3 Key Steps for Building a Successful Research Billing Compliance Process


Applied Clinical Trials

Building an accurate and consistent billing compliance process is a complex task.

Building an accurate and consistent billing compliance process is a complex task. It revolves around ensuring the entire team is effectively communicating across an institution and that the rules are properly interpreted and applied. Here are some steps that an institution can take to begin the process.

Make it a Team Effort

One of the biggest challenges in clinical research billing is coordination and communication. There are many people who need to exchange information. Key information may be in different parts of the research enterprise.

“It takes a team” to get clinical research billing right. Here are just some of the people and groups to consider involving in the process:

  • Principal Investigator

  • Clinical Research Coordinator

  • IRB process

  • Budget negotiators

  • Clinical Trial Agreement negotiators

  • Grant administration

  • Information Technology

  • Health Information Management

  • Registration/Scheduling

  • Medical center billing and coding

  • Physician professional fee billing and coding

  • Study fund managers

  • Managed care contract negotiators

Address Key Questions

There are many operational questions which must be asked in order to plot out a confident information flow for clinical research billing. The following are some of the most important.

Who are the patients enrolled in a research study?

The billing process must be able to identify the research patients. If the billing offices do not know who the research subjects are, billing will usually be done in the normal fashion and errors could occur.

Which services are part of the protocol?

Along with needing to direct certain charges to the study, even those services which can be billed to the Medicare program require extra work. There are special codes which must be used on Medicare claims that meet Medicare’s definition of “routine costs.”

Is the hospital billing office and the physician billing office treating the study in the same way?

Most times, if a service cannot be billed to insurance, then both the hospital technical charges and the physician professional fees must be directed to the study. If the hospital and the physician practice are interpreting the study information differently, then one of the provider entities could be getting the billing wrong.

Understand Key Concepts

For clinical research billing for Medicare program beneficiaries, there are two important concepts which must be understood: “qualifying clinical trial” and “routine costs.”

Medicare covers services that are “routine costs” during “qualifying clinical trials” as long as the services are not paid for by the sponsor or promised free in the informed consent form, and it is a service that Medicare generally pays for outside of a study.

Qualifying Clinical Trial

The concept of a qualifying clinical trial is a difficult one. The rules set out in NCD 310.1 can be difficult to follow. And there are different rules for device studies and non-device studies.

Generally, a qualifying clinical trial is a study that meets the following criteria:

  • Is one of the four types of “deemed” studies

  • Studies an item or service that is generally covered by Medicare under a “benefit category”

  • Enrolls subjects with diagnosed disease

  • Is designed for therapeutic purposes

For Category A and Category B IDE devices, and certain other device studies, the qualification process is performed by the provider’s Medicare Administrative Contractor. Every Medicare Administrative Contractor has unique rules and processes for approving a device study and their websites should be consulted.

(For specific rules on qualifying clinical trials, see Medicare NCD 310.1)

Routine Costs

Routine costs are the items and services which are covered by Medicare during a qualifying clinical trial. The Medicare program has a fairly complete definition for routine costs in NCD 310.1 and it is worth quoting it in full:

  • “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 noncovered 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”

These are just a few of the key steps for building a successful compliance process. To learn more, download the free eBook, “Building a Successful Clinical Research Billing Initiative.”

This post originally appeared on the Forte Clinical Research Blog.

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