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Top Five Clinical Trial MMSEA Reporting FAQs

By November 1, 2018 No Comments

For more than 35 years, MRC has been the premier destination for medical record review and retrieval services. Since the inception of Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), MRC has supported pharma with starting and maintaining clinical trial MMSEA reporting.

Here are some of the frequently asked questions we hear from pharma looking to start or update their data collection and MMSEA reporting program.

1. There are multiple companies that provide MMSEA Reporting Services. What makes MRC different?

Unlike our competitors, MRC is ready to tackle the intricacies tied to clinical trial reporting.  We offer a variety of data entry options that alleviate the burden of entering required reporting data into a rigid website or spending hours entering data into reporting file templates with more fields than is needed.

MRC is experienced in clinical trial MMSEA reporting, and we understand the significance of obtaining the data points from the clinical trial sites. We work as a part of your team to support successful data collection and report critical feedback so that you can make informed decisions.

As an added value, MRC provides custom tools specific to your reporting needs. For example, if your Adverse Event/Serious Adverse Event (AE/SAE) data is reported in another format, our team of specialists can assist you with identifying the correct ICD-10 code.

2. How does MRC work with CROs and the clinical trial site personnel?

On behalf of your team, MRC will contact the clinical trial site(s) to determine the most efficient approach to communicate with them for the collection of study participants’ information. MRC acts as an advocate for your team by answering any MMSEA questions that may come up during collection, and proactively alerting the pharma to any questions that require input.

3. How can MRC assist us with the MMSEA reporting process?

We are here to support you. MRC is experienced in assisting clients with training for CROs and clinical trial sites, so all parties clearly understand the requirement to provide the data needed to determine Medicare eligibility.

MRC will discuss the best way for you and your pharma to approach the data collection to protect your pharma and Medicare’s interest. MRC will audit and provide feedback on any documentation you create.

4. How will we know when to report and what information will we be provided by MRC?

MRC will advise you on your reporting period, which is one time per quarter. MRC will provide you with de-identified report using the subject code to show study participants’ Medicare eligibility status. MRC will send a report of the participants’ AEs/SAEs to be reported as Ongoing Responsibility for Medicals (ORMs) for your review, prior to reporting.

5. How else can MRC help?

During the contract negotiation or prior to implementing the work, MRC can provide cost estimates. The estimates can be based on your assumptions, the average assumptions based on our years of clinical trial MMSEA reporting, or a mixture of the two.

MRC can also take care of you when new studies begin. If your finance group requires a cost estimate in order to enter a Purchase Order (PO), we can work with you to create one.

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