Foundations of a Brachytherapy Practice

David Jeffrey Demanes, Ron DiGiaimo, Casilda Menchaca-Garcia, and Tamara Syverson

The purpose of this chapter is to describe the prerequisites and methods for establishing a successful high-quality brachytherapy service. The chapter covers the following topics.

Disclaimer: This chapter refers to current clinical reimbursement codes and charges to illustrate establishment of a business plan for clinical brachytherapy. Payment policies for brachytherapy vary widely within the United States and around the world. The information contained in this chapter (although accurate at the time of printing) may not be universally applicable; and payer policies are likely to change with time. In addition, there are acceptable variations in physician and hospital practices concerning clinical brachytherapy procedures, which may affect the nature of the services rendered and the associated reimbursement. Before the submission of a claim, the reader should contact the commercial or government payer (eg, Medicare, Medicaid) to verify applicable codes, coverage policies, and payment amounts for brachytherapy. The authors and the publisher of this book assume no responsibility for the consequences related to the use of information contained in this chapter.

TRAINING AND EDUCATION

BRACHYTHERAPY SPECIALTY PRACTICE PLANNING AND DEVELOPMENT

Determination of the Range of Services Provided

Development of a brachytherapy service requires strategic and tactical planning. The rationale for initiating a service is based on the clinical needs of the patients in the community and the vision and belief by the physicians that such treatments are valuable. Brachytherapy is applicable to any body site where localized radiation therapy is indicated. The safety and efficacy of brachytherapy are based on years of clinical experience and are supported by literature presented elsewhere in this book.

Brachytherapy has a significant role in the primary treatment of common diagnoses such as prostate, breast, skin, and gynecologic cancers. It is also utilized in cancers of the head and neck (H/N), sarcoma, anorectal, and other sites. It can be used in palliative situations and for patients who have previously received radiation therapy. The diversity of local clinical oncology practices and variation in resources may impact the development of a brachytherapy service in your community. The radiation oncologists should purposefully decide what kind of brachytherapy is going to be offered by the practice.

Analysis of patient demographics and case mix is the first step in deciding how to expand the practice. Second, a review of the number and kinds of brachytherapy services currently being provided by the practice should be made. Third is to determine what cases are being referred elsewhere for brachytherapy and to decide if they can be properly managed at the local facility or if it is preferable to refer them to centers of excellence. Fourth, knowledge of what oncology services is already being provided in the community can lead to charting the development of a new brachytherapy service. Cancers with high relative incidences where brachytherapy has a role are prime candidates for practice development.

Referral Networks and Promotion With Referring Physicians

Cooperation with other medical and surgical specialists is essential to practice development. It can vary from simple case referral to a simultaneous participation in a multidisciplinary clinic. The physicians may manage the patients sequentially and or be directly involved in the brachytherapy procedure. Examples of procedural cooperation include endoscopy with pulmonologist (endobronchial) or gastroenterologist (intraesophageal) applications, transperineal prostate brachytherapy with urologists, and a diversity of surgeries where the radiation oncologist (brachytherapist) participates as co-surgeon during intraoperative brachytherapy.

Regional Collaboration

Regional collaboration is an opportunity to develop a brachytherapy practice. Perhaps there are certain types of brachytherapy that other radiation oncologists in the region would prefer not to do. It is an opportunity for colleagues to collaborate where external beam is performed at one institution and the brachytherapy at another.

Facilities and Administrative Support

Hospital facilities and freestanding medical practices provide different physical layouts and variable capacities for providing and managing brachytherapy services. Some types of brachytherapy are feasible in outpatient settings, while others are not. Whether a certain type of brachytherapy can be performed at a particular facility depends on the anesthesia requirements, the type of radiation delivery system, and the location and duration that the implant must remain in the patient. Intracavity vaginal applications and brachytherapy of skin lesions, for example, can often be performed entirely as outpatient as a series of applications using little or no sedation. Other implants, such as endoscopy-based brachytherapy, can be done as serial same-day outpatient procedures, but they require moderate sedation in a suitable endoscopy venue (freestanding or hospital). Permanent seed prostate implants typically require anesthesia, but they do not require an overnight stay, so they are suitably performed in an ambulatory surgery center (ASC) or a hospital. Breast brachytherapy can be done either in the clinic under local anesthesia with or without sedation or done in the operating room depending on the type of applicator and the experience of the brachytherapy specialist. Hospital facilities are typically more able to manage the full-range brachytherapy services where there is a need for anesthesia, surgery, or inpatient care. Major interstitial implants of the H/N, abdomen, or pelvis mostly require inpatient facility resources, and patients who have pelvic template applicators are generally confined to bed rest and are usually done in a hospital. Cases where brachytherapy is performed in conjunction with major surgery also require the use of a hospital facility.

Administrative support (hospital or freestanding center) is essential for a successful brachytherapy service. A fully developed program requires special equipment, personnel, and the integration of many hospital or clinic services. To start a program, administrators usually like to have discussions framed in the context of a financial proforma (a tally of expenses and reimbursements). For the service to run properly, there must be a brachytherapy practice budget and regular administrative management and it is advisable to have regular strategic planning meetings with the key administrators or organizational leadership.

HOW TO BEGIN STRATEGIC PLANNING SPECIFIC TO BRACHYTHERAPY

Brachytherapy Strategic Planning

Assessment of demographics and estimation of the potential case volume can be complicated. Understanding the mixture of payers served by the medical community and knowledge of their various reimbursement policies is a fundamental practice planning exercise. It is equally important to critically and specifically evaluate managed care contracts, which determine in-network status and establish physician access to the payer’s clients. All of these factors can significantly impact the practice volume, affect the economic viability, and ultimately determine the success or failure of a brachytherapy practice. For these reasons, we recommend a feasibility study utilizing all the aforementioned factors and potential additional factors that are site specific.

Data Collection and Access to Managed Care

Brachytherapy is a common treatment type in a multimodality treatment program. In some cases, however, it is one of the several treatment options presented to the patient for consideration. In the case of multimodality treatment, the physician has the opportunity to interact with and educate other specialists on the value of brachytherapy on specific patients and in general. Referring physician and complete physician lists should be compiled for the practice from which invitations for individual or group interactions can be generated and distributed for special tumor board or a grand rounds focusing on brachytherapy. Importantly, for those patients where brachytherapy is a sole treatment, there is still opportunity for meaningful interaction with other specialists. For example, prostate seed implants or HDR prostate monotherapy procedures involve both the radiation oncologist and the urologist who together provide a combined expertise to achieve optimal patient outcomes. These interactions are, in and of themselves, a good opportunity to share knowledge and ideas about brachytherapy and those diseases for which it is indicated. There is no more powerful vehicles for practice development than the support and informed beliefs by your colleagues that brachytherapy is either an essential component or one of the best available treatment options for their patients.

As with many cancers, the potential brachytherapy patient is faced with a difficult decision to choose among several valid treatment options. Patients have become increasingly aware of data and alternatives because of increased media coverage and access to internet searches. Opportunities to educate patients through medical websites and referral to peer-reviewed journal articles are greater than ever before. Payers are also aware and interested in data that support the use of brachytherapy in their customers as they are routinely searching for higher or equal quality with lower cost. They typically have medical advisers and committees that review the literature and make judgments on the level of medical evidence that supports various types of brachytherapy that are periodically updated in various forums. Not unexpectedly, there is sometimes a lag between the development of evidence for brachytherapy and the payer policy. It is recommended you compile and maintain a database on the current evidence for various kinds of brachytherapy to present to the payers (typically in the form of appeal letters about individual cases).

Competitive Forces

Competition has always been and continues to be a fact of medical business life. It is, therefore, necessary in medicine, as in other businesses, to analyze the market forces to understand motivations of other providers, managed care systems, and large health care systems. It is advisable to make an assessment of the competition and to study the business and clinical practice relationships of your colleagues to radiation oncology services in your community. Nonradiation therapy providers such as primary care, family practice, and specialists such as urologists, surgeons, and medical oncologists typically control the referrals to radiation oncology. Some or most of these providers may be unfamiliar with brachytherapy. Specialists who make the diagnosis through performing biopsies or surgery (cancer diagnosis) have the first opportunity to present treatment options to the patient. Their understanding of the role and their belief in the benefits of brachytherapy are important in making a successful brachytherapy practice.

Similarly, competition within the radiation oncology specialty is a relevant consideration. In an ever-increasing competitive environment, other radiation oncologists may see brachytherapy as an opportunity for collaborative benefit for the community or, alternatively, may be viewed as a threat to their current patient volumes. Depending on the circumstances, joint ventures with other physicians may be possible to create a functional relationship that provides better service and greater patient access to quality cancer care.

Creation of a system within the practice to track brachytherapy (and other radiation oncology services) is a tool for education and a means for accumulation of medical evidence in support of brachytherapy. Tracking cases and outcomes in the form of a data registry allows the physician to improve individual practice and to generate outcome reports that can be used for presentations, abstracts, and publications in peer review journals. This information can be conveyed directly to the patients, to physicians in the community, to the hospital administrators, and to the payers. Electronic medical record systems have the potential to collect and manage data and if properly programmed can be used in “point of contact” data entry.

ORGANIZATION AND RESOURCES

Personnel

A brachytherapy service requires a team of personnel with a variety of skill sets. These personnel manage the multiple steps in the process of brachytherapy. These core personnel may be classified into three groups; (a) clinical; (b) physics, dosimetry, and therapy; and (c) administrative.

Clinical (Physicians, PAs, NPs, RNs, and MAs)

Radiation oncologists (brachytherapy specialists or practitioners) must have the brachytherapy procedural knowledge and skills necessary to insert the applicators, manage the patients, and administer radiation therapy as an authorized user of radioactive materials or its electronic counterpart termed electronic brachytherapy. These activities include integration of care with external beam radiotherapy (EBRT), coordination with other physicians and surgeons, selection of the proper brachytherapy methods, and clinical case management before, during, and after the procedure. The physician is at center stage in a brachytherapy program where training in procedures and radiation therapy will be applied. The patient will first be seen in consultation where the physician will decide if radiation therapy is indicated. The type and timing of external radiation and brachytherapy and their integration with other treatment modalities are part of the cognitive process of clinical treatment planning. The physician will then guide, direct, and supervise the brachytherapy from start to finish and be responsible for follow-up care of the brachytherapy patient.

PAs and NPs can be trained to do many of the evaluation and management services associated with brachytherapy in order to increase efficiency within the department. They can see patients independently, order and evaluate tests, order medications, and interact directly with patients and other physicians to coordinate care and manage patients. PAs can assistant and do some surgical procedures, but only the radiation oncologist can order and supervise the administration of radiation therapy. The clinical program and the management of complex patients will be facilitated by the expertise of a PA or NP or both. They can provide services significantly beyond the day-to-day capacity of a single radiation oncologist who will be busy performing and supervising the clinical and technical components (TCs) of brachytherapy.

LVNs and MAs may perform or assist in many brachytherapy nursing function, but they cannot administer medications.

Physics, Dosimetry, and Therapy: Medical Physicists, CMDs, and RTTs and Radiation Therapist Technologists

The medical physicist (MS or PhD) is responsible for supervision and management of the TCs of the brachytherapy service. They manage all of the equipment, perform or supervise all dosimetry, and, along with the physicians, direct and work closely with the therapists and dosimetrists. They perform regular quality assurance (QA) for equipment and do the radiation source calibrations as required by governmental agencies in keeping the principles of radiation safety and quality brachytherapy. They ensure the reproducibility and safety of the physical space, equipment, and computer interfaces required to perform complex brachytherapy. They also perform the clinical service to patients under treatment of continuing medical physics and special physics consultations. The medical physicist is the technology leader of the service. This person must be trained and capable of commissioning and managing all radiation therapy equipment related to brachytherapy and handling all radioactive sources and all radiation safety matters. The creation and maintenance of a safety program for brachytherapy will be led by the physicist. Supervision of the CMD and RTT personnel and management skill are important parts of the job. The physicist provides the necessary specialized understanding of the electronics and mechanics of the various imaging and treatment devices.

CMDs perform brachytherapy dosimetry calculations under the supervision of the medical physicist. They utilize simulation images to prepare the data set for contouring of clinical targets and adjacent organs at risk (OAR) in preparation for dose calculations. They then interact dynamically with physicians to optimally distribute the radiation to the target and avoid treatment of surrounding structures through the use of high-speed treatment planning computers and sophisticated brachytherapy software. The knowledge base of the physician, physicist, and CMD must include physics; biology; normal tissue tolerance standards; advanced treatment planning software; and clinical anatomy, radiation safety, and normal clinical practice guidelines and standards. They must be well versed in the treatment planning software, understand the implant anatomy and the dose constraints of normal adjacent structures. CMDs will commonly do the first-pass design of the clinical target volume (CTV) and OAR contouring, which of course, must be checked and modified by the physician.

