PRMR MUC List Commenting

Recommend with conditions.  Managing symptoms is an important aspect of patient-centered hospice care.  However, this measure should be submitted for and receive CBE endorsement. 

Please see the attached letter for comments on several of the measures under consideration for the Hospital Committee.

Recommend with conditions.  We appreciate the value of patient-reported data on care coordination.  However, the response rate on CAHPS surveys continues to decline.  Any additional items added to the survey should be balanced by removing other items to minimize the response burden on consumers. 

Recommend with conditions.  We appreciate the value of patient-reported data on care coordination.  However, the response rate on CAHPS surveys continues to decline.  Any additional items added to the survey should be balanced by removing other items to minimize the response burden on consumers. 

Recommend with conditions.  We appreciate the value of patient-reported data on care coordination.  However, the response rate on CAHPS surveys continues to decline.  Any additional items added to the survey should be balanced by removing other items to minimize the response burden on consumers. 

Recommend with conditions.  We appreciate the value of patient-reported data on care coordination.  However, the response rate on CAHPS surveys continues to decline.  Any additional items added to the survey should be balanced by removing other items to minimize the response burden on consumers. 

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Please see the attached for comments on several of the hospital measures from Stratis Health. 

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with conditions.  AHIP supports the use of PROs in provider quality reporting and value-based purchasing programs. The measure should be submitted and receive CBE endorsement to ensure it can be feasibly implemented. 

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with Conditions. AHIP appreciates the value of measurement in reducing healthcare costs. However, the measures must have appropriate clinical and social risk adjustment, exclusions, and attribution methodology Measures should be reviewed and CBE-endorsed.

Recommend with conditions. The measure should be submitted for and receive CBE endorsement

Recommend with conditions.  AHIP supports the use of PROs in provider quality reporting and value-based purchasing programs. The measure should be submitted and receive CBE endorsement to ensure it can be feasibly implemented. 

Please see the attached for comments from Stratis Health on multiple measures.

Recommend with conditions, the measure should be re-specified to add appropriate exclusions.  AHIP strongly supports the importance of vaccination against SARS-CoV-2, however, we note the Measure Applications Partnership's previous concerns that there is regional variation in vaccine hesitancy and this measure continues not to have an exclusion for patient refusal.  While we agree with the importance of this measure concept, the lack of exclusion for patient choice and the ability of clinicians to choose which measures to report in the MIP program, may lead to skewed results and data that is not reflective of performance as  only providers with high vaccination rates in their patient population would choose to report the measure.

Recommend.  We support the addition of this measure. 

Do not recommend. We appreciate the importance of safe prescribing of opioids but implementing this measure in a program like the Star Ratings could have unintended consequences for patients. While we agree opioids should be prescribed carefully there are select patient populations who may need opioids for a longer duration to address symptoms. These decisions should be between patients and their healthcare providers. 
We are concerned that implementing this measure in the Star Ratings at this time could have negative consequences for patients.  We believe it may be premature to move this measure from the Display Page without a full assessment of its current specifications and exclusions. We are concerned that moving this measure from the Display Page to the Star Ratings without adequate denominator exclusions could result in beneficiaries having limited treatment options.  
CMS should leave this measure on the Display Page to allow health plans, CMS, and the measure developer an opportunity to understand how this measure currently performs, potential negative consequences of its implementation, and if there is a need for refinement of the specifications to ensure that patients are not denied necessary treatments.  Leaving the measure on the Display Page would still allow health plans to understand and improve performance and consumers to assess health plan results.  We believe this would allow stakeholders the information they need while protecting patients from access challenges.

Recommend with conditions.  The version of the IET measure on the MUC list appears to include telehealth visits while the technical notes for the version currently included in the display measures does not include telehealth as a way to identify members for the measure denominator.  CMS should not add the modified version of the measure to the MA Star Ratings until is has been thoroughly tested and first put on display. 

Do not recommend. Currently, there are 2 Part C appeals measures in the Star Ratings program. One measure focuses on how fast an MA plan sends information on a denial that has been appealed for an independent review and the other measure focuses on how often an independent reviewer found the health plan’s decision to deny coverage to be reasonable. This proposed measure seems to duplicate this second Part C appeals measure that is already part of the MA Star Ratings program.

The GAO report cited by the measure developer notes that denials are not overturned only because of incorrect decisions by a health plan.  Denials are also overturned when an MA Organization made a correct initial decision based on the information available at the time but will find that the provider or beneficiary added new information in an appeal that demonstrates the denial should be overturned.  This measure does not seem to account for when denials are overturned due to the availability of new information or when there was an error in the initial submission and the currently available information to support the measure would not allow a measure to make such distinctions.

