Reimbursement ServicesReimbursement can make or break a device. We can help.
Every new medical device or drug is confronted by obstacles—and opportunities—posed by the United States’ unique and complex system of health care finance and insurance. The more innovative the product, the greater the opportunities and obstacles.
Among the keys to commercial viability and success, every entrepreneurial company needs to:
- Understand and assess, as early in the product development process as is feasible, the reimbursement landscape into which its product(s) will need to fit;
- Develop an actionable plan, fully integrated with the regulatory and clinical plans for the product, to secure commercially reasonable reimbursement in a timely and resource-efficient manner; and
- Organize and mobilize the personnel and other resources required to execute the plan successfully, and maintain or improve reimbursement over time.
Reimbursement engagements are tailored to your individual needs and may include:
- A robust health economic analysis to provide clinical and economic value to payers and providers.
- A reimbursement strategy roadmap to address policy, pricing, and evidence.
- A comprehensive reimbursement landscape assessment addressing all the elements of that landscape.
- The status of the product within insurance benefit structures;
- The availability of product or procedure codes for use in billing and how to secure new codes if required;
- The payment amount for existing codes and how payment will be set if the new coding is required;
- The applicability of current insurer coverage policies and the evidentiary burden for securing new or expanded coverage; and
- How the growth of value-based payment models will impact the product.
- An operational focus on one or more landscape elements of special concern (e.g., preparation and submission of an application for a new billing code; development of a dossier supporting coverage and/or desired payment; specification of the pharmacoeconomic model for assessment of the product’s impact on total costs).
- Design of a longer-term reimbursement function for the company, with recommendations for staffing and other resource requirements.
MEDIcept can help address your reimbursement issues, and develop a coordinated and comprehensive commercialization strategy. Our reimbursement experts have more than 20 years of experience as senior managers in the medical device and services sectors and have provided reimbursement assistance to dozens of development-stage companies across the life sciences and medical technology spectrum.
I need help NOW!
Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.
Need FDA or EU MDR/IVDR audit assistance?
Don’t do it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.