mr STEVEN LAPIERRE

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations. Submitted comments for the U.S. Dept of Commerce's investigation to determine the effects on the national security of imports of medical equipment including medical devices. Discussed the unique aspects and critical contributions of the U.S. medical technology sector as related to tariffs and other trade measures on imported medical devices and components and our support for policies that do not harm domestic manufacturing and global competition in the sector.

Issues related to FY2027 National Defense Authorization Act (NDAA) (S. 4784 & H.R. 8800) - Advocacy efforts on right to repair (RTR) proposals impacting servicing and repair of medical devices. Specifically, the Reform of Technical Data and Software Rights to Support Competition, Sustainment, and Readiness (section 861 of H.R. 8800), the Modifications to Technical Data Rights (section 804 of S. 4784), and other provisions related to healthcare and proprietary data.

Issues related to the issuance of dividends and stock buybacks, including provisions of H.R. 8800/S.4784, the National Defense Authorization Act of 2027.

Issues related to the U.S. House discussion draft of the Great American AI Act (GAAIA) - Advocacy and education efforts on the importance of FDA retaining regulatory authority over AI used in medical devices, and on redundant or potentially harmful regulations that could impair patient access to devices or hinder innovation. Issues related to SECURE Data Act (H.R. 8413) - Advocacy for the inclusion of healthcare-related carveouts with exemptions for HIPAA covered entities and business associates, health records, and certain clinical research and patient-safety data. Also, advocacy for the inclusion of language preempting state frameworks by establishing a single federal standard. Issues related to the Health Care Cybersecurity and Resiliency Act of 2026 (S.3315) - Advocacy related to the inclusion of language excluding medical device manufacturers from S. 3315 SEC. 8. Issues related to cybersecurity, including reauthorization of the Cybersecurity Information Sharing Act of 2015.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.

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.

Medical device procurement and supply chain resiliency. Ensuring VHA patient access to Med Tech as VHA manages supply chain and upgrades its medical surgery and prosthetics procurement contracting. Pain management - working to increase veteran access to multidisciplinary and multimodal pain management to provide for effective non-opioid treatment alternatives.

OECD 2 Pillar Framework Implementation - International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs Act (H.R. 591) and the Unfair Tax Prevention Act (H.R.2423), legislation regarding extraterritorial taxation. H.R. 1990 American Innovation and R&D Competitiveness Act of 2025. H.R. 1 (and Senate Amendment 2360) The One Big Beautiful Bill Act- Maintaining the International Tax regime as established in the 2017 TCJA legislation. Policies include proposed changes to GILTI, specifically Country by Country Reporting, the Section 250 deduction, Roundtripping, Section 899, and to return to pre-2022 R&D expensing rules.

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.

Senate Armed Services Committees Draft National Defense Authorization Act (NDAA) of Fiscal Year 2026 Warrior Right to Repair Act of 2025 Proposal- If enacted this legislation would enforce an expansive right to repair (RTR) policy on any businesses that contract with the Department of Defense. We are engaging in advocacy efforts towards the removal of this provision from the Senate bill in conference and to keep it out of the House Armed Services Committees NDAA legislation. We are educating lawmakers on the critical role of the Food and Drug Administration in maintaining product safety and effectiveness throughout the device lifecycle, and the potential risks associated with third-party servicing of medical technologies.

Medical device procurement and supply chain resiliency. Ensuring VHA patient access to Med Tech as VHA manages supply chain and upgrades its medical surgery and prosthetics procurement contracting. Pain management - working to increase veteran access to multidisciplinary and multimodal pain management to provide for effective non-opioid treatment alternatives.

OECD 2 Pillar Framework Implementation - International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs Act (H.R. 591) and the Unfair Tax Prevention Act (H.R.2423), legislation regarding extraterritorial taxation. H.R. 1990 American Innovation and R&D Competitiveness Act of 2025 - advocacy for legislation to return to pre-2022 R&D expensing rules. TCJA Reauthorization - Maintaining the International Tax regime as established in the 2017 TCJA legislation. Policies include proposed changes to GILTI, specifically Country by Country Reporting, and the Section 250 deduction.

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.

American Innovation and R&D Competitiveness Act of 2023 (H.R. 2673), Build It in America Act (H.R. 3938), & American Innovation and Jobs Act (S.866): Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules. OECD 2 Pillar Framework Implementation- International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs and Investment Act (H.R. 3665) legislation regarding extraterritorial taxation. H.R.7024 - Tax Relief for American Families and Workers Act of 2024: Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted. PFAS-Free Procurement Act of 2023 (S.2283) and Draft Legislation from Sens. Carper and Capito to improve the mitigation and remediation of PFAS contamination.

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

Senate Armed Services Committee's National Defense Authorization Act for Fiscal Year 2025 (S.4638) "Right to Repair" Provision (Sec. 828) - If enacted this legislation would would force an expansive "right to repair (RTR)" on any businesses that contract with the Department of Defense. We are engaging in advocacy efforts towards the removal of this provision from the final bill, educating lawmakers on the critical role of the Food and Drug Administration in maintaining product safety and effectiveness throughout the device lifecycle, and the potential risks associated with third-party servicing of medical technologies.

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. 2024 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical device's role to address the opioid epidemic. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders & device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity 2023 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. FY 2025 Inpatient Prospective Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements. Patient Access to Innovative New Technologies Act of 2024 (PAINT Act) (H.R. 7939)- legislation to change the frequency of review of medical devices applying for New Tech Add-On Payments (NTAP). National Plan to End Parkinsons Act (S.1064/H.R. 8585) (Public Law 118-66) - Legislation requiring the Department of Health and Human Services (HHS) to form a public private partnership (Parkinsons Advisory Committee) and to implement a project to support research into prevention, diagnosis, and treatment options for Parkinsons Disease. The Advancing Research for Chronic Pain Act (S.2922/H.R.7164) - this bill would require the Centers for Disease Control and Prevention (CDC) to analyze and regularly publish key population health data on chronic pain which will help guide future policy and research priorities to better treat and manage this disease impacting more than 50 million Americans. The Patient Access to Innovative New Technologies Act of 2024 (PAINT Act)(H.R. 7939) - Bill to reform the application process for medical technologies applying for the new technology add-on payment (NTAP). The bill would enable medical breakthroughs to be provided to Medicare beneficiaries without unnecessary delay.

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. 2024 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical device's role to address the opioid epidemic. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders & device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity 2023 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. FY 2025 Inpatient Prospective Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements. Patient Access to Innovative New Technologies Act of 2024 (PAINT Act) (H.R. 7939)- legislation to change the frequency of review of medical devices applying for New Tech Add-On Payments (NTAP). National Plan to End Parkinsons Act (S.1064/H.R. 8585) (Public Law 118-66) - Legislation requiring the Department of Health and Human Services (HHS) to form a public private partnership (Parkinsons Advisory Committee) and to implement a project to support research into prevention, diagnosis, and treatment options for Parkinsons Disease. The Advancing Research for Chronic Pain Act (S.2922/H.R.7164) - this bill would require the Centers for Disease Control and Prevention (CDC) to analyze and regularly publish key population health data on chronic pain which will help guide future policy and research priorities to better treat and manage this disease impacting more than 50 million Americans.

Senate Armed Services Committee's National Defense Authorization Act for Fiscal Year 2025 (S.4638) "Right to Repair" Provision (Sec. 828) - If enacted this legislation would would force an expansive "right to repair (RTR)" on any businesses that contract with the Department of Defense. We are engaging in advocacy efforts towards the removal of this provision from the final bill, educating lawmakers on the critical role of the Food and Drug Administration in maintaining product safety and effectiveness throughout the device lifecycle, and the potential risks associated with third-party servicing of medical technologies.

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

Medical device procurement and supply chain resilience. Ensuring VHA patient access to Med Tech as VHA manages supply chain and upgrades its medical surgery and prosthetics procurement contracting. EPA Rulemaking Restricting use of Ethylene Oxide (EtO) to sterilize medical devices. Advocacy efforts to educate lawmakers on the importance of EtO sterilization and need for VA/DOD to assess potential impact of proposed EPA rules on troop readiness and veteran/military personnel health care. Pain management - working to increase veteran access to multidisciplinary and multimodal pain management to provide for effective non-opioid treatment alternatives.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted. PFAS-Free Procurement Act of 2023 (S.2283) and Draft Legislation from Sens. Carper and Capito to improve the mitigation and remediation of PFAS contamination.

American Innovation and R&D Competitiveness Act of 2023 (H.R. 2673), Build It in America Act (H.R. 3938), & American Innovation and Jobs Act (S.866): Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules. OECD 2 Pillar Framework Implementation- International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs and Investment Act (H.R. 3665) legislation regarding extraterritorial taxation. H.R.7024 - Tax Relief for American Families and Workers Act of 2024: Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted. PFAS-Free Procurement Act of 2023 (S.2283) and Draft Legislation from Sens. Carper and Capito to improve the mitigation and remediation of PFAS contamination.

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

Medical device procurement and supply chain resilience. Ensuring VHA patient access to Med Tech as VHA manages supply chain and upgrades its medical surgery and prosthetics procurement contracting. EPA Rulemaking Restricting use of Ethylene Oxide (EtO) to sterilize medical devices. Advocacy efforts to educate lawmakers on the importance of EtO sterilization and need for VA/DOD to assess potential impact of proposed EPA rules on troop readiness and veteran/military personnel health care. Pain management - working to increase veteran access to multidisciplinary and multimodal pain management to provide for effective non-opioid treatment alternatives.

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

American Innovation and R&D Competitiveness Act of 2023 (H.R. 2673), Build It in America Act (H.R. 3938), & American Innovation and Jobs Act (S.866): Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules. OECD 2 Pillar Framework Implementation- International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs and Investment Act (H.R. 3665) legislation regarding extraterritorial taxation. H.R.7024 - Tax Relief for American Families and Workers Act of 2024: Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules

Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA MedSurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain. 2023 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders & device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity 2023 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. FY 2025 Inpatient Prospective Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted. PFAS-Free Procurement Act of 2023 (S.2283) and Draft Legislation from Sens. Carper and Capito to improve the mitigation and remediation of PFAS contamination.

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain. 2023 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders & device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity 2023 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.

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted. PFAS-Free Procurement Act of 2023 (S.2283) and Draft Legislation from Sens. Carper and Capito to improve the mitigation and remediation of PFAS contamination.

Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA MedSurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain. 2023 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders & device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity 2023 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.

Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations.

American Innovation and R&D Competitiveness Act of 2023 (H.R. 2673), Build It in America Act (H.R. 3938), & American Innovation and Jobs Act (S.866): Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules. OECD 2 Pillar Framework Implementation- International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs and Investment Act (H.R. 3665) legislation regarding extraterritorial taxation.

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA MedSurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain. 2023 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders & device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity 2023 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. EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.

Build Back Better Act (BBB) (H.R. 5376 & Senate Reconciliation Bill) - International tax provisions specifically changes to GILTI (Global Intangible Low-Taxed Income), interest deductions, and R&D expense deductibility USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy for the inclusion of legislation to return to pre-2022 R&D expensing rules

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

Breakthrough Pathway - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for certain interventional pain therapies to be conducted via telehealth 2023 Physician Fee Schedule - educating Members of Congress on unintended consequences of CMS's proposed update to labor inputs and how they impact medical services with high supply costs relative to labor 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. Food & Drug Administration: advocacy efforts on MDUFA, riders & device shortages Food & Drug Amendments of 2022 (H.R. 7667) - Medical Device User Fee Amendments (MDUFA V) once every five year reauthorization of the medical device user fee amendments MDUFA V Riders - device shortages, emerging signals, charge protocols & cybersecurity. Medical Device Supply Chain: USICA (S.1260) and Endless Frontier Act (HR2731) and Implementation of CARES Act -- Semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology CURES 2.0 Act (H.R. 6000)- 21st Century Cures Act 2.0 - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity PREVENT Pandemics Act (S.3799) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains America COMPETES Act of 2022 (H.R. 4521) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Build Back Better Act (BBB) (H.R. 5376 & Senate Reconciliation Bill) - International tax provisions specifically changes to GILTI (Global Intangible Low-Taxed Income), interest deductions, and R&D expense deductibility USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy for the inclusion of legislation to return to pre-2022 R&D expensing rules

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

FY 2023 Agriculture Appropriations Bill (House) - FDA Funding FY 2023 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2023 Labor HHS Appropriations Bill (House) - Report language encouraging CMS to extend expiring New Technology Add-On Payments (NTAPs) & Transitional Pass-Through Payments (TPTs) expiring during Public Health Emergency for an additional year FY 2023 Labor HHS Appropriations Bill (Senate) - Report language encouraging CMS to extend expiring New Technology Add-On Payments (NTAPs) & Transitional Pass-Through Payments (TPTs) expiring during Public Health Emergency for an additional year Implementation of task force recommendations

Build Back Better Act (BBB) (H.R. 5376 & Senate Reconciliation Bill) - International tax provisions specifically changes to GILTI (Global Intangible Low-Taxed Income), interest deductions, and R&D expense deductibility USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy for the inclusion of legislation to return to pre-2022 R&D expensing rules

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages

Breakthrough Pathway - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for certain interventional pain therapies to be conducted via telehealth 2023 Physician Fee Schedule - educating Members of Congress on unintended consequences of CMS's proposed update to labor inputs and how they impact medical services with high supply costs relative to labor 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. Food & Drug Administration: advocacy efforts on MDUFA, riders & device shortages Food & Drug Amendments of 2022 (H.R. 7667) - Medical Device User Fee Amendments (MDUFA V) once every five year reauthorization of the medical device user fee amendments MDUFA V Riders - device shortages, emerging signals, charge protocols & cybersecurity. Medical Device Supply Chain: USICA (S.1260) and Endless Frontier Act (HR2731) and Implementation of CARES Act -- Semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology CURES 2.0 Act (H.R. 6000)- 21st Century Cures Act 2.0 - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity PREVENT Pandemics Act (S.3799) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains America COMPETES Act of 2022 (H.R. 4521) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

Breakthrough Pathway - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for certain interventional pain therapies to be conducted via telehealth 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services 2022 Physician Fee Schedule - educating Members of Congress on unintended consequences of CMS's proposed update to labor inputs and how they impact medical services with high supply costs relative to labor 2021 CMS Final Rule "Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary"- advocacy for a new, voluntary Medicare Coverage of Innovative Technology (MCIT) pathway that provides four years of national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization. Medical Device Supply Chain: USICA (S.1260) and Endless Frontier Act (HR2731) and Implementation of CARES Act -- Semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. Food & Drug Administration: advocacy efforts on MDUFA, riders & device shortages Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology CURES 2.0 Act (H.R. 6000)- 21st Century Cures Act 2.0 - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity PREVENT Pandemics Act (S.3799) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains America COMPETES Act of 2022 (H.R. 4521) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

FY 2022 Agriculture Appropriations Bill (House) - FDA Funding FY 2022 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2022 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics & HHS public awareness campaign on pain management best practices FY 2022 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics & HHS public awareness campaign on pain management best practices Implementation of task force recommendations

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Breakthrough Pathway - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for certain interventional pain therapies to be conducted via telehealth 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services 2022 Physician Fee Schedule - educating Members of Congress on unintended consequences of CMS's proposed update to labor inputs and how they impact medical services with high supply costs relative to labor 2021 CMS Final Rule "Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary"- advocacy for a new, voluntary Medicare Coverage of Innovative Technology (MCIT) pathway that provides four years of national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization. Medical Device Supply Chain: USICA (S.1260) and Endless Frontier Act (HR2731) and Implementation of CARES Act -- Semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology CURES 2.0 Act (H.R. 6000)- 21st Century Cures Act 2.0 - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

FY 2022 Agriculture Appropriations Bill (House) - FDA Funding FY 2022 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2022 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2022 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics Implementation of task force recommendations

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Implementation of Bergman bill Public Law Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

American Families Plan, American Jobs Plan, bi-partisan infrastructure proposal(BIF)- the implications of changes to the headline rate, international provisions, R&D amortizations, and punitive importation surtax have on jobs and the medical device ecosystem

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

Breakthrough Pathway - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for certain interventional pain therapies to be conducted via telehealth 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services 2021 CMS Final Rule "Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary"- advocacy for a new, voluntary Medicare Coverage of Innovative Technology (MCIT) pathway that provides four years of national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization. Medical Device Supply Chain: Implementation of CARES Act and Endless Frontiers Act -- Device Shortages, Resilient Supply Chain, Domestic Incentives and Buy America Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology CURES 2.0 - 21st Century Cures Act 2.0 - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity

FY 2022 Agriculture Appropriations Bill (House) - FDA Funding FY 2022 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2022 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2022 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics Implementation of task force recommendations

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Implementation of Bergman bill Public Law Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 2021 CMS Final Rule "Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary"- advocacy for a new, voluntary Medicare Coverage of Innovative Technology (MCIT) pathway that provides four years of national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization.

FY 2021 Agriculture Appropriations Bill (House) - FDA Funding FY 2021 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2021 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2021 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics Implementation of task force recommendations

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft Yet-to-be released COVID Stimulus Bill (House & Senate)- Advocacy to secure medical device supply chain & prevent device shortages

FY 2021 Agriculture Appropriations Bill (House) - FDA Funding FY 2021 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2021 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2021 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics Implementation of task force recommendations

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate):Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Implementation of Bergman bill Public Law Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

FY 2021 Agriculture Appropriations Bill (House) - FDA Funding FY 2021 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2021 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2021 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I.

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Implementation of Bergman bill Public Law Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

FY 2020 Agriculture Appropriations Bill (House) - FDA Funding FY 2020 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2020 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2020 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax HR 1865 Further Consolidated Appropriations Act, 2020 - House end of year spending bill which included repeal of the 2.3% Medical Device Tax

FY 2020 Agriculture Appropriations Bill (House) - FDA Funding FY 2020 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2020 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2020 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Implementation of Bergman bill Public Law Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I.

FY 2020 Agriculture Appropriations Bill (House) - FDA Funding FY 2020 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2020 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2020 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA)) Interim Final Rule (IFR) HM 224I.

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Implementation of Bergman bill Public Law Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion of Rep. Bergman's VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic.

United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax HR 88, as amended, by the US House of Representatives - Legislation to extend the suspension of the Medical Device Tax for a further 5 years

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2019 Agriculture Appropriations Bill (House) - FDA Funding FY 2019 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2019 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2019 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House & Senate)

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. HR5418 - VA Medsurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2019 Agriculture Appropriations Bill (House) - FDA Funding FY 2019 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2019 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2019 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House & Senate)

North American Free Trade Agreement (NAFTA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2019 Agriculture Appropriations Bill (House) - FDA Funding FY 2019 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2019 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2019 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

North American Free Trade Agreement (NAFTA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: OCRA and other HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. HR6 -Substance Use-Disorder Prevention that Promises Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2680 - Opioid Crisis Response Act (OCRA) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S3120 - Helping to End Addiction & Lessen Substance Abuse Disorders Act (HEAL Act) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018(Sunshine Expansion Act) - Specifically, transparency and medical device's role in the opioid epidemic.

North American Free Trade Agreement (NAFTA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Draft Opioid Legislation: OCRA and other HELP Draft Bills, E&C Draft Bills, W&M Draft bills, Senate Finance Draft Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse.

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law.

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Draft Opioid Legislation: OCRA and other HELP Draft Bills, E&C Draft Bills, W&M Draft bills, Senate Finance Draft Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse.

North American Free Trade Agreement (NAFTA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2019 Agriculture Appropriations Bill (House) - FDA Funding FY 2019 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2019 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2019 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2018 Agriculture Appropriations Bill (House) - FDA Funding FY 2018 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2018 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2018 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-Tip) - Supporting passage for greater regulatory harmonization of product approvals and registration

Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition and "House Blueprint", and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Limitations on aircraft transportation of lithium batteries Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)

Public Law 112-144 - Implemenation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Senate HELP Discussion Draft - Proposed legislation to extend and revise the user-fee programs for Medical Devices

Limitations on aircraft transportation of lithium batteries Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)

Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-Tip) - Supporting passage for greater regulatory harmonization of product approvals and registration

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans.

Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-Tip) - Supporting passage for greater regulatory harmonization of product approvals and registration

Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition and "House Blueprint", and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Limitations on aircraft transportation of lithium batteries H.R. 2997 and S. 1405 - Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans.

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans.

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2018 Agriculture Appropriations Bill (House) - FDA Funding FY 2018 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2018 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2018 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans.

North American Free Trade Agreement (NAFTA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues

HR 1 - Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition and "House Blueprint", and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Limitations on aircraft transportation of lithium batteries H.R. 2997 and S. 1405 - Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)

Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition and "House Blueprint", and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions S108 & HR 184 - Legislation to repeal the 2.3% Medical Device Tax

Limitations on aircraft transportation of lithium batteries H.R. 2997 and S. 1405 - Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices

Public Law 112-144 - Implemenation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices

Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-Tip) - Supporting passage for greater regulatory harmonization of product approvals and registration

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2018 Agriculture Appropriations Bill (House) - FDA Funding FY 2018 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2018 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2018 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans.

Public Law 112-144 - Implemenation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain Senate HELP Discussion Draft - Proposed legislation to extend and revise the user-fee programs for Medical Devices

Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014 and for other purposes. Specifically provisions providing appropriations for the FDA's CDRH evaluation of medical technology. FY 2018 Agriculture Appropriations Bill (House) - FDA Funding FY 2018 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2018 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics FY 2018 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics

Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-TIP) - Supporting passage for greater regulatory harmonization of product approvals and registration

Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition and "House Blueprint", and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA. Public Law No 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Implementation H.R. 4063 - S. 1641 - Promise Act - Legislation to improve quality of Pain Care provided to veterans Medical device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology.

Comprehensive/Corporate Tax Reform W&M Discussion Draft - Includes lower corporate tax rate, research credit transition, and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions

Public Law No 113-6 - CONSOLIDATED AND FURTHER CONTINUING APPROPRIATIONS ACT, 2013 - Specifically, have been working on relief of 5% sequestration of FDA CDRH User Fees Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014, and for other purposes. Specifically provisions providing appropriations for the FDAs CDRH evaluation of medical technology. FY 2016 Agriculture Appropriations Bill (House) - FDA Funding FY 2016 Agriculture Appropriations Bill (Senate) - FDA Funding

Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-TIP) - Supporting passage for greater regulatory harmonization of product approvals and registration

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA. Public Law No 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy *Implementation H.R. 4063 - S. 1641 - Promise Act - Legislation to improve quality of Pain Care provided to veterans Medical device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology.

Public Law 112-144 - Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule H.R. 6 - 21st Century Cures Initiative - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies Innovation for Healthier Americans (Senate, companion) - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies FDA/CMS Breakthrough Pathway - H.R. 5009 - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction S. 524 - H.R. 943 - Comprehensive Addiction & Recovery Act (CARA) - Bill to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 4641 - Pain Best Practices

H.R. 4441 - Aviation Innovation, Reform and Re-authorization Act of 2016 - Limitations on aircraft transportation of lithium batteries S. 2658 - Federal Aviation Administration Re-authorization Act of 2016 - Limitations on aircraft transportation of lithium batteries H.R. 636 - FAA Extension - Limitations on aircraft transportation of lithium batteries

Public Law No 113-6 - CONSOLIDATED AND FURTHER CONTINUING APPROPRIATIONS ACT, 2013 - Specifically, have been working on relief of 5% sequestration of FDA CDRH User Fees Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014, and for other purposes. Specifically provisions providing appropriations for the FDAs CDRH evaluation of medical technology. FY 2016 Agriculture Appropriations Bill (House) - FDA Funding FY 2016 Agriculture Appropriations Bill (Senate) - FDA Funding

Comprehensive/Corporate Tax Reform W&M Discussion Draft - Includes lower corporate tax rate, research credit transition, and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions

FAA Re authorization - Limitations on aircraft transportation of lithium batteries

Public Law 112-144 - Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule H.R. 6 - 21st Century Cures Initiative - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies Innovation for Healthier Americans (Senate, companion) - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction S. 524 - H.R. 943 - Comprehensive Addiction & Recovery Act (CARA) - Bill to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 4641 - Pain Best Practices

H.R. 3326 Defend Trade Secrets Act - legislation to establish a Federal Civil cause of action for Trade Secret Misappropriation S. 1890 - Defend Trade Secrets Act - legislation to establish a Federal Civil cause of action for Trade Secret Misappropriation

Comprehensive/Corporate Tax Reform W&M Discussion Draft - Includes lower corporate tax rate, research credit transition, and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions

H.R. 234 - Cyber Intelligence Sharing & Protection Act (CISPA) - A bill to promote industry and government sharing of cyber intelligence H.R. 85 / H.R. 1073 - Critical Infrastructure Protection Acts - Bills to make improvements regarding cyber security and critical infrastructure protection

Trade Promotion Authority (TPA) - Supporting passage of authority to expedite pending and future trade agreements, such as TPP Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-TIP) - Supporting passage for greater regulatory harmonization of product approvals and registration

Public Law No 113-6 - CONSOLIDATED AND FURTHER CONTINUING APPROPRIATIONS ACT, 2013 - Specifically, have been working on relief of 5% sequestration of FDA CDRH User Fees Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014, and for other purposes. Specifically provisions providing appropriations for the FDAs CDRH evaluation of medical technology. FY 2016 Agriculture Appropriations Bill (House) - FDA Funding FY 2016 Agriculture Appropriations Bill (Senate) - FDA Funding

H.R. 9 - Innovation Act - Comprehensive Patent Reform - a bill to address the problem of abusive patent litigation H.R. 2045 - Targeting Rogue and Opaque Letters Act (TROL Act) - Increases transparency and accountability in patent demand letters and provides Federal Trade Commission (FTC) with the authority to levy fines on those who send deceptive demand letters Leahy, Schumer, Grassley, Cornyn Draft - Yet to be released legislation for comprehensive patent reform. H.R. 3326 Defend Trade Secrets Act - legislation to establish a Federal Civil cause of action for Trade Secret Misappropriation S.632 - The STRONG Patents Act of 2015: Support Technology & Research for Our Nations Growth - a bill to end frivolous patent lawsuits. Copyright Office Petition - Oppose third party researchers to access technology and software inside medical devices. S. 1137 - Patent Act - A Bill to Reform U.S. Patent Litigation S. 1890/ H.R.3226 - Bills to create a federal civil cause of action for Trade Secret misappropriation S. 1890 - Defend Trade Secrets Act - legislation to establish a Federal Civil cause of action for Trade Secret Misappropriation

FAA Re authorization - Limitations on aircraft transportation of lithium batteries

S. 149 - Medical Device Access & Innovation Protection Act - A bill to repeal the 2.3% medical device tax H.R. 160 - Protect Medical Innovation Act of 2015 - A bill to repeal the 2.3% medical device tax Comprehensive/Corporate Tax Reform W&M Discussion Draft - Includes lower corporate tax rate, research credit transition, and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions H.R. 880 - Research and Development tax credit extension H.R. 2029PATH Act - Permanent Tax Extender Package + 2 year Suspension of Medical Device Tax

H.R. 1020 - STEM Education Act of 2015 (Smith). Bill to increase STEM Education H.R. 840 - STEM Gateways Act (Kennedy). Bill to increase STEM Education S. 402 - STEM Master Teacher Corps Act of 2015 (Franken). Bill to increase STEM Education S. 442 - Innovation Inspiration School Grant Program Act (Shaheen). Bill to increase STEM Education S. 1177 ESEA Bill, Specifically Provisions to provide more funding and access to after school STEM Programs

H.R. 234 - Cyber Intelligence Sharing & Protection Act (CISPA) - A bill to promote industry and government sharing of cyber intelligence H.R. 85 / H.R. 1073 - Critical Infrastructure Protection Acts - Bills to make improvements regarding cyber security and critical infrastructure protection

H.R. 9 - Innovation Act - Comprehensive Patent Reform - a bill to address the problem of abusive patent litigation Trade Secrets - Yet to be introduced legislation to establish a federal civil cause of action for trade secret misappropriation. H.R. 2045 - Targeting Rogue and Opaque Letters Act (TROL Act) - Increases transparency and accountability in patent demand letters and provides Federal Trade Commission (FTC) with the authority to levy fines on those who send deceptive demand letters Leahy, Schumer, Grassley, Cornyn Draft - Yet to be released legislation for comprehensive patent reform. S.632 - The STRONG Patents Act of 2015: Support Technology & Research for Our Nations Growth - a bill to end frivolous patent lawsuits. Copyright Office Petition - Oppose third party researchers to access technology and software inside medical devices. S. 1137 - Patent Act - A Bill to Reform U.S. Patent Litigation S. 1890/ H.R.3226 - Bills to create a federal civil cause of action for Trade Secret misappropriation

H.R. 1020 - STEM Education Act of 2015 (Smith). Bill to increase STEM Education H.R. 840 - STEM Gateways Act (Kennedy). Bill to increase STEM Education S. 402 - STEM Master Teacher Corps Act of 2015 (Franken). Bill to increase STEM Education S. 442 - Innovation Inspiration School Grant Program Act (Shaheen). Bill to increase STEM Education S. 1177 ESEA Bill, Specifically Provisions to provide more funding and access to after school STEM Programs

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA. Public Law No 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy

Trade Promotion Authority (TPA) - Supporting passage of authority to expedite pending and future trade agreements, such as TPP Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-TIP) - Supporting passage for greater regulatory harmonization of product approvals and registration

Public Law 112-144 - Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule H.R. 6 - 21st Century Cures Initiative - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies Innovation for Healthier Americans (Senate, companion) - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies

H.R. 234 - Cyber Intelligence Sharing & Protection Act (CISPA) - A bill to promote industry and government sharing of cyber intelligence H.R. 85 / H.R. 1073 - Critical Infrastructure Protection Acts - Bills to make improvements regarding cyber security and critical infrastructure protection

H.R. 9 - Innovation Act - Comprehensive Patent Reform - a bill to address the problem of abusive patent litigation Trade Secrets - Yet to be introduced legislation to establish a federal civil cause of action for trade secret misappropriation. H.R. 2045 - Targeting Rogue and Opaque Letters Act (TROL Act) - Increases transparency and accountability in patent demand letters and provides Federal Trade Commission (FTC) with the authority to levy fines on those who send deceptive demand letters Leahy, Schumer, Grassley, Cornyn Draft - Yet to be released legislation for comprehensive patent reform. S.632 - The STRONG Patents Act of 2015: Support Technology & Research for Our Nations Growth - a bill to end frivolous patent lawsuits. Copyright Office Petition - Oppose third party researchers to access technology and software inside medical devices. S. 1137 - Patent Act - A Bill to Reform U.S. Patent Litigation

H.R. 1020 - STEM Education Act of 2015 (Smith). Bill to increase STEM Education H.R. 840 - STEM Gateways Act (Kennedy). Bill to increase STEM Education S. 402 - STEM Master Teacher Corps Act of 2015 (Franken). Bill to increase STEM Education S. 442 - Innovation Inspiration School Grant Program Act (Shaheen). Bill to increase STEM Education S. 1177 ESEA Bill, Specifically Provisions to provide more funding and access to after school STEM Programs

FAA Re authorization - Limitations on aircraft transportation of lithium batteries

S. 149 - Medical Device Access & Innovation Protection Act - A bill to repeal the 2.3% medical device tax H.R. 160 - Protect Medical Innovation Act of 2015 - A bill to repeal the 2.3% medical device tax Comprehensive/Corporate Tax Reform W&M Discussion Draft - Includes lower corporate tax rate, research credit transition, and base erosion Senate Finance Tax Reform Discussion Draft - International Tax Reform Provisions - Tax Extender Provisions H.R. 880 - Research and Development tax credit extension

Trade Promotion Authority (TPA) - Supporting passage of authority to expedite pending and future trade agreements, such as TPP Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-TIP) - Supporting passage for greater regulatory harmonization of product approvals and registration

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA. Public Law No 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy

H.R. 1020 - STEM Education Act of 2015 (Smith). Bill to increase STEM Education H.R. 840 - STEM Gateways Act (Kennedy). Bill to increase STEM Education S. 402 - STEM Master Teacher Corps Act of 2015 (Franken). Bill to increase STEM Education S. 442 - Innovation Inspiration School Grant Program Act (Shaheen). Bill to increase STEM Education

H.R. 234 - Cyber Intelligence Sharing & Protection Act (CISPA) - A bill to promote industry and government sharing of cyber intelligence H.R. 85 / H.R. 1073 - Critical Infrastructure Protection Acts - Bills to make improvements regarding cyber security and critical infrastructure protection

VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA. Public Law No 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA

FAA Re authorization - Limitations on aircraft transportation of lithium batteries

Trade Promotion Authority (TPA) - Supporting passage of authority to expedite pending and future trade agreements, such as TPP Transpacific Partnership (TPP) - Supporting passage for greater regulatory harmonization across Asia-Pacific country members and to include transparency and procedural fairness provisions in the agreement. Transatlantic Trade & Investment Partnership (T-TIP) - Supporting passage for greater regulatory harmonization of product approvals and registration

Public Law No 113-6 - CONSOLIDATED AND FURTHER CONTINUING APPROPRIATIONS ACT, 2013 - Specifically, have been working on relief of 5% sequestration of FDA CDRH User Fees Public Law No: 113-67 - Making continuing appropriations for fiscal year 2014, and for other purposes. Specifically provisions providing appropriations for the FDAs CDRH evaluation of medical technology. FDA Appropriations for FY 2016

H.R. 9 - Innovation Act - Comprehensive Patent Reform - a bill to address the problem of abusive patent litigation Trade Secrets - Yet to be introduced legislation to establish a federal civil cause of action for trade secret misappropriation. H.R. XX - Targeting Rogue and Opaque Letters Act (TROL Act) - Increases transparency and accountability in patent demand letters and provides the Federal Trade Commission (FTC) with the authority to levy fines on those who send deceptive demand letters Leahy, Schumer, Grassley, Cornyn Draft - Yet to be released legislation for comprehensive patent reform. S.632 - The STRONG Patents Act of 2015: Support Technology & Research for Our Nations Growth - a bill to end frivolous patent lawsuits. Copyright Office Petition - Oppose third party researchers to access technology and software inside medical devices.

H.R. 933 - Consolidated and Further Continuing Appropriations Act, 2013 -- Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology -- In particular have been working on relief of 5% sequestration of user fees H.J. Res 59 - Continuing Appropriations Resolution - Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology

VHA Directive 2009-053 - Pain Care Re-Authorization Directive - work for increased Veteran access to pain specialists, and alternative treatments in the VA VA Vendor Credentialing - Establishing a National Credentialing System for the VA S.2450/H.R. 4810 - Bills to allow Veterans access to healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow Veterans access to healthcare from non-VA facilities if unable to receive care from the VA in a timely manner.

H.R. 624 - CyberIntelligence Sharing & Protection Act (CISPA) of 2013 - A bill to promote Industry and Government sharing of cyber intelligence S. 1788 - Digital Trade Act of 2013 - A bill to promote internet enabled commerce and digital trade. H.R. 3696 - National Cyber Security & Critical Infrastructure Protection Act 2013 - A bill to make improvements regarding cyber security and critical infrastructure protection.

H.R. 2024 - End Anonymous Patents Act -- A bill to end frivolous Patent lawsuits H.R. 845 - Saving High-Tech Innovations from Egregious Legal Disputes Act of 2013 - A bill to end frivolous Patent lawsuits S. 1013 - Patent Abuse Reduction Act of 2013 - (Cornyn) A bill to end frivolous Patent lawsuits S. 866 - Patent Quality Improvement Act of 2013 - A bill to make improvements to the transitional program covered business method patents H.R. 3309 - (Goodlatte) "Innovation Act" - A bill to end frivolous Patent lawsuits H.R. 3349 - (Conyers ) "Innovation Protection Act" - A bill to end frivolous Patent lawsuits H.R. 2766 - (Issa, Chu) "STOP Act" - To make improvements to the transitional program for covered business method patents S. 1720 - (Leahy-Lee) - "America Invents Act" - A bill to promote transparency in patent ownership and make other improvements to the patent system. S. 2267 - A bill to establish a Federal Civil Cause of Action for Trade Secret Misappropriation S. 1770 - A Bill to provide civil liability for Trade Secret Misappropriation in certain circumstances Whitehouse/Graham Discussion Draft - A bill to increase penalties for Trade Secret Misappropriation H.R. 5233 - A bill to establish a Federal Civil Cause of Action for Trade Secret Misappropriation TROL Act - Clarifies the FTC act to allow the agency and state attorney's general to bring actions to stop abusive and bad faith patent demand letters

S.232 - Medical Device Access and Innovation Protection Act - repeals the 2.3% excise tax medical devices H.R. 523 - Protect Medical Innovation Act - repeals the 2.3% excise tax medical devices H.R. 905 - Research and Development Tax Credit Extension Act of 2013 - Amends the Internal Revenue Code to (1) make permanent the tax credit for increasing research activities, (2)increase the rate of the alternative simplified research tax credit H.R. 1295 - Medical Device Tax Elimination Act - Extends and enhances R&P tax credit H.R. 905 - Research and Development Tax Credit Extension Act of 2013 Comprehensive/Corporate tax reform Chairman's W&M Discussion Draft - Including lower corporate tax rate, research credit transition and base erosion Tax Reform Act of 2014 - A comprehensive bill to reform the nation's tax system Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act - A bill to extend a number of lapsed tax provisions

S. 358 - STEM Master Teach Corps Act of 2013 - to promote STEM education H.R. 1243 - Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 1089 - Stepping up to STEM Act of 2013 - to promote STEM education

H.R. 624 - CyberIntelligence Sharing & Protection Act (CISPA) of 2013 - A bill to promote Industry and Government sharing of cyber intelligence S. 1788 - Digital Trade Act of 2013 - A bill to promote internet enabled commerce and digital trade. H.R. 3696 - National Cyber Security & Critical Infrastructure Protection Act 2013 - A bill to make improvements regarding cyber security and critical infrastructure protection.

