Federal officials plan to propose an expansion of Medicare coverage for new telemedicine and mHealth technologies that are classified as “breakthrough devices.”
The Centers for Medicare & Medicaid Services has issued a proposed rule aiming at cutting short the lengthy review process for cutting-edge devices. This will give Medicare beneficiaries and their care providers the freedom to utilize technology. The US Food and Drug Administration will review the products for the purpose of long-term approval.
CMS Administrator, Seema Verma said innovators needed to prove their technologies were suitable for seniors. But that wasn’t possible since the technology was not yet covered by Medicare and thus widely used enough to show their suitability for Medicare beneficiaries.
The present efforts will make sure that seniors get access to the latest technologies while lowering the cost for innovators.
This proposed rule could motivate healthcare providers to put in more time and energy in telehealth and remote patient monitoring programs using new technology to improve patient care in the home setting especially for those suffering from chronic diseases.
This proposed Medicare Coverage of Innovative Technology (MCIT) pathway would permit Medicare coverage for FDA-designated breakthrough devices on the same day that the FDA provides market authorization. This occurs after 510(k) premarket notification, De Novo request, or premarket approval application - for those devices.
This granted coverage would be lasting for four years, and post that the FDA would review the technology. This order would also cover breakthrough devices classified for two years before the date this rule becomes effective.
CMS said that a breakthrough device should provide better treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. It must meet at least one part of a second criterion, like by being a “breakthrough technology” or offering a treatment choice when no other cleared or approved alternatives are available.
For people who are impacted by these diseases, MCIT would provide an assurance that they will get access to the latest breakthrough medical devices to treat them, provided the devices are a part of the Medicare benefit category.
CMS also mentioned that it believes the 4-year time period of Medicare coverage will motivate manufacturers to voluntarily develop evidence to prove that these treatments improve the health of Medicare patients.
This time period of coverage will let clinical studies with Medicare patients to be completed and provide broad immediate access and foster innovation. As soon as the MCIT coverage sunsets, manufacturers will have current coverage options like one or more Local Coverage Determinations (LCD), a National Coverage Determination (NCD), and claim by claim decisions.
This rule will clarify how CMS covers new telemedicine and mHealth technology, by the way of codifying the definition of “reasonable and necessary” for the Medicare population.
Under the present proposed definition, the device must be:
1) Not experimental and investigational
2) Safe and effective
3) Appropriate for use by Medicare patients.
Public comments on the proposed rule would be accepted through November 2.