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Quality Improvement Office

Clinical Research Billing Compliance

The Clinical Research Billing Compliance (CRBC) program seeks to mitigate risks when billing for items and services related to subject participation in a clinical trial. This is accomplished through education and training regarding regulatory requirements and ongoing monitoring of research billing activities.

Purpose

The purpose of the Clinical Research Billing Compliance program is to promote:

  • Compliance with federal guidelines for healthcare billings associated with clinical research
  • Consistency in payment terms as related to the research study contract, budget protocol, informed consent, Medicare Coverage Analysis (MCA) and Separation of Allowable Costs.
  • Communication between research teams and healthcare affiliates as regarding appropriate recovery of clinical research study costs and reducing risks of inappropriately billing patients and/or third party payors.

Coverage Analysis

During the budget construction phase of clinical trial initiation, a documented analysis of cost allocation must be completed. This coverage analysis is a systematic review of clinical trial documents to determine the costs of conducting the trial and specifically assign billable services and procedures to the sponsor, third party payer or patient/subject. It is the responsibility of the Principal Investigator (PI) to ensure that clinical services associated with research studies are billed appropriately. The analysis includes:

  • Qualifying trial determination: Medicare Coverage Analysis (MCA), or Device requirements
  • Separation of Allowable Costs
  • For services for which coverage is not yet established, a Supplemental Coverage Review by the Medicare contractor Medical Director or Fiscal Intermediary
  • Ensuring consistent cost allocation language in all study documents

Medicare Coverage Analysis (MCA)

In order to bill Medicare and/or Medicaid for research related routine care costs of items and services, a clinical trial must meet certain criteria to qualify for reimbursement. To determine whether your clinical trial meets the requirements for reimbursement by Medicare for routine costs, the MCA must be performed prior to enrolling study subjects and initiating clinical research procedures.

An online tool to determine whether your trial qualifies for reimbursement by Medicare is located in the 'Tool Kit' to the right. The summary determination at the end of the MCA will be retained in the ORC MCA database and may be printed and maintained with the study budget files for research billing purposes.

Separation of Allowable Costs

The primary objective of the Separation of Allowable Costs coverage analysis is to document that an allocation of costs analysis has been completed and all costs of a clinical trial are allocated to the appropriate payer whether it is the sponsor, a third party payer or the patient/subject.

The Principal Investigator (PI) is responsible for compliance with all billing rules for billing Medicare, Medicaid and third party insurers for services provided in the context of clinical research. The PI or his/her delegate is responsible for conducting a systematic review of clinical trial documents including the research protocol, Informed Consent, sponsor budget, itemized budget, and any other supporting documentation to determine the consistency of cost allocation of items and services to be billed. This internal analysis is required regardless of the funding source and cost allocation.

The Separation of Allowable Costs must be completed and maintained with the study budget files for research billing purposes.

FDA Investigational Device Exemption (IDE) Trials

Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, providers participating in and seeking Medicare reimbursement for items and services in Category A or B IDE studies, prior to submitting claims, 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) that 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

Interested parties do not need to submit both electronic and hard copies of requests.

(CMS Manual System, Pub 100-02 Medicare Benefit Policy, Transmittal 198, change request 8921, dated November 6, 2014, Subject: Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies)

Please notify CRBC office (researchcompliance@iu.edu) of any billing issues for assistance with coordination and resolution.

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