PIPC is pleased that the U.S. has made significant progress in advancing patient-centeredness in clinical and health systems research over the last several years. Recognizing the need to instill patient-centered principles into the foundation of our health care system, we strongly advocated for the authorization of the Patient-Centered Outcomes Research Institute (PCORI) in 2010 to change the culture of research to better respond to patient needs, outcomes, and preferences, an objective that PCORI is embracing as it shifts away from traditional investigator-initiated research topics to targeted and patient-driven research topics. Building on PCORI’s creation and an increased focus on patient-centeredness, Congress specifically allowed the Food and Drug Administration (FDA) to develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions as part of the Food and Drug Administration Safety and Innovation Act in 2012. This was a significant achievement for patient-centeredness in the drug development process. Additionally, the FDA is also increasingly focused on patient-reported outcomes in their policies and quality improvement programs. These developments highlight the recognition by policymakers that patients should not be in the back seat, but should instead be driving research, and are capable of translating patient-centered research into health care decision-making.
Since its founding, PIPC has been at the forefront of patient-centeredness in CER – both its generation at PCORI and translation into patient care. With a focus on the front end of clinical CER, PIPC’s members initially coalesced around the recognition that policymakers will find it difficult to develop a patient-centered payment and healthcare delivery system without an evidence base developed around patient-centered principles. As the concept of patient-centeredness becomes better defined in its application to research, PIPC looks forward to bringing the patient voice to the discussion of how to advance patient-centered principles in a value-based health care system, specifically in the development of new payment and delivery models.
More recently, work to shift from health care payment based on volume to “value-based” models has taken hold, in part due to broad cost-containment pressure and in part due to the expansion of value-based payment policy via the Affordable Care Act. This movement holds significant implications for patients – on the one hand, value-based payment reform can improve care quality, coordination and patient experience. At the same time, many forms of value-based payment put providers at financial risk for spending targets, which will fundamentally change the doctor-patient relationship, and create the risk of stinting on care that is best for the individual patient and, depending on how they are implemented could promote rigid “one-size-fits-all” applications of comparative effectiveness research. An opinion piece from Wharton School at University of Pennsylvania recognized that research shows that often the more expensive treatment is worth the additional costs, and in “such cases, net value, not cost containment for the sake of cost containment, should be our social goal.”
This broad trend toward value-based or alternative payment models (APMs) underscores the importance of ensuring that value-based tools support patient-centeredness in health care. Failure to advance patient-centeredness in payment reform risks blunting much of the progress that has been made to date in patient-centered research. APMs are increasingly utilizing evidence standards and value-based tools that rely on comparative effectiveness research (CER) and other sources of health care data, presenting both opportunities and challenges as we instill patient-centered principles in a value-based health care system. For example, Congress is beginning to recognize the value of patient-centeredness, referencing shared decision-making as a goal for new accountable care organizations (ACOs) and directing the Centers for Medicare and Medicaid Innovation (CMMI) to embrace concepts such as shared decision-making and evidence-based medicine in its guidance to demonstration project partners. Also, the experience with Patient-Centered Medical Homes (PCMHs) hold great opportunities for engaging patients in informed treatment and health care decision-making, and therefore advancing patient-centeredness.
Health care stakeholders – ranging from patients, providers, and innovators – understand that a value-based health care system that truly supports advancements in personalized medicine must be built on a foundation of patient-centeredness. By incorporating patient-centered principles throughout the building blocks of our health care system, we can provide high-quality care in a manner that is both beneficial to the individual patient and sustainable. Therefore, PIPC developed this paper to highlight some of the most important opportunities and issues to address in translating principles of patient-centeredness to APMs, or value based payment models. We intend for this white paper to better define how principles of patient-centeredness should be considered in the context of developing APMs and a value-based health system.
To provide context for the discussion of the role of patients in APMs, Part One identifies what it means to be patient-centered, including how the concept of patient-centeredness informs the role of patient engagement and patient empowerment in the healthcare system. Part Two describes in detail the foundation provided by a patient-centered evidence base that is built on patient-centered research methodologies and standards, as well as a data infrastructure that can collect and report information that is meaningful to patients. Once the evidence base is established, Part Three discusses how to apply and use the evidence to make a practical difference in the provision of healthcare and on health outcomes. Part Four highlights the concept of value for the patient. Part Five elaborates on how to build a patient-centered learning healthcare system through a discussion of how to develop measures and align incentives across the healthcare spectrum that provide crucial information on how the system is functioning. With measures and incentives aligned to meet principles of patient-centeredness, we will have the foundation to build patient-centric approaches to value-based payment models, allowing us to learn from existing and evolving APMs (e.g., Accountable Care Organizations, bundled payment systems, medical homes) the extent to which they are meeting patient-centeredness criteria, as discussed in Part Six. Finally, Part Seven describes select APMs and their opportunities and challenges for advancing patient-centeredness in care delivery.
PIPC acknowledges that we are designing the house while we are building it, and we view this as a living document that will evolve along with evidence-based medicine and payment policy. We highlight some of the challenges that need to be addressed within those building blocks that lead to patient-centeredness and offer a comprehensive set of recommendations for policymakers and health care decision-makers, including those in Congress and at the Center for Medicare and Medicaid Innovation (CMMI). While these recommendations are geared toward influencing improvements in federal policy, they have broader relevance for consideration by policymakers in other federal programs, State health programs, and private payers. Part Eight will conclude with a series of specific recommendations for policymakers seeking to fulfill the promise of patient-centeredness.