ESRD Dialysis Patient Life Goals Survey (PaLS) (3742)

Bayer US (“Bayer”) appreciates the opportunity to submit comments pertaining to the proposed endorsement of this measure. 

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture with nearly 25,000 employees in 300 sites across the United States. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation and are committed to the principles of sustainable development and to our social and ethical responsibilities as a corporate citizen.

Bayer is committed to improving patient outcomes and advancing health by closing gaps in care. We recognize the importance of value-based care and quality measurement and are pleased to submit feedback in response to Battelle’s open comment period on the Spring 2023 measure endorsement cycle.

Overall, Bayer supports the development and use of patient-reported measures to address care planning and shared decision-making for kidney health. We support endorsement of this measure as it highlights the importance of patient-centered care in ESRD quality and promote the use of shared decision-making. Shared decision-making is essential for patient-centered care and is important for improving patient experience, patient satisfaction, and health outcomes related to kidney care.

Although this measure is a great step to promoting patient-centered care and alignment with goals for renal care, we recommend that a patient-reported outcome measure should eventually be developed for patients living with ESRD, as well as those with earlier-stage CKD. This will help to ensure that care is aligned with patient goals earlier in the care journey and hold providers accountable for the patient-centricity of their discussions and decision-making, not just that the patient completed the survey.

Additionally, there are notable disparities in CKD and ESRD care, with higher prevalence of both conditions found in Black and Hispanic American populations than in white populations.¹ We encourage measure implementers to consider ways to identify disparities in care, such as using measure stratification by race/ethnicity and other social factors.

¹NIH. Kidney Disease Statistics for the United States. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease/ Accessed June 1, 2023.

Evaluating patients on their future goals and/or happiness frequently changes from day to day. People living on dialysis incur the same challenges of those that don’t. Will a patient’s care be modified because they don’t have a goal? What goals are acceptable? Who determines what goals are positive or negative? Living with any chronic illness can cause anxiety and depression. This survey is unreliable because people living on dialysis often feel like they are in survival mode. They may be experiencing chronic anxiety and depression and although they are being treated for their renal needs, their mental health is often untreated. Ultimately, I fear that a patient’s “goal” and a patient’s “worth” will become synonymous like in the days of the “Who Lives Panels”. A person’s worth is multifaceted. People have widely varying circumstances and support within their lives. What will the results of the survey yield? If a person has a “positive” goal, will their treatment be deemed a success? How will the survey improve their care? Conversely, if a person has a “negative” goal, how will their treatment be modified. 

Survey Alternative

Rather than asking what a person’s goals are, I would like to suggest that a survey after each dialysis treatment be performed. After each treatment, asking a person how they perceived their dialysis treatment could give people living on dialysis a voice. When people have a treatment, like dialysis, three times a week they frequently get frustrated with reporting ill side effects when their concerns on not addressed. Inquiring how a patient feels after treatment, would allow their reporting to be documented and addressed. 

I have lived with chronic kidney disease for 25 years. I was on dialysis 24 years ago before my transplant. I appreciate the measures that can help people living on dialysis. I fear this measure will be a step backwards.

Sincerely,

Cher Thomas

PLease see aomments form Renal Support Network.  Thank you.  

Please see attached comments form Renal SUpport Network 

I feel that finding staff that are compassionate and able to effectively communicate with ESRD would be helpful.  Also, it's fine to identify goals, but what are you doing to help achieve them.  A survey after dialysis would help in facilitating change and better service.

This is a waste of time and money! It fails to address the quality of life issue. My life goal while on dialysis was simply to stay alive and healthy enough for a transplant. Short term not long term goals were my focus.  

Such a survey could be used by unethical people to be utilized in a manner similar to the old “death committee system” in which some one uses the life goal information to decide who gets dialysis treatments and who isn’t “valuable” enough based on life goals. This idea is demeaning to all patients.

My understanding is that you are considering surveying patients about their “life goals.”

I have been on hemo-dialysis for almost a year now. My life goals as a patient are simple:

1. Survival

2. Survival

3. Survival

4. Going home after dialysis feeling as little beaten up as possible by blood pressure ups-and-downs, itching, cramps, chills, etc.

5. Being healthy enough to live the other 156 hours a week as fully as possible.

At the end of dialysis, I am certainly not “up” for doing surveys.  And the staff is too busy dealing with each of us as individuals medically to be focusing on surveys about our respective life goals.

Those of us with End Stage Renal Disease may go through several iterations of treatment options. I, for one, tried home Peritoneal Dialysis, but my body did not work with PD, and hence I needed to shift to center-based hemodialysis.  A transplant is not an option for me.  I say this to explain my hope that this survey isn’t a hidden push to get everyone on home dialysis  I can see PD as viable, but home hemodialysis as very complex and often not an option for individual patients.

So, while I understand the desire of medical planners to have useful statistical data to point to and draw on, I’m not sure this proposal is seeking reasonable data in a truly useful way. 

Doing good made akl goals kept very comfortable 

will lead to more survey fatigue and not sure how it will impact care for the better. 

I don’t feel this survey would be helpful. It would be more helpful to discuss goals with family and the care team. I would prefer you spend the money to  decrease the nursing shortage.

Dear Colleagues:

The National Forum of ESRD Networks (“The Forum” at www.esrdnetworks.org) appreciates this opportunity to offer comments regarding several quality metrics for chronic kidney disease (CKD) and end-stage renal disease (ESRD) that the Centers for Medicare and Medicaid Services (CMS) has offered for review. The Forum noted the current placement of CKD quality metrics under the “Primary Care and Chronic Illness Standing Committee” and hopes that in the future there is the opportunity to utilize a broader mandate under CKD recognizing the patient-centered implications of a continuum of care from CKD to ESRD. The Forum would also very much like to be more proactively engaged in stages earlier than the public commentary period given the representation of all Congressionally mandated and CMS contracted ESRD Networks. Given the limited time available to the Forum to provide comment on the current quality metrics, we would nevertheless like to offer some abbreviated thoughts regarding the following metrics:

• Delay in Progression of CKD Measure (CBE ID 3753): Whereas the Forum remains fully supportive of efforts to slow the progression of CKD and value-based payment models that encourage such process improvement, we are concerned about several areas of the proposed streamlined metric to include the limited exclusionary criteria of advanced or metastatic cancer. The Forum feels that there are several other acute and chronic disease states associated with limited life expectancy that should be accounted for in the denominator and would welcome the opportunity to make further recommendations. Furthermore, notwithstanding the separate mortality metric (see below), death as the competing event for CKD progression to ESRD has not been accounted for in this metric, so that death events may appear to halt progression to ESRD, leading to misleadingly favorable scores. Lastly, the Forum would also like to recognize the fact that delaying CKD progression measures that begin in the latter stages (i.e., stage 4) of CKD limits a provider’s ability to make meaningful change in the trajectory of the patient’s illness. The Forum therefore recommends initiating such quality metrics at earlier CKD stages if possible.
• Risk Standardized Mortality Ratio for Late-Stage CKD and ESRD (CBE ID 3754): The Forum again voices its appreciation regarding efforts to improve the outcomes of persons with CKD; however, the Forum has concerns regarding individual providers’ abilities to have consistent and direct impacts on all-cause mortality. Quality measures that assess outcomes outside of the nephrologist’s control may lead to ineffective strategies for efforts that are unlikely to succeed. The Forum would welcome the opportunity to discuss efforts more directly under the kidney care community’s control and place a focus of incentivizing improvements in these critically important areas.
• ESRD Dialysis Patient Life Goals Survey (PaLS) (CBE ID 3742): The Forum is supportive of efforts to better understand life goals of persons with CKD as well as efforts to better focus on person-centered outcomes with the ultimate goal of living well with kidney disease. While we do support the premise of this quality measure, the Forum has concerns regarding dialysis facility staffing shortages (and the increased burden on limited staff to obtain such important information), as well as the willingness of patients to participate in more surveys without clear indication of how it might benefit them. 

The Forum would once again like to thank CMS and PQM for the opportunity to comment on the above proposed quality measurements and offer its willingness to become more actively engaged in future discussions. 

Sincerely,

David Henner, DO - President, Forum of ESRD Networks

Kam Kalantar-Zadeh, MD, MPH, PhD - President-Elect, Forum of ESRD Networks

Daniel Landry, DO - Chair, Forum Medical Advisory Council

Preethi Yerram, MD -  Vice Chair, Forum Medical Advisory Council

This is will lead to more survey fatigue and not sure how it will impact care for the better.  

RSN supports patient reported outcomes measure that are meaningful and have the capacity to address and improve their dialysis treatment experience. We fail to see how “Life Goals” measure accomplishes this. To pursue life goals, one must feel well enough to do so and have the financial and emotional stability to do so.   Please see attachment.  

Dialysis patients are regular patients always in survival mode. Dialysis is really difficult. How we feel changes day to day. There are so many issues that can happen during treatment. It is understandable that patients don't always complete treatments. Checking a box on a survey that is rarely followed up on doesn't make much sense to me.  Many dialysis patients are underserved. Their life goals are surviving, paying the bills and putting food on the table. 

During day to day interaction with staff (communicating) would be the best way to find out what a patients's life goal is. Patients would also like to travel at times to see family but with how short staffed many facilities are, many times that is not even possible. So again the purpose of the survery? Not really sure?

I have been a CKD patient for 34 years. Being on dialysis (this last time) was for 6 years. It is a battle everyday.

Ultimately we want outcomes for patients to address and improve their day to day treatment.

Below please find RSN's comment.

https://www.rsnhope.org/wp-content/uploads/2023/06/CMSLifeGoals1.22.23.pdf

Kidney Care Partners (KCP) is a non-profit coalition of more than thirty organizations comprising the full spectrum of stakeholders related to dialysis care—patients and advocates, dialysis professionals, physicians, nurses, researchers, therapeutic innovators, transplant coordinators, and manufacturers.  KCP is committed to advancing policies that improve the quality of care and life for individuals at every stage along the chronic kidney and end stage renal disease care continuum, from prevention to dialysis, transplant, and post-transplant care.  KCP applauds Battelle and the Partnership for Quality Measurement (P4QM) for its commitment to serve as the new Consensus Based Entity (CBE) for the Centers for Medicare and Medicaid Services (CMS), and we appreciate the opportunity to comment on measures under review in the Primary Care and Chronic Conditions Spring 2023 Project.  We commend Battelle and the P4QM for undertaking this vital work, and we offer comment on the three new renal measures being considered within the project: 

• ESRD Dialysis Patient Life Goals Survey (#3742)
• Delay in Progression of Chronic Kidney Disease (#3753)
• Risk-Standardized Mortality Ratio for Late-Stage CKD and ESRD (#3754)

OVERARCHING ISSUES

KCP acknowledges there will be process and policy changes as the P4QM assumes its new role as CBE, and we look forward to working with Battelle as stakeholders navigate this transition.  As a threshold matter, however, we are concerned that these three renal measures are not being considered within the Renal Project, to which all renal-related measures have traditionally been assigned. We note that the dialysis facility, in particular, is a unique, tertiary care setting guided by unique Federal regulations and a unique punitive payment system.  ESRD Quality Incentive Program (QIP) penalties often disproportionally and paradoxically impact the most financially vulnerable facilities treating the most socially and medically disadvantaged patients.[1]  The Renal Standing Committee was constructed to ensure that measures being considered for use in the QIP are technically appropriate for use in this singular patient population and specialized care setting and will not inadvertently perpetuate the very disparities CMS and P4QM are working to address.  We strongly recommend these measures be properly reassigned to the P4QM Renal Standing Committee for endorsement consideration. Barring that, we urge P4QM to invite appropriate subject matter experts or sitting Renal Standing Committee members to participate in these measures’ review. 

