​Breakthrough Technology – Add-On Payments for Medical Devices and Antimicrobial Drugs

August 9, 2019

In its final FY 2020 Medicare Hospital Inpatient Prospective Payment System rule released on August 2, (see fact sheet), the Center for Medicare and Medicaid Services updated payment policies for medical devices that meet the FDA’s Breakthrough Devices designation. Devices that qualify would no longer be required to demonstrate evidence of “substantial clinical improvement” to receive new technology add-on payments. This reflects an easing in meeting add-on payment requirements.

This more liberal criteria would also apply to new antimicrobial drugs that are designated by FDA as Qualified Infectious Disease Products (QIDPs). The new technology add-on payment percentage would be increased to 75% for QIDPs. This is of particular important in the development of antibacterial and antifungal drugs that treat serious or life-threatening infections.

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