FDA Continues to Create Communication Pathways Between Payors and Companies

Why this News Brief

Rowinski Group considers the FDA’s efforts to facilitate communication pathways between medical technology companies and payors relevant because these pathways may offer companies opportunities to begin reimbursement planning for their medical or digital technology well before it is cleared or approved by the FDA.

News Brief

Since 2011, the FDA has continued to put into place processes intended to facilitate communication between medical technology companies and U.S. public and private payors. The objective is to expedite patient access to new medical technologies by shortening the time between a technology’s FDA regulatory clearance/approval and a payor(s) coverage/reimbursement decision. Medical technologies include devices, digital health, diagnostics and imaging systems.

This News-brief highlights the FDA’s most recent effort to bridge the communication gap between payors and medical technology manufacturers and their representatives and third-party packagers and distributors, collectively referred to as firms.

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The FDA effort is a pre-released guidance document. It is considered pre-released because the document is currently under review by the OMB (Office of Management and Budget) but we can get a preview of what to expect once OMB completes its review.

The (pre-released) document’s objective is to help ensure information provided by firms to payor(s) is unbiased, factual, not false or misleading, and is within the appropriate background and context. For cleared/approved medical technologies the FDA considers the exchange of information from firms to payors to be a form of labeling and is regulated by the FDA as such.

For medical technologies not cleared/approved and unapproved uses of cleared/approved technologies the FDA (currently) does not intend to enforce applicable post marketing labeling and submission requirements. However, the FDA is clear for these technologies the information from firms to payors also must be factual, not false or misleading. In response the pre-released guidance document outlines information the FDA believes is not misleading and false while allowing for the exchange of information to help firms and payors plan and budget for future coverage and reimbursement decisions.

The guidance document uses a Frequency Asked Questions (FAQ) format to summarize answers to common questions related to communications of health care economic information from firms to payors for: 1) cleared/approved devices, 2) unapproved devices, and 3) unapproved uses of cleared/approved devices. If you would like a copy of the pre-released FDA guidance document contact Daniel Zimmerman at d.zimmerman@reimbursement.consulting or hover over and click on SEND US A MESSAGE found in the lower left-hand corner of our website www.reimbursement.consulting.

We continue to monitor FDA's efforts to enhance patient access with a focus on facilitating company -payor communications. We will post updates as they become available. In the meantime, published on our website are links with more information on this FDA effort www.reimbursement.consulting.

About Us

Rowinski Group serves medical technology innovators who are financing, developing or selling medical devices, digital health technologies, diagnostics and imaging systems for the U.S. health-care market. The innovators we work for include companies (private and publicly traded), investment firms and governments located in the U.S., the Eurozone and Asia.

We help innovators to secure reimbursement and other monetization pathways for their medical technology and to build professional relationships with U.S. health insurance payers. Our main office is based in the San Francisco-Silicon Valley area, 10 miles (16km) south of the San Francisco airport and 30 miles (48 km) north of the San Jose airport.

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