A Much-Needed Standard for Oncology Clinical Pathways Has Arrived

Managing medical decision-making has become big business. Over the past few years, “clinical pathways” have become one of the most common tools for medical decision-making in oncology.

Until recently, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) were the primary standard for clinical decisions for treatment. However, as payers and providers started to respond to challenges for narrowing the wide variations in treatment choices for quality and cost management, clinical pathways were developed to more closely align preferred clinical choices for specific patient populations.

The earliest clinical pathways were created with extensive physician review and discussion regarding the levels of evidence and consensus identified in the NCCN Guidelines, and were housed deeply in the medical community. In this manner, US Oncology developed its Level 1 Pathways, and the University of Pittsburgh Medical Center created its Via Oncology pathways, both of which were made available within the medical community for adoption and continue to be available.

Clinical pathways are generally described as detailed, evidence-based processes for delivering cancer care for specific patient presentations, including the state and stage of disease. However, the oncology community has seen the commercial application and development of clinical pathways proliferate in recent years. Individual payers started to offer voluntary and not-so-voluntary physician participation in their own defined clinical pathways programs, with operational and financial carrots and sticks for degrees of participation.

Vendors began shopping clinical pathways programs to payers, employers, and even specialty pharmacies for use in oncology management and prior authorization programs.

By late 2014, significant questions were being raised by the medical community about these proliferating pathways. Some practices had to consider as many as 5 to 8 different payer pathways (depending on the insurance a patient has), all with different end points, recommendations, and methods of data entry and compliance, and with each claiming to be “evidence-based,” despite their variations and physician choices.

Payers were sometimes offering payment for compliance, but for compliance with the process and selection of their preferred pathways, not for the cognitive process of medical decision-making by the physician for the best options for the patient. And patients were expressing growing concerns about access to appropriate care and whether coverage may be denied for appropriate treatments if they happen to fall outside of the payer-preferred choices. The burdens of compliance and data entry were increasing exponentially for practices, and other burdens, such as prior authorization and medical review discussions, were not decreasing.

The biggest question regarding this proliferation of clinical pathways that were supposedly evidence-based is—How can physicians and patients reconcile conflicting pathways? How can we not worry that evidence is being distorted to meet some other agenda? Where are the standards to which we should hold a clinical pathways program, and how can providers work within their states and the nation to obtain some degree of consistency and protection for patients against poorly designed and implemented clinical pathways?

ASCO Issues New Statement on Clinical Pathways Development

The American Society of Clinical Oncology (ASCO) responded to the need for clarity regarding clinical pathways and has just released its Policy Statement on Clinical Pathways in Oncology.¹ Created by ASCO’s Task Force on Clinical Pathways and approved by ASCO’s Board of Directors on August 12, 2015, this statement articulates the guiding principles and a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathways concordance in a manner that promotes evidence-based, high-value care and respecting input from patients, payers, and providers.¹

ASCO’s policy statement clearly defines their guiding principles for the development of clinical pathways in oncology, and sets forth 9 distinct recommendations for clinical pathway development and implementation in the oncology setting. This policy statement provides a much-needed standard for oncology practices and state associations to use when comparing alternatives and when contracting with payers for oncology management programs.

The ASCO guiding principles for the development of clinical pathways in oncology address the role of practicing oncologists in the pathways themselves; the quality, transparency, updating, and process of any given oncology pathway; the necessary disclosures of individuals involved in the development of any given oncology pathway; the key parameters for patient coverage, adherence expectations, measured outcomes, and costs of care for pathways; as well as the mechanisms for communication between the provider and the payer for approvals, modifications, appeals, and adjusting prior authorization and off-pathway processes.

These guiding principles will be critical in supporting medical community challenges to nonconforming clinical pathways.

The 9 Recommendations

The 9 recommendations will also create a solid platform for providers to use in selecting which clinical pathways programs they will allow in their practices, as well as to pave the way for providers to assert the need and cost-effectiveness of selecting 1 conforming clinical pathway that must be accepted by all payers, rather than having multiple payer clinical pathways create chaos for patients and providers.

The 9 recommendations advise that¹:

1. A collaborative approach should be created to remove the administrative burdens associated with the many oncology pathways
2. Pathways development should be consistent and transparent
3. Pathways should include the entire cancer care, from diagnosis to survivorship and end of life
4. Pathways should promote best evidence-based care and be updated based on new knowledge and clinical experience
5. Pathways should consider patient variability and acknowledge that complete compliance is not always reasonable or desirable
6. Implementation of pathways should promote efficiencies for providers and payers
7. Education, research, and clinical trials access should be promoted
8. Robust criteria must support the certification of pathway programs; these criteria should be the guide for pathways program participation, and payers must accept certified pathway programs
9. All stakeholders should support research to understand the impact of pathways on outcomes.

A Game Changer

This ASCO Policy Statement on Clinical Pathways in Oncology should be a game changer in 2016. Providers, employers, and payers will finally have a common standard against which to review and compare the many programs that are now called clinical pathways.

Providers will have ground to stand on to hold payers and employers to accept a conforming clinical pathway chosen by the provider, and to not increase waste and economic burden on the healthcare system by allowing multiple pathways that do not conform to these guiding principles and recommendations.

Patients and their advocates will not have to worry about the agenda of a clinical pathway that is driven by their individual insurance, and can trust that the clinical pathways being considered by their physicians in choosing treatments conform to solid evidence and value parameters.

Reference

1. Zon RT, Frame JN, Neuss MN, et al. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology. J Oncol Pract. 2016 Jan 12. Epub ahead of print.