H.R. 2024 - End Anonymous Patents Act -- A bill to end frivolous Patent lawsuits H.R. 845 - Saving High-Tech Innovations from Egregious Legal Disputes Act of 2013 - A bill to end frivolous Patent lawsuits S. 1013 - Patent Abuse Reduction Act of 2013 - (Cornyn) A bill to end frivolous Patent lawsuits S. 866 - Patent Quality Improvement Act of 2013 - A bill to make improvements to the transitional program covered business method patents H.R. 3309 - (Goodlatte) "Innovation Act" - A bill to end frivolous Patent lawsuits H.R. 3349 - (Conyers ) "Innovation Protection Act" - A bill to end frivolous Patent lawsuits H.R. 2766 - (Issa, Chu) "STOP Act" - To make improvements to the transitional program for covered business method patents S. 1720 - (Leahy-Lee) - "America Invents Act" - A bill to promote transparency in patent ownership and make other improvements to the patent system. S. 2267 - A bill to establish a Federal Civil Cause of Action for Trade Secret Misappropriation S. 1770 - A Bill to provide civil liability for Trade Secret Misappropriation in certain circumstances Whitehouse/Graham Discussion Draft - A bill to increase penalties for Trade Secret Misappropriation H.R. 5233 - A bill to establish a Federal Civil Cause of Action for Trade Secret Misappropriation TROL Act - Clarifies the FTC act to allow the agency and state attorney's general to bring actions to stop abusive and bad faith patent demand letters

H.R. 933 - Consolidfated and Further Continuing Appropriations Act, 2013 -- Specificaly provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology -- In particular have been working on relief of 5% sequestration of user fees H.J. Res 59 - Continuing Appropriations Resolution - Specificaly provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology

VHA Directive 2009-053 - Pain Care Re-Authorization Directive - work for increased Veteran access to pain specialists, and alternative treatments in the VA VA Vendor Credentialing - Establishing a National Credentialing System for the VA S.2450/H.R. 4810 - Bills to allow Veterans access to healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow Veterans access to healthcare from non-VA facilities if unable to receive care from the VA in a timely manner.

S. 358 - STEM Master Teach Corps Act of 2013 - to promote STEM education H.R. 1243 - Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 1089 - Stepping up to STEM Act of 2013 - to promote STEM education

S.232 - Medical Device Access and Innovation Protection Act - repeals the 2.3% excise tax medical devices H.R. 523 - Protect Medical Innovation Act - repeals the 2.3% excise tax medical devices H.R. 905 - Research and Development Tax Credit Extension Act of 2013 - Amends the Internal Revenue Code to: (1) make permanent the tax credit for increasing research activities, (2) increase the rate of the alternative simplified research tax credit H.R. 1295 - Medical Device Tax Elimination Act - Extends and enhances R&P tax credit H.R. 905 - Research and Develpment Tax Credit Extension Act of 2013 Comprehensive/Corporate tax reform Chairman's W&M Discussion Draft - Including lower corporate tax rate, research credit transition and base erosion Tax Reform Act of 2014 - A comprehensive bill to reform the nation's tax system. Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act - A bill to extend a number of lapsed tax provision.

TPA - Working to secure passage of the Trade Promotion Authority to expedite pending and future trade agreements, such as TPP and T-TIP TPP - Supporting the passage of Transpacific Partnership for greater regulatory harmonization/convergence across Asia-Pacific country members, and to include transparency and procedural fairness provisions with the agreement T-TIP - Supporting the passage of the Transatlantic Trade and Investment Partnership agreement for greater regulatory harmonization/convergence of product approvals and registration

S. 358 - STEM Master Teach Corps Act of 2013 - to promote STEM education H.R. 1243 - Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 1089 - Stepping up to STEM Act of 2013 - to promote STEM education

H.R. 624 - CyberIntelligence Sharing & Protection Act (CISPA) of 2013 - A bill to promote Industry and Government sharing of cyber intelligence S. 1788 - Digital Trade Act of 2013 - A bill to promote internet enabled commerce and digital trade. H.R. 3696 - National Cyber Security & Critical Infrastructure Protection Act of 2013 - A bill to make improvements regarding cyber security and critical Infrastructure protection

H.R. 933 - Consolidated and Further Continuing Appropriations Act, 2013 - Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology -- In particular have been working on permanent relief of 5% sequestration of user fees H.J. Res 59 - Continuing Appropriations Resolution - Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology

S.232 - Medical Device Access and Innovation Protection Act - repeals the 2.3% excise tax medical devices H.R. 523 - Protect Medical Innovation Act - repeals the 2.3% excise tax medical devices H.R. 905 - Research and Development Tax Credit Extension Act of 2013 - Amends the Internal Revenue Code to: (1) make permanent the tax credit for increasing research activities, (2) increase the rate of the alternative simplified research tax credit H.R. 1295 - Medical Device Tax Elimination Act - Extends and enhances R&P tax credit H.R. 905 - Research and Development Tax Credit Extension Act of 2013 Comprehensive/Corporate tax reform Chairman's W&M Discussion Draft - Including lower corporate tax rate, research credit transition and base erosion Tax Reform Act of 2014 - A comprehensive bill to reform the nations' tax system. Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act. - A bill to extend a number of lapsed tax provisions.

TPA -Working to secure passage of the Trade Promotion Authority to expedite pending and future trade agreements, such as TPP and T-TIP TPP - Supporting the passage of Transpacific Partnership for greater regulatory harmonization/convergence across Asia-Pacific country members, and to include transparency and procedural fairness provisions within the agreement T-TIP - Supporting the passage of the Transatlantic Trade and Investment Partnership agreement for greater regulatory harmonization/convergence of product approvals and registration

VHA Directive 2009-053 - Pain Care Re-Authorization Directive - work for increased Veteran access to pain specialists, and alternative treatments in the VA VA Vendor Credentialing - Establishing a National Credentialing System for the VA

H.R. 933 - Consolidated and Further Continuing Appropriations Act, 2013 -- Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology -- In particular have been working on permanent relief of 5% sequestration of user fees H.J. Res 59 - Continuing Appropriations Resolution - Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology

H.R. 2024 - End Anonymous Patents Act -- A bill to end frivolous Patent lawsuits H.R. 845 - Saving High-Tech Innovations from Egregious Legal Disputes Act of 2013 - A bill to end frivolous Patent lawsuits S. 1013 - Patent Abuse Reduction Act of 2013 - (Cornyn) A bill to end frivolous Patent lawsuits S. 866 - Patent Quality Improvement Act of 2013 - A bill to make improvements to the transitional program covered business method patents H.R. 3309 - (Goodlatte) "Innovation Act" - A bill to end frivolous Patent lawsuits H.R. 3349 - (Conyers ) "Innovation Protection Act" - A bill to end frivolous Patent lawsuits H.R. 2766 - (Issa, Chu) "STOP Act" - To make improvements to the transitional program for covered business method patents S. 1720 - (Leahy-Lee) - "America Invents Act" - A bill to promote transparency in patent ownership and make other improvements to the patent system.

H.R. 624 - CyberIntelligence Sharing & Protection Act (CISPA) of 2013 - A bill to promote Industry and Government sharing of cyber intelligence S. 1788 - Digital Trade Act of 2013 - A bill to promote internet enabled commerce and digital trade. H.R. 3696 - National Cyber Security & Critical Infrastructure Protection Act 2013 - A bill to make improvements regarding cyber security and critical infrastructure protection.

Public Law 112-144 - Implementation Food and Drug Administration Safety and Innovation Act FDASIA H.R. 1919 - Safeguarding Pharmaceuticals Act of 2013 - Track and Trace Pedigree Program S. 957 - Drug Supply Chain Security Act - Track and Trace Pedigree Program H.R. 3204 - Drug Quality & Security Act - Became Public Law 113-54 - Track and Trace Pedigree Program

H.R. 2024 - End Annonymous Patents Act -- A bill to end frivolous Patent lawsuits H.R. 845 - Saving High-Tech Innocations from Egregious Legal Disputes Act of 2013 - A bill to end frivolous Patent lawsuits S. 1013 - Patent Abuse Reduction Act of 2013 - (Cornyn) A bill to end frivolous Patent lawsuits S. 866 - Patent Quality Improvement Act of 2013 - A bill to make improvements to the transitional program covered business method patents H.R. 3309 - (Goodlatte) "Innovation Act" - A bill to end frivolous Patent lawsuits H.R. 3349 - (Conyers ) "Innovation Protection Act" - A bill to end frivolous Patent lawsuits H.R. 2766 - (Issa, Chu) "STOP Act" - To make improvements to the transitional program for covered business method patents S. 1720 - (Leahy-Lee) - "America Invents Act" - A bill to promote transparency in patent ownership and make other improvements to the patent system.

H.R. 933 - Consolidfated and Further Continuing Appropriations Act, 2013 -- Specificaly provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology -- In particular have been working on relief of 5% sequestration of user fees H.J. Res 59 - Continuing Appropriations Resolution - Specificaly provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology

H.R. 933 - Consolidfated and Further Continuing Appropriations Act, 2013 -- Specificaly provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology -- In particular have been working on relief of 5% sequestration of user fees H.J. Res 59 - Continuing Appropriations Resolution - Specificaly provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaluation of medical technology

S. 358 - STEM Master Teach Corps Act of 2013 - to promote STEM education H.R. 1243 - Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 1089 - Stepping up to STEM Act of 2013 - to promote STEM education

H.R. 624 - CyberIntelligence Sharing & Protection Act (CISPA) of 2013 - A bill to promote Industry and Government sharing of cyber intelligence S. 1788 - Digital Trade Act of 2013 - A bill to promote internet enabled commerce and digital trade. H.R. 3696 - National Cyber Security & Critical Infrastructure Protection Act 2013 - A bill to make improvements regarding cyber security and critical infrastructure protection.

S.232 - Medical Device Access and Innovation Protection Act - repeals the 2.3% excise tax medical devices H.R. 523 - Protect Medical Innovation Act - repeals the 2.3% excise tax medical devicesH.R. 905 - Research and Development Tax Credit Extension Act of 2013 - Amends the Internal Revenue Code to: (1) make permanent the tax credit for increasing research activities, (2) increase the rate of the alternative simplified research tax credit H.R. 1295 - Medical Device Tax Elimination Act - Extends and enhances R&P tax credit H.R. 905 - Research and Development Tax Credit Extension Act of 2013 Comprehensive/Corporate tax reform Chairman's W&M Discussion Draft - Including lower corportae tax rate, research credit transition and base erosion

S. 232 - Medical Device Access and Innovation Protection Act - repeals the 2.3% excise tax medical devices H.R. 523 - Protect Medical Innovation Act - repeals the 2.3% excise tax medical devicesH.R. 905 - Research and Development Tax Credit Extension Act of 2013 - Amends the Internal Revenue Code to: (1) make permanent the tax credit for increasing research activities, (2) increase the rate of the alternative simplified research tax credit H.R. 1295 - Medical Device Tax Elimination Act - Extends and enhances R&P tax credit H.R. 905 - Research and Development Tax Credit Extension Act of 2013 Comprehensive/Corporate tax reform Chairman's W&M Discussion Draft - Including lower corporate tax rate, research credit transition and base erosion.

Implementation Food and Drug Administration Safety and Innovation Act FDASIA - Public Law 112-144 H.R. 1919 - Safeguarding Pharmaceuticals Act of 2013 - Track and Trace Pedigree Program S. 957 - Drug Supply Chain Security Act - Track and Trace Pedigree Program

H.R. 2024 - End Anonymous Patents Act -- A bill to end frivolous Patent lawsuits H.R. 845 - Saving High-Tech Innovations from Egregious Legal Disputes Act of 2013 - A bill to end frivolous Patent lawsuits S. 1013 - Patent Abuse Reduction Act of 2013 - A bill to end frivolous Patent lawsuits S. 866 - Patent Quality Improvement Act of 2013 - A bill to end frivolous Patent lawsuitsYet to be introduced - Chairman Goodlatte discussion draft - To end frivolous Patent lawsuits S.1013 -- Patent Abuse Reduction Act of 2013 (Cornyn) S.866 -- Patent Quality Improvement Act of 2013 (Schumer) H.R.2766 -- STOP Act - To make improvements to the transitional program for covered business method patents, and for other purposes (Issa/Chu)

S. 358 - STEM Master Teacher Corps Act of 2013 H.R. 1243 - Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 1089 - Stepping up to STEM Act of 2013 - to promote STEM education

S. 232 - Medical Device Access and Innovation Protection Act - repeals the 2.3% excise tax medical devices H.R. 523 - Protect Medical Innovation Act - repeals the 2.3% excise tax medical devicesH.R. 905 - Research and Development Tax Credit Extension Act of 2013-Amends the Internal Revenue Code to: (1) make permanent the tax credit for increasing research activities, (2) increase the rate of the alternative simplified research tax credit. H.R. 1295 - Medical Device Tax Elimination Act - Extends and enhances R&P tax credit H.R. 905 - Research and Development Tax Credit Extension Act of 2013 Comprehensive/Corporate tax reform Chairman's W&M Discussion Draft - Including lower corporate tax rate, research credit, transition and base erosion

H.R. 933 - Consolidated and Further Continuing Appropriations Act, 2013 -- Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaulation of medical technology -- In particular have been working on relief of 5% sequestration of user fees

Implementation Food and Drug Administration Safety and Innovation Act FDASIA - Public Law 112-144

H.R. 933 - Consolidated and Further Continuing Appropriations Act, 2013 -- Specifically provisions providing appropriations for the FDA's Center for Device and Radiological Health (CDRH) evaulation of medical technology

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination H.R. 5651 - Food and Drug Administration Reform Act 2012 - A bill to renew the FDA User Fee program and to reform the medical device review program. S. 3187 - FDA Safety and Innovation Act - A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. Senate draft legislation to establish a national track and trace system for pharmaceuticals, specifically relating to convenience kits

S. 758, A bill to establish a Science, Technology, Engineering and Math (STEM) Master Teacher Corps program S. 716, Innovation Inspiration School Grant Program Act - to promote STEM education H.R. 3373 - STEM Education innovation Act - to promote STEM education H.R. 6517 - The STEM Network Act - to promote STEM education

Appropriations for pain management awareness programs H.R. 5973 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 S. 2375 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 H.J. Res. 117 - Continuing Appropriations Act - provisions related to user fees for FDA

S. 17, the Medical Device and Innovation Protection Act - a bill to repeal the medical device tax S. 262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act - a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011 - a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011 - a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform - specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

Appropriations for the Food and Drug Administration, particularly the Center for Devices and Radiological Health Appropriations for pain management awareness programs H.R. 5973 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 S. 2375 Agriculture, Rural Development, FDA & Related Agencies Appropriations Act 2013 H.J. Res. 117 - Continuing Appropriations Act - provisions related to user fees for FDA

Cybersecurity - Provisions related to setting standards for information sharing between public and private entities regarding Cyber attacks

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development S. 1866, the Agree Act which calls for an increase in the rate of the alternative simplified research tax credit and makes such credit permanent Corporate tax reform- specifically the treatment of international earnings including the Chairman's International Tax Reform discussion draft

H.R. 658, the FAA Reauthorization and Reform Act of 2011, provisions related to the transportation of lithium batteries S.223, the FAA Reauthorization and Reform Act of 2011, provisions related to the transportation of lithium batteries

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

United States-Korea Free Trade Agreement, provisions specifically related to medical devices Columbia and Panama Free Trade Agreements

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.

H.R. 658, the FAA Reauthorization and Reform Act of 2011, provisions related to the transportation of lithium batteries S.223, the FAA Reauthorization and Reform Act of 2011, provisions related to the transportation of lithium batteries

Appropriations for the Food and Drug Administration, particularly the Center for Devices and Radiological Health Appropriations for pain management awareness programs

Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

Appropriations for the Food and Drug Administration Appropriations for pain management awareness programs

S.454, Strengthening Program Integrity and Accountability in Health Care Act of 2011, a bill to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011, to expand the permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities

S.454, Strengthening Program Integrity and Accountability in Health Care Act of 2011, a bill to prevent fraud, waste, and abuse under Medicare, Medicaid, and CHIP, and for other purposes H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2011, to expand the permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities

Appropriations for the Food and Drug Administration Appropriations for pain management awareness programs

S.23, America Invents Act, provisions related specifically to patents and innovative technologies H.R. 1249, America Invents Act, provisions related specifically to patents and innovative technologies

S.17, the Medical Device Access and Innovation Protection Act- a bill to repeal the medical device tax S.262, A bill to repeal the excise tax on medical device manufacturers H.R. 436, the Protect Medical Innovation Act- a bill to repeal the medical device tax H.R. 734, To amend the Internal Revenue Code of 1986 to repeal the medical device tax; H.R. 488, Save Our Medical Devices Act of 2011- a bill to repeal the medical device tax H.R. 942, American Research and Competitiveness Act of 2011- a bill to extend the research credit through 2012 S. 239, the Innovate America Act, a bill to support innovation through tax credits such as research and development Corporate tax reform- specifically the treatment of international earnings

Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system

United States-Korea Free Trade Agreement, provisions specifically related to medical devices

S.23, America Invents Act, provisions related specifically to patents and innovative technologies H.R. 1249, America Invents Act, provisions related specifically to patents and innovative technologies

Appropriations for the Food and Drug Administration Appropriations for pain management awareness

H.R. 658, the FAA Reauthorization and Reform Act of 2011, provisions related to the transportation of lithium batteries S.223, the FAA Reauthorization and Reform Act of 2011, provisions related to the transportation of lithium batteries

H.R. 4016, the Hazardous Materials Transportation Safety Act of 2009, specifically regarding the transportation of lithium batteries

S.515. Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R. 1260, Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R.5322, Patent and Trademark Office Funding Stabilization Act of 2010, provisions related specifically to innovative technologies H.R. 4954, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings

The FY2011 budget proposal and provisions related to the taxation of foreign earnings of U.S. multinational corporations. S. 3816, Creating American Jobs and Ending Offshoring Act, a bill that would limit deferral for U.S. companies that move production overseas and then import products back to the United States. S.1203, the GROWTH Act, a bill to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit H.R.4853, Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, a bill that includes extension of the R&D tax credit

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

S.560, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, or assist labor organizations and to provide for mandatory injunctions for unfair labor practices during the organizing efforts H.R. 1409, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, assist labor organizations, and to provide for mandatory injunctions for unfair labor practices during the organizing efforts

HR 2749, Food Safety Enhancement Act of 2009, grants FDA the authority and resources to oversee the safety of the nation's food supply. Includes provisions related to registration fees, device import safety fees, and unique identifier provisions.

H.R. 3795, to enact the Over-the-Counter Derivatives Markets Act of 2009, provisions related to changing the regulation on over-the-counter derivatives and how they are used by corporations H.R.4173, to provide for financial regulatory reform, to protect consumers and investors, to enhance Federal understanding of insurance issues, to regulate over-the-counter derivatives markets, and for other purposes with provisions specifically changing the regulation on over-the-counter derivatives and how they are used by corporations. S.3217, The Restoring American Financial Stability Act, on financial reform with provisions on the regulation of over-the-counter derivatives and Congo conflict minerals Conference Report H. Rept 111-517,Wall Street Reform and Consumer Protection Act, with provisions on the regulation of over-the-counter derivatives

H.R. 3795, to enact the Over-the-Counter Derivatives Markets Act of 2009, provisions related to changing the regulation on over-the-counter derivatives and how they are used by corporations H.R.4173, to provide for financial regulatory reform, to protect consumers and investors, to enhance Federal understanding of insurance issues, to regulate over-the-counter derivatives markets, and for other purposes with provisions specifically changing the regulation on over-the-counter derivatives and how they are used by corporations. S.3217, The Restoring American Financial Stability Act, on financial reform with provisions on the regulation of over-the-counter derivatives and Congo conflict minerals Conference Report H. Rept 111-517,Wall Street Reform and Consumer Protection Act, with provisions on the regulation of over-the-counter derivatives

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information. H.R.1032, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. S.422, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

S.560, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, or assist labor organizations and to provide for mandatory injunctions for unfair labor practices during the organizing efforts H.R. 1409, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, assist labor organizations, and to provide for mandatory injunctions for unfair labor practices during the organizing efforts

S.515. Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R. 1260, Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R.5322, Patent and Trademark Office Funding Stabilization Act of 2010, provisions related specifically to innovative technologies H.R. 4954, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings

HR 2749, Food Safety Enhancement Act of 2009, grants FDA the authority and resources to oversee the safety of the nation's food supply. Includes provisions related to registration fees, device import safety fees, and unique identifier provisions.

