119th Congress · introduced in the House · Sep 15, 2025
Ensuring Patient Access to Critical Breakthrough Products Act
Official title from Congress.gov
Latest action (Sep 17, 2025): Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Sep 15, 2025)
Ensuring Patient Access to Critical Breakthrough Products Act
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. Manufacturers must apply to the Centers for Medicare & Medicaid Services (CMS) to receive this designation. Qualifying devices must (1) have received priority review from the FDA, (2) received premarket approval (if applicable) based on clinical data that includes data from Medicare beneficiaries, (3) already generally qualify for Medicare coverage, and (4) not present an undue risk of harm that outweighs potential clinical benefits for Medicare beneficiaries.
The CMS must approve or deny applications within six months of receipt and must provide an explanation in the case of a denial. In addition, the CMS must make permanent coverage decisions before the end of the transitional period upon a timely request to do so, as specified.
The bill provides funds through FY2030 for the CMS to implement the bill.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Committee Consideration and Mark-up Session Held
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.
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.
Introduced in House
Introduced in House
Actions from Congress.gov, newest first.
Congressional oversight · Drug safety, medical device, and laboratory regulation · Health care costs and insurance · Health care coverage and access · Health programs administration and funding · Health technology, devices, supplies · Medicare
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
143 citations; showing the 25 most recently posted.
NOVOCURE INC. · lobbying firm or registrant: WILLIAMS AND JENSEN, PLLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$60,000
Paid to lobbying firm
Breakthrough pathway bill (H.R. 5343, S. 1717), CMS reimbursement of medical devices generally, and FDA issues related to medical devices.
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NOVOCURE INC. · lobbying firm or registrant: WILLIAMS AND JENSEN, PLLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
Breakthrough pathway bill (H.R. 5343, S. 1717), CMS reimbursement of medical devices generally, and FDA issues related to medical devices. CMS RAPID Proposed Rule.
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
MEDTRONIC INC · lobbying firm or registrant: MEDTRONIC, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$1,610,000
Spent on own lobbying
Issues related to coverage and payment for breakthrough medical devices, including Ensuring Patient Access to Critical Breakthrough Products Act (S. 1717; H.R. 5343) and CMS Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway proposal Issues related to coverage and payment of AI and digital health tec…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
SIEMENS MEDICAL SOLUTIONS USA, INC. · lobbying firm or registrant: AVENUE SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$70,000
Paid to lobbying firm
Monitor issues related to physician payment cuts; Monitor issues related to clinical lab tests; H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025; Issues related to Senate Finance Dear Colleague process; S. 1399, Health Tech I…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
EDWARDS LIFESCIENCES LLC · lobbying firm or registrant: AVENUE SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…t (TAVR) issued June 15, 2026; Medicare Coverage of Innovative Technology; Issues related to Transitional Coverage for Emerging Technologies (TCET) (CMS-3421); H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025; Issues related to Senate Finance Dear Colleague process
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
JOHNSON & JOHNSON SERVICES INC · lobbying firm or registrant: JOHNSON & JOHNSON SERVICES, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$2,220,000
Spent on own lobbying
…r Children Act of 2025, regarding all provisions - PL117-169 The Inflation Reduction Act, regarding all provisions related to drug pricing and implementation - H.R.5343/S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, regarding all provisions - H.R.4282, Contact Lens Prescription Verification…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HEARTFLOW, INC. · lobbying firm or registrant: HEARTFLOW, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$100,000
Spent on own lobbying
…dicare reimbursement; issues related to Medicare reimbursement of AI-enabled technology; Ensuring Patient Access to Critical Breakthrough Products Act (S. 1717/H.R. 5343); Health Tech Investment Act (S. 1399/H.R. 6197); H.R. 9260, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ADVANCED MEDICAL TECHNOLOGY ASSN · lobbying firm or registrant: ADVANCED MEDICAL TECHNOLOGY ASSN
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$1,080,000
Spent on own lobbying
…es related to coverage of telehealth services Issues related to Medicare coverage for digital health technologies - S. 1399/H.R. 6197 Issues related to S. 1717/H.R. 5343 Ensuring Patient Access to Critical Breakthrough Products Act Issues related to S. 2761/H.R. 5269 Lab Payments and Results Act Issues related to Medicare cover…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
JOHNSON & JOHNSON SERVICES, INC. · lobbying firm or registrant: ML STRATEGIES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
Issues related to cardiovascular health; H.R.5343 / S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025; issues related to Heart Recovery Awareness Day and H. Res. 1301, designat…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALZHEIMER'S ASSOCIATION · lobbying firm or registrant: ALZHEIMER'S ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,400,000
Spent on own lobbying
…t of 2023 (S. 526/H.R. 1092 118th Congress) Essential Caregivers Act of 2025 (H.R. 6766) Ensuring Patient Access to Critical Breakthrough Products Act (S. 1717/H.R. 5343) Linking Seniors to Needed Legal Services Act of 2025 (H.R. 6728) Amending the Rules of the House of Representatives to establish a Permanent Select Committee…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ZIMMER BIOMET · lobbying firm or registrant: THE MCMANUS GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…ery centers, included in Medicare Beneficiary Co-Pay Fairness Act of 2025(H.R. 3006/S. 1776) The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343/S. 1717)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ROCHE DIAGNOSTICS · lobbying firm or registrant: THE MCMANUS GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$40,000
Paid to lobbying firm
…ated to Medicare coverage and reimbursement for FDA-designated breakthrough medical devices, focusing on establishing a transitional coverage period, including H.R. 5343/S. 1717- Ensuring Patient Access to Critical Breakthrough Products Act of 2025.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
MEDICAL DEVICE MANUFACTURERS ASSOCIATION · lobbying firm or registrant: THE MCMANUS GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$30,000
Paid to lobbying firm
Issues related to Transitional Coverage for Emerging Technologies (TCET)(CMS-3421-NC), including H.R. 5343/S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act of 2025. Access to and reimbursement of medical devices in Medicare program.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
EDWARDS LIFESCIENCES LLC · lobbying firm or registrant: EDWARDS LIFESCIENCES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$300,000
Spent on own lobbying
Ensuring Patient Access to Critical Breakthrough Products (H.R.5343/S.1717) Regulatory Alignment for Predictable and Immediate Device coverage pathway Policies promoting medical innovation Heart Valve Disease Awareness AI in He…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
EDWARDS LIFESCIENCES LLC · lobbying firm or registrant: EDWARDS LIFESCIENCES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$300,000
Spent on own lobbying
CMS Coverage Policies For Medical Devices CMS Payment Policies for Medical Devices Ensuring Patient Access to Critical Breakthrough Products (H.R.5343/S.1717) (includes RAPID) Heart Valve Disease Awareness National Coverage Determination for TAVR Clinical Trials Coverage with Evidence Development
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NOVOCURE INC. · lobbying firm or registrant: NOVOCURE INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$160,000
Spent on own lobbying
General Medicare Issues. H.R.5343/S.1717 - Ensuring Patient Access to Critical Breakthrough Products Act of 2025.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
MEDICAL DEVICE MANUFACTURERS ASSOCIATION · lobbying firm or registrant: THORN RUN PARTNERS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$20,000
Paid to lobbying firm
Issues related to FDA approval of medical devices. Issues related to sterilization of medical devices. Barriers to market access for medical device companies. H.R.5343 - Ensuring Patient Access to Critical Breakthrough Products Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ADVANCED MEDICAL TECHNOLOGY ASSOCIATION (ADVAMED) · lobbying firm or registrant: THE NICKLES GROUP, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Medicare/Medicaid
$60,000
Paid to lobbying firm
Issues related to Medicare coverage of breakthrough technologies. Issues related to the RAPID coverage pathway. S. 1717 / H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act of 2025. Issues related to Medicare durable medical equipment competitive bidding and coverage o…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHILIPS HOLDING USA INC. · lobbying firm or registrant: PHILIPS HOLDING USA, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Medicare/Medicaid
$470,000
Spent on own lobbying
…utrality payments under Medicare Medicare Physician Fee Schedule reform S. 1717, Ensuring Patient Access to Critical Breakthrough Products Act (whole bill) and H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act (whole bill)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL HEALTH COUNCIL · lobbying firm or registrant: NATIONAL HEALTH COUNCIL
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Health Issues
$21,227
Spent on own lobbying
H.R. 1, One Big Beautiful Bill Act, implementation and patient access issues. S. 1816/H.R. 3514, Improving Seniors' Timely Access to Care Act. S. 1717/H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act. H.R. 3521/S. 4440, Clinical Trial Modernization Act. S. 2903/H.R. 5509, Safe Step Act. FY 2027…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
MEDICAL DEVICE MANUFACTURERS ASSOCIATION · lobbying firm or registrant: MEDICAL DEVICE MANUFACTURERS ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Medicare/Medicaid
$340,000
Spent on own lobbying
Issues related to Medicare coverage reform Issues related to the coverage for FDA Breakthrough products and the H.R. 5343 and S.1717 Ensuring Patient Access to Critical Breakthrough Products Act TCET Issues related to the Regulatory Alignment for Predictable and Immediate Device (…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ADVANCED MEDICAL TECHNOLOGY ASSOCIATION (ADVAMED) · lobbying firm or registrant: CROSSROADS STRATEGIES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 18, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…r medical technology. Issues related to cybersecurity of medical devices manufactured in China. Policies that could impact supply chain for medical technology. H.R.5343, Ensuring Patient Access to Critical Breakthrough Products Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ADVANCED MEDICAL TECHNOLOGY ASSOCIATION (ADVAMED) · lobbying firm or registrant: CROSSROADS STRATEGIES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 18, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…icies that support innovation in the medical device industry. Issues related to the coverage and reimbursement of medical devices and technology, including AI. H.R.5343, Ensuring Patient Access to Critical Breakthrough Products Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
INSIGHTEC, INC. · lobbying firm or registrant: RS GROUP CONSULTING LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 16, 2026 · issue area: Health Issues
$30,000
Paid to lobbying firm
Medicare coverage issues; H.R. 5343, the Ensuring Patient Access to Critical Breakthrough Products Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
F HOFFMANN-LA ROCHE LTD AND ITS AFFILIATES · lobbying firm or registrant: F. HOFFMANN-LA ROCHE LTD, AND ITS AFFILIATES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 16, 2026 · issue area: Medicare/Medicaid
$90,000
Spent on own lobbying
…linical Laboratory Fee Schedule (CLFS), specifically reforms to address payment cuts resulting from the Protecting Access to Medicare Act (PAMA) 2014. S.1717 / H.R.5343 The Ensuring Patient Access to Critical Breakthrough Products Act. Issues related to Medicare coverage and reimbursement for FDA-designated breakthrough medica…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing