Oct 24, 2017
By Robin Zon, MD, FACP, FASCO
- With increasing adoption of clinical pathways, concerns have been raised regarding the proliferation of pathways, lack of transparency in development and methodologies used, administrative burden, and other factors that could paradoxically hinder patient access, care quality, and parity.
- In response to member concerns, ASCO established the Task Force on Clinical Pathways to examine these concerns and subsequently published a policy statement in March 2016 to guide future development and implementation of pathway programs and criteria for high-quality pathways.
- ASCO’s recommendations and criteria to improve the development, implementation, and analysis of oncology pathways are first steps in managing enhancements to patient care while proving their benefit at the patient and societal levels.
- Pathways may be able to assist required practice transformation by serving as a central component of oncology practice and as a cornerstone of future reimbursement methodologies and quality efforts.
As providers, patients, and payers, we are witnessing an extraordinary number of opportunities and achievements shaping the practice of cancer care in today’s U.S. health care system. Oncology providers and patients are fortunate to experience the full potential of advancing research in treatments, including precision medicine and immunotherapy, resulting in meaningful increases in cancer survivors—15.1 million in 2016, with a prediction of more than 20 million in 2026. Furthermore, advances in learning health systems, such as ASCO’s CancerLinQ®, hold the promise of learning from every patient to improve care and inform research questions. However, as the American population ages and lives longer, there has been an unprecedented influx of patients with cancer. This influx is coupled with increased resource utilization characterized by soaring diagnostic and drug costs, resulting in financial toxicity to patients and increasing financial strain on the cancer care delivery system in its entirety.
In spite of the tension the U.S. health care system is experiencing, our patients want access to affordable, high-value care. In an effort to manage patients’ needs while improving the value of cancer care, payers and other stakeholders—including ASCO—are pursuing new payment and care delivery models that enhance quality while controlling spending. This movement has resulted in innovative, practice-changing payment models.
The trigger for this transformation was the Centers for Medicare & Medicaid Services’ (CMS) implementation of the Medicare Access and Chip Reauthorization Act (MACRA) of 2015, which encourages providers to participate in new payment models with increasing accountability in the delivery of high-quality care. This statutory program represents a paradigm shift away from volume-based, provider-centric reimbursement and toward patient-centric, value-based reimbursement to incentivize high-quality cancer care while controlling and/or reducing costs for the delivery of this care. As of January 1, 2017, all Medicare providers and patients are now active participants in this transformation through the Quality Payment Program (QPP). It is my opinion that well-designed clinical pathway programs can be a linchpin in adapting to this practice-changing reform.
ASCO Task Force on Clinical Pathways
Under ideal circumstances, clinical pathways are detailed, evidence-based protocols for delivering quality cancer care for patients with specific disease types and stages. In fact, providers and payers have used clinical pathways in oncology as a treatment management tool for more than a decade. They have used them to reduce unnecessary and costly treatment variation while enhancing quality by promoting adherence to evidence-based treatment plans and encouraging shared decision making with patients.
Cancer specialists often lead the development of pathways, and many in the oncology field view pathways as a means to improve, not hinder, care. However, with increasing adoption of pathways, ASCO members, the State Affiliate Council, and the Clinical Practice Committee articulated concerns regarding the proliferation of pathways, lack of transparency in development and methodologies used, administrative burden, and other factors that could paradoxically hinder patient access, care quality, and parity.
In response to member concerns, ASCO established the Task Force on Clinical Pathways to examine these concerns and subsequently published a policy statement in January 2016 to guide future development and implementation of pathway programs.1 The policy statement conveys a cautionary note that no current mechanism is in place to ensure the integrity, efficient implementation, and outcome assessments for these treatment-management tools. The statement includes nine recommendations intended to engage all stakeholders in facilitating a constructive dialogue for moving forward (Table 1).
The task force found no existing standards defining high quality and transparency in pathway program development and implementation, nor did it find standards analyzing the impact on care delivery and patient outcomes. Consequently, the policy statement calls for the development of robust criteria for multiple stakeholders to evaluate pathway programs and guide future development.
The nine individual criteria for high-quality clinical pathways in oncology, released in January 2017, formulate an overarching framework to assess pathway programs in three key areas: development, implementation/use, and analytics (Table 2).2 Notably, in the process of developing the criteria, the task force thoughtfully elicited and considered all stakeholder perspectives by initiating collaborative dialogue through direct stakeholder meetings and interviews with patient advocates, payers, vendors, and providers.
