Medical Device Electronic Labeling Act

Issues related to MDUFA implementation; FDA staffing Issues relating to the medical product supply chain Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to HR 3723 - the Medical Device Electronic Labeling Act Issues related to PFAS and EtO Chemical regulation Issues related to the Valid Act of 2023 - H.R. 2369 Issues related to cyber security Issues related to consumer and health data privacy Issues related to regulation of artificial intelligence in healthcare Issues related to FDA's third party review program Issues related to HR 5662/S 2907 - the Medical Device Recall Improvement Act

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

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

Issues related to MDUFA implementation; FDA staffing Issues relating to the medical product supply chain Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to HR 3723 - the Medical Device Electronic Labeling Act Issues related to PFAS and EtO Chemical regulation Issues related to the Valid Act of 2023 - H.R. 2369 Issues related to cyber security Issues related to consumer and health data privacy Issues related to regulation and reimbursement of artificial intelligence in healthcare Issues related to FDA's third party review program Issues related to HR 5662/S 2907 - the Medical Device Recall Improvement Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program Issues related to the President's Emergency Program for AIDS Relief (PEPFAR)

Client expense: $950,000 · Firm income: Not reported

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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program

Client expense: $1,042,000 · Firm income: Not reported

Issues related to MDUFA implementation; FDA staffing Issues relating to the medical product supply chain Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to HR 3723 - the Medical Device Electronic Labeling Act Issues related to PFAS and EtO Chemical regulation Issues related to the Valid Act of 2023 - H.R. 2369 Issues related to cyber security Issues related to consumer and health data privacy Issues related to regulation and reimbursement of artificial intelligence in healthcare Issues related to FDA's third party review program

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

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

- S 1375/HR 830, "HELP Copays Act", regarding all provisions. - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation. - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions. - S 1355/HR 2940, "PASTEUR Act", regarding all provisions. - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions. - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions. - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions. - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions. - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions. - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions. - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions. - HR 7174, "Ensuring Pathways to Innovative Cures (EPIC) Act", regarding all provisions - HR 8574, the "340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act", regarding all provisions - HR 7384, "Creating Hope Reauthorization Act", regarding all provisions - HR 7153/ S 3679 the "Dr. Lorna Breen Health Care Provider Protection Reauthorization Act", regarding all provisions Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program - the SUSTAIN 340B Act

Client expense: $1,520,000 · Firm income: Not reported

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.3723, Medical Device Electronic Labeling Act H.R.1328, Medical Device Nonvisual Accessibility Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

Client expense: $260,000 · Firm income: Not reported

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

Issues related to disparities of care, including H.R. 880 - Heart Health Enhancement through Access to Research and Training Act Issues related to medical device electronic labeling, including H.R. 3723 - 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 Sec. 328 of S.4638 - National Defense Authorization Act for Fiscal Year 2025 Issues related to FDA device shortage reporting Issues related to FDA third-party review program Issues related to artificial intelligence and other advanced software in health care

Client expense: $750,000 · Firm income: Not reported

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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program

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

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage Women's Health Research and Innovation Initiative (Executive Order) FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE); (H.R. 3723) Medical Device Electronic Labeling Act; FDA modernization Data Privacy legislation: H.R. 8818, the "American Privacy Rights Act of 2024" provisions covering biomedical research and HIPAA

Client expense: $100,000 · 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

- S 1375/HR 830, "HELP Copays Act", regarding all provisions. - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation. - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions. - S 1355/HR 2940, "PASTEUR Act", regarding all provisions. - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions. - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions. - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions. - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions. - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions. - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions. - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions. - HR 7174, "Ensuring Pathways to Innovative Cures (EPIC) Act", regarding all provisions - HR 8574, the "340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act", regarding all provisions - HR 7384, "Creating Hope Reauthorization Act", regarding all provisions - HR 7153/ S 3679 the "Dr. Lorna Breen Health Care Provider Protection Reauthorization Act", regarding all provisions Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program - the SUSTAIN 340B Act

Client expense: $2,340,000 · Firm income: Not reported

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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

Client expense: $960,000 · Firm income: Not reported

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.3723, Medical Device Electronic Labeling Act H.R.1328, Medical Device Nonvisual Accessibility Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

Client expense: $130,000 · Firm income: Not reported

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

Issues related to disparities of care, including H.R. 880 - Heart Health Enhancement through Access to Research and Training Act Issues related to medical device electronic labeling, including H.R. 3723 - 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 Sec. 328 of S.4638 - National Defense Authorization Act for Fiscal Year 2025 Issues related to FDA device shortage reporting Issues related to FDA third-party review program Issues related to artificial intelligence and other advanced software in health care

Client expense: $2,030,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage Women's Health Research and Innovation Initiative (Executive Order) FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE); (H.R. 3723) Medical Device Electronic Labeling Act; FDA modernization Data Privacy legislation: H.R. 8818, the "American Privacy Rights Act of 2024" provisions covering biomedical research and HIPAA

Client expense: $100,000 · 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

CGM Coverage policy Issues related to sterilization of medical devices Issues related to medical device electronic labeling H.R.3723, Medical Device Electronic Labeling Act H.R.1328, Medical Device Nonvisual Accessibility Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

Client expense: $170,000 · Firm income: Not reported

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

CGM Coverage policy Issues related to the sterilization of medical devices Issues related to medical device electronic labeling H.R.3723, Medical Device Electronic Labeling Act H.R.1328, Medical Device Nonvisual Accessibility Act Issues related to artificial intelligence and other machine learning advances in healthcare Issues related to advances in diabetes technology

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

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

Issues related to disparities of care, including H.R. 880 - Heart Health Enhancement through Access to Research and Training Act Issues related to medical device electronic labeling, including H.R. 3723 - Medical Device Electronic Labeling Act Issues related to hypertension, including H.Res. 1232, supporting the goals and ideals of National Hypertension Month H.R.1328 - Medical Device Nonvisual Accessibility Act 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 FDA third-party review program Issues related to artificial intelligence and other advanced software in health care

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- S 1375/HR 830, "HELP Copays Act", regarding all provisions. - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation. - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions. - S 1355/HR 2940, "PASTEUR Act", regarding all provisions. - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions. - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions. - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions. - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions. - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions. - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions. - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions. - HR 7174, "Ensuring Pathways to Innovative Cures (EPIC) Act", regarding all provisions - HR 8574, the "340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act", regarding all provisions - HR 7384, "Creating Hope Reauthorization Act", regarding all provisions Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program - the SUSTAIN 340B Act

Client expense: $1,120,000 · Firm income: Not reported

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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

Client expense: $880,000 · Firm income: Not reported

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage Women's Health Research and Innovation Initiative (Executive Order) FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE); (H.R. 3723) Medical Device Electronic Labeling Act; FDA modernization Data Privacy legislation: H.R. 8818, the "American Privacy Rights Act of 2024" provisions covering biomedical research and HIPAA

Client expense: $100,000 · 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

H.R.3723 - Medical Device Electronic Labeling Act.

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

- S 1375/HR 830, "HELP Copays Act", regarding all provisions. - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation. - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions. - S 1355/HR 2940, "PASTEUR Act", regarding all provisions. - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions. - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions. - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions. - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions. - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions. - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions. - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions. Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - 340B - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program

Client expense: $2,730,000 · Firm income: Not reported

Issues related to disparities of care Issues related to medical device electronic labeling,including H.R. 3723 - Medical Device Electronic Labeling Act 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 FDA third-party review program Issues related to the transport of medical devices with batteries Issues related to artificial intelligence and other advanced software in health care H.R. 5662/S. 2907, the Medical Device Recall Improvement Act

Client expense: $850,000 · Firm income: Not reported

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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

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

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage Women's Health Research and Innovation Initiative (Executive Order) FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE); (H.R. 3723) Medical Device Electronic Labeling Act FDA appropriations bill for FY 2024 regarding medical device sterilization; FDA modernization

Client expense: $190,000 · 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

H.R.3723 - Medical Device Electronic Labeling Act.