Likewise, it is unclear if the Scientific Methods Panel (SMP) will continue its work under Battelle.  If so, it is equally unclear whether these complex measures are slated for review by the Panel, as was the standard previously established by NQF.  Each of these three measures requires interpretation of intricate risk model and/or methodologic and psychometric performance data; many stakeholders rely on the SMP’s review and recommendations to help guide their decisions for such measures.  We urge Battelle to reconvene this important body to allow it to continue its vital work, and to assign these renal measures for SMP review.   

Finally, we note that detailed measure specifications and testing information were not posted until June 5, three weeks after the measures were initially released for comment and—importantly—just one day prior to the originally disseminated comment deadline date of June 6.  Later the same day, without warning or explanation, the comment deadline was abruptly extended to June 25, leaving stakeholders in the position of having to revise comments already prepared for submission.  While it is unclear on the P4QM website, it also appears that this may be a limited, “early” (pre-Standing Committee evaluation) comment period.  We assume there will also be a longer public comment period after the Standing Committee reviews the measures, but again, this information is not provided.  These are significant procedural changes from those of CMS’s prior CBE, NQF, which offered a multi-month continuous comment period for its projects.  As we navigate this unprecedented transition between CBEs, we stress the importance of providing a clearly defined consensus development process and detailed project timelines, and we urge the P4QM to make this information readily available to its stakeholders.

Measure-specific comments follow.

ESRD DIALYSIS PATIENT LIFE GOALS SURVEY (#3742)

KCP appreciates the underlying premise of the "Dialysis Facility-Level ESRD Dialysis Patient Life Goals Survey" (PaLS) measure, and we applaud CMS for its recognition of this important aspect of patient quality of life.  However, we have a number of serious concerns with the measure as presented on the P4QM website that would need to be addressed before we are able adequately review the measure or offer our support of its use in the penalty based ESRD QIP.

We note that CMS is proposing a facility-level process measure assessing the percent of eligible patients in a given dialysis facility that completed at least one scorable item of the survey. However, only patient-level testing data on the survey instrument itself was provided; there was no information provided on the facility-level process measure being proposed for use.  All information provided with the submission materials is on the survey t-score, based on the data collected during testing of the instrument—but the t-score is “currently not part of the calculation for process measure being proposed.”   CMS itself notes in the measure specifications that prior to implementation at the dialysis facility level, the response rate will need to be calculated at the dialysis facility level; it is unclear why this was not done prior to submission.  Detailed information (performance scores, reliability, validity) for the performance metric being proposed, as specified, is a foundational component of the consensus development and endorsement processes.  An assessment of the PaLS is not feasible in the absence of this information.

At NQF, a critical assessment of survey instruments’ methodologic and psychometric properties has been a required component of the Scientific Methods Panel (SMP) review.  It remains unclear if the SMP will continue its work at Battelle to provide such a critical assessment; nevertheless, KCP’s support of the measure is necessarily contingent upon a proper review of the survey’s methodologic and psychometric properties by the SMP or an equivalent body at Battelle. 

We also note that several of our patient and patient advocate members have raised concerns about the appropriateness of tying provider reimbursement to required questioning of patients on information so personal as life goals.  These members echoed patient reservations detailed by our sister organization, the Kidney Care Quality Alliance (KCQA), in its 2017 Expert Panel Report on Patient-Reported Outcomes for ESRD Patients: A Framework and Priorities for Measurement, again highlighting the mistrust some patients harbor with patient satisfaction and quality-of-life surveys for fear of potential differential treatment based on responses.  Yet, of course, patients must be comfortable answering honestly for such measures to drive improvements in care and quality.  As such, we do not believe the penalty-based ESRD QIP is the appropriate quality program for use of the PaLS measure.  While KCP unequivocally supports empowering patients to achieve their vision of a high-quality life, there are other measures that more appropriately address the clinical aspects of achieving health-related QOL goals. 

