Sarah Mossburg: Thank you for being here with us today. Can you please tell us a little bit about yourself and your current role?

Michelle Schreiber: I am the Deputy Director of the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS). I am also the Group Director of the Quality Measurement and Value-Based Incentives Group (QMVIG) within CCSQ. By background, I am a primary care physician who spent many years practicing medicine in the City of Detroit. I have also served in roles of chief quality officer and chief medical officer in several large systems and implemented many electronic medical record (EMR) initiatives in those roles.

Sarah Mossburg: Can you please tell us more about your department and your group within CMS and its role in improving patient safety?

Michelle Schreiber: CCSQ is the clinical and quality center, to a large degree, of CMS. Within CCSQ are multiple programs to support quality healthcare. These include Conditions of Participation; surveys and certification; regional medical offices; quality measurement, many of the value-based programs that we use for assessing performance; and the Quality Improvement Organization (QIO) networks, a provider engagement group, and information technology to support these programs. CCSQ works collaboratively across all centers in CMS including Medicare, Medicaid, the Marketplace and the Innovation Center to help ensure the highest-quality, best safety for all our beneficiaries, and for all Americans, as CMS is a major voice when it comes to healthcare in this country. In addition, CMS works closely with many other Federal partners such as Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), Food and Drug Administration (FDA), the Department of Veterans Affairs, and the Department of Defense to advance quality and safety.

The Quality Measurement and Value-Based Incentives Group (QMVIG) that I lead is responsible for many of the quality measures and value-based quality programs that are used within CMS. We develop or maintain measures ourselves or utilize measures developed by other “measure stewards” who own measures and are responsible for maintaining them. For example, AHRQ is an important measure steward for some patient experience measures and the patient safety indicators that are used by CMS. We, along with the guidance of multiple stakeholders (e.g., patients, clinicians, health care facilities, health plan providers, and many other organizations) make selections of what measures will be used in the various value-based programs. The National Quality Forum and the Measures Application Partnership provide important recommendations regarding use and removal of measures in many CMS programs as well. QMVIG also operationalizes the Medicare fee-for-service value-based quality programs, which are generally statutory (developed through specific legislation). The programs cover almost all facilities, including post-acute care from skilled nursing facilities, home health, and hospice; many hospital programs (such as the Hospital Readmission Reduction Program, the Hospital-Acquired Condition Reduction Program, the Hospital Value-Based Purchasing program, the dialysis programs, the inpatient psychiatric facility programs, the cancer programs); and clinician programs through the Merit-based Incentive Payment System, in which nearly a million clinicians across the country participate in quality programs.

Why are these important? These programs hold organizations accountable for quality and safety and make performance transparent to the public. These are the measures that people often track, are publicly reported, and link payments and penalties to performance (or lack of performance) around quality and safety. These programs have been influential in driving quality across American healthcare. Many people look to our websites, including the Care Compare sites, which provide performance measure information for public transparency so that consumers can make best informed care choices. Our Star Ratings are a simple way of rating many measures together. We have had great impact on quality and safety and are very proud of these many efforts.

Sarah Mossburg: Thanks for sharing, I agree. CMS has led the way in a lot of those areas. Recently you and some colleagues from CMS and the CDC published an article about healthcare quality and safety during the COVID-19 pandemic and beyond. Could you share with us your thoughts on how patient safety has improved in the past 10 years and how it shifted during the pandemic?

Michelle Schreiber: Over 20 years ago, To Err is Human and Crossing the Quality Chasm were released by the Institute of Medicine (now the National Academy of Science, Engineering and Medicine). Those reports pointed out how much room we have for improvement in quality and set forward the basic framework for quality: safe, timely, effective, equitable, efficient, and patient-centered care. Much work has been done in the past two decades to improve both quality and safety. There were indeed many gains made in the past 10 years—improvements in healthcare-acquired infections, decreases in patient falls, pressure ulcers, and other complications. But during the pandemic, we lost ground. Some of our patient safety metrics have lost almost all of the improvement ground that they had made.

We know that patient harm is still all too common. A recent report by the Office of the Inspector General (OIG) outlined that from 2010 to 2018, the percentage of Medicare patients who experienced harm did not decrease all that much. Their report noted that around 25% of all Medicare beneficiaries experience harm. Our concept of harm has grown, as we count more things now as harm. Nonetheless, it is sobering that the OIG finds even pre-pandemic, we still had a lot of opportunity to improve patient safety. However, another report, published after the OIG report, did demonstrate overall improvements that were made in patient safety pre-pandemic.

During the pandemic, however, the CDC’s data show that healthcare-associated infections went up, so we are losing some of the progress that had been gained. Falls and pressure ulcers also went up – in skilled nursing facilities, we saw rates of falls causing major injury increase by 17% and pressure ulcers increase by over 40%. There are many explanations for these increases — including COVID-19 itself. Patient’s conditions were more complicated; many patients stayed on ventilators or in intensive care units for a long time.

Nonetheless, the take-home message is that systems of safety did not endure and that we need to recommit our efforts on patient safety to create deep systems of patient safety. By that I mean highly reliable and resilient systems, making sure that known best safety processes are being followed, making sure that leadership and governance is clearly involved in patient safety, and making sure there is appropriate workforce and staff who not only understand what has to be done for patient safety, but are given the time to do it within a culture of safety, where they feel they can speak up (report errors or issues) without fear of retribution, and where the workforce itself feels safe from physical and psychological harm.

Sarah Mossburg: Yes, and we see that in the CMS National Quality Strategy that you released this year. It has a specific goal around promoting safety and preventing harm or death from healthcare errors. Can you give us some examples of some of the work CMS is undertaking?

Michelle Schreiber: CMS has been developing our CMS National Quality Strategy, one of the Agency cross-cutting initiatives, which also brings together quality activities that are being done across the Department of Health and Human Services and the federal government. We released the CMS National Quality Strategy at the CMS Quality Conference in April and it has eight major goals.

The first goal is to ensure quality and best outcomes across the entire patient care journey for all individuals — so, from the patient's point of view, no matter where they are in their journey, and no matter what age, ensuring that there is seamless care that is high quality, safe and coordinated.  We are looking to benchmark a select small number of fundamental quality measures to global benchmarks because we also recognize that, sadly, the United States has some of the lowest healthcare quality rankings among industrialized nations. We are focused on several key clinical areas in particular such as improving quality for maternal health, behavioral health, kidney health and organ procurement programs, nursing homes and long-term care, and prevention and wellness, among others.

The next key commitment is to equity. This is an important priority of the Biden administration, as well as the right thing to do. Certain disadvantaged populations have had higher mortality rates and suffered even more in the pandemic, for example, and inequities and gaps in care have been identified across the healthcare ecosystem. We need to ensure that we have high quality, safe healthcare that is equitable for all individuals and enables each person to achieve their maximum potential health.

The third goal of the national quality strategy is our recommitment to patient safety including supporting systems of safety and ensuring that organizations and providers are implementing known best practices. Workforce safety is part of patient safety. I would point out the Institute for Healthcare Improvement work, assisted by AHRQ, on the National Action Plan to Advance Patient Safety and the World Health Organization’s Global Patient Safety Action Plan. These reports have laid out many action steps that we know we can be taking. Following these recommendations would lead to improved safety.

Engaging persons and involving individuals, patients, caregivers, and their families, in having a voice in their healthcare is the next goal. We are committed to having more patient-reported outcomes measures directly reported from patients. For example, if you had a surgical procedure, did you actually feel better? Were you able to function better? Those are important questions, and we do not ask them often enough. Another patient safety initiative is ensuring that individuals have access to their medical information. Patients may see errors while reviewing their own medical information and may be able to make suggestions for correction. We believe it is important that patients have a role in patient safety, including sitting on governance committees or ensuring the patient stories are heard at leadership meetings. Organizations should ideally also have robust communication and resolution programs for when errors occur, as well as consistent and robust error identification and improvement systems. Finally, care and information must be delivered to individuals in a manner that is understandable in a cultural and language appropriate manner.

The fifth goal is around digital measures. CMS has a commitment to all measures eventually becoming digital. There is a lot of work to be done and we recognize that this will take time. However, we all know that healthcare requires data which is timely and interoperable; we certainly learned that during the pandemic. We needed to know who was immunized, what organizations had capacity, and what supplies were available. The only way to manage the immense amount of data in healthcare is through interoperable digital data systems. Our goal is to transform quality measures to digital, where measurement data becomes a byproduct of clinical workflow. This also allows the transition from primarily chart-abstracted or claims-based measures to including the rich clinical detail that data in the EMRs have.

Other goals of the CMS National Quality Strategy include one around scientific innovation and making sure that we always support scientific innovation, such as advanced analytics. We also have a goal to advance resiliency in the health care system, which has been a big lesson of the pandemic. There have been many workforce issues during the pandemic related to burnout and people leaving the professions. We need to be prepared for future challenges as well.

The last goal of the CMS National Quality Strategy is alignment. We recognize that over time the quality ecosystem has gotten confusing. There are a lot of measures and a lot of reporting programs. Sometimes measures are just slightly different from one program to another. If you are a system, you have to report each of those measures differently. I was previously the Chief Quality Officer at a major healthcare system, and I used to have a large Excel spreadsheet of 650 measures that we had to report. Some of them were just a little bit different. Measures are fundamental in driving performance but we aim to simplify and harmonize quality measures and reporting. We have a goal to improve alignment, not only within and across CMS, but also with our federal partners such as CDC and AHRQ. We also have an active alignment initiative with the Core Quality Measures Collaborative with the National Quality Forum (NQF) and AHIP (formerly America’s Health Insurance Plans) to align quality measures across all payers.

We are very excited about the CMS National Quality Strategy. We introduced it in April. We are seeking stakeholder comments and holding a series of stakeholder listening sessions. We will develop objectives, key results, and specific action steps that we believe will advance healthcare quality, safety, and equity.

Sarah Mossburg: That's great. Thank you so much for walking us through CMS’ National Quality Strategy. You just touched on the significant number of metrics for measuring patient safety that are collected across various healthcare settings. We would love to get some more of your thoughts on measurement as part of this conversation. Can you give us an overview of how CMS measures and tracks patient safety?

Michelle Schreiber: Yes; as part of our overall measurement strategy, we have the Meaningful Measures framework  to identify the important topics in quality and safety. The framework tracks very closely to our National Quality Strategy and patient safety is prominent among these domains. Within each of the domains, we have broken out cascades of measures that look at specific focus areas, including healthcare-acquired infections, complications, medication safety, safety of the EMR, patient falls with injury, and pressure injuries.

An emerging category of safety that I think is important is ambulatory safety. Many of the safety measures are hospital-centric, but we know that the majority of care happens outside the hospital. Errors happen in the ambulatory setting, in the home care setting, and in other facility settings. A newer area of safety focus is diagnostic accuracy especially in ambulatory settings. We know that there are errors made in the accuracy of a diagnosis, and the follow-through with the diagnosis. For example, how do we assess a nodule that is incidentally found on a chest x-ray yet not followed up and is now advanced lung cancer. How do we prevent that?

Traditionally, we have had a lot of measures around healthcare-acquired infections. That has been important because people die from healthcare-acquired infections, but we need a broader lens. The OIG report that I referenced earlier shows that there is still a great deal of harm occurring but that a lot of the harm was not captured in the various quality measures that we have. The OIG recommended that CMS develop additional quality measures to capture more types of common harm.  

In fact, we have been doing just that and have recently released new digital measures for common harms. Last year, we introduced two new electronic clinical quality measures (eCQMs) for glycemic control. This year we introduced another eCQM around opioid safety. We have several eCQMs that are in the pipeline so that we can make sure that we are capturing as many of those common harms as we can. We are looking to try and capture them electronically whenever we can. Electronically is important for a number of reasons; one is the robust clinical information from an EMR. But also, it can serve as a trigger tool for an organization; organizations can have almost immediate feedback on their electronic measures. There are some organizations in the country that have developed electronic trigger tools that are looking on a daily basis of what harm, or what even pre-harm, is occurring so that harm can be avoided. For example, we know that having femoral catheters can lead to more central line infections. Organizations can create a trigger tool to look through their EMR and identify what patients have femoral catheters in place. Then, if it is appropriate, remove them, or change them, to prevent central line-associated bloodstream infections from happening. Those electronic trigger tools are an incredible step forward in how we can improve safety and prevent harm. Finally, as noted earlier, we are seeking more safety measures that are patient reported or patient reported outcomes.

The last thing I want to mention is establishing the systems of safety and those key tools of high-reliability organizations that we have learned from different industries such as aviation and military. There are best practices on how to embed safety deeply in an organization so that safety practices are durable, sustainable, and part of every process. There are many lessons here, including communication strategies, culture, leadership, teamwork training, daily safety huddles, safety rounds—there are many opportunities. We wish to promote systems of safety to ensure that safety remains durable, even at times of immense stress. We recognize the very special circumstances of COVID-19, including the workforce and financial stresses, yet our obligation remains to ensuring the highest quality and safest care.