In an effort to provide the best tools for members to participate in pathway programs, develop pathways, understand the impact of pathways on patient care, and selectively integrate pathways into business management operations, the task force is moving forward with assessing programs using ASCO’s criteria for high-quality pathways. In a process that involves evaluating publicly available information and holding in-depth conversations with developers, ASCO is working to identify pathways that are developed, implemented, and analyzed in a way that promotes high-quality care. The evaluation is ongoing, and the assessment results will be published in the near future.
Pathways in Practice Transition to a Value-Based System
With the introduction of MACRA/QPP, the Oncology Care Model under the Center for Medicare & Medicaid Innovation, and other federal and state regulatory forces, pathways may be able to assist required practice transformation by serving as a central component of oncology practice and a cornerstone of future reimbursement methodologies and quality efforts.
Many oncology practices, health care institutions, and health insurance plans have implemented oncology-specific pathways, recognizing the value in promoting quality care while controlling care delivery costs. The Oncology Care Model demonstration program—considered an alternative payment model in the QPP—requires utilization of nationally recognized guidelines, including pathways derived from these guidelines, for treatment planning. In addition, ASCO’s proposed alternative payment model, the Patient Centered-Oncology Payment model (PCOP), adjusts payment based on quality of care and resource utilization and can also include pathway adherence performance. Current ASCO work includes integrating high-quality, high-value pathways into PCOP. Furthermore, pathway programs compliant with selected criteria should be considered for reporting quality measurements and reducing practice/physician administrative work.
We should be mindful that the meaning of the term “value” varies among stakeholder groups. Specifically, patients consider value care to include being offered the most up-to-date intervention/treatment at the right time while being given an improved the overall care experience. Reducing redundancy and unnecessary testing while assuring that the necessary clinical evaluations and treatments are being delivered is paramount to improving the patient experience while controlling and/or reducing health care costs. Patients also want state-of-the-art care, including personalized care, when available. Pathways that are comprehensive, that integrate components of the care continuum beyond treatment, and that are continuously
updated with advancing scientific knowledge and validated real-world evidence should be able to not only meet patient expectations but also protect patients’ concerns of undertreatment in the alternative payment model universe.
Providers’ perceptions of value, and how pathways can facilitate those perceptions, resonates with patients’ perceptions as stewards of their care. However, pathways also have the potential to benefit providers in other ways: increasing operational efficiencies by reducing administrative burden; serving as a tool for regulatory reporting and compliance; integrating new information in real time to educate oncology providers and patients when making care decisions; providing a mechanism for promoting clinical research; leveraging deemed pathways in the QPP regarding resource utilization and quality; and removing financial penalty for the provider–patient teams following high-quality, high-value pathways meeting ASCO criteria.
Policy Implications in Moving Pathways Forward
ASCO policy priorities for 2017-2018 include advancing policies and delivery system reform that supports oncology providers in their delivery of high-quality, high-value care. As presented here, pathway programs guided by the Task Force’s policy statement recommendations and criteria for high-quality clinical pathways in oncology are essential in supporting this goal and, as discussed, help leverage pathways in payment model reform.
However, some of the criteria may not be yet attainable, such as the call for integration of cost-effective technology and decision support in the Implementation and Use criterion. It is essential to speed implementation of the 21st Century Cures Act provisions promoting, as described in “Title III—Delivery” section of the law, interoperability of electronic health records (EHRs) and patient access to health data, discouragement of information blocking, reduction of physician documentation burden, and creation of a reporting system on EHR usability.3
This need is underscored by the fact that 42% of surveyed oncology practices cannot integrate patient information from other EHR systems into their own.4 From a policy standpoint, interoperability may not only enhance implementation of pathways at the provider level but also may better operationalize cancer-specific learning health systems, which, in turn, can be used to inform pathway recommendations with real-world evidence.
The Path Forward: Looking Ahead
The use of pathway programs to move toward fully integrated value-based care will likely evolve and increase. Patients, providers, and payers can all potentially benefit from the current ongoing practice transformation. ASCO’s recommendations and criteria to improve the development, implementation, and analysis of oncology pathways are first steps in managing enhancements to patient care while proving their benefit at the patient and societal levels.
Acknowledgements: The author wishes to thank Sybil Green, JD, and Stephen S. Grubbs, MD, FASCO, for review of the editorial.
Originally published in 2017 ASCO Daily News.