Ensuring Patient Access to Critical Breakthrough Products Act

Issues related to physician payments; issues related to Medicare 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 Appropriations Act, 2027, issues related to health care, generally.

Client expense: $100,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Health & Human Services, Dept of (HHS)

Issues 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 coverage of FDA's breakthrough devices Issues related to coverage of diabetes devices and supplies Issues related to Home Health Rule

Client expense: $1,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

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, designating February 20th Heart Recovery Awareness Day

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access and reimbursement of medical devices in Medicare program. Issues related to capping beneficiary copayments for Medicare beneficiaries in ambulatory surgery 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)

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5269/2761 - RESULTS Act Issues related 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.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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 Healthcare FDA Reauthorization/FDA User Fees Diversity in Clinical Trials Coverage with Evidence Development

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

General Medicare Issues. H.R.5343/S.1717 - Ensuring Patient Access to Critical Breakthrough Products Act of 2025.

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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.

Client expense: Not reported · Firm income: $20,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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 of diabetes technologies. The FY2027 IPPS final rule and issues related to new technology add-on payments.

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

S. 1399, the Health Tech Investment Act (whole bill) and H.R. 6197, the Health Tech Investment Act (whole bill) Site neutrality 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)

Client expense: $470,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 Labor, HHS, Education appropriations for programs affecting people with chronic diseases and disabilities. S. 494/ H.R.1189 National Plan for Epilepsy Act Senate Finance Committee RFI on Drug Pricing and Health Coverage H.R. 9599 SECURE 340B Act Discussion Draft - 340B Drug Pricing Integrity and Affordability for Patients Act S. 5244 SUSTAIN 340B Act H.R.7352/S. 4875 PASTEUR Act S.3267/H.R. 6130 ASAP Act

Client expense: $21,227 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 (RAPID) coverage pathway Issues related to the New Technology Add on Payment (NTAP) Issues related to coverage of telehealth services Issues related to physician fee schedule Issues related to CMS expansion of prior authorization requirements for medical procedures Issues related to reimbursement of artificial intelligence in healthcare Issues related to competitive bidding

Client expense: $340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

General education to advance policies 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.

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

General education to advance policies that support innovation in the medical device industry. Issues related to coverage and reimbursement of diagnostic tests, including issues related to FDA regulation of medical devices. Issues related to medical device sterilization. Policy issues related to the regulation of artificial intelligence for 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.

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Medicare coverage issues; H.R. 5343, the Ensuring Patient Access to Critical Breakthrough Products Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

(MED) Issues related to public health emergency preparedness, including Pandemic All-Hazards Preparedness Act and H.R.1108 The Diagnostics Testing Preparedness Plan Act. Issues related to the FDA regulation of diagnostics. Issues related to diagnostics to support Preeclampsia, Breast and Cervical Cancer, Alzheimer's and Influenza Preparedness Clinical Lab Fee Schedule reform, the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act H.R. 5269 / S. 2761 and Medicare coverage of FDA approved breakthrough diagnostics, S.1717 / H.R. 5343 The Ensuring Patient Access to Critical Breakthrough

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Access to and reimbursement of diagnostics in the Medicare program. H.R. 5269 / S. 2761 Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act - Issues related to Medicare reimbursement of Clinical 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 medical devices, focusing on establishing transitional coverage period.

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Breakthrough devices- H.R. 5343;

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Reimbursement: Medicare Coverage of Breakthrough Technologies (S. 1717/H.R. 5343); Transitional Coverage for Emerging Technologies (TCET)/Medicare Coverage for Innovative Technology (MCIT); supplies and services incident to a physician's services reimbursement. Medicare coverage of telehealth flexibilities CMS NPRM IPPS proposal to repeal New Technology Add on Payment (NTAP) and Transitional Pass-Through pathway for FDA Breakthrough Devices; proposal for adoption of unique device identifier (UDI) capture measure under the Medicare Promoting Interoperability Program. Medicare payment for FTE residents training in rural areas, "Rural Physician Workforce Production Act of 2025" (H.R. 1153) Medicare Program: Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (RAPID) Proposed Coverage Pathway proposal by CMS

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General discussions related to clinical trials infrastructure and government labs, and related matters. General discussions regarding diagnostic reimbursement policies. General discussions regarding domestic pharmaceutical manufacturing. H.R. 5269/S. 2761: Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act of 2025 - all provisions of the bill. H.R. 5343/S. 1717: Ensuring Patient Access to Critical Breakthrough Products Act - all provisions of the bill. H.R. 9061: Preeclampsia Risk Evaluation and Evidence-based Management through Personalized Testing (PREEMPT) Act - all provisions of the bill.

Client expense: $550,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, White House Office

Ensuring Patient Access to Critical Breakthrough Products Act of 2025(H.R. 5343 and S.1717) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. (CMS rulemaking for Transitional Coverage of Emerging Technologies (TCET) - advocacy for a new, voluntary Transitional Coverage of Emerging Technologies (TCET) pathway that provides national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization.) The Patient Access to Innovative New Technologies Act (PAINT Act) -- proposed legislation that aims to expand access to new medical technologies by improving the Medicare New Technology Add-on Payment (NTAP) program. It would create a single deadline for products in an alternative pathway, ensure breakthrough devices are eligible for conditional approval under NTAP, and prevent disruption in Medicare beneficiaries' access to new treatments. The Advancing Research for Chronic Pain Act (S. 5041), directs the CDC to regularly collect, analyze, and report data on the prevalence, burden, and impact of chronic pain in the US and build a centralized Chronic Pain Information Hub. The Relief of Chronic Pain Act (S. 3064), which would lower cost-sharing and bar step therapy and prior authorization for non-opioid treatments under Medicare Part D. Starting work on the Food and Drug Omnibus Reform Act of 2026 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders, and device shortages. Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) (Public Law 109-417) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains and advocacy for medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity. Support passage of the Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act of 2025 - Senate (S. 1031) & (H.R. 2120). This legislation would increase access to patient care, enhance the quality of cancer treatments, encourage innovation, reduce disparities for rural and underserved patients, and lower patient costs by saving Medicare about $200 million over 10 years. The WISeR Model (Wasteful and Inappropriate Service Reduction Model) - Advocacy efforts on inclusions in CMS' WISeR model, which is aimed at reducing inappropriate care and preventing improper payments under Medicare Part B by refining prior authorization processes for traditional fee-for-service Medicare. Engaged on the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway and efforts to streamline FDA-CMS coordination and Medicare coverage for Breakthrough Devices.

Client expense: $642,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Research into spinal muscular atrophy, timely access to care, treatments, medical devices, and home and community-based services, Medicaid home care (paid family caregiving & self-directed care), Give Kids a Chance Act (H.R.1261/ S.932- FDA Pediatric Priority Review Voucher Program), DOD Congressionally Directed Medical Research Program & Peer-Reviewed Medical Research Program, Local Coverage Determination related to seat elevation in Group 2 standard power wheelchairs, Labor-Health and Human Services, and Education Appropriations bill, Family Caregiver Awareness, Resources, and Education (CARE) Partnerships Act, Pediatric Palliative Care Homes, National Institute on Disability, Independent Living, and Rehabilitation Research funding, Seat Elevation in Group 2 Non-Complex Power Wheelchairs, Coverage of Standing Systems in Group 3 Power Wheelchair, Competitive Bidding for Tracheostomy, Ostomy and Urological Supplies; FDA Rare Disease Patient Listening Session, Coverage of Respiratory Assist Devices (RADs) and Home Mechanical Ventilators (HMVs), Accelerating Kids Access to Care Act (H.R. 1509/S. 752, National Institutes of Health grant management process & funding; Medicaid home and community-based services, Public Law 119-21 Medicaid Community Engagement Requirements - disability and medically frail definition; Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), Veterans STAND Act (H.R. 6835), Veterans SPORTS Act (S. 3138) Consolidated Appropriations Act of 2026 (P.L. 119-75); Timely Access to Coverage Decisions Act (H.R. 8500); HCBS Access Act ( H.R.8540/ S.5321); Supporting Our Direct Care Workforce and Family Caregivers Act (S. 4889); Safe Step Act (H.R. 5509/ S. 2903), Recognizing the Role of Direct Support Professionals Act to establish a Standard Occupational Classification (SOC) for Direct Support Professionals (S.3211)

Client expense: $75,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

As the statewide Trade Association for the Life Sciences, our Public Policy advocacy work remains to engage and educate the Pennsylvania Congressional Delegation to incentivize innovation and protect patient access. Ensuring Patient Access to Critical Breakthrough Products Act (HR 5343/S1717). This legislation provides Medicare coverage for medical devices approved through the FDAs Breakthrough Devices Program. Without this legislation, devices receiving the Breakthrough Device designation and approval must often wait upwards of two to three years for payment codes from the Centers for Medicare and Medicaid Services. Without this legislation, patients in Medicare face coverage and reimbursement delays in access to life-changing innovations.

Client expense: $6,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 Labor, HHS, Education appropriations for programs affecting people with chronic diseases and disabilities.

Client expense: $25,779 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to physician payments; issues related to Medicare 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 Appropriations Act, 2027, issues related to health care, generally.

Client expense: $100,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Health & Human Services, Dept of (HHS)

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 technologies, including Health Tech Investment Act (S. 1399; H.R. 6197) Issues related to prior authorization, including CMMI WISeR Model Issues related to non-opioid pain therapies Issues related to transcatheter heart valve NCD

Client expense: $1,180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ensuring Patient Access to Critical Breakthrough Products (H.R.5343/S.1717) (includes MCIT/TCET) Transitional Coverage for Emerging Technologies (TCET)/MCIT Policies promoting medical innovation Heart Valve Disease Awareness AI in Healthcare FDA Reauthorization/FDA User Fees Diversity in Clinical Trials Coverage with Evidence Development

Client expense: $280,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

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 MCIT/TCET) Heart Valve Disease Awareness National Coverage Determination for TAVR Coverage of Transcatheter Tricuspid Valve Replacement Coverage with Evidence Development

Client expense: $280,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 1399, the Health Tech Investment Act (whole bill) and H.R. 6197, the Health Tech Investment Act (whole bill) Site neutrality payments under Medicare Medicare Physician Fee Schedule reform Extension of Medicare telehealth waivers - H.R. 5081/S. 2709 - The Telehealth Modernization Act (all sections) 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) H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act - whole bill

Client expense: $660,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1399, the Health Tech Investment Act (whole bill) and H.R. 6197, the Health Tech Investment Act (whole bill) Site neutrality 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)

Client expense: $640,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5343 / S. 1717 - Ensuring Patient Access to Critical Breakthrough Products Act of 2025; H.R. 6197 / S. 1399 - Health Tech Investment Act; H.R. 4417 / S. 2927 - Mobile Cancer Screening Act; S. 1031 / H.R. 2120 - ROCR Value Based Program Act; H.R. 5269 / S. 2761 - RESULTS Act; and H.R. 2477, S. 1168 - Portable Ultrasound Reimbursement Equity Act of 2025. Issues related to access to care for new medical device technology in rural and underserved areas; and Issues related to Medicare reimbursement rates, including for mobile stroke units and in relation to artificial intelligence and in relation to radiopharmaceuticals.

Client expense: $860,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

- H.R. 1539, Medical Device Electronic Labeling Act, regarding all provisions - H.R. 929/S. 266, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, regarding all provisions - H.R. 946 ORPHAN Cures Act, regarding all provisions - S.864, HELP Copays Act, regarding all provisions - H.R. 2214, Delinking Revenue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act - S. 1954/ H.R. 5526 Biosimilar Red Tape Elimination Act, regarding all provisions - H.R.2527, Early Detection of Vision Impairments for 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 Modernization Act, regarding all provisions - H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act, regarding all provisions - S.1399 / H.R. 6197, the Health Tech Investment Act, regarding all provisions - H.R. 3521, the Clinical Trial Modernization Act, regarding all provisions - H.R. 3006 / S.1776, the Medicare Beneficiary Co-Pay Fairness Act, regarding all provisions - H.R. 3514, the Improving Seniors Timely Access to Care Act of 2025, regarding all provisions - H.R. 6549, the VA Contracting and Procurement Act, regarding all provisions - H.R. 5509 / S. 2903, Safe Step Act, regarding all provisions - H.R. 5256, 340B ACCESS Act, regarding all provisions - H.R. 7391, Community Health Center Drug Pricing Protection Act, regarding all provisions Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B and 340B Rebate Pilot - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - obesity treatments - MFN - Foreign Reference Pricing - CMS Outpatient Prospective Payment System rule - peripheral artery disease (PAD) - PBM and Insurer Reforms

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Breakthrough pathway bill (H.R. 5343, S. 1717), CMS reimbursement of medical devices generally, and FDA issues related to medical devices.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Breakthrough pathway bill (H.R. 5343, S. 1717), CMS reimbursement of medical devices generally, and FDA issues related to medical devices.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues 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 coverage of FDA's breakthrough devices Issues related to coverage of diabetes devices and supplies Issues related to Home Health Rule

Client expense: $971,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Monitor issues related to site neutral payments; 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

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to CMSs draft coverage policy for transcatheter aortic valve replacement (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

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access and reimbursement of medical devices in Medicare program. Issues related to capping beneficiary copayments for Medicare beneficiaries in ambulatory surgery 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)

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5269/2761 - RESULTS Act Issues related 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.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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, designating February 20th Heart Recovery Awareness Day

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education to advance policies that support innovation in the medical device industry. Issues related to coverage and reimbursement of diagnostic tests, including issues related to FDA regulation of medical devices. Issues related to medical device sterilization. Policy issues related to the regulation of artificial intelligence for 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.

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE