Understanding the intricate dynamics of payer preferences and decision-making criteria allows stakeholders in the healthcare landscape to align their offerings with payer requirements, fostering mutually beneficial relationships and ensuring the acceptance of innovative healthcare solutions.
Explore the crucial role of benefit-risk determination in EU MDR compliance and common pitfalls to avoid in medical device evaluation.
Economic data can be any data that tells a utility or benefit story. It can include health economics and outcomes research (HEOR) which measures and generates evidence of a product’s value and impact to support reimbursement and market access. But, for purposes of this blog post, we will use the term ‘economic data’ more broadly than the term HEOR.
In November 2021, the Medicare Coverage of Innovative Technology (MCIT) repeal was published in the Federal Register. This decision left start-up MedTech companies wondering if a U.S. Food and Drug Administration (FDA) Breakthrough designation would have advantages over traditional pathways and assist with the medical device reimbursement process.
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released the Final Rule, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary.” As part of Medicare’s Patients over Paperwork initiative, This final rule regulates how the largest U.S. federal payer will reimburse for innovative technologies, beginning March 15, 2021.
TOLEDO, OHIO (BUSINESSWIRE)—January 7, 2019—NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, is pleased to announce the acquisition of Reimbursement Strategies, LLC, a Minneapolis-based consultancy focused on reimbursement, health economics and market access for the international life science industry. For … Continued