Reimbursement Planning Model
Concept Assessment Phase
- Will it be in-patient or out-patient?
— If in, will current DRG cover it? If not, what ICD-9 changes need to take place?
— If out, will a C-code be needed? Will threshold be met?
- Will data be adequate to support coding and coverage needs? Will data timing work?
- What is publication schedule?
- Who will cover (Who pays?) this and why? What are current coverage policies?
- Who will do technology assessment (T/A)?
- Cost Effectiveness Analysis (CEA): will it work with clinical data being collected?
Pre-Market Phase
- Planning: What are anticipated health policy or reimbursement policy changes that may be required to successfully launch this procedure?
- Research: What guidelines and/or technology assessments exist for similar technology?
- Input to Clinical Study: What outcomes data will assist in advocating for coverage and payment with the payers?
Intro to Market
- FDA device categorization (for Medicare)
— Category A (experimental / investigational): No coverage
— Category B (non-experimental / investigational): May be covered
- Pre-launch reimbursement materials
— Provide reimbursement guide to assist physicians and hospitals with coding, coverage and payment under the clinical
- Payment/coverage strategy test
— Educate physicians and hospitals in coverage request process
— Adjust launch strategy as appropriate based on payer responses
Market Release
Implement launch strategies
- Coordinates tools for gaining coverage & payment
— Peer-reviewed journal articles (at least two)
— Demonstrate cost-saving
— Provider acceptance
— Provider assistance in coverage process
- Seek coverage
— case-by-case
— Payer-by-payer
— National vs local coverage for Medicare
Market Adoption
- Update launch materials
- Monitor health policy for changes that impact your product
- Adjust to market
Final Thoughts for Reimbursement
- Establish the function
- Start early
- Budget adequately
- Understand the process and risks
- Manage expectations
— Establish realistic time lines
— Establish realistic goals
— Reassess and remain flexible
[Source: lecture by Mitch Sugarman]
