PRMR MUC List Commenting

AGS supports the CAHPS® Hospice Survey measure and believes it captures important aspects of the care quality. 

AGS appreciates the inclusion of the Age-Friendly Hospital measure and believes that high-quality, person-centered, affordable, and age-friendly care as we grow older is critically important.

We understand that this is a combined measure of the Geriatrics Hospital Measure and Geriatrics Surgical Measure previously reviewed by the National Quality Forum’s Measures Application Partnership in 2022. While AGS remains concerned about the attestation requirement as a potential barrier to improvements in reporting practices as well as the accuracy of self-report, we believe that the measure raises awareness on important issues and is a helpful first step. The measure would provide hospitals the opportunity to start thinking about and planning for addressing the various domains included in the measure as well as submitting that data for review. To work towards a sustainable initiative, AGS recommends consideration of evolving this measure to be more data driven with more rigorous evidence. 

AGS supports the Patient Understanding of Key Information Related to Recovery After a Facility-Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure which allows patients to be active participants. This measure would be helpful considering ambulatory care healthcare professionals often have to address the sequelae of poor information sharing with patients following procedures. As an example, currently in the state of New York, the information is shared with patients via a 10-page printout that patients typically do not read or understand. 

Do not recommend.  First, while we agree with the concern and rationale for focusing on opioids, this proposal is out of step with how CMS has designed the existing opioid management programs. For example, current opioid management programs do not align with the 3 day supply standard, nor CDC guidance.  Since 2019, Medicare has had CMS mandates that require coverage determinations for a duration of use greater than 7 days in members with no opioids in recent claims history. The member can fill the 7 day supply and forfeit the remaining quantity without a coverage determination. Additionally, CMS' Drug management Program does not evaluate duration of use as a qualifying parameter, but rather Morphine Milligram Equivalent (MME) and prescriber/pharmacy shopping. Thus, a measure that evaluates a shortened supply of 3 days isnt facilitated by CMS' opioid programs. It will be difficult for CMS to enforce differing standards and requirements across multiple programs.

Further, there has been no evaluation of the existing measure (currently on the display page) and whether the current exclusions are sufficient. We urge measure developers or CMS to include denominator exclusions for beneficiaries who may be frail, or include a risk adjustment and/or stratification for age or disability.   We also suggest adding a requirement for documentation or rationale when a provider extends an opioid prescription beyond 7 days for efficacy and potential for abuse (example: Opioid Risk Tool). 

Support. 

Support

Recommend with modifications.  We support the goals and intent of this measure but we urge CMS to provide more information regarding how this information will be tracked. For example, how does the measure track a "contact" with a Community Service Provider (CSP)?  It's unclear whether the CSP reports a contact to the hospital, the hospital needs to proactively confirm that a contact was made with the CSP, or if some other element is being relied upon. Additionally, it does not appear that there are any verification or enforcement mechanisms to prevent the hospital/ACO from improperly or dishonestly noting that a contact was made. We also urge the measure developer or CMS to include additional exclusions for (1) patients that make contact with a CSP but may not be eligible for services and (2) locations with limited availability of resources. 

Recommend with modifications.  We support the goals and intent of this measure but we urge CMS to provide more information regarding how this information will be tracked. For example, how does the measure track a "contact" with a Community Service Provider (CSP)?  It's unclear whether the CSP reports a contact to the hospital, the hospital needs to proactively confirm that a contact was made with the CSP, or if some other element is being relied upon. Additionally, it does not appear that there are any verification or enforcement mechanisms to prevent the hospital/ACO from improperly or dishonestly noting that a contact was made. We also urge the measure developer or CMS to include additional exclusions for (1) patients that make contact with a CSP but may not be eligible for services and (2) locations with limited availability of resources. 

Recommend with modifications. Similar to the "Connection to a CSP" measure, we support the goals and intent of this measure but we urge CMS to provide more information on how this information will be tracked. For example, how does the measure track a "resolution", and which party is responsible for ensuring that resolution of the HRSN is properly logged?  It's unclear how that process occurs. Additionally, it does not appear that there are any verification or enforcement mechanisms to prevent the hospital/ACO from improperly or dishonestly noting that a resolution was made. 

Recommend with modifications. Similar to the "Connection to a CSP" measure, we support the goals and intent of this measure but we urge CMS to provide more information on how this information will be tracked. For example, how does the measure track a "resolution", and which party is responsible for ensuring that resolution of the HRSN is properly logged?  It's unclear how that process occurs. Additionally, it does not appear that there are any verification or enforcement mechanisms to prevent the hospital/ACO from improperly or dishonestly noting that a resolution was made. 

Do not recommend. While we believe the measure will bring a needed focus on substance use disorders, we have concerns with the measure in its current state. Plan clients do not always agree to share behavioral health data with us.  Similarly, we urge CMS to review federal, state, and territory laws and regulations that may impact the ability to provide complete information for beneficiaries for this measure. Current law and regulations addressing patient privacy may impact the exchange of information about screening for SUD and the ability to encourage follow-up care. For example, laws in California and Puerto Rico prevent the sharing of certain patient information with primary care providers without patient consent. Further, we ask CMS to analyze whether the Confidentiality of SUD Patient Records regulations (that is, regulations at 42 CFR Part 2), which protect the confidentiality of SUD treatment records and have specific rules related to consent, which would obstruct the intent of the IET measure. These barriers decrease our ability to intervene when we cannot identify the population that falls within the denominator.

Additionally, some barriers still exist within the industry.  For example, the shortage of mental health providers and Wi-Fi is still limited in rural areas where there tend to be higher rates of substance abuse disorders. Given these concerns, should CMS move forward, we urge CMS to ensure that telephonic medication management and ‘check-ins’ would meet measure compliance requirements.   

Do not recommend. CMS already uses an appeals measure (Reviewing Appeals Decisions) that looks at all Level 2 appeals decisions, not just denials. While this measure focuses on Level 1 appeals, this measure is so similar that it is duplicative and unnecessary, given the existing measure.  Second, there is insufficient evidence to demonstrate that this measure would be materially different or bring any additional value to the Star Ratings. Much of the information used by the measure steward to justify their expressed need for this measure came from the Public Use File (PUF).  Thus, the measure will not produce new information that cannot already be found in the public domain. Third, we note that some proper initial denials may be overturned later if an MA Organization receives more information from the provider or beneficiary between the initial decision and the appeal. However, this appeals measure fails to account for that and other situations that may result in an initial denial being overturned in the member's favor and, instead, only tracks whether the initial denial was upheld. Lastly, adding this measure to the MA / Part D Star Ratings would run counter to current CMS efforts to reduce the number of measures used in CMS programs and align those measures across CMS programs through the Universal Foundation.  
 

            Patients who had suffered traumatic brain injury and spinal cord injury will experience pain differently from other patients, and physicians frequently underestimate the long term impact of their self-reported severe, acute pain that is not adequately addressed.  I do not see acknowledgement of the prevalence of patients who suffered brain injury and/or spinal cord injury having acute pain that develops into chronic pain.  Besides opioid prescriptions, referrals to a pain clinic, massage and other non-opioid alternative options should be considered.  We also must recognize that provider bias and policies that require jumping through hoops in order to get adequate pain management to meet their needs are just two of the barriers they face to receiving care for their pain.  When left untreated or under-treated, the pain becomes more complex and chronic, and more difficult and costly to treat.  

References

https://www.ncbi.nlm.nih.gov/books/NBK299176/#:~:text=Long%2Dlasting%20and%20persistent%20pain,experience%20pain%20following%20the%20trauma.

https://aspe.hhs.gov/sites/default/files/documents/31b7d0eeb7decf52f95d569ada0733b4/CCM-TCM-Descriptive-Analysis.pdf

As a patient, as a family member, as a nurse and as a healthcare quality professional for over 20 years I am writing in support of 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 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. 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 Allen Dang.  I am writing as a Patient Safety Champion with Working Group on Systems and Policies Impacting Well-Being, which is a physician led network of individuals who feel that making healthcare safer is an urgent priority.  I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

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

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

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

As an organization dedicated to safety, Intermountain Health fully supports the need to minimize the opioid crisis in our patient populations. This process measure has good intentions and can benefit providers to be aware of their patient populations. However, the omittance of numerator exclusions is concerning, for without them, it is unclear how CMS plans to account for patients undergoing appropriate long-term opioid use or scenarios where withdrawal is risky such as patients undergoing methadone therapy. We applaud CMS's removal of some appropriate patient classifications from the denominator population, but these definitions seem quite narrow, and specific, and the measure seemingly has gaps related to the numerator.

As an organization dedicated to safety, Intermountain Health understands and respects the need for accurate assessment and reporting of hospital harm measures. However, an eCQM dedicated to capturing patient falls and resultant injuries will be challenged by the paucity of context captured by only diagnosis codes. Falls are documented in EMRs by nursing-defined data and may be difficult to accurately code and could require physician documentation that may land in free text notes. Diagnosis codes will catch the diagnosis of a discrete injury occurring from an inpatient fall, but injury levels as defined by NDNQI are not. This action may reduce the capture of falls resulting in minor or moderate injuries. Patient falls and resultant injuries are captured more accurately and with greater detail in the hospital's safety event reporting database. This includes, many times, the accurate final capture of injury levels. The severity of harm is not typically reflected until days post-fall. It is from these databases that sites pull data for submission to the NDNQI database. Additionally, hospitals choosing not to participate in NDNQI or who do not submit data to the database may define injury levels differently than hospitals that do participate.

As an organization dedicated to safety, Intermountain Health understands and respects the need for accurate assessment and reporting of patient safety indicator measures and failure-to-rescue rates. This measure seems like a good starting place, but we respectfully request further refinement before aligning this to a reporting program requirement. The numerator statement of "Patients who died within 30 days from the date of their first “operating room” procedure, regardless of site of death," seems simple enough. However, the lack of numerator exclusions forces the hospital to seemingly take responsibility for deaths that may not be related to the patient's surgery. A person may die within 30-days of a hospital stay for any number of reasons including trauma or self-harm. While it may be enlightening to capture all deaths for any cause for research reasons, reporting these as a hospital rate ascribes responsibility to the hospital, and yet, a hospital obviously has no control over whether a person who was recently a patient is subject to mortal trauma or takes their own life. It is our position that a hospital should not be seen as "failing to rescue" a person who commits suicide or dies in a traumatic accident 30-days after surgery.

