PRMR MUC List Commenting

MUC2023-162 Patient-Reported Pain Interference Following Chemotherapy among Adults with Breast Cancer

This patient reported outcome performance measure fills a gap in the existing measurement set for cancer care, directly supports performance improvement in the delivery of cancer care, and can support accountability and value-based payment. The Leapfrog Group strongly supports the inclusion of this measure on the MUC list.

On behalf of the Greater New York Hospital Association (GNYHA) membership, we appreciate the opportunity to comment on the 2023 Measures Under Consideration List. The GNYHA membership is comprised of more than 220 acute care hospitals, which include academic medical centers, safety net facilities, and the nation’s largest public hospital system, all of which serve underserved communities. GNYHA member hospitals are deeply committed to health equity and addressing health-related social needs (HRSN). However, GNYHA believes that the “Resolution of At Least One Health-Related Social Need” measure is not an appropriate addition to the Inpatient Quality Reporting (IQR) program.  

This measure would require hospital inpatient settings to report quarterly on whether patients resolved at least one of the social needs identified during their admission. Like the Connection to Community Service Provider measure, this measure would overburden the inpatient setting, which is not equipped with the staff, resources, or technology to follow patients long-term after they are discharged. The language in the measure definition is extremely unclear and will be confusing to implement. Additionally, this measure would not contribute to hospital quality improvement, rather it would place undue accountability on hospitals to resolve complex structural and environmental issues for which they have no control.

Overburdening the Inpatient Setting 

This measure would require staff working in the inpatient setting to track the status of patients with at least one identified social need for up to one year post-discharge to ascertain whether they “resolved” one of the social needs identified during the admission. However, the inpatient setting is intended to treat complex, acute health issues and is not designed for longitudinal care post-discharge. Hospitals undertake several activities to ensure that patients can be safely discharged, including discharge planning with dedicated staff, and post-discharge follow-up to identify potential issues or concerns that might require clinical follow-up, such as post-operative concerns and medication questions. Increasingly, social needs screening is conducted as part of discharge planning to identify unmet needs that could contribute to a readmission, as well as to comply with the newly implemented social needs screening measures in IQR. Hospitals also schedule post-discharge visits with the patient’s primary care provider or with the appropriate specialist who would follow the patient on an outpatient basis. These are short-term activities, lasting a few days past patient discharge, and it is not feasible for the inpatient setting to track patients for one year post-discharge. 

Measure Language 

The measure specifies that hospitals must report on the resolution of at least one need. However, whether a need is “resolved” can be subjective. For example, a patient with food insecurity can receive a service from a food pantry, which addresses their need in the short term. That same person may still suffer from food insecurity and may not interpret their need to be “resolved.” Even individuals who have received multiple interventions may still experience a social need. A person with SNAP benefits who also is connected to a food pantry may still be food insecure, and therefore may not have their need resolved. Additionally, some needs may have short term resolutions, while others may take much longer. For example, it can take several years for an unhoused person with substance use disorder to be permanently housed.  

If CMS is interested in measuring hospital follow-up on social needs, GNYHA would recommend the review of the National Committee for Quality Assurance’s Social Needs Screening measure. The measure provides flexibility on the kinds of activities health care providers can complete to meet the measure, including referrals, direct assistance, counseling, or education. These activities were adopted from the Gravity Project, a national public collaborative that is developing consensus-based data standards to improve social determinants of health data use and sharing. 

Measure Appropriateness for IQR 

The IQR program’s goal is to drive hospital quality improvement and reduce inpatient costs through measurement and transparency. The proposed Resolution of at Least One Social Need measure does not capture hospital quality of care—instead, it reflects the capabilities and capacity of the social service system and complex societal challenges. While hospitals are committed to addressing social needs and providing equitable care, their inpatient settings should not be held accountable for solving structural and environmental challenges impacting communities at large. 

GNYHA would welcome a dialogue with CMS on ways that hospitals are partnering with communities to address social needs.  

Please see the attached comment letter from the American College of Surgeons (ACS) in support of the Age Friendly Hospital Measure 

MUC2023-181 30-Day Risk-Standardized All-Cause Emergency Department Visit Following an Inpatient Psychiatric Facility Discharge (IPF ED Visit measure)

Leapfrog supports this measure. Patients discharged from inpatient psychiatric care are at greater risk than the rest of the population for adverse outcomes. This measure will support better follow-up care after discharge and improved cooperation between caregivers. The Leapfrog Group supports the inclusion of this measure on the MUC list.

MUC2023-188 Patient Safety Structural Measure

The Patient Safety Structural Measure is the most important measure on the MUC list this year. On behalf of our employer and consumer constituents, we offer our strongest possible support. It addresses a critical need: to accelerate improvement in patient safety, and sustain improvements. During the pandemic, there was significant increases in hospital-acquired infections and other safety problems, and we need hard-wired system to assure that public health emergencies or other events do not distract from the fundamental responsibility to protect patients from preventable harm. We are impressed that the measure incorporates the characteristics that hard-wire safety in hospitals according to significant evidence and experience over the past two decades since To Err Is Human. It recognizes the factors employers and other purchasers have considered priority issues for health systems: leadership, transparency, and a culture of safety. It offers specific standards for health systems to achieve greater performance on safety applying these evidence-based organizational principles, thus serving as a map for providers on the journey for safety.   It includes a wise pathway for health systems to incorporate patients and families as team members in the quest for safety. The measure is not only important for purchasers and consumers, but helpful to health care providers as they navigate toward safety. This is a breakthrough measure that has the potential to drive sustainable improvement in patient safety nationwide. The Leapfrog Group supports the inclusion of this measure on the MUC list.

MUC2023-190 Patient-Reported Fatigue Following Chemotherapy among Adults with Breast Cancer

This patient reported outcome performance measure fills a gap in the existing measurement set for cancer care, directly supports performance improvement in the delivery of cancer care and supports accountability and value-based payment. The Leapfrog Group strongly supports the inclusion of this measure on the MUC list.

Please find attached comments and suggestions regarding the Measures Under Consideration for the Cataract Cost Measures.  We encourage PRMR Clinical Committee and the Partnership for Quality Management teams to keep the PATIENT at the forefront as you evaluate these recommendations.   Patient Outcomes are, after all, a key tenet in achieving the Triple or Quadruple AIM.   

Thank you for the opportunity to provide these important patient-focused recommendations. 

The Alliance for Quality Improvement and Patient Safety (AQIPS) appreciates the opportunity to submit comments on a specific requirement under consideration under the proposed pre-rulemaking Patient Safety Structural Measure (Number MUC 2023-188).  AQIPS is the professional association for Federally Listed Patient Safety Organizations (PSOs) and their healthcare provider members to foster healthcare providers ability to improve patient safety and the quality of patient care delivery using the processes and protections of the Patient Safety and Quality Improvement Act of 2005 (42 U.S.C. 299b-21 et seq.; “The Patient Safety Act”).  The Patient Safety Act made possible privileged and confidential collaborative efforts to improve patient safety and the quality of the delivery of patient care across the continuum of healthcare for the benefit of patients.  The Patient Safety Act is a disclosure statute allowing healthcare providers to develop and share innovative safety strategies to improve the quality of patient care delivery. The Patient Safety Act incentivizes safety, quality and performance improvement as a shared responsibility among all healthcare providers throughout the healthcare continuum.  As organizations that are committed to fostering safety culture, systems improvement, and high reliability in healthcare, AQIPS member PSOs and our hospital members have a significant interest in this proposed MUC. 

AQIPS urges CMS to withdraw the Accountability and Transparency Domain subparagraph 2 that requires for a hospital to gain a point for this domain a hospital  must attest, among other things, that:

Our hospital reports serious safety events, near misses and precursor events to a Patient Safety Organization (PSO) listed by the Agency for Healthcare Research and Quality (AHRQ) that participates in voluntary reporting to AHRQ’s Network of Patient Safety Databases.

This provision is inconsistent with the Patient Safety Act and CMS lacks legal authority to regulate PSOs.  A plain reading of this proposed provision requires PSOs to report to the AHRQ Network of Patient Safety Databases (hereinafter “The National Patient Safety Database.) for hospitals to meet this measure.  This proposed provision also requires hospitals to report to the NPSD, although indirectly. Such reporting under this measure is not “voluntary” by hospitals or PSOs and, therefore, is inconsistent with the Patient Safety Act.  Recognizing that PSOs would be collecting a large amount of rich quality data that CMS, AHRQ, plaintiff lawyers and other entities would want to commandeer, Congress provided that PSOs cannot be compelled to disclose PSWP. 42 USC 299b-22(d)(4).  This prohibition includes being indirectly compelled through a measure in a rulemaking. 

As you know, PSOs are private, market-based programs accelerating patient safety to ensure the welfare of patients.  The PSO program is a self-regulatory program to allow quality improvement beyond regulatory requirements.  PSOs are not federally funded, are not subject to CMS jurisdiction and, as provided by the Patient Safety Act, cannot be directed by government agencies.  Hospitals choose a PSO to work with based on the PSOs programs and performance in providing value to the hospital. (See Patient Safety and Quality Improvement, 73 Fed. Reg. 70732, 70747 (Nov. 21, 2008).  Therefore, CMS cannot indirectly compel PSOs to “voluntarily” report to the NPSD.

The Patient Safety Structural Measure is an attestation-based measure that assesses whether hospitals demonstrate having a structure and culture that prioritizes patient safety.  However, this proposal goes well beyond hospitals structure and culture and extends to compelling valuable data from private sector entities.  AQIPS member PSOs gain rights to use of deidentified PSWP from their providers for patient safety activities, in the same manner as ‘23 and Me” gains rights to share genetic data with healthcare researchers, AI companies healthcare data and other private sector data collection companies.  Like claims data and genetic data, PSOs can monetize patient safety and quality event data (that does not contain PHI) which is used for research through the research disclosure permission or for patient safety activities. 

According to Agency for Healthcare Research and Quality, the work of federally listed PSOs and healthcare providers to reduce medical errors and increase patient safety in various clinical settings and specialties is highly valued, successful, and thriving. “Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety Act of 2005,” AHRQ, December 2021.  The healthcare and PSO community have developed programs, including National Safe-Tables, to revolutionize patient safety practice and to connect the healthcare system. 

The Patient Safety Structural Measure is an attestation-based measure that assesses whether hospitals demonstrate having a structure and culture that prioritizes patient safety.  The pre-regulation proposed measure goes well beyond hospitals to improperly mandate requirements that impact private sector entities and should be withdrawn.  Should you have any questions or require additional information, please contact me at [email protected].

Please find attached comments and recommendations pertaining to the Measures Under Consideration, Cataract Removal with Intraocular Lens Implantation.   Thank you for the opportunity to submit these comments and recommendations for consideration. 

Memo attached 

Hello members of the Pre-Rulemaking Measure Review committees.

Before I share my comment I would like to introduce myself- My name is Ajeet Singh, I am a physician hospitalist currently practicing at Rush University Medical Center in Chicago, and previously I completed my internal medicine training in Oakland’s county hospital at Highland Hospital. I am also public health trained, having completed my MPH in health policy and management at the Harvard TH Chan school of public health. I also have over a decade of work experience in building and implementing expanded outcomes measurement practices in clinical environments domestically and internationally. As such, I am intimately familiar with not only our patient’s clinical needs for their immediate health, but I also bring an understanding of how social determinants intimately shape peoples ability to improve their health, as well as how our regulatory environments enable or limit the capacity for change, and from my county training, how some of the most resource limited environments are attempting to address these needs.

I would like to speak in support of the inclusion of two specific measures to the IQR program and MSSP:

- the Connection to Community Service Provider quality measure (identified as MUC2023-199)

- the Resolution of at least 1 Health Related Social Need (identified as MUC2023-210)

In every day of my clinical practice, when I admit patients from the emergency department, I see the consequences of the material realities of our environment that impose countless obstacles and burdens on people in their aspirations to pursue their own health- these factors have long since been studied as social determinants of health, and reams of literature have substantially demonstrated the direct relationships these factors have on either enabling or crippling a community’s ability to seek a healthier future. Wherever I have practiced, my physician, nursing, social work, and case management colleagues have all already been working to collect this information, and diligently connect our patients to whatever local resources were available to even just marginally reduce their risk for scarcity when it came to nutrition, housing, income/job security, and more, let alone their immediate medical needs. Much of this information becomes lost in free-text entries, whether through our initial history & physical examination notes on the patient’s admission to the hospital, or in the social worker’s or case manager’s progress notes highlighting their unique needs and the aspirational progress being made to connect them with resources both within the health system and out in the community.

