[author: Patti Scamardo **]

Organizations have an obligation to report claims for individuals who have coverage under group health plans (GHPs) and non-group health plans (NGHPs) when a settlement has been paid or when the plan pays for ongoing medical care for Medicare beneficiaries.

Sponsors of clinical trials are also held to the same standards. However, there are a few obstacles sponsors – also referred to in these circumstances as responsible reporting entities (RREs) – face in reporting this information, specifically as it relates to Medicare.

They may, in fact, not be aware they need to report medical incidents arising from clinical trials involving Medicare beneficiaries. Out of the approximate 450 pages of the Medicare Medicaid and SCHIP Extension Act (MMSEA) NHGP User Guide, only one paragraph mentions clinical trials.

Chapter III, Chapter 6, Section 6.5.1.6 states:

• 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 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).

It is understandable how Medicare reporting can be overlooked. Nonetheless, clinical trial sponsors are not exempt from federal law, and must report or potentially have civil money penalties (CMPs) imposed on their organization, which currently run up to $1,428 per day per incident.

That obligation to report the personal information of study participants yet remain blind to it, however, presents clinical trial sponsors with their biggest dilemma.

Working with reporting agents that offer a clinical trial reporting service solves that problem. They operate as an intermediary between the sponsor and the site where the trial was conducted. The agent contacts the site on behalf of the sponsor to obtain the information and then reports the information to the Centers for Medicare and Medicaid Services (CMS). This maintains the integrity of the blind study and fulfills the sponsor’s obligation to report following federal law.

Knowing the “why” is reasonably straightforward. It is the “how” and “what to report” that requires greater expertise. For example, what type of injury or complication triggers reporting, what nuances must be considered as part of reporting, and what is the minimum threshold for reporting?

The paragraph on clinical trials in the User Guide is vague. It doesn’t define an injury or complication, only that when sponsors make a payment for that injury or complication, it is deemed reportable.

However, other portions of the User Guide can serve as guidance. Section 6.3 states that reporting for all ORM, including clinical trials, occurs when the sponsor is reimbursing a provider or the injured party, for specific medical procedures, treatment, services, or devices.

This same section states that a sponsor should report to CMS when it has assumed responsibility for ORM or is otherwise required to assume ORM – not when or after the first payment for medicals under ORM has actually been made.

Reporting for clinical trials falls under ongoing responsibilities for medical care. There are no minimum thresholds, but typically, a sponsor should use one of the following conditions to determine a minimum.

• Cases that fall under the same criteria that the sponsor must use for other non-Medicare clinical trial adverse effect reporting;
• Severe adverse effects only in which the sponsor reimburses the clinical trial site; or
• All complications regardless of whether a site has requested reimbursement.

A reporting agent will work with a sponsor from the beginning of their partnership to develop a standard for what will constitute a complication.

Moreover, the reporting agent can work with the sponsor to establish the communication protocol with the study sites, create a timeline for deliverables, and comply with all the complicated reporting guidelines from CMS, whether a 400-plus page User Guide, or otherwise.

Though clinical trials in the User Guide are barely mentioned, sponsors should heavily invest in ensuring they’re complying with federal law. Partnering with a reputable reporting agent is an important first step.

** Patti Scamardo is the advisory services lead at Epiq. She specializes in MMSEA’s section 111 mandatory insurer reporting.