June 27, 2016
Centers for Medicare & Medicaid Services
Department of Health & Human Services
P.O. Box 8013
Baltimore, MD 21244–8013
Submitted electronically to: www.regulations.gov
To Whom It May Concern:
The Center for Medicare Advocacy (the Center) is pleased to provide the Centers for Medicare & Medicaid Services (CMS) comments on the proposed rule on the Medicare Program Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule (CMS–5571–P).
The Center, founded in 1986, is a national, non-partisan law organization that works to ensure fair access to Medicare and to quality health care. We draw upon our direct experience with thousands of individuals to educate policy makers about how decisions affect the lives of real people. Additionally, we provide legal representation to ensure that people receive the Medicare coverage for which they qualify, and the quality health care they need.
Overall, we appreciate that the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) moves the Medicare program away from the flawed Sustainable Growth Rate (SGR) physician payment formula, and provides an opportunity to change provider incentives through payment mechanisms. Although we generally support the proposed rule’s MIPS and APM Incentive, we have some reservations regarding key aspects of the proposed rule. These concerns are addressed in the comments below.
I. Overarching Comments
While our comments below are separated between those applicable to Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APM), we offer the following overarching comments applicable to both topics.
A. Appropriate Outcome Measures
The Center echoes some of the comments to this proposed rule offered by the Medicare Payment Advisory Commission (MedPAC) in their June 2016 report to Congress. Specifically, incentive payments to physicians under MACRA’s new reimbursement system should be linked to the actual quality of care provided. Throughout our comments, we discuss how outcome measures might be better incorporated into this new system.
A focus on outcome measures, however, should not result in incentives to provide care only to individuals whose condition is expected to improve. Despite the Settlement in the Jimmo v. Sebelius case, which states that therapy and skilled nursing services are appropriate for Medicare beneficiaries in order to maintain an individual’s condition or slow deterioration, the Center continues to hear from beneficiaries who are denied such services because their conditions do not improve. Sometimes an individual’s condition cannot and will not improve; yet skilled nursing and/or therapy are necessary to maintain the individual’s vulnerable condition. Thus, any outcome measures implemented under MACRA must be based on meeting progress toward individually assessed needs, not improvements in the patient’s condition.
B. Socioeconomic Status
The Center applauds CMS for examining the HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) study regarding the issue of risk adjustment for socioeconomic status in quality measures, as required by the IMPACT Act, prior to making any changes to quality measures.
We reiterate our on-going concerns regarding risk adjustment for quality reporting and pay-for-performance programs based on socioeconomic/sociodemographic status (SES/SDS). We believe that adjusting for SES factors could lead to several harmful unintended consequences for disadvantaged patients. First, risk adjustment has the potential to mask existing disparities in care that low income patients receive, rather than expose and address these disparities. Attempting to adjust for, and over-simplify, the complexity of chronic conditions only perpetuates the inequities.
Also, risk adjustment could create two divergent standards of care for healthcare units based on the wealth or poverty of the populations they serve. Adjusting scores for healthcare units with significant proportions of disadvantaged patient populations would in effect lower the bar for healthcare units that treat these populations. This type of adjustment would allow distinct and unequal quality standards for poor patients and wealthy patients. Also, the root of the disparities in care is not likely to be addressed if the differences are concealed through the automatic and inaccurate inflation of performance scores.
We acknowledge that disparities exist between the quality of care delivered to low income populations and that delivered to higher income populations. We also recognize that there are social and economic reasons that require alternative interventions or approaches by healthcare units in order to limit disparities in care for different populations. It is critical to identify those factors, and develop systems to address and seek to overcome the obstacles to high quality care for these populations. Addressing the root causes is foundational in developing and employing changes that target these causes in order to improve care equitably.
We therefore welcome the results of the ASPE study, and look forward to future CMS proposals. We are confident that the proposals CMS will develop based on this ASPE data collection will be aimed at supporting high need patients by addressing health disparities. We therefore applaud CMS for the commitment to ground any possible future changes to the quality system in the data collected by the ASPE study.
We support CMS’ measured approach to incorporating socioeconomic status into quality measures. We look forward to reviewing any future measures and having the opportunity to comment on those measures when proposed.
II. Merit-Based Incentive Program System (MIPS)
The Merit-Based Incentive Program System (MIPS) is the consolidation of
three existing Medicare programs: (1) the Physician Quality Reporting System, (2) the Value-Based Payment Modifier, and (3) the Medicare Electronic Health Record (EHR) Incentive Program. In combining these three pre-existing programs under the MIPS umbrella, CMS is proposing to score eligible physicians, for the purposes of payment, through the use of four weighted performance categories: (1) Quality, (2) Resource Use, (3) Clinical Practice Improvement Activities, and (4) Meaningful Use of Certified EHR Technology. Based on the composite performance score of these four categories, eligible physicians will be subject to a payment increase or decrease of four % in 2019, five % in 2020, seven % in 2021, and nine % in 2022.
