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No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Prescription Drug Price Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · third_quarter · 3A
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Source: Senate LDA
Prescription Drug Price Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Prescription Drug Price Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Medicare Negotiation and Competitive Licensing Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Medicare Negotiation and Competitive Licensing Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Patient Protection and Affordable Care Enhancement Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Patient Protection and Affordable Care Enhancement Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Patient Protection and Affordable Care Enhancement Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Lower Costs, More Cures Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Lower Costs, More Cures Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Lower Costs, More Cures Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Preserve Access to Affordable Generics and Biosimilars Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Preserve Access to Affordable Generics and Biosimilars Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs;
Medicare Prescription Drug Price Negotiation Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Medicare Prescription Drug Price Negotiation Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Medicare Prescription Drug Price Negotiation Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Medicare Prescription Drug Price Negotiation Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Elijah E. Cummings Lower Drug Costs Now Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Elijah E. Cummings Lower Drug Costs Now Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Elijah E. Cummings Lower Drug Costs Now Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Elijah E. Cummings Lower Drug Costs Now Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Mental Health Parity Compliance Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Affordable and Safe Prescription Drug Importation Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Medicare Drug Price Negotiation Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Medicare Drug Price Negotiation Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Medicare Drug Price Negotiation Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Medicare Drug Price Negotiation Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Capping Drug Costs for Seniors Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Capping Drug Costs for Seniors Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Capping Drug Costs for Seniors Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Capping Drug Costs for Seniors Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Prescription Drug Price Relief Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Fairness in Orphan Drug Exclusivity Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Fairness in Orphan Drug Exclusivity Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Safe and Affordable Drugs from Canada Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Telemental Health Expansion Act of 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Telemental Health Expansion Act of 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Telemental Health Expansion Act of 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Pursuing Equity in Mental Health Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Preserving Patient Access to Home Infusion Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Preserving Patient Access to Home Infusion Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Preserving Patient Access to Home Infusion Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
The Heroes Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
The Heroes Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
The Heroes Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Plasma Donation Awareness Act of 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Plasma Donation Awareness Act of 2020
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Continuing Access to In-Home IVIG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Continuing Access to In-Home IVIG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Right Rebate Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Right Rebate Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Prescription Drug Price Relief Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Fair AMP Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Right Rebate Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Right Rebate Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Prescription Drug Pricing Reduction Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Prescription Drug Pricing Reduction Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
STOP Neglected Diseases of Poverty Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Preserving Patient Access to Home Infusion Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Preserving Patient Access to Home Infusion Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Preserving Patient Access to Home Infusion Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
Medicare Negotiation and Competitive Licensing Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Medicare Negotiation and Competitive Licensing Act of 2019
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Stop Price Gouging Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · third_quarter · Q3
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · first_quarter · Q1
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2019 · third_quarter · 3A
Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; Proposed FDA guidance on gastroparesis clinical trials; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after discharge from active duty;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 475, The Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act - provisions related to Part D and patient cost-sharing; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 691, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - provisions related to Part D and patient out-of-pocket costs; S. 801, H.R. 1781, Payment Commission Data Act of 2019 - provisions related to prescription drug pricing transparency and reporting; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
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2019 · fourth_quarter · Q4
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; S. 475, The Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act - provisions related to Part D and patient cost-sharing; S. 476, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act - provisions related to transparency of prescription drug pricing and pharmacy benefit managers; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; Policies that could be applied relative to transparency of drug pricing; H.R. 3 Lower Drug Costs Now Act 2019
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2019 · third_quarter · Q3
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; Proposed FDA guidance on gastroparesis clinical trials; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after discharge from active duty;
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2019 · second_quarter · Q2
H.R. 1, For the People Act of 2019 - provisions related to amending the Foreign Agent Registration Act; S.1762, Foreign Agents Disclosure and Registration Enhancement Act of 2019 - provisions related to amending the Foreign Agent Registration Act;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
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2019 · first_quarter · Q1
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals; CMS guidance to Medicare Advantage Plans allowing the use of step-therapy; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act;
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2018 · fourth_quarter · Q4
Discussions related to the implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals; H.R. 7217, IMPROVE Act; CMS guidance to Medicare Advantage Plans allowing the use of step-therapy; H.R. 6642, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; CMS guidance on 1332 waivers [CMS-9936-NC];
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2018 · third_quarter · Q3
Discussions related to the implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
S. 2852, H.R. 6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; Proposals related to drug pricing; H.R.2026, Pharmaceutical Information Exchange Act; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute;
