PRMR MUC List Commenting

The Federation of American Hospitals (FAH) and its members are fully committed to ensuring the highest quality and safest care to all individuals and hospitals are already actively monitoring and reporting patient safety activities, including the current patient safety-focused measures required by CMS. We are extremely concerned with the continued advancement of these structural measures that are burdensome for hospitals to report and more importantly lack any direct linkages to improvement in patient outcomes. In addition, we believe that many institutions will be able to meet some or most of the requirements outlined across the five domains including actively engaging patients and families in activities such as a Patient and Family Advisory Council, reporting to a Patient Safety Organization, participating in large-scale learning networks, and tracking progress on safety metrics against external benchmarks. There is a real risk that this measure will achieve a high level of overall performance (or “topping out”) quickly, which further leads us to question whether the effort to implement this measure is worthwhile or if it will need to be replaced by other process or outcome measures in the near future. 
The FAH urges CMS to first catalogue what hospitals are already doing before establishing new measures or requirements to preclude burden caused by overlap and redundancy. Further specificity regarding what would specifically satisfy each of the statements is also needed to ensure that every hospital interprets and attests to them consistently. 
Because of the importance of this issue, the FAH regrets that we cannot support consideration of this measure for the Hospital Inpatient Quality Reporting (IQR) Program at this time due to the need for additional specificity and lack of clear linkages that each of the statements as currently defined can improve patient outcomes. The FAH encourages the CMS to explore other measures that are more directly linked to quality improvement and accountability while also minimizing reporting burden for hospitals. As a result, the FAH requests that the PRMR recommendation should be “Do Not Recommend.”

The Federation of American Hospitals (FAH) does not support this measure since it relies on attestation of a hospital’s performance against a broad set of criteria. We do not believe that the measure will drive improvement on meaningful patient outcomes nor does an aggregated score of many structural components inform patients in their decision making process. The FAH believes that CMS should focus on developing and/or selecting outcome measures or process measures that are closely linked to outcomes rather than measures of attestation. As a result, the FAH believes that the PRMR recommendation should be “Do Not Recommend.”  

We recognize the importance of working to improve affordability and efficiency, and we appreciate the efforts to field test this measure. However, we share the concerns expressed by many stakeholders involved in this process. The proposed CKD cost measure concerns the AAFP for the following reasons: 

• The measure is not endorsed, which means it has not been rigorously reviewed by a consensus-based entity. It appears that it has only been tested by the measure developer. We believe measures should go through a rigorous endorsement process and be further tested and refined, as necessary, before they are considered for implementation. 
• It has been tested and analyzed only at the clinician GROUP level. However, the measure specifications state that it may be applied to the individual clinician or clinician group level. We do not support use of this measure at the individual clinician level. 
• Regarding the denominator exclusions, we recommend defining what constitutes “extremely low” treatment costs.
• The measure developer did not supply any evidence showing mechanisms by which clinicians can improve CKD care and slow progression to ESRD through implementation of cost containment measures.
• There is no clear plan for how an entity may improve performance on the measure focus. It also is important to recognize that physicians cannot control drug costs or coverage of drugs needed to treat patients with CKD (to slow progression to ESRD). 
• Not all communities have access to nephrologists (i.e., rural), so patients with stage 4 & 5 CKD would likely be attributed to a primary care physician (PCP) in those communities. 
• The measure does not meet the minimum reliability threshold of 0.60. Therefore, CMS would need to increase the case minimum to improve reliability. 
• The measure’s risk adjustment model uses CMS-HCC v24. However, as of Jan. 1, 2024, clinicians have been asked to use CMS-HCC v28. Thus, CMS should update the measure specifications accordingly. 

One possible solution could be a slow, phased implementation of this CKD cost measure. This could entail pay-for-reporting at the outset (or perhaps a zero percent weight) for a few years until the measure has been more thoroughly tested, the specifications have been further refined, and the measure as gained endorsement from a CBE.

The Federation of American Hospitals (FAH) supports the intent of this measure but we do not believe that CMS should consider including it in the Hospital Inpatient Quality Reporting (IQR) Program any time in the near future. Hospitals are actively reviewing the specifications and evaluating the feasibility of implementing the Screening for Social Drivers of Health measure. Many are reporting challenges around its implementation, particularly due to the lack of adequate specifications or assurances that the performance scores that result will be reliable and valid. 
This measure has not yet been tested for reliability or validity since only data for two screening tools (which are not required) were provided and most of the information outlined is based on CMMI’s Accountable Health Communities project, which involved community health centers/health systems and therefore does not provide sufficient information on how this measure would perform at the hospital level. The submission information does not provide adequate details around how a hospital must demonstrate the connection within 60 days following discharge. In fact, we were unable to determine the underlying evidence that demonstrates that completing that connection in that timeframe is feasible or linked to improved outcomes. We also question whether the performance scores can truly distinguish differences in the quality of care provided versus availability of services. CMS must evaluate the potential for unintended negative consequences when poorly specified and untested measures are implemented in value-based payment programs.
This measure must be tested for reliability and validity at the hospital level and endorsed by the Consensus-Based Entity prior to inclusion in the Hospital IQR Program and we believe that the PRMR recommendation should be “Do Not Recommend” at this time.

The Federation of American Hospitals (FAH) requests clarification on why this measure has been proposed for the Medicare Shared Savings Program (MSSP) prior to any review of the Screening for Social Drivers of Health (SDOH) measure. On our review of past Measures Under Consideration lists, no SDOH measure has been proposed for MSSP and we do not believe that any process measure focused on activities or outcomes after a positive screen should be considered first. 

The Federation of American Hospitals (FAH) supports the intent of this measure but we do not believe that CMS should consider including it in the Hospital Inpatient Quality Reporting (IQR) Program any time in the near future. Hospitals are actively reviewing the specifications and evaluating the feasibility of implementing the Screening for Social Drivers of Health measure. Many are reporting challenges around its implementation, particularly due to the lack of adequate specifications or assurances that the performance scores that result will be reliable and valid. 
This measure has not yet been tested for reliability or validity since only data for two screening tools (which are not required) were provided and most of the information outlined is based on CMMI’s Accountable Health Communities project, which involved community health centers/health systems and therefore does not provide sufficient information on how this measure would perform at the hospital level. The submission information does not provide adequate details around how a hospital must demonstrate the resolution of at least one social need in the year following discharge. We also question whether the performance scores can truly distinguish differences in the quality of care provided versus availability of services. CMS must evaluate the potential for unintended negative consequences when poorly specified and untested measures are implemented in value-based payment programs.
This measure must be tested for reliability and validity at the hospital level and endorsed by the Consensus-Based Entity prior to inclusion in the Hospital IQR Program and we believe that the PRMR recommendation should be “Do Not Recommend” at this time.

The Federation of American Hospitals (FAH) requests clarification on why this measure has been proposed for the Medicare Shared Savings Program (MSSP) prior to any review of the Screening for Social Drivers of Health (SDOH) measure. On our review of past Measures Under Consideration lists, no SDOH measure has been proposed for MSSP and we do not believe that any process measure focused on activities or outcomes after a positive screen should be considered first. 

We recognize the importance of working to improve affordability and efficiency, and we appreciate the efforts to field test this measure. However, we share the concerns expressed by many stakeholders involved in this process. The proposed ESRD cost measure concerns the AAFP for the following reasons: 

• The measure is not endorsed, which means it has not been rigorously reviewed by a consensus-based entity. It appears that it has only been tested by the measure developer. We believe measures should go through a rigorous endorsement process and be further tested and refined, as necessary, before they are considered for implementation. 
• It has been tested and analyzed only at the clinician GROUP level. However, the measure specifications state that it may be applied to the individual clinician or clinician group level. 
• Access to transplant services is not equal across the United States. TINS or clinician groups that do not have access to transplant services may not get severely ill CKD patients who need a transplant and therefore would not be excluded from the denominator. 
• The measure developer did not submit any evidence showing mechanisms by which clinicians can improve CKD care and slow progression to ESRD through implementation of cost containment measures.
• The measure’s risk adjustment model uses CMS-HCC v24. However, as of Jan. 1, 2024, clinicians have been asked to use CMS-HCC v28. Thus, CMS should update the measure specifications accordingly. 
• The measure does not meet the minimum reliability threshold of 0.60. Therefore, CMS would need to increase the case minimum to improve reliability. 
• The poor measure reliability suggests that this measure has a low capability of distinguishing the quality of performance between entities.

One possible solution could be a slow, phased implementation of this ESRD cost measure. This could entail pay-for-reporting at the outset (or perhaps a zero percent weight) for a few years until the measure has been more thoroughly tested, the specifications have been further refined, and the measure as gained endorsement from a CBE.”

The AAFP appreciates the intent of this measure and shares CMS’s desire to improve the quality of behavioral health care. We understand that measurement is one way to push toward health plan and system improvement. However, it is also important to acknowledge the following: 

• The measure is not endorsed, which means it has not been rigorously reviewed by a consensus-based entity. We believe measures should go through a rigorous endorsement process and be further tested and refined, as necessary, before they are considered for implementation. 
• While this measure is intended to be used only at the health plan level, health plans have historically applied health plan-level measures inappropriately to the individual clinicians and/or clinician groups in their networks. This is not appropriate for measures such as this that have only been tested and validated for use at the health plan level. 
• The data sources cited for this measure include EHR data, which means that plans will likely require that providers submit data from their EHR systems, thus increasing burden, and potentially added cost. 
• This measure is very difficult, if not impossible, for clinicians to track in the current health care landscape with a lack of interoperability across care settings and providers.
• Patient disinterest and refusal remains a significant challenge. Despite their best efforts, clinicians cannot force a patient to accept treatment for SUD.
• Some communities lack the resources necessary to assist patients with SUD. 
• The measure developer and steward did not perform and/or provide any patient/encounter- level reliability or validity testing data.

While this measure is being proposed for use in the MA Star Rating Program, we would also like to note that we do not support this measure for use as a clinician-level measure in CMS’s Universal Foundation. 

I am writing to support adoption of the patient report outcome measure for cancer care related to management of treatment related fatigue and pain. Symptoms related to cancer treatment including fatigue have acute and lasting effects on people having cancer care. Specifically, fatigue affects the ability and willingness to receive appropriate treatment and the completion of life saving treatment. There is substantial literature specifically in breast and other cancer types demonstrating this finding. Fatigue also limits social functioning and continuation of employment during therapy and after completion of therapy. Similarly, pain is one of the most common cancer and cancer treatment related symptoms that has profound impacts of well-being, function, quality of life, and longevity. 

The symptoms of fatigue, and assessment of pain interference (the companion measures submitted for MUC approval) are based on the clear evidence from the PROMOnc program that these measures can discriminate between quality of practices. 

Factors supporting approval of these measures:

1. Evidence shows that recognition and intervention of treatment related symptoms can improve long term quality of life and outcomes. Specifically, there are clear, controlled data that collection of patient-reported data and outcomes during cancer chemotherapy for advanced cancer improves quality of life during therapy, optimizes delivery of therapy, and is associated with prolonged survival.
2. The data from the PROMOnc study show discrimination between practices in the outcomes of these measures. 
3. While fatigue and pain are only two of the symptoms related to cancer treatment, assessment, management and care optimization, assessment of these is generally a component of a comprehensive symptom assessment and management program. These measures will not only address the issues of fatigue and pain but will serve as a proxy for an oncology practice that establishes and uses a a comprehensive program symptom management.
4. Given the findings of PROMOnc, these measures will therefore allow identification of high-quality practices that have implement patient reported outcomes programs and actively address symptoms to optimize care and outcomes. 

It is recognized that the PROMOnc study was limited to certain cancer types and the measures is limited to Stage I – III breast cancer. However, practices will most likely implement PRO programs across the spectrum of cancer types. While the measure only addresses breast cancer for practice assessment, the functional result is likely to be seen in enhanced symptom identification and management across the full spectrum of cancer types. 

The measure is designed to use data readily collectible from most electronic health records. The exception are elements of the PROMIS survey. Practices will need to incorporate these into other data they collect. Adding PROMIS elements will be valuable in addition to these measures in that it will information for the clinician to help people with fatigue as well as other symptoms related to cancer treatment. While there are other instruments available, and CMS may be flexible in the choice of PROMIS, there is value in standardization of data collection across practice types. 

In conclusion, these measures address key important issues in quality cancer care

1. They bring the patient voice to quality assessment using patient reported data.
2. The measures address key issues in treatment-related symptom identification and management.
3. Tools to address these measures will support management of other related symptoms.
4. These measures should provide reasonable discrimination of quality between practices of critical cancer treatment outcomes.

Thank you for the opportunity to comment on these measures. 

