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Ensuring Patient Access to Critical Breakthrough Products Act of 2025

USA119th CongressS-1717| Senate 
| Updated: 5/12/2025
Todd Young

Todd Young

Republican Senator

Indiana

Cosponsors (3)
Adam B. Schiff (Democratic)Alex Padilla (Democratic)John Barrasso (Republican)

Finance Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill, titled the "Ensuring Patient Access to Critical Breakthrough Products Act of 2025," aims to guarantee prompt Medicare coverage for innovative medical technologies. It establishes a 4-year transitional coverage period for devices designated as "breakthrough," during which Medicare will cover these products unless they are used off-label or pose an undue risk to beneficiaries. To qualify, a device must have received priority review from the Food and Drug Administration , and manufacturers can apply for this designation from the Secretary of Health and Human Services. The Secretary is required to make a determination within six months of application and must finalize a national coverage determination for these devices before their transitional coverage period expires. The legislation appropriates $10,000,000 annually to the Centers for Medicare & Medicaid Services Program Management Account for fiscal years 2026 through 2031 to implement these new provisions.
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Timeline

Bill from Previous Congress

S 116-3914
Ensuring Patient Access to Critical Breakthrough Products Act of 2020

Bill from Previous Congress

S 118-5349
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
May 12, 2025
Introduced in Senate
May 12, 2025
Read twice and referred to the Committee on Finance.
Sep 17, 2025

Latest Companion Bill Action

HR 119-5343
Committee Consideration and Mark-up Session Held
  • Bill from Previous Congress

    S 116-3914
    Ensuring Patient Access to Critical Breakthrough Products Act of 2020


  • Bill from Previous Congress

    S 118-5349
    Ensuring Patient Access to Critical Breakthrough Products Act of 2024


  • May 12, 2025
    Introduced in Senate


  • May 12, 2025
    Read twice and referred to the Committee on Finance.


  • September 17, 2025

    Latest Companion Bill Action

    HR 119-5343
    Committee Consideration and Mark-up Session Held

Health

Ensuring Patient Access to Critical Breakthrough Products Act of 2025

USA119th CongressS-1717| Senate 
| Updated: 5/12/2025
This bill, titled the "Ensuring Patient Access to Critical Breakthrough Products Act of 2025," aims to guarantee prompt Medicare coverage for innovative medical technologies. It establishes a 4-year transitional coverage period for devices designated as "breakthrough," during which Medicare will cover these products unless they are used off-label or pose an undue risk to beneficiaries. To qualify, a device must have received priority review from the Food and Drug Administration , and manufacturers can apply for this designation from the Secretary of Health and Human Services. The Secretary is required to make a determination within six months of application and must finalize a national coverage determination for these devices before their transitional coverage period expires. The legislation appropriates $10,000,000 annually to the Centers for Medicare & Medicaid Services Program Management Account for fiscal years 2026 through 2031 to implement these new provisions.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 116-3914
Ensuring Patient Access to Critical Breakthrough Products Act of 2020

Bill from Previous Congress

S 118-5349
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
May 12, 2025
Introduced in Senate
May 12, 2025
Read twice and referred to the Committee on Finance.
Sep 17, 2025

Latest Companion Bill Action

HR 119-5343
Committee Consideration and Mark-up Session Held
  • Bill from Previous Congress

    S 116-3914
    Ensuring Patient Access to Critical Breakthrough Products Act of 2020


  • Bill from Previous Congress

    S 118-5349
    Ensuring Patient Access to Critical Breakthrough Products Act of 2024


  • May 12, 2025
    Introduced in Senate


  • May 12, 2025
    Read twice and referred to the Committee on Finance.


  • September 17, 2025

    Latest Companion Bill Action

    HR 119-5343
    Committee Consideration and Mark-up Session Held
Todd Young

Todd Young

Republican Senator

Indiana

Cosponsors (3)
Adam B. Schiff (Democratic)Alex Padilla (Democratic)John Barrasso (Republican)

Finance Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted