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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.
Speeding Therapy Access Today Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 Cures 2.0 Discussion Draft; Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases
Speeding Therapy Access Today Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2021 · third_quarter · 3T
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Source: Senate LDA
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease
Lower Costs, More Cures Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Lower Costs, More Cures Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Elijah E. Cummings Lower Drug Costs Now Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Elijah E. Cummings Lower Drug Costs Now Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 Cures 2.0 Discussion Draft; Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease
Reduced Costs and Continued Cures Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Inflation Reduction Act of 2022
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Inflation Reduction Act of 2022
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 5376, Build Back Better Act Issues related to the Orphan Drug Tax Credit
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 Cures 2.0 Discussion Draft; Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases
Speeding Therapy Access Today Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease
Speeding Therapy Access Today Act of 2021
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 Cures 2.0 Discussion Draft; Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; 304B drug discount program
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies
Elijah E. Cummings Lower Drug Costs Now Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act Proposed Notice of Benefit and Payment Parameters Rule for 2021 General issues related to patient access for Part B and Part D drugs; issues related to home infusion for Part B patients; provision to allow plans to exclude cost-sharing assistance from the out-of-pocket maximum; Center for Medicare and Medicaid Innovation (CMMI) policy issues
Elijah E. Cummings Lower Drug Costs Now Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Executive Order 13948, on Lowering Drug Prices by Putting America First General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies
Elijah E. Cummings Lower Drug Costs Now Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 748--Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act FY 2021 IPPS Proposed Rule General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues
Elijah E. Cummings Lower Drug Costs Now Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Most Favored Nation (MFN) model interim final rule with comment period (IFC) Executive Order 13948, on Lowering Drug Prices by Putting America First; General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; rare disease patient and provider impacts from MFN
Strengthening Innovation in Medicare and Medicaid Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act Proposed Notice of Benefit and Payment Parameters Rule for 2021 General issues related to patient access for Part B and Part D drugs; issues related to home infusion for Part B patients; provision to allow plans to exclude cost-sharing assistance from the out-of-pocket maximum; Center for Medicare and Medicaid Innovation (CMMI) policy issues
Strengthening Innovation in Medicare and Medicaid Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Executive Order 13948, on Lowering Drug Prices by Putting America First General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies
Strengthening Innovation in Medicare and Medicaid Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 748--Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act FY 2021 IPPS Proposed Rule General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues
Strengthening Innovation in Medicare and Medicaid Act
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Most Favored Nation (MFN) model interim final rule with comment period (IFC) Executive Order 13948, on Lowering Drug Prices by Putting America First; General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; rare disease patient and provider impacts from MFN
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 748--Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act FY 2021 IPPS Proposed Rule General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues
Affordable Prescriptions for Patients Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
Affordable Prescriptions for Patients Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
Affordable Prescriptions for Patients Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
Affordable Prescriptions for Patients Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: ALEXION PHARMACEUTICALS, INC. · Firm: ALEXION PHARMACEUTICALS, INC.
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; 304B drug discount program
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act Proposed Notice of Benefit and Payment Parameters Rule for 2021 General issues related to patient access for Part B and Part D drugs; issues related to home infusion for Part B patients; provision to allow plans to exclude cost-sharing assistance from the out-of-pocket maximum; Center for Medicare and Medicaid Innovation (CMMI) policy issues
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Executive Order 13948, on Lowering Drug Prices by Putting America First General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 748--Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act FY 2021 IPPS Proposed Rule General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Most Favored Nation (MFN) model interim final rule with comment period (IFC) Executive Order 13948, on Lowering Drug Prices by Putting America First; General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; rare disease patient and provider impacts from MFN
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 Cures 2.0 Discussion Draft; Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
H.R. 5376, Build Back Better Act Issues related to the Orphan Drug Tax Credit
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2021 · second_quarter · Q2
H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 1730/S. 670, Speeding Therapy Access Today Act of 2021 General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; general issues related to health equity in rare disease
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, Lower Costs, More Cures Act of 2021 General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to telemedicine
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2021 · first_quarter · Q1
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; issues related to low volume DRGs and rare therapies
General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2020 · fourth_quarter · Q4
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Most Favored Nation (MFN) model interim final rule with comment period (IFC) Executive Order 13948, on Lowering Drug Prices by Putting America First; General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; rare disease patient and provider impacts from MFN
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; 304B drug discount program
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2020 · third_quarter · Q3
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Executive Order 13948, on Lowering Drug Prices by Putting America First General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute; COVID-19 telemedicine flexibility; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2020 · second_quarter · Q2
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies; general discussions on the Patient Centered Outcomes Research Institute
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 748--Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act FY 2021 IPPS Proposed Rule General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues
ALEXION PHARMACEUTICALS, INC. via ALEXION PHARMACEUTICALS, INC.
2020 · first_quarter · Q1
S. 2158 / H.R. 2507--Newborn Screening Saves Lives Reauthorization Act--General issues related to orphan disease drugs; Reauthorization of newborn screening programs; general issues related to drug cost and pricing policies
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act Proposed Notice of Benefit and Payment Parameters Rule for 2021 General issues related to patient access for Part B and Part D drugs; issues related to home infusion for Part B patients; provision to allow plans to exclude cost-sharing assistance from the out-of-pocket maximum; Center for Medicare and Medicaid Innovation (CMMI) policy issues
S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE