The Health Policy War Room

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

In this week's Healthcare HotShots, I get in the wayback machine and revisit May 2018 to look at President Trump's American Patients First blueprint to see if I can figure out what a second Trump Administration might do to lower prescription drug costs.

Earlier this week, the Government Accountability Office (GAO) released its latest bimonthly report to Congress on the status of the Federal Response to the COVID-19 pandemic . The GAO reviewed data from multiple sources including USAspending.gov, data obtained directly from agencies, Bloomberg, and other economic research groups. The GAO also developed health indicators that may be useful in continued measurement of response to this and future pandemics. The GAO found that over $2.2 trillion has been allocated for pandemic relief, of which agencies had obligated $1.5 trillion and recorded spending $1.3 trillion. Additionally, GAO found that more can be done to monitor the health care system's response to the pandemic, and they recommended four healthcare metrics that could be used to measure the system's ability to handle and react to emergencies. Finally, the GAO found that the economy is still weak, but appears to be improving with the help of the Federal Pandemic Response. T

After reading Dr. Adam Fein's blog about growth in the biosimilar market (here:https://www.drugchannels.net/2020/10/the-booming-biosimilar-market-of-2020.html) I decided to take my own look at Medicare payments for biologicals and their biosimilar competitors to see if there have been any recognizable changes. Read on to see what I found.... Biologicals are products that include blood, tissues, recombinant proteins and others that are developed using natural sources. Unlike small molecule drugs, which are chemically synthesized and have well known and understood chemical structures, biologics are exceptionally complex and can be complicated to manufacture. Because of their nature, biologics are highly susceptible to production variations -- making them difficult to replicate. This manufacturing sensitivity is what makes it virtually impossible for manufacturers to develop an exact replica, or a “generic” biologic. This is part of what led to the development of biosimilars. Biosimil

We know the Medicare Physician Fee Schedule is "budget neutral" but that doesn't mean that all physician specialities are treated equally. Here's a chart of some of the winners and losers in this year's proposed rule. Remember though, things can -- and will change by November when the rule is finalized. Read on for more... Every year the Centers for Medicare & Medicaid Services releases thousands of pages of proposed regulatory changes affecting the way the Medicare program pays for physician services. Since the Omnibus Budget Reconciliation Act of 1989 was passed -- and the Medicare Physician Fee Schedule began its transition in 1992, Medicare has paid for physician services on a relative value basis. By shifting the focus of payment from "reasonable and customary charges" to the resources required to provide the service, Medicare expected to reduce spending on physician services. The resource based, relative value unit system (RBRVS) looks to rank

It seems like CMS comes under constant fire for their efforts to serve as responsible stewards for the Medicare program. Lately it seems that CMS is taking fire for not going far enough with payment cuts. In this entry, I will look at the latest round of payment cuts to drugs purchased under the 340B Drug Discount Program. Read on for more... In 1992, the Veteran's Health Care Act amended the Public Health Services Act by creating section 340B and its eponymous Drug Discount Program. Originally intended to provide certain hospitals that cared for underserved populations a way to "stretch scarce federal resources" and provide funding to help provide care to their patient population. The program was originally limited to so-called Disproportionate Share Hospitals, Federally Qualified Health Centers, and Ryan White HIV Clinics. It has since been expanded to allow children’s hospitals, freestanding cancer clinics, critical access hospitals and others to participate. The progr