Do's and Don'ts of Research Billing
Under Medicare regulations, UW Health providers:
- CANNOT bill for services provided to patients if those services are provided for by a study sponsor or grant. These include:
- The investigational item or service, itself
- Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan)
- Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial
- CAN bill for routine costs in Medicare Qualified Clinical Trials and for reasonable and necessary items and services used to diagnose and treat complications arising from the patient’s participation in all clinical trials. Routine costs include:
- Items or services that are typically provided absent a clinical trial (e.g., conventional care)
- 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
- Items 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
The Research Billing Compliance Checklist provides more detail on what may and may not be billed for patients enrolled in a clinical trial.
What is a Medicare Qualified Clinical Trial (MQCT)?
A MQCT is a clinical trial eligible to receive Medicare coverage of routine costs. A MQCT must meet three requirements:
- The subject/purpose of the trial must be the evaluation of an item/service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
- The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.
- Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.
The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics:
- The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes.
- The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
- The trial does not unjustifiably duplicate existing studies.
- The trial design is appropriate to answer the research question being asked in the trial.
- The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully.
- The trial is in compliance with Federal regulations relating to the protection of human subjects.
- All aspects of the trial are conducted according to the appropriate standards of scientific integrity.
Some clinical trials are presumed to have the above characteristics and automatically qualify to receive Medicare coverage:
- Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA.
- Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA.
- Trials conducted under an investigational new drug application (IND) reviewed by the FDA.
- Drug trials exempt from having an IND under 21 CFR 312.2(b)(1) with PI certification.
See the NCD for Routine Costs in Clinical Trials for additional information.
UW Health Charges for Patients in Research Studies
UW Institute for Clinical and Translational Research Website
National Coverage Determination (NCD) for Routine Costs in Clinical Trials
Medicare Clinical Trial Policies Overview
Navigating the Clinical Trial Billing Maze, James B. Pfadenhauer, Journal of Oncology Practice 2(6) 2006
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