Medical Device Reimbursement: ReGARDD Forum Notes

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Perspectives on Medical Reimbursement

By JR Associates

What should medical device researchers know about premarket FDA submissions? And what should they understand about reimbursement in early stages of product development?  These core questions inspired the first educational seminar hosted by ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices) in April 2017, where our VP of Global Health Policy, Jo Ellen Slurzberg, was a featured speaker.

After Jo Ellen’s presentation, we discussed the forum with her in a brief Q&A session:

1) Could you introduce us to the seminar sponsor?

ReGARDD is a community of regulatory affairs specialists from North Carolina institutions that are funded in part by the NIH Clinical and Translational Science Awards (CTSA) Program. These prestigious institutions include:

Learn about ReGARDD, a consortium of academic institutions, devoted to sharing regulatory guidance for drug and medical device researchers

• The University of North Carolina at Chapel Hill
• Duke University School of Medicine
• Wake Forest School of Medicine
• RTI International

The consortium’s mission is to improve the drug and device development process through collaborative education and innovation.

2) Why did they stage this event?

Through a series of educational forums like this seminar, along with a growing collection of digital resources available on its website, ReGARDD supports academic researchers as they develop successful strategies in today’s dynamic regulatory environment. Specifically, the organization is creating a “one-stop-shop” with relevant historical information, best practices, lessons learned, and idea sharing for professionals who are new to the regulatory world of investigational drugs and devices (IND/IDE).

3) Tell us about your presentation topic:

“The Medical Device Reimbursement Life Cycle — Strategic Reimbursement Planning from Clinical Development to Commercialization”

My presentation looked at three key aspects of reimbursement that are essential for medical device researchers to understand:

• First, I explained how clinical trials and some investigational devices may be eligible for reimbursement by Medicare (CMS) and private insurers;
• Next, I focused on how life science researchers can incorporate strategic reimbursement objectives into product development plans;
• Finally, I talked about how early linkage with reimbursement can add value later in the product lifecycle.

4) What message did you convey about academic research, clinical trials and the reimbursement process?

It is important to embrace a reimbursement mindset during the clinical trial planning process and carry it through to patients in the medical center environment. This can be easier in academic settings because — unlike industry-sponsored trials — academic research organizations are inherently connected with the institution’s medical school and clinic where patients may be enrolled. At the ReGARDD forum, I focused on the fundamentals of billing requirements and how to apply for coverage. I explained how to capture reimbursement in clinical trial agreements and informed consent documents, and what is needed for correct claims processing. Also, I discussed the importance of inclusion in Institutional Review Board processes.

5) What should medical researchers understand about value creation and reimbursement?

There are multiple long-term benefits in aligning regulatory and reimbursement goals with academic clinical trials, and in establishing a reimbursement track record. Value is created when life science innovators demonstrate a commitment to the reimbursement process at an early stage of clinical development. That value-add is recognized when the institution seeks further investment to continue research and development, and when it initiates licensing discussions with potential partners. Value is also created for the institution’s translational department when trials have an opportunity to capture some reimbursement.

6) Why should reimbursement be part of the ReGARDD agenda?

Drug and device commercialization is more likely to succeed when researchers consider reimbursement in all thinking and planning. ReGARDD recognizes this. They also understand the importance of an organized and deliberate clinical trial strategy that meets reimbursement requirements for coverage, coding, claims processing and payment.

Heather Rosecrans EVP, Medical Devices & Combination Products, Greenleaf Health

Co-presenter Heather Rosecrans, F.R.A.P.S.

7) You were one of two speakers at this forum. Who else delivered a presentation?

I shared the stage with Heather Rosecrans, a former director of the FDA Center for Devices and Radiologic Health (CDRH). Heather focused on regulatory affairs issues, including tips for succeeding with premarket FDA submissions. Together, we discussed the nuances of working with both CMS and FDA. This sparked mutual dialogue and an information-rich learning experience for all who attended.

8) Why did you want to participate in this event?

I was honored to be part of this inaugural ReGARDD symposium — not just because its sponsors are among the most prestigious medical institutions in our nation, but also because they are committed to conducting high-quality clinical research at the institution level. Life science innovators can no longer afford to operate in isolation. More efficient, effective information sharing is vital to keep pace with the complexity of today’s medical technology, regulatory environment and healthcare market dynamics.

9) Why should medical technology professionals keep an eye on ReGARRD?

This was only the first symposium. ReGARDD will be hosting multiple forums and developing a variety of resources to support the medical research and development community. The four participating medical institutions are committed to expanding their considerable understanding of regulatory and FDA processes. They are working diligently together and within their own organizations to ensure that the clinical trials they manage and the medical products they develop will reach patients under the umbrella of appropriate FDA regulations. ReGARDD has potential to become a template for other similar research community partnerships.

10) What should we expect, going forward?

ReGARDD and the CTSA program aim to strengthen and support the spectrum of translational research in three ways:

• Accelerating the process of translating laboratory discoveries into effective medical treatments;
• Training a new generation of clinical and translational researchers, and
• Engaging communities in clinical research efforts.

I look forward to watching the program evolve and supporting its continued outreach.


To learn more about each of the institutions involved in ReGARDD, click on the links below:

Learn about members of ReGARDD, a North Carolina consortium of academic institutions, devoted to sharing regulatory guidance for drug and medical device researchersDuke University School of Medicine — Office of Regulatory Affairs and Quality serves is a no-cost resource for the clinical research community at Duke University Medical Center, offering regulatory and quality assurance support in all aspects of clinical research, from preclinical requirements to first-in-human studies and beyond.

The University of North Carolina at Chapel Hill — Office of Translational and Clinical Sciences (NC TraCS) Institute Regulatory Affairs team provides support, guidance and education to the research community of UNC and its affiliates — lowering regulatory barriers to translational research with comprehensive support for researchers as they navigate stages of investigational drug, medical device and biological product research and development.

Wake Forest School of Medicine — IND/IDE Navigator in the Clinical and Translational Science Institute (CTSI) provides regulatory support, guidance and education services to faculty investigators involved in US Food and Drug Administration (FDA) regulated clinical research at Wake Forest School of Medicine.

RTI International — An independent non-profit research institute dedicated to improving the human condition, with more than 5000 staff members in more than 75 countries, RTI is involved in hundreds of projects each year that address complex social and scientific challenges.


Are you a medical technology innovator? Do you need reimbursement guidance for a product you are developing?

See how our consultants assist early-stage life science ventures
Learn more about our comprehensive reimbursement services
• Contact us to discuss your reimbursement questions

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