PRMR MUC List

We support this measure and also feel it should eventually include assessing caregiver burden as well. 

We support this measure and also feel it should eventually include assessing caregiver burden as well. 

We support and agree with CMS’ hope that this will promote earlier delivery of palliative care and then hospice for people with advanced cancer. Would also be appropriate for others with advanced illness.

We support and agree with CMS’ hope that this will promote earlier delivery of palliative care and then hospice for people with advanced cancer. It would also be appropriate for others with advanced illness.

We support this measure and hope it promotes earlier hospice referral. It would also be appropriate for others with advanced illness as most Medicare beneficiaries get hospice for too short a time.

We support this measure and hope it promotes early referral to palliative care which evidence shows it can improve the quality of life for those with neurologic conditions. 

Please please include the American Society of Hematology's new quality measure assessing timely pain treatment in the emergency department for patients with sickle cell disease. I've worked with sickle cell data and with clinicians and patients dealing with the disease for two decades. The problem of delayed or inadequate treatment of pain crises in the emergency room setting is real, and it is huge. 

Please approve MUC2024-25 - Diagnostic Delay of Venous Thromboembolism (DOVE) in primary care.  As a widow, due to my husband’s undiagnosed hospital-associated venous thromboembolism, I strongly recommend this measure. The data measured in this recommendation will address several of the circumstances that led to his death (and millions more patients.) I am particularly imploring data collection that 1) increases awareness for and consideration of non-specific symptoms that have too long been underappreciated as symptoms of a potentially fatal VTE, and 2) establishing a 24hr norm to reach VTE diagnosis. VTE is a severe disease that frequently goes misdiagnosed or undiagnosed before resulting in death and permanent disability. The attached comment further outlines the importance of these two data measures. 

Please see attached comment

Screening for and diagnosing prediabetes should be a quality measure. An early diagnosis of prediabetes can prevent or delay the onset of type 2 diabetes if patients are referred to lifestyle modifications programs and/or prescribed medications to control abnormal glucose. Moreover, there are weight loss medications that have demonstrated the potential to prevent the onset of type 2 diabetes. Furthermore, preventing type 2 diabetes is a first step to preventing the downstream effects of chronic high blood sugar such as cardiovascular disease. However, type 2 diabetes and chronic conditions associated with the disease cannot be prevented unless a diagnosis of prediabetes is first established.  Moreover, a diagnosis of prediabetes is associated with increased continuity of care among rural dwelling patients. (see https://onlinelibrary.wiley.com/doi/epdf/10.1111/jrh.12907?domain=author&token=YAXZKXSQ88KICXFEDVSP) Therefore, if screening for prediabetes were a quality measure, overall population health may improve for 3 reasons: (1) improvements in continuity of care which may lead to receipt of other preventive screenings and services such as cancer screenings and vaccinations; (2) there are effective treatments for prediabetes; and (3) treatments for prediabetes improve overall health by improving diet and exercise which may lead to weight loss which reduces risk of type 2 diabetes, cardiovascular disease, and cancer. 

Premier supports adoption of measures that advance patient safety. However, Premier does not support adoption of this attestation-based measure which neither measures patient outcomes nor evaluates patient care. Premier strongly urges CMS to assess what (if any) gaps in quality measurement exist around patient safety in the current quality reporting programs and to work with stakeholders to develop meaningful outcome measures that provide hospitals with actionable quality data. As part of that, Premier urges CMS to work with stakeholders to advance the use of AI in its development of new digital quality measures. The use of AI has the potential to increase the availability of real-time, actionable quality data and to reduce provider burden and burnout. 

With respect to the addition of question 2F, Premier supports measures that reward hospitals for leveraging Group Purchasing Organization (GPO) to mitigate drug shortages. GPOs play a vital role in combatting shortages by vetting quality manufacturers, testing unique reimbursement models that create stability for drugs prone to shortages, and leveraging private-public partnerships to nationally scale private sector innovations that successfully address drug shortages for hospitals across the country. Since 2019, Premier’s voluntary ProvideGx Program (https://premierinc.com/providegx) identifies safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list. Guided by health systems with more than 1,600 hospitals across the nation, ProvideGx creates long-term committed buying contracts that provide participating manufacturers with the surety needed to increase production. Premier’s programs, including ProvideGx, currently provide hospitals access to more than 150 drugs that are or have been recently designated as shortage drugs.

Comments attached. 

