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New Rule Eliminates Time Between FDA Approval and Medicare Coverage

A recent rule change will eliminate the waiting period that takes place between the time certain medical devices are approved by the FDA and when Medicare beings covering them.

A recent Medicare rule change will put the latest technologies into the hands of seniors faster and more efficiently. 

Under current Medicare protocol, there is typically a lengthy and costly period of time between when a medical device gains Food and Drug Administration (FDA) approval and when Medicare begins covering the device. The new Medicare Coverage of Innovative Technology (MCIT) ruling aims to expedite that process and eliminate the waiting period for certain devices. 

The rule, issued January 12, will create an accelerated pathway for Medicare beneficiaries to access technologies deemed to be “breakthrough” by the FDA. These are typically devices used to diagnose or treat life-threatening or debilitating diseases like cancer and heart disease, and they use the latest technology to do so. 

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Such medical devices are typically covered by Medicare Part B or Medicare Advantage plans.

What does the MCIT rule mean for Medicare beneficiaries?

Under the MCIT rule, Medicare coverage of medical technology can begin simultaneously with FDA approval, for up to four years. Once that initial coverage period ends, Medicare will reevaluate the effectiveness of the device’s use based on clinical and real-life evidence to make a more permanent coverage decision.

The four-year window allows manufacturers of the medical devices time to improve their product in advance of a possible permanent Medicare coverage incentive.  

Former CMS Administrator Seema Verma said in a press release announcing the ruling, “Government processes have slowed beneficiaries’ access to innovative treatments. Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices.”

Coverage of these breakthrough devices will be nationwide and not dependent on location. The innovators of the devices will get to choose when they would like Medicare coverage to begin in order to help align the coverage process with manufacturing and distribution cycles. 

Additionally, the MCIT rule may be applied retroactively to cover breakthrough devices developed within the two years prior to the rule change that have not yet been cleared for Medicare coverage. 

Christian

About the author

Christian Worstell is a senior Medicare and health insurance writer with MedicareAdvantage.com. He is also a licensed health insurance agent. Christian is well-known in the insurance industry for the thousands of educational articles he’s written, helping Americans better understand their health insurance and Medicare coverage.

Christian’s work as a Medicare expert has appeared in several top-tier and trade news outlets including Forbes, MarketWatch, WebMD and Yahoo! Finance.

Christian has written hundreds of articles for MedicareAvantage.com that teach Medicare beneficiaries the best practices for navigating Medicare. His articles are read by thousands of older Americans each month. By better understanding their health care coverage, readers may hopefully learn how to limit their out-of-pocket Medicare spending and access quality medical care.

Christian’s passion for his role stems from his desire to make a difference in the senior community. He strongly believes that the more beneficiaries know about their Medicare coverage, the better their overall health and wellness is as a result.

A current resident of Raleigh, Christian is a graduate of Shippensburg University with a bachelor’s degree in journalism.

If you’re a member of the media looking to connect with Christian, please don’t hesitate to email our public relations team at Mike@tzhealthmedia.com.

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