Since the creation of the Value-Based Payment Modifier (VM) in the 2010 Patient Protection and Affordable Care Act as an early foray into pay for performance, Congress has taken many steps toward tying payments to the value of care. When Congress started to consider how best to replace the failed cost containment measure known as the sustainable growth rate formula, these efforts were a logical and convenient starting point to construct a replacement. Policymakers believed that their strategy to reduce the growth in spending by imposing caps on payments and blanket restrictions had failed. The new congressional strategy is to shift payment incentives away from growth in the volume of services and toward the provision of high-value care.
The QPP’s shortcomings
The development and passage of the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act (MACRA) in 2015 was seen as an important opportunity to tie Medicare payments more closely to the quality and cost (value) of care. It also provided the chance to reduce burden by streamlining the Centers for Medicare & Medicaid Services (CMS) legacy programs, including the Physician Quality Reporting System (PQRS), VM, and the EHR (electronic health record) Incentive Program (meaningful use) into a single program.
At the time, many stakeholders welcomed this new opportunity for CMS to modernize the mechanisms for measuring and incentivizing better quality of care at a lower cost. However, it is evident that the brief time frame for implementation, as well as a lack of opportunities to test new methods to meaningfully measure surgical care, have led to unforeseen challenges in attaining these goals. CMS is having difficulty reducing burdens associated with participating in the Quality Payment Program (QPP) while making quality measurement more meaningful to patients and clinicians. Because of this challenge, Congress and other stakeholders have begun looking for ways to aid CMS in its task of achieving value-based care.
Although MACRA allowed for new opportunities to define and measure quality in the QPP (the name CMS chose for its MACRA implementation initiative), CMS has relied heavily on defining quality based on the PQRS measures for use in the Merit-based Incentive Payment System (MIPS). These measures are inappropriate for the QPP because they lack rigor and were not created for benchmarking physicians in a value-based program. MIPS is designed to tie fee-for-service Medicare payments more closely to the value of care across four categories: Quality, Cost, Improvement Activities, and Promoting Interoperability. Both MIPS and Advanced Alternative Payment Models—the other pathway for physician payments under MACRA—require that reimbursement be adjusted based largely on the quality of care.
Additionally, the current MIPS measures are ill-suited for a program intended to incentivize the improvement of surgical quality because they are misaligned with surgical care models. The QPP is designed around how services are paid using aspects of claims data, which are a poor proxy for quality. QPP reporting is based on a clinician’s or group’s tax identification number, resulting in fragmented measures that do not always map to the patient.
The QPP also does not track with how patients experience care across a surgical episode. In clinical practice, an episode of care typically involves many clinicians from multiple specialties providing a number of coordinated services as a team of clinicians and providers. Because the MIPS framework follows the siloed nature of fee for service, physicians are adhering to MIPS requirements in a perfunctory manner in order to receive payment or avoid a penalty, rather than to enhance the quality of care that the team provides to a patient. Differentiating physicians with check-the-box measures that lack rigor neither informs care decisions nor compels quality improvement efforts, thus missing the intent of MACRA to drive value. In other words, retrofitting piecemeal disaggregated metrics for payment purposes fails to first recognize the major tenets of building a quality model. For a quality model to fit in an incentive payment program, it must first define the care required, and then define the points across time within the model to apply metrics. A model designed around time-based metrics will drive optimal care by rewarding overall performance.
Use of primary care measures
Congress clearly intended that quality measurement in MIPS would provide the information necessary to reward the provision of high-quality care and to drive improvement efforts. However, most surgeons are ranked based on measures in the CMS Web Interface or the Accountable Care Organization (ACO) Web Interface, which evaluate large group practices’ compliance with primary care services, such as immunizations, blood pressure control, diabetes control, and tobacco cessation. These measures are important gauges of a patient’s overall health but are unrelated to episodes of surgical care. They also do not provide the information surgeons need to improve care, including critical patient safety indicators. Large, multispecialty groups choose to report the CMS Web Interface measures because of the relative ease in reporting requirements. This is counter to the intent of MACRA, which includes the following provision:
Ensuring comprehensiveness of group practice assessment: The process established under clause (i) (related to group measurement) shall to the extent practicable reflect the range of items and services furnished by the MIPS eligible professionals in the group practice involved.1
This provision indicates that Congress did not intend for CMS to evaluate surgical care using primary care measures in the CMS Web Interface or ACO Web Interface.
