Gaps In Quality Measures Could Lead To Loss In Device Product Access, White Paper Says
Executive Summary
The latest value-based payment models sponsored by the US Centers for Medicare and Medicaid Services and other institutions lack adequate quality measures to effectively assess the value of medical technologies. That's resulting in patients losing access to device products, says a Discern Health white paper sponsored by AdvaMed.
You may also be interested in...
New HHS Chief Alex Azar Supports LDT Regulation, Cost-Saving Bundles
Alex Azar was confirmed as the next secretary of Health and Human Services with strong industry support. Azar comes to the role with some homework to do on key FDA medtech policies, but has expressed support for risk-based regulation of lab-developed tests and cost-saving bundled-payment models.
20-Plus Device-Related Episodes-Of-Care Included In New Medicare Bundled-Pay Models
The US Centers for Medicare and Medicaid Services' Innovation Center has launched a new voluntary bundled-payment model covering more than 20 different types of clinical episodes involving devices. But they will limit outcome evaluations to 90 days, which may not be long enough to demonstrate the value of some cardiac care and orthopedic devices.
Medtech's Unfinished Business For Congress In 2018: What's Ahead
US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.