Medicare to Cover Breakthrough Medical Devices

The U.S. Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of medical devices commercially available in the United States. In order to market a new medical device in the United States, the manufacturer must have enough valid scientific evidence to show that the device is safe and effective for its intended use. Gathering and submitting sufficient evidence to the FDA can take a significant amount of time.

Breakthrough Devices Program

For this reason, the FDA instituted the Breakthrough Devices Program. This program allows the FDA to work with manufacturers to speed up the development, assessment, and review of certain medical devices (while still protecting public health). In order to qualify for the Breakthrough Devices Program, a medical device must be a breakthrough in the diagnosis or treatment of a life-threatening or debilitating condition or must be more effective than currently approved devices.

Historically, the Breakthrough Devices Program has not benefited individuals with Medicare coverage. Even after receiving FDA authorization, medical devices needed sufficient scientific evidence in order to receive Medicare coverage. This caused a significant delay between FDA authorization and Medicare coverage for individuals who may benefit from the device.

Medicare Coverage of Innovative Technology

On March 15, 2021, the Medicare Coverage of Innovative Technology (MCIT) coverage pathway will take effect. This coverage pathway allows medical devices in the Breakthrough Device Program to receive Medicare coverage as early as the same day as FDA market authorization. This creates coverage for the device itself, all services needed for use of the device, and treatment for any complications that may result from use of the device.

In order to qualify for the MCIT coverage pathway, a device manufacturer must notify the Centers for Medicare & Medicaid Services (CMS) of their interest in MCIT. The device must be deemed “reasonable and necessary” by CMS (meaning safe and effective), appropriate for individuals with Medicare coverage, and not considered experimental. CMS then works with the manufacturer and the FDA to ensure Medicare coverage on the manufacturer’s designated start date, which can be as early as the date of FDA authorization.

The MCIT pathway grants Medicare coverage for four years from the start date. This allows Medicare recipients access to the device while clinical studies are still ongoing. The results of these studies can lead to long-term coverage of the device at the end of the four-year time period.

The MCIT pathway provides Medicare recipients earlier access to breakthrough devices that can make a significant difference in the diagnosis and treatment of life-threatening or debilitating conditions.