KCP also has concerns with the lack of any detail provided on potential implementation issues, including operational issues such as the anticipated administrative burden associated with administering the survey.  Likewise, patients’ increasing survey fatigue and potential privacy concerns with the PaLS are very real threats to validity that remain unaddressed. Third, the denominator currently includes only individuals able to “read and understand English”, excluding a wide swath of the dialysis population and potentially exacerbating disparities.  Finally, while considerable evidence highlighting the importance of patient life goals is presented in the submission materials, an association between the administration of a life goals survey with subsequent improved outcomes in the dialysis facility setting has not been demonstrated. 

We look forward to a detailed discussed on these issues by the Standing Committee.
 

[1] Sheetz KH, Gerhardinger L, Ryan AM, Waits SA.  Changes in dialysis center quality associated with the End-Stage Renal Disease Quality Incentive Program: An observational study with a regression discontinuity design.  Ann Intern Med.  2021 Aug;174(8):1058-1064.  doi: 10.7326/M20-6662.  Epub 2021 Jun 1.  PMID: 34058101.

The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. 

RPA appreciates the opportunity to provide comments on the measures submitted to the Spring 2023 measure cycle. RPA strongly believes that nephrologists must be involved in the review and assessment of the following measures:

• Risk Standardized Mortality Ratio for Late-Stage Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD) 
• Delay in Progression of Chronic Kidney Disease (CKD) Measure
• ESRD Dialysis Patient Life Goals Survey (PaLS) 

Furthermore, RPA was dismayed that no measure specifications were posted until June 5. We strongly urge PQM to make sure all measure materials are available for review when the call for comments open.  

While the RPA appreciates the value of patient-reported measures, we are concerned that this measure would add to the survey fatigue already faced by patients with ESRD. Patients are already expected to complete the following surveys:  Patient Activation Measure (PAM) twice a year; PHQ9; KDQOL; iCAHPS (also twice a year); dialysis facility specific surveys such as wellness surveys, as well as patient satisfaction every time they are discharged from a facility or have a procedure. Consequently, response rates to surveys are frequently lower than desired and can result in questionable statistical significance. RPA recommends that the measure developer explore having the survey questions added to one of the other surveys, rather than adding addition surveys for patients and providers to track and administer.

Testing and Validity

This measure is proposed as a facility-level process measure assessing the percent of eligible patients in a given dialysis facility that completed at least one scorable item of the survey. However, only patient-level testing data on the survey instrument itself was provided; there was no information provided on the facility-level process measure being proposed for use. All information provided with the submission materials is on the survey t-score, based on the data collected during testing of the instrument—but the t-score is “currently not part of the calculation for process measure being proposed.” The submission notes in the measure specifications that prior to implementation at the dialysis facility level, the response rate will need to be calculated at the dialysis facility level; it is it is unclear why this was not done prior to submission. Detailed information (performance scores, reliability, validity) for the performance metric being proposed, as specified, is an immutable component of the consensus development and endorsement processes.  Therefore, an assessment of the PaLS is not feasible in the absence of this information.

I comment as a nurse who cares for dialysis patients.    I believe patient life goals are very important and the healthcare team should be aware of each patient's goals, however, if this measure becomes mandatory it may not benefit many patients because it will become another "survey question" (patients already have survey fatigue) and it will be "checked yes" on every patient no matter if the life goals are known or not.

• This will lead to more survey fatigue and not sure how it will impact care for the better. 

    

• I fail to see how the facility can help an indigent patient much. 
• Our patients that want to travel now (and can afford it) are having trouble findings a chair time at many clinics due to the nursing shortage.  I don't think asking them about "life goals" will help with that.

See attachment