Premier supports this measure and believes hospitals are equipped to capture influenza vaccination information among healthcare personnel.

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier supports Hospital-Level, 30-Day, Risk-Standardized quality measures that focus on improving mortality and reducing complications or readmissions. Given the growth in Medicare Advantage (MA) enrollment, Premier supports the expansion of these measures to include MA beneficiaries.

However, Premier questions the application of these quality measures for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Premier is supportive of measures and efforts to address social needs. However, Premier urges CMS to work with stakeholders to develop consistent survey questions but continue to maintain the flexibility for how and when facilities screen patients so that facilities can best design their survey protocols to meet the needs of their patients and the capacity of their staff. Deployment of a standardized health related social needs (HRSN) screening would allow for alignment of "allowable values" across disparate screenings where a “low risk" answer is currently considered a positive screen for the IQR measure, leading to possible inflated positive screening rates. With Intervention for all positive screens required, lack of a standardized definition for "positive screen" may lead to further strain on systems with limited resources. Consideration should be given to using ICD-10 Z codes across programs to indicate a positive screen. With the move from screening to intervention, CMS needs to focus on a strong safety net regardless of location to ensure patient access to needed resources.  Premier encourages CMS to work with stakeholders to develop a measure that is meaningful for hospitals as they design interventions to address HRSNs in partnership with their communities. 

Premier strongly urges CMS to maintain the measure as voluntary as it continues to work through technical reporting challenges of eCQMS with providers. Premier also urges CMS to work with stakeholders to continue to evolve this measure to reduce burden on providers and patients. While many providers have already implemented processes to screen patients for social drivers, providers continue to face challenges with aggregating and reporting results for their entire patient population. For example, CMS recently clarified that while all patients should be screened at every visit only the last visit should be reported for purposes of the measure. Additionally, providers are still awaiting additional guidance from CMS on how to report certain cases, such as incomplete entries. To reduce burden, CMS should consider ways to develop an electronic clinical quality measure that allows providers to pull directly from electronic medical records.

Premier is supportive of measures and efforts to address social needs.   However, Premier urges CMS to work with stakeholders to develop consistent survey questions for health plans and hospitals alike. Hospitals should maintain the flexibility for how and when facilities screen patients so that facilities can best design their survey protocols to meet the needs of their patients and the capacity of their staff. Consideration should be given to using ICD-10 Z codes across programs to indicate a positive screen. With the move from screening to intervention, CMS needs to focus on a strong safety net regardless of location to ensure patient have access to needed resources. 

Premier also urges CMS to work with stakeholders to continue to evolve this measure to reduce burden on providers and patients. More work is required to streamline this measure to reduce unnecessary repetition of social needs screenings that result in patient frustration. 

Premier supports incentivizing communications about medications.  Healthcare providers can and should document when they communicate this information to other healthcare providers and patients/caregivers. However, Premier has concerns regarding patients self-reporting complex information given the high rates of dementia and memory deterioration among this patient population, which creates reliability issues with these types of measures.

Premier supports incentivizing communications about medications.   Healthcare providers can and should document when they communicate this information to other healthcare providers and patients/caregivers. However, Premier has concerns regarding patients self-reporting complex information given the high rates of dementia and memory deterioration among this patient population, which creates reliability issues with these types of measures.

While Premier is supportive of patient-reported outcome measures (PROMs) and acknowledges that PROMs can be the impetus for initiating conversations between patients and providers and improving shared-decision making, we urge CMS to maintain this measure as voluntary for a couple of years as ASCs get up to speed on the technical requirements. 

Premier urges CMS to maintain the measure as voluntary for a couple of years as it continues to work through the technical challenges of reporting eCQMS. If adopted, CMS should emphasize that the measure includes all ED patients regardless of transition to observation or inpatient status. This has been a major source of confusion for adoption of the current OP-40 ST Elevation Myocardial Infarction eCQM.

While supportive of this measure, Premier recommends voluntary reporting for this measure for a few years to give hospitals time to build out and test this eCQM measure properly. If adopted as a mandatory eCQM, the current OP-22 'Left Without Being Seen' measure should be retired as element 2 in the proposed measure will address that quality gap. Premier also supports the stratification for psychiatric/mental health disorders as a principal diagnosis, but there should also be individual stratification that reflect transfers out of the facility, non-ED observations, admissions, discharges from the ED, hospital trauma designation and level of trauma designation. Because there is a similar "mature" chart abstracted measure, timeframe cutoffs make more sense for the inclusion of this measure in the Hospital Outpatient Quality Reporting population than they do for Rural Emergency Hospital Quality Reporting. However, Premier is concerned that improvement on this measure will be minimal without giving hospitals additional resources. 

While supportive of this measure, Premier recommends voluntary reporting for this measure for a few years to give hospitals time to build out and test this eCQM measure properly. Premier has concerns about the ability of rural emergency hospitals to report this measure, as they may lack the appropriate IT resources. Unlike larger hospitals that use EHRs like Epic or Oracle Cerner, some smaller and rural hospitals use separate EHRs for their emergency department. It was noted within the Feasibility Study that only one REH designated facility was tested, therefore more testing is needed with additional rural emergency hospitals to ensure feasibility.

Additionally, rural hospitals face both financial and labor challenges that can impact the level of service in their EDs. CMS may consider making the measure voluntary for more than two years to better understand the causes for the ED delays, as well as what defines a “delay” in a rural setting. It is unclear whether time cutoffs such as >1 hour wait time, >4 hour for transfer, or >8 hour ED LOS are appropriate, especially given that the measure scores are reported as an "Access Failure" rate. Premier recommends working with stakeholders to validate the time cutoffs. For example, it might be better to use a median time as what defines a “delay” for these facilities than a sharp timeframe.

Premier supports adoption of this measure by the Hospital Inpatient Quality Reporting and Hospital Outpatient Quality reporting programs. Much of the change toward earlier hospice admittance is dependent on patient attitudes and how equipped hospital staff are to have these difficult discussions. While very worthwhile, limited resources for in-depth conversation about end-of-life issues may prevent substantive improvement.

Premier recommends testing this measure in the Hospital Inpatient Quality Reporting Program and Promoting Interoperability Program prior to implementing in the Hospital-Acquired Condition Reduction Program, given the financial impact of this measure. Additionally, publishing measure guidelines and benchmarks prior to implementation would allow facilities to determine priorities for improvement. As noted with other eCQM measures, this measure should be voluntarily reported for a few years prior to making it mandatory to give facilities time to build out the measure. With this measure in particular, there are a lot of details that can be challenging to capture properly as seen with reporting core clinical data elements for hybrid measures, including standard units of measurement and timing. 

AHIP recommends that PRMR support this measure for the MIPS program.  This measure would be the first lifestyle measure that could identify and prevent diabetes.  Prevention and early identification would be impactful for both individual and population health. 

Please see the PDF of my comments.

I am writing on behalf of HabitNu, a leading provider of CDC-recognized Diabetes Prevention Programs, to express our strong support for the inclusion of measure MUC2024-028 in the CMS Merit-based Incentive Payment System (MIPS).

As an organization deeply involved in diabetes prevention and management, we have firsthand experience with both the challenges of early identification of at-risk individuals and the significant benefits of early intervention. Our experience implementing diabetes prevention programs across diverse communities has shown that systematic screening is a crucial first step in connecting patients with life-changing preventive services.

We strongly support this measure for several key reasons:

The CDC estimates that 98 million American adults have prediabetes, with over 80% unaware of their condition. This measure directly addresses this awareness gap by incentivizing healthcare providers to implement systematic screening protocols for at-risk patients.
 

The measure aligns with the USPSTF's 2021 recommendation for screening adults aged 35-70 years who are overweight or have obesity, ensuring that screening efforts target those most likely to benefit from early intervention.
 

Implementation of this measure will significantly improve access to the Medicare Diabetes Prevention Program (MDPP), a fully covered benefit for Medicare recipients. Our experience has shown that provider awareness directly correlates with patient enrollment in lifestyle change programs.
 

Early identification and intervention through lifestyle change programs have consistently demonstrated effectiveness in lowering A1C levels and preventing or delaying the onset of type 2 diabetes. This approach represents a cost-effective strategy for reducing the long-term burden on our healthcare system. Quality measures tied to Medicare reimbursement create powerful incentives not only for individual providers but also for healthcare system leadership to prioritize preventive screening. This systemic approach is crucial for creating sustainable change in screening practices.
 

In our work implementing diabetes prevention programs, we have observed that healthcare providers who systematically screen for abnormal glucose are significantly more successful in connecting patients with preventive services. When providers are supported by quality measures and reimbursement incentives, they are better equipped to:

-Implement consistent screening protocols

-Identify at-risk patients earlier in disease progression

-Connect patients with covered preventive services

-Monitor and improve population health outcomes

Based on our extensive experience in diabetes prevention and the clear public health need, we strongly endorse the inclusion of measure MUC2024-028 in the MIPS program. This measure represents a crucial step toward systematic identification of individuals at risk for diabetes and will significantly enhance our nation's diabetes prevention efforts.

The implementation of this measure will create a stronger connection between screening and intervention, ultimately leading to better health outcomes and reduced healthcare costs. We believe this measure is both important and appropriate for inclusion in accountability programs.

Thank you for the opportunity to comment on this critical measure.

Sincerely,

Stephanie Watkins

Vice President of Operations

HabitNu

I am in support of MUC2024-074 - Median Time to Pain Medication for Patients with a Diagnosis of Sickle Cell Disease (SCD) with Vaso-Occlusive Episode (VOE)

As someone living with sickle cell disease, I have experienced firsthand the unbearable pain of vaso-occlusive episodes (VOEs). These crises are not just physically debilitating; they also come with the emotional toll of navigating a healthcare system that often fails to recognize the urgency of our needs. For many of us with sickle cell, the emergency department becomes the last resort. Yet, it is there that we frequently face delays, stigma, bias, and inadequate pain management.

Implementing the measure “Median Time to Pain Medication for Patients with Sickle Cell Disease and Vaso-occlusive Episodes” represents a vital step forward in addressing these long-standing inequities. The excruciating pain of a sickle cell crisis (VOE) cannot wait, it demands immediate, compassionate care. Unfortunately, the current reality for many patients with sickle cell disease, who are disproportionately Black or African American decent, is an average wait of 90 minutes or more before receiving necessary pain relief. This delay not only prolongs our suffering but also exacerbates the stigma we face, reinforcing misconceptions about our pain being exaggerated and dismissed.

Adopting this measure could transform the care experience for a marginalized community that has long been overlooked. By holding healthcare providers accountable for timely pain management, this initiative sends a powerful message: that patients with sickle cell disease deserve dignity, empathy, and equitable treatment. Moreover, reducing the time to pain medication could lead to better clinical outcomes, shorter hospital stays, and a significant improvement in the quality of life for patients like me.

I urge policymakers, healthcare providers, and stakeholders to prioritize the implementation of this measure. It is not just a clinical guideline; it is a lifeline for a community that has endured far too much pain and for far too long. Let this measure be a turning point in how we address the disparities faced by individuals with sickle cell disease, ensuring that no patient’s pain is left unheard or untreated.

Heather Avant, 

National Patient Advocate 

As a member of the non-pressure ulcers quality cost measure working group and a wound care clinician, I do not support the Non-Pressure Ulcers Episode-Based Cost Measure as currently proposed. I recommend that it be withdrawn until further refinements are made and additional testing can be conducted.

MUC2024-051: Prevalent Standardized Waitlist Ratio (PSWR)

The American Society of Nephrology (ASN) recognizes the importance of improving transplantation rates for patients with kidney failure but does not support the Prevalent Standardized Waitlist Ratio Measure. ASN believes that while referral to a transplant center and initiation or even completion of the waitlist evaluation process could be appropriate metrics for these levels of analysis in CMS quality programs, the proposed clinician/group-level Prevalent Standardized Waitlist Ratio (PSWR) measure is not. The waitlisting process is a decision made largely by each individual transplant center and is beyond the scope of control of the physicians/physician groups targeted in the measure. In reviewing the details of the measure, ASN offers the following comments: 

ASN objects to the attribution of successful/unsuccessful placement on a transplant waitlist to individual physicians or group practices. As stated above, it is the transplant center that decides whether a patient is placed on a waitlist, not the physician or group practice. The waitlisting process involves multiple parties that are unrelated to the nephrologist or care team, which can lead to potential obstacles and delays in care. Several factors beyond the control of the physician or physician group can impact the transplant waitlisting process. For example, changes in a patient's private insurance can affect the locations where they can be evaluated for transplant eligibility, disrupting the process multiple times. Penalizing physicians or group practices for events like these, which are beyond their control, highlights that the measure is misaligned with the principle that attribution models should fairly and accurately assign accountability.