Intermountain Health is dedicated to reducing disparity and increasing health equity for our community and patients. We have been early adopters of the components of the CMS Hospital Commitment to Health Equity measure and take great pride in the fact that we are meeting challenges in these areas of health risk to our communities. We are supportive of stronger measures capturing health equity performance than simple attestations. However, we do have some concerns with the specifications outlined in the HEI measure including CMS's plan to address small volume hospitals which may not have numerator populations for this composite score. Readmissions and mortality are well-defined measures for other CMS programs, including HRRP & HVBP. It is concerning that the measure specifications do not appear to align across all programs, as evidenced by the fact that the HEI composite does not identify the same numerator exclusions, e.g. COVID diagnoses. Additionally, while this measure is informative of the patient populations served at our hospitals, there is no manner in which hospitals can act upon the composite score and take meaningful action to make improvements to their performance.

Intermountain Health is dedicated to a positive patient experience and high levels of patient satisfaction with their care. From that foundation, Intermountain Health also has no concerns with additional questions included in HCAHPS surveys. HCAHPS are well established and have a streamlined workflow within our organization. However, we have concerns about what response thresholds CMS plans to establish for these sub-measures and corresponding proposals for achievement that CMS may require. There is a risk of survey burden from patients with the addition of nine additional questions, particularly in areas that are covered succinctly such as hospital quietness. Additionally, provided these questions are added to the HCAHPS workflow, most hospitals will be able to absorb these questions seamlessly. However, straight Patient Reported Outcome - Performance Measures (PRO-PM) data capture of this magnitude would require a hefty implementation on the part of hospitals. Data capture would be ponderous and burdensome. PRO-PM measures are in their infancy with hospitals and we would recommend not implementing too many measures of this type until hospitals have their feet under them with respect to this data capture.

Intermountain Health strives to effectively manage population health and to close gaps in care by addressing preventive health maintenance. This measure may be useful as a reporting option in driving those goals if it is available as a self-selected, optional eCQM. Other immunization eCQMs have provided reliable data thanks to established interoperability between EHRs and state immunization registries. However, CMS has retired the other existing adult immunization eCQMs in favor of a non-electronic, composite immunization measure.

We would like to raise one concern with this measure, which relates to the frequency with which measure criteria can be updated. The "Up to date" definition of COVID-19 vaccination has changed over time with evolving guidelines. Since measure specifications are only updated once per year, there may be a risk of setting a measure definition that becomes outdated before the next annual specification update.

As an organization dedicated to safety, Intermountain Health understands and respects the need to promote measures that aim to increase patient safety. However, attestation measures do not have the same level of significance as outcome measures like PSIs. Attestation to a structural measure, particularly one that may have multiple domains and levels, is made necessary for hospitals to participate in care but interpretation of achievement standards will vary widely across national organizations. Each domain and level is a significant amount of work for an organization. CMS should recognize that system-level support is essential to the successful implementation of this measure across all healthcare sites of varying sizes. That system-level work must be attributable to a hospital, which by its small size, may not be able to support the significant amount of work to fully meet the intent of the measure. Furthermore, attestation to structural measures provides no meaningful actionable data to be used for performance improvement. The improvement provided by the addition of pertinent services has already been achieved as evidenced by the attestation. There are many active excellent measures related to patient safety that provide discrete data with which a hospital can focus processes for their QAPI. If CMS is concerned about patient safety culture in hospitals, perhaps a better avenue would be to consider additions to CMS Conditions of Participation which can be assessed during site surveys where the culture can actually be viewed in situ.  

As an organization dedicated to reducing disparity, Intermountain Health understands and respects the need to promote measures that aim to increase health equity. However, attestation measures do not have the same level of significance as a measure that displays performance in terms of discrete data. Attestation to a structural measure, particularly one that may have multiple domains and levels, is made necessary for hospitals to participate in care but interpretation of achievement standards will vary widely across national organizations. Each domain and level is a significant amount of work for an organization. CMS should recognize that system-level support is essential to the successful implementation of this measure across all healthcare sites of varying sizes. That system-level work must be attributable to a hospital, which by its small size, may not be able to support the significant amount of work to fully meet the intent of the measure. Furthermore, attestation to structural measures provides no meaningful actionable data to be used for performance improvement. The improvement provided by the addition of pertinent services has already been achieved as evidenced by the attestation. There are already active measures that currently assess health equity in our communities. Using that data, hospitals can focus on targeted improvement for their QAPI that also best helps their community. If CMS is concerned about health equity culture in hospitals, perhaps a better avenue would be to consider additions to CMS Conditions of Participation which can be assessed during site surveys where the culture can actually be viewed in situ.  

My name is Gail Handley, and I’m writing 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. My personal focus, however, is mainly on Domain (4): Accountability and Transparency.

The medical error that changed my life occurred at U. of Michigan, where one of the first disclosure programs was created and soon became the national model. And although one of their stated core values is transparency, U-M and the many hospitals following in its footsteps, discharge the vast majority of their patients without being transparent about having a CRP.