CMS has a critical opportunity to standardize and universalize measures for documenting the work that we’re already trying to do, and build paths to reimbursing care teams for that effort. Less recognized but just as important though- is that this information would give incredible insight into where patients are requiring which resources, and where are those needs being addressed and resolved or where are gaps in needs either persisting or worsening. I must emphasize, these measures are NECESSARY BUT INSUFFICIENT. As I was training in my residency in the county environment of Oakland, California, my team would try their hardest to find temporary housing, enlist volunteer pre-medical students to help print out useful state/federal assistance application forms for the patient and help fill them out so that they can then afford some nutrition, let alone housing and other needs. Healthcare providers and their teams can spend all day connecting patients to resources, but in reality, it just connects them to waiting lines, where a response may or may not arrive within days, weeks, months, or even years. I would have the same patient get re-admitted to the hospital over and over every few weeks over years because she could not access affordable transportation for the treatment of her chronic diseases because she had to prioritize her shoestring budget towards cheap and thus low quality nutrition, while law enforcement would regularly sweep her temporary housing and dispose of the remainder of her belongings without an ounce of empathy. The community resources are just NOT SUFFICIENT. The literature and patient stories on this are abundant- and in order for us as a system to advocate for the needs of our patients, we must first make REAL and INESCAPABLE the reality of the patient experience by measuring these questions. This level of granularity would be so powerful to inform how hospitals, cities, states, and federal parties prioritize subsequent interventions across the patchwork sieve of wrap-around bandages that millions of Americans depend on every day.

So I want to close with a comment on the feasibility of these measures-

These measures were already tested extensively in CMS’ Accountable Health Communities model, where over 1 million beneficiaries were screened over 5 years where a quarter of the AHC awardees served mostly or exclusively rural counties. In the Comprehensive Primary Care Plus model, 86% of the Track 1 practices and nearly every Track 2 practice was implementing social risk screening according to reporting back in 2020. For subsequent years, when Track 2 practices were required to implement certain screening tools, Track 1 practices were just as likely to do so even though it was not required. And those screening results were immediately actionable- 93% of Track 1 practices reported acting on those results with 74% actively linking patients to community-based resources. Looking outside of just specialized government programs, a JAMA study found that 92% of all hospitals measured were already screening for one or more of the 5 SDOH domains specified here back in 2019. From the physician perspective, one survey found that 90% of providers want more tools to address SDOH in their practices. And from the patient perspective, another 2019 survey found 77% patients wanted their hospitals and doctors to look into how issues like food security, transportation, housing, and more are interfering with health concerns

Clinically, it is imperative that we push forward with these measures. Patients, physicians, and hospitals all want this to move forward. I hope the PRMR committee reviews these measures favorably, and we look forward to building upon the progress made by these measures in the coming years.

Thank you for your time and consideration.

Ajeet Singh, MD MPH

Re: Public Comment to CMS Proposed Patient Safety Structural Measure.  Number: MUC2023-188.

On behalf of ECRI, an Agency for Healthcare Research and Quality (AHRQ) listed Patient Safety Organization (PSO) and Evidence-based Practice Center (EPC), I would like to applaud the Centers for Medicare and Medicaid Services (CMS) for proposing this critically important new patient safety measure. ECRI agrees with the recommendations from the recent President’s Council of Advisors on Science and Technology (PCAST) report, A Transformational Effort on Patient Safety, calling for a nationwide transformational initiative on patient safety to support every hospital and practitioner with implementing safety solutions and sustaining them over time. 

As a member of the National Steering Committee for Patient Safety, ECRI has led efforts to implement the National Action Plan to Advance Patient Safety in hospitals and other healthcare settings across the country. Through our partnerships with healthcare providers, ECRI has witnessed firsthand how a total systems approach to safety can have a profound impact on the reduction of preventable harm and build a strong and resilient healthcare workforce.

Through ECRI’s review of the proposed measure we did see that several important elements of total systems safety were missing. ECRI recommends that CMS also include the following core elements of a total systems approach to safety:

• Develop an action-oriented great catch reporting program that uses recognition to encourage team members to report risks that could potentially cause harm. Great catches differ from traditional “good catches” by focusing on action responses to near miss events that are strong and reliable and have a system-wide impact.
• Implement a peer support program to create an environment that emphasizes peer support as part of its broader culture of patient safety and just culture, including fostering a culture in which all employees are resilient and mutually supportive before, during and after stressful events.
• Develop a structured process and establish clear channels for communication of risks and response plans to mitigate risks for hazardous or recalled medical supplies, medications, and equipment.
• Create an equity plan to increase inclusion, person-centeredness, and equitable health outcomes.
• Develop a process to assess, act on and learn from diagnostic errors.

ECRI agrees with the emphasis of the measure being placed on the five domains of:

• Domain 1: Leadership Commitment to Eliminating Preventable Harm
• Domain 2: Strategic Planning & Organizational Policy
• Domain 3:  Culture of Safety & Learning Health System
• Domain 4: Accountability & Transparency
• Domain 5: Patient & Family Engagement

The domains and the individual elements within each will create a much-needed standardized framework that will guide hospitals to practice a systems-based approach to safety. 

Through our work as both a PSO and EPC, the proposed statements within the five domains resonated with us as essential to a total systems safety approach. Along with the additional statements aforementioned, we would like to highlight specific statements that we feel will have a major impact.

Domain 1: Leadership Commitment to Eliminating Preventable Harm 

Statement: Our hospital leaders, including C-suite executives, place patient safety as a core institutional value. One or more C-suite leaders oversee a system-wide assessment on safety, and the execution of patient safety initiatives and operations, with specific improvement plans and metrics. These plans and metrics are widely shared across the hospital and governing board. 

ECRI supports the use of a system-wide assessment to create a baseline measure that improvement plans should be designed around. Associated action plans should include strong and high leverage actions that are aligned with organizational goals and metrics.

Domain 2: Strategic Planning & Organizational Policy

Statement: Our hospital has implemented written policies and protocols to cultivate a just culture that balances no-blame and appropriate accountability and reflects the distinction between human error, at-risk behavior, and reckless behavior.

ECRI supports the implementation of a just culture using consistent, fair, and systematic approaches to manage behavior to facilitate a balance between a nonpunitive learning environment and an equally important need to hold people accountable for their actions.

Domain 3: Culture of Safety & Learning Health System

Statement: Our hospital implements the following high reliability practices-The use of human factors engineering principles in the selection and design of devices, equipment, and processes.

As the largest independent device testing laboratory in North America, ECRI supports the use of human factors engineering in all aspects of a total systems approach to evaluate and improve safety. This includes assessing the complexity of devices, tools, technology, tasks, and the work systems in which team members conduct patient care.

Domain 4: Accountability & Transparency

Statement: Our hospital reports serious safety events, near misses and precursor events to a Patient Safety Organization (PSO) listed by the Agency for Healthcare Research and Quality (AHRQ) that participates in voluntary reporting to AHRQ’s Network of Patient Safety Databases.

ECRI supports organizational accountability and transparency that allows team members from across the organization to identify safety events, near misses and unsafe conditions across healthcare settings, promoting transparent organizational learning and nurturing a culture that promotes safety as a goal. Furthermore, we support healthcare organizations to report those events, near misses and unsafe conditions to a PSO to leverage the unique learning system provided under the federal Patient Safety and Quality Improvement Act. 

While we support this statement, we urge CMS to remove the portion “that participates in voluntary reporting to AHRQ’s Network of Patient Safety Databases” as this is a voluntary reporting program, and it is not required for PSOs to report data under the Patient Safety and Quality Improvement Act. 

Domain 5: Patient & Family Engagement

Statement: Our hospital incorporates patient and caregiver input about patient safety events or issues (such as patient submission of safety events, safety signals from patient complaints or other patient safety experience data, patient reports of discrimination).

ECRI supports partnering with patients, families, and caregivers in safety. This includes creating pathways for patients, families, and caregivers to report safety events with the expectation that their concerns will be reviewed and acted upon quickly with closed loop feedback on the resulting outcome and actions to improves safety.

While ECRI supports a standardized metric for safety, we also urge CMS along with other federal agencies to take actions to create a powerful national learning ecosystem where evidence-based best practices and safety lessons from other high- risk industries can be shared and modeled from to create innovative and sustainable change within healthcare systems. 

Furthermore, as healthcare providers continue to struggle to overcome the impact of the pandemic, they will need support and practical tools to meet the elements outlined in the measure. For example, the use of human factors engineering principles in the selection and design of devices, equipment and processes is demonstrated to be a powerful intervention, however in ECRI’s experience, most hospitals do not have access to human factors engineers and this creates inequities in how hospitals are able to address complex system safety issues.  A national learning ecosystem should address how an equitable approach can be taken to implement the best practices outlined in the measure. A total systems approach to safety should facilitate hospital teams to provide excellent care, not create additional disparate tasks and processes that complicate their work.

Finally, CMS should consider how other reliable and valid forms of measurement can contribute to understanding the impact of each of the safety domains and statements. A structural measure alone will not provide the detail that is necessary to drive continuous performance improvement.

In conclusion, ECRI supports CMS’s effort to transform patient safety through this proposed Patient Safety Structural Measure, but we recommend that they take a more comprehensive approach to ensure the successful and sustainable implementation of evidence-based practices for safety. Thank you for this opportunity to comment on this important advancement in patient safety. 

Marcus Schabacker, MD, PhD

President and CEO, ECRI

Hello members of the Pre-Rulemaking Measure Review committees.

Before I share my comment I would like to introduce myself- My name is Ajeet Singh, I am a physician hospitalist currently practicing at Rush University Medical Center in Chicago, and previously I completed my internal medicine training in Oakland’s county hospital at Highland Hospital. I am also public health trained, having completed my MPH in health policy and management at the Harvard TH Chan school of public health. I also have over a decade of work experience in building and implementing expanded outcomes measurement practices in clinical environments domestically and internationally. As such, I am intimately familiar with not only our patient’s clinical needs for their immediate health, but I also bring an understanding of how social determinants intimately shape peoples ability to improve their health, as well as how our regulatory environments enable or limit the capacity for change, and from my county training, how some of the most resource limited environments are attempting to address these needs.

I would like to speak in support of the inclusion of two specific measures to the IQR program and MSSP:

- the Connection to Community Service Provider quality measure (identified as MUC2023-199)

- the Resolution of at least 1 Health Related Social Need (identified as MUC2023-210)

In every day of my clinical practice, when I admit patients from the emergency department, I see the consequences of the material realities of our environment that impose countless obstacles and burdens on people in their aspirations to pursue their own health- these factors have long since been studied as social determinants of health, and reams of literature have substantially demonstrated the direct relationships these factors have on either enabling or crippling a community’s ability to seek a healthier future. Wherever I have practiced, my physician, nursing, social work, and case management colleagues have all already been working to collect this information, and diligently connect our patients to whatever local resources were available to even just marginally reduce their risk for scarcity when it came to nutrition, housing, income/job security, and more, let alone their immediate medical needs. Much of this information becomes lost in free-text entries, whether through our initial history & physical examination notes on the patient’s admission to the hospital, or in the social worker’s or case manager’s progress notes highlighting their unique needs and the aspirational progress being made to connect them with resources both within the health system and out in the community.

CMS has a critical opportunity to standardize and universalize measures for documenting the work that we’re already trying to do, and build paths to reimbursing care teams for that effort. Less recognized but just as important though- is that this information would give incredible insight into where patients are requiring which resources, and where are those needs being addressed and resolved or where are gaps in needs either persisting or worsening. I must emphasize, these measures are NECESSARY BUT INSUFFICIENT. As I was training in my residency in the county environment of Oakland, California, my team would try their hardest to find temporary housing, enlist volunteer pre-medical students to help print out useful state/federal assistance application forms for the patient and help fill them out so that they can then afford some nutrition, let alone housing and other needs. Healthcare providers and their teams can spend all day connecting patients to resources, but in reality, it just connects them to waiting lines, where a response may or may not arrive within days, weeks, months, or even years. I would have the same patient get re-admitted to the hospital over and over every few weeks over years because she could not access affordable transportation for the treatment of her chronic diseases because she had to prioritize her shoestring budget towards cheap and thus low quality nutrition, while law enforcement would regularly sweep her temporary housing and dispose of the remainder of her belongings without an ounce of empathy. The community resources are just NOT SUFFICIENT. The literature and patient stories on this are abundant- and in order for us as a system to advocate for the needs of our patients, we must first make REAL and INESCAPABLE the reality of the patient experience by measuring these questions. This level of granularity would be so powerful to inform how hospitals, cities, states, and federal parties prioritize subsequent interventions across the patchwork sieve of wrap-around bandages that millions of Americans depend on every day.

So I want to close with a comment on the feasibility of these measures-

These measures were already tested extensively in CMS’ Accountable Health Communities model, where over 1 million beneficiaries were screened over 5 years where a quarter of the AHC awardees served mostly or exclusively rural counties. In the Comprehensive Primary Care Plus model, 86% of the Track 1 practices and nearly every Track 2 practice was implementing social risk screening according to reporting back in 2020. For subsequent years, when Track 2 practices were required to implement certain screening tools, Track 1 practices were just as likely to do so even though it was not required. And those screening results were immediately actionable- 93% of Track 1 practices reported acting on those results with 74% actively linking patients to community-based resources. Looking outside of just specialized government programs, a JAMA study found that 92% of all hospitals measured were already screening for one or more of the 5 SDOH domains specified here back in 2019. From the physician perspective, one survey found that 90% of providers want more tools to address SDOH in their practices. And from the patient perspective, another 2019 survey found 77% patients wanted their hospitals and doctors to look into how issues like food security, transportation, housing, and more are interfering with health concerns

Clinically, it is imperative that we push forward with these measures. Patients, physicians, and hospitals all want this to move forward. I hope the PRMR committee reviews these measures favorably, and we look forward to building upon the progress made by these measures in the coming years.

Thank you for your time and consideration.

Ajeet Singh, MD MPH

The College of American Pathologists (CAP) supports the importance of PD-L1 testing and in fact has an upcoming clinical practice guideline covering this topic. However, the CAP also provides the following comments to assist with improving the measure.

In general, the CAP believes that the appropriateness of measuring performance against an evolving and inexact standard should be reconsidered. One possible consideration could be to respecify the current measure to indicate that simply considering PD-L1 testing regardless of specific testing platform utilized or result generated be considered Satisfactory for Performance Met, rather than demanding a “positive” test result on only FDA approved platforms.

There are several reasons for this suggested change. First, the CAP notes that “positive” is too imprecise a requirement in the context of this measure’s intended quality action. Positive test results can vary based on clones and platforms used as well as interobserver reproducibility, especially if different observers are using different validated scoring systems. Notably, PD-L1 does not offer a definite dichotomous decision-making tool, as has been noted in the literature. See:

1. Joseph E. Willis, Frederick Eyerer, Eric E. Walk, Patricia Vasalos, Georganne Bradshaw, Sophia Louise Yohe, Jordan S. Laser; Companion Diagnostics: Lessons Learned and the Path Forward From the Programmed Death Ligand-1 Rollout. Arch Pathol Lab Med 1 January 2023; 147 (1): 62–70. doi: https://doi.org/10.5858/arpa.2021-0151-CP
2. Ribas A, Hu-Lieskovan S. What does PD-L1 positive or negative mean? J Exp Med. 2016 Dec 12;213(13):2835-2840. doi: 10.1084/jem.20161462. Epub 2016 Nov 30. PMID: 27903604; PMCID: PMC5154949.

There is also spatial and temporal heterogeneity in PD-L1 expression in the same tumor. The results from the same tumor can be positive or negative based on sampling; within the tumor/invasive front/primary/ different metastatic sites different sites can have varying expression.

Additionally, the CAP urges caution relating to the test methodology. The wording casually includes "FDA approved test," which would restrict performance to a companion diagnostic test that underwent premarket approval.  That may not be required.  That is, shouldn’t PD-L1 testing by a laboratory validated method that doesn’t happen to be an FDA approved companion diagnostic be acceptable? Different immune checkpoint inhibitor (ICI) therapy agents have different approved companion diagnostics and scoring methods, and it may not be possible or necessary to access every approved test. The CAP suggests that laboratory developed tests that have been appropriately validated in a CLIA laboratory should be acceptable as testing methods as well.

Finally, given the intended longevity of a clinical quality measure, the CAP notes that PD-L1 testing requirements will continue to evolve and the current language of the measure may not provide sufficient flexibility. For instance, companion diagnostic testing is not required for nivolumab treatment in melanoma or NSCLC, but it is for pembrolizumab; this is because findings from clinical trials demonstrated similar outcomes irrespective of PD-L1 expression status. Furthermore, response to ICI may vary irrespective of PD-L1 expression status, and data suggest that response may occur independent of a positive test as narrowly specified in the draft measure. This is similar in concept to the evolving standards of HER2 testing, which are beginning to acknowledge “HER2 low” as a clinically relevant entity.

I write this comment in full support of all of the domains of the Patient Safety Structural Measures but especially Domain 4- Accountability and Transparency. All of the domains set forth excellent measures to advance the efforts to pursue zero preventable harm but the future of patient safety depends fully upon Accountability and Transparency. We cannot improve or learn unless we know what is broken and we need transparency amongst the clinical team AND with patients, families, and their loved ones to truly understand all of the contributory causes for the harm and the appropriate action plans needed to fix the and correct the gaps. Sharing metrics and  the lessons learned within the organization will also help drive accountability and high reliability.  In addition, the components of CANDOR listed within the Domain 4 Measures will substantially increase the degree of accountability within the organization and with that accountability we can sustain the improvement efforts. With the massive increase in emotional exhaustion and burnout within the clinical team highlights the need for all organizations to have an effective Care for the Caregiver program, a best practice with proven efficacy in reducing burnout and improving staff retention. All the CANDOR component can be implemented and hard wired into any healthcare organizations with a significant increase in the need for resources - the measures merely provide a best practice roadmap for the the logical alignment and coordination of the functions.  

Please see attached.

Please see attached

Comments from the American Society of Nephrology 

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who are members of the American Society of Nephrology (ASN), thank you for the opportunity to comment on the 2023 Pre-Rulemaking Measure Review (PRMR) Measures Under Consideration (MUC) List. 

While appreciative of the opportunity to comment on this critical issue for millions of Americans, ASN is once again disappointed by the limited timeframe for public comment from December 1-22, 2023. Furthermore, several key documents were not made available until midway through the public comment period. The MUC is integral to maintaining high quality care for patients and measuring resource use of clinicians in the Merit-based Incentive Payment System (MIPS). Please see our letter from September 25, 2023, (attached) after the public was given a two-week comment window for the entire 2023 Measure Set Review (MSR): End Stage Renal Disease Quality Incentive Program (ESRD-QIP). ASN is also sharing its concerns on timing and this letter with the Centers for Medicare and Medicaid Services as this has been an annual process challenge pre-dating the existing contractor.

Although ASN supports the development of episode of care cost measures, ASN has concerns relating to the four measures under consideration impacting individuals with kidney failure as well as general and transplant nephrologists and the kidney health team. Specifically, we comment on the following proposed measures: 

• MUC2023-203: Chronic Kidney Disease (CKD)
• MUC2023-204: End-Stage Renal Disease (ESRD)
• MUC2023-206: Kidney Transplant Management 
• MUC2023-138 ESRD Dialysis Patient Life Goals Survey (PaLS)

For background, kidney diseases are the ninth leading cause of death in the United States, resulting in more deaths than breast cancer, and, given the heightened risk of cardiovascular diseases associated with chronic kidney disease (CKD), kidney diseases contribute to millions of additional deaths in the United States from other causes. Unfortunately, kidney diseases and kidney failure are more common among Black, Hispanic or Latinx, Native or Indigenous Americans, Asian Americans, Hawaiians and other Pacific Islanders, people with lower incomes, and older adults. Each of these populations have also been disproportionately affected by the COVID-19 pandemic, exacerbating existing disparities. 

When compared to White Americans, Black Americans are 3.8 times more likely to develop kidney failure, while Hispanic or Latinx Americans are 2.1 times more likely to develop kidney failure. One out of every eleven Black American males will require dialysis during their lifetime. Further, Black, Indigenous, and Hispanic or Latinx Americans are less likely to receive a kidney transplant and are less likely to initiate home dialysis when requiring dialysis for kidney failure. 

While end-stage renal disease affects only one percent of Medicare beneficiaries, it represents seven percent of Medicare’s annual expenditures. Yearly costs for Medicare FFS patients on hemodialysis are approximately $100,000, whereas annual costs for patients with a kidney transplant are approximately $44,000. Costs for patients with CKD are more than double ($28,162/yr[i]) that for those without CKD ($13,604/yr). These statistics highlight the importance of the Partnership for Quality Measurement’s (PQM) actions on MIPS episode-based cost measures.

ASN supports the conceptual use of episode-based costs measures in MIPS, but we highlight the challenges with this approach for people with kidney diseases, a condition that typically is slowly progressive over decades, that is optimally treated with chronic disease management before it has become advanced, and that may have significant periods of transition. 

MUC2023-203 Chronic Kidney Disease 

ASN appreciates the thoughtful deliberations by the TEP and measure contractor to identify costs potentially related to CKD. We note that the TEP did not achieve consensus. We share the following considerations: 

1. Identifying advanced CKD: Patients are identified using ICD-10 codes for CKD Stage 4 and 5. ASN is reassured that a previous analysis conducted by the Center for Outcomes Research & Evaluation, the measure developer for the Delay in Progression of CKD measure, found that ICD-10 codes had high specificity, with over 80% of CKD stage 4/5 patients having laboratory evidence of CKD. However, CMS should closely monitor for gaming behavior in coding, as clinicians may code N18.9 CKD, unspecified to avoid having high-cost patients attributed to the CKD cost measure. As a result, in the long-term the appropriate identification of stage 4/5 patients could be impacted. 
2. Heterogeneity within advanced CKD: Individuals with CKD stage 4/5 differ tremendously from each other, with the estimated glomerular filtration rate (eGFR) and the quantification of albumin in the urine (often referred to as the urine albumin to creatinine ratio) providing substantial information about prognosis and therefore about projected costs. For example, using the Kidney Failure Risk Equation, a 70-year-old woman with an eGFR of 25 and a urine albumin to creatinine ratio of 20 mg/g has a 2.9% 2-year and an 8.7% 5-year risk of requiring dialysis. In contrast, a 70-year-old woman with an eGFR of 17 and a urine albumin to creatinine ratio of 900 mg/g has a 32.6% 2-year and a 70.9% 5-year risk of requiring dialysis. This is a TEN-FOLD higher risk. These same factors similarly identify cardiovascular disease risk and other costs. Unfortunately, despite being the best predictor of risk of dialysis and other adverse events and therefore the best predictor of cost, these critical variables are not included in the measure as they are not widely available in administrative data. Nephrologists look at these data to assign risk and plan therapies with people with advanced CKD, and any measure of risk that does not include these lacks face validity among the nephrology clinical community.
3. Access to care and selection: CMS should also closely monitor access to care for CKD Stage 4 and 5 patients, particularly those with significant comorbidities and those who are socioeconomically vulnerable. Given that nephrologists are now being held accountable for the costs of these patients, they are incentivized to see more stable early CKD (Stages 1-3) as opposed to advanced CKD patients (Stages 4 and 5) with more complex medical and social challenges.
4. Risk adjustment: Capture of hierarchical condition category [HCCs] coding is largely in the purview of primary care and other generalists, and therefore risk adjustment for nephrologists may be imperfect. Additionally, as noted above, critical risk identifiers (including social determinants of health) that account for much of the variability in risk are not included in the measure. 
5. Alignment with APMs: We support CMS’s efforts to align MIPS measures with CMMI measures found in APMs. In particular, we urge CMS to align MIPS CKD measures with those in the Kidney Care Choices (KCC) model. The transition to dialysis is not captured in the CKD Cost measure, but rather in the ESRD measure, which makes the scope of the CKD measure different from the optimal starts measure currently in the KCC model. 
6. Low Reliability: If moved forward, use of the CKD Cost measure should be restricted to practitioners/practices with larger numbers of evaluable patients because the reliability numbers are far below the goal reliability (0.293 for a threshold of 10 patients, 0.386 for a threshold of 20, and 0.448 for a threshold of 30). ASN recommends adopting a high threshold of patients of at least 30-50 to ensure appropriate measure reliability. 
7. Avoiding disincentives for high value care: ASN agrees with the decision to exclude sodium-glucose cotransporter-2 (SGLT2) inhibitor costs. Some patients with CKD stage 4 (with an eGFR of >20 ml/min/1.73m²) are candidates for initiating this drug class that should be continued until the initiation of dialysis. Avoiding disincentives for utilizing SGLT2 inhibitors is critical, and as drugs in the SGLT2 inhibitor class become generic, the cost effectiveness will likely only improve. ASN encourages CMS to develop a performance measure for SGLT2 inhibitor use that can directly measure this utilization. There are other novel, currently high-cost, medications that may also slow the progression of kidney disease, such as several new agents to treat glomerulonephritis (most notably IgA Nephropathy) as well as mineralocorticoid agonists and glucagon-like peptide-1 (GLP1) receptor agonists to treat diabetic kidney disease. The use of these novel therapies that will lead to improved clinical outcomes and lower long-term costs should not be disincentivized. 

MUC2023-204: End-Stage Renal Disease 

Conceptually, ASN supports the development of an ESRD measure because nephrologists who care for these patients often have the ability to shape care delivery and control some modifiable costs, including emergency department visits and inpatient admissions. This was shown in the ESRD Seamless Care Organizations (ESCO) model. 

ASN also has concerns regarding the measure. While reliability is better – at 0.571 for a threshold of 30 patients – there remains considerable room for improvement. Notably, with the absence of comorbidity codes on nephrologist MCP claims, there may be very little data on many patients who have a substantial comorbid condition burden. Also, nephrologists may have limited control over some cost issues given the multiple facilities and providers who may provide care for this population. Given the limited time provided, ASN is unable to provide more detailed comments at this time.

MUC2023-206: Kidney Transplant Management 

Conceptually, ASN supports the development of a kidney transplant management episode of care cost measure. Based on the information provided, however, ASN has numerous questions and concerns. Our ability to relate these in greater detail is impacted by the limited time provided to evaluate these measures. 

1. Risk adjustment: Appropriate risk adjustment for the post-transplant patient population is essential to avoid unintended outcomes. A kidney transplant with even a “low quality” kidney generally confers longer and better quality of life, and lower long-term costs, for patients as compared to dialysis. Recognizing these many benefits, the kidney community is working hard to increase the use of these less-than-perfect kidneys, thereby increasing patient access to the best therapy for kidney failure. Some patients who receive a lower-quality kidney—still for most recipients a better therapy than dialysis—have greater medical care needs, not only in the months immediately following their transplant surgery but also in later months post-90 days. There has been a major movement throughout CMS and the kidney community to remove disincentives to transplant higher Kidney Donor Profile Index (KDPI) kidneys and to provide transplants to individuals with greater comorbid condition burden, including older candidates.

