From Pay for Performance to Collaborative Quality Initiatives: Quality Care and Implications for the Limb Salvage Center

Chronic wounds are those that do not regain normal functional and anatomic characteristics within 3 months, and they can be broadly classified into the following 4 categories: pressure ulcers, diabetic ulcers, venous ulcers, and arterial insufficiency ulcers.¹ Data indicate that chronic wounds affect 1% to 2% of the population in economically developed countries, with rates as high as 15% in certain populations, namely Medicare beneficiaries in the United States.^1,2 Patient-reported outcomes for physical functioning and pain are consistently low in the setting of a chronic lower extremity wound, which has broad implications for quality of life, mortality, and cost.³ Chronic wounds are also a significant driver of cost in the US health care system. Estimated Medicare spending for all wound types was $28.1 billion to $96.8 billion in 2014²; by comparison, in 2017, a total of $34.6 billion was spent on insulin and medication to treat diabetes directly.⁴ Diabetic foot ulcers, specifically, accounted for $6.2 billion to $18.7 billion of estimated Medicare spending for all wound types in 2014.²

Patients with persistent wounds are at increased risk for lower extremity amputation (LEA). After LEA for chronic wounds, mortality rates rise dramatically, ranging from 60% to 80% at 5 years.^5,6 Given that diabetes-related amputations are on the rise in the United States, there is cause for concern.⁷

Therefore, it is critical for wound care specialists to engage in cost and quality improvement efforts. If providers do not establish self-directed initiatives for quality provision, stakeholders with differing agendas may produce initiatives through insurance policy reform and governmental mandates that are counterproductive to patient care and surgical practices. The onus is on limb salvage providers to take the lead and outline quality measures to ensure internally driven quality care.

This review outlines the current approaches to quality assessment in the surgical management of chronic wounds of the lower extremity and highlights areas for innovation, such as collaborative initiatives. The authors also describe the use of the Donabedian model to provide quality and value to patients with chronic wounds at the authors’ tertiary limb salvage center. The aim of this review is to offer a replicable method for limb salvage specialists to apply to their practices to foster increased collaboration between caregivers across all disciplines in an effort to increase quality care assurances for patients with chronic wounds of the lower extremity.

Quality care provision has become increasingly formalized in recent years as the US health care system struggles to cope with rising costs and variable care delivery. The National Academy of Medicine (formerly the Institute of Medicine) defines quality as the “degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”⁸ Multiple measures exist, but ultimately the derivation of value can be distilled into a 2-part relationship—that is, the ratio of outcomes to cost.⁹ This ratio can be explained by the following formula: v = o/c, where v indicates value; o, outcomes; and c, cost.⁹ This approach to quality relies on 2 factors for improving surgical care delivery—improving outcomes or reducing cost.

Donabedian¹⁰ first described the framework for evaluating quality care in 1966 after identifying limitations of the sole use of outcomes (ie, assessing outcomes without the appropriate context), such as questionable relevance and validity of success. To supplement outcomes, Donabedian¹⁰ introduced the concepts of structure, the physical setting and components around which medicine is practiced, and process, the manner in which medicine is practiced. The 3 domains viewed in conjunction would provide a multidimensional approach to identifying shortcomings and difficulties in a given care model.¹⁰ Since its inception, the Donabedian framework has been augmented, notably with the addition of pertinent antecedents of care by Coyle and Battles¹¹ in 1999. This domain refers to the influence of a patient’s environment and personal characteristics in assessing outcomes. Figure 1¹⁰ outlines the Donabedian model currently in wide use for quality assessment.

With the architecture of care better illustrated, it is possible to begin to work toward a value-based care system. As mentioned above, value is achieved by improving outcomes or decreasing costs. Often, cost is best addressed by spending more on certain services to reduce the need for other, more costly, services.⁹ It is necessary to shift the focus from spending on treatment to investing in prevention, which is typically more cost-effective. However, care must be taken to avoid reducing costs if doing so would jeopardize outcomes.⁹ In the numerator of the previously discussed equation, value is dependent on results (ie, outputs), not inputs; that is, increased value is achieved via improved outcomes rather than via increased volume of services delivered, which increases costs.⁹ Although processes, structures, and antecedents can never replace outcomes, the Donabedian framework evaluates these domains and their downstream effects on outcomes and thus, on value. It is, however, the identification and implementation of appropriate, modifiable, and meaningful quality measures that remain in question.

