Policy on Research Billing

Title

University of North Carolina at Chapel Hill Policy on Research Billing

Introduction

Purpose

The purpose of this document is to establish a uniform policy for billing of procedures, items, or tests provided to subjects who participate in clinical research studies. This policy supplements existing policies related to the conduct of clinical research studies. This policy is applicable to medical items or services provided as part of a clinical research study; however, it does not apply to studies that do not involve human subjects (as defined in University policies and/or federal regulations) or studies that do not involve a test article or clinical procedure (e.g. studies that only include survey and chart review). This policy must be followed regardless of the funding source of the clinical research study.

Scope of Applicability

This policy applies to all clinical research projects being conducted at the University of North Carolina at Chapel Hill (UNC-Chapel Hill) where charges for items, services, and procedures will flow through UNC Health hospital or professional (physician) billing systems and where UNC-Chapel Hill is a party to the research contract or award agreement. This policy is applicable regardless of whether research participants have, federal, state, or commercial health insurance.

Research in which there is no professional or hospital services provided and does not result in billable charges processed through hospital or professional (physician) billing systems (ex. chart reviews, survey research) and other studies as determined by the Director, Office of Clinical Trials are exempted from this policy.

The Research Billing Policy applies to the following members of the UNC-Chapel Hill research community:

• researchers (including academic staff, research assistants, research associates, research fellows and academic-related staff); and
• staff involved in research administration (including technical, clerical, and administrative staff) employed by the University, whether working on the UNC-Chapel Hill campus or while working on assignment in other locations.

This Policy is intended to reflect the content of other UNC-Chapel Hill research policies and procedures.

Policy

Policy Statement

Complex federal and private payer rules govern the conditions under which services, items, and tests associated with a clinical research study can be billed to study sponsors, study subjects, and/or their insurers. Accurate clinical research billing depends on planning and collaboration between the study team and a wide variety of individuals and offices before, during, and after the clinical research study is initiated. For purposes of this policy, individuals who receive billable services, items or tests associated with a clinical research study and who are clinical research study participants, are generically referred to as “study subjects.”

1. Each clinical research study must be:
   1. Conducted pursuant to the study’s billing coverage analysis (BCA) and approved billing grid (performed and generated by the UNC Office of Clinical Trials) that appropriately direct charges to the study account, the study subject, or the subject’s third party payer; and
   2. Reviewed by Office of Clinical Trials to approve the consistency of the study budget, as well as contractual and informed consent language with the coverage analysis and the billing grid in advance of opening the study to subject accrual.
2. For industry-funded research projects contracted through UNC-Chapel Hill, the final negotiated study budget must be submitted to Office of Clinical Trials prior to execution of the Clinical Trial Agreement (CTA, also called a “research contract”) to verify its alignment with the approved billing grid.
3. Clinical services, items, or tests billed to study sponsors, study subjects, and/or study subjects’ third-party payer must be fully documented in the medical record. These services must be consistent with:
   1. Applicable billing rules of the third-party payer that is billed;
   2. UNC Health procedures that establish safeguards to prevent billing errors; and
   3. Any grant provisions or contractual obligations entered into by UNC-Chapel Hill.
4. Potential costs to the study subject or subject’s third-party payer associated with participating in the clinical research study must be:
   1. Clearly disclosed and agreed to by the study subject; and
   2. Represented consistently across all study-related documents, including the protocol, grant, contract, budget, billing grid and Informed Consent Form, and such documents must not contain any language that indicates scenarios (including subject injury) in which Medicare, Tricare, or other federally funded health insurance programs will be charged first and the sponsor will pay the balance that the insurance does not cover. Such language is inconsistent with UNC-Chapel Hill position statements on subject injury in a clinical trial federal law.
5. Study teams must ensure that all study subjects:
   1. Are included in the CRMS or OnCore record;
   2. Have appropriate information about their research participation documented in their medical record in accordance with the policies of the study site; and
   3. Have their initial study enrollment and subsequent enrollment status changes reported within one business day, using the tools and procedures established by Office of Clinical Trials. Specific reporting methods and/or additional requirements may be established by the clinical sites of practice where the study is conducted.
6. Clinical research studies involving the use of an Investigational Device Exemption (IDE) device in which any study-related services, items or tests are billed to study subjects and/or study subjects’ third party payers (i.e., the study sponsor is not covering 100% of these costs) must be reviewed and approved by the Centers for Medicare and Medicaid Services (CMS) and/or its designated Medicare Administrative Contractor (MAC). The MAC must provide written confirmation that the study has been entered into its Medicare claims processing system. This review and approval process must be completed prior to the Office of Clinical Trials activating the study’s Epic Research Account and the commencement of study subject enrollment.
7. When a clinical research study ends (i.e., all study subjects have received all services in the study billing grid and study billing has ended), study teams must inform the Office of Clinical Trials and complete other steps under the Study Billing Closeout Process.

Definitions

Billing Coverage Analysis (BCA): detailed review of clinical research items, services, procedures and Medicare billing rules to determine the appropriate payer/funding source for each.

CMS: Centers for Medicare and Medicaid Services.

Routine Costs: items and services that would ordinarily be provided to beneficiaries and covered by insurance (including Medicare). These include items that are typically provided absent a clinical trial (conventional care) required solely for the provision of the investigational item or service (e.g. administration of a non-covered chemotherapeutic agent,) provided for the clinically appropriate monitoring of the effects of or prevention of complications from the investigational item, or services needed for reasonable and necessary care arising from the provision of an investigational item or service- in particular, for the diagnosis or treatment of complications.

Related Requirements

External Regulations and Consequences

• Centers for Medicare & Medicaid Services - National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)
• Centers for Medicare & Medicaid Services - Medicare Benefit Policy Manual, Chapter 14, Section 20: Medical Devices

University Policies, Standards, and Procedures

• Policy on Signing University Contracts

Contact Information

Policy Contact

Name: Christine Nelson
Title: Director
Unit: Office of Clinical Trials
Email: chrisnel@email.unc.edu
Phone: 919-843-0832