It would run counter to the kidney community’s goals of increasing access to kidney transplantation and increasing organ use to penalize clinicians providing appropriate care for people who have received less-than-perfect kidneys because that expected cost of care is not appropriately adjusted based on the quality of the donor kidney. For this reason, it is essential that information about donor kidney quality be available and be included in the risk adjustment. A data use agreement with Health Resources and Services Administration (HRSA) and/or HRSA contractors who manage the Organ Procurement and Transplantation Network (OPTN) would facilitate the necessary data-sharing for this aspect of the risk adjustment model. This is a critical step. 

1. Data sources: The proposal notes that the data sources for the measure are “Administrative Data (non-claims); Claims Data; Registries.” ASN requests more specific information about these data sources as understanding the data sources would help ASN understand the granularity of the data and make more informed recommendations about the measure. 

MUC2023-138: ESRD Dialysis Patient Life Goals Survey (PaLS)

ASN continues to have concerns that the PaLS tool has not been sufficiently validated for use in this fashion. Under validity testing, it is noted that “empirical validity testing was not performed at the measured entity level” and that entity level reliability testing was not available. While ASN certainly would support a measure that emphasizes patient life goals, it is not clear that this measure has been sufficiently validated to ensure that it is meaningful.

ASN is committed to promoting kidney health, advancing kidney care, and improving the lives of more than 37,000,000 Americans with kidney diseases. Meaningful, accurate cost measures and patient-centered quality measures are a key aspect of this commitment. 

Again, thank you. To discuss this letter, ASN’s concerns about the Partnership for Quality Measurement and the 2023 MSR: ESRD-QIP, or ASN, please contact ASN Regulatory and Quality Officer David White at [email protected]. 

Sincerely,

Michelle A. Josephson, MD, FASN

President

cc:       Chiquita Brooks-LaSure

            Dora L. Hughes, MD

[i]Table 6.1 https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who are members of the American Society of Nephrology (ASN), thank you for the opportunity to comment on the 2023 Pre-Rulemaking Measure Review (PRMR) Measures Under Consideration (MUC) List. 

While appreciative of the opportunity to comment on this critical issue for millions of Americans, ASN is once again disappointed by the limited timeframe for public comment from December 1-22, 2023. Furthermore, several key documents were not made available until midway through the public comment period. The MUC is integral to maintaining high quality care for patients and measuring resource use of clinicians in the Merit-based Incentive Payment System (MIPS). Please see our letter from September 25, 2023, (attached) after the public was given a two-week comment window for the entire 2023 Measure Set Review (MSR): End Stage Renal Disease Quality Incentive Program (ESRD-QIP). ASN is also sharing its concerns on timing and this letter with the Centers for Medicare and Medicaid Services as this has been an annual process challenge pre-dating the existing contractor.

Although ASN supports the development of episode of care cost measures, ASN has concerns relating to the four measures under consideration impacting individuals with kidney failure as well as general and transplant nephrologists and the kidney health team. Specifically, we comment on the following proposed measures: 

• MUC2023-203: Chronic Kidney Disease (CKD)
• MUC2023-204: End-Stage Renal Disease (ESRD)
• MUC2023-206: Kidney Transplant Management 
• MUC2023-138 ESRD Dialysis Patient Life Goals Survey (PaLS)

For background, kidney diseases are the ninth leading cause of death in the United States, resulting in more deaths than breast cancer, and, given the heightened risk of cardiovascular diseases associated with chronic kidney disease (CKD), kidney diseases contribute to millions of additional deaths in the United States from other causes. Unfortunately, kidney diseases and kidney failure are more common among Black, Hispanic or Latinx, Native or Indigenous Americans, Asian Americans, Hawaiians and other Pacific Islanders, people with lower incomes, and older adults. Each of these populations have also been disproportionately affected by the COVID-19 pandemic, exacerbating existing disparities. 

When compared to White Americans, Black Americans are 3.8 times more likely to develop kidney failure, while Hispanic or Latinx Americans are 2.1 times more likely to develop kidney failure. One out of every eleven Black American males will require dialysis during their lifetime. Further, Black, Indigenous, and Hispanic or Latinx Americans are less likely to receive a kidney transplant and are less likely to initiate home dialysis when requiring dialysis for kidney failure. 

While end-stage renal disease affects only one percent of Medicare beneficiaries, it represents seven percent of Medicare’s annual expenditures. Yearly costs for Medicare FFS patients on hemodialysis are approximately $100,000, whereas annual costs for patients with a kidney transplant are approximately $44,000. Costs for patients with CKD are more than double ($28,162/yr[i]) that for those without CKD ($13,604/yr). These statistics highlight the importance of the Partnership for Quality Measurement’s (PQM) actions on MIPS episode-based cost measures.

ASN supports the conceptual use of episode-based costs measures in MIPS, but we highlight the challenges with this approach for people with kidney diseases, a condition that typically is slowly progressive over decades, that is optimally treated with chronic disease management before it has become advanced, and that may have significant periods of transition. 

MUC2023-203 Chronic Kidney Disease 

ASN appreciates the thoughtful deliberations by the TEP and measure contractor to identify costs potentially related to CKD. We note that the TEP did not achieve consensus. We share the following considerations: 

1. Identifying advanced CKD: Patients are identified using ICD-10 codes for CKD Stage 4 and 5. ASN is reassured that a previous analysis conducted by the Center for Outcomes Research & Evaluation, the measure developer for the Delay in Progression of CKD measure, found that ICD-10 codes had high specificity, with over 80% of CKD stage 4/5 patients having laboratory evidence of CKD. However, CMS should closely monitor for gaming behavior in coding, as clinicians may code N18.9 CKD, unspecified to avoid having high-cost patients attributed to the CKD cost measure. As a result, in the long-term the appropriate identification of stage 4/5 patients could be impacted. 
2. Heterogeneity within advanced CKD: Individuals with CKD stage 4/5 differ tremendously from each other, with the estimated glomerular filtration rate (eGFR) and the quantification of albumin in the urine (often referred to as the urine albumin to creatinine ratio) providing substantial information about prognosis and therefore about projected costs. For example, using the Kidney Failure Risk Equation, a 70-year-old woman with an eGFR of 25 and a urine albumin to creatinine ratio of 20 mg/g has a 2.9% 2-year and an 8.7% 5-year risk of requiring dialysis. In contrast, a 70-year-old woman with an eGFR of 17 and a urine albumin to creatinine ratio of 900 mg/g has a 32.6% 2-year and a 70.9% 5-year risk of requiring dialysis. This is a TEN-FOLD higher risk. These same factors similarly identify cardiovascular disease risk and other costs. Unfortunately, despite being the best predictor of risk of dialysis and other adverse events and therefore the best predictor of cost, these critical variables are not included in the measure as they are not widely available in administrative data. Nephrologists look at these data to assign risk and plan therapies with people with advanced CKD, and any measure of risk that does not include these lacks face validity among the nephrology clinical community.
3. Access to care and selection: CMS should also closely monitor access to care for CKD Stage 4 and 5 patients, particularly those with significant comorbidities and those who are socioeconomically vulnerable. Given that nephrologists are now being held accountable for the costs of these patients, they are incentivized to see more stable early CKD (Stages 1-3) as opposed to advanced CKD patients (Stages 4 and 5) with more complex medical and social challenges.
4. Risk adjustment: Capture of hierarchical condition category [HCCs] coding is largely in the purview of primary care and other generalists, and therefore risk adjustment for nephrologists may be imperfect. Additionally, as noted above, critical risk identifiers (including social determinants of health) that account for much of the variability in risk are not included in the measure. 
5. Alignment with APMs: We support CMS’s efforts to align MIPS measures with CMMI measures found in APMs. In particular, we urge CMS to align MIPS CKD measures with those in the Kidney Care Choices (KCC) model. The transition to dialysis is not captured in the CKD Cost measure, but rather in the ESRD measure, which makes the scope of the CKD measure different from the optimal starts measure currently in the KCC model. 
6. Low Reliability: If moved forward, use of the CKD Cost measure should be restricted to practitioners/practices with larger numbers of evaluable patients because the reliability numbers are far below the goal reliability (0.293 for a threshold of 10 patients, 0.386 for a threshold of 20, and 0.448 for a threshold of 30). ASN recommends adopting a high threshold of patients of at least 30-50 to ensure appropriate measure reliability. 
7. Avoiding disincentives for high value care: ASN agrees with the decision to exclude sodium-glucose cotransporter-2 (SGLT2) inhibitor costs. Some patients with CKD stage 4 (with an eGFR of >20 ml/min/1.73m²) are candidates for initiating this drug class that should be continued until the initiation of dialysis. Avoiding disincentives for utilizing SGLT2 inhibitors is critical, and as drugs in the SGLT2 inhibitor class become generic, the cost effectiveness will likely only improve. ASN encourages CMS to develop a performance measure for SGLT2 inhibitor use that can directly measure this utilization. There are other novel, currently high-cost, medications that may also slow the progression of kidney disease, such as several new agents to treat glomerulonephritis (most notably IgA Nephropathy) as well as mineralocorticoid agonists and glucagon-like peptide-1 (GLP1) receptor agonists to treat diabetic kidney disease. The use of these novel therapies that will lead to improved clinical outcomes and lower long-term costs should not be disincentivized. 

MUC2023-204: End-Stage Renal Disease 

Conceptually, ASN supports the development of an ESRD measure because nephrologists who care for these patients often have the ability to shape care delivery and control some modifiable costs, including emergency department visits and inpatient admissions. This was shown in the ESRD Seamless Care Organizations (ESCO) model. 

ASN also has concerns regarding the measure. While reliability is better – at 0.571 for a threshold of 30 patients – there remains considerable room for improvement. Notably, with the absence of comorbidity codes on nephrologist MCP claims, there may be very little data on many patients who have a substantial comorbid condition burden. Also, nephrologists may have limited control over some cost issues given the multiple facilities and providers who may provide care for this population. Given the limited time provided, ASN is unable to provide more detailed comments at this time.

MUC2023-206: Kidney Transplant Management 

Conceptually, ASN supports the development of a kidney transplant management episode of care cost measure. Based on the information provided, however, ASN has numerous questions and concerns. Our ability to relate these in greater detail is impacted by the limited time provided to evaluate these measures. 

1. Risk adjustment: Appropriate risk adjustment for the post-transplant patient population is essential to avoid unintended outcomes. A kidney transplant with even a “low quality” kidney generally confers longer and better quality of life, and lower long-term costs, for patients as compared to dialysis. Recognizing these many benefits, the kidney community is working hard to increase the use of these less-than-perfect kidneys, thereby increasing patient access to the best therapy for kidney failure. Some patients who receive a lower-quality kidney—still for most recipients a better therapy than dialysis—have greater medical care needs, not only in the months immediately following their transplant surgery but also in later months post-90 days. There has been a major movement throughout CMS and the kidney community to remove disincentives to transplant higher Kidney Donor Profile Index (KDPI) kidneys and to provide transplants to individuals with greater comorbid condition burden, including older candidates.

It would run counter to the kidney community’s goals of increasing access to kidney transplantation and increasing organ use to penalize clinicians providing appropriate care for people who have received less-than-perfect kidneys because that expected cost of care is not appropriately adjusted based on the quality of the donor kidney. For this reason, it is essential that information about donor kidney quality be available and be included in the risk adjustment. A data use agreement with Health Resources and Services Administration (HRSA) and/or HRSA contractors who manage the Organ Procurement and Transplantation Network (OPTN) would facilitate the necessary data-sharing for this aspect of the risk adjustment model. This is a critical step. 

1. Data sources: The proposal notes that the data sources for the measure are “Administrative Data (non-claims); Claims Data; Registries.” ASN requests more specific information about these data sources as understanding the data sources would help ASN understand the granularity of the data and make more informed recommendations about the measure. 

MUC2023-138: ESRD Dialysis Patient Life Goals Survey (PaLS)

ASN continues to have concerns that the PaLS tool has not been sufficiently validated for use in this fashion. Under validity testing, it is noted that “empirical validity testing was not performed at the measured entity level” and that entity level reliability testing was not available. While ASN certainly would support a measure that emphasizes patient life goals, it is not clear that this measure has been sufficiently validated to ensure that it is meaningful.

ASN is committed to promoting kidney health, advancing kidney care, and improving the lives of more than 37,000,000 Americans with kidney diseases. Meaningful, accurate cost measures and patient-centered quality measures are a key aspect of this commitment. 

Again, thank you. To discuss this letter, ASN’s concerns about the Partnership for Quality Measurement and the 2023 MSR: ESRD-QIP, or ASN, please contact ASN Regulatory and Quality Officer David White at [email protected]. 

Sincerely,

Michelle A. Josephson, MD, FASN

President

cc:       Chiquita Brooks-LaSure

            Dora L. Hughes, MD

[i]Table 6.1 https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who are members of the American Society of Nephrology (ASN), thank you for the opportunity to comment on the 2023 Pre-Rulemaking Measure Review (PRMR) Measures Under Consideration (MUC) List. 

While appreciative of the opportunity to comment on this critical issue for millions of Americans, ASN is once again disappointed by the limited timeframe for public comment from December 1-22, 2023. Furthermore, several key documents were not made available until midway through the public comment period. The MUC is integral to maintaining high quality care for patients and measuring resource use of clinicians in the Merit-based Incentive Payment System (MIPS). Please see our letter from September 25, 2023, (attached) after the public was given a two-week comment window for the entire 2023 Measure Set Review (MSR): End Stage Renal Disease Quality Incentive Program (ESRD-QIP). ASN is also sharing its concerns on timing and this letter with the Centers for Medicare and Medicaid Services as this has been an annual process challenge pre-dating the existing contractor.

Although ASN supports the development of episode of care cost measures, ASN has concerns relating to the four measures under consideration impacting individuals with kidney failure as well as general and transplant nephrologists and the kidney health team. Specifically, we comment on the following proposed measures: 

• MUC2023-203: Chronic Kidney Disease (CKD)
• MUC2023-204: End-Stage Renal Disease (ESRD)
• MUC2023-206: Kidney Transplant Management 
• MUC2023-138 ESRD Dialysis Patient Life Goals Survey (PaLS)

For background, kidney diseases are the ninth leading cause of death in the United States, resulting in more deaths than breast cancer, and, given the heightened risk of cardiovascular diseases associated with chronic kidney disease (CKD), kidney diseases contribute to millions of additional deaths in the United States from other causes. Unfortunately, kidney diseases and kidney failure are more common among Black, Hispanic or Latinx, Native or Indigenous Americans, Asian Americans, Hawaiians and other Pacific Islanders, people with lower incomes, and older adults. Each of these populations have also been disproportionately affected by the COVID-19 pandemic, exacerbating existing disparities. 

When compared to White Americans, Black Americans are 3.8 times more likely to develop kidney failure, while Hispanic or Latinx Americans are 2.1 times more likely to develop kidney failure. One out of every eleven Black American males will require dialysis during their lifetime. Further, Black, Indigenous, and Hispanic or Latinx Americans are less likely to receive a kidney transplant and are less likely to initiate home dialysis when requiring dialysis for kidney failure. 

While end-stage renal disease affects only one percent of Medicare beneficiaries, it represents seven percent of Medicare’s annual expenditures. Yearly costs for Medicare FFS patients on hemodialysis are approximately $100,000, whereas annual costs for patients with a kidney transplant are approximately $44,000. Costs for patients with CKD are more than double ($28,162/yr[i]) that for those without CKD ($13,604/yr). These statistics highlight the importance of the Partnership for Quality Measurement’s (PQM) actions on MIPS episode-based cost measures.

ASN supports the conceptual use of episode-based costs measures in MIPS, but we highlight the challenges with this approach for people with kidney diseases, a condition that typically is slowly progressive over decades, that is optimally treated with chronic disease management before it has become advanced, and that may have significant periods of transition. 

MUC2023-203 Chronic Kidney Disease 

ASN appreciates the thoughtful deliberations by the TEP and measure contractor to identify costs potentially related to CKD. We note that the TEP did not achieve consensus. We share the following considerations: 

1. Identifying advanced CKD: Patients are identified using ICD-10 codes for CKD Stage 4 and 5. ASN is reassured that a previous analysis conducted by the Center for Outcomes Research & Evaluation, the measure developer for the Delay in Progression of CKD measure, found that ICD-10 codes had high specificity, with over 80% of CKD stage 4/5 patients having laboratory evidence of CKD. However, CMS should closely monitor for gaming behavior in coding, as clinicians may code N18.9 CKD, unspecified to avoid having high-cost patients attributed to the CKD cost measure. As a result, in the long-term the appropriate identification of stage 4/5 patients could be impacted. 
2. Heterogeneity within advanced CKD: Individuals with CKD stage 4/5 differ tremendously from each other, with the estimated glomerular filtration rate (eGFR) and the quantification of albumin in the urine (often referred to as the urine albumin to creatinine ratio) providing substantial information about prognosis and therefore about projected costs. For example, using the Kidney Failure Risk Equation, a 70-year-old woman with an eGFR of 25 and a urine albumin to creatinine ratio of 20 mg/g has a 2.9% 2-year and an 8.7% 5-year risk of requiring dialysis. In contrast, a 70-year-old woman with an eGFR of 17 and a urine albumin to creatinine ratio of 900 mg/g has a 32.6% 2-year and a 70.9% 5-year risk of requiring dialysis. This is a TEN-FOLD higher risk. These same factors similarly identify cardiovascular disease risk and other costs. Unfortunately, despite being the best predictor of risk of dialysis and other adverse events and therefore the best predictor of cost, these critical variables are not included in the measure as they are not widely available in administrative data. Nephrologists look at these data to assign risk and plan therapies with people with advanced CKD, and any measure of risk that does not include these lacks face validity among the nephrology clinical community.
3. Access to care and selection: CMS should also closely monitor access to care for CKD Stage 4 and 5 patients, particularly those with significant comorbidities and those who are socioeconomically vulnerable. Given that nephrologists are now being held accountable for the costs of these patients, they are incentivized to see more stable early CKD (Stages 1-3) as opposed to advanced CKD patients (Stages 4 and 5) with more complex medical and social challenges.
4. Risk adjustment: Capture of hierarchical condition category [HCCs] coding is largely in the purview of primary care and other generalists, and therefore risk adjustment for nephrologists may be imperfect. Additionally, as noted above, critical risk identifiers (including social determinants of health) that account for much of the variability in risk are not included in the measure. 
5. Alignment with APMs: We support CMS’s efforts to align MIPS measures with CMMI measures found in APMs. In particular, we urge CMS to align MIPS CKD measures with those in the Kidney Care Choices (KCC) model. The transition to dialysis is not captured in the CKD Cost measure, but rather in the ESRD measure, which makes the scope of the CKD measure different from the optimal starts measure currently in the KCC model. 
6. Low Reliability: If moved forward, use of the CKD Cost measure should be restricted to practitioners/practices with larger numbers of evaluable patients because the reliability numbers are far below the goal reliability (0.293 for a threshold of 10 patients, 0.386 for a threshold of 20, and 0.448 for a threshold of 30). ASN recommends adopting a high threshold of patients of at least 30-50 to ensure appropriate measure reliability. 
7. Avoiding disincentives for high value care: ASN agrees with the decision to exclude sodium-glucose cotransporter-2 (SGLT2) inhibitor costs. Some patients with CKD stage 4 (with an eGFR of >20 ml/min/1.73m²) are candidates for initiating this drug class that should be continued until the initiation of dialysis. Avoiding disincentives for utilizing SGLT2 inhibitors is critical, and as drugs in the SGLT2 inhibitor class become generic, the cost effectiveness will likely only improve. ASN encourages CMS to develop a performance measure for SGLT2 inhibitor use that can directly measure this utilization. There are other novel, currently high-cost, medications that may also slow the progression of kidney disease, such as several new agents to treat glomerulonephritis (most notably IgA Nephropathy) as well as mineralocorticoid agonists and glucagon-like peptide-1 (GLP1) receptor agonists to treat diabetic kidney disease. The use of these novel therapies that will lead to improved clinical outcomes and lower long-term costs should not be disincentivized. 

MUC2023-204: End-Stage Renal Disease 

Conceptually, ASN supports the development of an ESRD measure because nephrologists who care for these patients often have the ability to shape care delivery and control some modifiable costs, including emergency department visits and inpatient admissions. This was shown in the ESRD Seamless Care Organizations (ESCO) model. 

ASN also has concerns regarding the measure. While reliability is better – at 0.571 for a threshold of 30 patients – there remains considerable room for improvement. Notably, with the absence of comorbidity codes on nephrologist MCP claims, there may be very little data on many patients who have a substantial comorbid condition burden. Also, nephrologists may have limited control over some cost issues given the multiple facilities and providers who may provide care for this population. Given the limited time provided, ASN is unable to provide more detailed comments at this time.

MUC2023-206: Kidney Transplant Management 

Conceptually, ASN supports the development of a kidney transplant management episode of care cost measure. Based on the information provided, however, ASN has numerous questions and concerns. Our ability to relate these in greater detail is impacted by the limited time provided to evaluate these measures. 

1. Risk adjustment: Appropriate risk adjustment for the post-transplant patient population is essential to avoid unintended outcomes. A kidney transplant with even a “low quality” kidney generally confers longer and better quality of life, and lower long-term costs, for patients as compared to dialysis. Recognizing these many benefits, the kidney community is working hard to increase the use of these less-than-perfect kidneys, thereby increasing patient access to the best therapy for kidney failure. Some patients who receive a lower-quality kidney—still for most recipients a better therapy than dialysis—have greater medical care needs, not only in the months immediately following their transplant surgery but also in later months post-90 days. There has been a major movement throughout CMS and the kidney community to remove disincentives to transplant higher Kidney Donor Profile Index (KDPI) kidneys and to provide transplants to individuals with greater comorbid condition burden, including older candidates.

It would run counter to the kidney community’s goals of increasing access to kidney transplantation and increasing organ use to penalize clinicians providing appropriate care for people who have received less-than-perfect kidneys because that expected cost of care is not appropriately adjusted based on the quality of the donor kidney. For this reason, it is essential that information about donor kidney quality be available and be included in the risk adjustment. A data use agreement with Health Resources and Services Administration (HRSA) and/or HRSA contractors who manage the Organ Procurement and Transplantation Network (OPTN) would facilitate the necessary data-sharing for this aspect of the risk adjustment model. This is a critical step. 

1. Data sources: The proposal notes that the data sources for the measure are “Administrative Data (non-claims); Claims Data; Registries.” ASN requests more specific information about these data sources as understanding the data sources would help ASN understand the granularity of the data and make more informed recommendations about the measure. 

MUC2023-138: ESRD Dialysis Patient Life Goals Survey (PaLS)

ASN continues to have concerns that the PaLS tool has not been sufficiently validated for use in this fashion. Under validity testing, it is noted that “empirical validity testing was not performed at the measured entity level” and that entity level reliability testing was not available. While ASN certainly would support a measure that emphasizes patient life goals, it is not clear that this measure has been sufficiently validated to ensure that it is meaningful.

ASN is committed to promoting kidney health, advancing kidney care, and improving the lives of more than 37,000,000 Americans with kidney diseases. Meaningful, accurate cost measures and patient-centered quality measures are a key aspect of this commitment. 

Again, thank you. To discuss this letter, ASN’s concerns about the Partnership for Quality Measurement and the 2023 MSR: ESRD-QIP, or ASN, please contact ASN Regulatory and Quality Officer David White at [email protected]. 

Sincerely,

Michelle A. Josephson, MD, FASN

President

cc:       Chiquita Brooks-LaSure

            Dora L. Hughes, MD

[i]Table 6.1 https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who are members of the American Society of Nephrology (ASN), thank you for the opportunity to comment on the 2023 Pre-Rulemaking Measure Review (PRMR) Measures Under Consideration (MUC) List. 

While appreciative of the opportunity to comment on this critical issue for millions of Americans, ASN is once again disappointed by the limited timeframe for public comment from December 1-22, 2023. Furthermore, several key documents were not made available until midway through the public comment period. The MUC is integral to maintaining high quality care for patients and measuring resource use of clinicians in the Merit-based Incentive Payment System (MIPS). Please see our letter from September 25, 2023, (attached) after the public was given a two-week comment window for the entire 2023 Measure Set Review (MSR): End Stage Renal Disease Quality Incentive Program (ESRD-QIP). ASN is also sharing its concerns on timing and this letter with the Centers for Medicare and Medicaid Services as this has been an annual process challenge pre-dating the existing contractor.

Although ASN supports the development of episode of care cost measures, ASN has concerns relating to the four measures under consideration impacting individuals with kidney failure as well as general and transplant nephrologists and the kidney health team. Specifically, we comment on the following proposed measures: 

• MUC2023-203: Chronic Kidney Disease (CKD)
• MUC2023-204: End-Stage Renal Disease (ESRD)
• MUC2023-206: Kidney Transplant Management 
• MUC2023-138 ESRD Dialysis Patient Life Goals Survey (PaLS)

For background, kidney diseases are the ninth leading cause of death in the United States, resulting in more deaths than breast cancer, and, given the heightened risk of cardiovascular diseases associated with chronic kidney disease (CKD), kidney diseases contribute to millions of additional deaths in the United States from other causes. Unfortunately, kidney diseases and kidney failure are more common among Black, Hispanic or Latinx, Native or Indigenous Americans, Asian Americans, Hawaiians and other Pacific Islanders, people with lower incomes, and older adults. Each of these populations have also been disproportionately affected by the COVID-19 pandemic, exacerbating existing disparities. 

When compared to White Americans, Black Americans are 3.8 times more likely to develop kidney failure, while Hispanic or Latinx Americans are 2.1 times more likely to develop kidney failure. One out of every eleven Black American males will require dialysis during their lifetime. Further, Black, Indigenous, and Hispanic or Latinx Americans are less likely to receive a kidney transplant and are less likely to initiate home dialysis when requiring dialysis for kidney failure. 

