The U.S. healthcare system includes both public and private health insurance coverage for medical devices. Coverage of a device and its reimbursement are determined by each payer’s coverage policies. The two largest government insurance programs are Medicare and Medicaid, which are subject to federal and state requirements.

Reimbursement requires evidence to support claims that a technology leads to better patient outcomes at lower cost than existing solutions. Reimbursement by third-party payers is a separate process from regulatory approval, although without approval there will be no reimbursement.

2019年9月10日 · To be able to use a new medical device in a care setting, it must first be approved by the Food & Drug Administration (FDA). The type of regulatory approval a device must undergo depends on its claims, with the most common paths to market being Premarket Approval (PMA) and 510k.

2024年5月9日 · Understanding coding and coverage mechanisms are essential to developing a reimbursement strategy for a new medical technology. These Q&As address the differences between coding and coverage. My device has been cleared by the FDA. Does the regulatory approval guarantee coverage and payment for services using this device?

2021年12月10日 · Generate medical device revenue with a smart reimbursement strategy for medical devices. This article gives examples of how to secure reimbursement under challenging circumstances.

2023年7月1日 · Goals for a Medical Device Reimbursement Strategy. The following are what I consider as the goals for any medical device-related reimbursement strategy: Universal coverage from all insurers in all patient care settings; Unambiguous coding; Adequate institutional & physician reimbursement

2024年12月30日 · Payer reimbursement can play a critical role in the success of advanced medical devices. Without a clear path to securing reimbursement, even the most innovative devices may struggle to achieve widespread adoption. A medical device reimbursement strategy is a plan for securing payment and coverage for a medical device from healthcare payers.

2023年2月10日 · Reimbursement can impact your design, regulatory strategy, and financial returns on medical devices. Understanding the key components of reimbursement allows for a more streamlined process to market and must be considered early in the design process.

Medical communications, reimbursement, and continued compliance with regulatory requirements are integral to the successful sale and distribution of medical devices.

Medical devices play a pivotal role in modern medicine, ranging from simple diagnostic tools to life-saving implants. The cost of developing, manufacturing, and distributing these devices can be substantial, making reimbursement a crucial factor in the sustainability of the medical device industry. Here are some key aspects of its importance: