Clinical Research Billing Compliance FAQs

Frequently Asked Questions (FAQs) specific to the clinical research billing compliance are available below. For all available FAQs, please visit the Main FAQ page. This page includes an index with links to all specific FAQ pages.
  • What is a Coverage Analysis (CA)?
    A Coverage Analysis is a two part process of determining, and documenting the reasoning to support the determination meets Medicare’s criteria Qualifying Clinical Trial (MQCT) and for qualifying clinical trials prospectively documenting the funding source for the clinical trial’s patient care costs commonly known as billable events. In other words, prior to study enrollment the coverage analysis identifies which party (study sponsor, patient, third-party payor, etc.) should be billed for each patient care item/service.
  • How do I know whether the study needs to go through the Coverage Analysis process?
    If the research study includes any patient care services or items that may generate a charge in the patient billing system (i.e. IDX/GE Centricity, EPIC, etc.) then a CA is needed regardless if the charge is intended to be paid by the subject/their insurance or the research study. These patient care events are typically associated with a CPT and/or HCPCS code and are frequently referred to as “billable events”. In other words, if the study protocol includes a billable event, a CA is required. The CA is documented on an internal document called the Clinical Research Billing Compliance Study Documentation Form for each applicable study.
  • What are some examples of billable events?
    Clinic visits, blood draws, radiology, local lab tests, procedures, manual manipulation, etc. all could generate billable events.
  • Why do we need the billing codes now? The study is not activated yet.
    Obtaining billing codes allows you to determine the cost to conduct the item/service. Billing codes are unique and allow you to search coverage determinations and pricing based on codes.  Sponsors may describe an item/service differently than what is used for billing (ex: blood draw vs. venipuncture). This step provides greater transparency on the items.
  • Who does the Coverage Analysis?
    The Compliance Office will create the Billing Grid for Coverage Analysis.
  • How do I develop a Billing Compliance Plan (BCP)?
    Use the study documents to customize the BCP for each research study. The BCP is a tool you can use to create comprehensive documentation for budget proposal and development.
  • What are routine costs in clinical trials?

    For qualifying clinical trials, Medicare covers items and services considered to be “routine costs.”  Routine costs in clinical trials include:

    1. Items or services that are typically provided absent a clinical trial (e.g., conventional care);
    2. Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
    3. Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis.
    All other Medicare rules apply.
  • How can compliance with research billing rules be achieved?
    The Compliance Office helps support the research community with the complex research billing rules. Compliance with research billing rules can be achieved through coordination and communication of study payment information, transparency in study payment documents, understanding the background of the billing rules and recording items and services appropriately on the Billing Compliance Plan.
  • Who is responsible for research billing compliance?

    The Principal Investigator (PI) has ultimate responsibility for achieving research billing compliance, but the full support of the study team is needed in order to do so successfully. The PI has primary responsibility to understand and comply with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context. 

    Other site personnel (including patient service representatives, billers, coders, clinic administrators, etc.) are responsible for working with the Principal Investigator and study team to ensure that services for patients enrolled in research studies are scheduled, coded, billed and documented appropriately.

  • What can I do to make sure my PI is in compliance with billing rules?
    1. Determine whether your trial qualifies for Medicare coverage for routine care costs associated with the trial;
    2. Ensure consistency of payment terms across study documents;
    3. Closely review the Billing Grid for Coverage Analysis and the assigned billing designations;
    4. Ensure that there is supporting documentation to support each service classified as routine care;
    5. Ensure the Billing Compliance Plan is shared with key personnel involved in the day-to-day operations of the clinic and research team;
    6. Follow the billing designations that are listed on the study’s Billing Compliance Plan.
  • What must be included in the medical record as documentation for patients participating in a qualifying clinical trial?
    In addition to regular clinical documentation requirements, the billing provider must also document the trial name, sponsor, and sponsor-assigned protocol number in the patient’s medical record. The clinical trial number to be reported on the billing claim is the number assigned by the National Library of Medicine (NLM) website. National Clinical Trial (NCT)#, billing modifiers and diagnosis codes related to the study are also required elements for Medicare reimbursement.  See MLN Matters Number: MM8401 Revised for more information.
  • What qualified clinical trial cost types are not billable to study subjects or their insurance?
    Any item/service that is:
    • promised free in the informed consent
    • customarily provided by the research sponsor free of charge for any enrollee in the trial
    • The investigational item/service that is the objective of the clinical trial unless it is otherwise covered outside the study or by other CMS coverage determination.
    • Protocol activity/items/services that are not for the direct clinical safety and management of the subject at the time of the order (e.g., consent, inclusion/exclusion labs/imaging/services, research-only protocol activity, monthly CT scans for a condition usually requiring only a single scan).
  • What if it is determined the services on an NIH-sponsored study are determined by the coverage analysis to not be billable to Medicare and other third Party payors?
    If unfunded patient care costs in an NIH-sponsored study are determined by the coverage analysis to not be billable to Medicare and other third party payors, the Principal Investigator must secure other appropriate sources of funding. (See Medicare Clinical Trial Policy for detailed information:
  • Do Clinical Research Billing Compliance laws, rules and regulations apply only to Industry sponsored studies?
    No. Medicare and Private Payor rules and requirements for documentation, coverage, and billing DO apply to ALL clinical studies. The funding source or lack of an outside funding source (internally funded or unfunded) is not relevant.   Therefore, it is important to perform itemized coverage analysis to identify which protocol services are billable and, to enter timely, complete and accurate study, enrollment and encounter information.


        Medicare Clinical Trial Policy (National Coverage Determination 310.1)

        Medicare Claims Processing Manual, Ch. 32

        42 CFR 405.201-405.215, 411.15, and 411.406 (for device trials)

        CMS MLN Matters SE0822 (Jan 7, 2009)

        Decision Memo for Clinical Trial Policy (CAG-00071R)