November 24, 2021

Americans gravitate toward the cutting edge.  We like checking out the latest gadgets and getting our hands on the trendiest gizmos.  New technology brings wonderment to the observer and is subconsciously seen as a form of modern-age magic.  But high-tech wizardry is not just for awing and entertaining the masses; it has practical implications, as well.  Few sectors of society rely more heavily on, and benefit more greatly from, cutting-edge technology than the healthcare sector.  Newer and safer methods of performing heart surgery and treating cancer and saving lives continue to arrive on the scene.  It is our great fortune that American medicine is still recognized the world over as leading the pack in terms of the latest techniques and devices dedicated to the mission of healing. 

That said, we should remember that generating new devices and cutting-edge technologies relies on innovation.  Innovation starts with motivation.  Motivation is helped along by compensation, i.e., the promise of profit.  So, what happens when the reimbursement rug is suddenly pulled out from under the technology leaders and device designers?

Closing the Door

On Nov 12, the Centers for Medicare and Medicare Services (CMS) issued a press release in which the agency announced the rescinding of the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule (FR).  According to CMS, the action was taken because of concerns that the provisions in the FR “may not have been sufficient to protect Medicare patients.”  The press release indicated that CMS would replace the FR with new strategies they believed would be effective in providing a pathway toward medical device innovation without compromising patient safety.  According to CMS Administrator Chiquita Brooks-LaSure:

Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries.  The Medicare program needs to implement policies that balance access and appropriate safeguards.

By way of background, the MCIT/R&N FR would have granted expedited Medicare coverage for up to four years for certain Food and Drug Administration (FDA)-designated “breakthrough” devices once they are cleared for the market.   However, the current CMS leadership felt that the kinds of clinical studies needed for FDA market authorization under the FR might not consider the differences in clinical profiles, complexities of medical conditions, or associated treatments of the diverse population of Medicare patients.

A Change in Direction

Though CMS has now shut the door on the previous administration’s strategy to incentivize innovation in the medical device industry, the agency states that it intends to “explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the health care needs of people with Medicare.”  They claim that this will also help to establish a process in which the Medicare program covers new technologies “on the basis of scientifically sound clinical evidence,” with “appropriate health and safety protections in place” for Medicare beneficiaries. 

In an effort to echo these objectives, Dr. Lee Fleisher, CMS Chief Medical Officer and Director for the Center for Clinical Standards and Quality (CCSQ), stated:

CMS is committed to coverage that provides an appropriate balance of support for innovation with necessary protections for Medicare patients.  Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions.

While CMS has now rescinded the MCIT/R&N FR, the agency contends that there are “existing and proven pathways” that will allow for coverage of a specific medical device or service.  That is, devices may still receive coverage under one of the following methods of determination:

• Individual claim determinations
• One or more local coverage determinations
• National coverage determination

The CMS press release on this matter asserted that the agency intends to work with the FDA, Agency for Healthcare Research and Quality (AHRQ), medical device manufacturers, and other stakeholders to develop “an expeditious process to cover innovative devices that benefit Medicare patients.”  The agency plans to hold at least two stakeholder public meetings in 2022 to address future policy-making.

To view the rule that rescinds the previous FR, you can click on the following website link: https://public-inspection.federalregister.gov/2021-24916.pdf.  If you have a comment for us or a question about our hospital-specific services, you can reach out to us a info@miramedgs.com.