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information

The FY2011 budget proposal and provisions related to the taxation of foreign earnings of U.S. multinational corporations S.1203, the GROWTH Act, a bill to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit HR 4213, American Jobs and Closing Tax Loopholes Act, a bill that includes extension of the R&D tax credit

H.R. 4016, the Hazardous Materials Transportation Safety Act of 2009, specifically regarding the transportation of lithium batteries

S.515. Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R. 1260, Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R.5322, Patent and Trademark Office Funding Stabilization Act of 2010, provisions related specifically to innovative technologies

H.R. 3795, to enact the Over-the-Counter Derivatives Markets Act of 2009, provisions related to changing the regulation on over-the-counter derivatives and how they are used by corporations H.R.4173, to provide for financial regulatory reform, to protect consumers and investors, to enhance Federal understanding of insurance issues, to regulate over-the-counter derivatives markets, and for other purposes with provisions specifically changing the regulation on over-the-counter derivatives and how they are used by corporations. S.3217, The Restoring American Financial Stability Act, on financial reform with provisions on the regulation of over-the-counter derivatives Conference Report H. Rept 111-517,Wall Street Reform and Consumer Protection Act, with provisions on the regulation of over-the-counter derivatives

S.560, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, or assist labor organizations and to provide for mandatory injunctions for unfair labor practices during the organizing efforts H.R. 1409, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, assist labor organizations, and to provide for mandatory injunctions for unfair labor practices during the organizing efforts

H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. Provisions within the health care reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, Medicare secondary payer, bundling, gainsharing, medical device registry, and medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act, a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising

H.R. 4016, the Hazardous Materials Transportation Safety Act of 2009, specifically regarding the transportation of lithium batteries

H.R. 3795, to enact the Over-the-Counter Derivatives Markets Act of 2009, provisions related to changing the regulation on over-the-counter derivatives and how they are used by corporations H.R.4173, to provide for financial regulatory reform, to protect consumers and investors, to enhance Federal understanding of insurance issues, to regulate over-the-counter derivatives markets, and for other purposes with provisions specifically changing the regulation on over-the-counter derivatives and how they are used by corporations. S.3217, The Restoring American Financial Stability Act, on financial reform with provisions on the regulation of over-the-counter derivatives

HR 2749, Food Safety Enhancement Act of 2009, grants FDA the authority and resources to oversee the safety of the nation's food supply. Includes provisions related to registration fees, device import safety fees, and unique identifier provisions.

S.515. Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R. 1260, Patent Reform Act of 2009, provisions related specifically to innovative technologies

H.R. 3590, the Patient Protection and Affordable Care Act, the legislative vehicle used to pass Leader Reid's manager's amendment regarding health care reform on the Senate floor H.R. 3962, Affordable Health Care for America Act,to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes Other Senate and House Committee Health Reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, Medicare secondary payer, bundling, gainsharing, medical device registry, and medical device tax. Medicare Secondary Payer provision, which was included in Ways and Means Chairman's Mark for HR 3200, the America's Affordable Health Choices Act, that would have increased exposure to liability for suppliers S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity &Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1390, the Defense Authorization Bill, provisions related to pain management which would require a comprehensive pain care policy on pain management by the military health care system

H.R. 3795, to enact the Over-the-Counter Derivatives Markets Act of 2009, provisions related to changing the regulation on over-the-counter derivatives and how they are used by corporations H.R.4173, to provide for financial regulatory reform, to protect consumers and investors, to enhance Federal understanding of insurance issues, to regulate over-the-counter derivatives markets, and for other purposes with provisions specifically changing the regulation on over-the-counter derivatives and how they are used by corporations Senate draft legislation by Senator Dodd on financial reform with provisions on the regulation of over-the-counter derivatives

Medical device tax as included as a means to pay for health care reform in H.R. 3962, the Affordable Health Care for America Act and the Senate Manager's Amendment (SA3298) on health care reform H.Con Res 85 and S.Con Res 13, the FY2010 budget resolution and provisions related to the taxation of foreign earnings of U.S. multinational corporations H.R. 4213, the Tax Extenders Act of 2009, specifically including a provision to extend the research and development tax credit S.1203, the GROWTH Act, a bill to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit

HR 2749, Food Safety Enhancement Act of 2009, grants FDA the authority and resources to oversee the safety of the nation's food supply. Includes provisions related to registration fees, device import safety fees, and unique identifier provisions.

S.515. Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R. 1260, Patent Reform Act of 2009, provisions related specifically to innovative technologies

H.R. 4016, the Hazardous Materials Transportation Safety Act of 2009, specifically regarding the transportation of lithium batteries

Medical Device tax as mentioned as a proposal to pay for health reform H.Con Res 85 and S.Con Res 13, the FY2010 budget resolution, and provisions related to the taxation of foreign earnings of U.S. multinational corporations H.R. 422, a bill to permanently extend and strengthen the federal R & D tax credit S.1203, the GROWTH Act, a bill to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit

S.1679, the Affordable Health Choices Act, to provide affordable, quality health care for all Americans H.R. 3200, America's Affordable Health Choices Act of 2009, to provide affordable, quality health care for all Americans Other Senate and House Committee Health Reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, medicare secondary payer, bundling, gainsharing, medical device registry, and medical device tax. Medicare Secondary Payer provision, which was included in Ways and Means Chairman's Mark for HR 3200, the America's Affordable Health Choices Act, that would have increased exposure to liability for suppliers S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity &Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1390, the Defense Authorization Bill, provisions related to pain management which would require a comprehensive pain care policy on pain management by the military health care system

S.560, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, or assist labor organizations and to provide for mandatory injunctions for unfair labor practices during the organizing efforts H.R. 1409, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, assist labor organizations, and to provide for mandatory injunctions for unfair labor practices during the organizing efforts

HR 2749, Food Safety Enhancement Act of 2009, grants FDA the authority and resources to oversee the safety of the nation's food supply. Includes provisions related to registration fees, device import safety fees, and unique identifier provisions.

S.515. Patent Reform Act of 2009, provisions related specifically to innovative technologies H.R. 1260, Patent Reform Act of 2009, provisions related specifically to innovative technologies

H.R. 3795, to enact the Over-the-Counter Derivatives Markets Act of 2009, provisions related to changing the regulation on over-the-counter derivatives and how they are used by corporations

Over the Counter Derivatives, provisions related to changing the regulation

S.560, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, or assist labor organizations and to provide for mandatory injunctions for unfair labor practices during the organizing efforts H.R. 1409, the Employee Free Choice Act, a bill to establish an efficient system to enable employees to form, join, assist labor organizations, and to provide for mandatory injunctions for unfair labor practices during the organizing efforts

S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies S.1380, Medicare Payment Advisory Commission (MedPAC) Reform Act , a bill to make the commission an executive branch agency, and provide the Commission new resources and authority to implement Medicare payment policy S.301, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 3138, Physician Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research relating to health care S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising Medicare coverage of PLATINUM clinical trial

HR. 2454, American Clean Energy and Security Act, a bill to create clean energy jobs, achieve energy independence, reduce global warming pollution and transition to a clean energy economy S.5 a bill to reduce the dependence on foreign and unsustainable energy sources and risks of global warming

Senate and House Committee Health Reform bills with an emphasis on physician disclosure, comparative effectiveness research, pain research, bundling and gainsharing S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research relating to health care S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising

HR 1346 Medical Device Safety Act of 2009, a bill that would remove federal preemption protection for certain medical devices S 540 Medical Device Safety Act of 2009, a bill that would remove federal preemption protection for certain medical devices Reform of the 510(k) regulatory pathway Healthcare Reform

HR1- American Recovery and Reinvestment Act of 2009, buy america provision

Market Access, regulatory approvals and reimbursement for medical devices in Japan, EU, Korea, China, Brazil Trade agreements with Columbia and South Korea

S 515 Patent Reform Act of 2009, provisions related specifically to innovative technologies HR 1260 Patent Reform Act of 2009, provisions related specifically to innovative technologies

S.5 a bill to reduce the dependence on foreign and unsustainable energy sources and risks of global warming Johanns Amendment 735 to the Senate Budget Resolution regarding the capp and trade system

- HR 6331 Medicare Improvements for Patients and Providers Act of 2008, possible inclusion of remote monitoring provisions. - HR 5765 Medicare Remote Monitoring Access Act, a bill to provide Medicare reimbursement for doctors who remotely monitor chronically ill patients. - HR 2994 National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies. - S. 3387 National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies. - S. 631 Remote Monitoring Access Act of 2007a bill to provide Medicare reimbursement for doctors who remotely monitor chronically ill patients. - S. 2029 Physican Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices. - HR 5605 Physican Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices. - Medicare Coverage of Intracranial Angioplasty and Stenting. - Medicare Payment of Inpatient Hospital Services. - Medicare Coverage of Renal Stenting. - Medicare Coverage of Carotid Stenting. - Regulatory and Reimbursement Issues for Medical Devices in Medicare. - S. 3408 Comparative Effectiveness Research Act to compare cinical effectiveness of medical treatments, services and items.

