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Immediate Medicare Coverage for Designated Medical Breakthrough Devices

The United States House Committee on Ways & Means (the “Ways & Means Committee”) advanced the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) (the “Bill”) out of committee on June 27, 2024.

The Bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period.  The Bill requires the Centers for Medicare & Medicaid Services (CMS) to assign payment codes for such devices within three months of FDA approval and establish a process to allow for continued coverage after the transitional period has expired.

According to the Ways & Means Committee, “[r]ight now, instead of helping seniors, new devices sit on the sidelines for up to 5 years after FDA approval, helping nobody.  This bill provides an immediate four years of Medicare coverage for these devices to provide assistance to seniors while Medicare determines if the device should be permanently covered.”

Congresswoman Suzan DelBene, a sponsor of the Bill, stated that:

Our legislation advanced by the House Ways & Means Committee with a strong bipartisan vote today is a great step toward driving innovation and investment in state-of-the-art technologies while removing barriers that hinder access to care. By ensuring Medicare covers breakthrough medical devices, we are improving the quality of life for millions of seniors and providing them with new hope

The full text of the Bill is available here.

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