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Perspective Pharmaceutical and Medical Device Policy
Sanket S. Dhruva
Marcus A. Bachhuber
Rita F. Redberg
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Low-value care is common in clinical practice, leading to patient harm and wasted spending. Much of this low-value care stems from the use of medical device-based procedures.
We describe here a novel academic-policymaker collaboration in which evidence-based clinical coverage for device-based procedures is implemented through prior authorization-based policies for Louisiana’s Medicaid beneficiary population.
This process involves eight steps: 1) identifying low-value medical device-based procedures based on clinical evidence review, 2) quantifying utilization and reimbursement, 3) reviewing clinical coverage policies to identify opportunities to align coverage with evidence, 4) using a low-value device selection index, 5) developing an evidence synthesis and policy proposal, 6) stakeholder engagement and input, 7) policy implementation, and 8) policy evaluation. This strategy holds significant potential to reduce low-value device-based care.
Ideally, medical care is based on diagnostics and treatments for health conditions that have evidence that their benefits outweigh any potential harms. These considerations would be clearly communicated to patients prior to decision-making and care would lead to better quality of life and longer lives. In actuality, health care is rife with low-value care.1–3 Patients receive treatments that do not improve clinical outcomes,4 which can lead to physical, psychological, social, financial, and treatment burden-related harms, as well as overall dissatisfaction with health care.5 Overtreatment or low-value care costs the United States health care system a significant sum, likely tens of billions of dollars annually.6
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