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2018 · second_quarter · Q2
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax Reform Technical Corrections;
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals;
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
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2018 · first_quarter · Q1
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
Proposals for the Pandemic All Hazards Prepardness Act, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; S. 934, H.R. 2430, FDA Reauthorization Act of 2017 (P.L. 115-52); H.R. 4710, 340B PAUSE Act; S. 2312, HELP Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; S. 771, H.R. 1776, Improving Access To Affordable Prescription Drugs Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Proposals related to drug pricing; H.R.2026, Pharmaceutical Information Exchange Act; H.R. 3921, HEALTHY KIDS Act; S. 1827, KIDS Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; H.R. 749, Lower Costs Through Competition Act;
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2017 · fourth_quarter · Q4
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to protected classes; Discussions related to rebates and Medicare part D; Medicare payment proposals;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31); FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
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2017 · third_quarter · Q3
Senate and House Committee Tax Reform Proposals;
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to protected classes; Discussions related to rebates and Medicare part D; Medicare payment proposals;
P.L. 111-148, Patient Protection and Affordable Care Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 1628, American Health Care Act of 2017; S. 934, H.R. 2430, FDA Reauthorization Act of 2017; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; S. 348, Prescription Drug and Health Improvement Act of 2017; S. 771, H.R. 1776, Improving Access To Affordable Prescription Drugs Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; S. 1369, H.R. 2974, Stop Price Gouging Act of 2017; S. 892, Opioid Addiction Prevention Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; H.R. 849, the Protecting Seniors Access to Medicare Act; Proposals related to drug pricing; Implementation of P.L.114-255, 21st Century Cures Act; Issues related to depression and mental health;
HR 19 - Lower Costs, More Cures Act of 2019
Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 475, The Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act - provisions related to Part D and patient cost-sharing; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 691, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - provisions related to Part D and patient out-of-pocket costs; S. 801, H.R. 1781, Payment Commission Data Act of 2019 - provisions related to prescription drug pricing transparency and reporting; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions;
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 111-148, Patient Protection and Affordable Care Act - provisions related to PCORI reauthorization; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 938, The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) - provisions related to 180 day generic prescription drug exclusivity; H.R. 1188, S. 366, FLAT Prices Act - provisions related to prescription drug exclusivity periods and pricing; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 73, End Taxpayer Subsidies for Drug Ads Act - provisions related to direct-to-consumer prescription drug advertising; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, Safe Step Act - provisions related to step therapy policy; Patient Affordability Value and Efficiency Act (Not Yet Introduced) - to amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements; S. 2004, Emergency Access to Insulin Act of 2019 - provisions related to biologics exclusivity; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; S. 659, Biologic Patent Transparency Act - provisions related to prescription drug patent disclosures; H.R. 2069, S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - provisions related to increases in the wholesale acquisition costs of prescription drugs; S. 977, Transparent Drug Pricing Act of 2019 - provisions related to transparency and drug pricing; S.1140, Protecting Access to Biosimilars Act of 2019 - provisions related to biological products; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 2455, S. 1169, Ensuring Timely Access to Generics Act of 2019 - provisions related to citizen petitions; S. 1416, Affordable Prescriptions for Patients Act of 2019 - provisions related to prescription drug patents; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Bayh-Dole march-in rights policy issues; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing;
Policies to enhance patient access to medicines in Medicaid including rebate and waiver policy issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 476, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act - provisions related to transparency of prescription drug pricing and pharmacy benefit managers; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
Proposals for the Pandemic and All-Hazards Preparedness, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing; S. 64, The Preserve Access to Affordable Generics and Biosimilars Act; S. 102, H.R. 465, The Prescription Drug Price Relief Act of 2019; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act; S. 205, The Right Rebate Act of 2019; S. 366, H.R. 1188, FLAT Prices Act; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act; H.R. 1034, The Phair Price Act; H.R. 1035, The Prescription Drug Price Transparency Act; S. 474, The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 985, The Fair Access for Safe and Timely (FAST) Generics Act of 2019; S. 658, A bill to provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries; H.R. 1499, To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; H.R. 1506, Fair and Immediate Release (FAIR) of Generic Drugs Act; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 1503, Orange Book Transparency Act of 2019; Short on Competition Act (not yet introduced); S. 659, Biologic Patent Transparency Act; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute;
FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
H.R. 1, For the People Act of 2019, specifically proposals related to amending the Foreign Agent Registration Act;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; H.R. 1892, Bipartisan Budget Act of 2018; H.R.1625, Consolidated Appropriations Act, 2018 (P.L. 115-141);
S. 2852, H.R. 6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; H.R. 2077, Restoring the Patient's Voice Act of 2017;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R. 1892, Bipartisan Budget Act of 2018; H.R.1625, Consolidated Appropriations Act, 2018 (P.L. 115-141); FY2019, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Discussions related to CMS guidance to Medicare Advantage Plans on step-therapy;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R. 1892, Bipartisan Budget Act of 2018; FY2019, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; Proposals related to drug pricing; S. 1347, RxCAP Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; H.R. 5867, H.R. 6142, Reducing Drug Waste Act of 2018; Discussions related to mental health/depression in the opioid epidemic;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals; S. 260, H.R. 849, the Protecting Seniors Access to Medicare Act;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; H.R. 1892, Bipartisan Budget Act of 2018; H.R.1625, Consolidated Appropriations Act, 2018 (P.L. 115-141); H.R. 3268, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018; FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Base Erosion Anti-Abuse Tax (BEAT);
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
H.R. 1, Tax Cuts and Jobs Act; Senate and House Committee Tax Reform Proposals;
P.L. 111-148, Patient Protection and Affordable Care Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; S. 1369, H.R. 2974, Stop Price Gouging Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; H.R. 849, the Protecting Seniors Access to Medicare Act; Proposals related to drug pricing; S. 892, Opioid Addiction Prevention Act of 2017; S. 1827, H.R. 3922, Keeping Kids' Insurance Dependable and Secure Act; Proposals to reauthorize the Biomedical Advanced Research and Development Authority;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31); FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of