Clinical Research Billing Compliance

Guidelines for healthcare billing in clinical trials

Complying with federal guidelines for healthcare billing associated with a clinical trial is important but can be complicated. The Clinical Research Billing Compliance (CRBC) program at Indiana University helps researchers and research staff minimize risks when they are billing for services provided to human subjects participating in clinical trials. As a principal investigator, you are responsible for ensuring services associated with a clinical trial are billed accordingly. IU’s CRBC staff will provide support and guidance.

Coverage analysis

Coverage analysis (CA) is an independent review of a clinical study to determine which clinical procedures and services are billable to insurance.

Which studies need coverage analysis?

A documented coverage analysis is required for all clinical studies involving interventions in which any items or services are or may be invoiced to the patient insurer(s). Any clinical studies on human subjects submitted to the IU Institutional Review Board (IRB) must determine whether a CA will be required.

Why is it needed?

Coverage analyses are important to facilitate billing compliance, mitigate risks, and avoid billing errors. Additionally, a thorough CA can have the benefit of negotiating an accurate study budget.

A documented coverage analysis must be completed during the budget construction phase of initiating a clinical trial.

The coverage analysis includes:

  • Reviewing clinical study documentation to determine all clinical study procedures/interventions
  • For each clinical procedure/intervention, reviewing published practice guidelines, local coverage determinations, and national coverage determinations to decide whether the procedure/intervention is billable to insurance
  • Where no coverage decision exists, creating supporting documentation of routine care determinations. For assistance, review the Routine Care Decision Tree.
  • Ensuring that consistent cost allocation language appears in all study documents. Regardless of the funding source, you or your delegate is responsible for conducting a review of the clinical trial documents, including the research protocol, informed consent, sponsor budget, itemized budget, and other supporting documentation, to determine the consistency of cost allocation of items and services to be billed.

Not all clinical studies are eligible for coverage by Medicare. A clinical trial must meet certain criteria in order to bill Medicare and/or Medicaid, prior to enrolling study participants. The Medicare Coverage Analysis Worksheet is an online tool designed to determine whether a clinical trial meets the requirements for Medicare or Medicaid reimbursement. The analysis will be retained in the database, and you must keep a printable version with study budget files for billing purposes.

  • Investigational drug trials: For drug trials, Medicare covers only items and services provided as part of "qualifying clinical trials" that exhibit seven desirable characteristics. Review the Centers for Medicare & Medicaid Services website for more information, or complete the Medicare Coverage Analysis Worksheet.
  • Investigational device trials: Physicians who participate in an Investigational Device Exemption (IDE) clinical study and anticipate filing Medicare claims must notify their Medicare contractor. Prior to submitting claims, providers participating in Category A (Experimental/investigational) and Category B (Non-experimental/investigational) IDE studies approved by the Food and Drug Administration on or after January 1, 2015 are responsible for checking the Centers for Medicare and Medicaid (CMS) coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage.
  • Interested parties (i.e., study sponsors) who wish to seek Medicare coverage in Category A or B IDE studies must submit a request for review and approval via email to clinicalstudynotification@cms.hhs.gov or via hard copy to the following address:
Centers for Medicare and Medicaid Services
  • Center for Clinical Standards and Quality
  • Director, Coverage and Analysis Group
  • ATTN: Clinical Study Certification
  • Mail Stop: S3-02—1
  • 7500 Security Blvd.
  • Baltimore, MD 21244

The billing grid documents all clinical trial costs allocated to the appropriate payer, whether they are the sponsor, a third-party payer, or the patient/subject. A sample of a billing grid is available at the Office of Clinical Research website. As principal investigator, you are responsible for assuring compliance with all billing rules for Medicare, Medicaid, and third-party payers. The completed billing grid must be retained with your study files.

Need to know more?

If you have questions about Clinical Research Billing Compliance, call 317-274-8289 or email researchcompliance@iu.edu.

The Office of Clinical Research provides a team of coverage analysts who are skilled at Clinical Research Billing processes. For more information, or to access this team, please visit the Office of Clinical Research website.