New Initiative Prioritizes Quality-Focused Models

In April 2024, the leaders of the Center for Medicare and Medicaid Innovation (CMMI) published a blog post outlining their vision for improving quality and advancing patient-centered care via a new initiative called the Quality Pathway. The Quality Pathway would prioritize the design, evaluation, and expansion of payment models based on their impact to quality and redefine how quality has been measured to date by emphasizing patient-reported outcomes, achievement of patient-centered goals, and patient experience.

This is a significant change in thinking for CMMI. CMMI’s mandate is to test innovative payment and service delivery models and expand those that either (1) improve quality while maintaining cost, or (2) reduce cost while maintaining quality (though ideally achieving both aims). To date, only models that have demonstrated cost improvement have been selected for expansion.  Furthermore, the definition of quality has largely focused on utilization-based measures that could be calculated using claims data. While convenient and less burdensome for providers, CMMI acknowledges that the claims-centered measurement strategy fails to capture important dimensions of quality, most notably patient-centeredness.

Implementation Challenges

In the announcement and in subsequent comments from CMS at the Annual CMS Quality Conference, leaders acknowledged that this strategic turn will be an operational challenge.  Measuring quality in a patient-centered way will require working with new data sources and types—such as electronic health record (EHR) data and digital patient-reported data—which raises concerns of additional data collection burden placed on providers, existence of appropriate and validated metrics, and the state of data standardization and interoperability.

It will also require more creative ways of determining appropriate comparison groups quality outcomes, given that, unlike claims data, these new data points and sources may not be readily available from historical sources or from providers or patients outside the model participants. Moreover, CMMI will be tasked with determining what outcomes truly matter to patients and should be prioritized and measured for a given clinical population (a sizeable challenge, given that each outcome identified is not a one-size-fits-all variable).

Similarities with FDA Guidance

For pharmaceutical companies, these themes are familiar. There are clear similarities in concept and approach to the Food and Drug Administration’s (FDA) patient-focused drug development initiative and guidance.  And like the FDA guidance, key stakeholders are concerned about both what to measure and how to measure patient-centered aspects of performance. The patient-focused drug development initiative emphasizes that manufacturers should determine very early in the development process which outcomes and aspects of treatment matter most to patients, and then decide the best way to measure their product’s impact on those factors. In many cases, this will require developing and validating new clinical outcome assessments, just as new patient-reported outcome measures will need to be developed for CMMI demonstrations.

Opportunities for Manufacturers

Quality Pathway represents a compelling opportunity to engage with providers and payers in researching and developing approaches to defining patient-centered quality for key therapeutic areas of interest. Drug manufacturers can create a clear continuum of patient-centered quality by defining, measuring, and improving on the same key concepts from drug development through care delivery and payment models.

To ensure that quality-focused innovation models measure what is truly important to patients, researchers must understand both the total burden of a condition on patients’ and caregivers’ lives, as well as their preferences and priorities for treatment. These are also the same key questions that manufacturers need to answer to drive patient-focused drug development and to support patient-centered value assessments—putting manufacturers in the ideal position to make major contributions to the evidence base that CMMI will look to when designing their models. Studies that seek to understand the full impact of a disease on the daily living, mental health, social functioning, and economic functioning of both patients and caregivers should be a priority for all manufacturer health economics and outcomes research teams.

The announcement of the CMMI Quality Pathway also underscores the importance of manufacturers having a clear and compelling quality strategy for each therapeutic area. Both payers and providers face significant and increasing pressure to meet quality and value metrics from regulatory agencies and for value-based contracts. A given health system likely has accountability for dozens of quality metrics across programs such as the Merit-based Incentive Payment System (MIPS), Hospital Value-based Purchasing program, NCQA’s HEDIS®, the Medicare Shared Savings Program, and multiple commercial or managed care contracts. There are varying degrees of financial and reputational impact to the system from these measures. Manufacturers that understand which measures are highest priority for their health system and payer clients, and how their therapies can support success on those measures can build a strong value message into their market access activities.

A quality strategy should also look to the measurement landscape to determine if there is a measurement gap. For example, do validated measures exist for the concepts that research has determined should be measured? If not, what is the plan to fill those gaps?  While CMMI acknowledged that new measures need to be developed, it has historically looked to academia, professional societies, and private entities to develop measures. Manufacturers can play an important role in partnering with these stakeholders to identify and fill measurement gaps.

While it remains to be seen how CMMI will put the Quality Pathway into action and the effect it will have on payment models, the premise of elevating quality over cost is encouraging. The ultimate win for patients will be a health care system that prioritizes discovery of treatments that address their most pressing needs aligned with a payment system that incentivizes delivering those treatments in a patient-centered model.

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Avalere’s subject matter experts help clients understand perspectives and develop strategies to improve quality and optimize patient access to care. To learn more about Avalere’s work in quality, patient-centered research, and clinical outcomes, and how we can help you work with CMMI, connect with us.