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Legislative Progress
Introduced
February 25, 2019
Latest Action
February 25, 2019
Primary Sponsor
Richard J. DurbinDemocratic(IL)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,086 other S bills in the 116th — cohort avg 30d
Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 or the REFUND Act of 2019 This bill requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services (CMS) in relation to discarded amounts (i.e., amounts remaining after administration) of single-dose vial drugs that are covered under Medicare. Manufacturers that fail to comply are subject to civil penalties. The CMS must determine rebate amounts based on payment claims from providers. (Currently, providers may receive payment under Medicare for discarded amounts of single-dose vial drugs through the use of a specific claims modifier.)
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (22)
Read twice and referred to the Committee on Finance. (text: CR S1439)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2021 · fourth_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 S.4796, The Fair Care Act of 2020 H.R.5260 - Reduced Costs and Continued Cures Act -Drug pricing issues -Prescription Drug User Fee Act reauthorization -Issues related to prescription drug value -Issues related to the 340B Drug Discount Program
Client expense: $1,580,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
2021 · fourth_quarter · Medicare/Medicaid
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S. 2428- False Claims Amendments Act of 2021 S.1773 - Prescription Drug Pricing Dashboard Act H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125, the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation -Issues related to the International Pricing Index for Medicare Part B and general reference pricing -Issues related to CMMI
Client expense: $1,580,000 · Firm income: Not reported
2021 · fourth_quarter · Health Issues
H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 658- ADAPT Act- Accelerated Drug Approval for Prescription Therapies H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics
2021 · second_quarter · Health Issues
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;
2021 · first_quarter · Health Issues
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; 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 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; 42 USC 1395nn, Stark 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.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); 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. 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;
| Democratic |
| OH |
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Client expense: $1,580,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Client expense: $1,790,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Client expense: $690,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2021 · third_quarter · Health Issues
H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 658- ADAPT Act- Accelerated Drug Approval for Prescription Therapies H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5376 - Build Back Better Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to health equity, diversity, and inclusion in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues related to patient assistance and access - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data - Issues relating to screening and diagnostics
Client expense: $2,670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
2021 · third_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 S.4796, The Fair Care Act of 2020 H.R.5260 - Reduced Costs and Continued Cures Act - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value - Issues related to the 340B Drug Discount Program
Client expense: $2,670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
2021 · third_quarter · Medicare/Medicaid
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S.1773 - Prescription Drug Pricing Dashboard Act H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125, the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI
Client expense: $2,670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
2021 · first_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $3,175,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · first_quarter · Health Issues
H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data
Client expense: $3,175,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · first_quarter · Medicare/Medicaid
H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI
Client expense: $3,175,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · second_quarter · Medicare/Medicaid
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S.1773 - Prescription Drug Pricing Dashboard Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI
Client expense: $1,670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2021 · second_quarter · Health Issues
H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act S. 3300, Data Protection Act of 2021 H.R.3801, Data Localization Compendium Legislation - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues related to patient assistance and acces - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data
Client expense: $1,670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2021 · second_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $1,670,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2021 · second_quarter · Health Issues
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;
Client expense: $1,890,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2021 · first_quarter · Medicare/Medicaid
H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI
Client expense: $3,130,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · first_quarter · Health Issues
H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data
Client expense: $3,130,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · first_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $3,130,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · first_quarter · Health Issues
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; 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 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; 42 USC 1395nn, Stark 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.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); 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. 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;
Client expense: $650,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $1,010,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · fourth_quarter · Medicare/Medicaid
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; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; 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. 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. 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;
Client expense: $420,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Medicare/Medicaid
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;
Client expense: $1,190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · fourth_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Ac - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data
Client expense: $2,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI
Client expense: $2,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $2,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency
Client expense: $2,750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · third_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $2,750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · third_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation -Issues related to the International Pricing Index for Medicare Part B -Issues related to CMMI
Client expense: $2,750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · first_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency
Client expense: $2,790,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · first_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Issues related to prescription drug value
Client expense: $2,790,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · first_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI
Client expense: $2,790,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $940,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · third_quarter · Medicare/Medicaid
H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Medicare/Medicaid
H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Medicare/Medicaid
H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $940,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · second_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade
Client expense: $1,190,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · first_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response
Client expense: $1,690,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · fourth_quarter · Medicare/Medicaid
Discussions on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussions about the work of Aligning for Health to address social determinants of health; Support HR 1041 / S 586,Critical Access Hospital Relief Act of 2019, a bill to amend title XVIII of the Social Security Act to remove the 96-hour physician certification requirement for inpatient critical access hospital services; Support S 895, Rural Hospital Regulatory Relief Act of 2019, a bill to provide for a permanent extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals; Support S 948,Conrad State 30 and Physician Access Reauthorization Act, a bill to provide incentives to physicians to practice in rural and medically underserved communities, and for other purposes; Discussions in support of the Rural Emergency Medical Center Act (REACH) Act; Support for extension of the Rural Community Hospital Demonstration Program; Support for extension of the Frontier Community Health Integration Project Demonstration program; Discuss changes with House and Senate committees to Section 8122 of the SUPPORT for Patients and Communities Act; Letter of support to Energy and Commerce Committee for the hearing on legislation to strengthen our health care system and ACA market stability; Support HR 1781/ S 801, Payment Commission Data Act of 2019, a bill to amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information; Support S 551 Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 or the REFUND Act of 2019, a bill to amend title XVIII of the Social Security Act to require manufacturers of certain single-dose vial drugs payable under part B of the Medicare program to provide rebates with respect to amounts of such drugs discarded, and for other purposes; Support S 824/ HR 1767, Excellence in Mental Health and Addiction Treatment Expansion Act, a bill to increase the number of States that may conduct Medicaid demonstration programs to improve access to community mental health services; Statement submitted to Senate Finance Committee on the implementation of the Quality Payment Program (QPP) created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA); Support HR 2552Protecting Local Access to Care for Everyone Act of 2019 or the PLACE Act of 2019, a bill to direct the Secretary of Health and Human Services to prevent certain payment reductions for clinic visit services furnished at excepted off-campus outpatient departments of a provider under the Medicare program; Support HR 3022, Patient Access Protection Act, a bill to amend title XIX of the Social Security Act to repeal the reductions in Medicaid DSH allotments, and for other purposes; Letter of support to the Ways and Means Committee in support of legislation to improve the quality of an access to services for Medicare beneficiaries, help train the physician workforce and reduce administrative burden on rural hospitals; Support HR 3431, HEARTS and Rural Relief Act, a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2021; Support HR 3417,Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019 or the BETTER Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for patient improvements and rural and quality improvements under the Medicare program; Oppose HR 1384, Medicare for All Act of 2019, a bill to establish an improved Medicare for All national health insurance program; Oppose S 1129, Medicare for All Act of 2019, a bill to establish a Medicare-for-all national health insurance program; Letter to House Committee on Ways and Means for the hearing on Pathways to Universal Health Coverage addressing concerns with Medicare for All and believe that the variety of proposals that often are used interchangeably under that name are not the solution; Oppose HR 2452, Medicare for America Act of 2019, a bill to amend the Social Security Act to establish a Medicare for America health program to provide for comprehensive health coverage for all Americans; Letter to House Committee on Budget for the hearing on the Congressional Budget Offices (CBO) Key Design Components and Considerations for Establishing a Single-Payer Health Care System addressing concerns with Medicare for All; Oppose S 1261/ HR 2463, Choose Medicare Act, a bill to provide for the establishment of Medicare part E public health plans, and for other purposes; Oppose S 981/ HR 2000Medicare-X Choice Act of 2019A bill to establish a public health plan; Oppose S 1033/ HR 2085, CHOICE Act, a bill to amend the Public Health Service Act to establish a public health insurance option, and for other purposes; Oppose S 470, Medicare at 50 Act, a bill to amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States age 50 to 64 to buy into Medicare; Oppose HR 1346, Medicare Buy-In and Health Care Stabilization Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for an option for individuals who are ages 50 to 64 to buy into Medicare, to provide for health insurance market stabilization, and for other purposes; Submitted Statement to the House Committee on Rules for the Hearing Medicare for All Act of 2019; Comment on provisions of HR 2328,Reauthorizing and Extending Americas Community Health (REACH) Act, support for the Medicaid disproportionate share hospital(DSH) program provisions included in Title III; comments on Title IV, which contains provisions of the No Surprises Act and concern with the legislations approach to determining reimbursement for out-of-network providers; Support HR 3107 Seniors Timely Access to Care Act of 2019, this legislation would establish requirements for the use of prior authorization under Medicare Advantage plans; Meeting with the Senate finance committee to discuss changes to drug bill; Meeting with CMS to discuss changes to prior authorization; Meeting with Department of Labor to discuss issues with ERISA health plans; Met with CMS staff on rural hospital issues; Regulatory burden related to new CMS guidance on documenting Crossover bad debt; Sent a Comment letter to CMS on a final rule on program integrity enhancements to the provider enrollment process for Medicare, Medicaid and Children's Health Insurance Programs; Oppose S. 2860 Patient Access to Higher Quality Health Care Act of 2019, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals, and for other purposes; Support HR 4996, Helping MOMS Act of 2019, a bill amend title XIX of the Social Security Act to provide for a State option under the Medicaid program to provide for and extend continuous coverage for certain individuals, and for other purposes; Addressing hospital concerns about HR 3 Lower Drug Costs Now Act, a bill to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes; Sent comment letter requesting that CMS withdraw the proposed regulation related to Medicaid Program: Medicaid Fiscal Accountability Regulation ( MFAR) financing and supplemental payments. Given that the proposal would severely curtail the availability of health care services to millions of individuals and because many of its provisions are not legally permissible; Discussion with CMS for rural hospitals and critical access hospitals about the Medicare accelerated payment program, which is intended to provide necessary funds to providers, including rural hospitals and critical access hospitals, when there is a disruption in claims submission and/or claims processing; Submitted comments on CMSs proposed rule on Medicare Advantage and Part D prescription drug program for Contract Years 2021 and 2022. The letter focuses on several proposals addressing network adequacy; Letter sent to HHS, CDC, CMS, and SAMHSA requesting specialized guidance and assistance for providers who care for patients with behavioral health disorders; Support resetting the Improving Medicare Post- Acute Care Transformation (IMPACT) Act of 2014 in the next COVID-19 relief package. The IMPACT Acts implementation is behind schedule and does not take into account extensive payment reforms already underway in each post-acute care setting; Letter urging HHS to release substantial additional emergency funds to all hospitals in an expedited manner. This second wave of funding to all hospitals, targeted relief is necessary for hospitals in hot spots, hospitals with a high percentage of payments under Medicare Advantage, hospitals caring for high numbers of Medicaid patients, and rural hospitals; Support HR 6693 Critical Access Hospital Expansion Act of 2020, a bill to amend title XVIII of the Social Security Act to allow States to certify certain hospitals as necessary providers for purposes of designating such hospitals as critical access hospitals under the Medicare program; Support HR 6753/ S 3615 Rural Community Hospital Demonstration Extension Act of 2020, a bill to amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to extend the rural community hospital demonstration program; Letter urging CMS to use its authority to extend to LTCHs the existing 20% hospital add-on payment for Medicare beneficiaries diagnosed with COVID-19; Letter to CMS urging the agency to temporarily extend certain waivers and make others permanent beyond the COVID-19 public health emergency to allow hospitals to provide better and more cost effective care to their patients and communities; Sent comment letter to CMS about our concerns with the timeline proposed for implementation as well as the potential for penalties for noncompliance within this timeline on the Medicare Program: Electronic Prescribing of Controlled Substances; Sent comment letter on the FY 2021 Inpatient PPS proposed rule addressing CMS proposals related to payer-specific negotiated rate data collection, Medicare DSH payments, CAR T, bad debt, MS-DRG classifications, and quality programs, among other topics. Letter requesting that the CMS delay the implementation of the Appropriate Use Criteria for Advanced Diagnostic Imaging Services program to allow providers the opportunity to implement and test operational changes and acquire the education necessary to achieve compliance with the program; Sent comments to the CMS on the agencys long-term care hospital prospective payment system proposed policy changes and fiscal year 2021 rates; Letter to CMS asking for a delay in the start of repayments associated with the Medicare Accelerated and Advance Payment (AAP) Programs; Letter urging the CMS to continue its suspension of medical review activities throughout the ongoing COVID-19 public health emergency; Letter urging CMS to allow periodic interim payment (PIP) hospitals to carry out their accelerated payment repayment at cost settlement, as was initially communicated by the agency and also request