I am writing to support adoption of the patient report outcome measure for cancer care related to management of treatment related fatigue and pain. Symptoms related to cancer treatment including fatigue have acute and lasting effects on people having cancer care. Specifically, fatigue affects the ability and willingness to receive appropriate treatment and the completion of life saving treatment. There is substantial literature specifically in breast and other cancer types demonstrating this finding. Fatigue also limits social functioning and continuation of employment during therapy and after completion of therapy. Similarly, pain is one of the most common cancer and cancer treatment related symptoms that has profound impacts of well-being, function, quality of life, and longevity. 

The symptoms of fatigue, and assessment of pain interference (the companion measures submitted for MUC approval) are based on the clear evidence from the PROMOnc program that these measures can discriminate between quality of practices. 

Factors supporting approval of these measures:

1. Evidence shows that recognition and intervention of treatment related symptoms can improve long term quality of life and outcomes. Specifically, there are clear, controlled data that collection of patient-reported data and outcomes during cancer chemotherapy for advanced cancer improves quality of life during therapy, optimizes delivery of therapy, and is associated with prolonged survival.
2. The data from the PROMOnc study show discrimination between practices in the outcomes of these measures. 
3. While fatigue and pain are only two of the symptoms related to cancer treatment, assessment, management and care optimization, assessment of these is generally a component of a comprehensive symptom assessment and management program. These measures will not only address the issues of fatigue and pain but will serve as a proxy for an oncology practice that establishes and uses a a comprehensive program symptom management.
4. Given the findings of PROMOnc, these measures will therefore allow identification of high-quality practices that have implement patient reported outcomes programs and actively address symptoms to optimize care and outcomes. 

It is recognized that the PROMOnc study was limited to certain cancer types and the measures is limited to Stage I – III breast cancer. However, practices will most likely implement PRO programs across the spectrum of cancer types. While the measure only addresses breast cancer for practice assessment, the functional result is likely to be seen in enhanced symptom identification and management across the full spectrum of cancer types. 

The measure is designed to use data readily collectible from most electronic health records. The exception are elements of the PROMIS survey. Practices will need to incorporate these into other data they collect. Adding PROMIS elements will be valuable in addition to these measures in that it will information for the clinician to help people with fatigue as well as other symptoms related to cancer treatment. While there are other instruments available, and CMS may be flexible in the choice of PROMIS, there is value in standardization of data collection across practice types. 

In conclusion, these measures address key important issues in quality cancer care

1. They bring the patient voice to quality assessment using patient reported data.
2. The measures address key issues in treatment-related symptom identification and management.
3. Tools to address these measures will support management of other related symptoms.
4. These measures should provide reasonable discrimination of quality between practices of critical cancer treatment outcomes.

Thank you for the opportunity to comment on these measures. 

As the Chief Medical and Science Officer for the Society to Improve Diagnosis in Medicine (SIDM), I write to express our strong support for the Patient Safety Structural Measure (PSSM) and the Age-Friendly Hospital Measure on the CMS list of Measures Under Consideration (MUC).

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.  It is time to hold healthcare organizations accountable for the implementation of Safety Management Systems, modeled after those that have proven of value in other high-risk domains, such as transportation, chemical processing, etc. The PSSM is a crucial step in this direction.   It provides much needed guidance to hospital leaders on the steps they need to put in place for themselves and their organizations to establish transparency and accountability for delivering 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 we should all expect United States hospitals to be doing.  As the measure moves forward, we encourage CMS to consider opportunities within the structural domains to address one or more key opportunities to improve diagnostic safety in particular, such as assuring communication of re-interpreted or post-discharge test results to the ordering provider and the patient. 

The PSSM aligns with recent 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. We applaud CMS’s investment in this measure and the central role that patient advocates played on the TEP for its development, and look forward to its expeditious implementation. 

SIDM also strongly supports the Age-Friendly Hospital measure for inclusion in the CMS Hospital IQR program. The US population aged 65 and older is expected to double by 2050, posing challenges to providing evidence-based, person-centered care to our aging population. Diagnostic errors in older adults arise from unique factors including multimorbidity, polypharmacy, cognitive impairment, structural and social determinants of health, and disease presentations that differ from younger adults. Coupled with this challenge of receiving the correct diagnosis is the cross-cutting challenge of equity (including ageism, racism, and other forms of systemic bias) and the need to improve health equity when working to achieve diagnostic excellence for older adults.

We believe the Age-Friendly Hospital measure is a critical piece in the optimization of care for older adult patients because it uses a holistic approach to create a quality program that can better meet the unique needs of this often medically complex population. Developed in partnership with the American College of Surgeons (ACS), the Institute for Healthcare Improvement (IHI), and the American College of Emergency Physicians (ACEP), this “programmatic composite” measure will help build a safer environment and quality care for older adults who engage in medical services, and also help older adults and their caregivers know where to find the best hospital care. 

Thank you for the opportunity to share our support for these measures. 

Ron Wyatt, MD

Chief Medical and Science Officer

Society to Improve Diagnosis in Medicine

Please see attached for comments. Thank you.

December 22, 2023

Thank you for the opportunity to comment on Patient Safety Structural Measure (PSSM) (#MUC2023-188) on the CMS list of Measures Under Consideration. MedStar Health supports CMS’s continued commitment to assure that all patients receive safe, high quality, and equitable care. The intent and spirit of the PSSM further supports this goal.

MedStar Health offers the following comments regarding the Patient Safety Structural Measure:

Domain 1: Leadership Commitment to Eliminating Preventable Harm

• General Comment: We fully support the focus on the deliberate and intentional engagement of hospital leaders and board of directors in all patient safety initiatives. We have found this to be key to our success as a health system which prioritizes patient safety in a meaningful way.
• Statement 5 (Notification of Executives and Board members of Serious Safety Events in 3 business days): Our health system reports SSEs to the board of directors and to the CEO and other senior leaders, and we attest to the value of this approach. However, the technical approach to this attestation is misapplied and has a significant potential to negatively impact safety.  Understanding the true nature of a potential serious safety event for the purpose of sustained improvement requires a thorough event review, and premature determination of SSE status will inhibit this learning and add risks of ‘premature closure’ of the learning phase. Adding arbitrary deadlines creates a pressure to complete this work and making a determination regarding the event in 72 hours could compromise the quality and outcome of the review, limiting opportunities for organizational learning and improvements in safety for future patients. Additionally, the lack of a clear definition of “serious safety event” in the context of reporting these events to the CEO and the board in 3 business days could lead to variable application of, and adherence to, the spirit of this statement. 

