Project Description

Why this Newsletter

We are sending this brief as way to provide you with practical ideas on how to use reimbursement policy and data to help you adjust and define your business plans and objectives.

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The Federal Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) pilot program has been extended and is designed to hypothetically reduce the time between FDA marketing approval or clearance decisions and Medicare coverage approvals. This is done by allowing concurrent or parallel review by these two agencies prior to the product’s FDA clearance or approval.  Currently, the FDA and CMS approval processes are done in a serial fashion and are handled by different staff.

Medicare is one of the largest payers for medical devices. For new and emerging medical devices, having Medicare coverage approval in place prior to commencing U.S. sales can help to reduce market adoption risk and for privately held companies, may help to substantiate their valuation estimates.

If your company is planning to conduct a clinical trial for FDA clearance or marketing approval, contact us to discuss if the FDA-CMS Pilot Review program is worth considering  at info@rowinskigroup.com

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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

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