August 15, 2018 The Honorable Mike Kelly The Honorable Ron Kind U.S. House of Representatives U.S. House of Representatives 1707 Longworth House Office Building 1502 Longworth House Office Building Washington, D.C. 20515 Washington, D.C. 20515 The Honorable Markwayne Mullin The Honorable Ami Bera, MD U.S. House of Representatives U.S. House of Representatives 1113 Longworth House Office Building 1431 Longworth House Office Building Washington, D.C. 20515 Washington, D.C. 20515 Re: Health Care Innovation Caucus RFI on value-based provider payment reform, value-based arrangements, and technology integration. Dear Representatives Kelly, Kind, Mullin and Bera: On behalf of the more than 80,000 members of the American College of Surgeons (ACS), I would like to thank you for the opportunity to provide information on innovative solutions to increase the value of health care. As you may know, the ACS was founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice, and we look forward to working with the Health Care Innovation Caucus ( Caucus ) to find novel solutions to many of these issues. ACS has been at the forefront of surgical quality measurement and improvement for more than 100 years. When the ACS journey began many decades ago, we had as many hospitals as we have today in America. The early hospitals, however, had fewer beds and lacked consistency in surgical care and quality. Our answer was to develop care standards for every surgical facility. The result of these efforts greatly improved surgical care. Ultimately, our program spread throughout medicine and became the independent accrediting body known today as the Joint Commission. The ACS commitment to clinical standards did not end there. Over the last half century we have created the national ACS Trauma verification program. All too often people are critically injured and immediately seek care at a Level I trauma center because of their proven quality. In the last three decades we have developed new additions including the National Surgical Quality Improvement Program (NSQIP), Bariatric, and Cancer accreditation programs.
In the last year, the ACS published a new manual, entitled Optimal Resources for Surgical Quality and Safety, which describes key concepts for developing standards in quality, safety, and reliability, and explores the essential elements that all hospitals should have in place to ensure patient-centered care. Publication of this manual (commonly referred to as the Red Book ) further reinforces ACS commitment to high-quality and coordinated care. The ACS supported the legislative counterpart to these efforts: Congress passage of the Medicare Access and CHIP Reauthorization Act (MACRA), which promoted innovative quality and cost measures as well as the development of alternative payment models. We welcomed the legislative intent to improve care and have been hopeful the implementation of the law would promote meaningful surgical quality over the burdensome, insignificant measures used in many of the previous payment programs. Without real meaningful quality measurement, the aspirations of MACRA will fall short of achieving patient-centered quality care. For reasons we highlight below, we have concerns that the implementation of MACRA deviates from congressional intent and the ACS encourages Congress to work with key stakeholders to ensure the intent of MACRA is upheld. How can we develop better outcomes measures that accurately reflect quality, safety, and value without burdening innovation? Based on our extensive history in quality of care, the ACS has come to rely on several key principles. First, care has gotten far more complicated over the years and except for the simplest of medical problems, patients are rarely cared for by a single provider. Care involves various conditions or diseases and relies on coordinated teams of physicians and other providers in order to implement a care plan; establish short and long term goals; and actually deliver care as a team. Second, optimal care delivery requires setting standards for the cultural and structural elements of the care delivery system. Trauma standards, bariatric standards, and cancer care standards are three such examples and widely used accreditation programs exist in each of these areas. Measuring key performance indicators across the care continuum is essential. The third aspect of building optimal care relies on using data to create meaningful knowledge in the care journey. Building data systems which can support quality is a core element of the ACS infrastructure. Data must be standardized and have automated data flows from the digital health
information systems. Data must also be aggregated with intense rigor and cleaned or normalized before applying the rules engines for enriching and informing data analytics. The data provided are run through analytics with outcomes representations to the providers which can be trusted for reliability, validity and risk adjustment. These are highly technical processes in data science common to all other industries but applied only by a few medical specialties due to their costs. Yet, the knowledge gained from these efforts is incomparable. When highly reliable and valid data are used to help inform knowledge to a care team, it is never looked upon as burdensome; it is extremely important and helpful to optimizing care. The fourth principle requires digesting the knowledge gained from the data and applying improvement cycles and, where necessary, conducting research. The improvement projects used by the Centers for Medicare and Medicaid Services (CMS) and other payers are not patient-centric and lack team-based, improvement activities. A true quality program should use the key performance indicators within the organizational structure of team meetings to both define activities, such as a failure mode analysis, as well as apply improvement cycles. The current CMS and other payer quality measurement and improvement activities are payment systems which piggy-back on quality for a brief moment. We believe this is the inverse of a true patient-centered quality program. The quality program should be robust and complete, with a payment program fit to incentivize the value created by continuous quality improvement cycles. The current CMS and commercial payer claims-based measures are only useful when untoward events are uncommon or rare. The administrative claims measures used by payers otherwise are untrusted, lack usefulness and therefore, become burdensome. As the Caucus considers the issue of better measuring the quality and value of care provided, it is vital to incorporate the perspective of surgeons and surgical patients. We are best positioned to understand what elements of care are important to measure in order to evaluate quality of care and provide the information needed for improvement. MACRA, which was passed by Congress and signed into law in 2015, and is currently being implemented by CMS, created new opportunities to modernize the way we measure quality and value. However, surgical quality measurement as currently implemented in the Merit-based Incentive Payment System (MIPS) continues to suffer from the deficiencies noted
above. Furthermore, measures reported by large groups are typically related to primary care or are population-based and are not at all related to the care surgeons provide. These measures can be complex, burdensome, and frustrating as it takes time and resources away from other efforts that could have a greater impact for patients. Unfortunately, payments are adjusted in MIPS based on performance on these measures. This means that what affects payment is not directly related to what affects quality, contrary to what Congress intended upon the passage of MACRA. This is precisely why many surgeons find those measures burdensome. The right measures for quality and improvement, no matter how complex, are seen as beneficial to the patient and are therefore not a burden. While the Caucus has requested information on outcomes measures specifically, there is little variation in outcomes for many surgical procedures as judged by existing outcome measures due to decades of continuous quality improvement efforts. Therefore, outcome measures alone are not sufficient to verify that the highest quality care is made available to patients. For that reason, ACS has proposed to CMS that surgical quality measurement should include a combination of three elements: Standards-based facility-level verification programs, Patient reported experience and outcomes measures, and Traditional quality measures including registry and claimsbased measures. Combining these three elements will provide a much clearer picture of the quality of care provided to the patient, including not just the surgeon, but the entire care team. Standards-based facility- level verification programs: The importance of setting standards at the facility level to achieve quality outcomes cannot be overstated. Our experience tells us, if you put a surgeon with the highest technical skill level into an underperforming care team environment where the resources needed are not available and systems are not in place to protect the patient, that surgeon will struggle to provide the highest quality care. Conversely, if you put an average surgeon in a great care team delivery system, their outcomes are likely to improve and patients will receive better, more coordinated care. The aforementioned ACS Red Book describes key concepts for developing standards in quality, safety, and reliability, and explores the essential elements that all hospitals should have
in place to ensure patient-centered care. Publication of the Optimal Resources for Surgical Quality and Safety further reinforces ACS commitment to high-quality and coordinated care. Patient reported outcomes, or PROs : PROs are important to validate from the patient directly to ensure that their personal goals for their surgical care were met. PROs represent the views and perceptions of patients and can be extremely useful in improving patient care. These measures are the mainstay in the promotion of patient-centered care. Traditional quality measures: The ACS quality model includes traditional, claims-based or registry reported measures, primarily as an additional check to verify that quality care is being delivered. As noted above, there is so little variation in certain outcomes measures that their use may not be statistically valid due to the number of procedures performed annually vs. the large sample size that would be needed. Instead, attaining high quality care through a combination of ensuring that standards are being achieved and validating outcomes through measuring the patient s perspective on whether goals of care and other milestones are being achieved may be more reliable. However, if the correct measures are selected, and aggregated with limited effort on the part of the provider, they can be seen as informative and meaningful to physicians; and not burdensome. It is important to ensure that collection of these data enhances patient care rather than taking the focus away from what is important. Congress built into the MACRA program opportunities to improve the science of measuring physician quality. However, CMS currently has difficulty achieving the dual goal of making quality both more meaningful and less burdensome. This might be an opportunity for the Caucus and Congress as a whole to use its oversight role and work with CMS in order to meet the original intent of the law. How have population health, capitation, and direct provider contracting improved patients health? Earlier this year, ACS responded to a CMS request for information on Direct Provider Contracting (DPC). ACS noted in our response that DPC can become extremely complicated and requires safeguards to ensure quality and appropriate care is being
delivered. There are several important factors to consider for participation, for both physicians and patients, before such models should be tested. If properly structured and implemented with sufficient safeguards, DPC could be beneficial for patients who would receive more coordinated, team-based care. For providers and payers, the potential benefits of DPC would be to free up physicians and groups to practice medicine in the most efficient way possible, while providing additional opportunities for savings due to administrative burden reduction and a shift away from the incentives of a fee-for-service (FFS) based payment system. There is also a great deal of opportunity for the development of fully capitated models, although current models lack sufficient, granular information for them to work well for many specialties other than primary care. With additional development, including episode-based resource use and quality measurement, these models could work well and be a game changer for payment in health care. In developing the ACS-Brandeis Advanced Alternative Payment Model (A-APM), the ACS has learned much that could be applied to a specialty or condition specific DPC or capitated models. For example, when broken into coherent episodes of care that look at the entirety of the services received by the patient, wide variations in cost, services, number of providers involved, and other factors exist in CMS claims data. These variations may be due to multiple factors including patient differences, geographic practice patterns, variations in care models or even errors in coding. The ACS views DPC as a form of an APM. In DPC, various functions of the insurer are transferred to the physicians in signing a provider contract agreement. In traditional FFS agreements, insurers use vehicles such as prior authorization to restrict unnecessary services and assure patients that they will receive the right care at the right moment for the right reason, to the greatest extent possible. With DPC, processes would need to be developed to assure that patients continue to receive appropriate care. As the Caucus considers this issue, it will be important to understand how CMS will replace the current care authorization models with new models under DPC. A robust quality assessment framework, such as the one mentioned above, would also be necessary to enable patients to make informed decisions about who to contract with. Tools such as the Episode Grouper for Medicare or EGM which was developed by Brandeis University under contract with CMS and utilized in the ACS-Brandeis A-APM, allows claims to be grouped into meaningful, patient-specific episodes for comparison and analysis. This type of tool could be useful in both MIPS and APMs including DPC or capitated models, to provide insights into opportunities for improving the value of care and reducing unwarranted variation. As an example, the
EGM logic portrays physicians according to one of several categories, inspired by how CMS attributes care, but based on the provider s specific role for that patient. For patients, all services contribute to their overall care as well as the overall episode cost. The figure below demonstrates how a colon resection for cancer has large variations in the sheer number of physicians providing services to the patient, from as low as 1 service to as many as 63 different tax IDs. Providing this level of transparency in variation creates opportunities for improvement. ACS is currently working with several partners to explore options to provide the EGM as a public utility to create a standard for cost measurement across payers. We would welcome the opportunity to further discuss steps needed to make this tool available with members of the Caucus. How can Congress help the Centers for Medicare and Medicaid Innovation Center achieve its purpose of developing and testing innovative payment and delivery models? Congress has now made the transition from its legislative role to one of oversight to ensure that the MACRA law is being implemented in the best interest of Medicare patients, and as the law was intended. This is important because, unfortunately, actions taken by CMS and Health and Human Services (HHS) since the passage of MACRA may not be sufficient to take us to
