HR 5343
Ensuring Patient Access to Critical Breakthrough Products Act
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Bill overview
This bill, the Ensuring Patient Access to Critical Breakthrough Products Act, aims to ensure that Medicare covers new medical devices quickly. It establishes a ‘transitional coverage period’ for breakthrough devices – devices designated by the FDA as offering significant advancements – and creates a process for the Secretary of Health and Human Services to identify these devices. The bill also includes provisions for reviewing billing practices related to these devices and requires the Centers for Medicare & Medicaid Services to report on breakthrough device applications and designations.
Key provisions
- Establishes a ‘transitional coverage period’ of 4 years for breakthrough devices.
- Creates a process for the Secretary to designate devices as ‘breakthrough devices’ based on FDA priority review and clinical data.
- Defines ‘breakthrough device’ based on FDA designation and clinical data demonstrating potential benefits.
- Requires the Secretary to review billing practices for breakthrough devices to identify outliers.
- Mandates annual reporting to Congress on breakthrough device applications and designations.
- Addresses national coverage determinations for breakthrough devices during the transitional coverage period.
- Allocates $10 million annually from fiscal years 2025-2030 to support the implementation of the bill.
- Defines ‘priority review’ under the Federal Food, Drug and Cosmetic Act.
Who is affected
- Medicare beneficiaries
- Pharmaceutical manufacturers
Sponsors
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Primary sponsor
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119th CONGRESS — 1st Session
H. R. 5343
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program.
This Act may be cited as the Ensuring Patient Access to Critical Breakthrough Products Act
.
in subparagraph (O), by striking and
at the end;
in subparagraph (P), by adding and
at the end; and
by inserting after subparagraph (P) the following new subparagraph:
breakthrough devicemeans a device that—
is so designated by the Secretary under section 1899D; and
The term transitional coverage period
means, with respect to a breakthrough device, the 4-year period that begins on the date that such device is so designated by the Secretary under section 1899D.
Part E of title XVIII of the Social Security Act (42 U.S.C. 1395x et seq.) is amended by adding at the end the following new section:
For purposes of subsection (a), the criteria specified in this subsection are, with respect to a device, the following:
The device is provided with priority review pursuant to section 515B of the Federal Food, Drug, and Cosmetic Act.
In the case such device is cleared under section 510(k) of such Act, such device is so cleared based on clinical data, which may include clinical trial information from an applicable device clinical trial (as such terms are defined in section 402(j) of such Act), that included individuals entitled to benefits under part A or enrolled under part B.
The device would, without application of section 1862(a), otherwise be covered under part A or B.
The device does not, based on a review of clinical data, present an undue risk of harm that outweighs the potential clinical benefits for individuals entitled to benefits under part A or enrolled under part B, as determined by the Secretary.
With respect to a device that is the subject of an application described in subsection (a), in the case that the Secretary determines that such device does not meet the criteria specified in subsection (b), the Secretary shall notify the manufacturer of such device of such determination and include in such notification an identification of the specific criterion or criteria that such device failed to meet and an explanation of why such device failed to meet such criterion or criteria.
The Secretary shall submit to Congress on an annual basis a report specifying—
the number of applications received under this section during such year;
the number of devices designated as breakthrough devices under this section during such year; and
The Secretary may conduct a review of the medical necessity and reasonableness of a breakthrough device furnished by a provider of service or supplier that the Secretary determines has an aberrant billing pattern with respect to such a device or otherwise is an outlier with respect to the furnishing of such device compared to similarly situated providers of services and suppliers.