- HR 5465 Military Pain Care Act, a bill to promote greater access to chronic pain therapies in the DoD healthcare system. - HR 5658 Duncan Hunter National Defense Authorization Act for Fiscal Year 2009, provisions to promote greater access to chronic pain therapies in the DoD healthcare system. - S. 3002 Department of Defense Authorization Act, provisions to promote greater access to chronic pain therapies in the DoD healthcare system.

- Food and Drug Administration Globalization Act of 2008, a bill to increase FDA inspection of manufacturers in the US and abroad. - HR 6381Medical Device Safety Act of 2008, a bill that would remove federal preemption protection for certain medical devices. - HR 2900 Implementation of Food and Drug Administration Amendments Act of 2007, a bill to revise and extend the user-fee programs for prescription drugs and for medical devices. - HR 3014 Health Disparities, a bill to address disparities in the delivery of health care, specifically as it relates to cardiovascular care. - S. 3398 Medical Device Safety Act of 2008, a bill that would remove federal preemption protection for certain medical devices. - HR 6432 Animal Drug User Fee Act, a provision to make technical corrections to device user fee program.

- S.1145 Patent Reform Act of 2007, provisions related specifically to innovative technologies. - HR 1908 Patent Reform Act of 2007, provisions related specifically to innovative technologies.

- S.1145 Patent Reform Act of 2007, provisions related specifically to innovative technologies. - HR 1908 Patent Reform Act of 2007, provisions related specifically to innovative technologies.

- Market Access, regulatory approvals and reimbursement for medical devices in Japan, EU, Korea, China, Brazil. - Trade Agreements with Columbia, South Korea.

- HR 5465 Military Pain Care Act, a bill to promote greater access to chronic pain therapies in the DoD healthcare system. - HR 5658 Duncan Hunter National Defense Authorization Act for Fiscal Year 2009, provisions to promote greater access to chronic pain therapies in the DoD healthcare system. - S. 3002 Department of Defense Authorization Act, provisions to promote greater access to chronic pain therapies in the DoD healthcare system.

- HR 6331 Medicare Improvements for Patients and Providers Act of 2008, possible inclusion of remote monitoring provisions. - HR 5765 Medicare Remote Monitoring Access Act, a bill to provide Medicare reimbursement for doctors who remotely monitor chronically ill patients. - HR 2994 National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies. - S. 3387 National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies. - S. 631 Remote Monitoring Access Act of 2007a bill to provide Medicare reimbursement for doctors who remotely monitor chronically ill patients. - S. 2029 Physican Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices. - HR 5605 Physican Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices. - Medicare Coverage of Intracranial Angioplasty and Stenting. - Medicare Payment of Inpatient Hospital Services. - Medicare Coverage of Renal Stenting. - Medicare Coverage of Carotid Stenting. - Regulatory and Reimbursement Issues for Medical Devices in Medicare. - S. 3408 Comparative Effectiveness Research Act to compare cinical effectiveness of medical treatments, services and items.

- S. 2160 Veterans Pain Care Act, a bill to promote greater access to chronic pain therapies in the VA medical system. - HR 6122 Veterans Pain Care Act, a bill to promote greater access to chronic pain therapies in the VA medical system. - S. 2162 Veterans Mental Health and Other Care Improvements Act, a bill to promote greater access to chronic pain therapies in the VA medical system.

- HR 5465 Military Pain Care Act

- Medical device supplier contract with Veterans Administration - S. 2160 Veterans Pain Care Act

- Regulatory and Reimbursement Issues for Medical Devices in Medicare. - Implementation of Coverage, Coding and Reimbursement under 2003 Medicare Prescription Drug Improvement and Modernization Act. - HR 3162 Children's Health and Medicare Protection Act of 2007 - HR 976, Small Business Tax Relief Act of 2007 - Medicare Coverage of Intracranial Angioplasty and Stenting - Medicare Payment of Inpatient Hospital Services - S. 631 Remote Monitoring Access Act of 2007 - HR 5765 Medicare Remote Monitoring Access Act - Medicare Clinical Research Policy - S. 2029 Physican Payments Sunshine Act -HR 5605 Physican Payments Sunshine Act - S. 2221 Transparency Medical Device Pricing Act - HR 2994 National Pain Care Policy Act - Medicare Coverage of Renal Stenting - Comparative Effectiveness research - S. 999 Stop Stroke - HR 477 Stroke Treatment & Prevention Act

- Food and Drug Administration Globalization Act of 2008, a bill to increase FDA inspection of manufacturers in the US and abroad. - HR 6381Medical Device Safety Act of 2008. a bill that would remove federal preemption protection for certain medical devices. - HR 2900 Implementation of Food and Drug Administration Amendments Act of 2007, a bill to revise and extend the user-fee programs for prescription drugs and for medical devices. - HR 3014 Health Disparities, a bill to address disparities in the delivery of health care, specifically as it relates to cardiovascular care.

- HR 2419 Farm Bill, provisions relating to training physicians using live animals. - S 2302 Farm Bill, provisions relating to training physicians using live animals.

- HR 6331 Medicare Improvements for Patients and Providers Act of 2008, possible inclusion of remote monitoring provisions - HR 5765 Medicare Remote Monitoring Access Act, a bill to provide Medicare reimbursement for doctors who remotely monitor chronically ill patients. - HR 2994 National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies. - S. 631 Remote Monitoring Access Act of 2007a bill to provide Medicare reimbursement for doctors who remotely monitor chronically ill patients. - S. 2029 Physican Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices - HR 5605 Physican Payments Sunshine Act, a bill that would require disclosure of the relationships between physicians and the manufacturers of drugs and devices - S. 2221 Transparency Medical Device Pricing Act, a bill that would require thedislosure of pricing for medical devices. - S. 999 Stop Stroke, a bill to improve stroke prevention, diagnosis, treatment, and rehabilitation. - HR 477 Stroke Treatment & Prevention Act, a bill to improve stroke prevention, diagnosis, treatment, and rehabilitation - HR 3162 Children's Health and Medicare Protection Act of 2007, a bill to extend and improve the children's health insurance program. - HR 976, Small Business Tax Relief Act of 2007, a bill to extend and improve the Children's Health Insurance Program. - Medicare Coverage of Intracranial Angioplasty and Stenting - Medicare Payment of Inpatient Hospital Services - Medicare Coverage of Renal Stenting - Comparative Effectiveness research - Medicare Coverage of Carotid Stenting - Regulatory and Reimbursement Issues for Medical Devices in Medicare

- S.1145 Patent Reform Act of 2007, provisions related specifically to innovative technologies. - HR 1908 Patent Reform Act of 2007, provisions related specifically to innovative technologies.

- HR 5465 Military Pain Care Act, a bill to promote greater access to chronic pain therapies in the DoD healthcare system. - HR 5658 Duncan Hunter National Defense Authorization Act for Fiscal Year 2009, provisions to promote greater access to chronic pain therapies in the DoD healthcare system.

- S.1145 Patent Reform Act of 2007 - HR 1908 Patent Reform Act of 2007

- HR 2900 Implementation of Food and Drug Administration Amendments Act of 2007 - Medical Device Safety Act 2008 - HR 2419 Farm Bill

- Regulatory and Reimbursement Issues for Medical Devices in Medicare. - Implementation of Coverage, Coding and Reimbursement under 2003 Medicare Prescription Drug Improvement and Modernization Act. - HR 3162 Children's Health and Medicare Protection Act of 2007 - HR 976, Small Business Tax Relief Act of 2007 - Medicare Coverage of Intracranial Angioplasty and Stenting - Medicare Payment of Inpatient Hospital Services - S. 631 Remote Monitoring Access Act of 2007 - HR 5765 Medicare Remote Monitoring Access Act - Medicare Clinical Research Policy - S. 2029 Physican Payments Sunshine Act -HR 5605 Physican Payments Sunshine Act - S. 2221 Transparency Medical Device Pricing Act - HR 2994 National Pain Care Policy Act - Medicare Coverage of Renal Stenting - Comparative Effectiveness research - S. 999 Stop Stroke - HR 477 Stroke Treatment & Prevention Act

- Medical device supplier contract with Veterans Administration

- HR 2138 Investment in America Act of 2007 - S. 2209 Investment in America Act of 2007

- HR 2900 Food and Drug Administration Amendments Act of 2007 - S. 1082 Food and Drug Administration Revitalization Act - HR 1494 Pediatric Medical Device Safety and Improvement Act of 2007 - Update to International Classification of Diseases coding to 10th revision (ICD-10) - HR 2419 Farm Bill

- Regulatory and Reimbursement Issues for Medical Devices in Medicare. - Implementation of Coverage, Coding and Reimbursement under the 2003 Medicare Prescription Drug Improvement and Modernization Act. - HR 3162 Children's Health and Medicare Protection Act of 2007. - HR 976, Small Business Tax Relief Act of 2007 - Medicare Coverage of Intracranial Angioplasty and Stenting - Medicare Payment of Inpatient Hospital Services - S. 631 Remote Monitoring Access Act of 2007 - Medicare Clinical Research Policy - S. 2029 Physician Payments Sunshine Act - S. 2221 Transparency Medical Device Pricing Act - HR 2994 National Paincare Policy Act - Medicare Coverage of Renal Stenting - Comparative Effectiveness research

- HR 2900 Food and Drug Administration Amendments Act of 2007 - S. 1082 Food and Drug Administration Revitalization Act - HR 1494 Pediatric Medical Device Safety and Improvement Act of 2007 - Update to International Classification of Diseases coding to 10th revision (ICD-10)

- Regulatory and Reimbursement Issues for Medical Devices in Medicare. - Implementation of Coverage, Coding and Reimbursement under the 2003 Medicare Prescription Drug Improvement and Modernization Act. - HR 3162 Children's Health and Medicare Protection Act of 2007.

- Use of dedicated spectrum for medical devices

- Medical device supplier contract with Veterans Administration