Applied Policy ®

Menu

Archive Tag: Medical Devices

CMS Issues Proposed Rule to Establish National Medicare Coverage Pathway for Medical Devices with Breakthrough Designation and Modifies Definition of “Reasonable and Necessary”

Today, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to establish a Medicare coverage pathway for medical devices designated as breakthrough by the Food and Drug Administration (FDA). The new proposed Medicare Coverage of Innovative Technology (MCIT) pathway would significantly accelerate Medicare coverage of new breakthrough devices by beginning national coverage [...] Read More

Verma Announces Plan to Foster Innovation for Transformative Medical Technologies

On May 2, CMS Administrator Seema Verma announced the Trump Administration’s “comprehensive strategy” to foster innovation for and improve patient’s access to transformative medical technologies. The strategy, detailed by Administrator Verma in a speech at the Medical Device Manufacturers Association (MDMA) Annual Meeting, is based on two specific changes related to coding. CMS says that [...] Read More

CMS and FDA Decide to Extend Program for Parallel Review of Medical Device

On October 24, 2016, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced that they will be implementing and extending indefinitely the Parallel Review of medical devices pilot program. The two agencies are looking for nominations from manufacturers of innovative medical devices to participate in the program. Parallel […]

Read More

Medical Device Industry and Hospitalizations of Long-Stay Nursing Facility Residents Focus of First MedPAC Meeting of New Term

The Medicare Payment Advisory Commission’s (MedPAC’s) initial public meeting of the new term, which was held on September 8, may telegraph what the Commission may make recommendations to Congress on in the upcoming year. The meeting featured presentations and discussions on a wide range of issues, including a context for Medicare payment policy, an overview […]

Read More