3.0.0 5333 2022-10-28T01:46:02Z 2022-10-28T01:46:02Z House HR 2019-12-06 116 [Congressional Record Volume 165, Number 195 (Friday, December 6, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DelBENE:H.R. 5333.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8[Page H9347]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-12-09T17:32:19Z Referred to 2019-12-06T14:01:35Z hswm00 Ways and Means Committee House Standing Referred to 2019-12-06T14:01:30Z Ensuring Patient Access to Critical Breakthrough Products Act of 2020 116 3914 S 2020-06-08 Read twice and referred to the Committee on Finance. Related bill CRS 2019-12-09 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-12-06 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-12-06 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. IntroReferral H11100 2 House floor actions hswm00 Ways and Means Committee 2019-12-06 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-12-06 Introduced in House IntroReferral 1000 9 Library of Congress D000617 Rep. DelBene, Suzan K. [D-WA-1] Suzan DelBene D WA K. 1 N W000813 Rep. Walorski, Jackie [R-IN-2] Jackie Walorski R IN 2 2019-12-06 True C001097 Rep. Cárdenas, Tony [D-CA-29] Tony Cárdenas D CA 29 2019-12-06 True B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2019-12-06 True S001185 Rep. Sewell, Terri A. [D-AL-7] Terri Sewell D AL A. 7 2019-12-06 True M001198 Rep. Marshall, Roger [R-KS-1] Roger Marshall R KS 1 2019-12-06 True K000394 Rep. Kim, Andy [D-NJ-3] Andy Kim D NJ 3 2020-07-09 False P000605 Rep. Perry, Scott [R-PA-10] Scott Perry R PA 10 2020-07-09 False V000133 Rep. Van Drew, Jefferson [R-NJ-2] Jefferson Van Drew R NJ 2 2020-07-09 False 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 Health 00 2019-12-06 Introduced in House 2020-07-20T20:21:14Z 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).

]]> Ensuring Patient Access to Critical Breakthrough Products Act of 2019 Display Title Ensuring Patient Access to Critical Breakthrough Products Act of 2019 Official Title as Introduced To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes. Introduced in House IH Short Title(s) as Introduced Ensuring Patient Access to Critical Breakthrough Products Act of 2019 Introduced in House IH Introduced in House 2019-12-06T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr5333ih/xml/BILLS-116hr5333ih.xml 2019-12-09 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.