Domain 2: Strategic Planning & Organizational Policy

• Statement 4 (Requirement for patient safety curriculum for all clinical and non-clinical hospital staff): Assuring that an organization establishes an evidence-based patient safety and competency-based training program is an essential aspect of a robust patient safety management system. For over a decade we have provided safety training to every single associate and have seen value in this effort; however, we recommend that the requirement to establish “patient safety curriculum and competencies... for all non-clinical hospital staff” be further defined and refined to assure that educational resources are most effectively deployed. 

Domain 3: Culture of Safety & Learning Health System

• Statement 4; Bullet 1 (Requirement to conduct tiered and escalated rounding): While it is clear that safety huddles are effective and important, there are many other structures which have been implemented, and there is no evidence to suggest that mandating a specific approach is important. In the HRO concept of “sensitivity to operations,” it is important to define an overall requirement but allow hospitals to implement rounding in a way that is most effective in their environment.  We recommend that this Statement be expanded to include options to perform other communication and situational awareness interventions grounded in safety science. 
• Statement 4; Bullet 3 (Requirement to develop a data infrastructure to measure safety using data from the EHR): We highly recommend that CMS engage the major Electronic Health Record (EHR) developers early in the PSSM development and implementation process to assure that the functionality to easily access “data from the electronic medical record that enables identification and tracking of serious safety events and precursor events” is available to hospitals. One major opportunity towards forward movement in safety is a higher level of engagement and accountability for safety design by industry partners that will impact the design of safe hospital systems - such as medical devices, EHR, pharma, and others. 

Domain 4: Accountability & Transparency

• Statement 2 (Requirement to report safety events, near misses, precursor events to PSOs): The requirement to report “serious safety events, near misses and precursor events to a Patient Safety Organization (PSO)” expands the types of events reported to PSOs and could result in a substantial reporting burden for hospitals as well as challenges for PSOs to appropriately manage and analyze this increase in submissions. PSOs have shown value in some areas but have struggled to demonstrate impact in disseminating insights in a meaningful way that impacts safety on the national front. The first step should be to maximize the functionality and effectiveness of PSOs, then require reporting. Otherwise, critical safety resources are shifted to an effort that has limited return. Further, clear and concise definitions of near misses and precursor events will be required to assure consistency in data collection and analysis. 

MedStar Health supports CMS’s efforts to continually improve patient safety across our nation. Thank you, again, for the opportunity to provide public comments for the PSSM. 

My name is _____Kenneth Sapire_.  I am writing as a Patient Safety Champion in my anesthesia group in  US AND THE HOSPITAL that I work at, which is a patient led network of people who feel that making healthcare safer is an urgent priority.  I write in support of the Patient Safety Structural Measure (#MUC2023-188) on the CMS list of Measures Under Consideration.

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

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

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

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

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

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

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

Please see the attached comments from the American Society of Cataract & Refractive Surgery

Please see attached.

Please see attached.

Please see attached.

Please see attached.

Please see attached.

Recommend with conditions. This measure would address a critical, preventable patient safety risk. However, it should submitted for and receive CBE endorsement prior to implementation. 

Recommend with conditions. This measure would address a critical, preventable patient safety risk. However, it should submitted for and receive CBE endorsement prior to implementation. 

Please see comments attached

Recommend with conditions. This measure would address a critical, preventable patient safety risk. However, it should submitted for and receive CBE endorsement prior to implementation. 

December 22, 2023

Partnership for Quality Measurement
505 King Avenue
Columbus, OH 43201
[email protected]

Via electronic delivery

RE: MUC 2023 – 201 - Cataract Removal with Intraocular Lens (IOL) Implantation

Dear Members of the 2023-2024 Pre-Rulemaking Measure Review (PRMR) Clinician Committee:

On behalf of the American Society of Cataract and Refractive Surgery (ASCRS), a medical surgical specialty society representing nearly 7,000 ophthalmologists in the United States and abroad who share a particular interest in cataract and refractive surgical care, we appreciate the opportunity to provide feedback on the potential revisions to MUC-2023-201, the Cataract Removal with Intraocular Lens (IOL) Implantation Cost Measure. ASCRS has been an active participant in the Cataract Cost Episode Measure TEP, as well as the reevaluation workgroup.

ASCRS continues to have many of the same concerns we outlined in our February 2023 comments. In addition, upon further reflection and research, we have some new concerns, as well.

Please find below our specific comments and recommendations:

Trigger Code - 66984

While the revised Cataract Removal with Intraocular Lens (IOL) Implantation Measure specifications do not include the additional trigger code (66982), we want to reiterate that we continue to support the use of CPT code 66984 as the only trigger for the cataract episode cost measure. As we have indicated previously, in order to compare surgeon costs fairly and validly, there must be a homogenous group of surgical cases to compare.

Including other trigger codes, such as complex cataract surgery, 66982, in this cost measure would not yield comparable data to measure a physician’s resource use accurately. Patients undergoing cataract surgery that requires the use of the complex cataract code may suffer from a wide variety of ocular comorbidities or other non-ocular comorbidities, which could require varying levels of resource use depending on the condition. In addition, these patients often have complications requiring further surgery, such as a vitrectomy. To reiterate what was discussed during the initial review meeting the subsequent work group meetings, and our previous comments, complex cataract surgery may require additional supplies and increases the likelihood of potential complications, resulting in a range in value too significant to provide a homogenous patient group for a cost measure and should not be used as a trigger code.

As we have previously commented, ASCRS is also concerned that additional trigger codes and comorbidities would disproportionally affect small cataract practices. ASCRS members primarily practice in office-based settings of solo or small groups. Adding additional trigger codes would adversely impact smaller practices that do not do as many cataract procedures because it would only take one costly complex case to cause their Cost score to drop. Low volume cataract practices that provide care to patients with complex conditions would have greater exposure to receiving a penalty. In addition, some cataract surgeons do a majority of complex cases, and therefore, would be inappropriately penalized. It is also important to note that the majority of cataract cases are captured with 66984.

Removing Exclusions with Appropriate Risk Adjustment Methodology

While ASCRS, in conjunction with the workgroup discussion, initially agreed, with some skepticism, that the measure specifications could be updated to include patients with some of the ocular conditions and comorbidities that have been excluded with the proper and appropriate risk adjustment, we did express concern related to how exactly these codes would be risk adjusted and requested an explanation of the methodology. 

However, even after the explanation and statistical analysis during the meeting with Acumen, ASCRS continues to have significant concerns regarding the inclusion of patients with any significant co-morbidities in the cataract episode cost measure. As we have indicated previously, we continue to question whether or not this is a valid risk-adjustment methodology and do not trust that it is possible to properly risk adjust for the majority of these patients with significant ocular conditions and comorbidities. Further, we do not trust that the algorithms described will properly risk adjust for the myriad of comorbidities and conditions that can be exacerbated as a result of the cataract surgery procedure through no fault of the surgeon. A foundational principle is to develop cost measures that are within the control of the physician to whom they will be attributed and to compare a homogeneous group. 

We remain concerned that CMS risks creating a system that encourages the care of uncomplicated cataract patients and discourages the care of the sickest, most complex cataract patients, which could not be coded for a complex cataract procedure 66982 – and therefore, excluded. This will result in these patients, whose care is more difficult and expensive, being at risk of losing timely access to care.

To reiterate, some cataract surgeons are in high-volume practices where they may avoid the problem of adverse risk selection, while others do not and may choose to see lower-risk patients. Choosing a course of treatment for a patient to not adversely impact a resource use score becomes a problematic, ethical dilemma for a physician who wants to uphold his or her sworn duties. Not only would this situation place physicians in an ethical quandary, the day-to-day task of monitoring the cost of care for each patient would add considerably to the already heavy regulatory burdens physicians face. 

Therefore, we have identified a list of risk adjusted codes ASCRS believes should not be risk adjusted and continue to be excluded. Please click here to view: 

https://ascrs.org/-/media/81da3965d25f4cd287b56ca2ef482ceb.ashx

The codes highlighted in yellow should be EXCLUDED.  The remaining codes highlighted in green are acceptable for risk adjustment.

Acumen’s methodology document clearly states:

Services, and their Medicare costs, are assigned to an episode only when clinically related to the attributed clinician’s role in managing patient care during the episode. …Unrelated services are not assigned to the episode. For example, the cost of care for a chronic condition that occurs during the episode but is not related to the clinical management of the patient relative to the cataract removal procedure with IOL implantation would not be assigned. 

When thinking through which conditions should be included and excluded, we came back to the above statement to guide our thinking. 

On the other hand, during the workgroup calls, an additional directive about the importance of including as many cases as possible in the measure was stated. Interestingly, this priority is not found in the methodology document.  When these two principles (basically “quality” vs. “volume”) were in conflict, the organizers of the workgroup gave preference to including as many cases as possible (volume), while we strongly give preference  to “quality”-- including only the cases that make the cost measure as fair, appropriate and transparent as possible.

Diagnosis/Conditions Added to Exclusions

The following Diagnosis/Conditions have never been included in the exclusions list, but after further review, we believe they were missed previously by the workgroup, and should now be added to correct the original omissions. The explanations are included below.

Herpes Virus

Surgery and the local trauma to ocular tissues related to the act of uncomplicated cataract surgery can reactivate the herpetic virus (HSV) in patients with latent disease. Reactivation can lead to out-of-control inflammation in some patients after surgery requiring referrals to corneal or uveitis specialists, as well as the PCP and/or a rheumatologist. Furthermore, patients can go to emergency rooms or urgent care offices, or need additional blood work or diagnostic testing, all of which will increase the costs, even though the initial surgery was uncomplicated. 

B005.0 Herpesviral ocular disease, unspecified

B00.51 Herpesviral iridocyclitis

B00.52 Herpesviral keratitis

B00.53 Herpesviral conjunctivitis

B00.59 Other Herpesviral disease of the eye

Zoster Virus 

Surgery and the local trauma to ocular tissues related to the act of uncomplicated cataract surgery can reactivate the varicella roster virus (VZV) in patients with latent disease.  Reactivation can lead to out- of - control inflammation in some patients after surgery requiring referrals to corneal or uveitis specialists, as well as PCP and/or a rheumatologist.  Furthermore, patients can end up in the emergency room or urgent care

offices, all of which increase the cost, even though the initial surgery was uncomplicated.

B02.30 Zoster ocular disease, unspecified

B02.31 Zoster conjunctivitis

B02.32 Zoster iridocyclitis

B02.33 Zoster keratitis

B02.34 Zoster scleritis

B02.39 other herpes zoster eye disease

Retinal Degenerations

Patients with peripheral retinal degenerations have a higher chance of retinal tears and detachments, even with uncomplicated cataract surgery. The additional office visits with a retina surgeon and additional treatments including laser retinopexy, pneumatic retinopexy, pars plana vitrectomy, or scleral buckling surgery would drive up the cost after surgery.

H33.3 Hereditary retinal degeneration

H35.5 Peripheral retinal degeneration with retinal break

H35.4 Peripheral retinal degeneration

H35.41 Lattice degeneration of retina

Anterior Scleritis

Surgery and the local trauma to ocular tissues related to the act of uncomplicated surgery can lead to anterior scleritis.  Scleritis typically occurs in patients with underlying autoimmune diseases (sometimes prior to officially being diagnosed by the PCP). These patients tend to have significant inflammation and require visits to the PCP and rheumatologist (or urgent care/emergency room); additional blood work and diagnostic testing may also be needed. They are sometimes referred to a uveitis specialist to help with diagnosis and control of the underlying inflammation process.  Other forms of scleritis have been placed on the exclusion list for these reasons, including posterior scleritis, brawny scleritis, and “other” scleritis.  All forms of scleritis can be exacerbated at the time of uncomplicated cataract surgery, including anterior scleritis. We believe that anterior scleritis was overlooked. 

H15.01 Anterior Scleritis

H15.011 OD

H15.012 OS

H15.013 Bilateral

Posterior Polar Cataracts 

Posterior Polar Cataracts (officially called posterior subcapsular polar cataracts) are well documented to have higher risk and complication rates during cataract surgery. With higher vitrectomy rates, these patients often need second surgeries and/or additional treatment within the postop period for treatment of pressure-related and associated vireo-retinal sequelae. 

H25.041 (OD) Posterior polar cataract

H25.042 (OS)

H25.043 (OU)  

(Recurrent) Corneal Erosions

Patients with certain underlying corneal dystrophies or history of trauma are prone to RCE, which can require additional medical or surgical treatment, such as PRK, stromal micro puncture, and amniotic membrane placement during the post-op 90-day global window.  Uncomplicated cataract surgery can exacerbate these conditions.  In addition, preservatives in the post-operative drops may subject the cornea to increased risk of erosions and worsening of keratitis sicca after surgery. 

H18.831 (OD). RCE

H18.832 (OS)

H18.833 (OU)

Punctate Keratitis

Uncomplicated cataract surgery can exacerbate keratitis. In addition, preservatives in the post-operative drops may subject the cornea to increase risk of punctate keratitis after surgery.  Treatment for this diagnosis could include amniotic membrane placement. 

H16.141 (OD) Punctate Keratitis 

H16.142 (OS)

H16.143 (OU)

Neurotrophic Keratitis

Uncomplicated cataract surgery can exacerbate keratitis. In addition, preservatives in the post-operative drops may subject the cornea to increase risk of punctate keratitis after surgery.  Treatment for this diagnosis could include amniotic membrane placement.

H16.231 (OD)

H16.232 (OS)

H16.233 (OU)

Exposure Keratoconjunctivitis

Uncomplicated cataract surgery can exacerbate keratitis at the time of surgery.   In addition, preservatives in the post-operative drops may subject the cornea to increased risk of exposure keratitis after surgery. Treatment for this diagnosis could include  amniotic membranes placement.  

H16.211 (OD)

H16.212 (OS)

H16.213 (OU)

Filamentary Keratitis

Uncomplicated cataract surgery can exacerbate keratitis. In addition, preservatives in the post-operative drops may subject the cornea to increase risk of punctate keratitis after surgery.  Treatment for this diagnosis could include amniotic membrane placement.

H16.121 (OD)

H16.122 (OS)

H16.123 (OU)

Lagophthalmos

Patients with lagophthalmos typically have dry eyes due to corneal exposure issues.  Uncomplicated cataract surgery can exacerbate keratitis. In addition, preservatives in the post-operative drops may subject the cornea to increase risk of punctate keratitis after surgery. Patients may need referral to an oculoplastics specialist. Treatment for this diagnosis could include amniotic membrane placement.

H02.2 Lagophthalmos

H02.20 Unspecified lagophthalmos

H02.201 RUL

H02.202 RLL

H02.203 OD unspecified lid

H02.204 LUL

H02.205 LLL

H02.206 OS Unspecified lid

H02.20A OD upper and lower lids

H02.20B OS upper and lower lids

H02.20C bilateral upper and lower lids

H02.21 Cicatricial Lagophthalmos

H02.211 RUL

H02.212 RLL

H02.213 OD Unspecified lid

H02.214 LUL

H02.215 LLL

H02.216 OS Unspecified lid

H02.21A OD upper and lower lids

H02.21B OS upper and lower lids

H02.21C bilateral upper and lower lids

H02.22 Mechanical Lagophthalmos

H02.221 RUL

H02.222 RLL

H02.223 OD Unspecified lid

H02.224 LUL

H02.225 LLL

H02.226 OS Unspecified lid

H02.22A OD upper and lower lids

H02.22B OS upper and lower lids

H02.22C bilateral upper and lower lids

H02.23 Paralytic Lagophthalmos

H02.231 RUL

H02.232 RLL

H02.233 OD Unspecified lid

H02.234 LUL

H02.235 LLL

H02.236 OS unspecified lid

H02.23A OD upper and lower lids

H02.23B OS upper and lower lids

H02.23C bilateral upper and lower lids

Exophthalmic Conditions

These conditions are usually related to other underlying diseases. Exophthalmos can result in exposure to keratitis, which requires additional treatment and office visits. 

H05.2 Exophthalmic Conditions

H05.20  unspecified exophthalmos

H05.21 displacement (lateral) of the globe

H05.211 OD

H05.212 OS

H05.213 bilateral

H05.24 Constant exophthalmos

H05.241 OD

H05.242 OS

H05.243 bilateral

H15.0 Scleritis

H15.00 Unspecified scleritis

H15.001 OD

H15.002 OS

H15.003 Bilateral

Diagnosis/Conditions Previously Excluded that Should Continue to be Excluded 

The following are diagnosis/conditions that were previously excluded and do not appear in either the excluded list or the risk adjusted list in the revised measure. They should continue to be excluded. The explanations are included below.

Psuedoexfoliation Glaucoma and Syndrome

There is an increased risk of complications during cataract surgery in patients with pseudoexfoliation.  Not all patients will require iris hooks or iris retraction rings; therefore, these surgeries would be coded as 66984.  Yet some of these patients may have zonular weakness and have higher rates of vitrectomy and other complications that require additional medical and surgical treatment. Vitreous loss is 5-10 times more common in these eyes. These patients are also at risk for later post operative complications, such as IOL/posterior bag dislocation which, depending on the severity, can happen during the 90-day global period.  This will lead to additional office visits and referrals to retinal surgeons and/or surgeons who perform IOL fixation surgery. 

H40.141 (OD) Pseudoexfoliation Glaucoma

H40.142 (OS)   

H40.143 (OU)

Other Age-Related Cataracts

Not every patient with pseudoexfoliation has glaucoma. Patients with pseudoexfoliation without glaucoma are still at higher risk for complications during cataract surgery. According to the American Academy of Ophthalmology, the ICD -10 code for pseudoexfoliation of lens capsule is H25.89 other age-related cataracts. If doctors are coding this correctly, other age-related cataracts must be included in the exclusion list. 

H25.89 other age-related cataracts 

Mature Cataracts

Cataract surgery on a severe, mature cataract is far more complex and riskier than an average cataract.  Even though it is not coded at 66982, surgery on a severe cataract has a higher chance of complications, including corneal failure or vitreous prolapse, leading to the need for additional referrals and follow up surgery during the 90-day post op period.  Mature cataract is also coded H25.89.

H25.89 other age-related cataracts.

Traumatic Cataracts

Due to the history of trauma resulting in cataracts, patients tend to have higher complication rates during surgery due to abnormal anatomy, scarring, limited visibility, and increased risk of inflammation.  These patients are also at risk for higher post-op inflammation. Therefore, these patients should be excluded.

H26.101 (OD) Traumatic cataract

H26.102 (OS)

H26.103 (OU)

AMD – Wet and Dry

All patients with AMD are at higher risk for needing additional treatments and office visits after cataract surgery.  That is why the anti-VEGF injections are excluded from the cost measure.  HOWEVER, these patients still require retina specialist office visits and diagnostic testing (ie OCT, FA, etc.) that drives up the cost after surgery.  ALL forms of AMD should be excluded.  Dry AMD can convert to WET at any time, including during the 90-day post op period. Furthermore, AMD may be under-diagnosis at the time of cataract surgery, as these patient’s dense cataracts may prevent adequate view on exam or OCT for proper diagnosis.

Dry (nonexudative) AMD early dry stage:

H35.3111     H35. 3121         H35.3131

Dry (nonexudative) AMD intermediate dry stage:

H35.3112     H35. 3122         H35.3132

Dry (nonexudative) AMD advanced atrophic w/o sub foveal involvement:

H35.3113     H35. 3123         H35.3133

Dry (nonexudative) AMD advanced atrophic with sub foveal involvement:

H35.3114     H35. 3124         H35.3134

Wet (exudative) AMD w active choroidal neovascularization:

H35.3211   H35.3221     H35.3231

Wet (exudative) AMD w inactive choroidal neovascularization:

H35.3212   H35.3222     H35.3232

Wet (exudative) AMD w inactive scar:

H35.3213   H35.3223     H35.3233

Cost Measure Look-Back Rules

In the years since the cost measure was created, Medicare’s rules for how soon the original office consult and the surgical date have been relaxed.  The cost measure look-back rules should be relaxed to reflect this change.  We suggest increasing the look-back period from 60 days to 180 days.

Service Assignment – Clinically Related Services

This revised cataract surgery episode cost measure adds the costs of additional clinically related services, such as durable medical equipment (DME), pre-operative testing, emergency department (ED) visits for ocular issues, and additional telehealth visits.  While ASCRS believes it is fair to include these in the service assignments, we stress that these costs should be accounted for only when these services are absolutely related to the trigger code, 66984, and within the episode window.

Assigning Medicare Part B Medication Costs – Omidria and Dextenza

Pass-through status must be preserved as an unbiased method of accounting for the utilization of new and innovative drugs. 

As ASCRS previously commented, while Omidria and Dextenza are no longer on pass-through, there may be new drugs coming onto the market with pass-through status in the future. Therefore, ASCRS wants to reiterate its  opposition to including any pass-through drug in the cataract episode measure. As we have previously argued, including any pass-through drug in this cost measure defeats the purpose of pass-through status, which is to pay separately for new and innovative high-cost drugs as they are introduced into the marketplace, giving physicians time to become familiar with the new treatment option and its benefits. This time is used to provide unbiased utilization data, with no cost implications/penalties, which is ultimately used in the formula to update the APC payment once the drug comes off pass-through and is bundled into the facility payment. Including pass-through drugs in the cataract cost-episode measure risks influencing that data because physicians will choose not to use the drug based on its cost, rather than its clinical merits.

Dextenza and Omidria

The measure now includes Dextenza, as well as the previously included Omidria, even though the workgroup did not reach a consensus on whether the measure should include or exclude specific Part B drugs. 

Dextenza and Omidria both have an FDA indication for reducing post operative pain and have been given a special payment status of non-opioid pain management drugs and are, therefore, paid separately in the ASC setting. They are both expensive medications that are under direct discretion/control of the surgeon to use. 

Dextenza 

As we previously commented and continue to maintain, given that Dextenza has the ability to reduce/eliminate the need for Medicare Part D postoperative topical corticosteroids, a class of mediation used routinely after cataract surgery, ASCRS does not support the inclusion of Dextenza into the Cataract Episode Measure and again, recommends this medication be excluded from the cost measure. 

Omidria

However, as we have commented previously and still maintain, Omidria has an FDA indication for postoperative pain, but does not replace any medications that are routinely used after cataract surgery. Therefore, ASCRS continues to support the inclusion of this drug in the cost measure.

Medicare Part D Drugs Related to Cataract Surgery

ASCRS continues to oppose the inclusion of Medicare Part D drugs in the cataract episode-based cost measure because physicians cannot control their cost and, we therefore, support that this measure does not include them.

We continue to remain unconvinced that Acumen/CMS is able to standardize all Part D drug costs and accurately account for the varying costs beneficiaries pay for drugs based on their plan or even the pharmacy where they fill the prescription. As we discussed during our workgroup meeting and in our previous comments, other factors unrelated to the clinical   merits of the drug, such as formulary design, pharmacy benefit managers (PBMs), and patient incentives including manufacturer’s coupons, make it impossible for the surgeon to predict what drug is the most cost effective and what the patient will pay. These many factors that impact the price or availability of specific drugs are outside of the physician’s control.

As a reminder, and discussed previously, there are currently FDA-approved, on-label Medicare Part B drugs administered during the time of surgery with post-operative indications for pain and inflammation, which replace the need for some Medicare Part D post-operative medicated eyedrops however, there are no FDA-approved drugs administered during surgery for post-operative infection control. In addition, there are off-label compounded drugs administered during cataract surgery that are also for post-operative pain, as well as for infection that are bundled into the facility payment. Consequently, cataract surgeons must prescribe patients some combination of drugs to treat post-operative pain, inflammation, and/or infection. While there are both branded and generic post-operative drops available, it is impossible for the surgeon to know what price a particular patient will pay based on the plan they have or the pharmacy where they fill the prescription. 

Additionally, we are concerned that including Part D prescription drug costs in the cataract cost episode measure may inappropriately penalize physicians who select the most medically appropriate treatment for their patients. There are instances where an ophthalmologist would prescribe self-administered post-operative drops rather than administer a drug with a post-operative indication at the time of the surgery. For example, a patient may be allergic to an active ingredient in a drug that would be administered at the time of surgery. Since the patient is allergic to an ingredient in the medication, the ophthalmologist would not use it during surgery and instead, prescribe self-administered post-operative eye drops. It is essential that CMS recognize that the most appropriate methodology for determining cost should be flexible to allow for choice of a treatment option that is best for the patient and will lead to better outcomes.

Due to the factors discussed related to the clinical necessity of cataract surgeons prescribing post-operative eyedrops after surgery, and the inability of physicians to predict the cost of a drug based on the complex structure of the pharmaceutical market and the absence of transparency, they have no ability to control the costs of Medicare Part D drugs, and therefore, should not be included in the episode-based cost measure.

Methodology, Scoring and Feedback Process

While ASCRS is interested in continuing to collaborate on the cataract surgery cost episode measure and other future measures that focus on anterior segment procedures, we believe the MIPS scoring and feedback process needs to improve.