While end-stage renal disease affects only one percent of Medicare beneficiaries, it represents seven percent of Medicare’s annual expenditures. Yearly costs for Medicare FFS patients on hemodialysis are approximately $100,000, whereas annual costs for patients with a kidney transplant are approximately $44,000. Costs for patients with CKD are more than double ($28,162/yr[i]) that for those without CKD ($13,604/yr). These statistics highlight the importance of the Partnership for Quality Measurement’s (PQM) actions on MIPS episode-based cost measures.

ASN supports the conceptual use of episode-based costs measures in MIPS, but we highlight the challenges with this approach for people with kidney diseases, a condition that typically is slowly progressive over decades, that is optimally treated with chronic disease management before it has become advanced, and that may have significant periods of transition. 

MUC2023-203 Chronic Kidney Disease 

ASN appreciates the thoughtful deliberations by the TEP and measure contractor to identify costs potentially related to CKD. We note that the TEP did not achieve consensus. We share the following considerations: 

1. Identifying advanced CKD: Patients are identified using ICD-10 codes for CKD Stage 4 and 5. ASN is reassured that a previous analysis conducted by the Center for Outcomes Research & Evaluation, the measure developer for the Delay in Progression of CKD measure, found that ICD-10 codes had high specificity, with over 80% of CKD stage 4/5 patients having laboratory evidence of CKD. However, CMS should closely monitor for gaming behavior in coding, as clinicians may code N18.9 CKD, unspecified to avoid having high-cost patients attributed to the CKD cost measure. As a result, in the long-term the appropriate identification of stage 4/5 patients could be impacted. 
2. Heterogeneity within advanced CKD: Individuals with CKD stage 4/5 differ tremendously from each other, with the estimated glomerular filtration rate (eGFR) and the quantification of albumin in the urine (often referred to as the urine albumin to creatinine ratio) providing substantial information about prognosis and therefore about projected costs. For example, using the Kidney Failure Risk Equation, a 70-year-old woman with an eGFR of 25 and a urine albumin to creatinine ratio of 20 mg/g has a 2.9% 2-year and an 8.7% 5-year risk of requiring dialysis. In contrast, a 70-year-old woman with an eGFR of 17 and a urine albumin to creatinine ratio of 900 mg/g has a 32.6% 2-year and a 70.9% 5-year risk of requiring dialysis. This is a TEN-FOLD higher risk. These same factors similarly identify cardiovascular disease risk and other costs. Unfortunately, despite being the best predictor of risk of dialysis and other adverse events and therefore the best predictor of cost, these critical variables are not included in the measure as they are not widely available in administrative data. Nephrologists look at these data to assign risk and plan therapies with people with advanced CKD, and any measure of risk that does not include these lacks face validity among the nephrology clinical community.
3. Access to care and selection: CMS should also closely monitor access to care for CKD Stage 4 and 5 patients, particularly those with significant comorbidities and those who are socioeconomically vulnerable. Given that nephrologists are now being held accountable for the costs of these patients, they are incentivized to see more stable early CKD (Stages 1-3) as opposed to advanced CKD patients (Stages 4 and 5) with more complex medical and social challenges.
4. Risk adjustment: Capture of hierarchical condition category [HCCs] coding is largely in the purview of primary care and other generalists, and therefore risk adjustment for nephrologists may be imperfect. Additionally, as noted above, critical risk identifiers (including social determinants of health) that account for much of the variability in risk are not included in the measure. 
5. Alignment with APMs: We support CMS’s efforts to align MIPS measures with CMMI measures found in APMs. In particular, we urge CMS to align MIPS CKD measures with those in the Kidney Care Choices (KCC) model. The transition to dialysis is not captured in the CKD Cost measure, but rather in the ESRD measure, which makes the scope of the CKD measure different from the optimal starts measure currently in the KCC model. 
6. Low Reliability: If moved forward, use of the CKD Cost measure should be restricted to practitioners/practices with larger numbers of evaluable patients because the reliability numbers are far below the goal reliability (0.293 for a threshold of 10 patients, 0.386 for a threshold of 20, and 0.448 for a threshold of 30). ASN recommends adopting a high threshold of patients of at least 30-50 to ensure appropriate measure reliability. 
7. Avoiding disincentives for high value care: ASN agrees with the decision to exclude sodium-glucose cotransporter-2 (SGLT2) inhibitor costs. Some patients with CKD stage 4 (with an eGFR of >20 ml/min/1.73m²) are candidates for initiating this drug class that should be continued until the initiation of dialysis. Avoiding disincentives for utilizing SGLT2 inhibitors is critical, and as drugs in the SGLT2 inhibitor class become generic, the cost effectiveness will likely only improve. ASN encourages CMS to develop a performance measure for SGLT2 inhibitor use that can directly measure this utilization. There are other novel, currently high-cost, medications that may also slow the progression of kidney disease, such as several new agents to treat glomerulonephritis (most notably IgA Nephropathy) as well as mineralocorticoid agonists and glucagon-like peptide-1 (GLP1) receptor agonists to treat diabetic kidney disease. The use of these novel therapies that will lead to improved clinical outcomes and lower long-term costs should not be disincentivized. 

MUC2023-204: End-Stage Renal Disease 

Conceptually, ASN supports the development of an ESRD measure because nephrologists who care for these patients often have the ability to shape care delivery and control some modifiable costs, including emergency department visits and inpatient admissions. This was shown in the ESRD Seamless Care Organizations (ESCO) model. 

ASN also has concerns regarding the measure. While reliability is better – at 0.571 for a threshold of 30 patients – there remains considerable room for improvement. Notably, with the absence of comorbidity codes on nephrologist MCP claims, there may be very little data on many patients who have a substantial comorbid condition burden. Also, nephrologists may have limited control over some cost issues given the multiple facilities and providers who may provide care for this population. Given the limited time provided, ASN is unable to provide more detailed comments at this time.

MUC2023-206: Kidney Transplant Management 

Conceptually, ASN supports the development of a kidney transplant management episode of care cost measure. Based on the information provided, however, ASN has numerous questions and concerns. Our ability to relate these in greater detail is impacted by the limited time provided to evaluate these measures. 

1. Risk adjustment: Appropriate risk adjustment for the post-transplant patient population is essential to avoid unintended outcomes. A kidney transplant with even a “low quality” kidney generally confers longer and better quality of life, and lower long-term costs, for patients as compared to dialysis. Recognizing these many benefits, the kidney community is working hard to increase the use of these less-than-perfect kidneys, thereby increasing patient access to the best therapy for kidney failure. Some patients who receive a lower-quality kidney—still for most recipients a better therapy than dialysis—have greater medical care needs, not only in the months immediately following their transplant surgery but also in later months post-90 days. There has been a major movement throughout CMS and the kidney community to remove disincentives to transplant higher Kidney Donor Profile Index (KDPI) kidneys and to provide transplants to individuals with greater comorbid condition burden, including older candidates.

It would run counter to the kidney community’s goals of increasing access to kidney transplantation and increasing organ use to penalize clinicians providing appropriate care for people who have received less-than-perfect kidneys because that expected cost of care is not appropriately adjusted based on the quality of the donor kidney. For this reason, it is essential that information about donor kidney quality be available and be included in the risk adjustment. A data use agreement with Health Resources and Services Administration (HRSA) and/or HRSA contractors who manage the Organ Procurement and Transplantation Network (OPTN) would facilitate the necessary data-sharing for this aspect of the risk adjustment model. This is a critical step. 

1. Data sources: The proposal notes that the data sources for the measure are “Administrative Data (non-claims); Claims Data; Registries.” ASN requests more specific information about these data sources as understanding the data sources would help ASN understand the granularity of the data and make more informed recommendations about the measure. 

MUC2023-138: ESRD Dialysis Patient Life Goals Survey (PaLS)

ASN continues to have concerns that the PaLS tool has not been sufficiently validated for use in this fashion. Under validity testing, it is noted that “empirical validity testing was not performed at the measured entity level” and that entity level reliability testing was not available. While ASN certainly would support a measure that emphasizes patient life goals, it is not clear that this measure has been sufficiently validated to ensure that it is meaningful.

ASN is committed to promoting kidney health, advancing kidney care, and improving the lives of more than 37,000,000 Americans with kidney diseases. Meaningful, accurate cost measures and patient-centered quality measures are a key aspect of this commitment. 

Again, thank you. To discuss this letter, ASN’s concerns about the Partnership for Quality Measurement and the 2023 MSR: ESRD-QIP, or ASN, please contact ASN Regulatory and Quality Officer David White at [email protected]. 

Sincerely,

Michelle A. Josephson, MD, FASN

President

cc:       Chiquita Brooks-LaSure

            Dora L. Hughes, MD

[i]Table 6.1 https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd

Comments from the AAMC to the Clinician Committee are attached.

My name is Dr Viji Kurup.  I am writing as a Patient Safety Champion with Patients for Patient Safety US, which is a patient led network of people who feel that making healthcare safer is an urgent priority.  I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

It is a fundamental moral and ethical responsibility to deliver safe care. Patient safety is at a crossroads, having seen a decline in commitment and systematic improvement for many years, accelerated by the pandemic. I believe that our hospitals and health systems have struggled in their commitment to safe care because it is under resourced and not a priority.

The Patient Safety Structural Measure provides much needed guidance to hospital leaders on the ways that they can deliver safer care. It also creates a way to recognize the hospitals and health systems who are exemplars for their leadership and action on patient safety. The questions the Patient Safety Structural Measure asks hospital leaders to attest to reflect what patients in the United States expect all hospitals to be doing, and it aligns with other national guidance such as the Safer Together: The National Action Plan to Advance Patient Safety.

For all these reasons I strongly support the Patient Safety Structural Measure.  Thank you for this opportunity to make this public comment.

I fully and heartily support the PSSM, MUC2023-188 and urge its adoption by CMS.  Many years ago, I worked at Beth Israel Hospital in Boston, MA, and the Director, whose name escapes me, proposed and adopted for BIH the then revolutionary Patient's Bill of Rights, for the first time setting the standards by which patients, and their families as I recall, were to be treated and what they could expect from the health professionals at BIH.   Unexpected reactions to otherwise proper medical treatments are an unfortunate fact of life.  However, the death by medical mistake, such as the one suffered by our children's 55 year old orthodontist and another suffered by my classmate's wife are inexcusable, unacceptable result of laziness, inattention, or incompetence.   Perpetrators of these tragedies, and administrators aiding and abetting coverups and obfuscation of these tragedies, should not be able to escape exposure, publicity, and appropriate punishment. 

Knowing the truth about a medical provider and the facility in which he or she operates is a keystone of informed consent.  If you knew a doctor or a hospital had caused one or more medical errors, would you consent to treatment?  Please adopt MUC2023-188.  Thank you.

MUC2023-156- Screening for Social Drivers of Health (SDOH)

In general, it feels like this aligns with the direction CSMC is heading in but worry about the realities of the scope of work since this will basically mandate SDOH screening everywhere. This policy mentions some outpatient visits that don't seem that relevant, why would we screen for someone coming to get an X-ray but not in the PCP office? We also wonder about duplicative screening and what processes will be in place to validate previous screening or flexibilities in terms of how often screening takes place. This aligns with the CMS Universal Foundation (meaningful measures 2.0 mentioned in Rationale). Also again- emphasis on screening without any incentive to follow up or provide a resource which can be dangerous. We would want this to be an eQCM and not structural measure. Inclusion of interpersonal violence is under review by other measures so that should be determined prior to finalizing this policy.

The National Association of ACOs agrees with the intent of this measure and supports inclusion of this measure in the Part C & D Star Ratings program. Ensuring that patients have timely access to care that is clinically appropriate and necessary is critical and this measure will increase transparency around the prior authorization process. 

MUC2023-199- Connection to Community Service Provider

This would be a very difficult measure to comply with.  It has taken a tremendous amount of resources to get the SDOH screening for all adult inpatients up and running. To follow up so closely with a new measure such as this will be difficult for many reasons including: (1) Current SDOH screening processes may not include the question for patients to assess if they want help with services so that may require a revision of processes that were likely just recently rolled out, (2) Assumes that the community organizations have the bandwidth and capacity to accommodate the volume of referrals they are getting. Our experience is that orgs that 6 months ago were easily able to accommodate our social care referrals, are now back logged and have waiting lists given the volume of referrals they are now getting since there are many hospitals now referring to them.  (3) hospitals would have to hirer people to follow up patients within 60 days to know if they followed up -- this would be difficulty given current financial constraints.  Besides the financial considerations, tracking down people after a hospital stay can prove to be quite difficult.   

The National Association of ACOs (NAACOS) agrees with the intent of this measure but asks that PRMR consider the potential for unintended consequences that may result from its use. We are concerned that there is a real risk that this measure will not truly represent the quality of care provided. Specifically, a health plan’s ability to provide treatment options to patients may be very dependent on the availability of services within a community or region and the measure does not currently account for those instances. In addition, because the measure relies on administrative claims, it does not capture patient choice such as refusal of treatment. We were unable to identify any analyses or other information demonstrating that the developer has evaluated the degree to which these scenarios (e.g., availability of services in an area) impact the validity of the performance scores. As a result, we do not believe that it is appropriate to recommend this measure for the Part C & D Star Ratings program at this time. However, we caution that use of this measure in other programs like the MSSP should not move forward until or unless CMS is able to share this data with ACOs.