Administration and Practice Management

Practice administrator, front office staff (clinical coordinators, surgery schedulers, receptionists, etc.), and coding and billing staff are essential personnel in a brachytherapy practice.

Other administrative personnel include surgery scheduler, receptionist, authorization coordinator, billing and coding personnel. The complexity and multiple steps of brachytherapy make it somewhat challenging to coordinate. Administrative personnel must function in a complex setting where surgical procedures are scheduled and performed in an office setting, an ASC, or as inpatients. They coordinate consultations and office visits and interact with patients, payers, hospital personnel, and other physicians. The person coordinating the process may go by any of several titles such as brachytherapy scheduler, brachytherapy clinical navigator, or other similar terms. The job may require more than one person in a busy practice.

A dedicated brachytherapy clinical coordinator (navigators) may overlap in function with front office personnel. They are skilled administrative professionals specifically knowledgeable in brachytherapy who orchestrate the interactions of patients with the clinical care team. They coordinate procedures, and interact directly with physicians, operating room and nursing staff, and other hospital and clinic personnel to manage the multistep multidisciplinary process of brachytherapy. Billing and coding unique to brachytherapy require these administrative persons to have a specialized knowledge of brachytherapy billing in addition to the usual skill set. They must be capable of explaining the basics of the brachytherapy procedures and processing authorization requests, predeterminations, and internal and external appeals for coverage. Last but not least, a high-quality image technology team must be available. Electronic health records, billing and coding, and data management all required sophisticated computer hardware and software. In this era of rapidly evolving technology, it is both essential and expensive to develop and maintain the high level of IT needed to sustain a quality brachytherapy program.

Radiation Safety Officer

Radiation safety officers play an important and necessary role in connection with the brachytherapy service. They are typically physicists or physicians with expertise in radiation safety of the patient and staff in conjunction with brachytherapy. Radiation safety officers and the radiation safety committee ensure that the regulatory aspects of the medical use of radionuclides, that is, radioactive sources (and electronic brachytherapy), are correctly observed. They also monitor radiation exposures from brachytherapy-related diagnostic and therapeutic radiation. The radiation safety officer educates new staff and patients and gives regular in-service training sessions for all staff involved with brachytherapy services.

Other Physicians Directly Connected With the Brachytherapy Procedure

Facility

Brachytherapy requires a certain amount of physical space depending on the intended scope of practice. For practices limited to permanent seed implants and other LDR brachytherapy performed in the hospital, it consists of equipment storage, a “hot lab” for storage and handling of sealed radionuclides, and a room for computerized dosimetry calculations. HDR afterloading, on the other hand, requires significantly more of a facility due to shielding requirements and the nature of HDR treatment delivery. As a minimum starting point, treatment time in the linear accelerator vault can be scheduled for HDR. This arrangement may be a way to start a program, but imposes marked limitations on the scope and volume of the HDR brachytherapy service. Instead it is preferable to design and build a dedicated brachytherapy suite so there is less functional overlap between the external beam and brachytherapy portions of the practice. Although the patient services are different, some of the EBRT facility such as waiting room, front office, clinic space, examination rooms, and administrative offices can be used for dual purposes.

Ideally a brachytherapy suite should be built within the department of radiation oncology or it should be constructed as an adjacent separate entity. Shielding requirements for HDR are less than for a linear accelerator, but significantly more than for a CT scan or fluoroscopic simulation. Conversion of a space for the use for HDR brachytherapy requires considerable financial resources, space planning, physics commissioning, radioactive materials licensing, and arrangements for the adjacent support and storage spaces (perioperative patient care bays with vital sign monitoring, suction and oxygen, brachytherapy equipment, anesthesia equipment, crash cart, secure medication cabinet, a place for disposable medical supplies, etc.).

A dedicated HDR brachytherapy suite requires space for each step in the process of care: (a) applicator insertion, (b) simulation radiography, (c) computerized dosimetry, and (d) HDR treatment delivery. The first thing to determine is what level of pain management will be needed and, if anesthesia is used, where and how to manage patients after the procedure (outpatient, overnight short stay, or as an in-patient). One option is to only do procedures that require no more than conscious sedation in the brachytherapy suite and to do more complex procedures that require anesthesia either in an ASC or the hospital. This approach is initially the least expensive, but patient transportation to and from these venues poses some logistic and economic challenges. On the other hand, construction of an anesthesia ready brachytherapy suite is more expensive to build and staff. A dedicated HDR brachytherapy suite would have the following elements: