Applications

Real-World Impact: How Patient Benefit Can Transform Healthcare

The patient benefit framework has the potential to transform healthcare delivery, policy, and research. By focusing on what matters most to patients, we can improve outcomes, drive innovation, and create a more equitable and effective healthcare system.

Applications

Patient Benefit can inform CMS drug price negotiations under the Inflation Reduction Act (IRA) by ensuring that patient priorities are considered when determining the value of a drug.
Example: CMS can use patient-reported outcomes to assess the impact of a drug on patients’ quality of life, functional ability, and overall wellbeing.

Case Study

Potential Use of Patient Benefit in IRA Drug Price Negotiations

The Inflation Reduction Act of 2022 granted the Centers for Medicare & Medicaid Services (CMS) new authority to negotiate prescription drug prices within Medicare Part D—a significant departure from previous limitations. In implementing this authority, CMS emphasized the inclusion of “clinical benefit” in its pricing decisions. However, the agency faced challenges in defining and operationalizing this concept. Despite intentions to engage stakeholders through public listening sessions and guidance documents, CMS’s process drew criticism for insufficient patient and caregiver input and lack of transparency. This paper critiques the shortcomings in CMS’s approach and proposes a framework focused on “patient benefit” rather than solely clinical measures. The proposed model emphasizes collaboration with patient communities to identify relevant health outcomes, prioritize those outcomes using scientifically validated methods, and establish metrics to evaluate drug performance. This patient-centered approach offers a more meaningful and inclusive pathway to assessing value in Medicare drug price negotiations.

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Patient Benefit can enhance value-based payment models by rewarding providers for delivering patient-centered care and achieving patient-defined outcomes.
Example: Payment models can be designed to incentivize providers to improve patients’ quality of life, reduce symptom burden, and enhance their ability to engage in daily activities.

Case Study

Calculating Patient Benefit and Physician Payment

Value-Based Payment (VBP) models were introduced to reform Medicare’s traditional fee-for-service system by rewarding care quality over quantity, aiming to slow rising healthcare costs while improving patient outcomes. However, implementation has fallen short due to inconsistent quality measurement, misaligned incentives, and an oversimplified assumption that higher quality always reduces cost. Current VBP frameworks often fail to consider the diverse needs of patients, upfront costs of innovation, and providers’ limited control over many cost drivers—resulting in perverse incentives to cut care, avoid complex patients, or exit Medicare altogether. To address these issues, this paper proposes redefining the value equation by replacing generic “quality” with “patient benefit,” thereby prioritizing what truly matters to patients and caregivers. This shift would promote more meaningful care planning and ensure reimbursement better reflects patient-centered outcomes, paving the way for a more equitable and effective Medicare payment system.

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Patient Benefit can guide medical product development and clinical trials to focus on patient-relevant outcomes and address unmet needs.
Example: Researchers can use patient input to identify the most important endpoints for clinical trials, ensuring that new treatments are evaluated based on what matters most to patients.

Patient Benefit can improve coverage decisions and access determinations by aligning them with patient priorities and values.
Example: Insurers can use patient-reported outcomes to assess the value of different treatments and services, ensuring that patients have access to the care that best meets their needs.

Case Study

Coverage with Evidence Development for Medical Devices

The Centers for Medicare & Medicaid Services (CMS) determines coverage for new medical technologies based on whether they are “reasonable and necessary” for Medicare beneficiaries, often relying heavily on clinical outcome data. However, this approach can overlook critical aspects of the patient experience, such as functional improvements, slowed disease progression, or the psychological value of hope. In situations where clinical evidence is limited, CMS may use Coverage with Evidence Development (CED) to allow conditional access while additional data are collected. This paper argues for integrating “patient benefit” into CMS’s coverage framework to address gaps in current evaluation methods. By explicitly incorporating patient-centered values alongside clinical metrics, CMS can make more nuanced, representative, and meaningful decisions—ensuring coverage policies better reflect the needs, experiences, and expectations of the populations they are designed to serve.

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Patient Benefit can enhance quality measurement and improvement initiatives by incorporating patient-centered metrics and promoting patient engagement.
Example: Hospitals and clinics can use patient surveys and focus groups to identify areas for improvement and track progress over time.

Hear from the experts: Explore diverse perspectives on Patient Benefit.

Applications

Real-World Impact: How Patient Benefit Can Transform Healthcare

Applications

Case Study

Potential Use of Patient Benefit in IRA Drug Price Negotiations

Case Study

Calculating Patient Benefit and Physician Payment

Case Study

Coverage with Evidence Development for Medical Devices

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