The pay-for-performance (P4P) structure has been widely adopted throughout the United States, largely through the Patient Protection and Affordable Care Act and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), to support the shift to value-based care via reimbursement.^12,13 In the previously used fee-for-service (FFS) payment scheme, the field of wound care was especially susceptible to exploitation, given that patients require serial care episodes involving multiple, specialized procedures. In 2018, a Florida-based company that contracts with various hospitals to provide wound care services was fined more than $20 million for billing Medicare for overused and medically unnecessary hyperbaric oxygen therapy.¹⁴

With the establishment of the Quality Payment Program in 2015 by the Centers for Medicare and Medicaid Services (CMS) under MACRA, all eligible Medicare Part B FFS providers are required to participate in 1 of 2 P4P financial pathways—the Merit-Based Incentive Payment System (MIPS) or Advanced Alternative Payment Models (APMs)—or else incur financial reimbursement penalties.¹³ In the performance period beginning January 2017, 83% to 90% of providers did not qualify for an Advanced APM and were required to participate in MIPS.¹³ The MIPS was established with the intent of driving FFS providers away from inferior and expensive practices while rewarding them for offering quality care. However, implementation of MIPS has been largely punitive, with penalizing of institutions that do not achieve a certain performance threshold. For the 2019 performance period, the performance threshold to receive a neutral payout was doubled (15–30 MIPS points), with a maximum 7% penalty levied against underperformers.^15,16 For the 2020 performance period, the threshold was increased by half (45 MIPS points), with a maximum 9% penalty.¹⁷

Historically, P4P programs have not driven quality care as intended. Before implementation of MIPS, CMS launched a 6-year program, the Premier Hospital Quality Incentive Demonstration (HQID), to demonstrate the efficacy of a P4P system.¹⁸ However, an early study on this initiative demonstrated a lack of evidence supporting a decrease in 30-day mortality among participating hospitals.¹⁸ More recently, a systematic review of P4P systems in high-income countries (United States, United Kingdom, France) did not find significant improvements in patient outcomes, quality of care, health equity, or resource use, which suggests the current landscape to be insensitive to financial incentives.¹⁹

Thus, P4P has become a misnomer for pay for compliance (ie, rewarding adherence to processes rather than rewarding superior results).²⁰ There are many limitations to P4P, as Porter and Teisberg²⁰ have described, including insensitivity to financial incentives and no guarantee of improved outcomes. Adherence to set processes creates the wrong incentives and may discourage innovation by leading providers who are instructed to conform.²⁰ From a P4P perspective, a focus on process adherence is undermined by patient heterogeneity and the multidimensional nature of processes.²⁰ Instead, a focus on process improvement rather than on adherence may be a superior approach to achieving high-value care.

Specialists in the field of wound care can take lessons from colleagues in other specialties. The Society of Thoracic Surgeons (STS) was the first professional society to create a specialty database to track patient outcomes, which drove the creation of national standards of care.²¹ That initiative was spurred by the unchecked reporting of the Health Care Financing Administration (the predecessor of CMS), which published death rates from 1986 to 1993 that were criticized for inadequately adjusting for risk. In response, the STS published their own database in 1989 and published risk-adjusted models in subsequent years.²²

More recently, several national clinical and administrative databases focusing on outcomes and cost improvement have been developed for stakeholders to assess quality on a nationwide scale. The National Surgical Quality Improvement Program (NSQIP) from the American College of Surgeons (ACS) and the Nationwide Inpatient Sample (NIS) from the Healthcare Cost and Utilization Project (HCUP) are two such registries. These databases have been instrumental in mapping the current health care landscape in the United States on a macroscopic level. Each database has numerous limitations, however, which prevent a detailed analysis of any one condition or factors affecting outcomes and costs. For example, NIS does not record complications after discharge for the indexed admission, and the cost of stay is not itemized for in-depth analysis.²³ Neither NSQIP nor NIS includes wound dimensions and characteristics, longitudinal assessment of comorbidities, or specific location of treatment. These limitations are especially challenging for the chronic wound specialist caring for patients who are complex, where the specialist requires long-term analysis of outcomes and cost for adequate care improvement.

Data are translated to care improvement when they are processed within a framework of appropriate quality measures, derived via the Donabedian model and other national guidelines. As Donabedian stated in 1988, “good structure increases the likelihood of good process, and good process increases the likelihood of a good outcome.”²⁴ For example, the authors’ institution has emphasized patient functionality (outcome) following lower extremity surgical reconstruction, leading to the use of standardized functional scales (process), such as the Lower Extremity Functional Scale (LEFS).²⁵ Xiong et al²⁶ performed a systematic review of relevant quality measures in foot and ankle care. Although that study was not specific to chronic wounds, it categorized quality measures via the Donabedian model and identified inequity. Of the 28 measures, 84% were categorized as process measures, while 13% and 3% were categorized as outcome and structure measures, respectively.²⁶ The validity of 1 domain cannot be deemed superior to the other because the validity of either domain relies on the inherent linkage between the 2 domains; for example, outcomes measures are only as valid and robust as the process and/or structures measures.²⁴ Furthermore, the success of one measure (eg, designing an efficient process) may be founded on the existence of another (eg, having the capable structure in place).^24,26 Of note, Xiong et al²⁶ also highlighted a research disparity between fields, identifying 28 measures for foot and ankle care in their study compared with 134 measures for upper limb care identified in a previous study.²⁷ Insufficient availability of quality measures is a limitation to supporting a value-based care model.²⁶

The authors’ limb salvage center works to rectify the current imbalance in quality evaluation and continually evaluates quality measures to improve patient care. Chronic wound care is a multifaceted process, and no individual provider is equipped to manage all aspects of it. Therefore, the tertiary limb center with which the authors are affiliated employs a multidisciplinary team of experts with a passion for chronic wound care.^28,29 A carefully designed referral pattern is used along with the reconstructive elevator model to provide specialized care in an expedited fashion while minimizing unnecessary referrals.²⁸ Dedicated operating rooms and ergonomically designed clinics have increased patient access and safety.²⁹ To minimize loss of patients to follow-up, the authors of this review have implemented a more seamless model for patient flow from the outpatient clinic to the operating room.²⁹ Judicious use of free tissue transfer and comprehensive preoperative vascular examination has allowed the authors’ center to achieve high rates of flap success (93%) and avoidance of amputation (ie, lower limb salvage [79%]) in the highly comorbid population of patients with diabetic foot.^30–32 Finally, the inclusion of patient-centered outcomes as part of the surgical goals and the use of standardized scales at the authors’ institution has resulted in high rates of postoperative ambulation and high functional outcomes scores.^25,30 The authors have previously reported a postoperative ambulation rate of 86% in patients with diabetic foot treated with free tissue transfer, with 79% of patients ambulating independently.³³

Figure 2 outlines the core factors assessed using the Donabedian model. Evaluation of antecedents, such as patient ambulation status and comorbidity status, provides a baseline for assessing the overall health and quality of life of the patient population. Acknowledgment of existing structures is necessary to accurately identify both the potential and the shortcomings of relevant infrastructure. Appraisal of workflows and other processes is important to identify areas for improvement that, if properly addressed, can result in enhanced quality care delivery. Continuous measurement of outcomes provides an endpoint for measuring overall success and guiding efforts to improve antecedents, structures, and outcomes.

Standardization of care delivery and quality provision remains elusive in the United States. The evidence supports a multidisciplinary approach to the management of chronic diabetic foot ulcers to reduce mortality and major amputation rates.^34-36 The composition of multidisciplinary teams is diverse and teams are deployed in an ad hoc manner, leading to significant regional variation in amputation rates and mortality.^34,37-39 Furthermore, inequitable distribution of limb salvage modalities has been described; receiving care at an urban teaching hospital is the strongest protective factor against amputation and the strongest predictor of salvage via other reconstruction techniques.³⁷ The vascular surgery literature has similarly reported that access to centers with high-intensity, integrated, multidisciplinary care results in reduced amputation rates.⁴⁰ When these modalities are unavailable, timely treatment may be delayed, resulting in wound exacerbation,⁴¹ and providers may find amputation to be the most practical option within their scope of practice.³⁹

With the implementation of quality assessment and standardization of care, tertiary limb salvage centers can have profound effects on outcomes measures. The success of the multidisciplinary model can be attributed to the use of teams involving multiple specialties, both surgical and nonsurgical, with designated leadership adhering to clear referral pathways, care algorithms, and treatment goals.³⁴ Hsu et al⁴² reported that after 10 years of adapting and expanding the multidisciplinary wound care team at their institution, the rate of major LEA declined from 15.27% in the period 2004 to 2009 to 6.08% in the period 2010 to 2013. A trend analysis showed major LEA for hospitalized patients with diabetes declined from 372.72 per 100 000 in 2004 to 61.74 per 100 000 in 2013.

The accomplishments at a single institution hardly constitute a breakthrough in improving health care as a whole, however. In 2006, Porter and Teisberg²⁰ theorized that the sole method of increasing value swiftly and broadly is through inter-provider competition based on risk-adjusted results, assuming these metrics become the critical driver of behavior by referring providers, health plans, patients, and providers themselves. Current systems allow best practices to be optional, with medical excellence achieved by physicians who are highly committed to their practice. Competition on results, though emphasizes that best practices be mandatory, encouraging provider collaboration, including among competitors, and the formation of quality improvement organizations. Historically, this has been accomplished in the care of patients with cystic fibrosis via the sharing of optimized protocols, which improved care universally. Ultimately, it would be necessary for competition to be unrestricted by geography, health networks, or provider groups to see true benefit. The incentive to excel will be continual, since competition will indefinitely move from one outcome to the next.²⁰

Many tertiary limb salvage centers, including that of the authors of this review, are taking the necessary steps to increase quality through comprehensive analysis. Use of the Donabedian model in a single institution can improve outcomes; however, such change remains microscopic in scale. Though a network connecting multiple institutional ecosystems could disseminate measurable improvements in a more robust and global manner, thereby fostering healthy competition.

Figure 3 illustrates the next possible frontier for outcomes research—collaborative quality initiatives. These programs offer a forum in which to combine the expertise of multidisciplinary teams and a platform for physicians to share all quality metrics in a nonjudgmental and nonpunitive manner. Sharing data with the aim of improving patient care is an ideal means for identifying and subsequently addressing structure, process, and outcomes measures.⁴³ One such example of data sharing is the Virginia Surgical Quality Collaborative (VSQC), a regional collaborative within the ACS NSQIP that includes 6 institutions in Virginia.⁴⁴ Enhanced Recovery After Surgery (ERAS) is a well-validated perioperative management model designed to decrease surgical stress and improve recovery; use of these protocols has been shown to decrease complications and costs across multiple specialties.⁴⁵ Members of the VSQC agreed to address complications after colectomy, which are common and ubiquitous, by implementing a joint ERAS program across participating institutions; this involved sharing protocols, order sets, and educational material, as well as meeting semi-annually to share results and information.⁴⁴ That collaboration resulted in significant reductions in length of stay, from 4 days to 3 days (P <.001), as well as a reduction in overall complications, from 16% to 9% (P <.001), in patients who underwent laparoscopic surgery.⁴⁴

Another example, but on a much larger scale, is the Blue Cross Blue Shield of Michigan (BCBSM) collaborative quality initiative movement, described by Billig et al.⁴⁶ Blue Cross Blue Shield of Michigan is the largest private insurer in that state and has partnered with multiple hospitals 

throughout Michigan to create 20 collaborative quality initiatives spanning multiple specialties. To further promote collaboration and volunteering of data, BCBSM uses a pay-for-participation model with each hospital or provider group within each collaborative quality initiative based on case volume. In addition, hospitals are encouraged to promote quality improvement via a separate P4P reward program.^46,47 Five of the most long-standing collaborative quality initiatives have collectively saved $1.4 billion in estimated costs statewide.^46,48 Outcomes have improved as well, with data from the Michigan Surgical Quality Collaborative showing reductions in sepsis and negative pathology hysterectomies by 14% and 20%, respectively, in the period 2016 to 2017.^46,49

Achieving great outcomes is labor- and resource-intensive, however. While decreases in total cost for care episodes have been attributed to multidisciplinary limb salvage centers, profitability remains in question.^35,36 The cost of diabetic foot ulcer management by a multidisciplinary team varies widely, and the numbers reported by 1 institution may not apply to another. Hicks et al³⁶ reported a mean cost of $24 226 per wound care episode (higher than others in the literature,^50–52 which was estimated to equate to less than $18 per day in net revenue). The inflated cost may not be surprising, considering that a patient may be seen by specialists in vascular surgery, plastic surgery, orthopedic surgery, podiatry, endocrinology, and infectious diseases, as well as by dedicated wound care nurses and physician assistants.³⁶ Assessment of both the monetary cost and the superior patient outcomes, however, may show the costs to be justified, which calls into question current reimbursements in the multidisciplinary setting.³⁶ One area in which research is lacking and that may benefit from a collaborative quality initiative is the profitability and sustainability of multidisciplinary limb salvage centers. As mentioned previously, the experience at 1 institution may not translate to another institution; thus, reform efforts that involve multiple stakeholders may illuminate a more universal solution.

The Society for Vascular Surgery Vascular Quality Initiative, a vascular surgery organization that exemplifies collaborative initiatives, has been instrumental in improving the quality of care for patients with peripheral arterial disease.⁵³ No similar collaborative initiative optimized specifically for improving care for patients with chronic wounds has been developed. Establishing a criterion standard set of quality measures is not an endeavor for a single stakeholder. Ideally, such measures would be developed via the collaboration of multiple care providers, incorporate valuable and diversified perspectives, and involve analysis of large pools of data that are representative of the patient population and foundational for evidence-based change. A regional quality collaborative initiative for limb salvage specialists, similar to that of BCBSM, could potentially be immensely valuable.

With the development of relevant quality measures, it would be possible to maintain a large and encompassing database within the collaborative quality initiative once data can be submitted without penalty or prejudice. Such an entity would address chronic wound-specific shortcomings of existing databases, such as NSQIP and NIS. In addition, a cohort of multiple institutions could provide the basis for a system of checks and balances in which objective data are used to discourage biased or unfounded practices. Collaborative-oriented efforts already exist in the private sector. For example, Healogics manages nearly 700 hospital wound care clinics in the United States and maintains one of the largest wound care databases, with more than 5.5 million wounds.^14,54 Multiple institutions that together evaluate the wound health of a population on a systemic level serve a different purpose than a database managed by a single company whose aim may be focused on maximizing revenue. Finally, it is important to note that the measurement of quality is also fluid; new measures are continuously established, and irrelevant measures are abandoned. A field-specific database could allow the collection of newer patient-based measures, such as WOUND-Q, with continuous movement towards patient-centered medicine.⁵⁵

This article is limited by its qualitative approach and lack of data-driven results. However, identifying shortcomings in care quality assessment is necessary to institute change. As more multidisciplinary limb salvage centers emerge and collaborative quality initiatives become established, presuppositions of the Donabedian care model in chronic wound management can be tested and possibly validated.

Limb salvage specialists have an important role in improving health care quality and determining whether the process becomes internally or externally driven. Existing tools for quality assessment are imperfect, and the consequence of low-quality chronic wound management can be devastating. Through collaboration and the use of validated quality assessment tools such as the Donabedian model, chronic wound specialists can be leaders in developing and implementing quality care measures.

Authors: Kevin G Kim, BS¹; Manas Nigam, MD¹; Jenna C Bekeny, BA¹; Cameron M Akbari, MD, MBA²; John S Steinberg, DPM¹; Christopher E Attinger, MD¹; Kenneth L Fan, MD¹; and Karen K Evans, MD¹

Affiliations: ¹Department of Plastic and Reconstructive Surgery, MedStar Georgetown University Hospital, Washington, District of Columbia; ²Department of Vascular Surgery, MedStar Georgetown University Hospital; Washington, District of Columbia

Disclosure: The authors disclose no financial or other conflicts of interest.

ORCID: Kevin Kim: 0000-0002-3028-9664; Jenna Bekeny: 0000-0002-7517-4326; Christopher Attinger: 0000-0001-7114-6275; Kenneth Fan: 0000-0001-5951-5576; Karen Evans: 0000-0003-1056-2114

Correspondence: Karen Kim Evans, MD, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC 20007; karen.k.evans@medstar.net