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1 Mr. Andy Slavitt Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-5517-FC P.O. Box Security Boulevard Baltimore, MD Submitted electronically: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Dear Acting Administrator Slavitt, The American Society for Radiation Oncology (ASTRO) appreciates the opportunity to provide written comments on the Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused final rule, published in the Federal Register on November 4, ASTRO members are medical professionals, practicing at hospitals and cancer treatment centers in the United States and around the globe, and who make up the radiation therapy treatment teams that are critical in the fight against cancer. These teams include radiation oncologists, medical physicists, medical dosimetrists, radiation therapists, oncology nurses, nutritionists and social workers, and who treat more than one million cancer patients each year. We believe this multidisciplinary membership makes us uniquely qualified to provide input on the inherently complex issues related to Medicare payment policy. The final rule establishes the Quality Payment Program (QPP) as prescribed in the Medicare Access and CHIP Reauthorization Act (MACRA). The rule includes specific criteria for the establishment of the Merit-Based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the Physician Fee Schedule. The rule also establishes incentives for participation in Alternative (APMs) and includes criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) for making comments and recommendations on Physician-Focused (PFPM). In the final rule, CMS underscores its commitment to using the initial QPP years as an opportunity to focus on educating clinicians on MIPS program participation and increasing opportunities for clinicians to join Advanced APMs.

2 Page 2 ASTRO appreciates the opportunity to comment on the final rule. We are particularly appreciative of the educational programs that CMS has launched since issuing the final rule. The various webinars and conference calls have helped us educate ASTRO members on the new QPP program and what it means for their practices. Below are general comments about the rule, as well as key areas where we believe additional clarification is necessary to ensure success in the MIPS and APM programs. General Comments ASTRO is pleased that CMS made several changes in the final rule that are consistent with the recommendations made in our proposed rule comment letter to support greater participation by radiation oncologists. Most importantly, the final rule recognizes the complexity of the QPP program by modifying what would have been an insurmountable implementation period. The Pick Your Pace program established for 2017 provides physicians with the flexibility to participate in the MIPS program at different levels based on their MIPS readiness. While ASTRO appreciates this more thoughtful approach to implementation in 2017, we urge CMS to consider expanding this stepped implementation approach through 2018 to ensure broad opportunities among participating providers. Such a significant wholesale change of the Medicare payment system requires a thoughtful, phased-in approach. Achieving a successful QPP will take several years to accomplish. For the APM program, ASTRO remains concerned about barriers to entry for Advanced APMs applicable to radiation oncologists. Although the agency acknowledged ASTRO s concerns and made a few adjustments in the final rule, we believe that there will be limited opportunities to test new models due to commitments that have been made to existing models, such as the Oncology Care Model. We continue to urge CMS to explore the implementation of additional models so that broader groups of providers, including radiation oncologists, can participate and actively engage in true value-based care. Merit-Based Incentive Payment System (MIPS) MIPS Eligibility CMS changed the MIPS eligible clinician participation criteria in order to exempt more small practices from the program. MIPS eligible clinicians must bill $30,000 or more in Medicare Part B allowed charges and treat 100 or more Medicare patients per year in order to be eligible for the MIPS program. ASTRO appreciates the revised eligibility criteria; however, it remains unclear whether physicians practicing as part of a physician group can retain exempt status as an individual practitioner, even if the entire multi-physician practice as a whole meets the threshold. Is the order of operations for eligibility at the group level, then at the individual level? Is CMS providing eligibility notifications at the group level or at both the group and individual level? Additionally, ASTRO asks for clarification whether group reporting is an all or nothing option. For example, can one eligible clinician within a group

3 Page 3 decide to report as an individual and the remaining group members report jointly as a group or can groups subdivide into smaller groups? MIPS Composite Score Methodology According to the final rule, a MIPS composite score will be developed for each TIN/NPI. Thus, eligible clinicians who operate under multiple TINs will receive a score for each TIN. In the proposed rule, CMS indicated that multiple TIN/NPIs would be aggregated and averaged for a final Composite Performance Score. According to the final rule, it seems that the highest TIN/NPI will count as the final Composite Performance Score (CPS) but this change in policy is not clear. ASTRO urges CMS to clarify how the final, overall CPS will be determined for physicians operating under multiple TIN/NPIs. Partial MIPS Participation for 2017 As previously stated, ASTRO is pleased with CMS decision to provide eligible clinicians the flexibility necessary in order to successfully participate in the MIPS program through the implementation of the Pick Your Pace program in However, the requirements for partial participation are not entirely clear. The verbiage in the final rule executive summary states: (1) Clinicians can choose to report to MIPS for a full 90-day period or, ideally, the full year, and maximize the MIPS eligible clinician s chances to qualify for a positive adjustment. In addition, MIPS eligible clinicians who are exceptional performers in MIPS, as shown by the practice information that they submit, are eligible for an additional positive adjustment for each year of the first 6 years of the program. (2) Clinicians can choose to report to MIPS for a period of time less than the full year performance period 2017 but for a full 90-day period at a minimum and report more than one quality measure, more than one improvement activity, or more than the required measures in the advancing care information performance category in order to avoid a negative MIPS payment adjustment and to possibly receive a positive MIPS payment adjustment. Based on the executive summary, our understanding is that (1) for Full Participation eligible clinicians must report on all performance categories for a period of 90 consecutive days up to a full year and (2) for Partial Participation eligible clinicians may report on only one of the performance categories for a consecutive 90 day period. This guidance is in stark contrast to the guidance shared on a December 13, 2016 CMS webinar, as well as in CMS issued slides, in which CMS staff stated that full participation, referred to as Full Year does not include a 90 day reporting period option and partial participation, referred to as Partial Year requires reporting in each of the three performance categories. ASTRO urges CMS to clarify the reporting requirements for full and partial MIPS participation. If the CMS staff guidance is accurate, then the only difference between partial and full participation is the length of time reporting takes place and the amount of data that is submitted. CMS staff have also stated that Positive adjustments are based on the performance data submitted, not the amount of information or length of time data is submitted. If this is also accurate, then eligible clinicians have no better chance of getting

4 Page 4 a positive adjustment with partial participation than if they were to do full participation. This significantly reduces the value of the flexible Pick Your Pace program, we urge CMS to confirm that the information shared in the executive summary is correct and ask that Agency staff modify their guidance accordingly. Quality Performance Category In the final rule, the Quality Performance Category was modified to eliminate the requirement of a cost cutting measure during the 2017 transition period. Additionally, the weight of the Quality Performance Category was increased to 60 percent in order to account for the reduction in the Resource Use Performance Category. In the final rule, CMS also finalized specialty specific measures sets. ASTRO thanks CMS for moving the Radiation Oncology measures from the Radiology measures set to a subset under Oncology. This better aligns Radiation Oncology with broader Oncology care quality measures. However, some confusion remains on the details of the requirements. In 2017, eligible clinicians will be required to report at least six measures on at least 50 percent of all patients, including at least one outcome measure, if available. If no outcomes measures are available in the applicable measures, eligible clinicians are required to report another high priority measure. The Radiation Oncology measure set contains four measures: 1) pain intensity quantified, 2) plan of care for pain, 3) radiation dose limits and 4) avoidance of overuse of bone scan for prostate patients. It is our understanding that since this measure set contains less than six measures, then the eligible clinician or group will only be required to report on each measure in the set and do not need to seek measures outside of the measure set. ASTRO seeks confirmation of this and urges CMS to clarify how measure scoring will be performed when fewer than six measures are reported. Additionally, how will CMS know that the 50 percent patient threshold has been met if the Agency only has access to claims data regarding Medicare Part B patients? How will CMS count the private payer patients that will contribute to the 50 percent threshold? Additionally, on a November 17 CMS National Stakeholder s Call, CMS officials indicated that the Agency would accept other clinically applicable measures in those cases where a specialty specific set has less than six measures. ASTRO seeks further clarification regarding this comment. Specifically, how will CMS determine which measures outside of a measures set are clinically applicable? How will this information be relayed to physicians participating in the program? ASTRO is also concerned that many measures in MIPS were developed and tested for manual abstraction. These measures may not be feasible in an environment where they are expected to be automatically extracted from electronic health records, and thereby reported on 50 percent of applicable patients (increasing thresholds in subsequent years). In the field of radiation oncology, an example is the radiation dose limits to normal tissue measure. We look forward

5 Page 5 to working with CMS to determine the feasibility automatically abstracting this data from EHRs. Improvement Activities Performance Category The Improvement Activities Performance Category will account for 15 percent of the MIPS Composite Score in the first year of the program. This category rewards clinical practice improvements, such as activities focused on care coordination, beneficiary engagement, and patient safety. ASTRO appreciates CMS decision to reduce the number of activities required to achieve full credit for 2017 from six medium-weighted or three high-weighted activities to four mediumweighted or two-high weighted activities, as well as the inclusion of a reduced reporting requirement for small practices. ASTRO urges CMS to consider increasing the weight of this category. Of all the MIPS categories, we believe that Improvement Activities is the most influential and will contribute to quality improvement and patient safety, allowing physicians to drive change and innovation. Advancing Care Information Performance Category As required by MACRA, CMS finalized the weight for the Advancing Care Information (ACI) Category at 25 percent. The Agency also reduced the number of required measures from 11 to 5. All other measures will be optional for reporting. The Agency also established two measure set options for reporting based on the Certified Electronic Health Records (CEHRT) edition used by the eligible clinician. ASTRO appreciates the Agency s decision to reduce the number of required measures and the establishment of two measure set options. This recognizes the continued resource challenges that many physicians face in adopting CEHRT. In the final rule, CMS recognizes that many physicians have little control or influence over the CEHRT utilized by their employers. ASTRO appreciates that the Agency has established an ACI exemption for eligible clinicians who operate in Place of Service (POS) 21 Hospital Inpatient, 22 Hospital Outpatient or 23 Emergency Department settings. We ask that CMS clarify how the ACI Category weight will be reallocated to the other performance categories for those eligible clinicians deemed exempt from ACI. ASTRO urges CMS to shift the entire 25 percent weight to the Improvement Activities Category. This would make a more even distribution of the two remaining categories of Quality (60%) and IA (40%). As previously mentioned, we believe that category has the the most potential for advancing value based care. Cost Performance Category In the final rule, CMS reduced the weight to zero for the Cost Performance Category in ASTRO appreciates this decision and urges CMS to consider continuing with this weight through Providing eligible clinicians with two years of performance data based on the other three categories, could benefit the MIPS program by demonstrating how costs can be

6 Page 6 reduced due to the application of quality measures, improvement activities and CEHRT utilization. This information will be valuable in determining how to appropriately apply the cost category in the future to further track and reduce spending while maintaining high quality care based on an established baseline. Alternative (APMs) MACRA mandates that Qualifying APM Participants (QPs) who participate in eligible Advanced APMs or Other Payer Advanced APMs receive incentive payments. The final rule confirms much of the proposed criteria for the incentive payment program and finalizes the definitions, requirements, procedures and thresholds of participation governing the program. ASTRO remains concerned about the complexity of the APM program, although some changes were made to simplify requirements and encourage participation among broad ranges of specialties, including radiation oncology. ASTRO will continue to devote resources to support the development and adoption of radiation oncology-focused APMs that meets the CMS criteria. As established in MACRA, Advanced APMs must adopt CEHRT; provide for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS; and either bear financial risk for monetary losses that are in excess of a nominal amount or be a Medical Home Model. CEHRT must be used by eligible practitioners to meet the Meaningful Use objectives and measures in specific years. In the final rule, CMS recognizes the need for MIPS eligible clinicians and Advanced APM participants to use the same EHR systems. ASTRO appreciates the Agency s decision to align the definition of CEHRT in both programs. Additionally, CMS modified its CEHRT adoption requirement, which would have increased the eligible clinician adoption rate over a period of time. The final rule requires CEHRT adoption by 50 percent of eligible clinicians participating in Advanced APMs. ASTRO appreciates this decision as it aligns with our recommendation that CMS maintain the adoption threshold at 50 percent. In the final rule, CMS recognized that for Advanced APM measures to be comparable to MIPS measures, the measures should have an evidence-based focus and, as appropriate, target the same priorities (for example, clinical outcomes, use and overuse). Advanced APMs must include at least one of the following types of measures provided that they have an evidence-based focus and are reliable and valid: Any of the quality measures included on the proposed annual list of MIPS quality measures (Include at least one outcome measure if an appropriate measure exists); Quality measures that are endorsed by a consensus-based entity; Quality measures developed under the CMS Quality Measures Development Plan; Quality measures submitted in response to the MIPS Call for Quality Measures; or Any other quality measures that CMS determines to have an evidence-based focus and be reliable and valid.

7 Page 7 ASTRO appreciates CMS willingness to clarify that MIPS-comparable quality measures can include QCDR measures provided that QCDR measures used by an Advanced APM for payment have an evidence-based focus and are reliable and valid. CMS finalized its financial risk standard as proposed. To be an Advanced APM, an APM must provide that, if actual expenditures for which an APM entity is responsible under the APM exceed expected expenditures during a specified performance period, CMS can withhold payment for services to the APM Entity or the APM Entity s eligible clinicians; reduce payment rates to the APM Entity and/or the APM Entity s eligible clinicians; or require the APM Entity to reimburse CMS. ASTRO appreciates CMS decision to revise the nominal financial risk construct in the final rule. The complex application of a marginal risk and a minimum loss rate were replaced with a more straightforward approach based on total cost of care benchmarks. There are now two pathways for an APM to meet the Advanced APM nominal amount standard: 1) for performance periods in 2017 and 2018, 8 percent of the average estimated total Medicare Parts A and B revenues of participating APM Entities (the revenue-based standard); or 2) for all performance periods, 3 percent of the expected expenditures for which an APM Entity is responsible under the APM. For episode payment models, expected expenditures means the target price for an episode. These are the total amounts that an APM Entity potentially owes CMS or foregoes under an Advanced APM. CMS intends to increase the revenue-based nominal amount standard for future performance periods. CMS seeks comment on the amount and structure of the revenue-based nominal amount standard for QP Performance Periods in 2019 and later. Specifically, the Agency is seeking comment on 1) setting the revenue-based standard for 2019 and later at up to 15 percent of revenue; or 2) setting the revenue-based standard at 10 percent so long as risk is at least equal to 1.5 percent of expected expenditures for which an APM Entity is responsible under an APM. ASTRO urges CMS to reconsider any efforts to increase the revenue-based nominal amount in the future. Advanced APMs will need adequate time to mature and develop before increases in nominal risk should be considered. This is especially important in light of the fact that CMS has not included any recognition of the business risk or the investments necessary to establish an Advanced APM in its consideration of nominal financial risk. While ASTRO appreciates that CMS recognizes that business risk and investments are a valid issue, we are disappointed that the Agency wants to explore ways to increase the nominal amount at risk in the future, without giving this particular issue consideration first. Additionally, ASTRO urges CMS to consider the variation in costs associated with operating a physician practice Radiation oncology clinics that have extremely high fixed costs and urges that to be recognized. Fixed and variable costs differ by practice type. Practices with significant fixed costs have limited variable costs, which is where the most savings can be generated. Radiation oncology clinics are an example of a practice type in which the ratio of fixed costs far exceeds variable costs. The total capital required to open a freestanding radiation oncology center is approximately $5.5 million. These facilities require an

8 Page 8 additional $2 million in annual operating and personnel expenses. These significant fixed investments far outweigh the variable costs of operating a radiation oncology clinic and should be given consideration as part of any alternative payment model nominal risk adjustment. While it is important to reduce the cost of care and drive value in healthcare, it is also important to ensure that efforts to generate savings do not cause access to care issues for those specialties with high fixed costs. Physician Focused Payment Model (PFPM) The final rule confirms the criteria for evaluating Physician Focused (PFPM). The Physician Focused Payment Model Technical Advisory Committee (PTAC) is expected to review, comment on and provide recommendations to the Secretary of HHS regarding PFPM presented by specialty societies and other stakeholder groups. In the final rule, CMS states that while the PTAC serves an important advisory role in the implementation of PFPMs, there are additional considerations that must be made by the Secretary beyond what is provided by PTAC, such as competing priorities and available resources. Additionally, CMS confirmed that the decision to test a model recommended by the PTAC would not require submission of a second separate proposal to CMS. CMS also confirmed that stakeholders can propose PFPMs as either Advanced APMs or other APMs that lead to better care for patients, better health for communities and lower health care spending. ASTRO appreciates this clarification and urges CMS to continue providing specialty societies and other stakeholder groups with more information regarding the collaborative role that the PTAC will have with CMMI on the review and consideration of PFPM applications. ASTRO appreciates the opportunity to provide CMS with comments on the Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models final rule. Any questions regarding our comments can be submitted to Anne Hubbard, Director of Health Policy, at anne.hubbard@astro.org or Sincerely, Laura I. Thevenot Chief Executive Officer