our shared end goals. While some of these actions may have been well intentioned and taken in the name of reducing reporting requirements or reducing overall burdens of participation, others seem counter to the very spirit of the law, such as the failure to move forward on any of the APMs reviewed by the Physician-focused Payment Model Technical Advisory Committee (PTAC). Congress attention and guidance are needed to ensure the law is implemented correctly so that physicians who are providing high quality, high value care to their patients are able to succeed. Specifically, CMS Centers for Medicare and Medicaid Innovation Center (CMMI) needs additional guidance from Congress at this point to ensure that the intent of moving the physician payment system toward quality and value through APMs is upheld. While APMs hold great promise in transferring patient care from a fee-forservice model to one of team-based, patient-focused, quality care, CMMI has shown a reluctance to be truly innovative. The health care community has rallied to meet Congress challenge to develop new physician-focused models. As of August, the PTAC has received 27 proposed new models for consideration. Fifteen of these models have been reviewed by the PTAC with recommendations sent to the Secretary of HHS. Ten of these were recommended favorably for testing or implementation, including the ACS- Brandeis A-APM which was the first submitted to the PTAC. However, no action has been taken to test or implement any of them. In fact, Secretary Azar, in a single letter, recently declined to move forward on the testing of eight of these PTAC-recommended models. Instead, CMMI seems focused on creating new versions of preexisting CMS models such as the Bundled Payments for Care Improvement Advanced (BPCI) or the Accountable Care Organization (ACO) Track 1+. MACRA payment incentives and the establishment of PTAC clearly incentivize the development of and participation in APMs. ACS and others have recognized the value of creating such models and have expended significant time, effort and resources in doing so. Our experience with the PTAC was a positive one and has helped greatly in refining the ACS-Brandeis A-APM, and our thinking on A-APMs, as well as informing our positions on quality and cost measurement in team-based health care. However, the disconnect between the PTAC recommendation process and the testing of new models by CMMI is a significant barrier to innovation. While we believe there is great merit in the move toward A-APMs and plan to continue work on developing core concepts of the ACS-Brandeis A-APM, it is unfortunate that the input from the broader health care community has not led to the implementation of
physician-built APMs by CMMI. As this process continues, additional guidance may be necessary in order to achieve the move to episodic and, ultimately, capitated APMs. How can Congress and other policy-makers move beyond EHRs to the promise of digital health information? Health Information Technology (HIT) could have a significant impact on value-based payment models and the overall quality and efficiency of care if it were implemented in such a way as to create a truly interoperable patient digital health information environment where data could flow freely to where it is most needed to inform care decisions. Past congressional efforts have been successful in spreading the adoption of electronic health records (EHRs) technology among providers but have been too focused on this single tool. We need to look beyond EHRs to fully attain the promise of digital health information. Patients do not commonly exist in a single EHR. Oftentimes a patient will see different clinicians for outpatient care, visit an ambulatory care center, be admitted to skilled nursing, seek care at home or require hospitalization. All of those sites of service have their own digital records. Personal health devices on smart phones and smart watches represent some of the other repositories containing valuable health information. It is important to move the conversation from talking about EHRs to considering a patient s individual digital health information in a patient cloud. The technology is available; the patients and clinical community are working toward this effort. However, the EHR community and many different government agencies such as HHS, CMS, the National Institutes of Health (NIH), the Agency for Healthcare Research Quality (AHRQ), the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA), among others, each have their own idea about who should set standards and how those standards should be implemented. It is only through a single set of standards that we will fully achieve the ultimate patient cloud for optimal care. These interoperability standards would assist in the development of patient and clinical care application programming interfaces (APIs). They would facilitate clinical analytics from registries and move the nation closer to machine learning and artificial intelligence.
It is vitally important that we move our focus on digital health information to interoperable digital services through standards and technology rather than overly focusing on EHRs. In conclusion, the ACS appreciates the opportunity to provide comments on innovative solutions to increase the value of health care. In the years since the passage of MACRA, we have sought to leverage our decades of experience to inform the rule making process. While some of our suggestions have been adopted, much is left to be accomplished and Congress attention to this matter is welcome and extremely important. If the promise of MACRA in moving physicians to more streamlined, value focused payment models in MIPS and ultimately in A-APMs is to be accomplished, continued effort on the part of both Congress and the provider community will be needed. If you would like to further discuss any of the concepts included in this letter, please contact Mark Lukaszewski, at mlukaszewski@facs.org or at (202) 672-1509 Sincerely, David B. Hoyt, MD, FACS Executive Director