Medical Device Electronic Labeling Act

Third-party servicing of medical devices, right-to-repair of medical devices, remanufacturing of medical devices Cybersecurity of medical devices FDA regulation of Artificial Intelligence S. 4519, the Medical Device Electronic Labeling Act (whole bill) and H.R. 1539, the Medical Device Electronic Labeling Act (whole bill)

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

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

Graduate Medical Education (GME): -"Resident Physician Shortage Reduction Act of 2025" (H.R. 4731) which would increase GME positions in rural areas; -the "Public Health and Bio-Preparedness Workforce Loan Repayment Reauthorization Act of 2025" (H.R. 4445) FDA Modernization: -Modeling non-animal studies for medtech -Biotechnology: reduce regulatory barriers; align public-private investment -Medical Device Electronic Labeling Act (IFU) bill (FDA issue) (H.R. 1539) FDA Reform: -Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) Nursing Workforce Shortage Artificial Intelligence (AI): -Presidential E.O. 14179 setting forth national policy framework for AI and Congressional action to provide preemption of conflicting state requirements, safe and efficient adoption of AI. Right-to-Repair provision in House NDAA (H.R.4784/H.R. 8800) broadly would impact FDA regulated medical devices

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to medical device electronic labeling, including H.R. 1539/S. 4519 - Medical Device Electronic Labeling Act Issues related to hypertension Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices, including related to H.R. 8800/S.4784, the National Defense Authorization Act of 2027 Issues related to artificial intelligence and other advanced software in health care Issues related to Parkinsons disease Issues related to epilepsy Issues related to overactive bladder and urinary incontinence Issues related to pelvic venous disorder (PeVD) Issues related to the medical supply chain

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Third-party servicing of medical devices, right-to-repair of medical devices, remanufacturing of medical devices Cybersecurity of medical devices FDA regulation of Artificial Intelligence Efforts to improve access to healthcare for underserved communities and activities to enhance maternal healthcare Sustainability in healthcare throughout the value chain including procurement, product development and design, and the benefits thereof S. 4519, the Medical Device Electronic Labeling Act (whole bill) and H.R. 1539, the Medical Device Electronic Labeling Act (whole bill)

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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

Issues related to Privacy Legislation Issues related to remanufacturing and servicing medical devices Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 1539 - the Medical Device Electronic Labeling Act Issues related to National Defense Authorization Act Issues related to FDA regulation of diagnostic tests Issues related to the Countering CCP Act (S. 4939) Issues related to the Health Care Cybersecurity and Resiliency Act of 2025 (S. 3315)

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

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.1539, Medical Device Electronic Labeling Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology Issues related to CY 2026 rulemaking

Client expense: $370,000 · Firm income: Not reported

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

Graduate Medical Education (GME): -"Resident Physician Shortage Reduction Act of 2025" (H.R. 4731) which would increase GME positions in rural areas; -the "Public Health and Bio-Preparedness Workforce Loan Repayment Reauthorization Act of 2025" (H.R. 4445) FDA Modernization: -Modeling non-animal studies for medtech -Biotechnology: reduce regulatory barriers; align public-private investment -Medical Device Electronic Labeling Act (IFU) bill (FDA issue) (H.R. 1539) FDA Reform: -Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) Nursing Workforce Shortage Artificial Intelligence (AI): -Presidential E.O. 14179 setting forth national policy framework for AI and Congressional action to provide preemption of conflicting state requirements, safe and efficient adoption of AI. Right-to-Repair provision in House NDAA H.R.4784/H.R. 8800 broadly would impact FDA regulated medical devices

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.1539, Medical Device Electronic Labeling Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology Issues related to CY 2026 rulemaking

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), 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

Issues related to medical device electronic labeling, including H.R. 1539 - Medical Device Electronic Labeling Act Issues related to hypertension Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Issues related to artificial intelligence and other advanced software in health care Issues related to Parkinsons disease Issues related to diabetes Issues related to epilepsy Issues related to overactive bladder and urinary incontinence

Client expense: $940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to remanufacturing and servicing medical devices Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 1539 - the Medical Device Electronic Labeling Act Issues related to National Defense Authorization Act Issues related to FDA regulation of diagnostic tests.

Client expense: $1,100,000 · Firm income: Not reported

Graduate Medical Education (GME): -"Resident Physician Shortage Reduction Act of 2025" (H.R. 4731) which would increase GME positions in rural areas; -the "Public Health and Bio-Preparedness Workforce Loan Repayment Reauthorization Act of 2025" (H.R. 4445) FDA Modernization: -Modeling non-animal studies for medtech -Biotechnology: reduce regulatory barriers; align public-private investment -Medical Device Electronic Labeling Act (IFU) bill (FDA issue) (H.R. 1539) FDA Reform: -Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) Nursing Workforce Shortage Artificial Intelligence (AI): -Presidential E.O. 14179 setting forth national policy framework for AI and Congressional action to provide preemption of conflicting state requirements, safe and efficient adoption of AI.

Client expense: $200,000 · Firm income: Not reported

Government targets: 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. 6167, the Health Tech Investment Act, regarding all provisions Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - obesity treatments - MFN - Foreign Reference Pricing

Client expense: $1,510,000 · Firm income: Not reported

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.1539, Medical Device Electronic Labeling Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology Issues related to CY 2026 rulemaking

Client expense: $390,000 · Firm income: Not reported

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

Issues related to medical device electronic labeling, including H.R. 1539 - Medical Device Electronic Labeling Act Issues related to hypertension Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices, including S.2296 - National Defense Authorization Act for Fiscal Year 2026 and H.R. 3838, the Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 Issues related to artificial intelligence and other advanced software in health care Issues related to Parkinsons disease Issues related to diabetes Issues related to epilepsy Issues related to overactive bladder and urinary incontinence

Client expense: $990,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to remanufacturing and servicing medical devices Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 1539 - the Medical Device Electronic Labeling Act Issues related to FDAs third party review program Issues related to the President's Emergency Program for AIDS Relief (PEPFAR) Issues related to National Defense Authorization Act S. 2296/H.R. 3838 Issues related to FDA regulation of diagnostic tests.

Client expense: $942,000 · Firm income: Not reported

Health programs impacting MDMA. Issues related to medical devices. H.R.1539 - Medical Device Electronic Labeling Act. Issues related to Medical Device User Fee Amendments (MDUFA) implementation. Issues related to regulation and reimbursement of artificial intelligence in healthcare. Supply chain issues. Cyber security issues related to consumer and health data privacy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to medical device electronic labeling, including H.R. 1539 - Medical Device Electronic Labeling Act Issues related to hypertension Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices, including S.2296 - National Defense Authorization Act for Fiscal Year 2026 and H.R. 3838, the Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 Issues related to artificial intelligence and other advanced software in health care, including provisions of the One Big Beautiful Bill Act Issues related to FDA workforce and product review processes Issues related to H.R. 1, the One Big Beautiful Bill Act Issues related to Parkinsons disease Issues related to diabetes Issues related to epilepsy Issues related to overactive bladder and urinary incontinence

Client expense: $2,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.1539, Medical Device Electronic Labeling Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

Client expense: $370,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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 Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - obesity treatments - MFN - Foreign Reference Pricing

Client expense: $2,480,000 · Firm income: Not reported

Health programs impacting MDMA. Issues related to medical devices. H.R.1539 - Medical Device Electronic Labeling Act. Issues related to Medical Device User Fee Amendments (MDUFA) implementation. Issues related to regulation and reimbursement of artificial intelligence in healthcare. Supply chain issues. Cyber security issues related to consumer and health data privacy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 1539 - the Medical Device Electronic Labeling Act Issues related to FDAs third party review program Issues related to the President's Emergency Program for AIDS Relief (PEPFAR) Issues related to National Defense Authorization Act S. 2296/H.R. 3838

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

Issues related to medical device electronic labeling, including H.R. 1539 - Medical Device Electronic Labeling Act Issues related to hypertension Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices, including within the Department of Defense supply chain Issues related to FDA device shortage reporting Issues related to artificial intelligence and other advanced software in health care Issues related to FDA workforce and product review processes Issues related to H.R. 1, the One Big Beautiful Bill Act Issues related to Parkinsons disease

Client expense: $650,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.1539, Medical Device Electronic Labeling Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

Client expense: $290,000 · Firm income: Not reported

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

- H.R. 1539, Medical Device Electronic Labeling Act, regarding all provisions - 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, 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 Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - obesity treatments

Client expense: $1,030,000 · Firm income: Not reported

Third-party servicing of medical devices, right-to-repair of medical devices, remanufacturing of medical devices Cybersecurity of medical devices FDA regulation of Artificial Intelligence EPA ethylene oxide (EtO) regulations under FIFRA and NESHAP review - device sterilization Efforts to improve access to healthcare for underserved communities and activities to enhance maternal healthcare Sustainability in healthcare throughout the value chain including procurement, product development and design, and the benefits thereof H.R. 1539, the Medical Device Electronic Labeling Act

Client expense: $720,000 · Firm income: Not reported

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

Medicare Reimbursement: Medicare Coverage of Breakthrough Technologies (S. 1717); Transitional Coverage for Emerging Technologies (TCET)/Medicare Coverage for Innovative Technology (MCIT) Unique Device Identifier (UDI) in Medicare claims form FDA Reform: Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) FDA Modernization: modeling non-animal studies for medical device studies; Medical Device Electronic Labeling Act (H.R. 1539); draft legislation "Safe Medical Device Repair Act" third party right to repair Biotechnology: reduce regulatory barriers; align public-private investment Nursing Workforce Shortage

Client expense: $120,000 · 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

Health programs impacting MDMA. Issues related to medical devices. H.R.1539 - Medical Device Electronic Labeling Act. Issues related to Medical Device User Fee Amendments (MDUFA) implementation. Issues related to regulation and reimbursement of artificial intelligence in healthcare. Supply chain issues. Cyber security issues related to consumer and health data privacy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical Device Electronic Labeling Act (H.R. 1539)

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to medical device electronic labeling, including H.R. 1539 - Medical Device Electronic Labeling Act Issues related to hypertension Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Issues related to FDA device shortage reporting Issues related to artificial intelligence and other advanced software in health care Issues related to FDA workforce and product review processes

Client expense: $970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.1539, Medical Device Electronic Labeling Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

Client expense: $270,000 · 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. XXXX/ 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, H.R. XXX HELP Copays Act, regarding all provisions - H.R. 2214/ S. XXXX Delinking Revenue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act - PL117-169 The Inflation Reduction Act, regarding all provisions related to drug pricing and implementation Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day

Client expense: $3,340,000 · Firm income: Not reported

Issues pertaining to NIH research funding Issues pertaining to Medicare coverage of AID and CGM systems H.R. 919, the Chronic Disease Flexible Coverage Act H.R. 1539, the Medical Device Electronic Labeling Act

Client expense: $190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2332, To authorize the use of Federal Bureau of Investigation criminal history record information for administration of certain licenses, provisions related to license portability H.R. 1521, Dental and Optometric Care (DOC) Access Act of 2025, all provisions H.R. 929, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions S. 266, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions S. 526, Pharmacy Benefit Manager Transparency Act of 2025, all provisions H.R. 483, Health Care Efficiency Through Flexibility Act, all provisions H.R. 639, Doctor Knows Best Act of 2025, all provisions H.R. 21, Born-Alive Abortion Survivors Protection Act, all provisions H.R. 27, HALT Fentanyl Act, all provisions H.R. 1539, Medical Device Electronic Labeling Act, all provisions Cures 2.0/draft 21st Century Cures Act/implementation Maternal mortality Food labeling Buprenorphine prescribing/telehealth Artificial intelligence (AI)/payment Digital health/AI NIH Grants/indirect cost recovery Electronic Health Records (EHR) certification/improvements HIPAA/EHR/security Mental Health Parity and Addiction Equity Act (MHPAEA)/ERISA Industry Committee (ERIC) lawsuit Pulse Oximeters Vaccines Substance Use Disorder Coding Chronic Disease Obesity epidemic Scope of Practice Health Courts Physician practice data Non-economic damages calculation methods

Client expense: $8,000,000 · Firm income: Not reported

Medicare Reimbursement: Medicare Coverage of Breakthrough Technologies (legislation pending); Transitional Coverage for Emerging Technologies (TCET)/Medicare Coverage for Innovative Technology (MCIT) Unique Device Identifier (UDI) in Medicare claims form FDA Reform: Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) FDA Modernization: modeling non-animal studies for medical device studies; Medical Device Electronic Labeling Act (H.R. 1539) Biotechnology: reduce regulatory barriers; align public-private investment Nursing Workforce Shortage

Client expense: $200,000 · 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