In addition, the criteria for determining a patient's eligibility for transplantation can vary by geographic location. For example, one transplant center may require evidence of the absence of chronic osteomyelitis infection, heart failure, or other conditions, while another may apply different or additional criteria. ASN believes that the significant variability in listing rates among transplant centers undermines the validity of this measure. This measure, along with other waitlisting-related measures in their current proposed forms, highlights the need for metrics that align incentives across the entire continuum of care. ASN believes that the current proposed measure fails to achieve this alignment and urges CMS to implement measures that more accurately reflect the role of nephrologists in the transplantation process and promote high-quality care for patients.

MUC2024-060: In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey - Quality of Dialysis Center Care and Operations (QDCCO) measure

The American Society of Nephrology (ASN) believes it is critically important to measure patient experience related to their dialysis treatments and their interaction with nephrologists. While ASN supports shortening the survey tool to reduce the burden on patients, we are concerned that the measure has not been reviewed by the measure consensus-based entity. ASN urges CMS submit the measure for full endorsement, including the submission of validity and reliability testing before adding the measure to the ESRD QIP program.

We are pleased that CMS has refined the ICH CAHPS survey measure by shortening the tool to address the well-documented fact that the current tool is too long.  Pre-pandemic response rates are currently approximately 35 percent, raising concern for possible underrepresentation of patient groups. For instance, in a cross-sectional analysis of survey administration to 11,055 eligible in-center hemodialysis patients across the U.S., Dad et al. reported in 2018 that non-responders (6,541 [59 percent]) significantly differed from responders, broadly spanning individuals with fewer socioeconomic advantages and greater illness burden, raising limitations in interpreting facility survey results.  As CMS has recognized, these rates fell even more during the pandemic.

Fielding of the current measure has created such a high level of patient burn-out with completing the lengthy survey twice a year that the measure is no longer valid.  In fact, the current tool marginalizes people of color. Non-responders were more likely to be men, non-white, younger, single, dual Medicare/Medicaid eligible, less educated, non-English speaking, and not active on the transplant list. This situation should not be perpetuated.  In addition, the current tool excludes home dialysis patients, reducing the power of their voice in the process. There has been considerable success in adapting the tool for use with home dialysis patients by some dialysis providers, and ASN urges CMS to examine those efforts. ASN would be happy to join CMS and others in that dialogue. Specifically of concern:

• Continued exclusion of home dialysis patients.  While ASN appreciates the revisions of this measure, ASN remains concerned that CMS has not revised the survey tool to include home dialysis patients. 
• Reliability/Validity Studies. Given the historic problems with the ICH CAHPS measure’s validity, we believe it is premature for CMS to adopt the measure until the reliability and validity of the revised survey tool.

Legal issues prevent many hospitals in many states from implementing some of the CMS Patient Safety Structural Measures (PSSM) without the risk of substantial liability.  Because of the patchwork of state peer protection laws and states upholding the Federal Patient Safety Act protections, the measures will result in a disparate impact for hospitals, healthcare providers and patients.  In addition, the measures are not attainable by all hospitals and are not meaningful in improving patient safety or in informing patients about the quality of care of hospitals.   If CMS is going to incentivize patient safety activities through federal funding and rating measures, the Federal government must support the federal protections of the Federal Patient Safety Act (42 U.S.C. 299b-21 et seq.) to allow hospitals in all 50 states, the District of Columbia and U.S. territories to implement those patient safety practices. 

To Whom It May Concern, 

The Healthcare Distribution Alliance (HDA) appreciates the opportunity to provide comments on the Pre-Rulemaking Review (PRMR) of the Measures Under Consideration (MUC) list for 2024.

HDA represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. 

Specifically, we write in comment of MUC2024-027, which amends the “Patient Safety Structural Measure” to require hospitals to attest to the following: 

• Our hospital purchases medications by utilizing contracting provisions that promote supply chain resiliency, including multi-year contracts with volume guarantees and stringent “failure to supply” clauses, either directly with vendors or indirectly through wholesalers or Group Purchasing Organizations.
• Our hospital has policies and procedures to respond to medication shortages and outages, including ensuring continuity of pharmaceutical services to meet patient needs during emergencies for a minimum of 7 days.

As the logistics experts of the supply chain, distributors play a critical role in bolstering resilience within the pharmaceutical supply chain, helping to ensure that patients and providers can access lifesaving medications and other medical supplies during steady-state and crisis conditions. To that end, HDA encourages continued public-private collaboration in joint decision-making, private-sector resource utilization, healthcare workforce investment, and emergency preparedness and response. 

