Approaching Clinical Pathway Development as an Art

Abstract: In health care, rules and regulations are in place for good reason, but there is an art to integrating them into care effectively to benefit patients as well as the other stakeholders­—clinically and financially. When it comes to clinical pathways, we can take this to mean that one needs to thoroughly understand all the rules established by the Food and Drug Administration, Centers for Medicare & Medicaid Services, and others to then craft a clinical pathway that can deliver optimum clinical and financial outcomes and can simultaneously satisfy all regulations. To be impactful, clinical pathways must be able to alter care delivery to align with new value-based models of care. Treatment choices and care plans should be designed with value-based care goals in mind, which often includes responsibility for total cost of care, as opposed to fee-for-service care design. To this end, clinical pathways should be innovated to comprehensively optimize care flow and stakeholder behaviors.

Key Words: value-based care, clinical pathways, art of medicine, fee-for-service

“The art of medicine” is an oft-spoken phrase, but what does it really mean? or what should it mean?¹ After all, medicine is a science governed by very specific rules, so why speak in terms of art? Perhaps if we frame it in terms of a well-known Pablo Picasso quote, it may become clearer: “Learn the rules like a pro, so you can break them like an artist.”² Picasso was well-trained in the skills of drawing, such as in lights, shadows, dimensions, and color. His early works capture his mastery of the basic rules of art, but his later works bend and break common rules and conventions to create truly thought-provoking pieces (Box 1).

Rules, regulations, and standards from governing bodies like CMS and FDA are important for myriad reasons, and this article in no way condones breaking such rules. But there is value in taking strict parameters and finding creative ways to implement them so as to execute care that is successful beyond minimum standards. 

One physician reflecting on his career described the art of medicine in the following way: 

With constant attention to details, consistently honing my communication skills, staying alert to the advances within my science, and allowing myself to be touched by the best and the worst of humanity, I developed my unique style of practice, the expression of my dedication, my compassion, and eventually, my art.¹

The “care” in health care is caring deeply for the lives of human beings—subjective experience and compassion are inevitably intertwined within the medical and financial choices in care delivery. However, market realities cannot be ignored. The shift to value-based care is reflective of the need to combat the growing problems in health care—sky-rocketing costs and less available resources. Controlling these problems means standardizing processes to promote more consistent, high-quality care and being able to meet quality measures. 

Health care professionals need to take action if they want to continue to deliver medical care in their own uniquely artistic way within these value-based care parameters. The same author above continued: 

The commercialization of health care, with its metrics and algorithms, was preventing me and my fellow physicians from realizing our destiny…. Unless physicians take the opportunity to alter the character of their medical practice, this transformation from shift worker to physician–healer will never occur, and the caring, healing touch of the physician’s hand will continue to disappear.¹

Clinical pathways offer an avenue for physicians to “alter the character of their medical practice” and to take control of their futures. If physicians take the lead on designing comprehensive clinical pathways that integrate not only FDA, CMS, and other reimbursement requirements but also their own creativity in delivering care, then they have a concrete means of preserving their unique role as physicians within value-based care. Otherwise, they risk having outside metrics and analysts dictating how they should practice, often with only bottom-line costs in mind. Collaboration with other invested stakeholders on pathways creation is essential for broad success in the market, but at least physicians can have a solid voice in design and implementation.

Pathways, which can streamline and standardize high-quality care and provide solid evidence of improved resource and financial outcomes, need to satisfy and benefit the many stakeholders in the health care market—including patients. To do this, the same philosophy of artistry can be applied to the development of innovative clinical pathways. The first step would be to develop a cogent value story that assesses the needs of all parties on the receiving end of the narrative—look at the needs of and incentives for each audience. In health care, priorities and perceptions of value differ depending on myriad issues, including but not limited to, how market access customers are incentivized and how they have structured their risk contracts. Without gaining an understanding of the audience’s priorities and perceptions, we run the risk of clinical pathways failing to guide providers in a way that improves outcomes both in clinical and financial terms.

Clinical pathways are often built from a narrow or generic point of view, only encompassing certain elements of the patient journey or some stakeholders’ goals. This article lays out the elements and processes that are necessary to articulate a clear, comprehensive, and impactful clinical pathway that creates better value for all involved. Future advancement through clinical pathways requires new ways of thinking about care operations and collaborations—artistic design that goes beyond current conventions. 

Progress on Value-Based Care

The transition from volume to value is relevant to both payers and health systems (Figure 1). In the past, financial risk management was mostly a payer issue; however, health systems are now moving in this direction as evidenced by their shift from the “per diem” model to value-based care, which often includes managing financial risk. The per diem model is one whereby payment is made or received for each individual service performed and product used. In hospitals, per diem payment is based on the number of patients cared for. For payers, the per diem model is represented within prescription drug plans (PDPs), where their responsibility is limited to drug costs. As such, the incentives provided to PDPs focused on simply reducing prescription volume, rather than improving clinical outcomes or reducing the total cost of care. In a similar fashion, fee-for-service (FFS) health systems are also limited in their view on volume, as a hospital receives less revenue under this model for less patients cared for in their hospital.

