Medicare will cover all medical devices designated by the Food and Drug Administration as a “breakthrough” technology.
The final rule, released Tuesday, will cover the use of a breakthrough device for four years after it receives FDA market authorization. CMS said it will evaluate devices based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries before deciding whether to cover them permanently. The agency said the rule is necessary because the existing Medicare coverage determination process is too slow and could delay Medicare beneficiaries’ access to the latest medical technology.
The changes “will create a new, accelerated Medicare coverage pathway for innovative products … like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease,” CMS said in a statement.
CMS claimed the new rule would encourage more innovation by streamlining Medicare coverage of new devices. Under the current system, Medicare Administrative Contractors—16 in total—decide whether to cover a device within their region. Devicemakers have to apply separately to each contractor to get coverage approval.
“After the final rule takes effect, upon manufacturer request, Medicare may cover (eligible) breakthrough devices the FDA has approved, including breakthrough devices that received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date,” CMS said in a statement.
The rule takes effect March 15.
Medical device-makers lauded the plan when CMS first announced it last summer. But patient-safety groups like ECRI worry it could threaten the safety of Medicare patients because devices are usually tested on much smaller groups before clearance compared with drugs, and vulnerable seniors typically aren’t included in the studies. Other experts agree.
“This four-year timeline may incentivize the manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years,” CMS said in a statement.