IGRT modalities in the refurbished market to go up significantly within the next two years as early buyers start shopping for replacements of their own.
Position precision
Modern radiation treatment places an un- precedented emphasis on dose distribution and patient positioning. “The major thrust of research into the area of treatment delivery technologies over the last few decades has been a concerted effort to target tumors accurately and as tightly as possible while sparing surrounding tissue,” says ASTRO’s Health Policy Council chair, Kavanagh. “Proper patient immobilization is an essential component of the overall process of care.”
With advancements delivering a higher level of accuracy, radiation oncologists are able to more safely utilize higher dose, and by extension, treat over a shorter span of time than in the past.
The positioning products available for stereotactic therapy necessarily provide vast mechanical improvements over their precursors, as well as a greater emphasis on patient comfort. Some of these products rely on complex chemical reactions to achieve positioning goals, like the MoldCare Head Cushion from Bionix. The cushion is a soft fabric bag containing resin coated polystyrene beads that are coated in a moisture- cured polyurethane resin. When sprayed with room temperature water it becomes malleable and can be formed to the patient’s head and neck. After five to 10 minutes, the cushion hardens to form a rigid, custom- support which can be used to reproduce stereotactic treatment positioning. The CIVCO Vac-Lok uses a vacuum system to remove air from a cushion filled with Styrofoam balls while the patient rests upon it.
Alpha Cradle products require physicians to combine two bottles of chemicals and shake the mixture for 10 seconds. This mixing triggers an exothermic reaction, which produces a foamy sub- stance that expands up to 40 times the original volume. This process takes place within a bag on which the patient rests his weight for 15 minutes. Patients may experience a comfortably warm feeling as the foam expands and hardens beneath them, producing a closed-cell polyurethane cast.
DOTmed spoke to Jeffrey Kostich Sr., the President of Smithers Medical Products, the company that manufactures Alpha Cradle products. “As equipment becomes more precise, defining smaller margins, it’s not positioning that’s important, it’s repositioning,” says Kostich, “being able to reproduce the set-up position each day the patient comes in for treatment.”
When Kostich entered the industry in 1984, “some hospitals were using sand bags and foam wedges to put the patient in place, while others would physically tape the patient down.” Some hospitals would experiment with plaster of paris molds for Medulloblastoma patients. “Children had to be anesthetized while making these forms and while lying in them.” Kostich says thermoplastics were introduced shortly thereafter, and continue to yield good results for head and neck patients.
Alpha Cradle technology originated in Europe and was introduced to the American market at a 1981 ASTRO exhibit. Over the years, Kostich has reformulated the foam to make it more comfort- able for the patient. “How many owners of medical companies have strapped themselves into their own pieces of equipment?,” asks Kostich. “It’s important to remember this is all about treating and caring for patients who have been struck with cancer.”
Many positioning devices are designed specifically to immobilize the patient, such as arm holding wing boards and breast boards. QFix manufactures a number of products to that end, such as the Tilt-Pro Tilting Base, which allows precise angling of the head and neck. For brain tumors, a stereotactic head frame, like the Leksell from Elekta, may ensure that the radiation beam can reach its target from multiple angles, like a gantry, while preserving nearby tissue.
Meryl Ginsberg, director of public relations at Varian Medical Systems, spoke to DOTmed on behalf of Varian’s product management team. She discussed the company’s contributions to the positioning marketplace. “The PerfectPitch six-degrees-of-freedom robotic couch was designed for the precision and functionality required to deliver radiosurgery treatments in the brain and in the rest of the body,” says Ginsberg. They also offer a real-time tumor tracking system called Calypso.
Industry leaders see a future in image-guided therapy
Fluoroscopic, cone-beam CT, and MR imaging, have all arrived at the treatment table. That means physicians can monitor the location of a tumor in therapy more efficiently than ever. DOTmed spoke to several industry experts about the trends they are seeing in image-guided therapy, as well as their latest imaging modalities.
“The utilization of MR in radiation therapy planning has tripled over the last six years,” says Aenne Guenther, VP of marketing and sales for Siemens Radiation Oncology. “Now the market is at a tip- ping point to really utilize MR in a more clinical, routine way.” Guenther says MR is particularly useful to radiation therapy imaging be- cause it uses non-ionizing radiation and therefore contributes zero dose to the treatment.
“You want to make your results reproducible,” says Guenther. “Patient positioning must always be the same.” With hypofractionated procedures there is no wiggle room for missing the cross hairs, so image guidance is an invaluable ally. The MAGNETOM RT Pro Edition from Siemens integrates MR soft tissue differentiation and functional MR imaging into radiation therapy. Guenther says the package, which operates in conjunction with either the MAGNETOM Aera or MAGNETOM Skyra, is different from what a diagnostic radiologist might expect from a typical MR system. “There was always distortion in MR images, but radiology wasn’t concerned because you only needed to know if there was a tumor,” says Guenther, but the MAGNETOM RT Pro Edition features a built-in automatic quality assurance program to correct any geometric distortions.
Accuray utilizes MR treatment imaging with CyberKnife, a linear accelerator that operates with advanced robotic technology instead of a traditional gantry. DOTmed spoke to Terry Chang, director of CyberKnife marketing at Accuray, who says, “CyberKnife is the most sophisticated way to handle motion. It’s a closed feedback loop where the patient is always imaged to verify the tumor is where it should be.” He says that the robot moves in accordance with that motion and no user intervention is required, nor are any immobilization accessories.
“It’s all about precision,” says Chang. “You might be fast, you might be powerful, but if you aren’t delivering radiation directly to the tumor you might as well go back to chemotherapy or surgery.” To explain the significant amount of movement a tumor may experience if the treatment table is adjusted, he compares a patient’s body to a bag of water. “You might say I moved the table that way, but what about the actual patient? The laws of physics say if you move the table one way the patient moves the other way. That variability is an enemy of precision.”
In 1993 Brainlab began developing its own linear accelerator technology. Stefan Seifert, director of the radiotherapy product line for the company, described their ExacTrac software to DOTmed as, “an in-room based monitoring system that detects intra-fractional motion during treatment delivery.” The system can be implemented as part of a Novalis configured linear accelerator or independently on any gantry-based accelerator.
Varian’s TrueBeam and Edge linacs are compatible with their On- Board Imager, a tool which offers high resolution digital imaging in the treatment room. Those linacs may also utilize gated RapidArc radiation so, “imaging can take place throughout the course of a treatment,” says Ginsberg. “RapidArc ensures that targeting is as ac- curate as possible for treating thoracic and other tumors that move.” The On-Board Imager allows for all imaging modalities, (cone-beam CT, radiographic, and fluoroscopic) at the time of treatment.
Like the CyberKnife, GE’s Deviceless 4D eliminates the need for immobilization when creating motion-compensated 4D CT scans. Although not part of radiation therapy itself, Deviceless 4D is a movement tracing technology that informs treatment planning. Paul Anderson, general manager of Oncology for GE Healthcare, told DOTmed that Deviceless 4D utilizes time-stamped anatomical readings of the patient. “We’re using internal anatomy to determine the respiratory wave form,” says Anderson, “it’s a method much more forgiving [than immobilization], and accounts for the partial com- pression that might be in there.”
Similarly, an offering from Elekta, called Symmetry, provides 4D imaging of where a lung tumor resides throughout the breathing cycle. Elekta has also gotten into patient immobilization through extension of their radiotherapy modalities. Using radio-frequency identification system technology and optical markers, they’ve created a program called Identify. Dee Mathieson, senior vice president, oncology business line management for Elekta, and Kevin Brown, Elekta’s global vice president of scientific research, told DOTmed about the system.
“Identify can guide and monitor the exact position of treatment accessories. Working in the background, it is fully integrated with MOSAIQ (Elekta’s patient information management system) and only intervenes when needed.” Elekta has also teamed with Royal Philips to install an MR guided radiation therapy system in the Netherlands. Mathieson says, “The higher the quality of the images, the more confident the clinical operator can be when positioning the radiation beam, thereby increasing the dose to the tumor cells and further reducing the unwanted dose and thus the side effects of the treatment.”
Although CT is still the gold standard for radiation therapy planning because you need to measure electron density of the tissue, MR provides added value when it comes to areas like the head, neck, or pelvis. “Treatments are becoming more and more effective, more and more curative,” says Siemens’ Guenther, “but the more cancer patients survive, the more important it is to take better care of normal tissue toxicity.”
The significance of brachytherapy
Unlike external beam treatments, brachytherapy involves placing a radioactive material inside or next to the tumor being treated. This method of radiation delivery allows for higher doses to be administered because there is no beam potentially damaging healthy tissue with its exit dose. Candidacy for brachytherapy depends on the cancer, (early stage prostate and breast cancer, among them) as well as considerations of practicality and affordability to the patient. “Some patients live too far away from a radiation therapy center and cannot commit to a schedule of daily radiotherapy over a period of several weeks,” says 21st Century Oncology’s Mantz. Those circumstances may recommend brachytherapy over external beam therapy.
According to Radiation Oncology Solutions’ Vano, HDR (High Dose Rate) brachy- therapy is one of the most economical types of radiation therapy available, and is in particularly high demand in developing countries. “However,” says Vano, “HDR systems rely on radioactive sources and, until recently, the availability of such sources was controlled by the manufacturers of the de- vices, which for obvious reasons don’t like refurbished equipment.” A study called EM- BRACE illustrates a 90 percent increase in successfully controlling tumors when utilizing MR to guide brachytherapy treatment for locally advanced cervical cancer
The software situation
In describing the network of specialists he and his colleagues draw from on a daily basis, Dr. Leslie Botnick at Vantage Oncology emphasizes the importance of interconnectivity. “We use a medical review process, initially by different groupings based on disease expertise. How to best treat breast, prostate, pancreas, head and neck, and detail what you should contour, what normal tissue to protect, what doses you can give normal tissue.” They start with a small group and move on to larger groups
throughout the network; as cases are dis- cussed, it becomes an educational process for those involved. Botnick contrasts this approach to medicine with what he calls “line medicine,” where individual specialists offer diagnoses without communicating with one another.
The Carl Zeiss Group applies that philosophy of inclusion to its TARGIT (targeted intraoperative radiation therapy) Academy, an intensive and hands-on training resource for users of their INTRABEAM modality. The company describes the academy as offering, “A multidisciplinary faculty with extensive experience with INTRABEAM.” These experts are available to INTRABEAM users and will, “share their knowledge about the TAR- GIT technique based on clinical evidence, experience, and research.”
“A linear accelerator— even the most sophisticated linear accelerator— is a tool,” says Ginsberg, “and only as good as the skills and talents of the professionals who use them.” She says one of Varian’s core objectives is the aggregation of images, treatment plans, patient records, and professional expertise. The company aims to unite physicians and unlock the vast amounts of clinical data that is currently housed in disparate places around the world.
The need for shared expertise echoes the health industry’s push for EHRs; demand for accessibility and uniformity is of particular importance to radiation oncologists using unfamiliar and groundbreaking technology. As the modalities for cancer treatment improve, the software they utilize often rep- resents an opportunity to bring physicians together. Citing better outcomes and longer lives in general, Ginsberg says, “Having access to the right treatment information at the right time, in order to understand each patient’s entire treatment history, has never been more essential.”
Gregor Thörmer, global segment man- ager for MR in radiation therapy at Siemens, describes the software utility that operates with their MAGNETOM RT Pro Edition, called Dot (Day optimizing throughput). With the Dot system, “it’s possible to ex- change imaging protocol sets with other experts and import them on another system.” Siemens also joined up with Varian to design ARIA; a comprehensive image and information management solution designed with an emphasis on meaningful user experience. The full Access communications platform from Radiologica is another offering that prioritizes usability.
Elekta created the MOSAIQ Radiation Oncology Information System in the interest of centralizing radiation oncology and particle therapy patient data into an open system interface that can be accessed by multi-disciplinary teams across multiple lo- cations. “We are developing software that can optimize patient and department work- flows,” says Mathieson. “Coupled with the ability to aggregate data and learn from it, this will permit more personalized care.”
Brainlab’s Elements system is yet an- other example of manufacturers prioritizing
integrated and customizable radiotherapy solutions. Seifert says, “Elements bridges departments and offers working, scalable connections between clinical subspecialties like neurosurgery, spine surgery, orthopedics, and radiation oncology.” The system can be used online or offline, and from certain tab- lets and smartphones. Brainlab also offers membership to a clinical forum called the Novalis Circle network, “where doctors and programs worldwide can connect to collabo- rate, develop and share new ideas, enabling a rapid exchange of joint scientific research.”
Chang describes the software in Accuray’s CyberKnife as “holistic,” meaning that everything—software, accelerator, interface—are all built and designed in-house to ensure developments in one area inform developments in another. Chang says that by not involving other companies in the software design process, Accuray is able to assemble modalities that are fully integrated. “There are other vendors who allow third party planning software, but we think there’s value in a tightly integrated approach,” says Chang. “There’s a lot of nuances and idiosyncrasies that a delivery system has and for any vendor to try to adapt software to those is quite challenging,” says Chang.
Cutting the surgery out of cancer
During the conversation with GE’s Anderson, he referenced the aging population of baby boomers and the impact that generation has had, and will continue to have, on the demand for faster, better, and more afford- able cancer therapy. That theme of increasing demand is not something that will be going away any time soon, and although recent breakthroughs have made significant impact, there is always more that needs to be done.
Mantz at 21st Century Oncology sees adaptive therapy on the horizon, which he describes as, “the use of repeat volumetric imaging of the radiotherapy patient during a course of care and then the application of sophisticated volume rendering and rapid treatment planning algorithms to that imaging in order to create a customized treatment plan
on a per-fraction basis.” In effect, this therapy would allow delivery to be continuously modified during, and throughout, treatment. Mantz says an initiative is already underway with several research groups, (including his own) but requires significant software development before it can become viable.
Vantage Oncology’s Botnick feels that physicians have only scratched the surface with curative non-surgical therapy at sites like the lung, where removal of the tumor may not always be necessary. “Distinguishing what we should and shouldn’t do will take an increasing role,” says Botnick, “and the challenge is diminishing side effects while keeping up local control rates and cure rates to go along with hopeful improvement and systemic treatment.”
“As we move toward even better imaging with MR, our consortium partners are convinced that we will be able to treat more indications,” say Elekta’s Mathieson, “particularly in the abdomen, where soft tissue imaging will be significantly improved, and that radiation therapy will be a viable alternative to other modalities, such as surgery.”
For patients, cancer treatment is not un- like enlisting in a civil war with one’s own body. Positive outcomes hinge on a paradox where one part of the body is destroyed, but all other parts are preserved. Incidentally, the origins of chemotherapy are tied to the mustard gas exposure soldiers experienced during the two world wars. When those soldiers were observed to have low white blood cell counts, researchers saw a link to lymphoma treatment.
As science and technology evolve, physicians are learning to eradicate the enemy with more efficiency, with fewer casualties, and with fewer injuries in the line of duty. It is a matter of economics, not only financial but with regards to toxicity. Balancing those factors in the name of better patient out- comes is a central topic in the health care industry and the dissemination of the latest radiation treatments.