Through this framework, CMS envisions that MIPS will incentivize physicians to “engage in improvement measures and activities that have a proven impact on patient health and safety and are relevant to their patient population.” As discussed below, however, the Center is concerned that actual improvements in performance might be jeopardized by the proposal to offer physicians too much latitude in their selection of how they will be measured.
B. Quality Category
The Quality section of the proposed rule would afford physicians “the flexibility to determine the most meaningful measures and reporting mechanisms for their practice.” As a result, physicians will be given the authority to self-select just six measures out of all potential MIPS measures in a given year. In comparison to the current model, the Physician Quality Reporting System already requires physicians to report on at least nine measures. By allowing physicians to self-select so few measures, certain critical measures could be ignored while clinicians emphasize their self-determined strengths. CMS risks rewarding physicians for spotlighting only the positive qualitative aspects of their practices to the detriment of the Medicare program and its beneficiaries. As CMS acknowledges in the proposed rule, physicians could game the system by “report[ing] only on measures for which they have a sufficient sample size.”
Although we acknowledge that not all physician practices are alike and that physicians need a modicum of flexibility in reporting to CMS, we strongly urge CMS to maintain greater control of the reporting under MIPS and to provide more thoroughly defined measurements. Further, we strongly urge CMS to incorporate more reporting requirements that would assess the actual and overall quality of care being provided to beneficiaries.
C. Resource Use Category
While the Center recognizes there may be value in measuring the costs per episode of care or per particular conditions under the MIPS program, any analysis of costs must be coupled with an analysis of patient outcomes and patient needs prior to any determination of what constitutes appropriate funding. Such a holistic weighing of considerations could serve to offset clinician incentives to lower costs at the detriment of patient needs.
The Center welcomes CMS’s recognition that some clinicians have a larger concentration of disadvantaged patients and that resource use measures—derived from administrative claims data—should be adjusted accordingly. Additionally, CMS lists the right kind of risk factors that should be taken into account: a combination of chronic conditions, current health status, recent care utilization, geography, ethnicity, health status, and certain demographic and socio-economic characteristics.  We request, however, clarification on the definitions CMS uses for “socioeconomic and demographic characteristics,” as they are currently undefined. Furthermore, we welcome that MIPS clinicians and their patient pool will be measured relative to their peers. Nevertheless, given that four of the measures applied to administrative claims data measure coronary diseases and diabetes—ailments that especially affect less advantaged groups—it is particularly important that well-designed risk adjustment methods be in place that do not penalize or dis-incentivize clinicians from treating disadvantaged groups. As previously outlined, we support CMS in examining the ASPE study regarding the issue of risk adjustment for socioeconomic status in quality measures, as required by the IMPACT Act, prior to making any changes to quality measures.
D. Clinical Practice Improvement Activities Category
Clinical Practice Improvement Activities (CPIA) have the potential to promote care coordination, meet the health and safety needs of patients, and create greater communication between providers and patients. The CPIA category should lead to sustained transformation and improvement of clinical practice over time. The Center recognizes the potential this category has in future years to improve the quality of care that patients receive. In order for this to come to fruition, the great potential of the CPIA category should be tweaked in future years to better guarantee that the category’s goals can be realistically met.
i. CPIA Measures
The Center seeks clarification from CMS on how clinicians can meet specific measures. The proposed rule should provide specificity to adequately guide clinicians to properly complete the measures and meet goals established by the CPIA category. The following clinician measure demonstrates the current lack of specificity: “Participation in research that identifies interventions, tools or processes that can improve a targeted patient population.” Additionally, what is to stop a clinician from not understanding the following measure and interpreting as he or she sees fit: “Engage patients and families to guide improvement in the system of care”? The Center welcomes the attention CPIA places on health disparities, but the measures relating to this subject are so vague that they could be better served by more specificity. One measure reads as follows: “Take steps to improve healthcare disparities, such as Population Healthcare Toolkit or other resources identified by CMS…Refer to the local Quality Improvement Organization (QIO) for additional steps to take for improving health status of communities.”
In order for clinicians to better understand and reduce health disparities, there should be measures that specifically incentivize the reporting of data that is disaggregated by race/ethnicity, sexual orientation, and gender identity. As in other places throughout the list of CPIA measures, specific examples of clinician mitigation of health disparities would better guarantee that the goal of this measure is achievable.
