Gordon Kuntz is a health care consultant and strategic advisor with over 30 years’ experience in a multitude of health care settings, working with payers and providers, and in technology and strategy. He began his involvement with oncology care pathways in 2004 as a consultant with US Oncology as they were deploying Level 1 pathways. He subsequently led payer strategy with ION Solutions, a division of AmerisourceBergen, where he gained familiarity with many other pathways vendors, especially in the context of the oncology medical home model. As senior director of strategy for Via Oncology, he deepened his knowledge of the pathway development process, physician adoption, and how both impact cancer center strategies. Mr Kuntz now provides support in strategy and product design as well as assistance in navigating the cancer care ecosystem to established and emerging companies.
Implementing clinical pathways in a cancer center is a large undertaking with multiple implications that ripple throughout the organization. The cancer centers that have the most success start with a strong strategic underpinning; they and their staff fully understand the “why” of implementing pathways.
In prior articles in this series, we have explored what clinical pathways are, as well as an overview of the strategies most commonly deployed by cancer centers in implementing pathways.1,2 The strategic landscape for most cancer centers will typically include 4 to 6 concurrent initiatives, likely linked to growth, quality improvement, cost containment, and/or workforce well-being. This article will dig more deeply into how pathways can support the most common business strategies for: (1) cancer center growth and care quality and (2) cost containment.
Why Pathways Support an Array of Business Strategies
Pathways are uniquely positioned to support multiple business strategies for a cancer center for several reasons. Importantly, they function at the point of treatment decision-making. Other clinical systems, such as pathology systems, operate prior to and support the treatment decision-making process, and electronic medical records or order entry systems record the treatment decisions reached by the clinician. Pathways systems, on the other hand, guide and record the decision process and the reasons a clinician made certain treatment decisions. This insight is critical to numerous initiatives that intend to promote quality.
Pathways also ensure that the most clinically appropriate, evidence-based decisions are being considered and, in many cases, applied. However, pathways remain flexible to individual patient circumstances. Pathways are designed to account for, on average, the most common circumstances surrounding a particular disease presentation and be applicable for about 80% of patients. Treatment decisions made by thousands of oncologists for hundreds of thousands of patients over the last 10 to 15 years reinforce this design intent.3 The remaining 20% are treated off-pathway due to a physician’s professional judgement.
While an on-pathways treatment recommendation is not always the least expensive option, it is recommended because it is the most effective and least toxic option for most patients. However, the important corollary here is that the on-pathway recommendation is also not necessarily the latest (and possibly most expensive) new therapy. Newly introduced technologies, combination therapies, and drug discoveries must compete with clinical trial evidence against established therapeutic regimens. Newer does not necessarily mean better, and the consistent focus on efficacy, toxicity, and cost means that patients can be assured that the most appropriate treatments for their disease presentation are being considered. This helps ensure that the practice is managing the barrage of new technologies and drugs appropriately, which helps control costs and reduce variability.
Growth & Quality Strategies
Marketing
Pathways can be used to promote a cancer center’s quality message in one of 2 ways. Some cancer centers market themselves as having unique talents and the most highly skilled and trained doctors. These organizations often reference the pathways they use as being their own branded version. This may be true whether the pathways they follow are supplied by a vendor or are of their own creation; in either case, the message from these institutions is that there is some sort of “special sauce” in use at their facility and that the pathways used by the cancer center gives the patient their best chance at survival.
Other cancer centers promote the fact that the best minds in cancer have collaborated with them to create the pathways they use. Being part of a large consortium that determines standard-of-care treatments helps the cancer center show they are providing the best possible care and are adhering to treatments most likely to produce positive outcomes for patients.
Payer Relations
My career in health care has taught me that payers value predictability. They want to maintain high-quality standards for care delivery and certainly would prefer costs to be lower, but they place a high value on predictability. If costs are predictable across a population, they can price the risk appropriately. With too much variability, the underwriting risk increases. and their products may be priced out of the market.
Pathways directly help practices demonstrate consistent adherence to evidence-based standards of care and help reduce unnecessary variation.4,5 Some payers have their own pathways they want practices to follow; others feel their goals will be met if cancer centers follow some pathway and may not necessarily try to dictate which one. The act of following clinical pathways—any evidence-based pathway—is better, in their eyes, than not following any at all.