Measures that lead to optimal surgical outcomes
Surgeons are trained to establish access to appropriate, well-structured surgical care with all the processes in place to meet the patient’s expected goals for an optimal outcome. Quality surgical care, therefore, focuses on access, structure, process, and outcomes that are based on the Donabedian quality of care framework.2 However, CMS’ Meaningful Measures initiative has sought to devalue process measures in favor of clinical outcome measures because CMS has determined that many process measures will quickly “top out,” meaning most physicians who report these measures will quickly achieve high performance.
As a result, it is hard for CMS to show variation in order to benchmark physicians for payment based on performance.3 CMS’ removal of topped-out measures may seem logical when quality is used to rank providers for payment. Yet, the College’s decades of experience in building reliable quality programs have demonstrated that to achieve better outcomes, the right process and structural measures are essential because process and structure provide the foundation for optimal care. In fact, ACS Quality Programs attempt to identify and top out adherence to all critical structural aspects and processes associated with improving outcomes.
Contrary to this formula, the measures CMS considers topped out and does not value are critically important to patient safety. Identifying quality surgical care is not about one topped-out metric; it is about defining all of those processes and structural elements to ensure that the performance of the surgical team is topped out, so that patients have the best chance of experiencing an optimal outcome. True surgical quality seeks to provide surgical services with zero defects or complications and to achieve each patient’s goals.
High-value process measures are essential to coordinated surgical care and tell an important story of a patient’s continuum of care. For example, a patient preparing for an operation needs optimization of their anticoagulants, any antiepileptics, appropriate antibiotics, deep vein thrombosis prophylaxis, proper operating room positioning, appropriate surgical approach, and so forth. Each step taken to meet enhanced recovery is crucial. Informing a patient of his or her individual risk factors also is integral to preoperative planning and obtaining a patient’s informed consent.
An example of a process measure that CMS has determined is topped out and plans to phase out of the program is use of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) Surgical Risk Calculator measure. CMS policy does not value this measure, but the College maintains that every patient undergoing an operation should have access to a risk calculator that predicts the likelihood of a positive outcome. This step in preoperative planning provides an opportunity for the surgeon and the patient to engage in shared decision making, including whether an operation is the ideal form of treatment. Shared decision making does not occur commonly enough, but most patients consider it an essential part of care planning.
CMS also focuses on the use of clinical outcome measures, which are difficult to translate into payment. Decades of research and continuous quality improvement efforts have made adverse outcomes, such as surgical site infection and other complications, increasingly rare. ACS NSQIP has demonstrated that low surgeon-specific case volumes, coupled with minimal variance from one surgeon to the next, make it difficult to rely on clinical outcomes for ranking surgeons.4 Therefore, high case numbers are needed to show variation, which is very difficult to achieve at the individual level over a 12-month period, but is required for most of the QPP measures. The College agrees that it is still important to track key clinical outcomes to identify outliers, but high-value process measures and structural measures are the foundation for providing quality care and should be valued as such in the QPP. What is missing from surgical measurement is evaluating the outcome of a procedure from the perspective of the patient—that is, patient-reported outcomes (PROs).
PROMs: Allowing patients to determine success
Patient and family engagement are increasingly recognized as critical in evaluating surgical care because most surgical procedures are elective and performed with the goal of improving a patient’s well-being. Therefore, the PRO often is the best determinant of whether an operation was a success. Examples of PROs include functional goal attainment, severity of symptoms, quality of life, and/or experience with a specific condition or surgical episode. PROs can be measured using PRO performance measures (PRO-PMs) to distinguish between each provider’s quality of care.5 Because PROs can be measured across all patients, they do not pose the same statistical validity challenges seen when using clinical outcome measures to identify rare clinical events (readmissions, surgical site infection, reoperation, and so on) across surgeons. Hence, episode-based PRO measures (PROMs) could be beneficial for use in the QPP and to benchmark performance.
