# What This Bill Does: Faster Access to Breakthrough Medical Devices for Medicare Patients

This bill speeds up how quickly Medicare covers and pays for new medical devices that the FDA has identified as "breakthrough" innovations. Think of breakthrough devices as cutting-edge medical tools that represent a significant improvement over existing options—things like advanced surgical instruments, diagnostic equipment, or implantable devices that offer real benefits to patients.

Here's the practical impact: When a device gets FDA approval as a breakthrough product, Medicare will automatically cover it and start paying for it right away, rather than making patients and hospitals wait months or years while the government studies whether it's worth the cost. For the first four years after approval, these devices get special payment treatment that covers their costs without requiring the usual lengthy review process. During this time, hospitals and doctors can use these devices and get paid for them, even if Medicare hasn't finished collecting all the data about long-term effectiveness. The bill also requires the government to assign billing codes for these devices within three months of FDA approval, so providers can actually bill for them quickly.

After that four-year period ends, Medicare will decide whether to keep covering the device based on real-world evidence about whether it actually improves patient care and outcomes. This creates a balance: patients get faster access to promising new medical technology, while Medicare still eventually evaluates whether the devices are truly worth the investment. The bill also includes special rules for completely new types of devices that don't fit into existing Medicare categories, requiring the government to report to Congress on how these devices are working and whether they're helping patients.

Ensuring Patient Access to Critical Breakthrough Products Act of 2021

DelBene, Suzan K.

Ensuring Patient Access to Critical Breakthrough Products Act of 2021 This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. The Centers for Medicare &amp; Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).