MUC2023-210- Resolution of At Least 1 Health-Related Social Need

Comment: This would be a very difficult measure to comply with. Given that we are not a closed health system, many of the patients who screen positive for a HRSN during an inpatient stay, do not then subsequently follow up in our ambulatory practices.  As a results, complying with this measure would means hiring new staff to locate and rescreen patients for the SDOH domain that they were previously positive in. This would very challenging, particularly considering that many of the patients we care for that have the highest social need are also at high likelihood of having contact information that changes overtime.

The National Association of ACOs (NAACOS) and its members are committed to advancing efforts that address health inequities, including quality measures work that addresses this issue. NAACOS requests clarification on why the Screening for Social Drivers of Health (SDOH) measure was not first proposed for the Medicare Shared Savings Program (MSSP). No measures have been submitted on the Measures Under Consideration (MUC) list for MSSP in the previous two years and we do not believe that this measure should be considered without first introducing the screening measure as has been the case in other value programs. While we support the intent of this measure and its application to accountable care organizations (ACOs), the measure is not accurately specified for use by an ACO. Specifically, the measure is currently limited to patients who are discharged from the hospital, which limits the scope of the measure and increases the measure’s complexity when implemented for MSSP. In addition, this measure has not been tested to demonstrate reliability and validity and we question whether the performance scores can truly distinguish differences in the quality of care provided versus availability of services. We urge CMS to first refine the SDOH measures based on feedback from the field and then propose first the screening for SDOH for MSSP. While many ACOs are already working in this area, there are multiple challenges with the measure specifics that ACOs will need time to adjust to in workflow changes and other operational challenges that will need to be planned for. By allowing ACOs and others to gain experience with screening for these important risk factors, we will address patients’ needs while also building the capabilities to be successful with this particular measure as it has been designed specifically. 

The National Association of ACOs (NAACOS) and its members are committed to advancing efforts that address health inequities, including quality measures work that addresses this issue. NAACOS requests clarification on why the Screening for Social Drivers of Health (SDOH) measure was not first proposed for the Medicare Shared Savings Program (MSSP). No measures have been submitted on the Measures Under Consideration (MUC) list for MSSP in the previous two years and we do not believe that this measure should be considered without first introducing the screening measure as has been the case in other value programs. While we agree that resolving the social needs for patients is important and positively impact patients’ quality of life, we do not believe that CMS should move forward with this measure until it is precisely specified and tested. For example, the measure is currently limited to patients who are discharged from the hospital, which limits the scope of the measure and increases the measure’s complexity when implemented for MSSP. In addition, this measure has not been tested to demonstrate reliability and validity and we question whether the performance scores can truly distinguish differences in the quality of care provided versus availability of services. While they may address critical gaps in care, there is a risk of unintended negative consequences when poorly specified and untested measures are implemented in value-based payment programs. We urge CMS to first refine the SDOH measures based on feedback from the field and then propose first the screening for SDOH for MSSP. By allowing ACOs and others to gain experience with screening for these important risk factors, we will address patients’ needs while also building the capabilities to be successful with this particular measure as it has been designed specifically. 

My name is Wanda Clevenger.  I am a nurse and for the past 20 years have worked in patient safety. Recently, while at the bedside of a family member who was neglected and permanently harmed at a large, tertiary care hospital, I came to fully appreciated how compromised quality care standards and patient safety have become. Patients and their loved ones are left out of the care process even when attempting to bring attention to a pending care crisis. When communicating to staff incidents of neglect and harm, I was asked by staff to escalate these issues because they felt powerless to do so. I asked that patient safety incident reports be completed on my family member's care issues, I have no idea if my request was followed through on.     

My personal and professional experiences informs my role as a Patient Safety Champion with Patients for Patient Safety US, a patient led network of people who feel that making healthcare safe is an urgent priority.  I write in strong support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.
 

It is a fundamental moral and ethical responsibility to deliver safe care. My great concern is that patient safety is no longer prioritized. Neglect and harm seem to be a widely accepted component of our health care delivery system. This is not right and should not be tolerated. 

The Patient Safety Structural Measure provides much needed guidance to hospital leaders on the ways that they can deliver safer care. It also creates a way to recognize the hospitals and health systems who are exemplars for their leadership and action on patient safety. The questions the Patient Safety Structural Measure asks hospital leaders to attest to reflect what patients in the United States expect all hospitals to be doing.  In addition, the PSSM aligns with other national guidance such as the Safer Together: The National Action Plan to Advance Patient Safety, the CMS National Quality Strategy, and the September 2023 Report to the President: A Transformational Effort on Patient Safety, issued by the President’s Council of Advisors on Science and Technology.

For all these reasons I strongly support the Patient Safety Structural Measure.  Thank you for this opportunity to make this public comment.

The Federation of American Hospitals (FAH) supports addressing important patient safety concerns
during an inpatient stay but questions whether this measure demonstrates a sufficient performance gap
to support its use in the Hospital Inpatient Quality Reporting or the Promoting Interoperability Programs since the performance scores ranged from 0.0 to 0.258 across 12 hospitals. This measure must also be endorsed by the Consensus-Based Entity prior to inclusion in any program. 

In addition, the FAH also strongly encourages CMS to assess the feasibility of collecting the required data
elements from electronic health record systems (EHRs) and determine if the measure is reliable and
valid across a broader set of EHRs vendors and hospitals. Assessment of how the measure performs
using only two vendor systems and twelve hospitals should not be considered sufficient. eCQMs require significant resources and time for hospitals to implement and only those eCQMs with demonstrated gaps in care should be implemented. As a result, the FAH believes that the PRMR recommendation should be “Recommend with Conditions.”

The Federation of American Hospitals (FAH) is very concerned with the current reliability of this measure. Specifically, testing demonstrated that reliability is 0.231 using the measure’s case minimum of 25 patients and it required roughly 600 patients to achieve 0.7. We believe that the measure requires a higher case minimum to improve its reliability. Additional information regarding the evidence linking a hospital’s ability to improve patient outcomes in the 30 days following discharge is needed as it appears that the supporting literature provided focused primarily on inpatient stays and we question whether there is sufficient evidence to expand beyond the hospital stay.  This measure must also be endorsed by the Consensus-Based Entity prior to inclusion in any program. As a result, the FAH believes that the PRMR recommendation should be “Recommend with Conditions.”

The Federation of American Hospitals (FAH) supports addressing important patient safety concerns
during an inpatient stay but believes that this measure must be endorsed by the Consensus-Based Entity prior to inclusion in the Hospital Inpatient Quality Reporting or the Promoting Interoperability Programs.

In addition, the FAH also strongly encourages CMS to assess the feasibility of collecting the required data
elements from electronic health record systems (EHRs) and determine if the measure is reliable and
valid across a broader set of EHRs vendors and hospitals. Assessment of how the measure performs
using only three vendor systems and thirteen hospitals should not be considered sufficient. eCQMs require significant resources and time for hospitals to implement and only those eCQMs with demonstrated gaps in care should be implemented. As a result, the FAH believes that the PRMR recommendation should be “Recommend with Conditions.”
 

The Federation of American Hospitals (FAH) believes that the reliability of this revised measure should be re-assessed and proposed changes reviewed and approved by the Consensus-Based Entity prior to implementation in the Hospital Inpatient Quality Reporting or the Promoting Interoperability Programs. As a result, the FAH concludes that the PRMR recommendation should be “Recommend with Conditions.”

The Federation of American Hospitals (FAH) does not believe that the outcomes of this measure align with the definition of readmission in the Patient Protection and Affordable Care Act of 2010. By including observation stays and emergency department visits, this measure goes beyond the original intent of the Hospital Readmissions Reduction Program (HRRP) and we believe that CMS must ensure compliance with statutory requirements for this program. As a result, the FAH opposes the addition of this measure in HRRP and believes that the PRMR recommendation should be “Do Not Recommend.”

The Federation of American Hospitals (FAH) does not believe that the outcomes of this measure align with the definition of readmission in the Patient Protection and Affordable Care Act of 2010. By including observation stays and emergency department visits, this measure goes beyond the original intent of the Hospital Readmissions Reduction Program (HRRP) and we believe that CMS must ensure compliance with statutory requirements for this program. As a result, the FAH opposes the addition of this measure in HRRP and believes that the PRMR recommendation should be “Do Not Recommend.”

The Federation of American Hospitals (FAH) does not believe that the outcomes of this measure align with the definition of readmission in the Patient Protection and Affordable Care Act of 2010. By including observation stays and emergency department visits, this measure goes beyond the original intent of the Hospital Readmissions Reduction Program (HRRP) and we believe that CMS must ensure compliance with statutory requirements for this program. As a result, the FAH opposes the addition of this measure in HRRP and believes that the PRMR recommendation should be “Do Not Recommend.”

The Federation of American Hospitals (FAH) does not support the inclusion of this index in the Hospital Inpatient Quality Reporting (IQR) program. We do not believe that the index is a true indicator of the disparities in care provided by a hospital as it is limited to the readmission and mortality measures. The rationale for the use of these measures does not adequately describe what evidence was used to determine that just those two outcomes are the best indicators of disparity by a hospital. We believe that it is critical for CMS to identify which measures might best signal whether a true disparity care exists rather than use this limited set. We also urge CMS to thoughtfully consider whether the resulting index score provides information that is actionable to drive quality improvement and meaningful to inform patient decision making.

We appreciate the removal of imputed race and ethnicity from the analysis. While we understand that those variables that can be used to identify disparities remain limited, we urge CMS to carefully consider what data are used, particularly given the emerging concerns with the Area Deprivation Index and its limitations in discerning differences in some communities and for some social risk factors.

As a result, we believe that significant work must be completed to ensure that the metrics used are appropriate and evidence-based to distinguish disparities in care, meaningful for improvement purposes, actionable for patients. In addition, the variables by which these measures are analyzed must be proven to be reliable and valid in their representation of the social risk factors. The FAH believes that the PRMR recommendation should be “Do Not Recommend.” 
 

The Federation of American Hospitals (FAH) does not believe that we have sufficient information in order to comment on whether these new sub-measures should be added to the HCAHPS Survey measure Hospital Inpatient Quality Reporting or the Hospital Value-Based Purchasing Programs. In previous years when new or replacement sub-measures were proposed (e.g., MUC16-263), CMS provided information on the changes that would be made to the survey items and resulting sub-measures. On the December 15 Hospital Measures Listening Session, CMS staff indicated that changes beyond the inclusion of these three sub-measures were planned but that this information would not be made available until the next rulemaking cycle. We believe that this information is needed and should be shared with the Hospital Committee and publicly during this review.

The FAH continues to advocate and support refinements to this survey based on the findings of the Modernizing the HCAHPS Survey report (FAH, 2019). Specifically, the analysis of response rates for HCAHPS from 2008 (33%) to 2017 (26%) revealed a percentage change of -22% overall and an average 0.8 percentage point drop per year. It is our hope that this erosion of participation can be reduced and one avenue is to ensure that the topics addressed in HCAHPS remain relevant and capture what matters most to patients such as care coordination and efficiency and teamwork of the care team. The FAH is encouraged to see CMS’ move in this direction through these proposed changes but requests additional information on the potential removal or replacement of items prior to the final voting of the Recommendation Group of the PRMR Hospital Committee.  

Reference: 
Federation of American Hospitals. Modernizing the HCAHPS Survey. Released June 2019. Available at: https://www.fah.org/fah-ee2-uploads/website/documents/Modernizing_HCAHPS_-Recommendations_from_PELs.pdf. 
 

The Federation of American Hospitals (FAH) does not believe that we have sufficient information in order to comment on whether these new sub-measures should be added to the HCAHPS Survey measure Hospital Inpatient Quality Reporting or the Hospital Value-Based Purchasing Programs. In previous years when new or replacement sub-measures were proposed (e.g., MUC16-263), CMS provided information on the changes that would be made to the survey items and resulting sub-measures. On the December 15 Hospital Measures Listening Session, CMS staff indicated that changes beyond the inclusion of these three sub-measures were planned but that this information would not be made available until the next rulemaking cycle. We believe that this information is needed and should be shared with the Hospital Committee and publicly during this review.

The FAH continues to advocate and support refinements to this survey based on the findings of the Modernizing the HCAHPS Survey report (FAH, 2019). Specifically, the analysis of response rates for HCAHPS from 2008 (33%) to 2017 (26%) revealed a percentage change of -22% overall and an average 0.8 percentage point drop per year. It is our hope that this erosion of participation can be reduced and one avenue is to ensure that the topics addressed in HCAHPS remain relevant and capture what matters most to patients such as care coordination and efficiency and teamwork of the care team. The FAH is encouraged to see CMS’ move in this direction through these proposed changes but requests additional information on the potential removal or replacement of items prior to the final voting of the Recommendation Group of the PRMR Hospital Committee.  

Reference: 
Federation of American Hospitals. Modernizing the HCAHPS Survey. Released June 2019. Available at: https://www.fah.org/fah-ee2-uploads/website/documents/Modernizing_HCAHPS_-Recommendations_from_PELs.pdf. 

The Federation of American Hospitals (FAH) does not believe that we have sufficient information in order to comment on whether these new sub-measures should be added to the HCAHPS Survey measure Hospital Inpatient Quality Reporting or the Hospital Value-Based Purchasing Programs. In previous years when new or replacement sub-measures were proposed (e.g., MUC16-263), CMS provided information on the changes that would be made to the survey items and resulting sub-measures. On the December 15 Hospital Measures Listening Session, CMS staff indicated that changes beyond the inclusion of these three sub-measures were planned but that this information would not be made available until the next rulemaking cycle. We believe that this information is needed and should be shared with the Hospital Committee and publicly during this review.

The FAH continues to advocate and support refinements to this survey based on the findings of the Modernizing the HCAHPS Survey report (FAH, 2019). Specifically, the analysis of response rates for HCAHPS from 2008 (33%) to 2017 (26%) revealed a percentage change of -22% overall and an average 0.8 percentage point drop per year. It is our hope that this erosion of participation can be reduced and one avenue is to ensure that the topics addressed in HCAHPS remain relevant and capture what matters most to patients such as care coordination and efficiency and teamwork of the care team. The FAH is encouraged to see CMS’ move in this direction through these proposed changes but requests additional information on the potential removal or replacement of items prior to the final voting of the Recommendation Group of the PRMR Hospital Committee.  

Reference: 
Federation of American Hospitals. Modernizing the HCAHPS Survey. Released June 2019. Available at: https://www.fah.org/fah-ee2-uploads/website/documents/Modernizing_HCAHPS_-Recommendations_from_PELs.pdf. 

The Federation of American Hospitals (FAH) does not believe that we have sufficient information in order to comment on whether these new sub-measures should be added to the HCAHPS Survey measure Hospital Inpatient Quality Reporting or the Hospital Value-Based Purchasing Programs. In previous years when new or replacement sub-measures were proposed (e.g., MUC16-263), CMS provided information on the changes that would be made to the survey items and resulting sub-measures. On the December 15 Hospital Measures Listening Session, CMS staff indicated that changes beyond the inclusion of these three sub-measures were planned but that this information would not be made available until the next rulemaking cycle. We believe that this information is needed and should be shared with the Hospital Committee and publicly during this review.

The FAH continues to advocate and support refinements to this survey based on the findings of the Modernizing the HCAHPS Survey report (FAH, 2019). Specifically, the analysis of response rates for HCAHPS from 2008 (33%) to 2017 (26%) revealed a percentage change of -22% overall and an average 0.8 percentage point drop per year. It is our hope that this erosion of participation can be reduced and one avenue is to ensure that the topics addressed in HCAHPS remain relevant and capture what matters most to patients such as care coordination and efficiency and teamwork of the care team. The FAH is encouraged to see CMS’ move in this direction through these proposed changes but requests additional information on the potential removal or replacement of items prior to the final voting of the Recommendation Group of the PRMR Hospital Committee.  

Reference: 
Federation of American Hospitals. Modernizing the HCAHPS Survey. Released June 2019. Available at: https://www.fah.org/fah-ee2-uploads/website/documents/Modernizing_HCAHPS_-Recommendations_from_PELs.pdf. 

While this measure is currently only proposed for the inpatient setting and MSSP, CMS intends to implement it within ambulatory care settings in future years. The AAFP appreciates the overall intent of this measure and shares a strong desire to increase social needs screening and intervention with an aim to help patients and improve outcomes. However, it is premature to implement this measure in a payment program that holds ACOs and clinicians accountable. The health care and social care infrastructures prevent this measure from feasibility in “the real world.” Discretely capturing and measuring "connection" to a CSP is very difficult for ambulatory care physicians and other clinicians.

We would like to share the following more detailed feedback:

• The measure is not endorsed, which means it has not been rigorously reviewed by a consensus-based entity. We believe measures should go through a rigorous endorsement process and be further tested and refined, as necessary, before they are considered for implementation. 
• This measure has been tested and analyzed only at the facility (hospital) level. However, this measure is being proposed for use in the MSSP program. ACOs should not be held accountable for a measure that has only be tested and validated at the facility level.  
• This measure specifies that screening is initiated in hospitals. However, some communities do not even have hospitals. Therefore, it is not appropriate to hold ACOs accountable. 
• The current health and social care systems and IT infrastructure make this measure very difficult to operationalize: 
  • Many CSPs do not accept electronic referrals. 
  • CSPs often do not collect any patient-level information when they assist members of the community, and they often do not share data back with the individual’s primary care physician. Therefore, closing the loop is challenging, if not impossible, in the current environment.
  • Furthermore, there are no claims generated when a patient accesses a CSP. 
  • Some communities do not have the social resources/CSPs necessary to help alleviate social needs. If the community does not have the resources, then ACOs and PCPs should not be held accountable.

It is especially important to note that this measure does not align with CMS policy published in the recent Medicare Physician Fee Schedule final rule. The proposed measure focuses on the connection to community services upon discharge, but CMS is now implementing new codes for “community health integration services” which cannot be initiated in the Emergency Department or inpatient setting. Instead, CMS envisions the patient connecting with their longitudinal source of care (primary care) upon discharge who would connect them to these services. Thus, the proposed process measure would encourage behaviors that are not aligned with broader CMS payment strategy. Instead, we encourage CMS to consider development of a new measure that focuses on whether patients have been connected to their primary care physician or other longitudinal source of care after discharge.  

The Federation of American Hospitals (FAH) supports the development and implementation of measures that seek to address inequities in care and those factors that may directly or indirectly impact an individual’s ability to achieve positive health outcomes. Regrettably, the FAH is unable to support the inclusion of this measure in the Hospital Outpatient Quality Reporting (OQR) Program for several reasons.

We continue to question why these specific social drivers of health were selected and what if any evidence demonstrates that process is linked to improvements in health outcomes. Over the last two consecutive review cycles, the Measures Application Partnership (MAP) placed conditions on this measure, which remain unanswered. Specifically, the MAP asked that the measure be tested for reliability and validity and subsequently submitted to a Consensus-Based Entity (CBE). None of the measures focused on social drivers of health have been submitted for endorsement consideration nor has any additional information around the feasibility, reliability, or validity of the measures been released. In addition, it remains unclear how CMS plans to address the additional conditions from the MAP around additional details on how potential resources, tools, and best practices map to the individual drivers.  

Furthermore, the FAH continues to question the degree to which this measure could be considered actionable. This measure assesses the rate of screens completed by a hospital in the absence of any information on the degree to which a facility has been equipped with the necessary resources and tools to address the individual’s needs.

The FAH believes that these questions and concerns must be addressed and endorsement by the CBE should be achieved prior to implementation of this measure in the Hospital OQR Program. As a result, the FAH believes that the PRMR recommendation should be “Do Not Recommend.”

The Federation of American Hospitals (FAH) supports the development and implementation of measures that seek to address inequities in care and those factors that may directly or indirectly impact an individual’s ability to achieve positive health outcomes. Regrettably, the FAH is unable to support the inclusion of this measure in the Hospital Outpatient Quality Reporting (OQR) Program for several reasons.

We continue to question why these specific social drivers of health were selected and what if any evidence demonstrates that process is linked to improvements in health outcomes. Over the last two consecutive review cycles, the Measures Application Partnership (MAP) placed conditions on this measure, which remain unanswered. Specifically, the MAP asked that the measure be tested for reliability and validity and subsequently submitted to a Consensus-Based Entity (CBE). None of the measures focused on social drivers of health have been submitted for endorsement consideration nor has any additional information around the feasibility, reliability, or validity of the measures been released. In addition, it remains unclear how CMS plans to address the additional conditions from the MAP around additional details on how potential resources, tools, and best practices map to the individual drivers.  

Furthermore, the FAH continues to question the degree to which this measure could be considered actionable. This measure assesses the rate of screens completed by a hospital in the absence of any information on the degree to which a facility has been equipped with the necessary resources and tools to address the individual’s needs.

The FAH believes that these questions and concerns must be addressed and endorsement by the CBE should be achieved prior to implementation of this measure in the Hospital OQR Program. As a result, the FAH believes that the PRMR recommendation should be “Do Not Recommend.”
 

The Federation of American Hospitals (FAH) supports the development and implementation of measures that seek to address inequities in care and those factors that may directly or indirectly impact an individual’s ability to achieve positive health outcomes. Regrettably, the FAH is unable to support the inclusion of this measure in the Hospital Outpatient Quality Reporting (OQR) Program for several reasons.

We continue to question why these specific social drivers of health were selected and what if any evidence demonstrates that reporting the positivity rate for any one of these drivers is linked to improvements in health outcomes. Over the last two consecutive review cycles, the Measures Application Partnership (MAP) placed conditions on this measure, which remain unanswered. Specifically, the MAP asked that the measure be reviewed by a Consensus-Based Entity (CBE) to address reliability and validity concerns. None of the measures focused on social drivers of health have been submitted for endorsement consideration nor has any additional information around the feasibility, reliability, or validity of the measures been released. In addition, it remains unclear how CMS plans to address the additional MAP condition around how the results of this measure in particular will be shared and contextualized for public reporting.  

Furthermore, the FAH continues to question the degree to which this measure could be considered actionable and the resulting performance scores should be attributed to a hospital. This measure assesses the rate of positive screens but does not appear to address the degree to which a facility has been equipped with the necessary resources and tools to address the individual’s needs. In the absence of this information, the FAH does not believe that a rate of positive screens will reflect the quality of care provided by a hospital.

The FAH believes that these questions and concerns must be addressed and endorsement by the CBE should be achieved prior to implementation of this measure in the Hospital OQR Program. As a result, the FAH believes that the PRMR recommendation should be “Do Not Recommend.”

The Federation of American Hospitals (FAH) supports the development and implementation of
patient-reported outcomes performance measures (PRO-PMs) and specifically the focus of this PRO-PM for the Hospital Outpatient Quality Reporting Program but we also believe that additional questions and work remain before their widespread use such as the degree to which multiple PRO-PMs could lead to survey fatigue for patients, the potential impact that additional PRO-PMs may have on the reporting of well-established measures such as OAS CAHPs, and what level of data collection burden for an individual PRO-PM is acceptable for a hospital or other healthcare provider. We also encourage CMS to continue to evaluate the feasibility of collecting the data required for the PRO-PM across a diverse set of facilities beyond the original 15 sites. To what extent do these data impact clinical workflows and are additional staff resources required? What additional costs might an individual clinician and facility encounter as a result of implementation of this PRO-PM?

Furthermore, the measure requires a higher case minimum in order to achieve an acceptable minimum threshold for reliability of 0.7 or greater and it must also be endorsed by the Consensus-Based Entity prior to inclusion in any program. As a result, the FAH believes that the PRMR recommendation should be “Recommend with Conditions.”

The Federation of American Hospitals (FAH) and its members are fully committed to achieving equity in the provision and quality of health services and we believe that many of the priorities included in this structural measure are currently addressed by hospitals and health systems. Many already have in place language and communication access plans woven into their frameworks for ongoing provision of culturally competent care to patients with limited English proficiency and hearing or vision disabilities. These plans typically form part of the curricula for onboarding and refresher training of patient-facing staff. Hospitals also maintain certified electronic health record technology (CEHRT) capabilities as required under the Centers for Medicare and Medicaid Services (CMS) Promoting Interoperability Program for hospitals. These activities also overlap with accreditation requirements of hospitals generally or of special hospital programs (e.g., accreditation of bariatric surgery programs that mandates culturally competent care of morbidly obese patients). Hospital associations already have underway a variety of programs addressing equity, including organizational focus and leadership. 
The FAH urges CMS to first catalogue what hospitals are already doing before establishing new measures or requirements to preclude burden caused by overlap and redundancy. A complete environmental scan, listening sessions, focus groups, and/or a Technical Expert Panel would be helpful. In addition, the FAH believes that CMS has the opportunity to address inequities in care through existing measurement efforts. For example, the collection of race/ethnicity, payer, and gender have always been included in the electronic clinical quality measure (eCQM) specifications as supplemental data elements. CMS could choose to make the collection and reporting of these data required. This change would allow hospitals to collect the data, use it for improvement purposes, and receive automatic credit through reporting of these data rather than require them to attest to it through a structural measure. Further specificity regarding what would specifically satisfy each of the statements is also needed to ensure that every hospital interprets and attests to them consistently. For example, what constitutes a majority of patients under question 2b and what are the minimum requirements for participation in a local, regional, or national quality improvement activity under question 4a?
Because of the importance of this issue, the FAH regrets that we cannot support consideration of this measure for the Hospital Outpatient Quality Reporting (OQR) Program at this time due to the need for additional specificity and lack of clear linkages that each of the statements as currently defined can improve outcomes in health equity. The FAH encourages the CMS to explore other measures that are more directly linked to quality improvement and accountability while also minimizing reporting burden for hospitals. As a result, the FAH believes that the PRMR recommendation should be “Do Not Recommend.”