Prescription Drug Pricing Reduction Act of 2020
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Prescription Drug Pricing Reduction Act of 2020 This bill alters several programs and requirements relating to the prices of prescription drugs under Medicare and Medicaid. Among other things, the bill requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services (CMS) for certain drugs covered under Medicare for which the average manufacturer price increases faster than inflation; requires drug manufacturers to issue rebates to the CMS for discarded amounts of certain single-dose drugs covered under Medicare, based on information reported by providers; reduces the annual out-of-pocket spending threshold, and eliminates beneficiary cost-sharing above this threshold, under the Medicare prescription drug benefit; requires the CMS to publish certain information, as reported by pharmacy benefit managers (PBMs), relating to drug discounts and rebates, and payments between PBMs, health plans, and pharmacies; requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with PBMs under Medicaid; and increases the maximum rebate payable by drug manufacturers under the Medicaid Drug Rebate Program.
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Filing registrants (13)
Read twice and referred to the Committee on Finance. (Sponsor introductory remarks on measure: CR S4228)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
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
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
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress Budget Reconciliation/Biden Administration Build Back Better Plan COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $200,000 · Firm income: Not reported
2021 · fourth_quarter · Medicare/Medicaid
Implementation of S. 2003 of the SUPPORT Act of Patients and Communities Act, provisions related to the implementation of Every Prescription Conveyed Securely Act; Final Rule, Department of Health and Human Services: Office of Inspector General, issued November 20, 2020 entitled 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 Services Fees; outreach on pharmacy direct and indirect remuneration in Medicare Part D; HR 19/S 2164 - Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing and Part D reform; HR 3 - Elijah E. Cummings Lower Drug Costs Act Now, provisions establishing drug pricing and Part D cost sharing; value-based contracting for pharmaceuticals; 116th Congress S. 4199, H.R. 3684/ P.L. 117-58, Infrastructure Investment Act, provisions related to the repeal of a rule repealing the safeharbor for drug rebate; H.R. 5376, Build Back Better Act, provisions relating to insulin cost-sharing; Medicaid and Medicare drug pricing; Medicare Part D reform, repeal of the rebate rule and audit/transparency provisions on PBMs.
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Health Issues
Education on the value of biosimilars; outreach on PBMs role in social determinants of health and education and outreach on drug patent thickets and other pharmaceutical anticompetitive behavior and on the important role PBMs play in holding down drug costs; Final Rule, Department of Health and Human Services: Office of Inspector General, issued November 20, 2020 entitled 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 Services Fees; outreach on pharmacy direct and indirect remuneration in Medicare Part D; HR 19/S 2164 - Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing and Part D reform; HR 3 - Elijah E. Cummings Lower Drug Costs Act Now, provisions establishing drug pricing and Part D cost sharing; value-based contracting for pharmaceuticals; 116th Congress S. 4199, H.R. 3684/ P.L. 117-58, Infrastructure Investment Act, provisions related to the repeal of a rule repealing the safeharbor for drug rebate; H.R. 5376, Build Back Better Act, provisions relating to insulin cost-sharing; repeal of the rebate rule and audit/transparency provisions on PBMs.
Client expense: $80,000 · Firm income: Not reported
2021 · third_quarter · Medical/Disease Research/Clinical Labs
Medicare Part B drug payment reform Elijah E. Cummings Lower Drug Costs Now Act (HR 3) Prescription Drug Pricing Reduction Act of 2020 (S 4199) Lower Costs, More Cures Act of 2021 (HR 19)(S 3129) Build Back Better Act (HR 5376)
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Health Issues
| Republican |
| IA |
| Lisa Murkowski | Republican | AK |
| Martha McSally | Republican | AZ |
| Mike Braun | Republican | IN |
| Rob Portman | Republican | OH |
| Steve Daines | Republican | MT |
| Susan M. Collins | Republican | ME |
| S 1505 |
116th |
| Related bill |
| HR 5882 | 116th | Related bill |
| HR 5281 | 116th | Related bill |
| HR 4649 | 116th | Related bill |
| HR 4629 | 116th | Related bill |
| HR 3029 | 116th | Related bill |
| HR 1781 | 116th | Related bill |
| HR 1264 | 116th | Related bill |
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
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 · Medicare/Medicaid
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress Budget Reconciliation/Biden Administration Build Back Better Plan COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $140,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · third_quarter · Medicare/Medicaid
Implementation of S. 2003 of the SUPPORT Act of Patients and Communities Act,--provisions related to the implementation of Every Prescription Conveyed Securely Act, Final Rule, Department of Health and Human Services: Office of Inspector General, issued November 20, 2020 entitled 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 Services Fees,; outreach on pharmacy direct and indirect remuneration in Medicare Part D; H.R. 19/S. 2164-Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing and Part D reform; H.R. 3-Elijah E. Cummings Lower Drug Costs Act Now, --Provisions establishing drug pricing and Part D cost sharing; value-based contracting for pharmaceuticals; 116th Congress S. 4199, Prescription Drug Pricing Reduction Act of 2020,--provisions related to PBMs, Part D cost-sharing, inflation rebates and drug pricing; H.R. 2846, Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021-formulary tiering of biosimilars and generics in Medicare Part D; . H.R.5237 -"To amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes--provisions related to drug price negotiation, PBM audits, pharmacy disclosures and payments and drug rebates; S. 2327, Seniors Prescription Drug Relief Act, provisions allowing Medicare beneficiaries to spread their cost-sharing across a plan year; H.R. 3684, Infrastructure Investment Act,--provisions related to the repeal of a rule repealing the safe harbor for drug rebate; S.Con.Res.14 - A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031 provisions related to drug pricing and a change to the safe harbor rules for drug rebates.
