A Faster Way to Get Life-Saving Technologies to Patients

Groundbreaking medical technology could soon begin reaching patients more quickly. 

That’s because the Centers for Medicare and Medicaid Services has proposed transitional coverage for emerging technologies. The designation would allow patients to access FDA-approved medical devices and advancements while researchers gather evidence required for regulatory coverage.  

Bridging the Gap for Patients 

Transitional coverage would smooth the pathway to care by bridging the gap between the time when the FDA approves a new device and the time when the Centers for Medicare and Medicaid Services establishes coverage for that device or technology. It would get life-changing medical technologies into the hands of those who can’t afford to wait.  

One patient advocacy organization, Heart Valve Voice US, commended the move toward “timely and predictable” coverage during the transitional period. “Having additional treatment options is paramount,” the organization emphasized in a letter to the Centers for Medicare and Medicaid Services, so long as there are not “additional burdens placed on beneficiaries.”  

National Coverage & Widespread Accessibility  

Transitional coverage would occur through a national coverage determination by the Centers for Medicare and Medicaid Services. This process requires that treatments or devices stand up to evidence-based scrutiny to demonstrate that they are “reasonable and necessary” for certain conditions or patient populations.  

“We recognize that new approaches are needed,” the agency explained in its proposal, “to make decisions on certain new items and services, such as medical devices, more quickly.” 

The Centers for Medicare and Medicaid Services cited several potential benefits of transitional coverage, including “facilitating early, predictable and safe beneficiary access to new technologies” and “encouraging evidence development if notable evidence gaps exist for coverage purposes.” 

If transitional coverage can be administered without adding extra costs or frustrations for patients, the agency will indeed extend access to breakthrough treatments and devices to the many Americans who stand to benefit.