Developing a comprehensive reimbursement strategy for a novel technology first requires an assessment of the regulatory strategy and the provider, patient, and payer markets for a product. Argenta will work with you to consider and explore a range of questions as part of the reimbursement assessment process, including the following:
What is the patient and payer mix?
- Are the majority of your patients enrolled in Medicare (over the age of 65 or disabled)?
- What percentage of patients do you anticipate will be under the age of 65?
- What percentage of patients do you anticipate will be Medicaid?
- Will your technology qualify for Orphan Drug status?
How should you prepare for Medicaid coverage?
- Does Medicaid currently have a Preferred Drug List for your class of drug?
- Do you plan to participate in the supplemental rebate programs or State Pharmacy Assistance Programs?
How should you prepare for Medicare coverage?
- Is there an existing National Coverage Decision or Local Coverage Decision that will encompass your technology?
- Will you be considered a drug or a biologic?
- Will you participate in Medicare Part D?
How should you prepare for commercial payer coverage?
- Will your therapy be considered a drug or a medical benefit?
- What class of drugs do you anticipate that the payers will place your product in?
- Will you be distributed by a specialty pharmacy?
- How can you utilize your clinical trial(s) to gather some or all of the data that will be required?
- What role will technology assessment play in this process?
How will your product be coded?
- What are the relevant sites of service?
- Which codes currently exist in these settings?
- Which codes will need to be acquired?
- What is the timeline for implementing the coding strategy?
- What is the process for the application(s)?
How will your product be priced and paid?
- Does the coding structure in each site of service enable payment for your technology?
- Will your pricing enable your end users to be paid adequately within the existing coding structures?
What type of support will your end users require upon launch?
- Provider and facility reimbursement guides
- Health plan formulary guide and clinical presentations
- Health plan technology assessment dossiers (if a medical benefit)
- Customer training presentations
- Sales training presentations
- Field Reimbursement Team
- Customer Reimbursement Support Line
- Continuing education program