Another concerning area is noncoverage of drug trials. Patients who participate in Medicare Advantage Plans have contracted their care to a managed care organization. These plans do not pay for routine costs in drug trials. Billing must go to a Medicare fee-for-service plan for payment.

Continue Reading


Communication errors between the health care team members can result in problematic third-party billing. Five scenarios commonly lead to billing the wrong payor for care or services provided to clinical trial participants.

Sponsor-provided services Clinical trial sponsors provide money for and contract for participants’ care to include particular tests or procedures (eg, CT scans, radiographs, laboratory tests). Although these services may be part of routine care, in this case, these services should be billed to the sponsor not a third-party payer. Orders and scheduling of these items and services should be coded as sponsor-provided so they can be removed from a bill or submitted as a noncovered service to Medicare or a private payor.

Services promised in the informed consent The language in the consent form tells the participant that all clinical-trial services are being provided at no cost to them, but the facility allows an invoice to be submitted to a payor. Nurses and principal investigators involved in providing care in a clinical trial should familiarize themselves with the information presented in the consent form and be clear on the clinical trial services.

Research-only purposes The study protocol will state which services are needed for research purposes. For example, a clinical trial may require participants to undergo echocardiography for measurement as part of the objectives. This echocardiography is outside the routine care for the participant. The order for this procedure needs to indicate that the sponsor is to be billed, as the procedure is for research only.

Nonqualifying clinical trial A nonqualifying clinical trial is one that does not meet the minimum standards of the NCD. Prevention or healthy-volunteer studies, trials of elected cosmetic surgery, and some phase I studies are examples of nonqualifying trials. Medicare or any government payor cannot be billed for any services provided to patients participating in a nonqualifying trial.

Medicare Advantage Plans (Medicare Part C) Medicare Advantage Plans do not cover clinical trials involving drugs. Therefore, billing for drug trial participants should be submitted to regular Medicare fee-for-service plan. Medicare Advantage Plans, however, allow payment for device studies that have FDA exemptions.


Care of clinical trial participants is part of an oncology nurse’s daily routine; therefore, communication in regard to the clinical trial billing intent is important. Communication includes sharing information relative to the patient’s care among everyone who may touch that clinical trial participant throughout the continuum of care. The documents that provide this communication are the coverage analysis, informed consent, and schedule of events.

Incorrectly billing Medicare for items or services rendered in clinical trials can trigger an investigation under the False Claims Act (FCA). Both criminal (31 USC §3729) and civil (31 USC §3730) components of the FCA include monetary fines. Civil actions for violations of the FCA can be brought up by private citizens, as well as the US Attorney General, on behalf of both the person and the US government.2 Improper billing to private insurers can lead to allegations of insurance fraud.


Today’s medical environment is very complex. The financial aspect of a patient’s care often involves multiple payors. The billing for services is tied into the day-to-day administration of care. This places some of the burden for accurate billing on nurses and billers in a variety of settings that provide care. The sponsor of a clinical trial does not pay for everything that is provided to patients participating in the trial, especially in the case of clinical trials for patients with cancer. Efforts to clarify financial responsibility, using coverage analysis, informed consent, and schedule of events, still allow for billing errors. Billing issues are further complicated by statutory laws. With additional provisions of the Affordable Care Act on the horizon, who pays for health care provided in clinical trials will be again altered.

Clinical trials are essential to the continued advancement of patient care, and patients, especially those with cancer, are encouraged to participate in them. However, clinical trials also entail extra concerns for nurses. Using the tools of communication to identify who the payor is for each item or service provided to patients participating in a clinical trial will help when scheduling care and prevent billing errors. ONA 

Kelly Willenberg is president at Kelly Willenberg, LLC, in Chesnee, South Carolina.

HOW TO TAKE THE POST-TEST: To obtain CE credit, please click here after reading the article to take the post-test on


1. States requiring coverage of clinical trial costs. National Cancer Institute Web site. Accessed December 3, 2012.

2. National coverage determination (NCD) for routine costs in clinical trials (310.1). CMS Centers for Medicaid Medicare Services Web site. Accessed December 3, 2012.

HOW TO TAKE THE POST-TEST: To obtain CE credit, please click here after reading the article to take the post-test on