Ensuring Patient Access to Critical Breakthrough Products Act of 2021

Summary

Ensuring Patient Access to Critical Breakthrough Products Act of 2021 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 four-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).

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Timeline

1. 22 June 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

2. 22 June 2021

   Introduced

   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.

   Source: IntroReferral

3. 22 June 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 22 June 2021

   Introduced

   Introduced in House

   Source: IntroReferral

5. 23 June 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 22 June 2021 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 22 June 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 22 June 2021

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 22 June 2021

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. DelBene, Suzan K. [D-WA-1] · D · Sponsor
• Rep. Walorski, Jackie [R-IN-2] · R · Sponsor
• Rep. Cárdenas, Tony [D-CA-29] · D · Sponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Sponsor
• Rep. Sewell, Terri A. [D-AL-7] · D · Sponsor
• Rep. Upton, Fred [R-MI-6] · R · Sponsor
• Rep. Suozzi, Thomas R. [D-NY-3] · D · Cosponsor
• Rep. Houlahan, Chrissy [D-PA-6] · D · Cosponsor
• Rep. Dunn, Neal P. [R-FL-2] · R · Cosponsor
• Rep. Bera, Ami [D-CA-6] · D · Cosponsor
• Rep. McGovern, James P. [D-MA-2] · D · Cosponsor
• Rep. Boyle, Brendan F. [D-PA-2] · D · Cosponsor
• Rep. Correa, J. Luis [D-CA-46] · D · Cosponsor
• Rep. Wenstrup, Brad R. [R-OH-2] · R · Cosponsor
• Rep. Crenshaw, Dan [R-TX-2] · R · Cosponsor
• Rep. Schrier, Kim [D-WA-8] · D · Cosponsor
• Rep. Wild, Susan [D-PA-7] · D · Cosponsor
• Rep. Pappas, Chris [D-NH-1] · D · Cosponsor
• Rep. Peters, Scott H. [D-CA-50] · D · Cosponsor
• Rep. Craig, Angie [D-MN-2] · D · Cosponsor
• Rep. McKinley, David B. [R-WV-1] · R · Cosponsor
• Rep. Kelly, Mike [R-PA-16] · R · Cosponsor
• Rep. Lieu, Ted [D-CA-36] · D · Cosponsor
• Rep. Aguilar, Pete [D-CA-33] · D · Cosponsor
• Rep. Cheney, Liz [R-WY-At Large] · R · Cosponsor
• Rep. Emmer, Tom [R-MN-6] · R · Cosponsor
• Rep. Miller, Carol D. [R-WV-1] · R · Cosponsor
• Rep. Steel, Michelle [R-CA-48] · R · Cosponsor
• Rep. Dean, Madeleine [D-PA-4] · D · Cosponsor
• Rep. Smucker, Lloyd [R-PA-11] · R · Cosponsor
• Rep. Joyce, John [R-PA-13] · R · Cosponsor
• Rep. Smith, Jason [R-MO-8] · R · Cosponsor
• Rep. Lamb, Conor [D-PA-17] · D · Cosponsor
• Rep. Auchincloss, Jake [D-MA-4] · D · Cosponsor
• · hsif00 · Standing
• · hswm00 · Standing

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