Dear Acting Administrator Slavitt,

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1 June 27, 2016 Mr. Andy Slavitt, Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C Re: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models (CMS-5517-P) Dear Acting Administrator Slavitt, Families USA appreciates the opportunity to offer comments on the proposed rule: Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models (CMS P). Families USA is a national, non-partisan, non-profit consumer advocacy organization dedicated to the achievement of high quality, affordable care for all in this country. We commend the Centers for Medicare & Medicaid for its commitment to delivery system and payment reform initiatives that improve health care outcomes and beneficiary experiences while lowering costs. We believe the proposed Merit-Based Incentive Payment System and Advanced Alternative Payment Model Incentive include many improvements that will help accelerate the movement towards value-based care and greater participation in alternative payment models. We offer the following comments and recommendations to strengthen the proposed rule. We look forward to continued work with CMS on implementing these provisions and other payment and delivery reform efforts. If you have any questions about our comments and recommendations, please contact Ellen Albritton, Policy Analyst, at ealbritton@familiesusa.org. Sincerely, Ellen Albritton, Policy Analyst Families USA

2 Families USA shares CMS s commitment to accelerating the transition from volume to value. We agree that alternative payment models hold great promise for improving care quality and value, as well as improving health outcomes for patients and ensuring the long-term sustainability of the health care system. We applaud CMS for their commitment to this goal and believe that the proposed Merit-Based Incentive Payment System (MIPS) and the Advanced Alternative Payment Model Incentive (Advanced APMs) programs are a strong step in the right direction. Our recommendations stem from a desire to ensure that as we accelerate the movement of providers into Advanced APMs we also ensure that the right structures are in place to protect consumers, to incent providers to deliver the highest-value care, and to align these incentives across payers to promote improvements across the health care system. However, we see clear opportunities to build on the proposed rule to ensure that it truly meets the goals of the statute, as well as the goals of CMS, and creates a true, meaningful guide path to move providers from MIPS into Advanced APMs. We want to ensure that the rule creates strong incentives for ready providers to move into Advanced APMs, to ensure that there aren t competing financial incentives for high performing providers to stay in MIPS. We believe that CMS has the opportunity to strengthen the rule in several key ways to ensure that incentives are aligned to promote greater participation in Advanced APMs and to ensure Advanced APMs are driving improvements in care quality and value across the health care system. These recommendations include: Increased consumer engagement in the design and implementation of Advanced APMs Greater focus on patient-centered care delivery models to support Advanced APMs in improving quality while being accountable for the costs of care Developing polices to accelerate movement to Advanced APMs for providers currently in APMs this may require changing APM structures to allow providers to move into an Advanced APM more rapidly than the current APM structure might allow Consider setting limits on the number of years that providers can stay in the MIPS APM track without moving towards participating in an Advanced APM model. Without time limits, some high performing providers may see greater financial benefit from remaining in the MIPS track rather than moving forward in to the Advanced APM track Prioritize developing new Advanced APM models that meet the Medical Home Model criteria and are primary care centric. This is critical to ensure primary care providers have meaningful opportunities to participate in Advanced APMs Strengthen Advanced APM standards to ensure that they all place meaningful emphasis on quality improvement and care transformation. Our additional comments and recommendations below aim to strengthen this rule further, and focus on the following areas: Greater alignment between the four MIPS performance categories to help drive greater improvement in quality, outcomes, and cost, and to put providers on the path to accepting more accountability for the total cost of care in APMs Strengthened reporting requirements to ensure continuous quality improvement that is meaningful to patients and their caregivers

3 Increasing the focus on health equity throughout each of the components of MIPS and APMs Merit-Based Incentives Payment System Quality Performance Category In order to drive quality improvement, quality measurement and reporting must measure things that are clinically meaningful and should emphasize outcomes over process measures. Quality measurement should also incorporate patient experience measures and patient-reported outcome measures (PROMs), as the way people experience care and how well their care is helping them to achieve their own goals is paramount to ensuring care is patient-centered. Quality measures should also be disaggregated by race/ethnicity, gender, gender identity, sexual orientation, age, and disability status Quality Data Submission Criteria Submission Criteria Submission Criteria for Quality Measures Excluding CMS Web Interface and CAHPS for MIPS We appreciate providers concerns that previous quality reporting requirements to report nine measures and to report measures in each of the domains identified in the National Quality Strategy (NQS) were not aligned with the availability of applicable, clinically meaningful measures. We also understand that previous all-or-nothing approaches to quality reporting may have discouraged some providers from engaging in quality measurement and reporting efforts. In response to these concerns, we believe that CMS has proposed the quality performance category with a sufficient amount of flexibility to ensure that all providers have the opportunity to participate and be successful in MIPS. The development of new, clinically meaningful quality measures is imperative to ensure that all provider types, including those brought into MIPS in future years, are able to report on a sufficient number of quality measures that address the different domains of the NQS and that can drive quality improvement across the entire health care system. (See below for our comments on the measure development process.) As these new measures are being developed, we encourage CMS to ensure quality measure reporting parity as much as possible across different specialties and providers through already available measures. Additionally, we recommend that providers with fewer than six applicable measures be required to report cross-cutting measures, in addition to any applicable measures, to reach the six measure minimum. The cross-cutting measures in Table C of the proposed rule are aligned with priority areas for improved quality measurement, such as care coordination, patient safety, and population health, and are applicable across the health care system. Reporting these cross-cutting measures will give these providers valuable experience in quality measure reporting, and will ensure that all providers in MIPS are held to similar standards in the quality performance category.

4 We agree with CMS that outcome measures are more valuable than clinical process measures and are instrumental to improve the quality of care that patients receive, and we are pleased that eligible clinicians (ECs) must report at least one outcome measure. As more outcome measures also become available, we strongly support CMS s plans to increase the required number of outcome measures and the overall number of high priority measures that ECs must report. Furthermore, intermediate outcome measures should only be counted as outcome measures if there is a strong evidence base supporting the intermediate outcome as a valid predictor of outcomes that matter to patients. We also commend CMS for including underuse measures in the category of appropriate use. Underuse of evidence-based clinical interventions can be as harmful to a person s health as overuse of services and can illuminate important disparities in the delivery of care. As CMS continues the move towards value-based payment where providers are accountable for the cost of care, we encourage CMS to focus efforts on the development of underuse measures that can serve as a consumer protection for ensuring that providers are not limiting access to needed care in order to reduce costs. As the quality performance category incorporates more outcome measures, we also recommend that CMS focus on developing and incentivizing the use of PROMs, as these measures provide the best way to assess how well providers are delivering care in a way that meets the specific needs and goals of their patients. PROMs are particularly important for measuring and improving the quality of care delivered to patients nearing the end of their lives or experiencing a health condition that will not improve clinically. We support requiring ECs to report at least one cross-cutting measure. Reporting on these measures helps to drive patient-centered care, regardless of population, health condition, or medical specialty. Having measures that can span across the health system are particularly important for assessing and improving the care of individuals with multiple chronic conditions and they can help advance a team-based approach to care. We also support CMS s proposal to allow ECs to report on more than six measures and to be scored on only the top six measures on which ECs perform the best. This approach can encourage ECs to engage in quality improvement activities tied to additional measures they choose to report. Overall, this will also give providers additional experience with quality reporting and will prepare them to be successful in the quality performance category as requirements for additional measures or for a higher number of high priority measures are incorporated into MIPS. We strongly encourage CMS to require that all reported quality measures be stratified by demographic characteristics such as race, ethnicity, gender, gender identity, sexual orientation, primary language, and disability status. Where possible, we also recommend that these characteristics be broken down into subgroups to capture the most meaningful data. This type of stratification is essential to the identification and ultimately the reduction of disparities in care and health outcomes and is foundational to transforming our health care system into one that provides high quality care to traditionally underserved communities.

5 We appreciate the careful consideration CMS is giving to the issue of additional riskadjustment for quality measures. As both public and private payers increasingly move to pay providers based on the quality of care they provide and the overall health of their patients, we remain concerned about how these new payment models may adversely impact safety net providers and others who provide critical care to patients whose health is adversely impacted by poverty, discrimination, and other barriers to needed services. We look forward to reviewing the Office of the Assistant Secretary for Planning and Evaluation s (ASPE) report to Congress on this issue, and we encourage CMS to carefully consider the findings and recommendations in this report, as well as the various approaches to risk adjustment, which may include: adjusting for socio-economic status, comparing providers of similar size and/or type to other providers like them, and adjusting for geographic variation. We also encourage CMS to engage with safety net providers, community-based organizations, and other key stakeholders in determining the best approach to riskadjustment. We are pleased with the announcements CMS has already made regarding available technical assistance and other resources for small practices, and we encourage CMS to make continued assistance available to small practices, those located in rural areas and health professional shortage areas, and those who serve high numbers of vulnerable patients. Performance Criteria for Quality Measures for Groups Electing to Report Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey Patients and their caregivers are the best sources of information about the quality and experience of the care they are receiving. For this reason, patient experience measures must be a part of measuring the overall quality of care, and we commend CMS for including this type of measure as one of the high priority measures under MIPS and for including a bonus point for reporting CAHPS. As CAHPS is currently the best tool we have to assess experience of care, we believe CAHPS should continue to be required for all practices with at least 100 ECs, as it was under PQRS. Given the importance of patient experience measures, we also urge CMS to work with other stakeholders to improve upon CAHPS and/or develop additional tools for measuring patient experience. For example, we believe certain supplemental item sets, such as Cultural Competence, reflect areas of significant importance to patients and their families and should be included beyond just the core CAHPS survey. Additionally, we encourage CMS to consider ways to make CAHPS easier for patients to complete, including different options for how it is administered and employing skip logic to reduce its redundancy, and to make it more meaningful to providers, such as by disaggregating by different types of patients. It is unclear in the proposed rule if providers who choose to report CAHPS still have to report an outcome measure. We hope CMS can clarify this in the final rule, and we strongly encourage CMS to require that providers reporting CAHPS still submit an outcome measure, if one is available.

6 Data Completeness Criteria We agree with CMS that including all-payer data, where possible, provides a more complete picture of each MIPS eligible clinician s scope of practice and provides more access to data about specialties and subspecialties. Including all-payer data also creates an opportunity to push quality improvement and value-based strategies throughout the entire health care system. However, we do have concerns that including all-payer data, combined with the amount of flexibility some providers have in choosing which quality measures to report, may end up obscuring the quality of care actually received by Medicare beneficiaries. For example, as proposed, qualified clinical data registry (QCDR), qualified registry, and electronic health record (EHR) submissions must only contain a minimum of one quality measure for at least one Medicare patient. Given the unique health needs and vulnerable situations of many Medicare patients, we recommend CMS implement additional requirements or safe guards for the inclusion of all-payer data to ensure the quality of care for Medicare beneficiaries is being accurately measured and continues to improve. We support CMS raising the data completeness thresholds above what was required under PQRS and increasing these thresholds even higher in future years of MIPS, as this helps guard against any selection bias that might exist and gives a more complete picture of the provider s performance. Application of Quality Measures to Non-Patient-Facing MIPS Eligible Clinicians Recognizing that non-patient-facing MIPS ECs may not currently have any applicable crosscutting measures, we encourage CMS to work with other stakeholders to develop such measures that would apply to these clinicians. Even though they may not see patients themselves, these clinicians still play an important role in ensuring the delivery of safe, appropriate, high-quality care. We support allowing non-patient-facing clinicians to report through a QCDR that can report non-mips measures, but refer you to our comments below on the approval of such measures for additional comments. Global and Population-Based Measures Global and population-based measures present an important opportunity to continue the movement away from payment based on a fee-for-service model and towards alternative payment models that focus on the total cost of care and accountability for quality health care delivery at all levels of the health care system. These measures promote greater care coordination and the integration of social and community-based services, particularly for chronic conditions that have a major impact on the cost of care and beneficiaries quality of life. For these reasons, we strongly support CMS s inclusion of the acute and chronic composite measures and the all-cause hospital readmission measure. Annual List of Quality Measures Available for MIPS Assessment We support adding the Medicaid Adult Core Set to MIPS, which is particularly important for people dually enrolled in Medicare and Medicaid who have greater need and higher costs.