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

Government targets: HOUSE OF REPRESENTATIVES

- S 1375/HR 830, "HELP Copays Act", regarding all provisions - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions - S 1355/HR 2940, "PASTEUR Act", regarding all provisions - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - 340B - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program

Client expense: $1,160,000 · Firm income: Not reported

Issues related to disparities of care Issues related to medical device electronic labeling,including H.R. 3723 - Medical Device Electronic Labeling Act 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 FDA third-party review program Issues related to the transport of medical devices with batteries Issues related to artificial intelligence and other advanced software in health care H.R. 5662/S. 2907, the Medical Device Recall Improvement Act

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE); (H.R. 3723) Medical Device Electronic Labeling Act FDA appropriations bill for FY 2024 regarding medical device sterilization; FDA modernization

Client expense: $110,000 · 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

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 VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan

Client expense: $680,000 · Firm income: Not reported

Issues related to disparities of care Issues related to medical device electronic labeling,including H.R. 3723 - Medical Device Electronic Labeling Act 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 FDA third-party review program Issues related to the transport of medical devices with batteries Issues related to artificial intelligence and other advanced software in health care

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- S 1375/HR 830, "HELP Copays Act", regarding all provisions - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions - S 1355/HR 2940, "PASTEUR Act", regarding all provisions - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions Issues related to: - obesity - biosimilars - health equity and diversity in clinical trials - myopia - ambulatory surgical services - access to sterilization capacity for medical technologies - FDA approval pathways for medical technologies - peripheral artery disease - cardiovascular health - stroke care - FDA medical device shortage reporting requirements - alternative funding programs - 340B - PBM practices - health care workforce wellbeing

Client expense: $2,350,000 · Firm income: Not reported

H.R.3723 - Medical Device Electronic Labeling Act.

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

Government targets: HOUSE OF REPRESENTATIVES

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE) (H.R. 3723) Medical Device Electronic Labeling Act FDA appropriations bill for FY 2024 regarding medical device sterilization; FDA modernization

Client expense: $150,000 · 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

(HCR) H.R. 2369 The Verifying Accurate Leading-edge IVCT Development Act, H. R. 1305 Saving Us from Pandemic Era Resistance by Building a Unified Global Strategy Act of 2023", Issues related to public health emergency preparedness, including Pandemic All-Hazards Preparedness Act, H.R. 3795 The Diagnostics Testing Preparedness Plan Act, H.R. 3631 The State Stockpile Act, H.R.3723 Medical Device Electronic Labeling Act, and influenza preparedness

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

Issues related to disparities of care Issues related to medical device electronic labeling,including H.R. 3723 - Medical Device Electronic Labeling Act Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Issues related to medical device-based pain treatments Issues related to FDA device shortage reporting Issues related to FDA third-party review program Issues related to reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Issues related to the transport of medical devices with batteries

Client expense: $780,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Implementation of P.L. 117-328 regarding device change control plans. H.R.3723 - Medical Device Electronic Labeling Act 1.

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

Government targets: HOUSE OF REPRESENTATIVES

- S 1375/HR 830, "HELP Copays Act", regarding all provisions - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions - S 1355/HR 2940, "PASTEUR Act", regarding all provisions - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions Issues related to: - obesity - biosimilars - health equity and diversity in clinical trials - myopia - ambulatory surgical services - access to sterilization capacity for medical technologies - FDA approval pathways for medical technologies - peripheral artery disease - cardiovascular health - stroke care - FDA medical device shortage reporting requirements - alternative funding programs - 340B - PBM practices - health care workforce wellbeing

Client expense: $850,000 · Firm income: Not reported

Medicare Reimbursement: Medicare coverage of breakthrough technologies (H.R. 1691); Transitional Coverage for Emerging Technologies (TCET); CMS NPRM TCET UDI inclusion in Medicare claims form Nursing Workforce Shortage FDA Reform: cellular therapy RMAT designation; medical device shortage reporting; domestic production of medical products; use of real world data (RWD) and real world evidence (RWE) (H.R. 3723) Medical Device Electronic Labeling Act FDA appropriations bill for FY 2024 regarding medical device sterilization

Client expense: $150,000 · 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

Issues related to disparities of care. H.R. 3723 - Medical Device Electronic Labeling Act. Issues related to the sterilization of medical devices. Issues related to servicing and repair of medical devices. Issues related to medical device-based pain treatments. Issues related to FDA device shortage reporting. Issues related to FDA third-party review program. Issues related to reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA). Issues related to the transport of medical devices with batteries.

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

(HCR) H.R. 2369 The Verifying Accurate Leading-edge IVCT Development Act, Issues related to public health emergency preparedness, including Pandemic All-Hazards Preparedness Act, H.R. 3795 The Diagnostics Testing Preparedness Plan Act, H.R. 3631 The State Stockpile Act, H.R.3723 Medical Device Electronic Labeling Act, and influenza preparedness

Client expense: $140,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office