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Reduced Costs and Continued Cures Act of 2021
Legislative Progress
Introduced
September 10, 2021
Latest Action
November 1, 2022
Primary Sponsor
Scott H. PetersDemocratic(CA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
95pct
417d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Reduced Costs and Continued Cures Act of 2021 This bill establishes and alters several programs and requirements relating to the prices of prescription drugs. For example, the bill establishes and alters several requirements under Medicare and Medicaid, including requiring drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for covered drugs under Medicare that cost $100 or more and for which the average manufacturer price increases faster than inflation, capping annual out-of-pocket spending under the Medicare prescription drug benefit, and increasing the maximum rebate amount under the Medicaid Drug Rebate Program. The bill also makes changes relating to market exclusivities and manufacturer price concessions for prescription drugs, including authorizing the Federal Trade Commission to initiate proceedings against parties to settlements of patent infringement claims that have anticompetitive effects with respect to drugs or biologics, limiting in certain instances the number of patents that the manufacturer of a biologic can assert in a lawsuit against a company seeking to sell a biosimilar version, and nullifying regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws.
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Filing registrants (11)
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2023 · fourth_quarter · Medicare/Medicaid
340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Patient Cost-Sharing and Smoothing Data Privacy ---General Drug Pricing ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.1067: Ensuring Timely Access to Generics of 2023 ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Coverage Determination ---H.R.5547/S.476: Maintaining Investments in New Innovation (MINI) Act ---H.R.4531: Support for Patients and Communities Reauthorization Act ---H.R.5539: ORPHAN Cures Act Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Medicaid Drug Rebate Program Rule (MDRP) ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.2630/S.652: Safe Step Act ---H.R.5378: Lower Costs, More Transparency Act ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure
Client expense: $2,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · third_quarter · Medicare/Medicaid
340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Patient Cost-Sharing and Smoothing Data Privacy ---General Drug Pricing ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.133:Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.1067: Ensuring Timely Access to Generics of 2023 ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Coverage Determination Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Medicaid Drug Rebate Program Rule (MDRP) ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.2630/S.652: Stage Step Act ---H.R.5378: Lower Costs, More Transparency Act ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure
2023 · third_quarter · Health Issues
Inflation Reduction Act Medicare Part D 6 Protected Classes H.R.5237, The Reduced Cost and Continued Cures Act S.3427, The Neuroscience Center of Excellence Act of 2021 FDA Neurology Drug Program SMART Prices Act (S. 1264) Lowering Drug Costs for American Families Act (H.R. 4895) Executive Order on Strengthening Access to Affordable, High Quality Contraception & Family Planning Services Accelerating Kids Access to Care Act (S. 2372, H.R. 4758) The Modernizing and Ensuring PBM Accountability Act (no bill # yet) Medicaid Drug Rebate Proposed Rule
Client expense: $210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
Inflation Reduction Act Medicare Part D 6 Protected Classes Executive Order on Drug Pricing H.R.5237, The Reduced Cost and Continued Cures Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees FDA Neurology Drug Program H.Res.1390, Expressing support for the protected class
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
Inflation Reduction Act Medicare Part D 6 Protected Classes Executive Order on Drug Pricing H.R.5237, The Reduced Cost and Continued Cures Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees FDA Neurology Drug Program H.Res.1390, Expressing support for the protected class
Client expense: $200,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| FL |
| HR 5260 |
117th |
| Related bill |
| HR 4417 | 117th | Related bill |
| HR 2891 | 117th | Related bill |
| HR 2884 | 117th | Related bill |
| HR 2873 | 117th | Related bill |
| HR 2855 | 117th | Related bill |
| HR 2706 | 117th | Related bill |
Client expense: $2,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Medicare/Medicaid
H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)
Client expense: $42,877 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 7667- Food and Drug Amendments of 2022, support passage S.4248- Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, support passage H.R. 5435- BRAIN Act of 2021, establishing a Neuroscience Center of Excellence at the Food and Drug Administration, support passage H.R.315 - Common Sense Cannabis Reform for Veterans, Small Business and Medical Professionals Act, monitor to support H.R. 6000 - Cures 2.0 Act, supporting the goals of Rep. Upton/DeGette's Cures 2.0 initiative aimed at accelerating medical research, patient access to novel therapeutics and authorizing the Administration's Advanced Research Projects Agency for Health (ARPA-H) proposal -support passage S. 3726- CARE for Long COVID Act- support passage S.4447 - Modernizing Accelerated Approval Act, support passage and inclusion in Senate FDASLA package. S. 3799 Prevent Pandemics Act - support passage Lisa Blunt Rochester- Long-COVID RECOVERY NOW Act, support passage (bill number forthcoming)
Client expense: $58,169 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: 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.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · 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
2022 · fourth_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 7667- Food and Drug Amendments of 2022, support passage S.4248- Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, support passage H.R. 5435- BRAIN Act of 2021, establishing a Neuroscience Center of Excellence at the Food and Drug Administration, support passage H.R.315 - Common Sense Cannabis Reform for Veterans, Small Business and Medical Professionals Act, monitor to support H.R. 6000 - Cures 2.0 Act, supporting the goals of Rep. Upton/DeGette's Cures 2.0 initiative aimed at accelerating medical research, patient access to novel therapeutics and authorizing the Administration's Advanced Research Projects Agency for Health (ARPA-H) proposal -support passage S. 3726- CARE for Long COVID Act- support passage S.4447 - Modernizing Accelerated Approval Act, support passage and inclusion in Senate FDASLA package. S. 3799 Prevent Pandemics Act - support passage Lisa Blunt Rochester- Long-COVID RECOVERY NOW Act, support passage (bill number forthcoming)
Client expense: $45,264 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act Medicare Part D 6 Protected Classes Executive Order on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees FDA Neurology Drug Program H.Res.1390, Expressing support for the protected class
Client expense: $360,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to the 340B Drug Pricing Program - regarding all bio-pharmaceutical related provisions HR 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 Issues related to the Inflation Reduction Act of 2022
Client expense: $640,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022; Draft legislation on pharmacy DIR fee reform
Client expense: $320,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office
2022 · fourth_quarter · Medicare/Medicaid
Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting of drugs in Medicare, Medicaid, and/or private insurance plans H.R. 3 (Lower Drug Costs Now Act) Interim Final Rule implementing a Most Favored Nation (MFN) Model for importing foreign price controls for certain Medicare Part B drugs (CMS-5528-IFC) S.Con.Res. 14 (FY22 Budget Resolution) price control provisions to repeal noninterference clause in Medicare Parts C & D H.R. 2884 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5237 (Reduced Costs and Continued Cures Act) H.R. 5376, Inflation Reduction Act, and subsequent versions of FY 2022 Budget Reconciliation price control provisions from H.R. 3, including repeal of noninterference clause in Medicare Parts C & D, and provisions expanding government-run health care, restrictions on private, Medicare, and Medicaid rates, coverage, and reimbursement, Medicare program changes reducing beneficiary choice, plan design, and competition H.R. 2617 (legislative vehicle for the Consolidated Appropriations Act FY 2023 with Senate amendment #6552) potential government price controls-related provisions
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)
Client expense: $11,123 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
2022 · third_quarter · Medicare/Medicaid
H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)
Client expense: $11,123 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
2022 · third_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: 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.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $1,908,258 · 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
2022 · third_quarter · Medicare/Medicaid
H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation. H.R. 5376, Inflation Reduction Act (support passage, particularly drug pricing provisions)
Client expense: $42,877 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
2022 · third_quarter · Medicare/Medicaid
Issues related to access and reimbursement of Chimeric Antigen Receptor Theraph (CAR T) Issues related to the 340B Drug Pricing Program - regarding all bio-pharmaceutical related provisions HR 5237, to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescrition drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients/ out-of-poclet costs HR 3, Elijah E. Cummings Lower Drig Costs NOW Act regarding all bio-pharmaceutical provisions Issues related to the Inflation Reduction Act of 2022
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
Client expense: $3,220,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · third_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)
Client expense: $3,220,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · third_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Client expense: $720,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2022 · third_quarter · Health Issues
Inflation Reduction Act Medicare Part D 6 Protected Classes Medicare Part D Redesign proposal Notice of Benefit and Payment Parameters Proposed Medicaid Regulation Executive Orders on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act H.R.5376, The Build Back Better Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees FDA Neurology Drug Program
Client expense: $280,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022
Client expense: $400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office
2022 · third_quarter · Medicare/Medicaid
Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting of drugs in Medicare, Medicaid, and/or private insurance plans H.R. 3 (Lower Drug Costs Now Act) Interim Final Rule implementing a Most Favored Nation (MFN) Model for importing foreign price controls for certain Medicare Part B drugs (CMS-5528-IFC) S.Con.Res. 14 (FY22 Budget Resolution) price control provisions to repeal noninterference clause in Medicare Parts C & D H.R. 2884 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5237 (Reduced Costs and Continued Cures Act) H.R. 5376 and subsequent versions of FY 2022 Budget Reconciliation price control provisions from H.R. 3, including repeal of noninterference clause in Medicare Parts C & D, and provisions expanding government-run health care, restrictions on private, Medicare, and Medicaid rates, coverage, and reimbursement, Medicare program changes reducing beneficiary choice, plan design, and competition
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medicare/Medicaid
H.R.3 - Elijah Cummings Lower Drug Costs Now, monitor legislation S.151- "COVID HCBS Relief Act of 2021"- support passage H.R. 4131- "To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, and for other purposes."- support passage H.R. 2455 - The Resetting the IMPACT Act (TRIA) of 2021." - support passage H.R. 1319- The American Rescue Plan Act of 2021, support passage H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage Senate Reconciliation/Senate Finance prescription drug pricing package - supporting provisions that allow Medicare to negotiate for a specific amount of drugs, implement a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a smoothing mechanism so that people in Medicare can spread their costs over the course of the year, and limit drug price increases by implementing rebates if prescription drug prices rise faster than inflation.
Client expense: $42,877 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: 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.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.799: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $1,457,755 · 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
2022 · second_quarter · Medicare/Medicaid
Issues related to access and reimbursement of Chimeric Antigen Receptor Theraph (CAR T) Issues related to the 340B Drug Pricing Program - regarding all bio-pharmaceutical related HR 5237, to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescrition drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients/ out-of-poclet costs HR 3, Elijah E. Cummings Lower Drig Costs NOW Act regarding all bio-pharmaceutical provisions HR 19, Lower Cost, More Cures Act of 2021, regarding all bio-pharmaceutical related issues
Client expense: $1,590,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
Medicare Part D Negotiation/Non-Interference Repeal Bills Act Medicare Part D 6 Protected Classes Medicare Part D Redesign proposal Notice of Benefit and Payment Parameters Proposed Medicaid Regulation Executive Orders on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act H.R.5376, The Build Back Better Act S.3427, The Neuroscience Center of Excellence Act of 2021 Prescription Drug User Fees
Client expense: $270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Client expense: $740,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act
Client expense: $460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office
2022 · second_quarter · Medicare/Medicaid
Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting of drugs in Medicare, Medicaid, and/or private insurance plans H.R. 3 (Lower Drug Costs Now Act) Interim Final Rule implementing a Most Favored Nation (MFN) Model for importing foreign price controls for certain Medicare Part B drugs (CMS-5528-IFC) S.Con.Res. 14 (FY22 Budget Resolution) price control provisions to repeal noninterference clause in Medicare Parts C & D H.R. 2884 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5237 (Reduced Costs and Continued Cures Act) H.R. 5376 and subsequent versions of FY 2022 Budget Reconciliation price control provisions from H.R. 3, including repeal of noninterference clause in Medicare Parts C & D, and provisions expanding government-run health care, restrictions on private, Medicare, and Medicaid rates, coverage, and reimbursement, Medicare program changes reducing beneficiary choice, plan design, and competition
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: 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.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,715,700 · 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
2022 · first_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021
Client expense: $3,170,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · first_quarter · Medicare/Medicaid
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing-Related Provisions ---Immunization Information Systems Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations
Client expense: $3,170,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · first_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Client expense: $830,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · first_quarter · Medicare/Medicaid
H.R.3 - Elijah Cummings Lower Drug Costs Now, monitor legislation S.151- "COVID HCBS Relief Act of 2021"- support passage H.R. 4131- "To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, and for other purposes."- support passage H.R. 2455 - The Resetting the IMPACT Act (TRIA) of 2021." - support passage H.R. 1319- The American Rescue Plan Act of 2021, support passage H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage
Client expense: $58,183 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
Medicare Part D Negotiation/Non-Interference Repeal Bills Act Medicare Part D 6 Protected Classes Medicare Part D Redesign proposal Notice of Benefit and Payment Parameters Proposed Medicaid Regulation Executive Orders on Drug Pricing S. 2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Cost and Continued Cures Act H.R.6000, the CURES 2.0 Act H.R.5376, The Build Back Better Act FDA Neuroscience Center of Excellence S.3427, The Neuroscience Center of Excellence Act of 2021
Client expense: $400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P)
Client expense: $2,010,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office
2022 · first_quarter · Medicare/Medicaid
Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting of drugs in Medicare, Medicaid, and/or private insurance plans H.R. 3 (Lower Drug Costs Now Act) Interim Final Rule implementing a Most Favored Nation (MFN) Model for importing foreign price controls for certain Medicare Part B drugs (CMS-5528-IFC) S.Con.Res. 14 (FY22 Budget Resolution) price control provisions to repeal noninterference clause in Medicare Parts C & D H.R. 2884 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5237 (Reduced Costs and Continued Cures Act) H.R. 5376 and subsequent versions of FY 2022 Budget Reconciliation price control provisions from H.R. 3, including repeal of noninterference clause in Medicare Parts C & D, and provisions expanding government-run health care, restrictions on private, Medicare, and Medicaid rates, coverage, and reimbursement, Medicare program changes reducing beneficiary choice, plan design, and competition
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals
Client expense: $2,100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2021 · fourth_quarter · Health Issues
Medicare Part D Negotiation/Non-Interference Repeal Bills Senate Finance Prescription Drug Pricing Reduction Act H.R.3-The Lower Drug Costs Now Act Medicare Part D 6 Protected Classes Medicare Part D Redesign proposal Notice of Benefit and Payment Parameters Proposed Medicaid Regulation Executive Orders on Drug Pricing FDA Neuroscience Center of Excellence S.2327, Seniors Prescription Drug Relief Act H.R.5237, The Reduced Costs and Continued Cures Act H.R.5376, The Build Back Better Act S.3427, The Neuroscience Center of Excellence Act of 2021
Client expense: $320,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Medicare/Medicaid
H.R.3 - Elijah Cummings Lower Drug Costs Now, monitor legislation S.151- "COVID HCBS Relief Act of 2021"- support passage H.R. 4131- "To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, and for other purposes."- support passage H.R. 2455 - The Resetting the IMPACT Act (TRIA) of 2021." - support passage H.R. 1319- The American Rescue Plan Act of 2021, support passage H.R. 2815, BIOSIM Act, support passage H.R. 2855, the STAR Rating for Biosimilars Act, support passage H.R. 2846- Ensuring Access to Lower-Cost Medicines for Seniors Act of 021 - support passage S.2210/H.R. 4131- Better Care Better Jobs Act - support passage S.2315- Medicaid Saves Lives Act, support passage S.2327- Seniors Prescription Drug Relief Act- support passage S.2562-Choose Home Care Act of 2021- support passage S.2612- Prevent Interruptions in Physical Therapy Act of 2021- support passage S. 2694- Nursing Home Improvement and Accountability Act of 2021 - support passage H.R. 5011- Choose Medicare Act, support passage H.R. 5099- Lowering Medicare Premiums and Prescription Drug Costs Act, support passage H.R. 5165 - Improving Medicare Coverage Act - support passage 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." - monitor for position determination H.R. 5260 - Reduced Costs and Continued Cures Act - monitor for position determination H.R. 5536 - SMART Act - support passage H.R. 5514 Choose Home Care Act of 2021, support passage
Client expense: $45,264 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)
2021 · fourth_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: 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.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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
Client expense: $1,918,904 · 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
2021 · fourth_quarter · Medicare/Medicaid
H.R. 2163 - To amend the Employee Retirement Income Security Act to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for an medication step therapy protocol, and for other purpose - regarding all bio-pharmaceutical related provisions. H.R 2071 - 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 - regarding all bio-pharmaceutical related provisions. S.908/H.R 2139 - A bill to amend title XVII of the Social Security Act to provide for the negotiation of lower covered Part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare Part D, and for other purpose - regarding all bio-pharmaceutical related provisions. International Reference Pricing/Most Favored Nation - regarding all bio-pharmaceutical related issues. No bill number. Issues related to the six protected classes of medicines under Medicare Part D - regarding all bio-pharmaceutical related issues. No bill number. H.R 1319 - The American Rescue Plan - regarding all bio-pharmaceutical related provisions. H.R 4385 - Cancer Drug Parity Act/Oral Parity - regarding all bio-pharmaceutical related provisions. Issues related to the 340B Drug Pricing Program - regarding all bio-pharmaceutical related provisions. No bill number. Issues related to access and reimbursement of Chimeric Antigen Receptor Therapy (CAR T). No bill number. H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act - Establishes several programs and requirements relating to the prices of prescription drugs, health care coverage and costs, and public health - regarding all bio-pharmaceutical related provisions H.R. 19 - Lower Cost, More Cures Act of 2021 - To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration, and for other purpose - regarding all bio-pharmaceutical related provisions 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 - regarding all bio-pharmaceutical related provisions. H.R 5376 the Build Back Better Act - regarding all bio-pharmaceutical related provision.
Client expense: $710,000 · 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)
2021 · fourth_quarter · Health Issues
HR 1319 - American Rescue Plan Act of 2021 - regarding all bio-pharmaceutical related provisions S.464 - Safe Step Act - regarding all bio-pharmaceutical related provisions H.R 2071 - 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 - regarding all bio-pharmaceutical related provisions. S.908/H.R 2139 - A bill to amend title XVII of the Social Security Act to provide for the negotiation of lower covered Part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare Part D, and for other purposes - regarding all bio-pharmaceutical related provisions. International Reference Pricing/Most Favored Nation - regarding all bio-pharmaceutical related issues. No bill number. Issues related to the six protected classes of medicines under Medicare Part D - regarding all bio-pharmaceutical related issues. No bill number. H.R 1319 - The American Rescue Plan - regarding all bio-pharmaceutical related provisions. Cancer Drug Parity Act/Oral Parity - regarding all bio-pharmaceutical related provisions. No bill number. Issues related to the 340B Drug Pricing Program - regarding all bio-pharmaceutical related provisions. No bill number. Issues related to access and reimbursement of Chimeric Antigen Receptor Therapy (CAR T). No bill number. Essential Medicines/Buy American - regarding all bio-pharmaceutical related provisions. No bill number. 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 - regarding all bio-pharmaceutical related provisions. H.R 5376, the Build Back Better Act - regarding all bio-pharmaceutical related provisions.
Client expense: $710,000 · 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)
2021 · fourth_quarter · Health Issues
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Client expense: Not reported · Firm income: $350,000
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2021 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020
Client expense: $3,370,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · fourth_quarter · Medicare/Medicaid
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Patient Cost-Sharing and Smoothing Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act;H.R.5376 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021
Client expense: $3,370,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2021 · fourth_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals
Client expense: $430,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Occupational Safety & Health Administration (OSHA), SENATE, Small Business Administration (SBA), Treasury, Dept of, White House Office