Another impediment towards the kind of meaningful transformation of patient health that CPIA sets out are the points that clinicians can receive for these many process measures. While a clinician can receive points for conducting a mental health screening, he or she is not judged on how well he or she completes a measure. One solution to this problem might be for measures to be more outcome based and less process based. CMS could also better guarantee how well a clinician performs on a measure by conducting audits that monitor clinician practices.
The lack of effective measures and minimal participation providers may use to satisfy CPIA measures also acts as a barrier to achievement of the program’s goals. Some high-level activities receive 30 points of the required 60 CPIA points and medium activities are worth 20 points. It is possible to do two 30-point activities and meet the CPIA requirement. Moreover, activities only have to be performed for at least 90 days out of 365. Conducting mental health evaluations for only three months of the year, for instance, would not likely meet the needs of patients who get their yearly checkup during the other nine months of the year the clinician chooses not to satisfy CPIA’s measures. With this limitation in mind, the Center recommends that CMS extend this requirement.
The Center appreciates that CMS is open to recommendations every year for possible new measures and new language designed to help clinicians and CMS meaningfully transform patient care. As written, however, clinicians can marginally complete the Clinical Practice Improvement Activity category’s measures. The Center hopes that in future years CMS will continuously improve the CPIA category to be more meaningful, more evidence-based, and better positioned to promote better patient health outcomes.
E. Advancing Care Information Category
The Center strongly supports measures within the Advancing Care Information portion of MIPS that lead to greater openness and communication between providers and patients, patient engagement in their health care, care coordination, and interoperability.
The measures that providers may complete to be in compliance are not sufficient enough, however, to meaningfully achieve the above-cited goals. In future years, the Center recommends more stringent measures and scoring in order to better ensure that there is a meaningful transformation that leads to better outcomes for patients.
One of the primary impediments to such interoperability and outcomes is the so called “one-patient” threshold for satisfying many of the measures within ACI. This low threshold, and the ease at which clinicians may complete ACI requirements, does not encourage substantial advances for Medicare patients. A clinician can score, for instance, both base score and performance score points by electronically transmitting one prescription a year—doing this gives a clinician 1/5th of their required ACI score. The Center recognizes that it may be important for providers who never had to previously participate in the Meaningful Use program to catch up to those providers who already have experience with Electronic Health Records and the measures associated with them. We therefore encourage CMS to make the ACI measures more difficult, more meaningful, and more likely to improve patient health outcomes after FY 2017. If FY 2017 is a time for newly-participating physician assistants and nurse practitioners to acquire and learn EHR technology, all participating clinicians might be able to satisfy more meaningful measures in future years.
In successive years, measures should not merely be process measures such as those that award 10 points (10% of the ACI score) if a patient “views, downloads, or transmits information.” This example can become a meaningful outcome measure if it instead measured patient needs met as a result of patients viewing and downloading information concerning, for instance, at-home physical therapy exercises a clinician has recommended. CMS could also, for example, measure outcomes resulting from patient-clinician information exchanges to complete prescription medication changes.
Another way to better meet patient needs in future years is to adjust the clinician’s possible base score. After FY 2017, it will no longer be necessary to allow a base score—created as a way for newly-participating clinicians to learn EHR technology and satisfy some basic ACI requirements—to make up 50 % of the total ACI score because clinicians will have become more familiar with certified electronic health record technology during FY 2017. Furthermore, in FY 2017 physicians who previously participated in the meaningful use program and have an existing familiarity with EHR and CERHT can easily satisfy ACI requirements; the kinds of measures they can satisfy in FY 2017 are partly less stringent than the measures satisfied under the Meaningful Use program. In future years, the Center recommends lowering the total number of possible base measure points designated for EHR technology and basic ACI requirements so that clinicians will satisfy more meaningful performance score measures.
ii. “Meaningful User” Threshold
The Secretary can at any time certify that 75% of participating clinicians become “meaningful users” of Certified Electronic Health Records Technology and can then lower the weight of the ACI category from 25% of the total MIPS score to 15%. The definition of what a “meaningful user” is undefined in the proposed regulation. The Center recommends that “meaningful user” be specifically defined, to better achieve substantive improvements in interoperability and better patient health outcomes in the ACI subset of MIPS. Given the low bar with which clinicians may complete certain ACI measures, even if 75% of all participating MIPS clinicians achieve a 100% score on ACI in FY 2017, patient health outcomes would not likely change that much as a result.
The Center recommends that, following the development of more meaningful ACI measures in future years, CMS define a meaningful use threshold as one in which at least 90% of participating clinicians receive 100% of their ACI points. It is important to clearly define expectations and set a higher standard in order to achieve interoperability and EHR-aided, improved health outcomes for Medicare beneficiaries. For similar reasons, the Center also opposes any move to lower the meaningful use threshold below the current 75% amount.
iii. Attempts to Prevent Information Blocking
The Center supports CMS’s proposed requirement that clinicians certify they have not prevented interoperability and they have shared patient information with other clinicians. The Center requests this self-reported measure be validated by audits of clinician EHR systems in order to certify whether clinicians engage in information blocking.
III. Alternative Payment Models (APMs)
A. Assessments in Advanced APMs
The proposed rule provides that Advanced APMs must do the following: (1) require participants to use certified EHR technology, (2) require APMs to base payments on “quality measures comparable to those in the quality performance category of MIPS,” and (3) require APM entities to “bear more than a nominal amount of risk for monetary losses.” By adhering to these Advanced APM participation requirements, Qualified Participants (QPs) could receive in FY 2017 a lump sum bonus of five % of the estimated aggregate payments from the Medicare Part B services they provided in the preceding year. Nevertheless, the proposed rule provides few requirements that ensure that APM incentives are truly rewarding physicians for delivering quality care.
The Center is concerned about how meaningful an Advanced APM assessment will actually be when the proposed rule emphasizes that “[w]hether an APM is an Advanced APM depends solely upon how the APM is designed, rather than on assessments of participant performance within the APM.” The proposed rule attempts to reconcile the assessment gap between an Advanced APM and the participant’s actual performance by arguing that “[p]erformance assessments are already part of APMs, and [CMS] believe[s] it is important and consistent with the statutory framework to continue to foster flexibility in structuring the specific rewards and consequences of performance within each APM.”
Unfortunately, it is unclear how the design of an Advanced APM necessarily equates to proper performance assessments, especially when flexibility is a factor. For instance, the proposed rule highlights that “an APM that ties payments to performance on quality measures comparable to those under MIPS may be an Advanced APM regardless of an Advanced APM Entity’s actual performance on those quality measures.” However, as illustrated above, quality measures such as those under MIPS already provide physicians the opportunity to self-select only the qualities that they want to have measured. We do not believe that multiple layers of self-selected quality measures assist in incentivizing physicians to improve the delivery of care. Given the increased rewards inherent in the Advanced APM model over time, we strongly urge CMS to undertake additional, more meaningful, performance assessments.
B. Outcome Measures
The proposed rule argues that outcome measures are “a priority measure type”
and that CMS wants to encourage that outcome measures be factored in when quality performance assessments are being completed. In this aim, the proposed rule states that an “Advanced APM must include at least one outcome measure if an appropriate measure . . . is available on the MIPS list . . . at the time when the APM is first established.” Unfortunately, the proposed rule continues by adding that, if no outcome measures were actually on the MIPS list at the moment the APM was established, “CMS would not require an outcome measure be included after APM implementation.” Again, the proposed rule’s limited timing and subsequent failure to require any meaningful outcome measure might undermine CMS’ stated objectives. Ensuring that well-defined outcome measures are necessarily included in performance assessments will ensure that beneficiaries are receiving better care. Medicare value-based payments must ensure that physicians have an incentive to secure better health outcomes.
C. Clinical Care Model
The Center urges CMS to require that Advanced APMs use a clinical care model that results in improved delivery of care and reinforces a strong foundation of primary care (for example, greater care coordination and communication; use of shared care planning and partnership with patients at all levels of care; timely access to care; and demonstration of improved patient care experience).
With the exception of models considered to be Medical Home Models, there are no requirements for the Advanced APM program addressing the clinical care delivered by the underlying APM. Meaningful transformation to value based payment requires that the transition to APMs also result in improved delivery of care.
We strongly recommend that as entities take on financial accountability for quality performance and value, assume financial risk, and move towards capitation-like payment models, these entities must likewise be able to demonstrate they promote and support a sustainable, patient-centered model that is accessible, effective, and evidence-based.
We therefore recommend that CMS add an additional criterion for Advanced APMs that requires them to demonstrate their payment approach will reinforce the delivery of coordinated patient-and family-centered care with a strong primary care foundation.
We strongly encourage CMS to consider requiring all models qualifying as Advanced APMs meet care delivery requirements similar to those for Advanced APM Medical Home Models. Further, we urge CMS to require Medical Home Models seeking to qualify as an Advanced APM to meet all seven requirements laid out in the rule’s definition of a Medical Home Model.
