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HR 5333 116th Congress House Health Congressional oversight Drug safety, medical device, and laboratory regulation Government studies and investigations Health care coverage and access Health information and medical records Health technology, devices, supplies Home and outpatient care Hospital care Medicare Public contracts and procurement

Ensuring Patient Access to Critical Breakthrough Products Act of 2019

Introduced: December 6, 2019 Introduced by: DelBene, Suzan K. Democratic · Washington See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 9, 2019
Referred to the Subcommittee on Health.
Dec 6, 2019
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Dec 6, 2019
Introduced in House
 Plain-English summary Congressional Research Service

Ensuring Patient Access to Critical Breakthrough Products Act of 2019

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 three-year transitional period. The Centers for Medicare & 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).

What's happening now December 9, 2019

Referred to the Subcommittee on Health.

 Committees of jurisdiction 3
 Cosponsors 6
All 6 Democratic 2 Republican 4