key: cord-0979129-srsl8kpr authors: Eichler, Thomas J. title: RO Model: The Work Continues to Get it Right date: 2020-10-14 journal: Int J Radiat Oncol Biol Phys DOI: 10.1016/j.ijrobp.2020.10.007 sha: 74bf8138d1d8933742ac000f55253dd9829db119 doc_id: 979129 cord_uid: srsl8kpr nan In September 2019, Immediate Past Chair of the ASTRO Board of Directors, Dr. Brian Kavanagh, published an editorial in the Red Journal entitled "Radiation Oncology APM: Why Us? Why Now?" 1 This was a thoughtful look at the rationale for engaging with CMS to create a payment model for our specialty that was both fair and predictable, placing value over volume. In the wake of the posting of the Radiation Oncology Model (RO model) Final Rule, I feel that it is critical to follow up on Dr. Kavanagh's hopeful comments and ASTRO's response to the emerging model. The recent publication of the Final Rule 2 establishing an alternative payment model (APM) for ~30% of all eligible Medicare fee-for-service (FFS) radiotherapy episodes nationally has unleashed a justified firestorm of criticism directed at the Centers for Medicare and Medicaid Services (CMS), largely due to their refusal to compromise on multiple aspects of the program, including an unrealistic timeline and punitive discount factors. ASTRO issued a comprehensive analysis within four days and has begun an aggressive campaign to delay the operational date and to scale back some of the economic impact, but before addressing those factors in more detail, it is instructive to understand how we arrived at this moment. The RO Model has been nearly 20 years in the making. From 2003-09, radiation oncology expenditures overshot the sustainable growth rate (SGR) target by more than 300% compared to 2002 expenditures. This was largely due to the advent of IMRT, which was not identified by a CPT code in 2003 (and thus no expenditure), to being the #4 code by 2011 with over $1 billion in Medicare expenditures, once a CPT code had been applied to the service 3 . Part of the IMRT growth was a consequence of non-radiation oncologists establishing "practices" which included radiation oncology services in a manner that exploited a loophole in the Stark self-referral laws. Patients treated in these practices were much more likely to be treated with IMRT than those in practices that did not have such structures. ASTRO made curbing self-referral its #1 legislative priority in 2007, focusing on urology-owned radiation oncology practices. Despite significant advocacy efforts, a 2013 NEJM publication by Jean Mitchell 4 , and government watchdog reports documenting the abuse of the self-referral loophole, there was insufficient legislative support to fix this issue. Radiation oncology expenditures, specifically for IMRT, continued to rise steeply, which drove CMS and the AMA's Relative Value Update Committee (RUC) to demand significant changes to codes and values for IMRT, conventional treatment delivery and image guidance. As a result, in 2013-14, ASTRO led the restructuring and revaluation of the treatment delivery codes, representing approximately 50% of Medicare reimbursement for radiation therapy services under the MPFS. The ASTRO Health Policy team rose to the occasion and skillfully balanced the demands of CMS and the RUC by creating a revised code set that reflected changes in practice and technology and provided sustainable values, albeit at rates below some of the predecessor codes. CMS, however, went beyond the recommendations of the RUC and ASTRO and proposed significant additional cuts to freestanding centers. As further cuts were looming, ASTRO's advocacy team worked tirelessly to lobby Congress successfully for passage of the Patient Access to Medicare Protection Act (PAMPA) in December 2015 5 which temporarily froze radiation oncology reimbursement. For more than a decade, the ASTRO Health Policy and Government Relations teams have worked tirelessly to fend off a variety of proposed cuts, most of which were delayed, significantly decreased or scrapped altogether. In 2016, ASTRO estimated that more than $500 million in cuts to the specialty had been avoided due to these advocacy efforts. PAMPA and subsequent ASTRO lobbying to extend the freeze on the G code placeholders, saved millions in additional revenue for practices. In addition to PAMPA's payment freeze, the Center for Medicare and Medicaid Innovation (CMMI) was pushed by Congress to develop an alternative payment model for radiation oncology by 2018. With accumulating payment threats to radiation oncology hospital outpatient departments and the threat to radiation oncologist autonomy posed by the Oncology Care Model's emphasis on medical oncology leadership, ASTRO leadership felt that such a potentially dramatic change would best serve patients and ASTRO members alike if radiation oncologists proactively led APM development. As a result, ASTRO created a Payment Reform Work Group, with representatives from across practice settings, which met on a regular basis with CMMI to help guide the structure of the proposed APM. On July 18, 2019, CMS issued the "Medicare Program: Specialty Care Models to Improve Quality of Care and Reduce Expenditures" 6 , the long-awaited Proposed Rule with far-reaching ramifications for our specialty. ASTRO spent considerable time and money to analyze the Rule and submitted a 41-page comment letter on September 16, 2019 7 , which cited several components of the Model with which ASTRO had serious reservations. Typically, comments from stakeholders are reviewed by CMS, responses are written and the rule methodically moves to senior administration and budget officials for review before publication of the final rule in the Federal Register, usually over the course of 2-3 months. The volume of comments in response to the RO Model proposed rule, however, precluded a timely resolution and the document did not reach the Office of Management and Budget until March 10, 2020, just as the country was beginning to close up shop due to COVID-19. As the clock ticked and the reality of the pandemic took hold, ASTRO surveyed the membership and documented 8 the financial toll stemming from effects of the lockdown, resulting in another letter from ASTRO to CMS 9 in July urging the agency to further modify the RO Model and, specifically, to provide participants a minimum of 6 months between final rule publication and implementation and reduce proposed payment cuts. On September 18, the final rule was posted. The ASTRO advocacy team had a detailed action plan already in place to respond to the issuance of the final rule, which was quickly operationalized. The initial review of the final rule yielded a number of disturbing findings, most prominently the unrealistic expectation of a January 1, 2021 go-live date for approximately 950 practices for which the model is mandatory. Additional adverse features of the rule include steeply discounted bundle payment amounts for participating physician groups and facilities among other reimbursement barriers that have real potential for imposing financial hardship among participants, threatening their long-term viability and jeopardizing access to care by vulnerable cancer patients. On September 22, ASTRO issued a detailed analysis of the plan to the membership 10 . The present challenge is that this final rule does not allow for much flexibility. The timing of the release of the final rule, close to an election, limits prospects for legislative remedies. Nonetheless, our efforts have been focused on engaging our Congressional champions on both sides of the aisle to persuade the Agency to push the start date back by at least six months and to reduce the proposed savings from $230M as is estimated in the final rule to $100M. Both efforts may be challenging to achieve, and in the short term anything more ambitious might be dismissed out of hand. The ASTRO advocacy team has also met with CMS Administrator Seema Verma, at which time our numerous concerns were expressed forcefully, including our frustration that the overwhelming majority of our suggestions were completely ignored with a procedural opaqueness that is, frankly, shocking. The pool of trust and good will is rapidly evaporating. There's an old political maxim, "It's better to be at the table than on the table." As Dr. Kavanagh pointed out, ASTRO felt that "…radiation oncology should lead the development and execution of value-based care for our specialty rather than leave it entirely to others to define the future for us….", and, indeed, this has been ASTRO's intent since the beginning. Yet, despite the angst that the model is creating, we now have a plan on the table which, one would hope, could be incrementally adjusted to ensure fairness without being punitive and ultimately create a payment system that is stable and fairly rewards true value-based care. Those adjustments, however, will take time and an all-out advocacy effort by ASTRO and our membership. Again citing Dr. Kavanagh's prudence, "…we hope ASTRO members will give us their perspectives on how the model could affect their practices and patient care. Then we will need to channel this input into advocacy that improves the CMS model into one that works well for all practices and supports high-quality radiation oncology care…" ASTRO has always punched above its weight because our members have supported the efforts of the advocacy team. Now, more than ever, we need your help so that our collective voice can be heard, loud and clear, in Washington to promote fairness and flexibility as we enter this new era of reimbursement. Radiation Oncology APM: Why Us? Why Now? Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures, 85 Fed Sources for the SGR "hole Urologists' use of intensity-modulated radiation therapy for prostate cancer Public Law 114-115: Patient Access and Medicare Protection Act" (129 Stat. 3132, 12/28/15) Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures, 84 Fed American Society for Radiation Oncology Initial impact and operational responses to the COVID-19 pandemic by American radiation oncology practices American Society for Radiation Oncology American Society for Radiation Oncology, CMMI Radiation Oncology Alternative Payment Model "RO Model" Final Rule Summary