The Patient-Centered Outcomes Research Institute has funded an ongoing project to determine the comparative effectiveness of bariatric surgical procedures using PROMs.7 The ACS is committed to the further development of episode-based PROMs, but additional resources are needed, including a means of deploying the measures on a national scale. The ACS is conducting pilot studies in ACS NSQIP and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP®) to test the feasibility of PROs. The early findings in the NSQIP study demonstrate that a large-scale implementation of PROs using electronic measurement across a large number of operations is possible. Nonetheless, several barriers to implementation were identified, including stakeholder buy-in on the value of PROs for improving surgical care, workflow integration, and the lack of innovative technology. However, it is reasonable to anticipate that these challenges can be overcome—especially with increasingly sophisticated technologies for implementing PROs, such as computer adaptive testing based on item response theory, and improved interoperability across registries, EHRs, and other data sources.6
Standards-based verification programs improve patient outcomes
The ACS developed and published Optimal Resources for Surgical Quality and Safety (also known as the Red Book) to guide surgeons in leading surgical quality improvement and patient safety efforts in their institutions, departments, and practices. This manual builds on the four-point strategy that the College uses in all of its quality programs: establish the standards, build the infrastructure to support the standards, develop databases to measure performance against those standards, and provide external peer-review verification.8
Verification programs are intended to ensure that the resources, staff, and infrastructure are in place to provide the highest possible quality care to the patient. It is well established in the peer-reviewed literature that verification leads to better surgical outcomes. The effectiveness of accreditation can be seen in patients whose lives have been saved by receiving care at an ACS Committee on Trauma-verified trauma center.
Similarly, in the last decade, the U.S. has seen a dramatic improvement in perioperative mortality for patients undergoing bariatric surgery. The improvement is associated with more than 800 bariatric centers that have been verified through the MBSAQIP. The entire care experience linked all the team members together in their roles and contributions to optimize care. The result has been that one-year patient mortality decreased from up to 4.6 percent (1997–2000) across Medicare beneficiaries to less than 1 percent today across all patients.9,10 One study specifically demonstrated the value of accreditation for Medicare beneficiaries. In this study, 90-day mortality fell 50 percent (1.5 percent to 0.7 percent), readmissions decreased 25 percent (19.9 percent to 15.4 percent), and reoperations declined 33 percent (3.2 percent to 2.1 percent) after the implementation of the 2006 CMS national coverage decision for bariatric surgery, which required MBSAQIP accreditation.11
Nonetheless, CMS fails to recognize how high-value process and structural standards link to ensuring quality care. Key to a successful quality program is the collection of data, review of the outcomes, and use of that information to drive improvement, all within a structure that verifies the appropriate resources are available.12
Creating a meaningful surgical quality measurement system
The ACS maintains that CMS should work with stakeholders to develop measures that are more meaningful to providers, with the goal of improving the value of care. As discussed, it is important to first develop the surgical care model, then define the standards to measure the team around that care model, and track the clinical outcomes and PROs. The last step involves determining the measures that will be deployed and how they can be recognized as part of an incentive payment program. CMS should work with the ACS to develop a pilot surgical quality measurement system that includes a combination of three elements: standards-based facility-level verification programs, PRO-PMs, and traditional quality measures, such as registry and claims-based measures. These elements would provide a meaningful measurement of the quality of care provided and the actionable information necessary for improvement. Combining these three elements will provide a much clearer picture of the quality of care provided to the patient during an episode of care, including whether the procedure met patient goals.
Disbursement of MACRA measure development funding
MACRA allocated $15 million a year for five years starting in 2015 to incentivize the development of innovative quality measures. Unfortunately, the first $30 million was not awarded until late 2018, leaving a remaining $45 million that has yet to be distributed. This funding has been slow to flow to new measure development, and measures that have been funded are very limited in scope. The ACS submitted a proposal to fund the development of a value-based measurement framework to measure surgical care but funding was not granted. This money was intended to be used to help fill gaps where measures fail to meaningfully measure care delivery.
Because CMS has been slow to release these funds, major gaps in quality measurement continue to exist. For example, there is an overwhelming need for further study and development of episode-based PROs, especially considering the benefit of using PRO-PMs to distinguish individual provider performance, and for patient-centricity. The ACS believes that CMS should distribute the remaining quality measure development funds and support innovative solutions to improve the quality and value of care from the patient perspective.
Congressional action needed to achieve value-based care
The ACS has sought to educate members of Congress about the issues associated with a fragmented quality measure framework. Congress has taken note of the College’s concerns and has begun to take action. Reps. Raul Ruiz, MD (D-CA); George Holding (R-NC); Brian Higgins (D-NY); and Larry Bucshon, MD, FACS (R-IN), are leading a congressional sign-on letter to CMS encouraging the agency to work with stakeholders to develop innovative and meaningful quality measures. The letter highlights concerns with the present framework and emphasizes the need to drive value-based care as Congress intended in MACRA. Perhaps with additional oversight and direction from Congress, CMS will shift implementation to align with Congress’ original intent.
