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Ensuring Patient Access to Critical Breakthrough Products Act of 2020
Legislative Progress
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vs 5,086 other S bills in the 116th — cohort avg 30d
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).
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (1)
2020 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare policies on continuous glucose monitoring and closed loop systems. Issues related to value based health care and modernization of fraud and abuse laws. Issues related to Medicare coverage and payment for Breakthrough-designated medical devices, including H.R. 5333/S. 3914, the Ensuring Patient Access to Critical Breakthrough Products Act. Issues related to telemedicine and remote patient monitoring. Issues related to proposed Medicare Physician Fee Schedule cuts. Issues related to Medicare prior authorization policies.
Client expense: $771,000 · Firm income: Not reported
Read twice and referred to the Committee on Finance.
Introduced in Senate
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Sources: Congress.gov
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Medicare/Medicaid
Issues related to Medicare policies on continuous glucose monitoring and closed loop systems. Issues related to value based health care and modernization of fraud and abuse laws. Issues related to Medicare coverage and payment for Breakthrough-designated medical devices, including H.R. 5333/S. 3914, the Ensuring Patient Access to Critical Breakthrough Products Act. Issues related to telemedicine and remote patient monitoring.
Client expense: $1,867,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Medicare/Medicaid
Issues related to Medicare policies on continuous glucose monitoring and artificial pancreas device systems. Issues related to value based health care and modernization of fraud and abuse laws. Issues related to Medicare coverage and payment for Breakthrough-designated medical devices, including H.R. 5333/S. 3914, the Ensuring Patient Access to Critical Breakthrough Products Act. Issues related to telemedicine and remote patient monitoring.
Client expense: $1,019,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR)