Clinical Research Billing Compliance
Research billing compliance ensures the medical billing of clinical services provided to study subjects is in accordance with CMS Federal Guidelines and National Institutes of Health (NIH).
All HMH research studies with billable services are required to use HMH’s clinical trial management system (OnCore).
A Medicare Coverage Analysis (MCA) is required for research studies which may bill protocol required routine care services to patients or third-party payors (medical insurance companies).
HMHRI’s Director of Clinical Research Business oversees the administration of OnCore and ensures that the terms of clinical trial agreements align with the IRB approved protocols including the informed consent and study budget.
Routine medical audits and for-cause audits are conducted to ensure compliance with HMH policies and federal regulations.
HMH Contact Information
Sergio Garcia
Director, Clinical Research Business
Related policies
OnCore Utilization for Clinical Trials
Medicare Coverage Analysis
Meet your Research Compliance Team
Michelle Benson, Ph.D. - Director of Research Compliance
Martin Kleber - Research Compliance Auditor
Jordan Phillips - Conflicts of Interest Analyst
Amanda Ortiz - Conflicts of Interest Analyst
Clinical Research Billing Compliance
Research billing compliance ensures the medical billing of clinical services provided to study subjects is in accordance with CMS Federal Guidelines and National Institutes of Health (NIH).
All HMH research studies with billable services are required to use HMH’s clinical trial management system (OnCore).
A Medicare Coverage Analysis (MCA) is required for research studies which may bill protocol required routine care services to patients or third-party payors (medical insurance companies).
HMHRI’s Director of Clinical Research Business oversees the administration of OnCore and ensures that the terms of clinical trial agreements align with the IRB approved protocols including the informed consent and study budget.
Routine medical audits and for-cause audits are conducted to ensure compliance with HMH policies and federal regulations.
- Clinical Research Billing Compliance
- Conflicts of Interest
- Data Management and Sharing
- Export Controls
- Foreign Interactions and Research Security
- Privacy and Cyber Security Considerations for Research
- Research Compliance
- Research Misconduct
- Research Compliance Audit and Monitoring Program
- Responsible Conduct of Research