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · second_quarter · Medical/Disease Research/Clinical Labs
Medicare Part B drug payment reform Elijah E. Cummings Lower Drug Costs Now Act (HR 3) Prescription Drug Pricing Reduction Act of 2020 (S 4199) Lower Costs, More Cures Act of 2021 (HR 19)(S 3129)
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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 · Medicare/Medicaid
Implementation of S. 2003 of the SUPPORT Act of Patients and Communities Act, provisions related to the implementation of Every Prescription Conveyed Securely Act,; Final Rule, Department of Health and Human Services: Office of Inspector General, issued November 20, 2020 entitled 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 Services Fees,; outreach on pharmacy direct and indirect remuneration in Medicare Part D; HR 19/S 2164-Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing and Part D reform; HR 3-Elijah E. Cummings Lower Drug Costs Act Now, --Provisions establishing drug pricing and Part D cost sharing; value-based contracting for pharmaceuticals; 116th Congress S. 4199, Prescription Drug Pricing Reduction Act of 2020,-provisions related to PBMs, Part D cost-sharing, inflation rebates and drug pricing; H.R. 2759, Pharmacy and Medically Underserved Areas Enhancement Act, To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacists services; H.R. 3831, To amend title XVII of the Social Security Act to provide for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies in Medicare Part D; S. 1773, Prescription Drug Pricing Dashboard Act,-provisions related to a CMS dashboards on prescription drug spending; H.R. 2846, Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021-formulary tiering of biosimilars and generics in Medicare Part D; potential suspension of pharmacy audits during the public health emergency; and Part D reform and modernization
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · second_quarter · Medicare/Medicaid
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · first_quarter · Medical/Disease Research/Clinical Labs
Medicare Part B drug payment reform Elijah E. Cummings Lower Drug Costs Now Act (HR 3) Prescription Drug Pricing Reduction Act of 2020 (S 4199) Lower Costs, More Cures Act of 2021 (HR 19)(S 3129)
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · first_quarter · Copyright/Patent/Trademark
Prescription Drug Pricing Reduction Act (PDPRA - S.4199); Pharmaceutical intellectual property issues; Consolidated Appropriations Act 2021 (HR.133)
Client expense: $1,840,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2021 · first_quarter · Medicare/Medicaid
Intellectual property; 340B Program; PPACA; Medicare & Medicaid prescription drug reimbursement, coverage and value; Prescription Drug Pricing Reduction Act (PDPRA - S.4199); Developing an Innovative Strategy for Antimicrobial Resistant Microorganism Act of 2019 (DISARM Act - S.1712); Consolidated Appropriations Act, 2021 (HR.133)
Client expense: $1,840,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2021 · first_quarter · Medicare/Medicaid
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315). Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $270,000 · 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 · Pharmacy
H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6411 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices H.R. 6649 - Lower Drug Costs for Seniors During COVID-19 Act of 2020 -Schakowsky - COVID H.R. 6739- Ensuring Seniors' Access to COVID Treatments Act - Casten - COVID H.R. 7062 - Affordable Insulin for the COVID-19 Emergency Act - Waters - Insulin/COVID H.R. 8190 - Biosimilar Insulin Access Act of 2020 - Grothman - insulin biosimilar S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs S. 3781 - PART Act - Peters - transparency S. 4134 - Increasing Access to Biosimilars Act of 2020 - Cornyn - CMS demonstration project; provider payments for providing biosimilars S. 4199 - Prescription Drug Pricing Reduction Act of 2020 - Grassley - lower drug prices in Medicare and Medicaid/ transparency S. 4439 - Make Medications Affordable by Preventing Pandemic Price-gouging Act of 2020 - Smith - COVID-19 drug be affordable and accessible Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Executive Office of the President (EOP), 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 the Vice President of the United States, SENATE, Treasury, Dept of, White House Office
2020 · fourth_quarter · Medicare/Medicaid
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 8624: Protecting Access to Innovation During COVID-19 Act - Provisions related to Medicare and prescription drug pricing H.R. 8702: Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 - Provisions related to Part B and physician reimbursement S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues Medicare Part B policy issues relating to ASP reporting, payment for drugs with non-covered versions, and drug wastage rebates AMP cap policy issues Vial size policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (RIN 0938-AT98) Final Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (RIN 0938-AT82) Final Rule: Transparency in Coverage (RIN 0938-AU04) Interim Final Rule with comment period: Most Favored Nation (MFN) Model (RIN 0938-AT91) Final 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 (RIN 0936-AA08)
Client expense: $5,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
2020 · fourth_quarter · Health Issues
S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020
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
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 8624: Protecting Access to Innovation During COVID-19 Act - Provisions related to Medicare and prescription drug pricing H.R. 8702: Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 - Provisions related to Part B and physician reimbursement S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues AMP cap policy issues Vial size policy issues Non-covered drugs policy issues Drug wastage rebates policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (RIN 0938-AT98) Final Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (RIN 0938-AT82) Final Rule: Transparency in Coverage (RIN 0938-AU04) Interim Final Rule with comment period: Most Favored Nation (MFN) Model (RIN 0938-AT91)/Executive Order Final 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 (RIN 0936-AA08)
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 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.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P) H.R. 8624 - Protecting Access to Innovation During COVID-19 Act H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 S. 1895 - Lower Health Care Costs Act S. 4199 - Prescription Drug Pricing Reduction Act of 2020 S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues Non-covered drugs policy issues Drug wastage rebates policy issues
Client expense: $660,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH); Issues related to Telehealth; H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $190,000 · 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 · Pharmacy
S. 4199 Prescription Drugs Pricing Reduction Act S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency
Client expense: $160,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Medicare/Medicaid
Intellectual property; 340B Program; PPACA; Medicare & Medicaid prescription drug reimbursement, coverage, and value; Prescription Drug Pricing Reduction Act (PDPRA)(S.4199); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 (DISARM Act)(S.1712); Consolidated Appropriations Act, 2021 (H.R.133)
Client expense: $950,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2020 · fourth_quarter · Copyright/Patent/Trademark
Prescription Drug Pricing Reduction Act (PDPRA) (S. 4199); Pharmaceutical intellectual property issues; Consolidated Appropriations Act, 2021 (H.R.133)
Client expense: $950,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
Gene therapy issues, value-based pricing, Prescription Drug Pricing Reduction Act of 2020 (S.4199)
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Medicare/Medicaid
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F) CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)
Client expense: $1,210,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Medicare/Medicaid
Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH); Issues related to Telehealth; H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act S. 1129/H.R. 1384, Medicare For All H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act
Client expense: $170,000 · 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
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F) CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)
Client expense: $5,960,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2020 · third_quarter · Pharmacy
H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6411 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices H.R. 6649 - Lower Drug Costs for Seniors During COVID-19 Act of 2020 -Schakowsky - COVID H.R. 6739- Ensuring Seniors' Access to COVID Treatments Act - Casten - COVID H.R. 7062 - Affordable Insulin for the COVID-19 Emergency Act - Waters - Insulin/COVID H.R. 8190 - Biosimilar Insulin Access Act of 2020 - Grothman - insulin biosimilar S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs S. 3781 - PART Act - Peters - transparency S. 4134 - Increasing Access to Biosimilars Act of 2020 - Cornyn - CMS demonstration project; provider payments for providing biosimilars S. 4199 - Prescription Drug Pricing Reduction Act of 2020 - Grassley - lower drug prices in Medicare and Medicaid/ transparency S. 4439 - Make Medications Affordable by Preventing Pandemic Price-gouging Act of 2020 - Smith - COVID-19 drug be affordable and accessible Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,230,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2020 · third_quarter · Medicare/Medicaid
Intellectual property; 340B Program; PPACA; Medicare & Medicaid prescription drug reimbursement, coverage, and value; Prescription Drug Pricing Reduction Act (PDPRA)(S.4199); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 (DISARM Act)(S. 1712)
Client expense: $1,450,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2020 · third_quarter · Copyright/Patent/Trademark
Prescription Drug Pricing Reduction Act (PDPRA) (S. 4199); Pharmaceutical intellectual property issues
Client expense: $1,450,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2020 · third_quarter · Pharmacy
S. 4199 Prescription Drugs Pricing Reduction Act S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency
Client expense: $200,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Pharmacy
The 340B Drug Pricing Program; FY 2021 L-HHS Appropriations; H.R. 4538, Closing Loopholes for Orphan Drug Act; S. 3631, Relief for Rural Providers During Emergencies Act; S. 4160, A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; S. 4199, A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes; H.R. 7838, To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes.
Client expense: $267,118 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
2020 · third_quarter · Health Issues
Gene therapy issues, value-based pricing, Prescription Drug Pricing Reduction Act of 2020 (S.4199)
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020
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 · second_quarter · Medicare/Medicaid
Intellectual property; 340B Program; PPACA; Medicare & Medicaid prescription drug reimbursement and value; Prescription Drug Pricing Reduction Act (PDPRA)(S.4199); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 (DISARM Act)(S. 1712)
Client expense: $1,730,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2020 · second_quarter · Copyright/Patent/Trademark
Prescription Drug Pricing Reduction Act (PDPRA) (S. 4199); Pharmaceutical intellectual property issues
Client expense: $1,730,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)