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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What do medical devices, molecular In-vitro diagnostic tests, imaging systems, medical mobile apps and telemedicine have in common?  From a health insurers’ perspective these seemingly disparate medical technologies do have commonality, in that their reimbursement approval processes are similar.

One milestone to obtaining reimbursement approvals from Medicare, Kaiser Permanente, Humana, and other payers is to secure Food and Drug Administration (FDA) 510K clearance, Denovo Designation or PMA approval.   For those companies developing medical mobile apps, the FDA recently issued guidance to provide regulatory clarity and predictability. The FDA does intend to apply regulatory oversight only to those mobile apps that are medical devices.  In the event the FDA does classify your app as a medical device, the payers will most likely follow suit.

This month the AMA House of Delegates approved a set of principles to help ensure there is appropriate coverage and reimbursement for telemedicine services.   While the AMA is not a medical insurance carrier, its policies and decisions do have a material impact on them.

Contact Daniel Zimmerman  d.zimmerman@rowinskigroup.com  for a copy of the 2014 FDA Mobile Medical Apps Guidance document or the 2014 AMA Telemedicine Coverage and Payment Report. 

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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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