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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2026 · third_quarter · Q3
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 and completion/implementation of the G7 side-by-side agreement.
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, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
Source: Senate LDA
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 and completion/implementation of the G7 side-by-side agreement.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
Ensuring Patient Access to Critical Breakthrough Products Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
VA Contracting and Procurement Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism.
VA Contracting and Procurement Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
VA Contracting and Procurement Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
Veterans STAND Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
Veterans STAND Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
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 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.
National Defense Authorization Act for Fiscal Year 2027
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
National Defense Authorization Act for Fiscal Year 2027
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
National Defense Authorization Act for Fiscal Year 2027
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Ensuring Patient Access to Critical Breakthrough Products Act of 2025
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Relief of Chronic Pain Act of 2025
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Health Care Cybersecurity and Resiliency Act of 2026
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
National Defense Authorization Act for Fiscal Year 2027
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
National Defense Authorization Act for Fiscal Year 2027
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
National Defense Authorization Act for Fiscal Year 2027
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Advancing Research for Chronic Pain Act of 2026
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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. To restore immediate tax deductions for research and development (R&D) expenses, reversing the requirement that companies amortize these costs over several years. 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.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and R&D Competitiveness Act of 2025
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and R&D Competitiveness Act of 2025
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and R&D Competitiveness Act of 2025
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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. To restore immediate tax deductions for research and development (R&D) expenses, reversing the requirement that companies amortize these costs over several years. 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.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Unfair Tax Prevention Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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. To restore immediate tax deductions for research and development (R&D) expenses, reversing the requirement that companies amortize these costs over several years. 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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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. To restore immediate tax deductions for research and development (R&D) expenses, reversing the requirement that companies amortize these costs over several years. 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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 and completion/implementation of the G7 side-by-side agreement.
VA Contracting and Procurement Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans.
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Tax Relief for American Families and Workers Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Tax Relief for American Families and Workers Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Tax Relief for American Families and Workers Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Tax Relief for American Families and Workers Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Privacy Rights Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.
American Privacy Rights Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.
PFAS-Free Procurement Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
PFAS-Free Procurement Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
PFAS-Free Procurement Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
PFAS-Free Procurement Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Artificial Intelligence Research, Innovation, and Accountability Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.
Artificial Intelligence Research, Innovation, and Accountability Act of 2024
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.
American Innovation and Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and R&D Competitiveness Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Defending American Jobs and Investment Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
Build It in America Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
PFAS-Free Procurement Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
PFAS-Free Procurement Act of 2023
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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 Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
American Innovation and Jobs Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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.
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.
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.
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.
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.
Inflation Reduction Act of 2022
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Inflation Reduction Act of 2022
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Build Back Better Act (BBB) (H.R. 5376) - 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
Inflation Reduction Act of 2022
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Inflation Reduction Act of 2022
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
United States Innovation and Competition Act of 2021
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
Build Back Better Act (BBB) (H.R. 5376) - 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
United States Innovation and Competition Act of 2021
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
United States Innovation and Competition Act of 2021
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
United States Innovation and Competition Act of 2021
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Great Lakes Fishery Research Authorization Act of 2017
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Great Lakes Fishery Research Authorization Act of 2017
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Great Lakes Fishery Research Authorization Act of 2017
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Great Lakes Fishery Research Authorization Act of 2017
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Stop Taxpayer-Funded Alcohol Marketing Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Stop Taxpayer-Funded Alcohol Marketing Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Stop Taxpayer-Funded Alcohol Marketing Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
Stop Taxpayer-Funded Alcohol Marketing Act
Client: BOSTON SCIENTIFIC CORPORATION · Firm: BOSTON SCIENTIFIC CORPORATION
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
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2026 · second_quarter · Q2
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. 2025 Reauthorization of the SUPPORT for Patients and Communities Act - Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical devices role to address the opioid epidemic. 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.
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.
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.
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 and completion/implementation of the G7 side-by-side agreement.
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.
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, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2026 · first_quarter · Q1
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.
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.
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. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism.
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. 2025 Reauthorization of the SUPPORT for Patients and Communities Act - Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical devices role to address the opioid epidemic. 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.
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 and completion/implementation of the G7 side-by-side agreement.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2025 · fourth_quarter · Q4
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. 2025 Reauthorization of the SUPPORT for Patients and Communities Act - Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical devices role to address the opioid epidemic. 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.
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. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans.
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 and completion/implementation of the G7 side-by-side agreement.
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.
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2025 · third_quarter · Q3
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.
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. VA Authorization Bill of 2025- Specifically provisions to streamline product procurement and the purchase order processes.
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. To restore immediate tax deductions for research and development (R&D) expenses, reversing the requirement that companies amortize these costs over several years. 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.
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. 2025 Reauthorization of the SUPPORT for Patients and Communities Act - Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical devices role to address the opioid epidemic. 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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2025 · second_quarter · Q2
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. 2025 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 devices 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, and 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. 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. FY2025 Impatient Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements. 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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2025 · first_quarter · Q1
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. 2025 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 devices 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, and 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. 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. FY2025 Impatient Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements. 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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2024 · fourth_quarter · Q4
Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2024 · third_quarter · Q3
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.
Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2024 · second_quarter · Q2
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2024 · first_quarter · Q1
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2023 · fourth_quarter · Q4
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2023 · third_quarter · Q3
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.
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2023 · second_quarter · Q2
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2023 · first_quarter · Q1
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
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, interest deductions, and R&D expense deductibility.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2022 · fourth_quarter · Q4
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2022 · third_quarter · Q3
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
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2022 · second_quarter · Q2
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2022 · first_quarter · Q1
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
Build Back Better Act (BBB) (H.R. 5376) - 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
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2021 · fourth_quarter · Q4
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.
Build Back Better Act (BBB) (H.R. 5376) - International tax provisions specifically changes to GILTI (Global Intangible Low-Taxed Income), interest deductions, and R&D expense deductibility
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
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2021 · third_quarter · Q3
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 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 - 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
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2021 · second_quarter · Q2
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2021 · first_quarter · Q1
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. 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression HR 1580 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 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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2020 · fourth_quarter · Q4
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2020 · third_quarter · Q3
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. 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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2020 · second_quarter · Q2
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
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2020 · first_quarter · Q1
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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2019 · fourth_quarter · Q4
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2019 · third_quarter · Q3
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
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2019 · second_quarter · Q2
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2019 · first_quarter · Q1
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.
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
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2018 · fourth_quarter · Q4
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: 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. 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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2018 · third_quarter · Q3
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 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: 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.
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2018 · second_quarter · Q2
Limitations on aircraft transportation of lithium batteries H.R. 4 and S. 1405 - 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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2018 · first_quarter · 1A
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 and S. 1405 - Federal Aviation Administration Re-authorization Act of 2018 - Limitations on aircraft transportation of lithium batteries (House & Senate)
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2018 · first_quarter · Q1
Limitations on aircraft transportation of lithium batteries H.R. 4 and S. 1405 - 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.
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2017 · first_quarter · 1A
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
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2017 · first_quarter · 1A
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2017 · second_quarter · 2A
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
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)
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2017 · third_quarter · 3A
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2017 · fourth_quarter · 4A
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)
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2017 · fourth_quarter · Q4
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 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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2017 · third_quarter · Q3
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.
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2017 · second_quarter · Q2
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
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.
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2017 · first_quarter · Q1
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)
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.
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2016 · fourth_quarter · Q4
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: 113-67 - 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
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2016 · third_quarter · Q3
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2016 · second_quarter · Q2
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. 4063 - S. 1641 - Promise Act - Legislation to improve quality of Pain Care provided
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
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2016 · first_quarter · Q1
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
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. 4063 - Promise Act - Legislation to improve quality of Pain Care provided
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2015 · fourth_quarter · Q4
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. 4063 - Promise Act - Legislation to improve quality of Pain Care provided to Veterans Brooks Bill - H.R. 2805 (HCR)
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
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2015 · third_quarter · Q3
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
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2015 · second_quarter · Q2
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. 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
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2015 · first_quarter · Q1
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. 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
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2014 · fourth_quarter · Q4
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 Unique Device Identifiers (UDI) Implementation of UDI Rule 21st Century Cares Initiative - Draft legisation to accelerate the pace of biomedical Innovation and curs by Modernizing Federal Research and Regulatory Agencies
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
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2014 · third_quarter · Q3
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 Unique Device Identifiers (UDI) Implementation of UDI Rule
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
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2014 · second_quarter · Q2
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 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 Unique Device Identifiers (UDI) - Implementation of UDI Rule
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2014 · first_quarter · Q1
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 Unique Device Identifiers (UDI) - Implementation of UDI Rule
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.
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2013 · fourth_quarter · 4A
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 corportae tax rate, research credit transition and base erosion
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.
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2013 · fourth_quarter · Q4
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 lawsuitsS. 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.
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
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2013 · third_quarter · Q3
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
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
BOSTON SCIENTIFIC CORPORATION via BOSTON SCIENTIFIC CORPORATION
2013 · second_quarter · Q2
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
Implementation Food and Drug Administration Safety and Innovation Act FDASIA - Public Law 112-144 H.R. 1919 - Safeguarding America's Pharmaceuticals Act of 2013 - Track and Trace Pedigree Program S. 957 - Drug Supply Chain Security Act - Track and Trace Pedigree Program
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), 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. 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
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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)
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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 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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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 115-52 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.
Filing targets: HOUSE OF REPRESENTATIVES, 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 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.
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
Filing targets: HOUSE OF REPRESENTATIVES, 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 Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)
Filing targets: HOUSE OF REPRESENTATIVES, 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. 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.
Limitations on aircraft transportation of lithium batteries Federal Aviation Administration Re-authorization Act - Limitations on aircraft transportation of lithium batteries (House & Senate)
Filing targets: HOUSE OF REPRESENTATIVES, 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. 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.
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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.
Filing targets: HOUSE OF REPRESENTATIVES, 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. 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
Filing targets: HOUSE OF REPRESENTATIVES, 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. 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.
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)
Filing targets: HOUSE OF REPRESENTATIVES, 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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: HOUSE OF REPRESENTATIVES, 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
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
FAA Re authorization - Limitations on aircraft transportation of lithium batteries
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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. 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
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
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
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
Filing targets: HOUSE OF REPRESENTATIVES, 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. VA Vendor Credentialing - Proposals to establish a national credentialing system for VA
FAA Re authorization - 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. 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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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 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 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.
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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.
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.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
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. 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
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
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)
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
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
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE