May 25, The Honorable Dave Camp Chairman House Committee on Ways and Means 1102 Longworth House Office Building Washington, D.C.

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1 The Honorable Dave Camp Chairman House Committee on Ways and Means 1102 Longworth House Office Building Washington, D.C Dear Chairman Camp: The American Society for Radiation Oncology (ASTRO), representing more than 10,000 radiation oncology medical professionals who treat more than 1 million cancer patients each year, applauds your leadership and commitment to repealing the Medicare Sustainable Growth Rate (SGR) formula. ASTRO believes Medicare physician payment reform is critical to stabilizing and enhancing the Medicare program. Furthermore, we appreciate your intent to identify and learn from physician led efforts to improve clinical performance, as we are concerned that relying on payment solutions alone will not sufficiently provide meaningful reforms that improve quality and reduce costs while ensuring the longterm sustainability of the program. In radiation oncology, advanced technology and improved treatment techniques allow cancer centers to continually improve how to target radiation to kill the tumor while protecting healthy tissue. It is imperative that the continued advancements of radiation therapy that improve patient care not be stymied by across the board or arbitrary cuts. Congress should provide stability for Medicare providers and patients by enacting a permanent solution to the SGR. We appreciate the opportunity to provide you with information on ASTRO s quality improvement efforts, which we believe are increasingly robust, forward thinking and collaborative. Before we describe our efforts to improve quality and efficiency, we urge you to explore ways to sustain the Medicare program for current and future beneficiaries by considering the savings that could be generated from removing radiation therapy from the in office ancillary services (IOAS) exception under the physician self referral law. We are extremely concerned that misapplication of the IOAS exception to the physician self referral law is potentially leading to increased spending, unnecessary overutilization of services, and could also lead to compromised patient choice and care. Congress created the ancillary services provision to allow physicians to offer services that were integral to a single visit to the physician s office. Unfortunately, the expansive use of the IOAS exception by physician groups in a manner not originally contemplated by the law undercuts the purpose of the law and can substantially increase costs to the Medicare program and its beneficiaries. We are confident that closing this selfreferral loophole will create savings for the Medicare program by reducing inappropriate over utilization of health care services. The Government Accountability Office is examining this issue and expected to produce reports this year. Rewarding quality and efficiency ASTRO s Board of Directors has directed our organization to take a leadership role in developing new payment methodologies in oncology, perhaps including bundled payments, with the goal of incentivizing better quality, efficiency and improved patient outcomes. While we are in the early stages of this complex and expensive work, we are hopeful that we can produce tremendous breakthroughs that will

2 Page 2 secure fair payment for radiation oncology services while protecting high quality patient care. We look forward to sharing information with Congress as we move forward with this important activity. In the meantime, ASTRO continues to invest significant resources into developing clinical guidelines and quality measures and collecting data via registries to assess and improve performance. Evidence based clinical guidelines Over the past four years ASTRO has developed five clinical practice guidelines to improve patient care and reduce treatment variation. These topics include: Accelerated partial breast irradiation (APBI), Fractionation for whole breast irradiation, Palliative radiotherapy for bone metastases, Palliative thoracic radiotherapy for lung cancer, and Radiotherapeutic and surgical management of newly diagnosed brain metastases. These five guidelines have all been accepted for inclusion in the National Guideline Clearinghouse sponsored by the Agency for Healthcare Research and Quality. ASTRO also is developing an evidencebased clinical practice guideline on the role of post operative radiation therapy for endometrial cancer as well as post operative radiotherapy after radical prostatectomy (joint ASTRO/American Urological Association guideline). Finally, ASTRO is exploring a guideline on radiation therapy in the treatment of lung cancer. ASTRO relies heavily upon best practices in clinical guideline development recommended by the Institute of Medicine. While developing these collaborative guidelines is an exhaustive and resource intensive endeavor, ASTRO is committed to continuing to invest significant time, money and energy into guideline development, as we believe they represent the foundation of new payment methodologies that can appropriately reward radiation oncologists for achieving high performance. Given that radiation oncology is a specialty that relies on, and has made dramatic advances in effective cancer care through the use of complex, breakthrough technologies, ASTRO has recognized the need for clinical practice statements on the appropriate use of new technologies in the delivery of radiation therapy. Therefore, ASTRO recently launched an initiative to develop and promulgate Best Practices Statements. These statements will use the Rand Appropriateness Methodology and a modified Delphi approach to address important clinical questions. Experts in the field will engage in consensus deliberations on evidence to determine the appropriateness of different technologies in the treatment of cancer. ASTRO s first such statement is underway, and it will address the appropriate use of different technologies in the treatment of post operative endometrial cancer. Quality Improvement: Measure development Clinical guidelines and consensus statements to guide practice serve as the impetus for the development of quality measures. The development, implementation, and monitoring of quality measures relative to radiation oncology practice is an integral part of ASTRO s quality improvement portfolio of activities. A newly developed measure, External Beam Radiotherapy for Bone Metastases, is being considered for endorsement by the National Quality Forum (NQF). Given the interdisciplinary team approach to cancer treatment, ASTRO also has partnered with other medical societies to develop multidisciplinary measures. An oncology measure group that was jointly developed with the American Society for Clinical Oncology (ASCO) is being reviewed by the Quality Measurement and Health Assessment Group at CMS.

3 Page 3 ASTRO also has worked closely with the AMA Physician Consortium for Performance Improvement (PCPI) to develop NQF endorsed quality measures included in the Medicare Physicians Quality Reporting System (PQRS). Quality Improvement: Physician level performance The Performance Assessment for the Advancement of Radiation Oncology Treatment (PAAROT) program is an example of ASTRO s commitment to continuous quality improvement at the physician level. For PAAROT, physicians select a baseline sample of 10 consecutive medical records and enter data on a series of measures for every medical record in the sample. Performance is computed per measure across the sample of medical records and is compared to aggregate peer data and pre established performance goals. Next, pursuant to the review of the scores for each measure, physicians select a measure for performance improvement. An improvement plan is developed and implemented over the course of three months. Finally, re measurement is completed by selecting another sample of 10 consecutive records and re entering all measures in every record in the sample to assess the impact of the quality improvement plan. All data collected in PAAROT are HIPAA compliant and de identified. PAAROT meets the American Board of Radiology (ABR) criteria for Practice Quality Improvement as part of the requirements of the ABR Maintenance of Certification Program. Patient safety A culture of safety and quality control is woven into the fabric of our field, with checks and balances at every level to ensure that the safest and most effective care is delivered to our patients. All available evidence indicates that radiation oncology errors are very rare. However, one error is too many. In our ongoing efforts to improve safety, ASTRO has enhanced its ongoing patient safety and quality projects and developed an action plan called Target Safely, which already has: Worked with cancer patient groups to create a list of questions patients should ask to better understand the safety checks and balances that are put into place to guard against errors; Urged all radiation oncology practices to consider only using technology that has successfully passed rigorous interoperability testing; Enhanced our educational programs focus on safety and quality issues; and Developed several white papers on safety considerations in the clinic, including safe use of Intensity Modulated Radiation Therapy (IMRT) and Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy (SRS/SBRT). Three more white papers on Image Guided Radiation Therapy (IGRT), High dose rate (HDR) brachytherapy and peer review in the clinic are nearing completion. ASTRO is now building on Congress bipartisan Patient Safety Act of 2005 by beginning work with a federally certified Patient Safety Organization to create an unprecedented national medical error reporting system for radiation oncology to detect potential problems and identify national error trends. ASTRO also is calling on Congress to help us further improve the safety of radiation therapy by working with us to establish minimum education and credentialing standards for radiation therapy personnel through immediate passage of the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging in Radiation Therapy (CARE) Act HR The bill was introduced by Rep. Whitfield (R KY) and

4 Page 4 Rep. Barrow (D GA) and boasts more than 110 bipartisan cosponsors. In some states, basic training standards are voluntary, allowing individuals to perform some radiation oncology procedures without any formal education. Without a minimum level of standards, patients could be at risk, so we urge Congress to immediately pass the CARE Act. Accreditation, in particular, plays an important role as a powerful tool to help ensure that clinics are meeting safety and quality standards. ASTRO and the American College of Radiology (ACR) partner to provide accreditation program that aims to ensure that radiation therapy clinics are fully competent to perform the services they provide. ASTRO/ACR accreditation provides impartial third party peer review through assessment of daily practices that demonstrate an impact on professional competence according to recognized standards of the scientific community. More than 300 practices have been accredited since ASTRO strongly supports practice accreditation and encourages its members to participate in the program. Patient registries ASTRO, in partnership with our foundation the Radiation Oncology Institute (ROI) is developing the National Radiation Oncology Registry (NROR), the first of its kind for radiation oncology. The intent of the registry is to improve the care of cancer patients by capturing real time, real world reliable information on radiation treatment delivery and health outcomes through a prospective electronic registry infrastructure. The pilot project for this nascent registry is scheduled to begin in the fall of 2012 and will be focused on radiation oncology treatments for patients with localized prostate cancer. The objectives for NROR are to: Collect patient specific radiotherapy data electronically; Determine national patterns of care and gaps in quality of treatment; Provide benchmark data and tools to individual practitioners for quality improvement; and Generate hypotheses linking processes of care and outcomes and identifying subpopulations for whom a particular form of radiation therapy is most effective. Last month, ROI hosted a high level forum for thought leaders and visionary registry stakeholders to raise awareness of the NROR, gather recommendations from the group and build longer term involvement from the community. Forum attendees included radiation oncologists, representatives from NIH, FDA, and CMS, foundation and professional society participants, private payers, patient advocates, and industry leaders. To date, the NROR Data Dictionary has been developed, IT user requirements for the database have been written, and the IT vendor has been chosen to build the NROR infrastructure skeleton. While the promise of the data collected by registries, such as NROR, to inform quality improvement efforts and to demonstrate the value (or lack thereof) of particular health care services is great, considerable resources are needed to launch and sustain these efforts. ASTRO strongly supports NCI s funding for clinical trials conducted through the cooperative groups, as we believe these trials are needed to help us answer key questions. We note, however, that observational data obtained in registries will give us a more complete view of how particular subpopulations (e.g., particular genetic markers, particular comorbidities) respond to treatment outside of a controlled clinical trial environment. We anticipate that the insights gained from this knowledge will have a significant impact on the cost and quality of cancer care provided to all Americans. As federal programs like Medicare will

5 Page 5 benefit tremendously from this information, we recommend Congress provide federal seed money for registries that meet certain criteria. Establishing criteria for registries might include requirements on how registries track patients across various registries (e.g., it would be ideal to track patients with both cardiac conditions and cancer across various registries) and how to address certain privacy and HIPAA issues. We urge Congress to provide federal funding to support registry efforts and to create a regulatory environment that supports these efforts. Electronic health records/e prescribing A 2011 survey of ASTRO members found that approximately 80% of radiation oncology practices have adopted and are using health information technology (HIT) in cancer care. Radiation oncology specific electronic health records (EHRs) help clinicians manage the complex radiation therapy treatments for cancer patients. The software automates radiation therapy prescribing, provides clinical decision support, manages clinical trials and documents all activities, enabling reporting and outcomes analysis. Radiation oncology specific EHRs contain essential data elements and have the ability to assist with the management of post treatment care and support. Radiation oncology EHRs also provide important patient safety protections, by providing real time monitoring of patient care to ensure the right patients are receiving the right treatments. By demonstrating a commitment to overcome barriers to adoption and ensuring that their patients benefit from the improved delivery of care made possible by HIT, radiation oncologists are leaders in this area. Treating a cancer patient with radiation requires the coming together of multiple complex systems, people and processes. In a typical radiation oncology clinic, information flows from imaging equipment through treatment planning software, to treatment management software and finally to the treatment delivery machine, which delivers a precise dose of radiation to the patient. The main challenge that clinicians experience is the robust transfer of information through these systems when each system in a clinic may be developed by a different vendor. A treatment plan could be made on vendor A s equipment and then that information would be transferred to vendor B for treatment management and finally to vendor C for delivery. Achieving seamless connectivity through these different vendor systems poses a constant obstacle for radiation oncologists. Attaining compatibility with hospital information systems is also a necessary component of the treatment process for hospital based providers. Due to the many handoffs necessary before a patient can actually be treated for cancer with radiation, there are risks of error and concern for patient safety. To help prevent any errors, ASTRO has been the chief financial supporter and lead organization in the IHE RO (Integrating the Healthcare Enterprise Radiation Oncology) program since This program brings together radiation oncologists, physicists, other cancer care professionals and the medical device industry to create an environment of interconnectivity and interoperability where vital clinical information is passed seamlessly from system to system, within and across practices, and made readily available at the point of care. In 2007, IHE RO successfully demonstrated connectivity for basic information exchange across eight different medical systems in the radiation oncology treatment planning process. In 2008, IHE RO completed an effort to seamlessly transmit and align multi modality tumor images, a key component of the treatment planning process, across different systems using standards based interchanges. Additional projects for enhancing the treatment delivery process and other advanced information exchange efforts are underway with the goal of full device interoperability by These integration profiles have already been implemented

6 Page 6 by many radiation oncology software companies, and we hope that these integration profiles can be implemented by all radiation oncology software manufacturers. ASTRO believes e prescribing also can positively contribute to improved beneficiary health outcomes by enhancing quality and efficiency. To that end, we support efforts to promote widespread adoption of electronic prescribing among Medicare beneficiaries. ASTRO appreciated modifications made to the Medicare E prescribing program to enable more physicians to participate, but we continue to be disappointed by limitations that hinder radiation oncologists ability to fully participate in the program. Because of the prescribing patterns of radiation oncologists (prescriptions are reported during weekly management visits and not when the evaluation and management visit is reported), a change in the program now allows our members to avoid penalties but it remains difficult to earn a bonus even if they are electronically prescribing. Quality incentive programs should be designed to enhance patient care and should not be driven by the predominant coding practice. These programs should be flexible enough to capture the various ways different specialties provide high quality care to their unique patient population. Regulatory burden ASTRO supports CMS anti fraud programs that are part of a federal crackdown on waste and abuse. However, we oppose the use of recovery audit contractors (RACs) to perform prepayment review. We believe that the program s contingency fee structure inappropriately incentivizes the Recovery Auditors to conduct fishing expeditions that are exceedingly burdensome for physician practices. The Recovery Audit Prepayment Review Demonstration expands the reach of the Recovery Auditors by incentivizing them to perform prepayment review, a task for which they have neither experience nor expertise. Based on our members experience with the Recovery Auditors, we believe that they are incapable of efficiently or accurately conducting prepayment review. Specific to radiation oncology, Radiation Oncology Benefit Management companies (ROBMs) have entered the marketplace over the past couple of years. ASTRO actively monitors ROBM activity and has established ongoing communication with several ROBMs. We have found that their activities often cause unnecessary delays in the staging, workup and treatment planning for cancer patients, as well as increased costs for providers who must navigate the tedious authorization process. Based on this experience we are very concerned about the expansion of RAC activities in the area of prepayment reviews and Medicare adoption of ROBMs. ASTRO also is very concerned about the simultaneous implementation of five significant initiatives that will result in extraordinary administrative and financial burdens on physicians. These initiatives include the value based payment modifier, penalties under e prescribing, PQRS, meaningful use and ICD 10 implementation. Inevitably, many providers will have one or more of these adjustments applied to their Medicare payments. The resulting impact of these converging dates for payment adjustments is that there will not be one Medicare payment rate, but rather several that will be affecting physician reimbursement. This will potentially create greater complexity for Medicare contractors paying out claims as well as unexpected changes in cash flow for providers. We believe Congress should work with the CMS to ensure that these timelines are reconsidered and better aligned. ASTRO is particularly concerned with implementation of the PQRS. For years, ASTRO has devoted significant resources to develop measures to participate in PQRS, and we have actively promoted the program to our membership despite its shortcomings. In particular, we find it difficult to develop

7 Page 7 measures for incorporation into the program due to the overly rigid timelines that require measures to be included in the proposed Medicare Fee Schedule rule in the year before incorporation into the program. As an example, in conjunction with the American Society for Clinical Oncology, ASTRO submitted an oncology measure group to CMS in October of 2011 to be included in the 2013 PQRS program. Unfortunately, in the 2012 Physician Fee Schedule final rule, CMS indicated it would not add new measures given the impending implementation of ICD 10. Since this decision, however, CMS has delayed ICD 10 implementation. ASTRO met with CMS officials in February 2012 and again requested that the agency consider adding a new oncology measure group for 2013 comprised of measures currently in the PQRS program. We have not yet been notified of a final decision, but we are concerned that the implementation timelines of the PQRS (and Medicare EHR meaningful use program) will unfairly prevent an oncology measure group from being available for radiation oncologists to use to satisfy reporting requirements in These restrictive deadlines hinder the ability of willing physicians to participate in these programs and breeds general cynicism in the government s ability to operate effective quality programs. We urge Congress to address these issues in a way that does not further complicate these initiatives or add burden to physicians. ASTRO appreciates the opportunity to share our important quality efforts with the Committee and urges Congress to find ways to provide federal support to accelerate and expand these examples of physicianled initiatives while removing regulatory barriers. As you look to develop and implement new payment methodologies, we urge you to consult closely with medical specialties, including ASTRO, to ensure that new payment reforms appropriately account for the unique characteristics of all physicians. Thank you again for your leadership on Medicare payment reform, and we look forward to working with you to rein in health care spending and improve the quality and efficiency of health care while protecting access to life saving cancer care for all Americans. Please feel free to contact Dave Adler, ASTRO s director of government relations at (703) with any questions. Sincerely, Laura I. Thevenot Chief Executive Officer