But the shift to value-based care for both groups has meant that, instead of per diem payments, payments are being bundled. The bundling of payments makes each party accountable for a greater piece of the pie, such as clinical outcomes and the total cost of care. Under value-based care, especially where financial risk for total cost of care is included, hospitals now are incented to keep patients out of the hospital and instead healthy in the community.

Health System Positions

Health systems’ shift from FFS care to value-based care has not been seamless by any means, with varying degrees of success. Some large health systems, such as Kaiser Permanente, Geisinger Health, and UPMC have taken on full risk and are, thus, fully engaged in value-based care. These systems have the means to take on value-based risk, because they manage their own health plans. As the payer and provider (some literature now refers to these as “payviders”),³ they are better positioned to deliver value through management of the total cost of care.

Despite these systems taking on risk, many others are still firmly planted in the FFS camp, and a few are caught between these two scenarios.⁴ For those caught between FFS and value-based care, the COVID-19 pandemic has added a sense of urgency to picking a side. There is a good chance that the current environment will advance value-based care much more quickly than it would have otherwise, as it appears that health systems that embrace value-based care will be more likely to weather the COVID-19 storm. Data shows that most risk programs saw a substantial reduction in physician visits, in-office procedures, and other services during the COVID-19 pandemic, resulting in significant profits (Table 1).⁵ This is not to suggest for a moment that reductions in care and visits due to COVID equals success in value-based care, but the financial records of plans at financial risk does demonstrate that it has resulted in financial gains, at least in the short run. Programs and systems looking to survive will take note of such outcomes. It is important to note that true value-based care includes both financial and clinical successes in both the short and long term.

But one group’s expenses translate to another’s revenue depending on their reimbursement models, so the opposite effect has been felt by FFS systems, which have seen a significant reduction in their revenue. As a result, we would predict most health systems will work to strengthen one position or otherwise risk failure, especially in the face of median margins dropping to -8% as reported by Kaufman Hall.⁶ This further points out the increasing benefit of managing full risk rather than struggling to exist in the FFS world.

How to Deliver Value

Although payers have unique perspectives, they all have common rules or requirements as dictated by CMS and other regulatory bodies (Table 2). These regulations often force access—or exclude it. For example, specific treatments or practices may be excluded from coverage or be an absolute requirement. Adherence to these structural rules ensures the basic integrity of a clinical pathway; it is critically important to know such rules before we can innovate around them with clear rational.

With these absolute rules in mind and the objectives of the stakeholder determined, it is time to start building a clinical pathway that delivers on their perception of value. Often this is referred to as developing a value story.^7,8 It begins with pulling out the care attributes from each specific treatment in terms that matter to the audience (Figure 2). It is critical first to identify unmet patient needs: the “why” and “who” of creating pathways. “What” outcomes are deemed to be priority should then be built into the equation, along with how to measure them. Then one can focus on how to arrange that care for the right patient at the right time—“how” that care should be delivered and in what setting, or “where.”
Viewing all of these elements together is how architects of clinical pathways can articulate a value story following the patient journey that can deliver improved outcomes. It is this artistry that creates much more than a basic instructional guide; instead, the product is an artful picture with value built in.

There are, of course, several sources for determining the attributes of a treatment or diagnostic. The starting point for most is the FDA-approved indication, but often this lacks enough specificity to be truly useful. Thus, it usually must be supplemented with data from the treatment’s clinical study design as well as real-world evidence (RWE). Compendium publications also play a role in pairing down treatment options, especially when treatments are comparable clinically but may have varying toxicity profiles or cumulative costs (Table 3).

The “Why” and “Who”

Building the foundation of a value story requires an evaluation of the unmet needs in the treatment of a disease state. Often times for health systems, these unmet needs can be found in their Community Health Needs Assessments (CHNA). The CHNA is a requirement under the Internal Revenue System tax code Section 501(r)(3)(A).⁹ Specifically, every nonprofit hospital organization is required to CHNA every 3 years and to adopt an implementation strategy to meet the community health needs identified through the CHNA. A CHNA requires that the following steps be completed:

1. Define the community it serves.
2. Assess the health needs of that community.
3. In assessing the community’s health needs, solicit and take into account input received from persons who represent the broad interests of that community, including those with special knowledge of or expertise in public health.
4. Document the CHNA in a written report that is adopted for the hospital facility by an authorized body of the hospital facility.
5. Make the CHNA report widely available to the public.

An additional source for identifying a community’s care gaps may come from the Country Health Ranking.¹⁰ The County Health Rankings, a collaboration between the Robert Wood Johnson Foundation and the University of Wisconsin Population Health Institute, measure the health of nearly all counties in the nation and rank them within states. The care gap findings from these sources can be built into the design of a clinical pathway.

