ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?

Today’s healthcare system offers significant challenges, as well as opportunities that are shaping the practice of cancer care. On the one hand, oncology providers and patients are fortunate to witness the benefits from advancing science and precision medicine, including new drugs and biologic therapies. Additionally, our clinics are filled with increasing numbers of cancer survivors—more than 14 million in 2014.¹ On the other hand, the demand for cancer services is increasing as the American population ages and expands. These realities have resulted in tremendous tension on our healthcare system, as evidenced by soaring cancer care costs, attributable to increases in utilization and rising drug prices which result in particular financial toxicity to patients.²

In response to mounting pressures to improve the value of cancer care, payers and other stakeholders, including the American Society of Clinical Oncology (ASCO), are pursuing new payment and care delivery models that enhance quality while lowering spending.³ Moreover, in exchange for the US Congress Sustainable Growth Rate formula repeal in April 2015, the Medicare Access and CHIP Reauthorization Act of 2015, also known as, MACRA, was codified to encourage physicians to participate in new payment models in exchange for increased accountability in delivering high-quality care. This has resulted in a paradigm shift away from remunerating quantity of care toward rewarding quality and value. Clinical pathways are one of the tools being adopted to meet the aims of better managing utilization by reducing unnecessary and costly treatment variation, while meeting the stated goals of enhancing quality and value.

As the leading professional organization representing physicians who care for people with cancer, ASCO has been a leader in assisting oncology providers in providing the highest quality care to all patients with cancer. ASCO’s clinical practice guidelines provide critical guidance to practicing oncologists and represent ASCO’s efforts to ensure that evidence-based medicine is the gold standard in oncology.

ASCO’s Quality Oncology Practice Initiative (QOPI) offers a way to provide assessment, achieve program recognition, assess and improve safety, and engage clinical staff in an ongoing culture of quality improvement. Additionally, ASCO’s QOPI Certification program provides a mechanism to formally certify those practices that achieve the highest standards of oncology care delivery to their patients. Our community’s embrace of quality is reflected in the high rate of participation and certification in QOPI.

Clinical pathways represent another important tool for promoting high-quality, high-value cancer care. Currently used by healthcare providers, commercial organizations, and other health systems, pathways are also increasingly being adopted by insurance plans in the United States, with an estimated 60 individual health insurance plans in the United States currently implementing oncology pathways programs.⁴ More than 170 million individuals covered by those insurance plans are potentially being treated under a health plan-sponsored pathways program—many under active treatment for cancer.⁴ Furthermore, approximately 15% of oncology “lives” were treated according to clinical pathways in 2010; a percentage expected to rise significantly over the coming years.⁵

Task Force on Clinical Pathways

Under ideal circumstances, clinical pathways are detailed, evidence-based treatment protocols for delivering quality cancer care for patients with specific disease types and stages. So, why is ASCO providing comment and guidance now? ASCO members have articulated concerns regarding the current proliferation of pathways in oncology, including lack of transparency, administrative burden, and other factors that could affect patient access and care quality. In response, ASCO established an ad hoc Task Force on Clinical Pathways last year to examine this issue. In January 2016, the Task Force issued a policy statement on clinical pathways in oncology to guide the future development and implementation of these treatment management tools.⁶

From the outset, it’s important to note that clinical pathways in oncology are viewed by many in the field as a way to improve, not hinder, care. Indeed, cancer specialists, themselves, are often leading the development of pathways as a means for promoting evidence-based care and shared decision making with patients. That said, the responsible use of pathways means that not all patients should be treated “on pathway” due to the presence of comorbidities or other patient-specific factors.

Additionally, the Task Force recognizes that there is a wide variation in the quality and utility of existing pathways, with some pathways placing priority on cost control, inserting hurdles for treating patients “off-pathways,” and being opaque about how a pathways program was designed, is updated, and even how decisions are made about what treatments are put on or off a pathways program. ASCO’s policy statement serves to convey a cautionary note, that we must be thoughtful and deliberate in the development and implementation of pathways to ensure that our patients receive the best and most appropriate evidence-based cancer care possible, as well as have access to well-designed clinical trials.

In releasing the ASCO Policy Statement on Clinical Pathways in Oncology, the Society has 3 primary objectives:

• To increase awareness about the growing use of clinical pathways in oncology, and concerns that exist about the manner in which they are being deployed
• To ensure quality, transparency, and consistency in the design and implementation of these treatment management tools
• To ensure that pathways are used in the way they are intended to ensure quality care and reduce costs.

Concerns about Clinical Pathways

The ASCO Task Force’s review of clinical pathways in oncology identified a range of concerns, including tremendous variation with regard to pathways that do not consistently offer an appeals process when denying off-pathways treatment; pathways that often have a cumbersome approval and appeals process and provide no reimbursement when off-pathways treatment is denied; pathways that do not cover rare cancers and those patients treated in the inpatient setting (eg, acute leukemias); pathways that do not disclose methodology used in development nor report all potential conflicts of interest by the pathway developers; and pathways that focus on cost savings, with efficacy and safety as secondary considerations.⁴

ASCO’s examination also found that the number of regimens offered for specific cancers varies widely from pathway to pathway, and treatment options within the same pathway can be different in different demographic regions.

Additionally, we discovered that the proliferation of oncology pathways has created major administrative burdens on oncology practices, some of which report having to adhere to multiple different pathways by differing payers for the same type and stage of cancer.⁷ Practices are increasingly forced to sift through the requirements of each payer’s pathway program on a patient-by-patient basis, diverting time away from direct patient contact and potentially eroding the doctor-patient relationship.

Need for More Data

At this juncture, the focus should be on learning, revising, and improving the process of pathway utilization through prospective research on current implemented pathways. Although some studies have shown that pathways can reduce costs while improving, or at least maintaining quality of cancer care, data are not complete.⁸ ASCO’s clinical pathways policy statement calls for additional research to understand the impact of pathways on care and outcomes.

ASCO Recommendations

ASCO envisions a collaborative effort for strengthening clinical pathways by involving all stakeholders, including physicians, patients, payers, clinical researchers, pathways developers, healthcare administrators, and policy makers—a specific recommendation articulated in its policy statement. Transparency, consistency, and the full promise of clinical pathways will not be fully realized until all concerns and perspectives are considered and thoughtfully addressed.

We believe that the ASCO policy statement will serve to engage all stakeholders in clinical pathways in oncology and facilitate a constructive dialogue for moving forward. The ASCO policy statement sets forth the following 9 recommendations that can provide the structure for this much-needed dialogue:

1. Pursue a collaborative, national approach to reduce the unsustainable administrative burdens associated with the unmanaged proliferation of oncology pathways. This would include eliminating preauthorization requirements if the patient meets the criteria for a selected pathway, and allowing physicians to select one, deemed pathway accepted by all payers.
2. Adopt a process for development of oncology pathways that is consistent and transparent to all stakeholders with public disclosure of methodologies for the pathway development and conflict of interest disclosures.
3. Ensure that pathways address the full spectrum of cancer care, from diagnostic evaluation through medical, surgical and radiation treatments, and include imaging, laboratory testing, survivorship and end-of-life care in order to maximize opportunities for value-based medical outcomes.
4. Update pathways continuously to reflect new scientific knowledge, as well as insights gained from clinical experience and patient outcomes, to promote the best possible evidence-based care. The emergence of big data and rapid learning systems further accentuate the need for rapid pathway refinements and more granular pathways to best serve the needs of distinct populations.
5. Recognize patient variability and autonomy, and allow for physicians to easily diverge from pathways when evidence and patient needs dictate. Appropriate variation considering varied patient comorbidities and therapeutic goals should be supported without significant administrative burdens.
6. Implement oncology pathways in ways that promote administrative efficiencies for both oncology providers and payers. In addition to removal of preauthorization when providers provide health services consistent with clinical pathways, the additional costs in complying with pathway adherence, which are not currently included in the codes for evaluation and management or care management, should be factored into payment for oncology services.
7. Promote education, research, and access to clinical trials in oncology clinical pathways. Furthermore, robust oncology pathways may help with collection of data outside of small trials and help advance understanding of therapy toxicities, patient comorbidities, and survival.
8. Develop robust criteria to support certification of oncology pathway programs; pathway programs should be required to qualify based on these criteria, and payers should accept all oncology pathway programs that achieve certification through such a process.
9. Support research to understand the impact of pathways on care and outcomes focusing on pathway development, dissemination and implementation, cancer care delivery, patient experiences, and impact on clinical outcomes and value.

The Future Vision for Pathways in Payment Reform

Oncology clinical pathways are likely here to stay, at least for the near future. Value-based pathways are considered by many an essential component of a comprehensive oncology payment reform initiative. This includes the ASCO model, which suggests payment adjustments based on quality, pathway adherence, and resource utilization, as well as alternative payment models such as the Oncology Medical Home. The future could also include the potential integration of rapid learning system data in optimizing the pathway evidence base, and therefore, improving the quality of patient care. Additionally, as pathways are used to measure outcomes, value-based pricing may also be realized, further promoting cost containment. The ASCO Value Framework, which assesses the relative value of cancer treatments by examining effectiveness, toxicity, and cost of regimens in a comparative manner, may also assist pathway development.⁹

The business model for incorporating pathways needs to be more fully examined and understood to assure sustainability of the care model for payers, providers, and patients. This includes mitigating administrative burden through oncology certification and acceptance of a deemed pathway by all payers.

Conclusion

• ASCO believes there need to be uniform standards for the development and implementation of clinical pathways that are transparent to oncology stakeholders including physicians, patients, and payers.
• Pathways should address the full spectrum of cancer care, and be updated in a timely manner to reflect new scientific knowledge, as well as insights gained from clinical experience and patient outcomes.
• Clinical trial access should be considered an on-pathway option.
• Pathways should recognize patient variability and autonomy, and off-pathway options when this is in the best interests of the patient.
• Finally, pathways must be implemented in ways that promote administrative efficiencies rather than burdens for oncology patients, providers, and payers with strong consideration for certification and deeming of pathways.

EBO

Recognizing the critical importance of this issue for physicians, patients, and payers throughout the United States, ASCO’s Task Force on Clinical Pathways will continue its efforts to ensure that pathways are developed in such a way that ensures quality, consistency, transparency, and administrative efficiency to all stakeholders. Our recommendations will form the basis of this work, which will involve consulting with payers, vendors, providers, and others to develop a collaborative approach to ensure that clinical pathways promote—and don’t hinder—high-quality patient care.

Author information:

Robin T. Zon, MD, FACP, FASCO, is chair of ASCO’s Task Force on Clinical Pathways and a practicing oncologist at Michiana Hematology-Oncology in South Bend, Indiana.

Address for correspondence:

Robin T. Zon, MD, FACP, FASCO

5340 Holy Cross Parkway

Mishawaka, IN 46545

E-mail:

docrzon@aol.com

Acknowledgement:

References

James N. Frame, MD, Charleston Area Medical Center, Charleston, West Virginia; Ray Page, DO, PhD, The Center for Cancer and Blood Disorders, Fort Worth, Texas; and members of the ASCO Task Force on Clinical Pathways, contributed to this commentary.

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