Awareness : Newsletter Articles

The Importance of the Medicare Coverage Analysis in Clinical Trials

To ensure appropriate reimbursement for the services provided to a patient in a clinical trial, research sites must develop a budget for each trial. One important step in developing a clinical trial budget is conducting a Medicare Coverage Analysis, sometimes referred to as an MCA. This identifies the services for which Medicare will pay under the Medicare Clinical Trial Policy. A methodical analysis also helps avoid compliance pitfalls with regard to inappropriate billing or double billing.

Non-compliant billing is subject to severe penalties, as well as civil and criminal actions.

Determining the eligibility of a clinical study’s related tests, procedures or interventions for Medicare coverage requires a detailed review of the clinical events specified in the protocol to determine which can be reimbursed. This sometimes cumbersome and time-consuming process is essential.

The first step is to determine whether the trial qualifies for coverage. To qualify, a trial should meet these criteria:

  • The purpose of the trial must be to evaluate an item or service that falls within a Medicare benefit category. For example, physicians’ services, durable medical equipment and diagnostic tests would be covered; cosmetic surgery would not.
  • The trial must have a therapeutic intent. Does it potentially improve the participants’ health outcomes?
  • The trial will enroll patients with a diagnosed disease, rather than healthy volunteers.

Private insurance

Starting in 2014, private insurance companies are required to pay for routine costs of care delivered in clinical trials. The Patient Protection and Affordable Care Act describes “routine patient costs” in clinical trials that health insurers must cover as “all items and services consistent with the coverage provided in the plan that is typically covered for a qualified individual who is not enrolled in a clinical trial.” This includes items such as hospital visits, imaging or laboratory tests and medication.