that the agency make alternative repayment approaches available, such as direct payments to the Medicare Administrative Contractor (MAC), for all hospitals; Comment letter on CY 2021 Home Health Prospective Payment System Rate Update proposed rule. While we continue to support the PDGM objective of increasing HH PPS payment accuracy, we remain concerned that CY 2020s large behavioral offset, 4.36%, was implemented on a prospective basis; Letter urging the CMS to withdraw the condition of participation (CoP) that hospitals report daily COVID-19 data and request that CMS immediately release detailed interpretive guidance so hospitals can take the necessary steps to come into compliance; Urged CMS to withdraw its Medicaid fiscal accountability proposed rule from its regulatory agenda because it would "severely curtail the availability of health care services to millions of individuals" and "many of its provisions are not legally permissible;" Submitted comment letter that disagree with CMS interim APC assignments of COVID-19 vaccine administration services to these New Technology APCs because they are inconsistent with longstanding CMS policy; Submitted comments responding to a CMS request for information on regulatory relief to support economic recovery urging the agency to take additional action to remove certain regulatory barriers standing in the way of efficiency and innovation, thus allowing hospitals to provide better and more cost-effective care to our patients and communities. In order to achieve these objectives, we ask the agency to temporarily extend certain waivers and make others permanent beyond the duration of the COVID-19 public health emergency; Urged a delay implementation of CMS price transparency rule and also asked the Biden Transition team for enforcement discretion with the rule; Letter urging Congress to include in the year-end legislation an extension of the congressionally-enacted moratorium on the application of the Medicare sequester cuts into 2021 and through the duration of the public health emergency (PHE); Letter urging Congress to continue to support the movement to value by ensuring that clinicians in advanced alternative payment models (APMs) continue to receive incentives established under the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA); Support S 5044, The Improving Seniors Timely Access to Care Act of 2020, a bill to amend title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans; Submitted a comment letter, urging CMS not to finalize proposals that would allow states to create a new type of direct enrollment marketplace in lieu of Healthcare.gov or a state-based marketplace. In addition, we do not support the codification in regulation of previous Section 1332 guidance that could allow states to pursue alternative approaches to coverage that would result in coverage losses; Support efforts to protect patients from surprise medical bills by including the No Surprises Act as part of the year-end legislative package; Submitted COVID-19 snapshot report for Congress to better understand the needs of hospitals and health systems during the public health emergency, which combines important data points with news articles and testimonials from the field to reiterate the dire circumstances hospitals and health systems face, and highlight why additional relief is necessary; Submitted comments in response to HRSAs proposal to include additional counties as eligible to receive Federal Office of Rural Health Policy (FORHP) grants, encouraged the agency to use a definition of rural that is inclusive and flexible, in order to broaden opportunities for providers in rural communities and urged HRSA to increase rural grant opportunities.
Client expense: $4,460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Medicare/Medicaid
H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI
Client expense: $2,020,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Ac - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data
Client expense: $2,020,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Pharmacy
S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value
Client expense: $2,020,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Medicare/Medicaid
H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; 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; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act; Pharmacist Provider Status draft legislation
Client expense: $330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · fourth_quarter · Medicare/Medicaid
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; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; 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. 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. 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;
Client expense: $410,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Medicare/Medicaid
H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 8406 - The HEROES 2.0 (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Executive Order on Lowering Drug Prices by Putting America First and Most Favored Nation (MFN) model Interim Final Rule H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures Act S. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Home administration for Part B medicines due to COVID-19 Reimbursement for biologics/biosimilars Issues related to Part D redesign Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Medicaid Value-Based Purchasing (VBP) Proposed Rule (Line Extensions & Manufacturer Co-pay Assistance) S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act of 2019
Client expense: $2,560,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2020 · fourth_quarter · Pharmacy
Issues related to prescription drug value. Issues related to supply chain and Buy America requirements. S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19/S.3129: Lower Costs, More Cures Act of 2019. Biosimilars. 340B issues. Patents and protection of intellectual property issues. Issues related to the COVID-19 pandemic, including patient access of Part B drugs. H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act. S.4775: Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R.113 [116th]: Consolidated Appropriations Act, 2021. Issues related to the end stage renal disease (ESRD) prospective payment system (PPS) proposed rule. S.551: REFUND Act of 2019, issues related to vial size.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $940,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office