Additional policy considerations for financial solution adoption

A range of Precision Financing Solutions will be necessary due to the distinctive differences between diseases, products, issues, and payer types. Each of the Precision Financing Solutions identified must take into account the implementation challenges arising from governmental regulations, given how government pricing and other regulations are currently written. Historical legislation and regulations are not always amended to permit innovative contracting approaches.

The table below depicts greater detail on each of these financial models, and on significant needs for change. Policy support is required to remove existing inadvertent barriers to these arrangements and to proactively facilitate broader utilization of innovative payment models.

Enabling change

Milestone-based contract

Multi-year milestone-based contract

Performance-based annuity

Payment over time/installment financing

Warranty

Regulatory

Revised Medicaid Best Price benchmarking

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Anti-Kickback Statute safe harbor inclusion

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FDA developer communication guidelines for early discussion & using outcome metrics not in label

HIPAA revisions to ease patient outcomes and insurer status collection & sharing

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Operational

Outcomes and insurer status data collection

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Provider reimbursement mechanisms

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Risk management

Center of Excellence

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Patient mobility mechanisms

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Reinsurance/Stop-loss evolution

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FoCUS has identified six key federal policy issues with policy recommendations. The most critical issue remains Medicaid Drug Rebates and performance-based agreements. A two-page summary of these recommendations may be found here.