Instead, it is only after an error is flagged by the hospital staff, that a patient is told about their program. While this is distinctly unfair to the patients whose harm was not flagged, there’s an additional sacrifice: Since these patients usually remain in the dark about their hospital’s CRP, they are unlikely to report their first-hand observations and experiences — potentially key to revealing undetected errors — and helping to improve future patient safety.

My position is that all patients and families should be informed about their hospital’s CRP, whether they experience a medical error or not. It’s not possible for the hospital to actually know why any particular patient or family might want to know, so why should hospitals be allowed to choose which patients or families to tell? What kind of transparency is that?

Thank you,

Gail Handley

Intermountain Health supports health equity and recognizes the importance of accurate assessment of determinants of health. While this measure as proposed is a good draft at capturing the sometimes nebulous outcome of referrals and notifications made in attempts to improve patient's lives and their communities, the measure does not account for a few key areas. To start,  as the measure is currently drafted, "follow-up" is not clearly defined. This will confuse hospitals and interpretation will vary widely across national organizations. Secondly, hospitals and their staff are not responsible or accountable for patient's choices. Determinants of health are impacted by many things in a patient's life, including their own choices. This measure calculates the rate of how many determinants of health are improved for patients. As free human beings, patients make personal choices that affect their own outcomes. Patients are free to make the choice to attend their follow-up appointments or referrals. Intermountain Health has concerns about ascribing accountability to hospitals by assigning the rate to their performance for public reporting. Hospitals have a role in improving determinants of health, but they are not the only factor that does. Additionally, this measure in its current state, is overly burdensome for hospitals. Implementation would require an overarching process to track follow-up rates by patients. An implementation of this magnitude would require multiple Business Service Agreements with appropriate external organizations. Finally, privacy is a concern for this measure as hospitals seeking to know if a patient followed up appropriately may be viewed with concern by patients, families, and communities.

Intermountain Health supports health equity and recognizes the importance of accurate assessment of determinants of health. While this measure as proposed is a good draft at capturing the sometimes nebulous outcome of referrals and notifications made in attempts to improve patient's lives and their communities, the measure does not account for a few key areas. To start,  as the measure is currently drafted, "follow-up" is not clearly defined. This will confuse hospitals and interpretation will vary widely across national organizations. Secondly, hospitals and their staff are not responsible or accountable for patient's choices. Determinants of health are impacted by many things in a patient's life, including their own choices. This measure calculates the rate of how many determinants of health are improved for patients. As free human beings, patients make personal choices that affect their own outcomes. Patients are free to make the choice to attend their follow-up appointments or referrals. Intermountain Health has concerns about ascribing accountability to hospitals by assigning the rate to their performance for public reporting. Hospitals have a role in improving determinants of health, but they are not the only factor that does. Additionally, this measure in its current state, is overly burdensome for hospitals. Implementation would require an overarching process to track follow-up rates by patients. An implementation of this magnitude would require multiple Business Service Agreements with appropriate external organizations. Finally, privacy is a concern for this measure as hospitals seeking to know if a patient followed up appropriately may be viewed with concern by patients, families, and communities.

Intermountain Health is dedicated to a positive patient experience and high levels of patient satisfaction with their care. From that foundation, Intermountain Health also has no concerns with additional questions included in HCAHPS surveys. HCAHPS are well-established and have a streamlined workflow within our organization. However, we have concerns regarding CMS's plans to implement an entirely additional survey for a large portion of hospital populations. We support that domains of "applicability, medications, and daily activities" are needed areas of communication, but an additional survey seems burdensome for hospitals and their patients. Perhaps a better option would be adding a domain to HCAHPS rather than an additional survey. We also express concern about what response thresholds CMS plans to establish for these measures and corresponding proposals for achievement that CMS may require. Additionally, provided these questions are added to the HCAHPS workflow, most hospitals will be able to absorb these questions seamlessly. However, straight Patient Reported Outcome - Performance Measures (PRO-PM) data capture of this magnitude would require a hefty lift on the part of hospitals. Data capture would be ponderous and burdensome. PRO-PM measures are in their infancy with hospitals and we would recommend not implementing too many measures of this type until hospitals have their feet under them with respect to this data capture.

Please see the attached file providing my comments on CBE ID  2517 Oral Evaluation Dental Devices

Timely Reassessment of Non-Pain Symptom Impact” MUC2023-166. 

This comment is being submitted on behalf of the Transparency Committee of Patients for Patient Safety US, in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

We support these measures because all five domains align with our mission to bring more transparency to healthcare.

Domain 1 demonstrates transparency ensuring the C-suite and governing boards are accountable for patient safety at their organizations. We support that the C-suite should notify the board members within three business days when a confirmed serious safety event resulting in significant morbidity, mortality, or other harm occurs in their organization.

Domain 2 calls out the need to cultivate a just culture. This approach seeks accountability without placing blame or engaging in retaliation as a response to harm events.

Domain 3 states that hospitals will have a dedicated team who conducts event analysis of serious safety events. The outcomes of these reviews should be shared throughout the organization and with patients and their families. This approach will avoid siloed learning and ensure transparency.

Domain 4 calls for public display of patient safety metrics for all to see. The reports should include explanation of the reporting, and details to connect with an evidenced-based communication and resolution program encompassing all the components mentioned in the measure.

Domain 5 highlights the need for patients and families to be involved in efforts to improve patient safety and demonstrate transparency. Patients and families should always have access to their medical records and never encounter information blocking.

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

Patients for Patient Safety US (Transparency Committee)

Hasan Abid

Rebeka Acosta

Jeff Brown

Susan Burke

Ky Corbet

Tracy Granzyk

Purnima Gupta

Carole Hemmelgarn

Mary Herold

Krista Hughes

Sally Kerr

Allison Know

Ariana Longley

Dave Mayer

Michele Bleech Napoliello

Donna Prosser

Leilani Schweitzer

Sue Sheridan

Tracy Thier

My name is Heather Blum, MPH, REHS/RS.  I am writing as a Patient Safety Champion with Patients for Patient Safety US, which is a patient led network of people who feel that making healthcare safe is an urgent priority.  I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration. I joined PFPS when my mother died during a routine outpatient surgery a few years ago.
It is a fundamental moral and ethical responsibility to deliver safe care. Patient safety is at a crossroads, having seen a decline in commitment and systematic improvement for many years, accelerated by the pandemic. I believe that our hospitals and health systems have struggled in their commitment to safe care because it is under resourced and not a priority.
The Patient Safety Structural Measure provides much needed guidance to hospital leaders on the ways that they can deliver safer care. It also creates a way to recognize the hospitals and health systems who are exemplars for their leadership and action on patient safety. The questions the Patient Safety Structural Measure asks hospital leaders to attest to reflect what patients in the United States expect all hospitals to be doing.  In addition, the PSSM aligns with other national guidance such as the Safer Together: The National Action Plan to Advance Patient Safety, the CMS National Quality Strategy, and the September 2023 Report to the President: A Transformational Effort on Patient Safety, issued by the President’s Council of Advisors on Science and Technology.
For all these reasons I strongly support the Patient Safety Structural Measure.  Thank you for this opportunity to make this public comment.

I am kidney transplant recipient and did dialysis for a little over 2 years.  I am having a hard time understanding how this life goals survey is going to be used?  Will it be given to a patient before they start dialysis and can be used to determine which type of dialysis will best help achieve those goals?   This should already be happening unless emergency circumstances prevent it.   For patients already on dialysis this could be used as a follow up to determine if their chosen option is allowing them to do some of their goals.  Another question is how will that survey results be used to improve care?  what kind of actions would take place?  I also feel there are a lot of other questions that should be asked to overall help improve overall care and achieve more life goals.  Please consider asking questions such as:  how do they feel after the treatment each time, did everything go well, what issues did you have, are they having any transportation issues, housing issues, financial issues, depression, transplant options.  This way the nursing staff can work on addressing any treatment related issues and social workers can help address some of the other issues and available options for help.

The American Society for Parenteral and Enteral Nutrition (ASPEN), appreciates the opportunity to submit comments in response to the proposed expansion of the Global Malnutrition Composite Score to include all adults 18 years and older included in CMS's Measures Under Consideration (MUC) List for 2024.  

Please see the attached letter.  Thank you.

My name is Lauren Licatino.  Patient safety is important to me because, as an anesthesiologist, I work every day in the operating rooms and procedural suites with patients who are at their most vulnerable. I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

The reasons I support this measure is because it states the kinds of patient safety best practices I expect as a patient of all hospitals 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 as their goal “zero preventable harm” as the patient safety strategic goal. Even if that goal is aspirational, it should be what every hospital is aiming 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 problems 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 or other bodies that focus on learning and prevention.

5.     Hospitals should engage the patients and families they serve in patient safety work.  They should also be focused on helping patients access our medical records and correct errors in them 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 Suz Schrandt, Founder & CEO of ExPPect, and Patient for Patient Safety US Champion. As a long-time chronic disease patient with a decade’s long tenure building and implementing patient engagement strategies, I have experienced and witnessed the devastating and terrifying consequences of unsafe care.  There is no more foundational or integral element of health care than patient safety.  In fact it is—or should be—the bare minimum expectation when we, as patients and families, seek care. I am writing in fervent and urgent support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

I support this measure because it encapsulates patient safety best practices that are desperately needed in the United States.  Hospital leadership must prioritize patient safety and create a culture of safety that seeks to learn and improve rather than to deny and defend.  Even as a trained attorney and well-versed patient advocate who was able to articulate my needs and concerns, I was harmed by a series of medical errors related to a joint replacement—my fourth such surgery.  I take small consolation in the fact that the surgeon apologized, and apologized for the right thing.  He acknowledged that I had tried to educate him about my numerous risk factors, that he had disregarded that information, and that harm had resulted.  What did not happen however, is any meaningful evidence that he and his team had learned from the event, changed or improved practice, or taken any steps to prevent such harm for future patients. 