Sarah Mossburg: Thinking about embedding systems approaches, how does that come together with national reporting programs? Do you think that they are helpful and related?

Michelle Schreiber: Yes, thank you so much for that question. I think that can be a very important component. Across the country, there are approximately 100 Patient Safety Organizations (PSOs). PSOs have the opportunity to look at data to see what the key safety issues are. Although they are very important, there is more that could be done. By looking at harm events and precursor events and leveraging advanced analytics, we can understand what those root causes of safety events are. We know that usually there are multiple different errors that occurred that led to the one error that affected the patient. I think robust reporting could be an important part of the national strategy on patient safety. Finally, there are likely improvements in safety that can be gained from creative technology and scientific solutions.

Sarah Mossburg: Thinking back over the last 10 years, how do you think the measurement landscape has changed versus what has stayed the same? What are measurement challenges that we continue to run up against?

Michelle Schreiber: To some degree, the measurement landscape, perhaps has not changed enough in 10 years. We still have a lot of process measures that are essentially checking a box. Did you do this screening? Did you take someone's blood pressure? That is great, but what is the outcome of the process and how is the patient actually doing? 

We are transitioning away from process measures, with much more focus on outcome measures, intermediate outcomes, and population outcome measures. For example, how are we controlling diabetes in a larger population? We measure the glycated hemoglobin and control of blood sugar. What we really want to know is what is the functional status of that patient with diabetes and how are we making sure that we are preventing long-term complications like amputation, heart disease, and blindness? Those are the kind of measures we need to move towards.

I spoke earlier about more patient-reported outcome measures. I have a personal belief that if we unleash the voice of the patient in quality reporting, we are going to see things differently. We are going to see care from their perspective. I think it will change our perception of what is quality and safe care overall and what is quality care for an individual. How do we make sure we are engaging in shared decision making, making sure that patients have a voice, that the care we are delivering actually meets the goals of the patient? We do that by shifting to more patient-reported outcome measures.

Another measurement change we will need to see is a shift to digital measures that come from the EMR or other digital sources, adding in other digital strategies such as telehealth. It does not mean the claims-based measures go away, but some measures move to become hybrids so that you have the claims plus the clinical information to provide a robust picture.

I also think that measures should, to the degree possible, reflect more than Medicare fee for service, as we often have a limited view of what quality is unless we are seeing it from multiple different lenses. We need interoperability to help us get data, no matter where care was provided. If you got your immunization at a local pharmacy, that will not necessarily be captured in the EMR where you get your care. We need interoperability to make sure that the state, your providers, your specialists know about that immunization. The interoperability of data is fundamentally important to the healthcare of the future.

Finally, as I noted earlier, we need to simplify and harmonize measures. There are those who believe there are too many measures; there are those who believe there are not enough. CMS has, over the past few years, reduced the overall number of measures. We need to ensure the right measures for the right use. We are actively working on that in our alignment initiatives. 

I think we have not changed as much as we could have or perhaps should have in the last 10 years, but we are on a trajectory of transitioning to many newer ways of thinking about and evolving measurement of quality and safety.

Sarah Mossburg: That was really great, and I have many follow-up questions and just not enough time to ask them all. My first follow-up question would be around the digital measurement piece. One of the national quality strategies is about embracing the digital age and sharing data. You have talked about the interoperability of data and I am wondering what else is part of CMS’ measure strategy and how it is transforming into a digital strategy. Could you speak to that a little bit more?

Michelle Schreiber: We have been working on our Blueprint for the digital strategy for quality and quality measures. It is a lot of work because there are many quality measures and opinions about them. The same is true when it comes to a digital strategy. CMS works closely with the Office of the National Coordinator (ONC) in doing several things that are fundamentally important.

First, there are some key paths that will promote interoperability. For example, making sure that nobody is information blocking. Making sure that people are joining ways of exchanging information, like health information exchanges or trusted exchange networks, and developing those broad policies around interoperability.

The next step is defining a data element digitally. You cannot have 20 different definitions of a data element, especially not in a binary digital world. It has to be precise. Through ONC’s United States Core Data for Interoperability (USCDI) process, work is ongoing to determine the standard definitions, the digital elements, and the way that they are reported. That has been a lot of work that ONC has led very effectively.

Following that is determining implementation of those data elements and data standards into the quality measures. How do we ensure that quality measures are compatible with being digital? Not just compatible in a way of meeting the standard data definitions, but work within the clinical workflow of the EMR that providers and facilities have now. Implementing EMRs is a challenge because an organization has to adapt their workflow and has to adapt their version of the EMR to be able to seamlessly report. Once that is done information can flow freely and there is little burden to the reporting. The process of getting there, however, is real work. Many providers feel burned out now by the EMR; they feel like they are data entry clerks. It does not have to be that way. There are opportunities to develop EMRs to be a bit more user-friendly and to configure them so that the product of the clinical work is what drives the measurement. It should be seamless.

There are numerous steps forward here. CMS has been advancing our work in digital measurement. We have tested measures using Fast Healthcare Interoperability Resources (FHIR®), the increasingly common way of digitally transmitting and collecting clinical information. Organizations are now (or soon will be) required to have FHIR API (application program interfaces) to share information.

This is a multiyear journey that requires the input of many people to achieve the long-term vision of interoperable, seamless, digital healthcare data.

As you can imagine, we have got work ahead of us, but the end product is very exciting – learning healthcare systems, in which data flows seamlessly and can be fed back quickly. These learning systems can leverage advanced analytics, machine learning, and artificial intelligence to provide clinicians with point-of-care information and to create a lifelong learning cycle that ties to clinical guidelines and to clinical decisions and support and to ongoing and iterative quality improvement. I think all of us can envision the system. It is the work now of getting there.

Sarah Mossburg: There is a lot of work to get there as you have mentioned, and it does sound like it has a substantial possibility to improve patient safety significantly. Is that right?

Michelle Schreiber: Absolutely, no question. And think about it, other industries have transformed digitally. None of us go to the bank anymore to access our accounts. You have got peer-to-peer mobile payment apps, online portals, and ATMs. None of us go to travel agents anymore to get a printed ticket handed to you for the airline. Healthcare is at the early stages of that journey of making data more interoperable and transparent, making sure that individuals have access to it, leveraging these advanced analytic tools. I think the transformation to come will be exceptional. The opportunity for improved quality and patient safety is very exciting.

Sarah Mossburg: You mentioned a journey of transformation, and one of the other follow-up questions that I had related to your earlier comments was the patient voice and engaging patients in quality and safety measurement. I would love to hear a little bit more about how CMS is integrating patient voices into the measurement strategy.

Michelle Schreiber: We are doing it in many different ways. For example, making sure that we are listening to our stakeholders, even when it comes to policy writing. By law, there is a 60-day public comment period in rule writing, and we hear comments from the public. We want to reach out and make sure that we are getting all of the voices at the table. Make sure that we are really engaging some of those voices that maybe have not been heard as much, like the smaller organizations, the rural health communities, the diverse communities, the safety net providers. It is one of our key priorities to engage a broad range of stakeholders.

The more we hear from patients, caregivers, individuals, and communities about their care, then the better we can understand care from their perspective. This is our commitment regarding quality measurement—a focus on patient safety metrics, equity, outcome measures and patient-reported outcomes. In the end, it is all about the patient and delivering the highest-quality care and safest outcomes for all individuals by ensuring that they are engaged in it.

Sarah Mossburg: I agree. Is there anything else you would like to share with us about where CMS is going next in terms of the state of patient safety and measurement work?

Michelle Schreiber: I do want to take just a moment to highlight more around equity because there are major equity issues in this country. There are some key initiatives that are in progress regarding quality measurement to support equity. One is coming to a standard definition of what data elements we should be collecting to understand gaps in equity. We do not have many of those standardized data elements. Can we effectively look at data by race, or ethnicity, or language, or many other factors? We want to make sure that we are serving all populations and all individuals. What are our data stratification methodologies for making sure that we are providing equitable care? And once we stratify data, how are we leveraging our value-based programs to provide confidential feedback reports? How are we ultimately leading to public transparency and linking payment to making sure that we are enabling all individuals to maximize their health and healthcare?

Part of our commitment in the CMS National Quality Strategy is that all of our value-based programs will have an equity component. We are very excited about this and think it is a critical step forward in ensuring that all individuals, regardless of background, get the safest and highest-quality care.

Sarah Mossburg: Thank you for highlighting that and thank you so much for taking the time to talk to us. We appreciate it.

Michelle Schreiber: It has been a pleasure to talk to you today. As you can see, this is my passion. I have been in the quality healthcare world for a very long time, and it is exciting to see many of the directions that we are all going. It is very exciting to see CMS’ leadership in this and our collaboration with many others. It takes that village, and it will take all of us to do this together.