Clinical Research Billing Compliance
Medical billing of clinical services provided to study subjects must be in accordance with Centers for Medicare & Medicaid Services (CMS) federal guidelines and the National Institutes of Health (NIH).
Routine medical audits and for-cause audits are conducted by HMH Research Compliance to ensure compliance with HMH policies and federal regulations.
OnCore
All Hackensack Meridian Health (HMH) research studies with billable services are required to use OnCore – HMH’s clinical trial management system. The HMH Research Institute’s director of Clinical Research Business oversees the administration of OnCore and ensures that the terms of clinical trial agreements align with IRB approved protocols, including the informed consent and study budget.
Medicare Coverage Analysis (MCA)
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).
Resources
- 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 Monitoring and Auditing Program
- Responsible Conduct of Research