Clinical pathways creators also need to identify “who” the right patient is. The “right” patient can be determined using the above data and clinical study design with a clear description of the patient demographics. Specific demographic information and other characteristics, diagnoses, and staging can identify appropriate patients for care. Of note, because clinical studies are designed to gain FDA approval, they do not take into account all the appropriate patients or the time frame for successful care. This broader perspective must come from additional information such as that available via RWE, which can refine clinical pathway focus for the “right” patient as additional information beyond the clinical trial data becomes available.

The “What” 

The “what” refers to what outcomes are the priority for that population. At the center of every clinical pathway is the drive to improve outcomes with the specifics based on the audience. While the specifics will vary, the major categories are the same for all health systems:

• Meeting requirements (ie, structural and procedural)
• Addressing market size (ie, member enrollment and retention)
• Reducing total cost of care
• Meeting quality measures
• Enhancing provider performance 
• Reducing administrative burden

Whiles several of these are straight forward in their handling, others require more art in how they are articulated. For example, while efforts to reduce administrative burden may be more tightly defined, provider performance may be more subjective and based on the context of the setting. 

The “How” and “Where”

The “how” applies to the implementation of the clinical pathway. This is where clinical pathways have greater application, laying out the timing and execution of the intervention to ensure appropriate utilization. Despite the importance of the “how,” often times clinical pathways fail here. Steve Jobs is reported to have said that “To me, ideas are worth nothing unless executed. They are just a multiplier. Execution is worth millions.”¹¹ Execution failures can occur from the ineffective application of the clinical pathways by health systems and providers. Improper timing of interventions is a concern; instruction on initiation and discontinuation of treatment as well as timing for referrals or consultations is essential. It may also be useful for clinical pathways to include a description on how they should be implemented. Staff training and the inclusion/integration of clinical pathways within electronic medical records (EMR) is extremely useful; these strategies would help to ensure that they are being used at the point of care and pulling from available data to better guide decisions. Studies have shown that clinical pathways that utilize the EMR reduced waiting times for patients and improved workflow integration.¹² Clinical pathways impart much less value when left in a paper or PDF format; rather, they should be executed through integration into the EMR workflow to encourage use and enable better collection of data.

The “where” applies to where clinical care should best take place. Sites of care can vary based on needed skills, both in personnel and facility requirements for care. This aspect is best addressed when one considers the physical patient journey, accounting for various stakeholders along the multiple sites of care. This is another area where COVID-19 has led to changes. In the past, providers were physicians who operated out of their office or the hospital setting. Because of the need for social distancing and staying at home, COVID-19 has resulted in far more nonphysician providers, such as advanced practice nurses, providing care in patients’ homes and through telemedicine-type methods. Reimbursement concerns have likewise shifted away from higher-cost hospital-based settings to these alternative sites.

Further, the “where” includes site of care where significant cost differences can exist between settings such as home, physician office, and provider-based hospital departments (PBD). The issue of care setting was addressed by the Medicare Payment Advisory Commission (MedPAC) in their 2014 report to Congress.¹³ In the MedPAC report, they noted the increasing trend of hospitals acquiring physician practices, thereby converting the acquired physician office locations into off-campus PBDs. Because Medicare reimbursement provided in a hospital site of care is greater than reimbursement for the same services provided in a physician office setting, the conversion from physician offices to PBDs increased costs for the provision of equivalent services simply based on the hospital ownership of a practice. Congress is addressing this through Section 603 of the Bipartisan Budget Act of 2015, stating that new off-campus PBDs would be paid at physician practice rates for all services.¹⁴ High-quality clinical pathways should try to address issues related to differences in sites of care.

Conclusion

Clinical pathways work best when they follow the full patient journey and can encourage optimal provider behavior to align with value-based goals of care. Developing impactful clinical pathways starts with needs assessment and collaboration among providers, patients, payers, and policymakers. Physicians can take initiative on clinical pathway development to ensure that the art of medicine is preserved as the field shifts to streamlined processes and value-based strategies. This artistry should shape the way all stakeholders view, design, and use pathways, so that all rules and standards are met while also ensuring the patient experience and clinical quality of care remains elevated.  

References

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9. Internal Revenue Service. Community Health Needs Assessment for Charitable Hospital Organizations - Section 501(r)(3). Updated August 21, 2020. Accessed October 22, 2020.  https://www.irs.gov/charities-non-profits/community-health-needs-assessment-for-charitable-hospital-organizations-section-501r3

10. University of Wisconsin Population Health Institute, Robert Wood Johnson Foundation. County Health Rankings. Accessed October 22, 2020.  https://www.countyhealthrankings.org/

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13. Medicare Payment Advisory Commission. Report to the Congress: Medicare Payment Policy. March 2014. Accessed October 22, 2020. https://www.medpac.gov/docs/default-source/reports/mar14_entirereport.pdf

14. Bipartisan Budget Act of 2015, HR 1314, 114th Congress (2015-2016). Accessed October 26, 2020. https://www.congress.gov/bill/114th-congress/house-bill/1314/text