Deep Dive: Clinical Trials and Section 111 Reporting

By Daniel Lindner  |  September 22, 2015

ISO Claims Partners is dedicated to demystifying Section 111. Today I’d like to take a deep dive into one reporting trigger of Ongoing Responsibility for Medicals (ORM) by exploring clinical trials.

Created by CMS specifically for Section 111 reporting, ORM is the responsibility “presently assumed” to pay for medical treatment related to an accident or injury. As a Responsible Reporting Entity (RRE), ask yourself: If a claimant presented a medical bill, would I have the responsibility to cover it? If your answer is yes, then you most likely have ORM. Whether you would pay for a particular service, such as chiropractic care, is not part of the consideration. ORM simply indicates the posture of the case.

Clinical Trials and ORM

When it comes to clinical trials, there are a range of possibilities. Although CMS generally doesn’t consider ORM likely in liability claims, it exists in certain circumstances (for example, in clinical trials in which a pharmaceutical/medical device company may occasionally offer to pay for medical treatment necessary during a clinical trial).

Accurate reporting can be tricky due to the nature of clinical trials. At its core, Section 111 reporting requires sending claims information to Medicare. If clinical trials are performed on a blind (or even double-blind) basis, obtaining information necessary in Section 111 reporting can be conflicting to the success of the trial itself. Medicare requires clinical trials to be reported as liability claims, with ORM seeming counterintuitive on the surface. Upon closer examination, however, it becomes clearer that the sponsors of clinical trials may fit within the category of RREs. Furthermore, when complications arise in a clinical trial, the Ongoing Responsibility for Medicals relating to such complications is often part of the clinical trial relationship.

CMS sets policies that require insurers or self-insureds to report claims, rather than create exemptions. Clinical trials are a great example of this. CMS policy on clinical trials is stated as follows:

“When payments are made by sponsors of clinical trials for complications or injuries arising out of the trials, such payments are considered to be payments by liability insurance (including self-insurance) and must be reported. The appropriate Responsible Reporting Entity (RRE) should report the date that the injury/complication first arose as the Date of Incident (DOI). The situation should also be reported as one involving Ongoing Responsibility for Medicals (ORM).” See NGHP User Guide version 4.7 Chapter 4 p. 6-26.

Clinical trials are rarely black and white. In many cases, the sponsor of a clinical trial may not know that a payment is made or that a complication or alleged injury has occurred. Companies may not even be aware that the reporting requirement exists in this circumstance.

Understanding that the reporting requirement exists — and what to do about it — are crucial steps. Clinical trial reporting is an area of Section 111 that requires the particular expertise of an industry expert or compliance vendor to add value to compliance protocol.

There are dozens of other arcane parts to Section 111 reporting — areas where mistakes in policy interpretation could leave room for over- or underreporting in critical areas. A practitioner should be able to understand and master how Section 111 affects clinical trials, accident and health reporting, hospital write-offs, and other important claims activities that we encounter daily.

Here at ISO Claims Partners, that’s something we do every single day. Our industry experts are readily available to assist you with Section 111 to ensure your full compliance with reporting requirements.

Daniel Lindner

Daniel C. Lindner is the director of Section 111 strategy for ISO Claims Partners. Dan joined the company as an MSP compliance manager, leading an ISO Claims Partners’ Medicare conditional payment investigation and negotiation team. Dan is a graduate of New England School of Law and a member of the Massachusetts Bar. Dan can be reached directly at 978-825-8152 or