Our family was financially responsible for the entire, preventable, hospitalization, and the weeks of therapy and follow-up care required to address the harm.  Requests to speak to hospital risk or safety personnel, or even to the patient relations department, went unheard.  This harm event could have been an opportunity to make care at this institution safer, and instead the only long-term effect is my own ongoing impairment. Perhaps worst of all, is the sense that this all happened in silence.  This harm—and all harms—should be reported to governing and accreditation bodies, and other organizations aimed at improving patient safety.  The goal for hospitals simply must be “zero preventable harm”, as recommended in the CMS National Quality Strategy.  In no other industry would we accept harm and even death of consumers as a normal part of doing business.  In this most important and essential industry, we must do better. 

My name is Suz Schrandt, Founder & CEO of ExPPect, and Patient for Patient Safety US Champion. As a long-time chronic disease patient with a decade’s long tenure building and implementing patient engagement strategies, I have experienced and witnessed the devastating and terrifying consequences of unsafe care.  There is no more foundational or integral element of health care than patient safety.  In fact it is—or should be—the bare minimum expectation when we, as patients and families, seek care. I am writing in fervent and urgent support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

I support this measure because it encapsulates patient safety best practices that are desperately needed in the United States.  Hospital leadership must prioritize patient safety and create a culture of safety that seeks to learn and improve rather than to deny and defend.  Even as a trained attorney and well-versed patient advocate who was able to articulate my needs and concerns, I was harmed by a series of medical errors related to a joint replacement—my fourth such surgery.  I take small consolation in the fact that the surgeon apologized, and apologized for the right thing.  He acknowledged that I had tried to educate him about my numerous risk factors, that he had disregarded that information, and that harm had resulted.  What did not happen however, is any meaningful evidence that he and his team had learned from the event, changed or improved practice, or taken any steps to prevent such harm for future patients. 

Our family was financially responsible for the entire, preventable, hospitalization, and the weeks of therapy and follow-up care required to address the harm.  Requests to speak to hospital risk or safety personnel, or even to the patient relations department, went unheard.  This harm event could have been an opportunity to make care at this institution safer, and instead the only long-term effect is my own ongoing impairment. Perhaps worst of all, is the sense that this all happened in silence. This harm—and all harms—should be reported to governing and accreditation bodies, and other organizations aimed at improving patient safety.  The goal for hospitals simply must be “zero preventable harm”, as recommended in the CMS National Quality Strategy.  In no other industry would we accept harm and even death of consumers as a normal part of doing business.  In this most important and essential industry, we must do better. 

Premier continues to support adoption of this structural measure as a first step in addressing health equity. Leading hospitals and other health care providers have long engaged in efforts to address health equity within their communities. This measure will incent providers to continue and expand these efforts. Premier also supports CMS’ efforts to adopt standardized measures across multiple settings. 

Premier urges CMS to work with stakeholders to finetune its portfolio of health-equity related measures. CMS should prioritize adopting a streamlined measure set that is consistent across settings and that provides meaningful and actionable data aimed at addressing social determinants of health and advancing health equity.

Finally, Premier continues to urge CMS to move past structural measures and reassess the ongoing need for this measure in the future as it works to expand its portfolio of health equity measures. As part of that, CMS should monitor for ongoing success of the measure in the Hospital IQR program and finetune the measure across programs if it no longer yielding desired results.

Premier continues to support adoption of this structural measure as a first step in addressing health equity. Leading hospitals and other health care providers have long engaged in efforts to address health equity within their communities. This measure will incent providers to continue and expand these efforts. Premier also supports CMS’ efforts to adopt standardized measures across multiple settings. 

Premier urges CMS to work with stakeholders to finetune its portfolio of health-equity related measures. CMS should prioritize adopting a streamlined measure set that is consistent across settings and that provides meaningful and actionable data aimed at addressing social determinants of health and advancing health equity.

Finally, Premier continues to urge CMS to move past structural measures and reassess the ongoing need for this measure in the future as it works to expand its portfolio of health equity measures. As part of that, CMS should monitor for ongoing success of the measure in the Hospital IQR program and finetune the measure across programs if it no longer yielding desired results.

Premier recommends that CMS continue to test this measure as a voluntary measure in the programs where it has been adopted and in any future programs. 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. As a result, Premier strongly urges CMS to maintain the measure as voluntary as it continues to work through these technical reporting challenges with providers.  

Finally, Premier urges CMS to work with stakeholders to continue to evolve this measure to reduce burden on providers and patients. For example, CMS should consider ways to develop an electronic clinical quality measure that allows providers to pull directly from electronic medical records.  

Premier recommends that CMS continue to test this measure as a voluntary measure in the programs where it has been adopted and in any future programs. 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. As a result, Premier strongly urges CMS to maintain the measure as voluntary as it continues to work through these technical reporting challenges with providers.  

Premier also continues to caution CMS from publicly reporting on certain metrics, such as the screen positive rate. Publicly reporting the rate of positive screening could make hospitals that serve a larger population of marginalized and underserved communities appear as though they are lower performing, without adjusting for the impact of serving patients who are affected by multiple social drivers of health. Further, if patients see a high rate of positive screenings attributed to a hospital, they may avoid going to that hospital for care, which could reduce access. There are a myriad of benefits to hospitals collecting data on the rate of positive screenings, and using those data to inform their programs and policies addressing health equity. However, we do not see the benefit of this measure as a public reporting tool. While CMS notes that this measure is not intended for hospital comparison, publicly reporting the results will encourage doing so.

Finally, Premier urges CMS to work with stakeholders to continue to evolve this measure to reduce burden on providers and patients. For example, CMS should consider ways to develop an electronic clinical quality measure that allows providers to pull directly from electronic medical records.  

While Premier is supportive of CMS adopting additional health-equity focused measures into the Hospital IQR Program, we have a number of concerns regarding the Health Equity Index (HEI) measure as currently designed, both as it relates to the statistical methods and data sources used to formulate the measure, as discussed in greater detail below. As a result, Premier strongly urges CMS to work with the hospital stakeholder community to first pilot a HEI measure prior to broad adoption to ensure that the reported information is accurate and actionable for hospitals and consumers in advancing health equity. 

The variables included in the HEI include the Area Deprivation Index (ADI), dual eligibility status and a set of demographic characteristics. Variables involving social determinants of health (SdoH characteristics have been shown to be highly correlated, and therefore composite calculations can over- or understate risk due to duplicative information content contained within those variables. More robust methods published in the academic literature should be considered to overcome these challenges. For example, dimension reduction methods (e.g., Principal Component Analysis, or PCA) have been used to identify unique aspects of SdoH risk across highly correlated variables and have been validated by quantifying the degree to which variation in hospital outcomes can be reduced by the improved metric. A social risk index based on PCA (rather than an arbitrarily weighted composite), improves the signal to noise ratio, better explains risk and more appropriately identifies high-risk populations. 

Additionally, while ADI is widely used in the literature, there is a growing concern from researchers and measure developers regarding its use to identify high-risk populations and adjust health outcomes. For example, not only does ADI neglect to account for the highly correlated nature of the variables of which it is comprised, serious concerns regarding the disproportional influence of home value in the index have recently been highlighted by researchers. 

Premier recommends that a composite index be formed from the census tract level data available in the AHRQ SdoH database. Not only does the AHRQ SdoH database have a more comprehensive set of data elements, but its licensing also supports broader use so that hospitals who rely on third parties can be better supported in their health equity needs.

Additionally, detailed documentation on the proposed HEI approach is lacking and, as such, Premier recommends that the measure developer produce more complete technical documentation for greater transparency. 

As CMS considers a measure of health equity, we recommend that the dual eligibility tiers within the Hospital Readmission Reduction Program (HRRP) be considered, so that duplicative methods are not in place (at the program level with HRRP and at the measure level with HEI) 

The HEI method should be further tested to measure the degree to which variation in health outcomes is explained through the index of SdoH variables (i.e. dual eligibity, ADI, and demographic characteristics). Again, we encourage CMS to consider more robust methods to avoid double counting information contained within the respective (correlated) SdoH variables. 

Given that increased SdoH risk is positively associated with unfavorable outcomes across Medicare Spending Per Beneficiary (MSPB), Hospital-Acquired Infections (HAIs), patient experience, and the Yale CORE risk standardized outcomes (at varying degrees) measures, CMS should consider evaluating health equity at a program level so that hospitals serving more marginalized communities are not unfairly penalized simply due to the populations they serve.

As a result, Premier does not recommend the HEI measure as it is currently designed. The measure developers should consider methodological concerns regarding correlated SdoH variables leading to improper measurement of risk and further reconsider the use of ADI as an input to the HEI. Lastly, CMS should consider addressing adjustments at the program level as a more comprehensive measure of health equity. 

Sources:

Korvink M, Gunn LH, Molina G, Hackner D, Martin J. A Novel Approach to Developing Disease and Outcome-Specific Social Risk Indices. Am J Prev Med. 2023 Oct;65(4):727-734. Doi: 10.1016/j.amepre.2023.05.002. Epub 2023 May 4. PMID: 37149108; PMCID: PMC10156642.

Kolak M, Bhatt J, Park YH, Padrón NA, Molefe A. Quantification of Neighborhood-Level Social Determinants of Health in the Continental United States. JAMA Netw Open. 2020 Jan 3;3(1):e1919928. Doi: 10.1001/jamanetworkopen.2019.19928. PMID: 31995211; PMCID: PMC6991288.

Hannan EL, Wu Y, Cozzens K, Anderson B. The Neighborhood Atlas Area Deprivation Index For Measuring Socioeconomic Status: An Overemphasis On Home Value. Health Aff (Millwood). 2023;42(5):702-709. Doi:10.1377/hlthaff.2022.01406 

While Premier supports adoption of additional measures related to social determinants of health, Premier urges CMS to work with stakeholders to operationalize the existing screening measures prior to adoption of new related measures. 

Additionally, there are several operational challenges with the measure as specified that CMS must address prior to adoption. Additional guidance is needed to clarify how CMS defines connection to a community service provider or how patients with multiple visits should be treated for purposes of reporting. For example, it is unclear if providers would need to make referrals every time the patient has an encounter with the provider or if prior referrals would count. 

As a result, Premier strongly urges CMS to work with the hospital stakeholder community to further finetune and pilot this measure prior to broader adoption in the Hospital IQR Program or other programs, such as the Medicare Shared Savings Program.

While Premier supports adoption of additional measures related to social determinants of health, Premier urges CMS to work with stakeholders to operationalize the existing screening measures prior to adoption of new related measures. 

Additionally, there are several operational challenges with the measure as specified that CMS must address prior to adoption. Additional guidance is needed to clarify how CMS determines if a social need has been resolved and how this information would be captured. For example, it could take several months after a hospital discharge for a social need to be resolved. It is unclear how hospitals would be aware of the resolution and the frequency in which hospitals would be required to follow-up with patients. While a hospital may play a role in coordinating follow-up care or referrals to address social needs, it should not be held responsible for whether the social need is ultimately resolved, as there are many factors outside the hospital’s control that may impact the final outcome. 

As a result, Premier strongly urges CMS to work with the hospital stakeholder community to further finetune and pilot this measure prior to broader adoption in the Hospital IQR Program or other programs, such as the Medicare Shared Savings Program.

While Premier supports inclusion of this measure, we recommend that testing be conducted to determine if volume bias exists in the measure. It has been shown in the literature that risk adjustment of infrequently occurring outcomes can be biased due to the increased likelihood of zero events in low-volume facilities. For example, consider Hospital A with an observed-to-expected (O/E) ratio of 0/3 compared to a larger Hospital B that has an O/E ratio of 0/20. Both hospitals would have an O/E value of 0, although the O/E for hospital B is arguably harder to obtain. For low-volume facilities, O/E ratios can remove important information contained within the denominator, such as the expected values. As a result, Premier recommends measure testing for the presence of volume bias and making adjustments as necessary for fairness.

Finally, we continue to urge CMS to work with stakeholders to advance the use of Artificial Intelligence (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. 

Source: 

Armbrister AJ, Finke AM, Long AM, Korvink M, Gunn LH. Turning up the volume to address biases in predicted healthcare-associated infections and enhance U.S. hospital rankings: A data-driven approach. Am J Infect Control. 2022 Feb;50(2):166-175. doi: 10.1016/j.ajic.2021.08.014. Epub 2021 Aug 21. PMID: 34425178.

While Premier supports inclusion of this measure, we recommend that testing be conducted to determine if volume bias exists in the measure. It has been shown in the literature that risk adjustment of infrequently occurring outcomes can be biased due to the increased likelihood of zero events in low-volume facilities. For example, consider Hospital A with an observed-to-expected (O/E) ratio of 0/3 compared to a larger Hospital B that has an O/E ratio of 0/20. Both hospitals would have an O/E value of 0, although the O/E for hospital B is arguably harder to obtain. For low-volume facilities, O/E ratios can remove important information contained within the denominator, such as the expected values. As a result, Premier recommends measure testing for the presence of volume bias and making adjustments as necessary for fairness.

Finally, we continue to urge CMS to work with stakeholders to advance the use of Artificial Intelligence (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. 

Source: 

Armbrister AJ, Finke AM, Long AM, Korvink M, Gunn LH. Turning up the volume to address biases in predicted healthcare-associated infections and enhance U.S. hospital rankings: A data-driven approach. Am J Infect Control. 2022 Feb;50(2):166-175. doi: 10.1016/j.ajic.2021.08.014. Epub 2021 Aug 21. PMID: 34425178.

While Premier supports inclusion of this measure, we recommend that testing be conducted to determine if volume bias exists in the measure. It has been shown in the literature that risk adjustment of infrequently occurring outcomes can be biased due to the increased likelihood of zero events in low-volume facilities. For example, consider Hospital A with an observed-to-expected (O/E) ratio of 0/3 compared to a larger Hospital B that has an O/E ratio of 0/20. Both hospitals would have an O/E value of 0, although the O/E for hospital B is arguably harder to obtain. For low-volume facilities, O/E ratios can remove important information contained within the denominator, such as the expected values. As a result, Premier recommends measure testing for the presence of volume bias and making adjustments as necessary for fairness.

Finally, we continue to urge CMS to work with stakeholders to advance the use of Artificial Intelligence (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. 

Source: 

Armbrister AJ, Finke AM, Long AM, Korvink M, Gunn LH. Turning up the volume to address biases in predicted healthcare-associated infections and enhance U.S. hospital rankings: A data-driven approach. Am J Infect Control. 2022 Feb;50(2):166-175. doi: 10.1016/j.ajic.2021.08.014. Epub 2021 Aug 21. PMID: 34425178.

Premier supports adoption of measures that advance patient safety. However, we do 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 Artificial Intelligence (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. 

As currently specified the EDAC measures are not easily replicable using available data sources. As a result, Premier recommends that if CMS moves forward with this measure in the Hospital Readmissions Reduction Program (HRRP) that it provides greater transparency on how the measure is developed and published.

As currently specified the EDAC measures are not easily replicable using available data sources. As a result, Premier recommends that if CMS moves forward with this measure in the Hospital Readmissions Reduction Program (HRRP) that it provides greater transparency on how the measure is developed and published.

As currently specified the EDAC measures are not easily replicable using available data sources. As a result, Premier recommends that if CMS moves forward with this measure in the Hospital Readmissions Reduction Program (HRRP) that it provides greater transparency on how the measure is developed and published.