Why this Newsletter

Rowinski Group considers the Federal Food and Drug Administration‘s (FDA) efforts to facilitate communication pathways between medical technology companies and payors relevant because the 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.


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) overage/reimbursement decision. Medical technologies include devices, digital health, diagnostics, and imaging systems.

This Newsletter 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.

The FDA effort is the June 2018 pre-released guidance document “Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities, Guidance for Industry and Review Staff”.  It is referred to as pre-release because the document is 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 key objective of this pre-released document 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 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 but allows for the exchange of information to help Firms and payors plan and budget for future coverage and reimbursement decisions.

This guidance document uses 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, “Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities, Guidance for Industry and Review Staff” send an email to Daniel Zimmerman at d.zimmerman@reimbursement.consulting

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


About Rowinski Group

Founded in 2004, Rowinski Group LLC is a reimbursement and healthcare payer data analytics consulting firm for medical device, digital health, diagnostics, and imaging companies. Rowinski Group is based in Silicon Valley – San Francisco bay area with offices at selected client locations.

Rowinski Group has two core service offerings; securing codes and reimbursement on behalf of companies and applying healthcare payer data analytics to help solve companies’ complex business issues such as responding to questions from the FDA and U.S. Payers.

Through these service offerings Rowinski Group helps U.S. and international companies build their U.S. market share for the medical technology they are developing and selling. For more information visit www.rowinskigroup.com