As you are aware, as ASCRS members began to receive feedback on the cataract episode-based cost measure, for the first time, as part of the 2022 performance year/2024 payment year score, and many of them were concerned with their low scores. Initially, there were issues with duplicate services appearing in the patient-level data, which added to the confusion.

We participated in joint call with the AAO, as well as with the Center for Clinical Standards and Quality and Acumen staff to discuss our concerns and also focused on the fact that the patient-level data files lack the data required to improve measure performance. The two organizations also recommended the addition of date of service and rendering provider fields to future reports.  It is clear that better education and meaningful feedback needs to be provided.  We strongly recommend that before the cataract cost episode measure is applied for the 2023 performance year/2025 payment, the application of the measure be reviewed with the TEP so that any inconsistencies in service attribution are corrected. 

Conclusion

We appreciate the opportunity to continue to provide input and additional comments. 

If you have any questions or need additional information, please contact, Mark Cribben, ASCRS Director of Government Relations at [email protected] or Nancey McCann ASCRS GR Consultant at [email protected].

Sincerely,

Parag Parekh, MD, MPA
Chairman, ASCRS Government Relations Committee
Member, MACRA Episode -Based Cost Measure TEP and Ophthalmology Clinical Subcommittee and Workgroup.

Recommend with conditions.  Addressing malnutrition is an important aspect of patient care; however, it looks like this measure may be duplicative with the frailty screening domain of the Age Friendly Hospital measure.  CMS should work with the developers to harmonize the measures or consider which measure may be optimal for the IQR program rather than implementing overlapping measures to ensure a parsimonious measure set and reduce provider burden. 

Recommend.  Replacing the current AMI readmissions measure with the EDAC measure would reduce excess utilization from ED visits and observation stays and ensure that patients are not subject to boarding to avoid counting as a readmission. 

Recommend.  Replacing the current HF readmissions measure with the EDAC measure would reduce excess utilization from ED visits and observation stays and ensure that patients are not subject to boarding to avoid counting as a readmission. 

Recommend.  Replacing the current PN readmissions measure with the EDAC measure would reduce excess utilization from ED visits and observation stays and ensure that patients are not subject to boarding to avoid counting as a readmission. 

Recommend with conditions.  The measure should be submitted for and receive CBE endorsement.  CMS and the measure developer should also explore ways to move beyond a process measure to an outcome measure to assess if dialysis facilities are delivering care in alignment with patient goals. 

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 experience of care.  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 experience of care.  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 experience of care.  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 believes that performance measurement is an underutilized tool to address healthcare disparities and supports the advancement of measure of health equity. Given the impact of social determinants of health on a person’s health outcomes, screening for social risk factors in an important first step in promoting health equity and eliminating health disparities.  We agree that screening for health needs can help providers connect patients to social services.  
 

Recommend with conditions.  Conceptually, we support the idea of the Screen Positive Rate measure as we would like to see equity measures that go beyond screening rates and promote action to address social risk.  While we agree the information on who screens positive would be useful to health care providers so they can provide assistance, we believe this measure must be implemented carefully to avoid unfairly penalizing providers serving vulnerable populations.   
•    While we support the confidential provision of this information to providers for the purposes of performance improvement, we would like more information on how this measure would be benchmarked for public reporting or payment before recommending its use for these purposes. We agree with the need to ensure patients are referred to needed services but do not believe this measure should be tied to payment or publicly reported until there is more information about how it performs.  
•    We also recommend that CMS work with the measure steward to refine this measure to include specific screening tools or provide implementation guidance on which screening tools should be used to promote consistency in screening for social determinants across the healthcare sector.  Additionally, we recommend that CMS and the measure steward work to ensure alignment with accepted data standards for SDOH.  We would recommend that CMS and the measure steward look to the work of the Gravity Project to identify data standards.  Ensuring consistency in the screening tools used and utilizing the work of the Gravity Project would align with work health care providers, electronic medical records companies, RHIOs, health insurance providers and government agencies are doing to address SDOH. 

Recommend with conditions. This measure could promote better collection of demographic data and monitoring for healthcare disparities. Better data and understanding of where there are deficits in quality are essential to advancing health equity.    CMS should ensure the measure is feasible to implement and submit the measure for CBE endorsement. 

Recommend with conditions. This measure could promote better collection of demographic data and monitoring for healthcare disparities. Better data and understanding of where there are deficits in quality are essential to advancing health equity.    CMS should ensure the measure is feasible to implement and submit the measure for CBE endorsement. 

Recommend with conditions.  This measure assesses an important outcome; however, it should be submitted for and receive CBE endorsement prior to use in a CMS program.

Recommend with conditions.  We appreciate the importance of this measure concept; however, structural measures can be burdensome to implement.  CMS should ensure the measure can be implemented without undue burden prior to implementation.  We note CMS is considering a number of structural measures.  We recommend a parsimonious approach to the use of structural measures to ensure measurement resources are used efficiently.  CMS should also work with hospitals to confirm implementation of this measure translates into improvements in patient safety. 

Recommend with conditions.  We appreciate the importance of this measure concept; however, structural measures can be burdensome to implement.  CMS should ensure the measure can be implemented without undue burden prior to implementation.  We note CMS is considering a number of structural measures.  We recommend a parsimonious approach to the use of structural measures to ensure measurement resources are used efficiently.  CMS should also work with hospitals to confirm implementation of this measure translates into improvements in patient safety. 

Recommend with conditions. We appreciate the importance of this measure concept; however, structural measures can be burdensome to implement.  CMS should ensure the measure can be implemented without undue burden prior to implementation.  We note CMS is considering a number of structural measures.  We recommend a parsimonious approach to the use of structural measures to ensure measurement resources are used efficiently.  CMS should also work with hospitals to confirm implementation of this measure translates into improvements in care for geriatric patients.

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. 

Recommend. This measure addresses an important patient safety concept.

Recommend. This measure addresses an important patient safety concept.

My name is Col Steven Coffee. I am an active duty military officer, husband, and parent but I write today as a Patient Safety activist and founding member of   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.
My journey and interest in patient safety is related to experiences my son (Steven II) experienced in the healthcare system.  At the tender age of with weeks old Steven II had a liver transplant due to diagnostic error and what I recognize now as gaps and seams in our health care system.   I firmly believe this change in our approach to care and measures is a fundamental moral and ethical responsibility the collective we (consumers, providers, and administrators/oversight) have 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.  As renowned organizational improvement expert Peter Drucker quipped  “You can't manage what you can't measure”, 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.

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