Finally, measures under consideration for the MA Star Ratings should be evidence-based clinical quality and patient experience measures and should not focus on compliance. CMS already has authority to oversee and does address denials and appeals through MA and Part D reporting requirements and audits/enforcement. Adding appeals/compliance related measures to quality programs would also be inconsistent with the agency’s latest efforts to streamline measure sets and move towards a “Universal Foundation” of quality measures in CMS’ quality rating and value-based care programs, including MA Star Ratings.

Recommend with conditions.  We agree with the importance of addressing SDOH and appreciate the concrete step of connecting patients with community service providers.  However, CMS should ensure this measure can be implemented feasibly and fairly as the availability of community service providers and their capacity to address new cases varies regionally and may be out of the control of a hospital or ACO. 

Recommend with conditions.  We appreciate that this measure addresses an outcome related to SDOH.  However, it is unclear how this measure would define "resolved."  Social determinants of health are often persistent and a connection with a community service provider may help ameliorate the effects of a social risk factor it does not guarantee that the factor will no longer be present.  Resolved should be defined in a way that ensure this measure is within the reasonable locus of control of the measured entity. 

My name is Gretchen Bietz. Patient safety is important to me because my closest girlfriend lost a child because of a series of medical errors 18.5 years ago and it has had a profound impact on her life and the lives of those around her. Hers is a cautionary tale that goes untold too often, and impacts more that it should.

I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration. I support this measure because it details the best patient safety practices I expect as a patient in the United States. It is important to me that:

1. Hospital leaders and boards of directors prioritize patient safety and are actively engaged in making sure the right safety practices are in place.
2. Hospitals adopt “zero preventable harm” as their patient safety strategic goal, as recommended in the CMS National Quality Strategy. Even if that goal is aspirational, it should be what every hospital aims to achieve.
3. Hospitals establish a culture of safety that engages all its staff and puts in place systems for preventing and learning from medical errors or other challenges that put patients at risk for harm or discrimination.
4. Hospitals have systems in place for reporting harm events and being open and honest with patients and the public when harm events occur. I also expect hospitals to report their events to government agencies, accreditation bodies or other organizations that focus on learning and prevention.
5. 5. Hospitals should engage the patients and families they serve in patient safety work, as recommended by the   President’s Council of Advisors on Science and Technology. Listen to our experiences and factor it in to your work to decrease preventable harm, bias and discrimination. They should also be focused on helping patients access our medical records and correct errors there when we find them.

For all these reasons I strongly support the Patient Safety Structural Measure. 

Thank you for this opportunity to make this public comment.

My name is Hamid Khosrowshahi and I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration. Please see my statement in attached PDF.
Thank you for this opportunity to make this public comment.

I endorse the spirit and general content of the CMS proposed patient safety structural measure (PSSM).  I believe there is an opportunity to infuse safety II concepts into the structural measure (enumerated below).

My specific feedback for consideration is:

1 - Domain #1 element 5:

• Transparency with governing board is important and must be productive to advance patient safety.  Boards must be mindful that notification of a serious safety event within three days of a confirmed serious safety event will most often not be accompanied by deep understanding of root causes and are even less likely to be accompanied by meaningful corrective actions beyond immediate mitigation when applicable.  Expectation of deep understanding and solutions within three days will be counterproductive to patient safety and runs the risk of surface learnings and solutions.
• We should have a national minimum standard of what qualifies as a serious safety event.  Definitions internal to health systems, Sentinel event definitions, NQF serious reportable event definitions vary markedly, and internal definitions often rely on a resource intensive classification process (were there deviations from accepted practice, was severe harm criteria met) that is highly sensitive to reporting culture.  

2 - Domain #2 element 1:  

• Zero preventable harm continues to be a widely used, aspirational goal.  When used as a metric or number to be achieved, it can promote perverse behaviors such as under-reporting.  I believe the structural measure should acknowledge the emerging concepts and learnings from the Safety II concept which argues that safety is not the absence of harm but the presence of ongoing capacity and adaptation; the analogy often used is "a successful marriage is not defined by the absence of divorce."

3 - Domain #2 element 5:  

• Agree with the inclusion of workforce safety as it is a moral imperative and a prerequisite for patient safety.  One could argue that the title of the structural measure should be changed to "patient and workforce safety structural measure."  Other items in the structural measure, like just culture, are as much about workforce safety as they are patient safety.
• Health systems should be supported with guidance on minimum standards of easily obtainable and operationalized workforce safety measurement plans.

4 - Domain #3 element 2:

• Should acknowledge the safety II concept and that often times a RCA2 or learning from events after they happen has diminishing returns and value.  Safety II promotes the notion that harm is often not predictable from past events and that it emerges from everyday variation.  In addition to RCA2 after events or in preference of RCA2 in certain circumstances, proactive learning from high-risk or high-impact scenarios to patients should be promoted or required by the measure (ex. medication administration outside of conventional patient care units).

Domain #3 element 4:

• In current state, data to measure safety events (serious, precursor) depends heavily on reporting culture and manual processes.  Health systems need support and guidance on how to use electronic medical records to identify and track serious safety events.  For example, reporting and tracking wrong site or wrong side surgeries or near misses are primarily dependent on human reporting in current state.

Thank you for the opportunity to comment.

Chapy Venkatesan, MD MS

Chief Quality and Safety Officer

Inova Health System

   The Patient Safety Action Network submits comments regarding proposed measures being reviewed by the Hospital Committee. Thank you for the opportunity to comment on these measures. We are pleased to see the number of outcome measures focusing on patient harm and efforts to change institutional practices within facilities. We support inclusion of facilities in addition to hospitals.  

   Up front, we want to state that outcome measures related to patient harm are important and meaningful for the public and patients. This shows that CMS continues to view patient safety as a priority, and we encourage the agency to include more for public reporting and for CMS payment programs. To facilitate accuracy and less burden, we would like to see more eCQM measures in the patient harm category. 

   Inclusion of an outcome measure of patient falls while hospitalized is an important measure since falls are among the most common harm event. Throughout CMS’s efforts since at least 2009, fall measures have failed to move forward without risk adjustment based on a patient’s condition. This is unfortunate as falls with moderate/serious injury are definitely preventable and thus true never events. We strongly oppose the risk adjustment of this measure, which excludes patients admitted due to a fall diagnosis. It makes no sense to eliminate the very patients who need the most protection. If this patient is a “known faller,” and not just one at risk of falls, extra vigilance is required. A hospital should certainly be able to document and separate when a fall happened prior to admission and while hospitalized. We suspect this exclusion has to do with the measure categorization of the injury from a fall - is it moderate or serious?  This could be addressed by documenting all falls. Those classified as “minor” injuries could actually be moderate or serious because the harm from a fall is not always immediately evident. The measure documentation should be finalized after a thorough examination of the patient’s condition can be assessed. A more reasonable approach to categorizing these events would be to stratify this measure by unit, allowing comparison within ICU, medical surgical or other specific units where patients are of similar risks. That would allow for a true assessment of a facility’s problems with prevention that could lead to care improvement.

   The Patient Safety Action Network submits comments regarding proposed measures being reviewed by the Hospital Committee. Thank you for the opportunity to comment on these measures. 

   We are concerned that the numerous “structural measures” lack visible mechanisms for audit and public accountability (even within the hospital setting) or any indication that the intent is to identify future needs for development of related outcome measures. These structural measures cover extremely important issues for patients - health equity (175, 176), patient safety (188) and the Age Friendly Hospital Measure (196).  Our concern is structural measures could be misleading to the public absent accountability.  This is an opportunity to include the public in measurement.  We recommend annual audits and public posting on the hospital’s website and in conspicuous locations at the facilities of the specific activities the facility should be doing along with their attestation reports to CMS indicating what they are doing. This is a simple method of accountability – patients, health care workers and the larger community will be able to actively participate in ensuring patient safety and health equity if they know what is expected of the hospital and what the hospital has attested to be doing. 

   It is our understanding that the intent is to eventually post these measures on Hospital Compare with a score of 1-5 possible (for each domain). Those postings should be done in context regarding details of what the hospital attests to doing. To fully inform the public of the meaning of this measure, each component of each domain should be revealed on Hospital Compare, either through a drill down function or link to each of the components. By doing this, the measure holds some promise in informing patients/the public of certain activities that could reduce patient harm as demonstrated by existing evidence. 

   We support this measure, even with our concerns stated above. It contains activities known to reduce harm and provides a specific blueprint for what hospitals should be doing to keep patients safe. It includes strong patient-centered care issues, patient involvement and encourages transparency. We know these types of measures are often quickly topped out as being adopted by nearly all hospitals, thus we encourage CMS to begin the process of translating these into outcome measures in the future. Doing so will validate their effectiveness in preventing patient harm. Short of that, it would be useful now for CMS to develop methods for presenting this measure with existing safety outcome measures for comparison. 

   In reviewing the measure details, we strongly support the inclusion of several important details: Domain 4, #2, attestation requires the use of PSOs that participate in AHRQ’s voluntary reporting database; this database is one of the few resources for identifying harm events that occur in US hospitals and most PSOs do not participate. We hope that this will cause hospitals to push more of them to do so.  In Domain 5, #4, the attestation regarding including patients and caregivers input into safety events/issues, mentions that the hospital incorporates “safety signals from patient complaints.” This is extremely important as these patient complaints are not visible to the public (or CMS) and should be actively used to inform the hospital and staff regarding patient experiences and making changes to prevent similar issues in the future. 

   We also noted several terms that we think could be better defined since not every hospital will interpret issues in the same manner: In Domain 1 there is a reference to “most senior governing board,” and we were not sure if that means officers of the board or those with the longest tenure.  In Domain 1, #5 – “individuals on the governing board” must receive a notice of serious events; that would be clearer by saying “each member of the governing board.” In Domain 2, #4, there is a reference to “non-clinical staff,” which should be defined – it is defined later under Domain 3, #4.

   Up front, we want to state that outcome measures related to patient harm are important and meaningful for the public and patients. This shows that CMS continues to view patient safety as a priority, and we encourage the agency to include more for public reporting and for CMS payment programs. To facilitate accuracy and less burden, we would like to see more eCQM measures in the patient harm category. 

   We support this strong outcome measure of patient harm for certain surgical patients, even though it only captures death among the healthiest of patients due to the incredibly long denominator exclusion list of documented POA health issues. We strongly object to the risk adjustment for patients who enter the hospital with COVID, which could exclude a wide range of patients, from healthy active 65-year-olds to older more challenging patients. The other risk adjustments would thoroughly cover the true risk of COVID POAs.

   Finally, there appear to be excessive exclusion regarding documentation errors and missing demographic information, which gives too much leeway for hospitals to simply toss out cases.

   We are pleased to see this measure applied to both FFS and Medicare Advantage patients and encourage this for all CMS measures considering the problems with these MA plans that have surfaced recently and, frankly, since they were created.  We would like to see this become an eCQM measure. 

We strongly support this eCQM outcome measure that captures patients without respiratory issues who have respiratory failure following surgery. Outcome measures related to patient harm are important and meaningful for the public and patients. This shows that CMS continues to view patient safety as a priority, and we encourage the agency to include more for public reporting and for CMS payment programs. We believe eCQM measures such as this one will facilitate accuracy and timliness in public reporting as well as less burden.  We would like to see more eCQM measures in the patient harm category. 

We strongly support this outcome measure of medical harm as in attempt to reduce hospital readmissions in both acute care and Veterans hospitals. Also, we would like to see this developed as an eCQM measure.  Outcome measures related to patient harm are important and meaningful for the public and patients. This shows that CMS continues to view patient safety as a priority, and we encourage the agency to include more for public reporting and for CMS payment programs. We believe eCQM measures facilitate accuracy and timeliness in public reporting as well as less burden for the providers.  We would like to see more eCQM measures in the patient harm category. 

We strongly support this outcome measure of medical harm as in attempt to reduce hospital readmissions in both acute care and Veterans hospitals. Also, we would like to see this developed as an eCQM measure.  Outcome measures related to patient harm are important and meaningful for the public and patients. This shows that CMS continues to view patient safety as a priority, and we encourage the agency to include more for public reporting and for CMS payment programs. We believe eCQM measures facilitate accuracy and timeliness in public reporting as well as less burden for the providers.  We would like to see more eCQM measures in the patient harm category. 

We strongly support this outcome measure of medical harm as in attempt to reduce hospital readmissions in both acute care and Veterans hospitals. Also, we would like to see this developed as an eCQM measure.  Outcome measures related to patient harm are important and meaningful for the public and patients. This shows that CMS continues to view patient safety as a priority, and we encourage the agency to include more for public reporting and for CMS payment programs. We believe eCQM measures facilitate accuracy and timeliness in public reporting as well as less burden for the providers.  We would like to see more eCQM measures in the patient harm category. 

Greetings.  I want to commend the CMS and Yale Corp team for the design of these 5 domains.  They are well thought out and simply stated.  As former Senior Vice President of Patient Safety at CommonSpirit Health for the past 15 years, I think you have all of the elements and design clearly stated.  I am assuming that CMS will provide more details on what it means to say "yes" - attest - the each of the domains/elements once they are published as a Condition of Participation. If not, this must be done for crystal clarity at each site.

The one concern I have is when a hospital/healthcare site starts using its voluntary reporting system as a benchmark, it is shown again and again that eventually reports stop coming in because no one wants to look bad. I also know that only 1% to 20% of events reported reach the patient and only 1 to 3% caused serious harm. Sites must use another means (besides events reporting systems) that is more objective for identifying harm, and measuring improvement. In reviewing domain 3, item #3 - Our hospital has a patient safety metrics dashboard and uses external benchmarks (such as CMS Star Ratings or other national databases) to monitor performance and inform improvement activities on safety events (such as medication errors, surgical/procedural harm, falls, pressure injuries, diagnostic errors, and healthcare-associated infections) - an events reporting system is extremely subpar.  Don Berwick and many others have agreed.  If healthcare is going to be safer for patients and those who provide it, there must be a way to "cast a broader net" to identify adverse events - not solely based on reported events or incoming lawsuits. Using the electronic health record (EHR) to identify harm, measure improvement, and transparently share results is the game changer for safer care.  If this is achieved, the harm to patients is identified and shared internally with leadership, and CANDOR is activated.  There is no doubt in my mind and with the many researchers that have published on this, we will see immediate improvement.  Healthcare wants to get it right in the identification of harm, but they need to be pushed to use the EHR to first identify harm and then the rest will follow (transparency, improvement, and ultimately, better/safer care).  When we used the EHR to identify harm events, we found 10x to 20x more patient harm than solely the events reporting system.  The events reporting system must exist to identify "near misses" and other process/behavior opportunities.

In summary, using the electronic health record to identify patient harm is the key to ultimately making your proposed 5 domains impactful for patients and drive safer care.

Thank you for leading change and measuring the impact of these 5 domains.

Happy holidays and cheers to the New Year.

Best,

Barbara Pelletreau, RN, MPH

Former, SVP Patient Safety, CommonSpirit Health

Greetings.  I want to commend the CMS and Yale Corp team for the design of these 5 domains.  They are well thought out and simply stated.  As former Senior Vice President of Patient Safety at CommonSpirit Health for the past 15 years, I think you have all of the elements and design clearly stated.  I am assuming that CMS will provide more details on what it means to say "yes" - attest - the each of the domains/elements once they are published as a Condition of Participation. If not, this must be done for crystal clarity at each site.

The one concern I have is when a hospital/healthcare site starts using its voluntary reporting system as a benchmark, it is shown again and again that eventually reports stop coming in because no one wants to look bad. I also know that only 1% to 20% of events reported reach the patient and only 1 to 3% caused serious harm. Sites must use another means (besides events reporting systems) that is more objective for identifying harm, and measuring improvement. In reviewing domain 3, item #3 - Our hospital has a patient safety metrics dashboard and uses external benchmarks (such as CMS Star Ratings or other national databases) to monitor performance and inform improvement activities on safety events (such as medication errors, surgical/procedural harm, falls, pressure injuries, diagnostic errors, and healthcare-associated infections) - an events reporting system is extremely subpar.  Don Berwick and many others have agreed.  If healthcare is going to be safer for patients and those who provide it, there must be a way to "cast a broader net" to identify adverse events - not solely based on reported events or incoming lawsuits. Using the electronic health record (EHR) to identify harm, measure improvement, and transparently share results is the game changer for safer care.  If this is achieved, the harm to patients is identified and shared internally with leadership, and CANDOR is activated.  There is no doubt in my mind and with the many researchers that have published on this, we will see immediate improvement.  Healthcare wants to get it right in the identification of harm, but they need to be pushed to use the EHR to first identify harm and then the rest will follow (transparency, improvement, and ultimately, better/safer care).  When we used the EHR to identify harm events, we found 10x to 20x more patient harm than solely the events reporting system.  The events reporting system must exist to identify "near misses" and other process/behavior opportunities.

In summary, using the electronic health record to identify patient harm is the key to ultimately making your proposed 5 domains impactful for patients and drive safer care.

Thank you for leading change and measuring the impact of these 5 domains.

Happy holidays and cheers to the New Year.

Best,

Barbara Pelletreau, RN, MPH

Former, SVP Patient Safety, CommonSpirit Health

   The Patient Safety Action Network submits comments regarding proposed measures being reviewed by the Hospital Committee. Thank you for the opportunity to comment on these measures. 

   We support this move toward assessing health equity issues within a hospital (175). However, in general, we are concerned that the numerous “structural measures” lack visible mechanisms for audit and public accountability (even within the hospital setting) or any indication that the intent is to identify future needs for development of related outcome measures. These structural measures cover extremely important issues for patients - health equity (175, 176), patient safety (188) and the Age Friendly Hospital Measure (196).  Our concern is structural measures could be misleading to the public absent accountability.  This is an opportunity to include the public in measurement.  We recommend annual audits and public posting on the hospital’s website and in conspicuous locations at the facilities of the specific activities the facility should be doing along with their attestation reports to CMS indicating what they are doing. This is a simple method of accountability – patients, health care workers and the larger community will be able to actively participate in ensuring patient safety and health equity if they know what is expected of the hospital and what the hospital has attested to be doing. 

   It is our understanding that the intent is to eventually post these measures on CareCompare with a score of 1-5 possible (for each domain). Those postings should be done in context regarding details of what the hospital attests to doing. To fully inform the public of the meaning of this measure, each component of each domain should be revealed on Hospital Compare, either through a drill down function or link to each of the components. By doing this, the measure holds some promise in informing patients/the public of certain activities that could reduce patient harm as demonstrated by existing evidence. 

  The Patient Safety Action Network submits comments regarding proposed measures being reviewed by the Hospital Committee. Thank you for the opportunity to comment on these measures. 

   We support this move toward assessing  ambulatory surgical centers' commitment to health equity issues. We commend CMS for going beyond the hospital walls for assessing these issues. 

   However, in general we are concerned that the numerous “structural measures” lack visible mechanisms for audit and public accountability (even within the hospital setting) or any indication that the intent is to identify future needs for development of related outcome measures. These structural measures cover extremely important issues for patients - health equity (175, 176), patient safety (188) and the Age Friendly Hospital Measure (196).  Our concern is structural measures could be misleading to the public absent accountability.  This is an opportunity to include the public in measurement.  We recommend annual audits and public posting on the hospital’s website and in conspicuous locations at the facilities of the specific activities the facility should be doing along with their attestation reports to CMS indicating what they are doing. This is a simple method of accountability – patients, health care workers and the larger community will be able to actively participate in ensuring patient safety and health equity if they know what is expected of the hospital and what the hospital has attested to be doing. 

   It is our understanding that the intent is to eventually post these measures on CareCompare with a score of 1-5 possible (for each domain). Those postings should be done in context regarding details of what the hospital attests to doing. To fully inform the public of the meaning of this measure, each component of each domain should be revealed on Hospital Compare, either through a drill down function or link to each of the components. By doing this, the measure holds some promise in informing patients/the public of certain activities that could reduce patient harm as demonstrated by existing evidence. 

I am writing in regard to the Patient Safety Structural Measure, Number MUC2023-188.

As part of the policy community, as a writer, as a consultant and as an activist, I have been an activist for patient safety improvement pretty much longer than all but a handful of individuals, none of them non-physicians. My 1997 book, Demanding Medical Excellence: Doctors and Accountability in the Information Age, had a full chapter on the problem (footnoted) and a full chapter on solutions well before the Institute of Medicine had even thought of writing something. With that background, let me simply say that measure is important and long overdue.

In 2001, Health Affairs published an article of mine called, "The Silence" and a response by the heads of what was then HCFA and AHCPR. We have broken the silence about the toll of medical errors, but that silence keep re-descending. CMS has the opportunity, and the legal and moral duty, to ensure that whether or not patient safety is a "trendy" topic, consistent actions are being taken by every hospital in the nation to improve it. Accept no excuses, accept no prevarication, accept no, "yes, buts." 

Structural change is critical.

Thank you.

Michael Millenson

Highland Park, Illinois

The Patient Safety Action Network appreciates the opportunity to comment on this measure. We strongly support the Health Equity Index (139) outcome measure that should reveal disparities within already existing outcome measures of readmissions. We believe this is a suitable prototype to test health equity and we would like to see future expansions for health equity issues through other outcome measures, such as hospital acquired infections and complications following surgeries. The measure details indicate this will report on “hospitals serving Medicare fee for service patients,” which we assume (hope) will include the experiences of non-Medicare and Medicare Advantage patients receiving care at these hospitals.

The Patient Safety Action Network appreciates the opportunity to comment on this measure. We strongly support the concept of age-friendly hospital measures to focus facilities on providing coordinated care for elders, who make up a significant portion of their patients and for whom CMS invests significant resources. This measure is a recognition that these issues need to be addressed. We agree with the stated purpose by the developers of explaining to patients what hospitals should be doing, but that requires more than simple attestations. Structure measures require accountability through disclosure of these attestations to the patients and public by posting them at the hospital in a high traffic area and by providing details on the CMS CareCompare website when scores are displayed; further this should eventually lead to outcome measures or at least be presented in a way that clearly shows whether the results line up with other reported outcomes. We disagree with the developer's statement that outcome measures are not useful to patients. 

   However, we believe this requires more work as a structural, attestation measure.  First, the measure allows a hospital to attest to doing these activities as long as 51% of elders get this care. It would have more impact if all patients receive these evidence based practices, i.e., it is the practice of the hospital to do these things. Simply stating they must do for a majority is not good enough. 

   Next, the letter with the measure states that it “focuses on team-based care of patients” yet there is no mention in the attestation activities of teams or coordination among staff.  Then, there are inconsistencies throughout regarding what the hospital must be doing in order to attest and what they “should” be doing. In our opinion, an attestation should be interpreted as “yes, we are doing this.” Yet this list is rife with ambiguity. Some are affirmative: “Data is collected” and “protocols exist,” but others lack affirmation with terms like “should be considered” or “should be included” instead of "are considered" or “are included.” 

   Finally, the ambiguous term “and/or” is used several times, which may create confusion as to whether the hospital must take an action multiple times or simply one time. One example in Domain 2 regarding medication management: an activity “should be undertaken upon admission, before major procedures, and/or upon significant changes in the clinical status.” For clarity, these should be changed to “and” or “or” depending on the intent. In contrast, Domain 4, #7 clearly states, “The assessments are performed on admission and again prior to discharge.” 

   We recommend these adjustments before using this measure. 

The Patient Safety Action Network appreciates the opportunity to comment on this measure.

We strongly support the inclusion of oncology units that is recommended for this existing CLABSI measure. Our members have long objected to the exclusion of oncology patients on the very basis that is stated in the PQM measure documentation, CLABSI/CAUTI “infections are serious and typically cause prolonged hospital stays, increase cost, and are associated with a higher risk of mortality. These risks are even greater for immunosuppressed patients. Fortunately, there is evidence-based literature to support the prevention of [CLABSI/CAUTIs] through proper insertion techniques and proper line management.”

For these very same reasons, we strongly object to the continuation of risk adjustments for these new measures and existing measures relating to hospital acquired infections. Infections are preventable, period. Simply because it might be more difficult to prevent for certain patients does not justify adjustments that hide those difficult cases. These risk adjustments should be removed. Further, with the current emphasis on health equity and considering the demographics of the populations that teaching hospitals usually serve, risk adjustment for medical school affiliation is discriminatory and a disservice to those populations. Patients who get their care from these facilities should expect the same level of safety as any other facility. For many years, our members and others have suggested alternative methods for addressing the issues raised by hospitals, such as stratification to compare hospitals with medical school affiliation with each other. Then we would get a truer picture of the safety of their care.  

The Patient Safety Action Network appreciates the opportunity to comment on this measure.

We strongly support the inclusion of oncology units that is recommended for this existing CAUTI measure. Our members have long objected to the exclusion of oncology patients on the very basis that is stated in the PQM measure documentation, CLABSI/CAUTI “infections are serious and typically cause prolonged hospital stays, increase cost, and are associated with a higher risk of mortality. These risks are even greater for immunosuppressed patients. Fortunately, there is evidence-based literature to support the prevention of [CLABSI/CAUTIs] through proper insertion techniques and proper line management.”

For these very same reasons, we strongly object to the continuation of risk adjustments for these new measures and existing measures relating to hospital acquired infections. Infections are preventable, period. Simply because it might be more difficult to prevent for certain patients does not justify adjustments that hide those difficult cases. These risk adjustments should be removed. Further, with the current emphasis on health equity and considering the demographics of the populations that teaching hospitals usually serve, risk adjustment for medical school affiliation is discriminatory and a disservice to those populations. Patients who get their care from these facilities should expect the same level of safety as any other facility. For many years, our members and others have suggested alternative methods for addressing the issues raised by hospitals, such as stratification to compare hospitals with medical school affiliation with each other. Then we would get a truer picture of the safety of their care.  

Patient safety is important to me, because my sister died from clinical errors. I am supporting  the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

The reasons I support this measure are because it states the kinds of patient safety best practices I expect as a patient.  It is important to me that:

1. Hospital leaders and boards of directors prioritize patient safety and are actively engaged in making sure the right safety practices are in place. 
2. Hospitals adopt “zero preventable harm” as their patient safety strategic goal, as recommended in the CMS National Quality Strategy.  Even if that goal is aspirational, it should be what every hospital aims to achieve.
3. Hospitals establish a culture of safety that engages all its staff and puts in place systems for preventing and learning from medical errors or other challenges that put patients at risk for harm or discrimination.
4. Hospitals have systems in place for reporting harm events and being open and honest with patients and the public when harm events occur. I also expect hospitals to report their events to government agencies, accreditation bodies or other organizations that focus on learning and prevention.
5. Hospitals should engage the patients and families they serve in patient safety work, as recommended by the President’s Council of Advisors on Science and Technology. Listen to our experiences and factor it in to your work to decrease preventable harm, bias and discrimination.  They should also be focused on helping patients access our medical records and correct errors there when we find them.

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

Barbara Lewis

In my capacity as an oncologist and the Program Director of the Michigan Oncology Quality Consortium, a consortium of nearly all medical oncologists and gynecologic oncologists in Michigan, I wish to advocate for the inclusion of two pivotal components in the 2023 MUC List: MUC2023-162, a comprehensive examination of Patient-Reported Pain Interference Following Chemotherapy among Adults with Breast Cancer, and MUC 2023-190, a dedicated investigation into Patient-Reported Fatigue Following Chemotherapy among Adults with Breast Cancer.

The landscape of cancer management is inherently complicated, marked by a spectrum of interventions that vary significantly in their respective degrees of adversity. A nuanced understanding of patient experiences and their capacity to endure diverse treatment modalities is of paramount importance, influencing not only patient physical well-being but also having profound implications on patients’ cognitive functioning and overall quality of life post-treatment. The metrics encapsulated within these measures specifically address enduring symptoms experienced by women following treatment of breast cancer, extending beyond the immediate treatment period and into protracted periods of convalescence. It is noteworthy that adept performance on these measures underscores the ability of premier medical oncologists to mitigate symptomatology, facilitating a smoother transition for patients into the post-cancer survivorship phase.

These measures occupy a critical niche within the contemporary landscape of cancer care assessment. With a dearth of Patient-Reported Outcome Performance Measures (PRO-PMs) tailored to the unique nuances of the cancer patient demographic, it should be noted that most research has focused on people living with advanced disease. There is thus an important gap given that the majority of breast cancer cancer diagnoses occur at an earlier, potentially curative stage

The Patient Safety Action Network appreciates the opportunity to comment on this measure.

We strongly support these new questions to the HCAPS survey. Combined, they will provide a fuller patient assessment of the care received in a hospital with some more specific questions. The questions regarding care coordination (146) are essential for safe patient care and lack of it is often identified as an issue when patient harm occurs. Restfulness (147) or lack thereof is among most common general complaints of hospital patients. Responsiveness of Hospital Staff (148) and providing useful information about a patient’s symptoms (149) cover additional important issues. We are interested in seeing which questions are being removed from the survey to make room for these new questions. We understand this will be revealed in the regulatory process, but it would be helpful to weigh the importance of the new v. the old. 

We have some concerns regarding certain exclusions where caregivers could provide valuable input, for example patients who died while in the hospital and those discharged to hospice or a nursing home. This is especially relevant to the Responsiveness of hospital staff because it includes a question about getting assistance to go to the bathroom, something these patients probably need more than others. 

The Patient Safety Action Network appreciates the opportunity to comment on this measure.

We strongly support these new questions to the HCAPS survey. Combined, they will provide a fuller patient assessment of the care received in a hospital with some more specific questions. The questions regarding care coordination (146) are essential for safe patient care and lack of it is often identified as an issue when patient harm occurs. Restfulness (147) or lack thereof is among most common general complaints of hospital patients. Responsiveness of Hospital Staff (148) and providing useful information about a patient’s symptoms (149) cover additional important issues. We are interested in seeing which questions are being removed from the survey to make room for these new questions. We understand this will be revealed in the regulatory process, but it would be helpful to weigh the importance of the new v. the old. 

We have some concerns regarding certain exclusions where caregivers could provide valuable input, for example patients who died while in the hospital and those discharged to hospice or a nursing home. This is especially relevant to the Responsiveness of hospital staff because it includes a question about getting assistance to go to the bathroom, something these patients probably need more than others. 

The Patient Safety Action Network appreciates the opportunity to comment on this measure.

We strongly support these new questions to the HCAPS survey. Combined, they will provide a fuller patient assessment of the care received in a hospital with some more specific questions. The questions regarding care coordination (146) are essential for safe patient care and lack of it is often identified as an issue when patient harm occurs. Restfulness (147) or lack thereof is among most common general complaints of hospital patients. Responsiveness of Hospital Staff (148) and providing useful information about a patient’s symptoms (149) cover additional important issues. We are interested in seeing which questions are being removed from the survey to make room for these new questions. We understand this will be revealed in the regulatory process, but it would be helpful to weigh the importance of the new v. the old. 

We have some concerns regarding certain exclusions where caregivers could provide valuable input, for example patients who died while in the hospital and those discharged to hospice or a nursing home. This is especially relevant to the Responsiveness of hospital staff because it includes a question about getting assistance to go to the bathroom, something these patients probably need more than others.