Trusted Fiduciary
Legal Compliance
Protecting patients through rigorous standards in privacy, transparency, and institutional accountability.
Ensuring Compliance While Advancing
Cost-Effective Care
Public Good Pharma’s Interventional Pharmacoeconomics (IVPE) programs are designed to help self-insured employers meet their legal obligations under ERISA and the Consolidated Appropriations Act (CAA) by ensuring healthcare expenditures are both reasonable and aligned with improving patient outcomes. Our programs reduce costs, improve transparency, and offer a legally sound framework for delivering innovative therapies.
Regulatory Alignment
Continuous monitoring of FDA and global
health authority guidelines to ensure protocol
integrity.
Patient Privacy
Data protection protocols
compliant with HIPAA and GDPR standards.
How IVPE Supports Legal Compliance
- Meeting Fiduciary Obligations:
- IVPE trials address employers’ fiduciary duty under ERISA and CAA to ensure healthcare spending is reasonable and beneficial for members.
- By validating cost-effective therapies, employers can demonstrate proactive measures to reduce unnecessary expenditures.
- 100% Voluntary Participation:
- All IVPE trials are voluntary, ensuring members can withdraw at any time without penalty.
- Participants are compensated for their involvement, with full medical expense coverage and informed consent processes safeguarding their rights.
- Comprehensive Risk Management:
- Trials are conducted under the oversight of experienced Contract Research Organizations (CROs), with insurance coverage in place to manage risks from adverse events.
- This framework minimizes potential liability for employers and protects participants.
Innovative De-Risking Strategies
Retrospective Trials and RCT Emulation
- Before launching prospective trials, PGP conducts rigorous reviews of medical literature and retrospective studies to analyze existing data.
- RCT emulation techniques are used to validate outcomes and further reduce uncertainty.
Biomarker Development
- IVPE trials include the identification of biomarkers to stratify patients most likely to benefit from lower-cost therapies.
- This approach supports the transition to personalized medicine, improving outcomes and aligning incentives with cost-effectiveness.
Changing Incentives for Better Healthcare
PGP’s IVPE model shifts the focus from maximizing revenue after FDA approval to advancing personalized medicine and achieving better, more cost-effective outcomes for both payers and patients. By aligning incentives with value-based care, IVPE trials reduce long-term healthcare costs while enhancing transparency and accountability.
Partner with Public Good Pharma
Our IVPE programs offer self-insured employers a compliant and forward-thinking solution to specialty drug cost management, legal risk mitigation, and better healthcare outcomes. Contact Us Today to learn how we can support your compliance and cost-saving goals.