7 Including this and other core sets, and incentivizing their use, can help to align quality improvement efforts across models and payers. Exceptions for QCDR Measures We support CMS s proposal for non-mips measures in QCDRs to go through a rigorous CMS approval process during the QCDR self-nomination period, and we encourage CMS to engage in a multistakeholder process as part of this approval process. Patients, physicians and other types of providers, and consumer groups have important and unique perspectives that should be incorporated to ensure that measures are addressing issues of importance to patients and their families. Patient representatives who are engaged should be supported with resources and technical assistance by CMS so that they can participate fully and feel empowered to provide their input. Consultation with Relevant Eligible Clinician Organizations and Other Relevant Stakeholders We encourage CMS to engage as broad array of stakeholder organizations as possible in the measure review and selection process. Provider groups, including nurses, physician assistants, nurse practitioners and others should be included. Patient and caregiver representatives should also be included. They have a unique perspective to bring to the process and are the best source of information for what kinds of measures are meaningful to them. Patient representatives who are engaged should be supported with resources and technical assistance by CMS so that they can participate fully and feel empowered to provide their input Resource Use Performance Category Families USA agrees with CMS that measuring resource use is an integral component of measuring value and we are generally supportive of the approach CMS has taken to capturing resource use. We also agree that one clear goal of measuring resource use is to provide physicians and groups with actionable information that can help improve the quality and value of care they deliver. Broadly, we encourage CMS to consider resource use performance as measurement of appropriate care delivery, rather than solely focusing on high-cost care episodes and the potential for overuse of certain health care services or procedures. While we do not disagree with the approach to measure resource use in part through episode-based care and total cost of care measures, we strongly urge CMS not to rely on episode-based measures in lieu of total per capita cost measures for populations with specific conditions (as used by the Value Modifier (VM) Program). As such, we offer a recommendation for improving this approach below. We support CMS s plan to incorporate new measures as they become available, and look forward to working with CMS and other stakeholders to further advance and refine resource use measurement. Additionally, we support CMS s plan to incorporate through future rulemaking recommendations from the ASPE study on the issue of risk adjustment for socioeconomic status (SES) on quality measures and resource use. While there is good evidence to suggest a correlation between SES and resource use, we agree that the ASPE study will help to provide a more definitive path forward for application of risk adjustment for SES in the Medicare program.

8 In developing the final rule we encourage CMS to consider further how resource use measurement can be better aligned with quality reporting, clinical practice improvement activities, and advancing care information. We believe that the four MIPS performance categories should work in concert to ensure that care is high-quality, high-value, and produces the best outcomes for patients. Where possible, we encourage CMS to identify opportunities for aligning these performance categories to ensure a complete picture of practice activities. Additionally, we encourage CMS to consider how the structure of resource use reporting can help support a glide path for MIPS clinicians into the advanced APM track, providing the necessary information to ensure their success in the track, as well as the right incentives to ensure that the rule truly meets the goals of moving the Medicare program from volume to value. Resource Use Criteria (a) Value Modifier Cost Measures Proposed for the MIPS Resource Use Performance Category Families USA strongly urges that CMS change the resource use criteria to include the four total cost of care measures for condition-specific groups from the VM program in addition to the total cost of care, Medicare spending per beneficiary (MSPB) measures, and episodebased measures. We do not support CMS s proposal to measure performance for conditionspecific groups solely through episode-based measures of care. By eliminating the four condition-specific total cost of care measures under the VM (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus) CMS misses a critical opportunity to capture the full breadth of resource use for chronic diseases with high incidence in the Medicare population. Without accurately capturing the full scope of care for individuals with specific conditions beyond acute care interventions, providers cannot accurately assess their performance in consistently delivering high-quality, high-value care to these individuals. Additionally, a focus on episode-based resource use, rather than an emphasis on total cost of care, runs counter to the goals of value-based alternative payment models and may fail to ensure that MIPS providers are appropriately prepared to succeed in the Advanced APM track. Furthermore, primary care has a central role in the long-term management of chronic disease to prevent progression. Without accurate measures to capture the full scope of resources necessary to manage chronic disease, inclusive of primary care, we cannot ensure that beneficiaries are receiving the right care for their needs. As such, we urge CMS to reincorporate these measures into the resource use performance category in the final rule Clinical Practice Improvement Activity Category The inclusion of the clinical practice improvement activities (CPIAs) in MIPS can help drive a patient-centered approach to continuous quality improvement and to delivery system reform that can not only improve health outcome and reduce costs in MIPS, but that also helps prepare providers to be accountable for the total cost of care and to participate in alternative payment models. In order for this to happen successfully, all clinical practice improvement activities

