3.0.0 3914 2023-01-11T13:46:17Z 2023-01-11T13:46:17Z Senate S 2020-06-08 116 ssfi00 Finance Committee Senate Standing Referred to 2020-06-08T22:50:22Z Ensuring Patient Access to Critical Breakthrough Products Act of 2019 116 5333 HR 2019-12-09 Referred to the Subcommittee on Health. Related bill CRS 2020-06-08 ssfi00 Finance Committee Senate Read twice and referred to the Committee on Finance. IntroReferral 2020-06-08 Introduced in Senate IntroReferral 10000 9 Library of Congress M001197 Sen. McSally, Martha [R-AZ] Martha McSally R AZ N 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 2020-06-08 Introduced in Senate 2020-07-21T21:21:19Z Ensuring Patient Access to Critical Breakthrough Products Act of 2020

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 2020 Display Title Ensuring Patient Access to Critical Breakthrough Products Act of 2020 Short Title(s) as Introduced Ensuring Patient Access to Critical Breakthrough Products Act of 2020 Introduced in Senate IS Official Title as Introduced A bill 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 Senate IS Introduced in Senate 2020-06-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s3914is/xml/BILLS-116s3914is.xml 2020-06-08 Read twice and referred to the Committee on Finance. 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.