Research Billing Compliance

Objective

To set forth compliance requirements for the medical billing of clinical services provided to subjects who participate in clinical trials or other human research studies in accordance with the Federal guidelines from CMS (http://www.cms.hhs.gov(link is external and opens in a new window)) and National Institutes of Health (NIH) (http://www.nih.gov(link is external and opens in a new window)); to help ensure that clinical services associated with research studies are not billed inappropriately or in duplicate to a patient or third-party payor; and to help ensure that the University adheres to all the regulations that govern medical billing practices in this area.

Policy

It is the policy of CUIMC that faculty, providers and staff work together to ensure that clinical services associated with a research study are billed appropriately and in compliance with relevant laws and regulations. Any research related billing must be coded and charged based on actual services rendered; must be allowable by regulations governing medical billing practices; must be in accordance with the terms of any sponsored research project; and must be consistent with the informed consent signed by the research subject. As research billing is subject to the federal regulations, it falls under the University Billing Compliance policy.

Roles and responsibilities of OFBC Education

  • Provide, and maintain procedures to enable compliance with regulatory requirements;
  • Provide guidance to principal investigators, study coordinators, department administrators and other designees on topics encompassed in this policy and its related procedures;

Monitoring and Auditing

  • Design and conduct compliance reviews of services provided to study subjects in order to monitor compliance with this policy and applicable medical billing regulations;
  • Conduct Research Billing Compliance Audits based on an annual research compliance risk assessment;
  • Receive and monitor all investigations of potential non-compliance issues reported to the Research Compliance Office;

Research Risk Based Assessment

A Research risk-based assessment will be performed for the institution once a year by the OFBC. The outcome of the assessment will set the research audit activity for the year.

Criteria Research Risk Based Assessment:

  1. Studies with a large volume of clinical services in the budget
  2. Implantable device studies
  3. Studies expected to have high enrollment number of subjects
  4. Previous history of compliance concerns
  5. No research coordinator or few study personnel associated with the study
  6. New Investigators
  7. Departments with large number of studies
  8. Studies involving minors

Enforcement

Corrective action plans to address any instances of non-compliance with CUIMC research related policies and with federal and state laws and regulations related to research.

 

 

 

 

Office for Billing Compliance
Policy#: 10040
Original Date of Issue: 1996
Revised: 3/22/2023
Reviewed: 3/1/2024