ASTRO's role in state advocacy
The American Society for Radiation Oncology now boasts a mature government relations department that has demonstrated an ability to promote radiation oncology in Washington, DC, and defend the specialty from threats to its future. ASTRO's government relations activities consist of legislative and regulatory advocacy on issues facing the specialty in Congress and the federal government, including direct lobbying, organizing and mobilizing grassroots support for legislation and issues, political giving through ASTRO's Political Action Committee, comment letters to federal agencies or proposed regulations, building strategic alliances with patient and provider groups, and numerous other efforts.
At the direction of ASTRO's leadership, ASTRO's government relations activities are focused on policy at the federal level. ASTRO maintains a qualified staff of registered federal lobbyists with experience and relationships geared toward advancing ASTRO's policy agenda in Washington, DC.
ASTRO's government relations staff does not include individuals with experience or relationships to advance policy issues at the state level. With limited resources available, ASTRO's leadership has continued to stress that government relations activities remain focused at the federal level, while supporting and coordinating with individual ASTRO members interested in moving policy at the state level.
It is in this context that ASTRO created its Grassroots State Captain network in 2008, with a dual purpose of leading efforts in each state to influence health care policy at the federal and state level. To support the work of the State Captains and others who wish to lead efforts to combat abusive self-referral at the state level, ASTRO's Government Relations Committee and staff have created this State Self-Referral Toolkit. It is our hope that this toolkit will provide ASTRO members significant guidance and support in their efforts to change self-referral laws in their states. In addition, we urge advocates to ensure that they keep ASTRO staff and leaders well informed of their efforts and progress, as well as coordinating with ASTRO staff to ensure that gains at the state level can support change at the federal level.
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Background—Self-Referral in Radiation Oncology
Physician self-referral is the practice of a physician ordering a service on a patient that is performed either by themselves or by a facility from which they derive a financial benefit for the referral. Most states have some restrictions on the practice of physician self-referral. However, each state is varied when it comes to which physician services are regulated by self-referral laws and to what degree they are restricted.
For patients with localized prostate cancer, external beam radiation therapy, radioactive seeds (brachytherapy), prostate surgery and active surveillance are all considered "clinically equivalent" treatments, according to a 2008 Agency for Healthcare Research and Quality comparative effectiveness review. The report noted that because the treatments have varying side effects, patient preferences are an important factor in determining a management strategy. The National Comprehensive Cancer Network clinical guideline states that a patient with clinically localized prostate cancer should be informed about the commonly accepted interventions, and a discussion of the anticipated benefits and risks of each intervention should occur with the patient.
Determining the most appropriate prostate cancer treatment option is an involved process that depends on the patient's preferences, age, concerns, co-morbidities and physiology. We believe that when referring urologists own radiation therapy facilities, they are so heavily incentivized to refer their patients for external beam radiation therapy services that their clinical decision-making becomes biased and likely leads to overutilization of radiation therapy. Specifically, these models channel referrals to a particular radiation therapy, called intensity modulated radiation therapy (IMRT). IMRT is particularly of interest because of the technical fees that are billed by the owner of the linear accelerator. In January 2009, the Institute for Clinical and Economic Review produced a report comparing the clinical benefit and costs of the various treatments for low-risk prostate cancer. The report concluded that the rates of survival and tumor recurrence are similar among the most common treatment approaches, although costs can vary considerably, with surgery and brachytherapy costing significantly less than IMRT.
Physicians, especially those who are in a position to refer patients for radiation therapy services, have realized that if the provision of these services and the related billing of the technical fees for the equipment can be "captured," financial gain can be achieved based upon the referral decisions. This business dynamic has been identified, packaged and is being marketed to physician groups, particularly within the urology community, by for-profit companies that specialize in fueling the enthusiasm about lucrative joint ventures with financially aggressive physicians.
Consequences of Self-Referral
Self-referral business models run counter to crucial health care policy goals, including patient choice, quality of care and access to services. By setting up a business model that holds radiation oncology services captive to the referring physician, and by driving patient referrals only in that direction, cancer patients are denied the independent clinical judgment and choice they need and deserve.
Under these arrangements, the quality of cancer care suffers. The physician practice will steer patients toward the services they wish to offer, rather than those that might be better for the patient. Perhaps of even greater concern is the fact that for some prostate cancer patients, it may simply be that "watchful waiting" is the most prudent course of treatment, while for others, surgery might be the best approach. However, with the financial return that a urology group can realize on IMRT treatments, there is considerable risk that "watchful waiting" or surgery will not be thoroughly presented to the patient as a viable treatment options. In addition, there is a population of patients who generally should not be treated at all, such as the elderly or those with serious co-morbidities.
On December 8, 2010, The Wall Street Journal investigated several urology group practices, including one of the largest, Integrated Medical Professionals (IMP), that have used the self-referral exception to bring external beam radiation therapy services into their offices. The article revealed two major findings:
- Urology groups that brought IMRT into their practices had utilization rates well above national norms for use of that treatment for prostate cancer. Moreover, the practice patterns for these groups showed dramatic utilization increases following equipment purchase.
- These practices treated a higher than average number of men over the age of 80 with radiation therapy for their low-risk prostate cancer. Experts agree that in most instances, 80+ year-old men with low-risk prostate cancer do not need aggressive treatment.
On February 15, 2011, The Washington Post also published a story exposing self-referral abuses in radiation oncology. The article quotes world-renowned Johns Hopkins urologist Patrick Walsh, MD, criticizing the "for-profit motive" affecting treatment decisions for some physicians involved in self-referral arrangements.
A A Baltimore Sun article in January 2012 described how a Maryland urology clinic's prostate cancer referrals for IMRT tripled after they purchased a radiation therapy machine. As the article states, "The more patients the Baltimore-area urologists referred for that expensive therapy alternative, the more revenue and profits they would generate."
- The Maryland data is part of a national study by Georgetown University coming out in mid-2012. It is expected to show that urology practices across the country drastically increased expensive IMRT referrals after they acquired a radiation therapy machine.
A published survey of radiation oncology residency program directors across the country revealed that 27 percent of residency programs in communities with these business arrangements reported a negative impact on residency training as a result of decreased referrals to their centers. While this is a small survey sample, it foreshadows large quality problems in the future if residents do not see the appropriate case mix of patients necessary to develop the skills they need to treat prostate cancer patients.
In 2012, independent reports from the Government Accountability Office and the Congressional Budget Office are expected to be released showing the clinical and economic impact to the Medicare program of physician self-referral on the provision of radiation oncology services.
Those benefiting financially from their ability to control radiation therapy services and the resultant revenues within their business unit assert that they are delivering "integrated care" or providing access in underserved areas. The notion that these are the driving forces in the creation of these financially lucrative business models is contradicted by the marketing materials published by at least one national for-profit purveyor of this approach, URORAD, based in McAllen, Texas, which highlight the potential for huge revenues by incorporating IMRT into a urology practice.
Politics at Play
Politically, groups supporting laws that limit the restrictions on self-referral are outspoken, willing to defend their business arrangements to their elected officials, and understand the concept of strength in numbers. Urology groups have been strategic in their approach to political giving, donating hundreds of thousands of dollars to their federal lawmakers. This is likely occurring with the same force at the state level.
Restricting physician self-referral at both the state and federal level is an uphill battle that will take a significant investment of resources, require a strong will, and likely will take years to achieve success. In some states, it may even be an impossible task. There are many factors at play that affect this issue. Before attempting to advance state legislation to restrict self-referral in radiation oncology, it would be wise to undertake a careful environmental scan of the various stakeholders, political relationships and existing state regulations.
State and Federal Intersection of Self-Referral
ASTRO's Progress on Self-Referral
State Self-Referral Laws
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Understanding the Structure and Procedure of State Legislatures
Influencing a state legislature requires a basic understanding of state government's structure and functions.
Most state legislatures meet every year, although there are a few that meet every other year. State legislative sessions are not full-time or year-round because most legislators often have full-time or part-time jobs outside of their government responsibilities. Most legislative sessions begin in January and end between May and June. When not in session, committees will often hold legislative and oversight hearings.
With the exception of Nebraska, all state legislatures consist of two houses: a Senate and a House of Representatives (sometimes called an Assembly). Most of the work in a state legislature is conducted through its committee structure. Often the most critical part of passing legislation is getting it approved by a committee. Committees can make or break a bill, as it is the responsibility of the committee to prepare the bill for floor debate, line up support, or decide to kill the legislation.
Most state legislatures have a hierarchy. Typical leadership arrangements include:
Senate House or Assembly
President of the Senate Speaker
President Pro Tempore Speaker Pro Tempore
Majority Leader Majority Floor Leader
Majority Floor Leader Minority Leader
Minority Leader Minority Floor Leader
Minority Floor Leader
How a bill becomes a law
Every member of the state legislature has the power to introduce a bill. After an idea is drafted into bill form (this can be done by the legislature's legislative counsel or by outside counsel), it is introduced by a bill sponsor and assigned a bill number. This step is known as the bill's "first reading." Be careful to choose a sponsor or author who is respected and who is regarded as having expertise in the subject matter. Optimally, the sponsor should be in a leadership position or chair or serve on the committee with jurisdiction over the bill's content.
After introduction, a bill usually is referred to one of the standing committees and/or subcommittees for consideration. Typically there are one or two committees/subcommittees that handle health care legislation. Major pieces of legislation will usually have a hearing during which testimony is taken. At this point, the role and power of the committee chair usually will determine a bill's fate. Be sure to do your research and learn about the committee leadership and members.
Whether the committee holds a hearing or not, it has a number of options available with respect to the bill's fate. The committee can simply sit on a bill, thus eliminating it from further consideration. The committee may also report the bill out of committee with either a favorable or negative recommendation. Amendments may be added to the bill during the committee proceedings.
Bill hearings are opportunities for advocates and opponents to argue the merits of the bill. Work with partners and lobbyists behind the scenes to influence committee members discussion of the bill during the hearing. Also, line up powerful speakers with convincing arguments in support of your bill.
The bill is then scheduled for consideration and placed on the calendar to be debated by the full chamber – known as the "Second Reading." In most states, bills may be amended at this stage. However, in some states, the introduction of amendments may prove to be more difficult at this point.
Following floor consideration, a bill is put to a final vote, sometimes referred to as the "third reading." In some states, a majority of the total membership of the legislative body is required to pass a measure. In others, only a majority of those voting is necessary. If defeated in one house, a bill is usually considered "dead" for the session.
If a bill passes the first chamber it goes to the second chamber where it must go through the same process again. If the bill passes the second chamber without amendments being added it goes to the governor. If the second chamber amends the bill in any way it must be sent back to the first chamber for approval. If the two chambers disagree on the amendments added in the second chamber, a conference committee is formed to resolve the differences.
Conference committee (if needed):
The conference committee usually consists of members of both chambers. The committee appointments are critical because the members write the conference report, which then must be passed by both chambers. Usually the two houses can only accept or reject a conference committee's report, even though the report may substantially alter the bill. Conference committees are powerful and can undo much of what has been accomplished up to this stage of the legislative process.
The governor of a state has several options when considering the fate of a bill:
- The governor may sign the bill, in which case it becomes law.
- The governor may permit the bill to become law without a signature. There is a specified number of days for the bill to be signed or vetoed, and if the governor does neither, it becomes law as if it had been signed.
- The governor may veto the bill.
While the steps outlined above typically play out in the open political arena, moving legislation forward requires constant advocacy with legislators and staff behind the scenes to support champions and overcome barriers from the opposition and undecided.
No two states are the same so it is important to take the time to learn about your state's unique procedures. You can visit your state legislature's website for more information or contact ASTRO's government relations staff for additional guidance.
2012 Governors and Legislatures
State Government Websites
State Legislature Websites
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Building a Coalition
Should we form a coalition?
Coalitions allow organizations to more effectively focus their collective resources, can help avoid duplication of efforts and can promote uniform messaging between member groups. Before you decide to form a coalition, make sure that there isn't already an effective organization in place. Check in with other organizations involved in the issue to be sure that they are willing to relinquish control of the issue to a coalition.
Define the scope
Once you have decided to form a coalition, you will need to define the scope of the coalition. You should do an analysis of your needs, problems, challenges and resources. What type of funding will you need? Do you need to hire staff or a lobbyist? The results of the analysis will provide the framework for a purpose statement and assist in formulating the scope and direction of an action plan.
The leadership of your coalition can be an individual, group or existing organization and should serve the following purposes:
- Perform the initial steps in forming the coalition.
- Be responsible for all communications.
- Provide information and management expertise.
- Facilitate consensus building.
- Provide materials and staff resources.
- Assume any fiscal and fiduciary responsibilities.
- Supervise any fundraising activities.
Outline the goals of the coalition
Coalition leaders should propose goals and objectives to the membership for consideration. Initial goals should be flexible so that the membership can help establish discrete goals and objectives that are relatively uncontroversial and widely supported. There should also be a mechanism for adding or changing goals and objectives over time.
Define the lifespan
For planning purposes, coalition members will need to know what milestones to expect in terms of coalition longevity. You should consider your goal completion in terms of one year, six meetings, the end of next year's legislative session or the accomplishment of a specific objective or objectives.
Name the group
The name of your coalition can attract or distract you from gathering possible supporters. The name should also give outsiders a sense of the collective goal. Consider naming the coalition after an issue rather than an organization. For instance, ASTRO is a member of the "Alliance for Integrity in Medicare" coalition fighting self-referral abuse at the federal level in partnership with radiologists, pathologists, physical therapists and others.
Coalitions should encourage diverse membership representation, multifaceted skills, temperaments and levels of involvement. Coalitions require a range of talent, so it is best to invite all who express a desire to be involved and then make them feel welcome and assist in defining their roles. It is important that the coalition be viewed as diverse instead of narrow. Depending on your state, consider all levels of involvement (i.e. community, county, region, state).
Think outside the box when looking to engage members. Consider all stakeholders, including:
- Hospital-based cancer programs.
- State and local hospital advocacy organizations.
- Patient advocate groups.
- Nursing organizations.
- Community cancer groups.
Your image is everything. Focus on how you present the coalition and its views. Your materials should provide a clear and concise description of the coalition and its members, goals and objectives, accomplishments, facts on the coalition's issue and how to get further information.
Financial resources for coalition activities may be available from various sources including:
- Membership fees. These can offer start-up capital and demonstrate commitment to the coalition.
- Corporate contributions. These can be tricky. Be sure to keep in mind the image you want to present.
- Shared expenses. A pay-as-you-go model could be agreed upon within coalition members to fund expenses.
ASTRO can be a useful tool in helping you identify other like-minded ASTRO members in your state. ASTRO has numerous resources and materials for your coalition to utilize and can help keep you updated on the progress in other states. ASTRO is always willing to provide guidance and some educational support. Feel free to contact ASTRO's government relations staff for assistance.
A State-Based Model fo Addressing Self-Referral Abuses by Richard Emery, MS, MBA, DABR
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Hiring a State Lobbyist
Abuses of the legislative process have tainted the view of lobbying, but in reality, when done ethically and in compliance with lobbying laws and regulations; it is a vital component of the political process. While physicians are busy treating patients, lobbyists focus full-time on legislative issues. Deciding to hire a lobbyist is an expensive and intensive endeavor. Before hiring a lobbyist, look closely at the political environment of your state and your legislative agenda.
Choosing the right lobbyist
After deciding to hire a lobbyist, ask around for recommendations from the state medical association or other physician colleagues. After compiling a list of lobbyists or lobbying firms, look into the following:
- What connections do the lobbyists have?
- Who are their clients? Are there any conflicts of interest?
- What experience do they have?
- Do they work solely on health care issues or have a broader portfolio?
Writing the job description
Determining the objectives and goals of your legislative efforts is the first step to writing a lobbyist job description. Once that has been defined, discuss the following:
- What is the scope of lobbying you expect? Will they lobby the legislature, regulatory agencies or both? Will they organize political fundraisers? Will they mostly set up meetings for you or be expected to personally communicate messages and requests on their own?
- What non-legislative services you need? Will your lobbyist set up a political action committee (PAC), file state compliance reports, attend hearings?
- What type of arrangement do you need? Full time or on an as-needed basis? Will you pay per legislative issue, session, annually or on retainer? Do you want monitoring services, an advocate or both?
Contracting your lobbyist
Lobbyists are expensive and costs can vary drastically between states, but they can be worth the cost. Depending on the lobbyist's connections to your state's political leadership, the more costly (but more effective), they can be. Explore whether other radiation oncologists in the state are interested in offsetting the costs. Before signing a contract, make sure you discuss fees, payment schedule, legislative success, expense reimbursement and a termination clause.
Just like any other employee or contractor, regularly assess the lobbyists' performance using realistic goals and expectations used in the hiring process. Schedule weekly or biweekly calls or meetings to receive reports, direct activities and assess performance. If goals are not being met, if skills don't meet promises made in the hiring process, or if the relationship isn't working out, don't be afraid to end the relationship and search for a new lobbyist.
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Developing a relationship with your state legislators
Creating personal relationships with state legislators is essential to influencing the legislative process. As a constituent, you are important to your legislators so don't be afraid to be the one to reach out first. Once you have decided to contact your legislator, keep in mind that:
- Face-to-face meetings are the most effective way to communicate.
- Once you have made personal contact, writing and calling your legislators becomes more valuable because there is a "face to the name."
Scheduling a meeting
To schedule a meeting, first:
- Find your legislators on the state government's website. Each website provides contact information for every legislator.
- Set up an appointment date and time that works best for both of you.
Meeting with your legislator
The first meeting will be the basis for all future communication, so choose somewhere you're most comfortable. Coffee, lunch, dinner, drinks, at home, your cancer center or the state capitol are all great locations for meetings.
- Unless you have a previous relationship, keep the first meeting short (30 minutes). Be sure to keep track of your time.
- Be friendly, sincere and non-threatening.
- Start from the beginning (i.e., What is radiation oncology? What is self-referral? Talk about patients you treat.)
- Don't forget your legislative ask—Ask for their support in ending self-referral abuse.
Preparation is critical to a successful meeting. Your legislator may ask questions or for advice on a specific topic — come prepared to discuss a variety of issues. Many legislators have not developed definitive positions on health issues. Having a trusting relationship is a great opportunity to help shape your legislator's views.
- Be ready to discuss current event topics that will peak your legislator's interest.
- Discuss current health-related headline news, particularly related to cancer.
- Have district-specific facts about your patients, your clinic, etc.
Gratitude goes a long ways in the political world. Follow up with a letter of thanks and include any additional information that you were unable to discuss during your meeting and any articles or resources that were discussed.
Make a point to stay in contact periodically with your legislators, even if it's a quick email every quarter. Legislators do not want to hear from you just when you need or want something.
Writing your legislator
Once you have established a relationship with your legislator, writing to them becomes much more effective. When writing be sure to:
- Write about one topic per letter.
- Be concise and direct.
- Include specific bill numbers and titles.
- Describe the impact on your practice, your patients and their legislative district.
- Ask your legislator to act on your issue.
- Do not use a form letter.
- Refer to the most recent meeting you had with your legislator. This helps with face and name recognition.
- Ask for a response.
Invite your legislators to tour your facility
Giving a tour of your cancer center is an excellent way to get to know your legislators, all while explaining what radiation oncology is in the environment where treatments are given. During the tour, explain what radiation oncology is, walk through treatment planning and the different pieces of equipment in your facility. Be sure to contact ASTRO government relations staff for additional help or tips before the tour.
It is never a waste of time
Don't see eye to eye with your legislator? Your legislator doesn't agree with your position on self-referral? It's ok! Educating and informing legislators is not a waste of time, regardless of their stance on the issue. Even if your legislator does not support you on self-referral, they may support you on other issues in the future.
Most legislators have medical advisory boards that they turn to when working on health care legislation. This is a great opportunity to develop a relationship with your legislator and is critical to ensuring that the voice of radiation oncology is heard on the state level. If your legislator doesn't have a radiation oncologist on their medical advisory board, ask to join. You should also let them know that you are willing to testify at hearings. This will help you and radiation oncology gain credibility with your legislator.
No one in politics likes to fundraise. Just like you would rather be treating patients, legislators would rather be working on policy and meeting with constituents than fundraising. Unfortunately raising money is necessary to stay in office. By becoming a part of this endeavor, you earn credibility with the candidate.
Hosting an event
Hosting a fundraiser is the perfect way to show your support for radiation oncology and the candidate. First, you will need to work with the legislator's fundraiser to:
- Set a fundraising goal/minimum expectation for the event.
- Schedule a date and time.
- Decide on a location. This can be at your home, cancer center, friend's home or wherever you are most comfortable.
- Determine the type of event. Most fundraisers are reception style with hors d'oeuvres or light refreshments.
Bringing in the money
After working out the logistics with the fundraiser, you will need to determine the scope of your fundraiser. Will your event be a radiation oncology-specific fundraiser or will it include other specialties?
When asking for money, make sure you:
- Ask colleagues within your practice to contribute.
- Communicate via phone, email, or in your practice's staff meeting.
- Ask those who have confirmed to attend your event to reach out to their own colleagues.
Fundraising do's and don'ts
- Practice your pitch before you approach your colleagues.
- Ask for more money than you think someone will give.
- Be personable when asking for money.
- Use peer pressure.
- Ask committed colleagues to reach out to their own network.
- Build a fundraising network. Create a list of colleagues you can go to next time you host an event.
- Introduce the legislator, then give them time to talk.
- Keep your comments brief at fundraisers.
- Check with the fundraiser to confirm that political contributions need to be made with personal, not business checks.
- Check your state's regulations before giving. State maximum giving levels vary between $100 -$500 per election cycle.
- Be afraid to ask for money.
- Wait to the last minute to fundraise.
- Have fundraisers on Friday nights. This tends to be the most difficult day the schedule an event.
- Discuss political fundraising in federal or state official buildings.
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Other Policy Approaches
In addition to a standard legislative fix, the dynamics in some states may necessitate more creative policy approaches to restrict self-referral. Alternative approaches that have been used include instituting Certificate of Need laws and challenging anticompetitive practices through your state's Attorneys General's office.
Certificate of Need laws
In order to open a new private practice, some states' laws require that the demand/need for the service in a given area be demonstrated and deemed appropriate. These are referred to as Certificate of Need (CON) laws. These laws are aimed at restraining overall health care costs and allowing coordinated planning of new services and construction. The laws vary from state to state and some states have laws specific to radiation therapy.
Challenging anticompetitive practices in radiation oncology markets
In 2011, Pennsylvania's Attorney General filed a complaint in federal district court challenging the 2005 merger of five urology practices. The complaint alleged that the urologists' merger violated federal and state law because it monopolized urology and radiation oncology services in and around Harrisburg. If your region has become monopolized by a urology practice this is an excellent alternative tactic to a legislative fix.
Certificate of Need Laws (CON Laws)
Working with Your State's Attorneys General's Office
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Engaging the Local Media
Engaging your local media is one of the most effective methods to bring attention to your issue. When your issue is highlighted by the media you can also influence other constituents, which your legislators will find compelling.
You can involve your local media by writing editorials or an op-ed, sending out press releases from your coalition, establishing relationships with reporters, or organized news events or press conferences.
ASTRO's media resources
ASTRO has many resources to help you involve the media with your state legislative activities, including:
- ASTRO's website - Find out who your local media are through our online database.
- ASTRO staff - Contact ASTRO's Communications Department for talking points, background material, B-Roll and stock photos for the media. Remember that ASTRO's communication team is always willing to assist you with your interactions with the media.
- ASTRO Media Guide – ASTRO has resources for you to use that include a guide to speaking with the media.
Utilizing new media
Social media can be intimidating, but when working with the press, it is an essential component to getting coverage on your issue. If you prove to be useful to the media, they will continue to use you as source of information and be more open to telling your story.
- 90 percent of journalists have a Twitter handle. See what they tweet about. Do they have a blog? If they mention health related topics, make sure you provide your medical perspective and respond to what they report.
- 40 percent of journalists prefer to receive tips via Twitter. When you have a success on your issue, tweet it to your local media.
How to handle pushback
Engaging the media can be daunting but always do your best to stay on message, no matter where they try to lead the discussion. Do not lose your cool, regardless of how frustrating the situation is. Always remember, nothing you say is ever really "off the record," so think before you speak. Also, be sure to turn questions into an opportunity to share your message.
Understanding Radiation Oncology: Talking Points
ASTRO Media Guide
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