9 should be evidence-based, and, in future years, should be measured in a way to ensure they are actually improving care. Contribution to Composite Performance Score (CPS) We support CMS requiring that practices must do more than attest to being a medical home by requiring practices to be also be accredited as a medical home by the proposed bodies. However, as the medical home model continues to spread, we encourage CMS to in future years allow accreditation through additional bodies, such as a state Medicaid programs, as long as the accreditation criteria remain substantially similar. Additionally, we recommend that in order to continue receiving the highest score possible in this performance category, that practices undergo regular re-accreditation by these bodies to ensure they are continuing to provide care in a manner consistent with being a medical home CPIA Data Submission Criteria Submission Mechanisms We are very supportive of CMS using administrative claims wherever technically feasible in order automatically count any CPIAs captured in these claims. By reducing reporting burden, ECs may be incentivized to choose CPIAs that can be captured in this way, increasing the overall number of activities that are reported with more than just attestation. Weighted Scoring With such a diversity of CPIAs that providers can choose from, it is clear that some of these activities require more time, effort, and investment from providers to implement, and these are the activities that typically have more potential to bring about true practice transformation. Providers who choose to pursue these activities, should be rewarded with higher weights for doing so. Similarly, some activities will be much easier for providers to undertake, and these activities, taken alone, would not produce a transformation in the delivery of care. By assigning these activities a lower weight, providers will have to do more of these activities, and this additional experience with CPIAs may help prepare practices to do higher-weighted CPIAs in the future. We are supportive of the current high and medium tiers, and we recommend CMS to consider adding a lower tier for future performance periods if it appears some medium tier activities have been too highly weighted. Required Period of Time for Performing an Activity We strongly urge CMS to reconsider the 90-day minimum for performing an activity and to instead require that these activities be performed throughout the entire performance year. We recognize that some of the listed activities are episodic and will not be performed on a daily basis, but the episodes of these activities should still be performed throughout the year. A 90-day minimum for clinical practice improvement activities is not consistent with patientcentered medical home principles or with what it takes for practice transformation to occur. We recognize 90 days is a commonly used length of time for conducting quality improvement (QI) cycles and that there is evidence to support this amount of time as a best practice for

10 conducting such efforts. However, the clinical practices targeted for improvement by these QI initiatives are not designed to end after the 90 days, but instead to continue forward as part of the clinical workflow so that any improvement in the quality of care and/or health outcomes is sustained. For example, the development of a care plan can lead to significant improvements in the quality and the experience of care, but the care plan will fail to be useful if it is not updated as necessary and used consistently in caring for a patient. The requirements for clinical practice improvement activities should reflect the goals of not only improving care, but sustaining those improvements. Application of CPIA to Non-Patient-Facing MIPS Eligible Clinicians and Groups We support increasing the requirements in this category for non-patient-facing clinicians and groups as more activities are identified. Even clinicians who are non-patient-facing play an important role in ensuring the safety, effectiveness, and appropriateness of the care that is provided. Special Consideration for Small, Rural, or Health Professional Shortage Area Practices We are supportive of CMS taking into consideration the challenges that small, rural, and health professional shortage area practices may face in conducting clinical practice improvement activities. We encourage CMS to continue to make additional resources and technical assistance available to these practices to help offset upfront costs and to help ensure they can be successful in this performance category, with the goal of increasing the minimum number of required activities over time. Just as CMS engaged with high performing practices of these types in determining the proposed special consideration, we also encourage CMS to engage with practices that may not be as high performing to help understand the particular challenges that have kept them from higher performance CPIA Subcategories We are pleased with CMS s inclusion of additional subcategories, particularly the subcategories of Achieving Health Equity and Integrated Behavioral and Mental Health. We also strongly support the inclusion of Social and Community Involvement as another subcategory. Given the large influence non-clinical factors have on a person s health, it is imperative for providers to create strong linkages with social and community-based services and to ensure that providers adequately understand the unique challenges or barriers to care and good health their patients are facing. This is especially true for providers caring for vulnerable patients, and incentivizing providers to create these linkages can help providers address health disparities. Activities in this category should include employing community health workers (CHWs) or integrating CHWs employed by community-based organizations into care teams, establishing a community advisory council, and creating formal linkages with social services providers and communitybased organizations.

11 CPIA Inventory As the inventory of CPIA activities for the 2017 performance year is finalized, and as the inventory is updated for future performance years, we encourage CMS to focus on those activities for which there is an evidence-base for improving the quality or experience of care. We are also concerned about the lack of specificity for many of the provided clinical practice improvement activities. We recognize that some amount of flexibility is desirable so that these activities can be implemented in a variety of different settings and so that providers can undertake these activities in a way that is most meaningful for their particular patient population. However such broadly defined activities may lead to ECs getting points for conducting activities in a very minimal way that fails to meaningfully improve care, or in a way that lacks fidelity to the core elements of an activity that are necessary for it to be successful. We want to ensure these activities do not become merely check the box requirements, but instead help move practices towards more high-quality, patient-centered care. As one example, the Care Coordination subcategory includes the following activity: Implementation of regular care coordination training. Though we strongly support improving care coordination, we are concerned that such a broadly defined activity could lead to providers or practices not using an evidence-based training, not implementing the training with high fidelity, or conducting it too infrequently, given the vague requirement for regular training. If not done well, care coordination training is unlikely to lead to or help sustain improvement in the quality or experience of care. Including more details for this activity regarding currently available care coordination training models or core elements that need to be included in care coordination could also make this activity more attractive to providers who may be unsure of how to conduct care coordination trainings We also find the lack of minimum thresholds of many activities concerning, and we strongly encourage CMS to establish such thresholds for clinical practice improvement activities. Though we recognize that requiring all patients served by a provider or practice to be reached by these activities is likely not a possible, or even an appropriate, standard, particularly in the first performance year. However, we do believe that providers should only be rewarded for the activities they perform that can improve the quality and experience of care for a meaningful number of patients. For example, we recommend establishing a minimum percentage of patients who request and are able to get same or next day appointments in order for providers to get credit for this activity in the Expanded Practice Access subcategory. Similarly, in the Achieving Health Equity category, we encourage CMS to establish a minimum number or percent of total patient population in order for providers to get credit for Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare. Establishing such minimums will help reinforce these activities as more than check the box measures.

12 We also offer the following comments on the clinical practice improvement activities subcategories: Expanded Practice Access o Recommend that CMS clarify that activities in this subcategory must include access to a patient s medical record. This ensures that patients can feel confident that any providers they meet with through the use of telehealth services, services provided at alternate locations, and related activities designed to increase access to care are able to provide them safe, high-quality care. o Recommend that Collection of patient experience and satisfaction data on access to care and development of an improvement plan, such as outlining steps for improving communications with patients to help understanding of urgent care needs be moved to the Beneficiary Engagement subcategory. Though we are supportive of this activity, it does not actually create increased access for patients, as all other activities in this subcategory do, and it aligns well with activities in the Beneficiary Engagement subcategory. Population Management o Encourage CMS to change Take steps to improve healthcare disparities to a highly weighted activity. o Encourage CMS to explicitly include community health workers as an outreach strategy for proactive management of patients with chronic conditions Care Coordination o Recommend CMS explicitly include community health workers as a pathway to neighborhood/community-based resources Achieving Health Equity o Recommend CMS engage with practices who have proven success in reducing health disparities in order to provide more options for activities in this subcategory. Since reducing disparities is imperative for improving care quality, there should be more options to make it easier for providers to choose an activity from this subcategory. Emergency Response and Preparedness o Strongly recommend the exclusion of the following activity: Participation in domestic or international humanitarian volunteer work. Participating in humanitarian volunteer work, whether in the United States or abroad, is very unlikely to lead to improvements in the quality or experience of care for a provider s patients.

13 CMS Study on CPIA and Measurement Study Purpose We are very supportive of CMS s plan to conduct a study to examine clinical quality workflows and data capture using a simpler approach to quality measures. We also encourage CMS to use this study as an opportunity to explore additional methods, beyond attestation, that providers can use to report on the clinical practice improvement activities they conduct and the effectiveness of those activities. CPIA Policies for Future Years of the MIPS Program Request for Comments on Call for Measures and Activities and Process for Adding New Activities and New Subcategories Central to the addition of any new activities or subcategories should be evidence that those activities lead to improved quality or experience of care for patients and their caregivers. We also reiterate our comments above about adding new quality measures to the process for adding new activities: We encourage CMS to engage as broad array of stakeholder organizations as possible in the review and selection process for new activities. Provider groups, including nurses, physician assistants, nurse practitioners and others should be included. Patient and caregiver representatives should also be included. They have a unique perspective to bring to the process and are the best source of information for what kinds of quality improvement activities are meaningful to them. Patient representatives who are engaged should be supported with resources and technical assistance by CMS so that they can participate fully and feel empowered to provide their input. Request for Comments on Use of QCDRs for Identification and Tracking of Future Activities We are supportive of using QCDRs to identify and track future activities. For those activities that did not originally appear on CPIA inventory, we encourage CMS to engage in a rigorous validation and review process that includes robust engagement from multiple stakeholders Advancing Care Information Performance Category We believe that health information technology (HIT) is a useful tool for both improving care delivery and engaging the patient in their own health care. These tools can also support consumers by allowing them to track, manage, and assert preferences for their own care. With these priorities in mind, we support CMS s focus on interoperability, care coordination, and patient engagement through Advancing Care Information. While we believe that this rule represents a positive step in the right direction, we urge CMS to ensure that advancing care information requirements and measures become more robust over time. We also encourage the development of new measures that may better capture patient preference and experience using health IT.

14 Clinical Quality Measurement Full-year reporting period We view efforts to provide consumers with accessible and accurate health information as an ongoing process, so we are supportive of the requirement for a full calendar year of reporting. Reporting Requirements & Scoring Methodology Base Score Under the new criteria for eligible clinician under MIPS, many clinicians will be graded on health IT utilization for the first time. We recognize the need to accommodate newly eligible clinicians and appreciate flexibility within the ACI category to grade clinicians on having the technology to report health IT performance measures. However, we believe that the "one patient threshold" for reporting all measures in the base score is far too low. In subsequent MIPS performance years, there should be a high expectation for all eligible clinicians to use health IT routinely and with high proficiency to supplement their care delivery. The requirement, as currently constructed, does not drive use of health IT and may hinder consumers ability to use their health information. Such a low threshold essentially creates check-the-box process measures for health IT rather than encouraging substantial uses. Measuring performance for a single patient or encounter is hardly representative of whether providers are robustly using health IT to improve patient care and outcomes. We strongly encourage CMS to increase the threshold for the base score measures to five percent starting in reporting year A minimum standard of five percent is well below or equal to all Meaningful Use thresholds for 2017, and signals a genuine expectation by CMS that organizations make the process changes necessary to support electronically-enabled care. Additionally, CMS should consider increasing the weight of the performance score relative to the base score, to further emphasize performance on high-value and person-centered uses of health IT. Performance Score With respect to the performance score, we strongly support the prioritization of measures that promote the policy objectives of interoperability, care coordination and patient and family engagement. These measures have great potential to improve the quality, efficiency and experience of care. Consumers need a comprehensive and accurate view of their health and health care, and they should be able to direct their health information based on personal preferences. We support the inclusion of measures that assess individuals use of online access to their health information and secure exchange with care team members. In future years, we suggest that CMS reward clinicians for improvement through bonus points. Specifically, we recommend that clinicians who increase their ACI performance score by five percentage points or more would receive two bonus points to be added to their total ACI performance score. Comparison of providers total ACI scores over time gives providers the flexibility to experiment with health IT functionalities (and specific measures) in the ways that make the most sense for their practices and patient populations.

15 MIPS Scoring Methodology Scoring the Quality Performance Category Quality Measure Benchmarks We support CMS s proposal of excluding reported measures with a performance rate of 0 percent from the benchmarks. We agree that this would skew the benchmarks and would do so in a way that could lead to performance scores being higher than they should be. We are also supportive of CMS s plan to score measures that are new to MIPS or lack a historical benchmark for other reasons. Not doing so would significantly delay the scoring of badly needed new measures, such as those for population health or care coordination. Assigning Points Based on Achievement We are very supportive of the overall approach to assigning points based on achievement, and we believe that scoring the quality performance category to account for achievement is an important step in going beyond simply a pay for reporting program. Ensuring that providers are paid, in part, on their performance on quality measures and not just for reporting measures is a key element in helping providers to prepare for taking on increased financial risk in alternative payment models. Though we are supportive of CMS s proposed approach to scoring topped out measures differently, we are concerned that approximately half of the MIPS quality measures are topped out and that several have a median score of 100%. We encourage CMS to consider ways to discourage providers from reporting or placing limits on the number of topped out measures clinicians can report, and to remove at least some topped out measures in a systematic way moving forward. Additionally, in future years we strongly encourage CMS to incorporate health equity into a provider s quality achievement score. Delivering high quality care to every patient, regardless of who they are, must be a part of any payment and delivery reform efforts. Case Minimum Requirements and Measure Reliability and Validity Since providers will be aware of the case minimums ahead of time and are able to choose which quality measures they report, we are concerned that holding harmless those providers who report measures that do not meet the case minimum may lead to gaming of this performance category. We encourage CMS to implement a strict validation and review process and to establish safeguards, such as a limit on the amount of measures that can be reported below the case minimum while still being held harmless. Incentives to Report High Priority Measures Given the importance of outcome measures and patient experience measures, we support CMS in awarding two bonus points for reporting additional measures in these categories, and of awarding one bonus point for reporting additional other high priority measures.

16 Measuring Improvement Broadly, we are supportive of incorporating improvement into the overall quality performance score. Doing so not only ensures that providers who make large gains in their performance can be rewarded, but also fosters an expectation of continuous quality improvement, even for the highest performers. We are most supportive of the second of CMS s proposed options for incorporating improvement. By layering bonus points on top of the provider s performance score, both performance and improvement will be factored into the overall score. Scoring the CPIA Performance Category Calculating the CPIA Performance Category Score Overall, we encourage CMS to consider how performance in the CPIA category may be better aligned with the other MIPS performance categories. We believe the greatest potential for meaningful practice transformation and quality improvement and the best way to prepare providers to take on more risk in alternative payment models is to align their use of health IT and implementation of CPIAs with their performance on quality measures and resource use. Greater alignment among the four categories would also help to assess how well specific CPIAs are improving quality, costs, and outcomes. CMS proposes that the practices self-identifications as medical homes or as participating in alternative payment models would be verified as appropriate. Given that medical homes automatically receive the highest possible score in the CPIA category and that participants in APMs automatically receive half of the highest possible score, we recommend that CMS verify each claim of participating in a medical home or APM. We agree with CMS that it important to structure this category in a way that discourages or prevents providers from submitting the same CPIA year after year. We hope that as providers implement these activities and gain more experience with them, that they will become established parts of their workflows, thus allowing them to choose new CPIAs in future years. We also strongly urge CMS to go beyond attestation for this category as soon as possible. Though we understand that this is a new reporting category, we believe that many of the activities in the CPIA inventory already have built-in outputs that could be used to verify that these activities are taking place. For example, many of the activities involve HIT, which would produce some documentation that the activity has occurred. Others involve engaging with Patient Safety Organizations, Quality Improvement Organizations, or other third parties who could verify their partnership with a practice or provider. Finally, as CMS works to incorporate improvement over time into the CPIA category, we encourage CMS to consider how successfully using these activities to reduce disparities can be a part of the improvement evaluation. We appreciate and fully support the inclusion of the Achieving Health Equity subcategory, but ultimately it is not enough for only a few selected activities to be focused on addressing health disparities. Instead, reducing disparities should be a goal of activities across the various subcategories.

17 Public Reporting on Physician Compare We support CMS in publically reporting each provider or group s Composite Performance Score, as well as their scores in each performance category. We also encourage CMS to allow the option for those accessing Physician Compare to drill down even further into providers scores, such as the breakdown between performance and improvement in the quality performance category and relative contributions of the base score and performance scores in a provider s advancing care information category. Providing aggregate information for MIPS will also be useful to consumers and other stakeholders, as it will allow for tracking of which measures and activities, for instance, providers choose to report on over time. We also urge CMS to include measure data stratified by race, ethnicity, and gender, gender identity, sexual orientation, primary language, and disability status whenever this information is available. This type of stratification is essential to having a full picture of variation in quality of care being delivered to different groups across different providers. Advanced Alternative Payment Models (APMs) Overall, Families USA is supportive of the direction CMS is moving with respect to promoting the adoption of Advanced APMs. Our comments below focus on changes that will: 1.) Increase consumer input and involvement in determining the future of Advanced APMs; 2.) Promote participation in Advanced APMs among primary care clinicians and practices; 3.) Create a smoother glide path for MIPS providers/practices who want to transition to Advanced APMs; 4.) Influence design of future Advanced APMs so that they promote primary care as the foundation of a successful model, 5.) Protect Medicare beneficiaries from unintended consequences of performance-based incentives, such as patient selection and underservice. 6.) Ensure that other payer Advanced APM incentives are aligned with Medicare Advanced APMs and drive meaningful quality improvements. Broadly, we recommend that CMS consider how to increase transparency and opportunities for public input into the development of APM models in the future. The relative success of Advanced APMs at driving improvements in care delivery and health outcomes is largely dependent on the underlying care delivery models that are certified under this program. Patients, caregivers, and consumers bring a critical perspective as to how our health care system needs to be reformed to truly meet their needs. They should be seen as key partners in developing new care models, advancing health equity, and improving patient-centered care. We urge CMS to consider developing formal opportunities for public and stakeholder input into the development of future models, including creating opportunities for public comment from all stakeholders, and establishing an advisory committee of patients and consumer advocates to consult in developing new models. Such a committee should play an advisory role throughout the development of a model and not be limited to just providing feedback on how to communicate new care models to consumers after they have been