A manufacturer completed acquisition of a wound care device and needed an informed decision on the impact on price, access and reimbursement based on the type of FDA submission, 510k predicate device or Pre Market Approval (PMA) designation to support strategic forecasting prior to initiating clinical trial design. 

Triage conducted an assessment of the Medicare, National and Local Coverage Determinations (LCD) and private Payer coverage policies and reimbursement rates for all approved products, based on the FDA 510k and PMA submission and labeled indications. Comprehensive interviews were conducted with commercial Medical Policy directors at national and regional insurers to assess the value of the product profile, coverage and reimbursement variables based on FDA filing status.

Results and Impact
Outcomes informed the manufacturer that the value of investing in a clinical program to support a PMA submission would provide increased access and price potential thereby avoiding placement on the lowest payment tier under Medicare’s “Low Cost” categorization system.  

  • Defined the key drivers of value and clinical endpoints to support superiority over existing products
  • Impact of a PMA submission as Payers move away from the fee for service to a ‘pay for performance’ model 
  • Recommendations on a contracting strategy were employed
  • Pricing strategy based on unit size to increase physician use and reducing waste 
  • Demonstrated the incremental value of a clinically focused sales effort 

Our work provided a clear understanding of the impact of a fully funded clinical program to demonstrate and document increased reimbursement over other products in a crowded market.

Comparative Coverage

A manufacturer wanted to understand the difference in access and reimbursement for a device based on FDA designation