Innovative Payment Arrangements
Generally, “innovative payment arrangements” is code for increased financial risk for the practice. The risk may be one-sided (a bonus, for example), or 2-sided (bonus if targets are met; lost revenue if not). Either way, managing that risk is essential to success, and managing risk means thinking like a payer. Again, payers value predictability, so practices agreeing to cost-based targets should consider the same issues. Hitting cost-based targets depends on the ability to make individual treatment decisions that include only necessary and appropriate care. Without pathways to ensure that each care decision is appropriate and that unnecessary variations in care are avoided, practices will have a much more difficult time being successful in innovative payment arrangements.
Program Requirements
One of the most common reasons practices decide to implement pathways is due to some program requirement by a payer. Several payers and care management models require the use of evidence-based pathways as a condition of participation. Some may specify a particular pathway, but often the choice of pathway is left to the practice as long as the pathway chosen meets certain quality and reporting criteria. Medicare’s Oncology Care Model (OCM), for example, requires that practices track their use of “nationally recognized guidelines.”6 Aetna, when its oncology medical home model was launched, required the use “evidence-based pathways.”7 While Via Oncology was used by a majority of practices participating in Aetna’s oncology medical home initiative as of 2015, Aetna did allow “practices that are already using a pathway to keep it.”8
Provider Alignment & Network Development
In 2016 and 2017, 658 oncology practices were acquired by hospitals, and another 168 practices merged or were acquired.9 Each practice acquired by hospitals or merged with another practice arrives with its own practice patterns and preferences. Additionally, some hospitals are pursuing a network strategy, leveraging their local or regional brand and working closely with, but not necessarily acquiring, community practices in their area. These community practices may feed more challenging cases to the hospital or may serve as sites for clinical trials in conjunction with the facility. In either case, the acquiring or network-sponsor entity has strong business reasons for wanting to minimize variance in the treatment patters of the remote sites. In some cases, it may have to do with drug contracting through a group purchasing organization. In other cases, it may be due to the need to highlight clinical trials available through a trials network centered on the hospital. A shared pathways system can help reinforce common standards of care across multiple sites.
Promote Clinical Research
Practices for whom clinical trials are an important business strategy—because of the prestige they bring, the caliber of staff they attract, and the types of patients that seek out these institutions—all have a need to more consistently identify patients eligible for trials at the time of treatment decision.
Research hospitals may participate in 150 or more clinical trials at any one time. Many larger community practices are involved with clinical trials as well. A lack of awareness of trial availability can compound the typically low rate of accruals to treatment trials. “Less than 2% of patients diagnosed with cancer participate in a clinical trial in the United States,”and one in 10 trials are halted for lack of accrued participants.10
Most pathways systems consider clinical trials to be “on pathway,” and many even present at least limited trial data. There are separate clinical trial systems for patient accrual and a screening process is still required to determine final eligibility, but simply identifying likely candidates for a trial based on the disease presentation and reminding physicians of availability are steps in the right direction and likely to increase trial accrual rates.11
Cost Containment
Again—and this is important to highlight—not all on-pathway regimens are less costly than off-pathway choices, but there are ways that pathways can help a cancer center manage costs. In clinics with high proportions of patients with Medicaid and other government-funded insurance or those that are considering risk-based contracts, pathways are an effective means of justifying the use of high-cost therapies and limiting their use to only the necessary cases. Unlike many other practices for whom the margin on drugs contribute to the practice’s economics, these practices must operate within a fixed budget. Without pathways, justifying medical necessity to payers or the practice’s pharmacy and therapeutics committee —and staying within the budget—becomes very difficult.
The design of pathways includes a cost component, after having considered efficacy and toxicity, but only about 5% of treatments that are recommended are based on the cost criterion.12 Frequently, pathways are used to highlight the high cost of a potential treatment to physicians, so that they can factor that into the specific patient situation. One of the reasons physicians may elect to order an alternate, off-pathway treatment is due to the financial burden faced by patients. If patients cannot afford their treatment, they may decide to skip doses or split pills, especially in oral regimens, resulting in substandard response. Alerting physicians to have a conversation with patients and their families about potential treatment costs is an important aspect of the patient’s care.
