Clinical Research Billing Compliance

Policies & Guidance

The Clinical Research Billing Compliance Plan and Policies are intended to supplement existing Health Care Billing Compliance Plans and are not intended to duplicate or replace existing plans.

The Clinical Research Billing Compliance Plan and policies provide a framework in which clinical research billing is conducted in accordance with federal laws, regulations and guidelines applicable to clinical research billing activities as well as any other areas of research compliance determined to be appropriate.

Clinical Research Billing Compliance Policies:

IU Financial Services:

This listing is not inclusive and other policies/regulations may apply:

  • Financial Management Services - provides explanations and examples of various transaction processing documents, shows training schedule dates, allows you to sign up for classes online, lists department contact information, and gives helpful tips on using the system.
  • Accounts Receivable - provides references to information regarding contacts, collection policies, reporting, invoicing and standard operating procedures.
  • Accounts Payable Disbursement Voucher - explains what a Disbursement Voucher is and how it is used.
  • Accounts Payable Inquiry- enables you to check the payment status of Disbursement Vouchers and Purchase Orders
  • Accounting Services - homepage for IUPUI campus that lists department contact information, describes the Electronic Payment and Invoicing Center (EPIC) and provides additional information and training opportunities for Disbursement Vouchers.
  • Human Subjects Policies - Indiana University Human Subjects Research Compliance Federal Regulations & Policy Information

Federal Regulations and Guidance:

This listing is not inclusive and other policies/regulations may apply:

  • Stark Anti-Kickback Law and Regulatory Safe Harbors
  • Fraud and Abuse Laws – Health care, Medicare, Insurance
  • OIG Compliance Program Guidance for Third Party Medical Billing companies, Hospitals, Individual and small group Physician Practices
  • 45 CFR 46 - DHHS Regulations on the Protection of Human Research Subjects
  • 21 CFR 50 - FDA Regulation on Human Subjects, Informed Consent
  • 21 CFR 56 - FDA Regulation on Institutional Review Boards
  • 21 CFR 312 - FDA Regulation on Investigational New Drug Applications (IND)
  • 21 CFR 812 - FDA Regulation on Investigational Device Exemptions (IDE)
  • 21 CFR 54 - FDA Regulation on Financial Disclosure by Clinical Investigators
  • Medicare Carriers Manual and Medicare Coverage Issues Manual - Policies and procedures based on statutes, regulations, guidelines, models, and directives- Chapter 32
  • 42 CFR Chapter IV - CMS, DHHS Regulation regarding public health
  • OIG, A-110, A-21 - Office of Management and Budget circular on financial compliance for financial awards