Medicare beneficiaries receiving home health services soon might gain quicker access to innovative medical devices, under a new federal proposal.

The Centers for Medicare & Medicaid Services measure essentially would give certain medical devices a new pathway.

For a device to qualify, it would need to overcome two hurdles. First, it would need to provide effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. Second, the device would need to meet one of the following requirements:

  • It represents a breakthrough technology
  • No approved or cleared alternatives exist
  • It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute; or
  • Device availability is in the best interest of patients

CMS has also proposed a new definition for the term “reasonable and necessary.”