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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.
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3 Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule final rule implementation, and legislation Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem Oppose drug importation proposals Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance Support capping Medicare beneficiary out of pocket costs Support expanded access to telehealth Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule
Reserved for the Speaker.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2023 · fourth_quarter · Q4
Support legislation to reform Congressional Budget Office scoring of health care legislation
Oppose WTO TRIPS waiver for COVID diagnostics and therapeutics
Source: Senate LDA
Client: CALIFORNIA LIFE SCIENCES · Firm: CALIFORNIA LIFE SCIENCES
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3 Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, final rule, implementation, and legislation Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the elife sciences ecosystem Oppose drug importation proposals Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule regarding cost-sharing assistance Support capping Medicare beneficiary out of pocket costs Support expanded access to telehealth Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule Implement Medicare Drug Price Negotiation program in least harmful way - MFP at ceiling for innovative products, broad orphan drug exclusion, welcome patient and stakeholder input
Elijah E. Cummings Lower Drug Costs Now Act
Client: CALIFORNIA LIFE SCIENCES · Firm: CALIFORNIA LIFE SCIENCES
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule final rule implementation, and legislation. Oppose legislative proposal to reform Patent system and Intellectual Property issues negatively impacting the life sciences ecosystem. Oppose drug importation proposals. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance. Support expanded access to telehealth. Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
Elijah E. Cummings Lower Drug Costs Now Act
Client: CALIFORNIA LIFE SCIENCES · Firm: CALIFORNIA LIFE SCIENCES
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule final rule implementation, and legislation. Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem. Oppose drug importation proposals. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance. Support capping Medicare beneficiary out of pocket costs. Support expanded access to telehealth. Support value-based purchasing provision, but opposed line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
Elijah E. Cummings Lower Drug Costs Now Act
Client: CALIFORNIA LIFE SCIENCES · Firm: CALIFORNIA LIFE SCIENCES
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, final rule implementation, and legislation. Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem. Oppose drug importation proposals. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance. Support capping Medicare beneficiary out of pocket costs. Support expanded access to telehealth. Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
Support R&D and NOL tax incentives, Orphan Drug Tax Credits, repeal R&D tax amortization
Oppose "march-in" rights and "compulsory licensing" proposals Support transferable exclusivity extensions to incentivize novel antibiotic R&D
Support promulgation of TCET rule Support breakthrough device coverage bill Support legislation proposing coverage for multicancer screening
Oppose drug importation proposals Support diversity in clinical trial policy Support medical device change control plans legislation Oppose legislation that expands Medicare Drug Pricing Negotiation Program Support bipartisan effort to address health care workforce shortage Support incentives for antimicrobial resistance development (PASTEUR Act) Support legislation that applies additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans Support legislation to prohibit pharmacy benefit managers (PBMs) from linking rebates paid by manufacturers to the list price of a drug and instead implement a flat service fee paid to PBMs. Support legislation providing for e-labeling of medical devices
Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem Support capping Medicare beneficiary out of pocket costs Support value-based purchasing provision, but opposed line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule Support legislation to expand and clarify the exclusion for orphan drugs under the Medicare Drug Price Negotiation Program Oppose CMS proposed changes to the Medicaid Drug Rebate Program (MDRP) to redefine how Medicaid Best Price is calculated Implement Medicare Drug Price Negotiation program in least harmful way - MFP at ceiling for innovative products, broad orphan drug exclusion, welcome patient and stakeholder input
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2023 · third_quarter · Q3
Support NIH research funding Support promulgation of TCET rule Support breakthrough device coverage bill Support bipartisan PAHPA reauthorization
Oppose proposals to reduce data exclusivity Oppose proposals to restrict data uses Oppose WTO TRIPS waiver for COVID diagnostics and therapeutics
Address concerns with provisions of patent litigation reform, including inter partes review Oppose "march-in" rights and "compulsory licensing" proposals Support transferable exclusivity extensions to incentivize novel antibiotic R&D
Labor/HHS/Ed Appropriations: Drug Pricing; FDA; NIH; biodefense/pandemic; CDC; science/math education; U.S. Preventive Services Task Force; eLabeling; Orphan Drug Tax Credit Support legislation to reform Congressional Budget Office scoring of health care legislation
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem Oppose drug importation proposals Support capping Medicare beneficiary out of pocket costs Support expanded access to telehealth Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule Implement Medicare Drug Price Negotiation program in least harmful way - MFP at ceiling for innovative products, broad orphan drug exclusion, welcome patient and stakeholder input
Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices Support legislation proposing coverage for multicancer screening Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices Support public education campaign on pandemic preparedness Oppose drug importation proposals Support diversity in clinical trial policy Support medical device change control plans legislation Oppose legislation that expands Medicare Drug Pricing Negotiation Program Support bipartisan Pandemics and All Hazards Preparedness Reauthorization Support bipartisan effort to address health care workforce shortage Support incentives for antimicrobial resistance development (PASTEUR Act) Support legislation providing for e-labeling of medical devices
Support R&D and NOL tax incentives, Orphan Drug Tax Credits, repeal R&D tax amortization
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2023 · second_quarter · Q2
Labor/HHS/Ed Appropriations: Drug Pricing, FDA, NIH, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation; Coronovirus funding and response FDA Appropriations; PTO Appropriations; eLabeling appropriations language. Drug Pricing proposals, Orphan Drug Tax Credit; semiconductor/CHIPS funding; oppose budget reconciliation with drug pricing
Support NIH research funding Support implementation of 21st Century Cures Act Support promulgation of TCET rule Support alternatives to animal research Support breakthrough device coverage bill Support bipartisan PAHPA reauthorization
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3 Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, final rule, implementation, and legislation Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the elife sciences ecosystem Oppose drug importation proposals Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule regarding cost-sharing assistance Support capping Medicare beneficiary out of pocket costs Support expanded access to telehealth Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule Implement Medicare Drug Price Negotiation program in least harmful way - MFP at ceiling for innovative products, broad orphan drug exclusion, welcome patient and stakeholder input
Address concerns with provisions of patent litigation reform, including inter-partes review Support STRONGER Patents Act Oppose "march-in" rights and "compulsory licensing" proposals Support transferable exclusivity extensions to incentivize novel antibiotic R&D Support incentives for onshore and near shore critical manufacturing capacities
Banking reform, Federal Reserve and Treasury oversight of regional banks
Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices
Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices Support legislation proposing coverage for multi-cancer screening Support FDA modernization efforts and vaccine awareness Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices Support improvements to the Strategic National Stockpile for pandemic testing preparedness Support public education campaign on pandemic preparedness Support re-authorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program Oppose drug importation proposals Support diversity in clinical trial policy Support medical device change control plans legislation Oppose drug pricing proposals that allow Medicare to directly negotiate prices Support bipartisan Pandemics and All Hazards Preparedness Re-authorization Support alternatives to animal testing in trials Support bipartisan effort to address health care workforce shortage Support incentives for antimicrobial resistance development (PASTEUR Act)
Support R&D and NOL tax incentives, Orphan Drug Tax Credits, repeal of R&D tax amortization
Oppose proposals to reduce data exclusivity Oppose proposals to restrict data uses Oppose WTO TRIPS waiver for COVID diagnostics and therapeutics Support USTR resolution process with Mexico trade authority to allow biotech corn into Mexican market
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2023 · first_quarter · Q1
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3 Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule final rule implementation, and legislation Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem Oppose drug importation proposals Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance Support capping Medicare beneficiary out of pocket costs Support expanded access to telehealth Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule
Support NIH research funding Support implementation of 21st Century Cures Act Support promulgation of TCET rule Support alternatives to animal research Support breakthrough device coverage bill
Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices Support legislation proposing coverage for multicancer screening Support FDA modernization efforts and vaccine awareness Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices Support improvements to the Strategic National Stockpile for pandemic testing preparedness Support public education campaign on pandemic preparedness Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program Oppose drug importation proposals Support diversity in clinical trial policy Support medical device change control plans legislation Oppose drug pricing proposals that allow Medicare to directly negotiate prices Support bipartisan Pandemics and All Hazards Preparedness Re-authorization Support alternatives to animal testing in trials Support bipartisan effort to address health care workforce shortage
Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices
Support R&D and NOL tax incentives, Orphan Drug Tax Credits, repeal of R&D tax amortization
Labor/HHS/Ed Appropriations: Drug Pricing, FDA, NIH, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation;Coronavirus funding and response; FDA Appropriations; PTO Appropriations; eLabeling appropriations language. Drug Pricing proposals, Orphan Drug Tax Credit; semiconductor/CHIPS funding; oppose budget reconciliation with drug pricing
Address concerns with provisions of patent litigation reform, including inter partes review Support STRONGER Patents Act Oppose "march-in" rights and "compulsory licensing" proposals Support transferable exclusivity extensions to incentivize novel antibiotic R&D Support incentives for onshore and near shore critical manufacturing capacities
Oppose proposals to reduce data exclusivity Oppose proposals to restrict data uses Oppose WTO TRIPS waiver for COVID diagnostics and therapeutics Support USTR resolution process with Mexico trade authority to allow biotech corn into Mexican market
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2022 · fourth_quarter · Q4
Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices.
Address concerns with provisions of patent litigation reform, including inter partes review. Support STRONGER Patents Act. Oppose "march-in" rights and "compulsory licensing" proposals. Support transferable exclusivity extensions to incentivize novel antibiotic Research and Development.
Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices. Support legislation proposing coverage for multicancer screening. Support FDA modernization efforts and vaccine awareness. Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices. Support improvements to the Strategic National Stockpile for pandemic testing preparedness. Support public education campaign on pandemic preparedness. Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Oppose drug importation proposals. Support diversity in clinical trial policy. Support medical device change control plans legislation. Oppose drug pricing proposals that allow Medicare to directly negotiate prices. Support alternatives to animal testing in trials.
Support Research and Development and NOL tax incentives, Orphan Drug Tax Credits, repeal Research and Development tax amortization.
Oppose proposals to reduce data exclusivity. Oppose proposals to restrict data uses. Oppose WTO TRIPS waiver for COVID diagnostics and therapeutics. Support USTR resolution process with Mexico trade authority to allow biotech corn into Mexican market.
Labor/HHS/Ed Appropriations: Drug Pricing, FDA, NIH, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation. Coronavirus funding and response. FDA Appropriations. PTO Appropriations. E-Labeling appropriations language. Drug Pricing proposals, Orphan Drug Tax Credit. Semiconductor/CHIPS funding. Oppose budget reconciliation with drug pricing.
Support NIH research funding. Support implementation of 21st Century Cures Act. Support promulgation of TCET rule. Support alternatives to animal research.
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, final rule implementation, and legislation. Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem. Oppose drug importation proposals. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance. Support capping Medicare beneficiary out of pocket costs. Support expanded access to telehealth. Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2022 · third_quarter · Q3
Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices.
Address concerns with provisions of patent litigation reform, including inter partes review. Support STRONGER Patents Act. Oppose "march-in" rights and "compulsory licensing" proposals. Support transferable exclusivity extensions to incentivize novel antibiotic Research and Development.
Support NIH research funding. Support implementation of 21st Century Cures Act. Support implementation of MCIT rule. Support alternatives to animal research.
CALIFORNIA LIFE SCIENCES via CALIFORNIA LIFE SCIENCES
2022 · second_quarter · Q2
Address concerns with provisions of patent litigation reform, including inter partes review. Support STRONGER Patents Act. Oppose "march-in" rights and "compulsory licensing" proposals. Support transferable exclusivity extensions to incentivize novel antibiotic Research & Development.
Support NIH research funding. Support implementation of 21st Century Cures Act. Support implementation of MCIT rule.
Labor/HHS/Ed Appropriations: Drug Pricing, FDA, NIH, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation; Coronavirus funding and response FDA Appropriations; PTO Appropriations; eLabeling appropriations language. Drug Pricing proposals, Orphan Drug Tax Credit.
Oppose proposals to reduce data exclusivity. Oppose proposals to restrict data uses. Oppose WTO TRIPS waiver for COVID diagnostics and therapeutics
Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices. Support legislation proposing coverage for multicancer screening. Support FDA modernization efforts and vaccine awareness. Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices. Support improvements to the Strategic National Stockpile for pandemic testing preparedness. Support public education campaign on pandemic preparedness. Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Oppose drug importation proposals. Support diversity in clinical trial policy. Support medical device change control plans legislation. Oppose drug pricing proposals that allow Medicare to directly negotiate prices.
Support Research and Development and NOL tax incentives, Orphan Drug Tax Credits, repeal Research and Development tax amortization.
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule final rule implementation, and legislation. Oppose legislative proposal to reform Patent system and Intellectual Property issues impacting the life sciences ecosystem. Oppose drug importation proposals. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance. Support capping Medicare beneficiary out of pocket costs. Support expanded access to telehealth. Support value-based purchasing provision, but opposed line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
Labor/HHS/Ed Appropriations: Drug Pricing, FDA, NIH, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation. Coronavirus funding and response. FDA Appropriations. PTO Appropriations. E-Labeling appropriations language. Drug Pricing proposals. Orphan Drug Tax Credit. Semi-conductor/CHIPS funding. Oppose budget reconciliation with drug pricing.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule final rule implementation, and legislation. Oppose legislative proposal to reform Patent system and Intellectual Property issues negatively impacting the life sciences ecosystem. Oppose drug importation proposals. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule re cost-sharing assistance. Support expanded access to telehealth. Support value-based purchasing provision, but oppose line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
Oppose proposals to reduce data exclusivity. Oppose proposals to restrict data uses.
Support Research & Development and NOL tax incentives. Orphan Drug Tax Credits
Support exemptions from California's COVID-19 stay-at-home order for the life sciences community.
Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices
Support FDA user fee programs and review process consistency and predictability. Support FDA modernization practices. Support legislation proposing coverage for multicancer screening. Support FDA modernization efforts and vaccine awareness. Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices. Support improvements to the Strategic National Stockpile for pandemic testing preparedness. Support public education campaign on pandemic preparedness. Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Oppose drug importation proposals. Oppose drug pricing proposals that allow Medicare to directly negotiate prices.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE