What’s New in Medical Device Regulation and Reimbursement for 2018

With so much changing in healthcare, we keep our finger on the pulse of medical device regulation and reimbursement and how new policy can affect the commercial success of health products. Here are just a few of the biggest topics for 2018:

Real World Evidence (RWE)
Announced and released in August 2017, the FDA’s guidance on the collection of real world data and use of real world evidence has become a major topic of discussion and question for industry in 2018. The collection of patient data through electronic health record systems and patient-reported outcome measure tools offers an opportunity for expanded FDA labeling or an expedited regulatory strategy if approached correctly.

Upcoming changes to FDA electronic medical device reporting 
FDA has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018. This will affect Device Problem Codes and Manufacturer Evaluation Codes.

Bundled Payments for Care Improvement Advanced (BPCIA)
The Centers for Medicare & Medicaid Services (CMS) are rolling out the BPCIA model in October 2018. The model builds on the earlier success of bundled payment models and offers a single payment for a particular episode of care. BPCIA is voluntary, but qualifies as an alternative payment model (APM) under the Medicare Access and CHIP Reauthorization Act (MACRA). This implementation marks another step away from fee-for-service payment and toward value-based payment.

What impact will these trends make on your product development and commercialization? Contact us and learn more about what our team can offer.