The cost that is considered as part of pathways development is generally only the cost of the drug itself. While this is the most direct and easiest cost component to identify, it tells but a small part of the cost story. Historically, chemotherapy has accounted for about 20% of the total cost of care, with the balance being in diagnostic testing, physician fees, inpatient hospital fees, imaging, labs, etc.13 With the median annual list price of newly introduced chemotherapy drugs rising from $79,000 in 2013 to $150,000 in 2017,14 the proportion of the total cost of care attributed to chemotherapy may have increased as well. Accurately determining—or even reasonably estimating—total cost of care is difficult due to the variability in individual patient response and the lack of readily available cost data from multiple provider sources. Despite these challenges, initiatives are under way in several areas to provide better total cost estimates by disease and stage or line of therapy. Should this data become available—even in rough estimates—it would advance the conversation about the high cost of cancer care and potentially change pathway recommendations. For example, if Drug A has roughly equal efficacy and toxicity profiles as Drug B, and Drug A cost 50% more than Drug B, Drug B would, today, be recommended. However, if the total cost of care associated with Drug B, because of increased monitoring, imaging, genetic testing, hospitalization, intensity, or other factors, was 50% higher than Drug A, Drug A would be the recommended—if we were in a position to consider total cost of care. This analysis would be especially useful in risk-based contracting arrangements as the total cost of care is what ultimately matters to payers and other risk-bearing entities.
Operational Efficiency and Reducing Cognitive Burden
The use of pathways allows everyone in the care team to focus on delivering the right treatment more efficiently. Pathways can help the care team not only determine the most appropriate treatment regimen but also ensure that supportive care is provided based on standard-of-care recommendations. If doctors and nurses are following pathways recommendations, everyone can be assured that the care team is treating the patients with the best available care plan without necessarily checking and re-checking with every staff member.
In addition, the proliferation of targeted therapies, clinical trials, and workup testing among more refined patient populations means that oncologists have more and more treatment options to consider for every patient. Pathways provide a logical way to narrow the list of appropriate choices. The final determination is still up to the oncologist and explicitly relies on her professional judgement. But without pathways, it would be easy to overlook a recent development that may be meaningful to a patient’s outcomes.
Conclusion
Every cancer center pursues a variety of business strategies simultaneously, most often in the areas of growth, quality improvement, cost containment, and/or workforce well-being. Pathways serve as a key tool supporting many of these strategies. Identifying how pathways can contribute to a cancer center’s business strategies is a necessary first step to succeeding with these strategies. However, for pathways to be truly effective, they must be used consistently throughout the organization. Gaining acceptance of a tool like pathways among physicians can be challenging and requires a culture shift to be truly effective; I will explore ways to achieve this culture shift in my next column.
References
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2. Kuntz G. First things first: deciding why your practice is implementing pathways.
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3. Via Oncology. Who develops the Via Pathways? https://www.viaoncology.com/wp-content/media/content_development_slides.pdf. Published 2017. Accessed March 19, 2019.
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6. Centers for Medicare & Medical Innovation. Evaluation of the Oncology Care Model, Performance Period One. innovation.cms.gov website. https://innovation.cms.gov/Files/reports/ocm-secondannualeval-pp1.pdf. Published December 2018. Accessed March 19, 2019.
7. Aetna. Oncology Quality Program Participant. aetna.com website. https://www.aetna.com/docfind/cms/html/Oncology.html. Accessed March 19, 2019.
8. Rinde M. Oncologists say clinical pathways are too confining. September 10, 2015. https://www.onclive.com/publications/oncology-business-news/2015/september-2015/oncologists-say-clinical-pathways-are-too-confining. Accessed March 19, 2019.
9. Finnegan J. Many independent oncology clinics closed or acquired by hospitals. FierceHealthcare. May 1, 2018. https://www.fiercehealthcare.com/practices/many-independent-oncology-clinics-closed-acquired-by-hospitals-community-oncology. Accessed March 19, 2019.
10. Rimel BJ. Clinical trial accrual: obstacles and opportunities. Front Oncol. 2016;6:103. doi:10.3389/fonc.2016.00103
11. Shamah CJ, Saphner TJ. Effect on clinical trial participation by integration of a clinical pathway program into an electronic health record (EHR). J Clin Oncol. 2016;34(suppl 7):167-167. doi:10.1200/jco.2016.34.7_suppl.167
12. McCutcheon S, Ellis PG, Hess R, Krebs M, Lokay K. Frequency of efficacy, toxicity and cost as the deciding factor when determining clinical pathways. J Clin Oncol. 2017;34(suppl 15):e18169. doi:10.1200/JCO.2016.34.15_suppl.e18169
13. The total cost of cancer care challenge. Oncol Bus Rev. 2018;11(5). https://obroncology.com/article/the-total-cost-of-cancer-care-challenge/. Accessed March 25, 2019.
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