In January, the US Centers for Medicare & Medicaid Services published a new rule that would allow the makers of breakthrough-designated devices to register for a programme that provides reimbursement for their products immediately after FDA approval. Abi Millar dives into the device reimbursement debate and assesses the chances that the rule will come into effect before the end of the year.
Medical device regulation can often be a delicate balancing act. On one hand, you need to be absolutely scrupulous if you want to ensure that devices are safe for patients to use. If the approval process is rushed, you may endanger the very people the devices are designed to help.
On the other hand, unnecessarily tight controls, or protracted approval timelines, can be dangerous in their own right. Through holding up approval, you may be depriving patients of a life-changing – or life-saving – innovation.
It’s a common story and one that has come to the fore yet again with the decision to delay the new Medicare Coverage of Innovative Technologies (MCIT) rule in the US. This rule, originally slated to come into effect in March 2021, was subsequently postponed till May and again till December – a decision some have compared to ‘kicking the can down the road’.
Read the rest of this article in the August 2021 edition of Medical Technology