The special consideration given to Medical Home Models as Advanced APMs acknowledges the critically important role of primary care. We strongly support the separate financial standards for Medical Home Models and appreciate CMS’s attention to place a high-value on the provision of primary care.
However, with regards to the requirements around Medical Home Models, we urge CMS to go further and require Medical Home Models seeking to qualify as Advanced APM to meet all seven of the domains listed in the proposed rule’s definition of a Medical Home Model: (1) planned coordination of chronic and preventive care; (2) patient access and continuity of care; (3) risk-stratified care management; (4) coordination of care across the medical neighborhood; (5) patient and caregiver engagement; (6) shared decision making; and (7) payment arrangements in addition to, or substituting for, fee-for-service. All seven domains are key elements of a true Medical Home Model. Particularly with respect to first six criteria, we can identify no criterion that could acceptably be missing from a high-quality medical home.
The requirements for Medical Home Models also need much greater definition and specificity, particularly with respect to patient and caregiver engagement and to shared decision-making.
D. Transparency, Consumer Protections, and Stakeholder Engagement in Advanced APMs
Encouraging transparency, the proposed rule states that CMS will develop a method to identify and notify the public of specific APMs that CMS considers are Advanced APMs. The proposed rule clarifies that “making this information available in an accessible format is important for stakeholders to understand how CMS applies the Advanced APM criteria to existing APMs, and to be informed as early as possible about whether an APM they are considering joining is an Advanced APM.” We agree; however, we believe accessibility alone is not sufficient to ensure that the voices of beneficiaries are heard. Although the process may be transparent after the fact, we strongly encourage CMS to develop additional processes to allow stakeholder engagement during the period of determination. Patients, advocates, and physicians should be included in the entire process as co-creators, and not only informed at the end of the process.
The Center urges CMS to thoughtfully develop and properly measure enhanced consumer protections as more clinicians move into Advanced APMs. Greater transparency in Advanced APM measurements would provide helpful information for patient advocates to assist CMS, improve future Advanced APMs, and help ensure they are not encouraged to select only the healthiest patients.
New models should better protect disadvantaged and at-risk patient populations from the get-go. When new Advanced APMs are considered, CMS should provide their quality and resource-use data to the public for comment. Further, given the complexity of certain Advanced APMs, we encourage CMS to require them to provide linguistically and culturally appropriate materials for patients. We ask CMS to provide prototypes of these materials to patient advocates to review before they are finalized.
The Center for Medicare Advocacy greatly appreciates the opportunity to provide comments on the proposed rule on the Medicare Program Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule.
For additional information, please contact our Senior Policy Attorney, David Lipschutz at 202-293-5760 or Dlipschutz@MedicareAdvocacy.org. Thank you.
 MedPac. “Medicare and the Healthcare Delivery System.” June 2016. http://medpac.gov/documents/reports/june-2016-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf (site visited June 22, 2016). P. 49.
 Center for Medicare Advocacy. “Why the Jimmo v. Sebelius Case Matters: Improvement Standard Stories.” http://www.medicareadvocacy.org/why-the-jimmo-v-sebelius-case-matters-improvement-standard-stories/ (site visited June 22, 2016).
 Id. at 28162.
 See id. at 28163 (“MIPS eligible clinicians will include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians.”).
 Id. at 28247
 Id. at 28247.
 81 Fed. Reg. at 28185.
 See id. at 28187 (arguing that the reduction “decreases the MIPS eligible clinician’s reporting burden while focusing on more meaningful types of measures”).
 Although CMS notes that it plans to increase reporting requirements over the next few years through notice and comment rulemaking, the requirements currently proposed will have a negative impact on beneficiaries in the meantime by not making physicians accountable for the total quality of the care they provide. Id.at 28187.
 Id. at 28196-7.
 Id. at 28197.
 Id. at 28196.
 Id. at 28573.
 Id. at 28580.
 Id. at 28573.
 Id. at 28585.
 Id. at 28211.
 Id. at 28215.
 CMS. “Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.” Proposed Rule. https://www.federalregister.gov/articles/2016/05/09/2016-10032/medicare-program-merit-based-incentive-payment-system-mips-and-alternative-payment-model-apm (site visited May 23, 2016). P. 28228.
 Id. at 28226.
 Id. at 28386.
 Id. at 28165.
 Id. at 28294.
 Id. at 28298.
 Id. at 28299.
 See supra notes 12-7 and accompanying text.
 81 Fed. Reg. at 28302.
 Id. at 28298.