The Aequitas Group
Case Studies
Patient Assistance Program Design - Insulin Products
Insight
A global leader in dialysis products wanted to explore possible programs that could be developed to encourage greater interest in the client’s product and involve the distribution of the product, separate from patient assistance programs.
Strategy
The Aequitas Group was asked to assess the appropriateness of possible program scenarios that were being considered by the client and provide them with an assessment of the liabilities, risks and cures for these programs, with the goal of steering any program that might be implemented by them towards compliance with the legal advisories as articulated by the Health and Human Services (HHS) Office of Inspector General (OIG).
Execution
A review of laws and regulations specific to drug distribution assistance to patients (not including patient assistance programs) was performed by a licensed attorney at The Aequitas Group, and provided the client with a summary of applicable laws and regulations, identified key statutes that had been interpreted broadly by various pharmaceutical companies, and helped develop a risk assessment the client could use to inform the internal decision.
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