Plasma Donation Awareness Act

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), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

Client expense: $1,300,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3808--Medicare IVIG Enhancement Act--Coverage for Intravenous immune globulin and its administration in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. HR 7346--To amend title XVIII of the Social Security Act to provide for coverage and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under part B of such title, and for other purposes. Coverage for alpha 1 proteinase inhibitor and its administration in the home under Medicare Part B. S 1281, HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases. HR 5376--Build Back Better Act--Medicare Part D restructure, direct negotiation of Medicare pricing, restriction on use of orphan drug tax credit. Highlighting issues that could arise if these measures are included in a scaled back version of BBBA.

Client expense: $420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5376--Build Back Better Act--Medicare Part D restructure, direct negotiation of Medicare pricing, restriction on use of orphan drug tax credit HR 3808--Medicare IVIG Access Enhancement Act--Coverage for Intravenous immune globulin in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. S. 1281, HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases.

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 1281 & HR 3468: "Plasma Donation Awareness Act"; Educational meetings on Grifols, presence in district/state, and unique cost considerations of plasma medicines;

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to public health; COVID-19 response; H.R. 1319 American Rescue Plan Act; S.1281 and H.R. 3468 - Plasma Donation Awareness Act; drug pricing; H.R. 5376 Build Back Better Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), SENATE, State, Dept of (DOS), U.S. Customs & Border Protection, White House Office

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), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - 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. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; E.O. 13951, An America-First Healthcare Plan;

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), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; 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; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;

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), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; 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; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2021 - 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. 5376, Build Back Better Act (and reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; 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;

Issues related to public health; COVID-19 response; H.R. 1319 American Rescue Plan Act; S.1281 and H.R. 3468 - Plasma Donation Awareness Act; drug pricing

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), SENATE, State, Dept of (DOS), U.S. Customs & Border Protection, White House Office

HR 3--Elijah E. Cummings Lower Drug Costs Now Act--Medicare Part D restructure, reference pricing, direct negotiation of Medicare pricing HR 3808--The Medicare IVIG Access Enhancement Act--Coverage for Intravenous immune globulin in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. S 1281; HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases.

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

S 1281 & HR 3468: "Plasma Donation Awareness Act"; HR 1319 "American Rescue Plan Act"; Educational meetings on Grifols, presence in district/state, and unique cost considerations of plasma medicines;

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE

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), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; 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; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;

HR 3--Elijah E. Cummings Lower Drug Costs Now Act--Medicare Part D restructure, reference pricing, direct negotiation of Medicare pricing HR 3808--The Medicare IVIG Access Enhancement Act--Coverage for Intravenous immune globulin in the home under Medicare Part B when used for chronic inflammatory demyelinating polyneuropathy. S 1281; HR 3468--Plasma Donation Awareness Act--Adding "and plasma" to the Blood Donation Awareness Campaign created by the CARES Act. Highlighting the importance and need of plasma collection as the raw material to manufacture therapies in treating rare diseases.

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Customs & Border Protection

Issues related to public health; plasma donation awareness; COVID-19 response; H.R. 1319 American Rescue Plan Act; S.1281 and H.R. 3468 - Plasma Donation Awareness Act; drug pricing

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), SENATE, U.S. Customs & Border Protection