GETTING COVERAGE FOR AN EFFECTIVE PRODUCT
Addressing a specific clinical condition with an effective and unique approach is essential to adoption of any new medical device. Ensuring that your product is supported by scientific evidence that is credible and robust will enable you to gain coverage by commercial and government health care payers.
VALIDATE THE EFFECTIVENESS
OF YOUR PRODUCT
Assess the evidence to support the product
Critical review of the scientific studies and peer reviewed literature to support the claims of your product’s effectiveness and utility is an essential. A credible and compelling dossier that stands up to critical review by clinicians and health plan medical policy reviewers will help you gain coverage for your product.
Get insight from clinicians who have experience with the product and related products
It is essential to get validation by clinicians who may have worked with your company as consultants as well as independent academic and community clinicians who have used the product. It is also important to get value statements, if possible, by medical professional organizations and associations in support of the product’s effectiveness and utility.
PAYER COVERAGE CHALLENGES
Develop communication and promotions materials to present to appropriate audiences
Based on the scientific evidence, support by clinicians and professional organizations are important to help payers make appropriate coverage determinations. It is essential to develop clear, credible and convincing documentation for review by the payer entities for successful adoption and coverage determination.