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