Starting an IORT Program: Logistical Challenges
A variety of photon and electron beam IORT delivery systems are currently available (Table 2). The choice of an IORT device may be driven by several factors, including intended clinical application, physical parameters of the machine and associated radiation safety issues, and the cost of accessories and maintenance. Treatment of breast cancer has emerged as the most common application of IORT, but the utility of this modality was first established in the treatment of abdominal, pelvic, and thoracic tumors. IORT programs that have a practice limited to breast cancer may find that the capabilities of kilovoltage x-ray units are adequate. The range of treatment depths and larger field sizes available with an electron beam device may be more suitable for hospital-based programs where IORT would also be utilized in the treatment of visceral sites, such as sarcomas, or rectal, head and neck, pancreatic, or pediatric cancers. Although dedicated IORT units are designed to be portable and self-shielded, differences in storage, portability, and shielding requirements should be evaluated. IORT is delivered using applicators that are reusable for some devices, and single-use for other devices; therefore, an analysis of the upfront and per patient costs of a machine and accessories is essential to determine the economic viability of a new IORT program. Finally, the costs and manpower required for maintenance of an IORT delivery system, as well as the technical support offered by a manufacturer, can vary considerably and should be researched before making a purchase.
When establishing a new IORT program, the proctoring process begins with a site visit by the entire team to an IORT center of excellence. The visiting team members should include surgeons, radiation oncologists, physicists, dosimetrists, operating room nurses, and nurse navigators who will be involved in the program. Ideally, a minimum of three cases should be observed. When the IORT device has been installed and commissioned, temporary hospital privileges at the new IORT center should be requested for an outside expert to proctor the first two cases. The IORT expert then submits a letter of competency to Medical Staff. Depending on the availability of cases, the process to obtain privileges to perform IORT may take weeks to months to complete. Physics and therapy personnel from the radiation oncology department are essential participants in the planning and commissioning process for an IORT program. Training and proctoring support for the physicists should be arranged with the device manufacturer. Visits to other sites with active IORT programs, as well as dry runs with a proctor, should include physics staff. Upon delivery of the IORT system, machine calibration measurements must be taken by a physicist to establish specific dosimetric properties of the device in preparation for treatment planning. The physicist will need to submit documentation to the state regulatory agency for approval prior to commencing treatments for patients with a new radiation device. Depending on the state agency involved, it may take several weeks for this approval to be obtained. The physics department is responsible for developing policies and procedures for machine warm-up and treatment quality assurance. Initially, a longer period of time may need to be blocked in the IORT suite for the radiation therapist to perform machine warm-up procedures and troubleshooting before the surgical case begins. Physicists are also responsible for scheduling periodic maintenance inspections, and they should be involved in negotiating a service contract with the manufacturer if needed.
New operating room policies and procedures may need to be developed and approved prior to treating the first IORT patient. The hospital radiation safety officer should be involved in educating operating room staff on radiation precautions specific to the IORT system that will be used. Radiation devices that are not typically sterilized in a conventional radiation therapy setting may need to be sterilized for use in IORT cases. These can include in vivo dosimetry tools, such as diodes and nanodots, or dose-shaping tools, such as boluses and shields. If manufacturer guidelines are not available for sterilizing these materials, they may not be approved for use by hospital operating room management, and alternatives will have to be researched, purchased, or developed locally.
The delineation of privileges and proctoring requirements for the radiation oncologists performing IORT are specific for each institution, and individual Medical Staff regulations may need to be satisfied. IORT is usually a special privilege similar to other advanced radiation skills, such as APBI and yttrium bead delivery. Competency for this privilege could be met by completing training in residency or a fellowship with a recommendation by a program director, or by a certificate of training from a hands-on post-residency course approved by the department of radiation oncology. A new physician without specific IORT training who requests privileges could be proctored (for a minimum of two cases) by a Medical Staff member with IORT privileges or an industry expert. Medical Staff is then supplied with a letter of certification from the proctor regarding competency.
At our institution, a decision was made to implement the IORT breast program in three phases. Phase one consisted of postoperative adjuvant whole-breast standard fractionated radiation in conjunction with an IORT boost. Phase two consisted of whole-breast hypofractionated radiation in conjunction with an IORT boost. Phase three consisted of single-fraction IORT using dosing and eligibility criteria similar to that of the Milan protocol without WBI. Phases two and three of our breast IORT program are being carried out using in-house protocols that were approved by our institutional review board. These eligibility criteria are outlined in Table 3. The primary endpoints of these protocols are feasibility and acute toxicity.
Starting an IORT Program: Financial Considerations
Reimbursement: technical charges
Although clinical advances in the radiotherapeutic management of early-stage breast cancer have been rapid, advances in remuneration for IORT are evolving at a slower pace. Certainly, there are remuneration implications for treating with a single fraction. The reimbursement for standard external beam radiation is divided into professional physician fees, including consultation, treatment planning, and weekly radiation treatment management, as well as technical fees, including CT simulation, dosimetry, and treatment delivery. Both components are impacted by single-fraction delivery.
The current Medicare fees for technical reimbursement for a course of standard fractionated WBI, including treatment planning and delivery, amount to $10,275: $8,381 for the whole-breast external beam component plus $1,894 for the electron boost component (Table 4). The current technical reimbursement for a 3-week hypofractionated course of WBI is $6,032 (plus/minus the electron boost component).[16,17] Other radiation modalities offering patients the partial-breast radiation option (implanted devices and external beam) shorten treatment times and reimburse more. The Medicare technical reimbursement for APBI (brachytherapy) is $11,793.[16,17]
In comparison, the current technical reimbursement for a single IORT breast treatment is less than one-fifth that of standard fractionated WBI: the Medicare reimbursement is currently $1,322. This is less than the current reimbursement for the electron component when delivered as a boost with standard traditional and hypofractionated external beam radiation therapy.
In addition to technical reimbursement adjustments, the use of IORT also has a significant impact on the radiation oncologists’ professional reimbursement. The current Medicare professional reimbursement, including global charges, for a standard 6½-week course of WBI (including electron boost) ranges from approximately $5,200 to $5,500, depending upon whether a two- or three-field plan is utilized. Similarly, professional charges for a 3- to 4-week course of hypofractionated WBI is just over $4,000. In comparison, the professional fees for single-fraction IORT are approximately $696. This reflects the loss of reimbursement for simulation, treatment device, immobilization, port film verification, and daily treatment delivery.
The professional IORT codes continue to evolve, however. At present, the Current Procedural Terminology (CPT) codes for single intraoperative delivery (electrons or x-ray), 77424/25, are not separately reimbursed according to the 2012 Medicare fee schedule. The charge is bundled into other ambulatory payment classifications (ie, surgical). For 2013, the Centers for Medicare and Medicaid Services (CMS) has assigned a national average payment of $483 for these codes. With regard to treatment management codes, the IORT management code, 77469, is similar to other radiation treatment management codes, such as 77427. Currently, the IORT management code is assigned 8.74 Relative Value Units (RVUs), is reimbursed $279, and is a one-time billable code. (CMS is proposing to increase the RVUs to 9.11 in 2013). In contrast, the weekly management code for standard WBI is assigned an RVU of 3.37 by CMS and pays $170 to $190. This amounts to a total management reimbursement of $1,190 to $1,330 over a 6½-week course of standard WBI, compared with $279 for a single fraction for IORT. In 2012, CPT 77470 is considered part of the treatment management code and should not be billed separately.
Whether at a free-standing facility or a hospital-based facility, the loss of reimbursement from both technical and professional fees is an important consideration, and one must realize that overall, reimbursement can drop to as low as 10% of that from standard fractionated WBI. Although it is possible that an intraoperative radiation breast program could increase patient volume, in reality the increase may not be sufficient to offset the severe reimbursement losses.
The establishment of a breast IORT program provides an attractive alternative for the radiotherapeutic management of select patients with early-stage breast cancer. The IORT program, however, creates logistical challenges, requires new treatment paradigms, and has a potential financial impact on the radiation oncologist and institution. The scheduling of cases requires coordination of surgeons, radiation oncologists, and OR resources, as well as demanding additional manpower from medical physicists and radiation therapists. Decisions regarding the subsequent management of patients who have been irradiated but who have positive margins, as well as regarding the sequencing of systemic therapy in patients requiring WBI, need to be agreed upon prior to starting the program. Radiation oncology departments must consider the reimbursement impact and additional manpower resources that are required to establish an IORT program. It is imperative that all members of the multidisciplinary team be involved from the inception.
Financial Disclosure: The authors have no significant financial interest or other relationship with the manufacturers of any products or providers of any service mentioned in this article.