We are concerned, however, that the above attestations may not be appropriate or operationally feasible in a distributor’s contract due to the nature of logistics in the pharmaceutical supply chain. For instance, while contract language varies from distributor to distributor, it is generally understood that products may become unavailable for a variety of reasons that are not within the control of the hospital or distributor. Such situations could run contrary to a “stringent” failure-to-supply clause and unfairly penalize hospitals. 

While evaluating MUC2024-027, we urge CMS, the PRMR advisory group, and the PRMR recommendation groups to engage with wholesale drug distributors to understand distributors’ unique relationship with hospitals, including the kinds of services that distributors provide to promote resiliency. HDA is available at your earliest convenience to help facilitate that engagement. Please contact Kala Shankle, Vice President of Regulatory Affairs, [email protected] should you have any questions. 

Please see attached comments on behalf of the National Association of Chronic Disease Directors (NACDD). 

Thank you for the opportunity to submit a public comment for MUC 2024-025.

There are concerns with the measure specifications. The denominator requires several symptoms as a qualifying event. The ICD, CPT, and RxNorm codes must appear within the same encounter. Venous thromboembolism (VTE) is difficult to diagnose. Does the measure restrict definitive cases to those diagnosed and treated in the emergency department?  Thus, if a patient is diagnosed during a primary care physician (PCP) visit and sent elsewhere for the imaging study and prescribed anticoagulation afterward – this would not meet the denominator and would not count as a success.

The time interval is not practical in many clinical settings and may also lead to overuse of imaging. 

Additionally, the measure testing results show low reliability, indicating that the measure is not reliable enough for use in a federal program.

We urge the developer to address these concerns before implementation in a federal program.

Thank you for the opportunity to submit a comment for MUC 2024-026.

There are concerns with the measure specifications. The denominator reflects patients 18 years and older with “complex care needs”, defined as two or more chronic conditions, a behavioral health condition, or a social need.  The developer should refine the definition for a complex care need, as many younger healthy patients would meet the denominator through concurrent chronic conditions, such as allergies and GERD. It is also unclear what constitutes a social care need. While the measure is supported by evidence based on older adults, the denominator includes patients starting at age 18. The denominator age should be modified based on the evidence.

Although the measure shows high reliability at the group practice level, it has not been tested at the individual physician level. The measure developer must test this measure at the individual physician level before inclusion in the MIPS program.

There are also feasibility issues with documenting goals and plans in a structured format. Natural language processing/artificial intelligence is not advanced enough to extract this information reliability. Additionally, it is burdensome to document and collect data for three denominators.

Thank you for the opportunity to submit a comment for MUC 2024-031.

Sustained virological response (SVR) is almost wholly dependent on receipt of direct-acting antivirals (DAA). There may still be some access issues and variable willingness of patients to adhere to therapy. In addition, DAAs are very effective at achieving SVR, though not 100% effective, and effectiveness may be slightly lower in patients with HIV or hepatitis B (HBV) coinfection. In general, HBV is treated prior to treating HCV due to the risk of flare. The measure excludes patients who do not have repeat HCV DNA testing for reasons including concomitant infection but does not exclude people with concomitant infection from the denominator. The measure developer should consider adding this as an exception, as well as patients who decline treatment.

Thank you for the opportunity to submit a public comment for MUC 2024-080.

The measure specifications are unclear. The measure requires a physician to document the “plan of care” at every visit. Does this mean that “plan of care” activities, i.e., balance or gait training, PT or OT, and/or home safety evaluations, are ordered continuously? There are concerns that the narrative documentation attesting that the patient is in care will require a check box linked to a SNOMED code to satisfy the numerator.

The measure testing results show high reliability at the individual physician level, but the developer needs to test this measure at the group practice level before inclusion in the MIPS program.

Thank you for the opportunity to comment on MUC 2024-082.

There are concerns with the measure specifications. The denominator assumes a style of medical practice is not necessarily accurate, specifically that conversations, counseling, and orders for cancer screening only occur during comprehensive, wellness, or other targeted visits. In primary care, physicians raise or address cancer screening at any visit or even outside of visits. The numerator should define what qualifies as “high-quality counseling”.  Additionally, there are patients who either decline screening or accept orders for screening but do not complete the orders, which is not addressed in the numerator. It is important to address screening in this subset of patients. 

While the measure is tested for reliability at the group level, there is no testing data at the individual physician level. The developer must test this measure at the individual physician level before inclusion in the MIPS program.

There are also feasibility issues. The developer indicates the survey takes 5-7 minutes to complete, and data indicates a primary care visit is between 7-11 minutes. It does not seem like 1 visit would be enough time to complete the survey and also address patient concerns.

Subject:  Support for ASH’s New Quality Measure MUC2024-074 on "Median Time to Pain Medication for Patients with Sickle Cell Disease with Vaso-Occlusive Episode" 

Dear Centers for Medicare & Medicaid Services,

I am writing on behalf of the International Association of Sickle Cell Nurses and Professional Associates (IASCNAPA) to say that we strongly support the quality measure  that the American Society of Hematology (ASH) has proposed for the Hospital Outpatient Quality Reporting Program and Rural Emergency Hospital Quality Reporting Program: MUC2024-074- "Median Time to Pain Medication for Patients with Sickle Cell Disease with Vaso-Occlusive Episode." In order to address the long-standing inequities in care that people with sickle cell disease (SCD) experience, this policy is a crucial first step.
 

During vaso-occlusive episodes, SCD patients frequently experience protracted delays in pain relief, which causes needless suffering, complications, and mistrust of the medical system. This measure, which standardizes the median time to pain medication, emphasizes the value of prompt and fair care, promotes accountability, and pushes emergency rooms to streamline care routes.
 

We advocate the inclusion of additional elements to provide comprehensive emergency department care for patients with sickle cell disease (SCD). These factors include:

1) Comprehensive Pain Management Protocols
2) Education and Training for Emergency Department Employees
3) Access to Multidisciplinary Teams
4) Patient-Centered Care Measures
5) Post-Emergency Follow-Up Plans for Continuity of Care

IASCNAPA applauds CMS for taking this measure into account in its quality reporting programs and ASH for taking the initiative in addressing the pressing needs of the SCD community. CMS may greatly improve the care experience and results for people with SCD, especially in underserved and rural regions, by implementing this measure and adding the recommended extra elements.

Sincerely, 

Yvonne M. Carroll, RN, JD

Board Member, IASCNAPA

Thank you for the opportunity to submit a comment for MUC 2024-072.

The rationale for the scoring and the way it will be used are not clearly articulated. It is not clear what the expected score would be.  The scoring will differ in settings that are serving populations with different levels of need. The measure aims to increase physicians’ use of   screening tools to identify and address social needs.  Hypothetically, if physicians do improve, the score would go down (i.e., greater percentage positive in year one than in subsequent years because of connecting patients to services).  How does the measure account for improvement? We recommend the developer adjust the scoring to support improvement in addressing social needs. 

The developer should add an exclusion for patients who decline screening or decline follow-up.  Physicians should not be penalized for patient refusal of offered services. This defies the principles of patient-centered care and could also lead to unintended consequences.  Physicians would be incentivized to pressure patients to provide information they are not comfortable with. These patients are typically excluded from performance measures.  We also recommend that patients who screen negative be classified as meeting the measure and reflected in the measure scoring.

There are too many components included in the measure. We recommend a separate measure for social needs screening and another for follow-up for positive screens. If a patient is found to screen positive in an ambulatory setting, the challenge is the follow-up component.  The follow-up requires a treatment plan, infrastructure, and dedicated resources to implement. California is one state that has mandated that health plans cover health-related social needs screenings as well as mandated an adequate network of social workers to provide the follow-up.  However, these requirements are not supported by the reimbursement mechanisms currently in place at the clinician level (i.e., CPT codes).

In 2022, ACP released a position paper that supports payment reform to achieve greater equity and value in health care.  ACP acknowledged that socioeconomic factors are significant contributors to health outcomes in this country.  The proposal advocates that payment models be adjusted to decrease health inequities and address social drivers of health. ACP recommends that the integration of routinely identifying social needs and follow-up be supported by new payment models to support these efforts.

Please see the attached letter from the American Diabetes Association. 

Thank you for the opportunity to submit a comment for MUC 2024-088.

This measure is currently in the MIPS program with a shorter follow-up period (14 days). The extended 30-day follow-up period is more realistic and should also be adopted for the MIPS program.

A major limitation of this measure is the ability to demonstrate a follow-up plan. It is unclear what constitutes follow-up care. The developer should include a definition for the appropriate follow-up care. The measure specifications should also exclude patients who decline screening.

Depression treatment is often a team-based effort between different types of clinicians. This measure does not account for continuity of care.

Finally, data interoperability is necessary to track care across systems and structured data fields related to depression management. This is not currently readily available.  Documenting this measure is not standardized across different systems/practices. HCPCS G-codes require manual entry or sophisticated systems that automate entry based on routine clinical workflows, adding administrative burden.

The National Association of Chronic Disease Directors (NACDD) and its more than 7,000 members seeks to strengthen state-based leadership and expertise for chronic disease prevention and control in states and nationally. NACDD’s core membership is comprised of the 59 State and eight Territorial Health Department Chronic Disease Directors and their staff who protect the health of the public through primary and secondary prevention efforts and work on “upstream” root causes of chronic conditions. In addition, NACDD unites chronic disease professionals across the United States working in state, tribal, and territorial health departments, nonprofits, academia, and the private industry to promote health and to reduce the burden of chronic disease. As a national, nonprofit, professional Association, we advocate, educate, and provide technical assistance, to inform programming and grow chronic disease prevention knowledge, leadership, and capacity among our Membership.
 

General Comments
On behalf of our members, NACDD appreciates the opportunity to provide a public comment in support of adopting the MUC2024-028 Screening for Abnormal Glucose Metabolism in Patients at Risk of Developing Diabetes (Screening). Screening for prediabetes and undiagnosed type 2 diabetes plays a vital role in enhancing prevention and care for type 2 diabetes. According to the Centers for Disease Control and Prevention (CDC), approximately 97.6 million American adults have prediabetes, with more than 80% unaware of their condition¹. Additionally, 38.4 million adults have diabetes, including 8.7 million who are undiagnosed¹. The prevalence of prediabetes and diabetes increases with age, emphasizing the importance of early identification. Early detection enables patients to access effective interventions that reduce the risk of disease progression and complications. These risk reductions can result in better quality of life, improved productivity, and reduced healthcare costs associated with complications.
 

This Screening measure aligns with the 2021 United States Preventive Services Task Force (USPSTF) recommendation to screen adults aged 35 to 70 years who have overweight or obesity for prediabetes and type 2 diabetes². It also supports the National Clinical Care Commission’s (NCCC) recommendation to Congress and the Secretary of Health and Human Services (HHS) to adopt the Screening measure developed by the American Medical Association as part of a strategy to prevent diabetes in high-risk individuals³.
 

By targeting a population focusing on high-risk individuals that stand to benefit significantly from glucose screening, this measure is both clinically appropriate and meaningful for improving patient care. Its implementation is feasible for most healthcare organizations, as the necessary data elements are typically captured in electronic health records (EHR). Furthermore, the measure has been validated and demonstrated to be reliable through testing results, ensuring its effectiveness in practice.
 

Identification of prediabetes is crucial so that older adults with prediabetes can receive effective interventions, such as the Medicare Diabetes Prevention Program, to decrease the likelihood of progression to type 2 diabetes. What’s more, screening older adults at risk of developing diabetes will also identify individuals with formerly undiagnosed type 2 diabetes, who can then be offered appropriate treatment and care. NACDD believes that screening for abnormal glucose is an important preventive service and is reasonable to include in accountability and quality improvement programs, including CMS’s Merit-based Incentive Payment System (MIPS).
 

One benefit of approving this recommendation as a quality measure is that it will ensure that all people at risk of developing diabetes are tested, regardless of a clinician's or an individual's perception that they are not at risk, particularly as they age. Another benefit of approving this recommendation is that uncontrolled diabetes may be detected before complications with the eyes, kidneys, heart, etc., develop. A third benefit is that more people will have the opportunity to reverse prediabetes by participating in the National DPP Lifestyle Change Program if their risk is identified early.

Thank you for the opportunity to comment on adopting the MUC2024-028 Screening for Abnormal Glucose Metabolism in Patients at Risk of Developing Diabetes (Screening).

Sincerely,

John W. Robitscher, MPH
Chief Executive Officer
National Association of Chronic Disease Directors

¹CDC. (2024, July 23). National Diabetes Statistics Report. Retrieved November 15, 2024, from Diabetes website: https://www.cdc.gov/diabetes/php/data-research/
²US Preventive Services Task Force. (2021). Screening for Prediabetes and Type 2 Diabetes: US Preventive Services Task Force Recommendation Statement. JAMA, 326(8), 736–743. https://doi.org/10.1001/jama.2021.12531

³Report to Congress on Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications. National Clinical Care Commission, 2021, https://health.gov/about-odphp/committees-workgroups/nationalclinical-care-commission/report-congress.