The Health Policy War Room

On August 2, 2021, CMS placed on display at the Federal Register the final fiscal year 2022 Inpatient Prospective Payment System Final rule. Amongst the over 2,000 pages are CMS's final decisions on New Technology Add-on Payments (NTAP) for FY 2022. The NTAP program was designed to identify new technologies and to ensure that payment under the IPPS would be adequate so that early adopters of  new technologies would not be financially disadvantaged. Under the traditional NTAP pathway, a technology must be considered "new",  the charges of cases involving the technology must be more than 75 percent of the unadjusted rate for the MS-DRG to which the technology is assigned, and the technology must represent a substantial clinical improvement over existing technologies.  Beginning in 2021, CMS implemented an alternative NTAP pathway for technologies granted "break-through" approval by the FDA and for certain antimicrobial products. For this alternative pathway, techn...

Earlier this week, I blogged about the FDA's new Digital Health Center of Excellence, the virtual group responsible for all things regulatory in nature affecting digital health. As a part of their remarks to begin the first of two listening sessions, the FDA provided a list of thirteen areas on which the DHCoE will focus. Included among these were "Software as a Medical Device" and "Software in a Medical Device". I wanted to dive a bit deeper into what appears on the surface to be a small difference but in reality has a mighty impact -- at least it does today.  Software as a Medical Device   In 2013, as a part of their final document titled " Software as a Medical Device (SaMD): Key Definitions " the International Medical Device Regulators Forum (IMDRF) released its definition of "Software as a Medical Device" (SaMD):  The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes th...

Last month, the U.S. Food and Drug Administration announced the formation of its Digital Health Center of Excellence (DHCoE) , a combination of virtual and dedicated resources housed within the Centers for Devices and Radiological Health designed to support developers of digital health products and devices.  The FDA defines digital health as " mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine" that have the " potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual." Recognizing that technology is advancing rapidly, and that innovation is promoting interconnectivity between health devices, health care providers, and information systems, the FDA saw a need to reform its own workflows in ways that empower the developers of digital health products with the information needed to balance the risks and rewards of digital ...