To ensure that MACRA is being implemented appropriately, key congressional committees have convened hearings over the last several years at which the ACS has either testified or submitted a statement for the record. Most recently, Frank G. Opelka, MD, FACS, ACS Medical Director for Quality and Health Policy, Washington, DC, testified at a May 8 Senate Finance Committee hearing. Dr. Opelka provided the College’s perspective on the status of MACRA implementation, highlighting the problems with the current MIPS measurement framework and focusing on how to achieve the shared goal of improving quality of care.
Next steps for defining surgical quality
It is evident to the nation’s surgeons and the ACS that patients have limited knowledge about surgical quality, and understanding the value of surgical care remains constrained by the approach payors use to define value. In the 20 years that have passed since the Institute of Medicine released To Err Is Human, policymakers should have recognized that the current approach is indeed an error.13 It is time to step back and rethink surgical quality in the QPP.
The ACS approach to quality improvement in surgical domains such as trauma, cancer care, and obesity care through verification programs and risk-adjusted, clinical outcomes has proven effective. PROMs are growing in their availability but require further development and study. It is time for policymakers to express surgical value by combining these elements of surgical care into a program that ensures the best efforts to account for structural standards and processes of care within each of the surgical domains. This program should encompass enriched clinical data sets for risk-adjusted outcomes to be measured within a surgeon’s workflow with support from health information platforms (EHRs and registries) to reduce the excessive burden created by the current fragmented system. Episode-specific, procedure-specific PROs should play a dominant role in this measurement framework. Together, these elements should form a team-based composite that defines the value of care patients receive from the entire team in shared accountability and includes the patient’s voice.
References
- Medicare Access and CHIP Reauthorization Act of 2015. Available at: www.govinfo.gov/content/pkg/PLAW-114publ10/html/PLAW-114publ10.htm. Accessed May 28, 2019.
- Donabedian A. Evaluating the quality of medical care. Milbank Memorial Fund Q. 1966;3:166-206. Reprinted in Milbank Q. 2005;83(4):691‐729.
- Centers for Medicare & Medicaid Services. Quality Payment Program Year 3 (2019): Final Rule overview. Available at: www.ama-assn.org/system/files/2018-11/medicare-payment-macharris.pdf. Accessed April 30, 2019.
- Quinn CM, Bilimoria KY, Chung JW, Ko CY, Cohen ME, Stulberg JJ. Creating individual surgeon performance assessments in a statewide hospital surgical quality improvement collaborative. J Am Coll Surg. 2018;277(3):303-312.
- Basch E, Spertus J, Dudley RA, et al. Methods for developing patient-reported outcome-based performance measures (PRO-PMs). Value Health. 2015;18(4):493-504.
- Liu JB, Pusic AL, Matroniano A, et al. First report of a multiphase pilot to measure patient-reported outcomes in the American College of Surgeons National Surgical Quality Improvement Program. Jt Comm J Qual Patient Saf. November 2018 [Epub ahead of print].
- Greene M, Goldman R, Chang D, Hutter M. The development of patient-reported outcomes for national implementation in the MBSAQIP lessons learned from the PCORI funded LOBSTER PROMs alpha pilot. Poster session presented at the ASMBA 34th Annual Meeting at Obesity Week 2017 Abstracts, Washington, DC, October 2017. Available at: www.soard.org/article/S1550-7289(17)30732-3/fulltext. Accessed May 21, 2019.
- Hoyt DB, Ko CY, Jones SR, Cherry R, eds. Optimal Resources for Surgical Quality and Safety. Chicago, IL: American College of Surgeons; 2017.
- Flum DR, Salem L, Elrod JA, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA. 2005;294(15):1903-1908.
- Nguyen NT, Hohmann S, Slone J, Varela E, Smith BR, Hoyt D. Improved bariatric surgery outcomes for Medicare beneficiaries after implementation of the Medicare national coverage determination. Arch Surg. 2010;145(1):72-78.
- Flum D, Kwon S, MacLeod K, et al. The use, safety and cost of bariatric surgery before and after Medicare’s national coverage decision. Ann Surg. 2011;254(6):860-865.
- Nguyen NT, Blackstone RP, Morton JM, Ponce J, Rosenthal R. Quality in bariatric surgery. In: The ASMBS Textbook of Bariatric Surgery. Volume 1. New York, NY: Springer; 2014.
- Institute of Medicine Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press; 2000.
