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Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
43pct
1d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Star Rating for Biosimilars Act This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish quality measures regarding biosimilar biological products under the five-star performance rating system for Medicare Advantage plans. The measures must assess the level of access that plans provide to covered biosimilars, including with respect to formularies, cost-sharing, and utilization management. The CMS must also incorporate such measures into similar rating systems for plans under the Medicare prescription drug benefit.
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Filing registrants (8)
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Social Security.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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
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 · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency 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 · 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 · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act 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.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care 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 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.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, 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.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 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 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 · 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)
2022 · fourth_quarter · Medicare/Medicaid
S. 1427--Increasing Access to Biosimilars Act HR 2869--Increasing Access to Biosimilars Act HR 2815--Bolstering Innovative Options to Save Immediately on Medicines Act HR 2855--Star Rating for Biosimilars Act HR 5376--Inflation Reduction Act of 2022--Drug pricing/biosimilars Women's health
Client expense: $600,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Drug pricing legislation. H.R.4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022. H.R.2815 - BIOSIM Act. H.R.2855 - Star Rating for Biosimilars Act. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. H.R.5376 - Inflation Reduction Act of 2022. Efforts surrounding user fees. H.R.7006 - INSPECTIONS Act.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. H.R.2617 - Consolidated Appropriations Act, 2023, as it relates to the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023. H.R.2815 - BIOSIM Act. H.R.2855 - Star Rating for Biosimilars Act. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. H.R.5376 - Inflation Reduction Act of 2022
Client expense: Not reported · Firm income: $90,000
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)
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)
2022 · third_quarter · Health Issues
Drug pricing legislation. H.R.4502 - Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022. H.R.2815 - BIOSIM Act. H.R.2855 - Star Rating for Biosimilars Act. H.R.2869 - Increasing Access to Biosimilars Act of 2021. S.1427 - Increasing Access to Biosimilars Act of 2021. H.R.5376 - Inflation Reduction Act of 2022. Efforts surrounding user fees. H.R.7006 - INSPECTIONS Act.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. H.R.4502 - Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2022. H.R.2815 - BIOSIM Act. H.R.2855 - Star Rating for Biosimilars Act. H.R.2869 - Increasing Access to Biosimilars Act of 2021. S.1427 - Increasing Access to Biosimilars Act of 2021. H.R.5376 - Inflation Reduction Act of 2022
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act 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.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care 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 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.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, 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.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 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 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)
2022 · third_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency 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)
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)
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)
2022 · third_quarter · Medicare/Medicaid
S. 1427--Increasing Access to Biosimilars Act HR 2869--Increasing Access to Biosimilars Act HR 2815--Bolstering Innovative Options to Save Immediately on Medicines Act HR 2855--Star Rating for Biosimilars Act HR 5376--Build Back Better Act--Drug pricing/biosimilars S Con Res 14--FY22 Budget Resolution--Drug pricing/biosimilars Women's health
Client expense: $280,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Build Back Better Act Drug Pricing Reform ASP+8 for biosimilars Domestic Manufacturing Medicare implications on biosimilars Appropriations pertaining to FDA inspections and American Made preferences HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain H.R. 2815 - The BIOSIM Act H.R. 2869 / S. 1427 - Increasing Access to Biosimilars Act of 2021 H.R. 2855 - Star Rating for Biosimilars S. 2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S. 1176 - Onshoring Essential Antibiotics Act S. 1693 - Medical Supplies for Pandemics Act 340B Drug Pricing Program HR 3683 Securing America's Pharmaceutical Supply Chain S 2640 Disease X Act S. 2662 Industrial Finance Corporation Act H.R. 7400 /S. 3991 American Made Pharmaceuticals Act Biosimilar Patient and Provider Education (including Part D) FDA foreign inspections S. 3799 PREVENT Pandemics Act ASPR/BARDA funding and policy H.R. 2870 Essential Medicine Strategic Stockpile Act (EMSSA) H.R. 5376 Inflation Reduction Act
Client expense: $250,000 · Firm income: Not reported
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.
2022 · second_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. H.R. 4502, Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2022 H.R. 2815, BIOSIM Act H.R. 2855, Star Rating for Biosimilars Act. H.R. 2869, Increasing Access to Biosimilars Act of 2021. S. 1427, Increasing Access to Biosimilars Act of 2021. Build Back Better: S. Con. Res. 14, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
Drug pricing legislation. H.R. 4502, Issues related to Drug Pricing Reduction and increasing access to Biosimilars. H.R. 4502, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022. H.R. 2815, BIOSIM Act H.R. 2855, Star Rating for Biosimilars Act. H.R. 2869, Increasing Access to Biosimilars Act of 2021. S. 1427, Increasing Access to Biosimilars Act of 2021. Build Back Better: S. Con. Res. 14, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031. Efforts surrounding user fees. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act 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.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care 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 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.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, 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.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) 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)
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)
2022 · second_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency 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)
2022 · second_quarter · Medicare/Medicaid
S. 1427--Increasing Access to Biosimilars Act HR 2869--Increasing Access to Biosimilars Act HR 2815--Bolstering Innovative Options to Save Immediately on Medicines Act HR 2855--Star Rating for Biosimilars Act HR 5376--Build Back Better Act--Drug pricing/biosimilars S Con Res 14--FY22 Budget Resolution--Drug pricing/biosimilars Women's health
Client expense: $300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
Build Back Better Act Drug Pricing Reform ASP+8 for biosimilars Domestic Manufacturing Medicare implications on biosimilars Appropriations pertaining to FDA inspections HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain H.R. 2815 - The BIOSIM Act H.R. 2869 / S. 1427 - Increasing Access to Biosimilars Act of 2021 H.R. 2855 - Star Rating for Biosimilars S. 2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S. 1176 - Onshoring Essential Antibiotics Act S. 1693 - Medical Supplies for Pandemics Act 340B Drug Pricing Program HR 3683 Securing America's Pharmaceutical Supply Chain S 2640 Disease X Act S. 2662 Industrial Finance Corporation Act American Made Pharmaceutical Act
Client expense: $250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office
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)
2022 · first_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act 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.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care 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 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.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, 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.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, 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)
2022 · first_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 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 H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, 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)
2022 · first_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022 H.R. 2815, BIOSIM Act H.R. 2855, Star Rating for Biosimilars Act. H.R. 2869, Increasing Access to Biosimilars Act of 2021. S. 1427, Increasing Access to Biosimilars Act of 2021. Build Back Better: S. Con. Res. 14, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Health Issues
Drug pricing legislation. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022. H.R. 2815, BIOSIM Act H.R. 2855, Star Rating for Biosimilars Act. H.R. 2869, Increasing Access to Biosimilars Act of 2021. S. 1427, Increasing Access to Biosimilars Act of 2021. Build Back Better: S. Con. Res. 14, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031. Efforts surrounding user fees. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Medicare/Medicaid
S. 1427--Increasing Access to Biosimilars Act HR 2869--Increasing Access to Biosimilars Act HR 2815--Bolstering Innovative Options to Save Immediately on Medicines Act HR 2855--Star Rating for Biosimilars Act HR 5376--Build Back Better Act--Drug pricing/biosimilars S Con Res 14--FY22 Budget Resolution--Drug pricing/biosimilars Women's health
Client expense: $300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, 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
2022 · first_quarter · Health Issues
H.R. 1319 - American Rescue Plan Act of 2021 - support passage H.R. 5376, Build Back Better Act, support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage S.464/H.R. 2163- Safe Step Act, support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage Wyden Releases Principles For Lowering Drug Prices for Americans, support passage H.R. 2503, Social Determinants Accelerator Act of 2021, support passage S.1524/H.R.3029- Health Care Price Transparency Act, support passage H.R. 2884- Affordable Prescriptions for Patients Through Improvement t o Patent Litigation Act, support passage H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, support passage H.R. 5365, Primary Health Services Enhancement Act, support passage H.R. 2575, Social Security Disability Insurance Return to Work Act, monitor for position determination S.2565- Expanding Access to Palliative Care Act, monitor for impact on people affected by MS H.R. 4714- Disabled Access Credit Expansion Act of 2021- support passage S. 1435, Affordable Prescriptions for Patients Act of 2021, monitor for position determination H.R. 3971, Double Dip Elimination Act, monitor for position determination H.R. 3765, Disability Employment Incentive Act, support passage H.R. 5801, Help Copays Act, support passage
2022 · first_quarter · Health Issues
Build Back Better Act Drug Pricing Reform ASP+8 for biosimilars Domestic Manufacturing Medicare implications on biosimilars Appropriations pertaining to FDA inspections HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain H.R. 2815 - The BIOSIM Act H.R. 2869 / S. 1427 - Increasing Access to Biosimilars Act of 2021 H.R. 2855 - Star Rating for Biosimilars S. 2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S. 1176 - Onshoring Essential Antibiotics Act S. 1693 - Medical Supplies for Pandemics Act 340B Drug Pricing Program HR 3683 Securing America's Pharmaceutical Supply Chain S 2640 Disease X Act S. 2662 Industrial Finance Corporation Act American Made Pharmaceutical Act
Client expense: $200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office
2021 · fourth_quarter · Medicare/Medicaid
S. 1427/HR 2869--Increasing Access to Biosimilars Act HR 2815--Bolstering Innovative Options to Save Immediately on Medicines Act HR 2855--Star Rating for Biosimilars Act HR 5376--Build Back Better Act--Drug pricing/biosimilars S Con Res 14--FY22 Budget Resolution--Drug pricing/biosimilars Issues related to Medicare reimbursement for biosimilars
Client expense: $460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Health Issues
Build Back Better Act Drug Pricing ASP+8 for biosimilars Domestic Manufacturing Medicare implications on biosimilars Pass Through Status Extension Appropriations and reach out pertaining to FDA inspections HHS Supply Chain Readiness HHS Biosimilar Uptake 340B Drug Pricing Program American-Made, Security of the American Pharmaceutical and Medical Supply Chain H.R. 2815 - The BIOSIM Act H.R. 2869 / S. 1427 - Increasing Access to Biosimilars Act of 2021 H.R. 2855 - Star Rating for Biosimilars S. 2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S. 1176 - Onshoring Essential Antibiotics Act S. 1693 - Medical Supplies for Pandemics Act 340B Drug Pricing Program HR 3683 Securing America's Pharmaceutical Supply Chain S 2640 Disease X Act S. 2662 Industrial Finance Corporation Act
Client expense: $160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, White House Office
2021 · fourth_quarter · Pharmacy
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act - Rep. Pallone, Frank, Jr. [D-NJ-6] - drug pricing H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021 - Rep. Rush, Bobby L. [D-IL-1] - generic drugs H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - Advancing Education on Biosimilars Act of 2021 - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - Part D price negotiation H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd [D-TX-35] - Part D price negotiation H.R. 2148 - Prescription Drug Price Relief Act of 2021 - Rep. Khanna, Ro [D-CA-17] - excessive drug pricing H.R. 2608 - Ensuring Seniors Access to Local Pharmacies Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - rural health H.R. 2829 - End Price Gouging for Medications Act - Rep. Welch, Peter [D-VT-At Large] - reference prices H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 - Rep. McKinley, David B. [R-WV-1] - biosimilar drugs H.R. 2855 - Star Rating for Biosimilars Act - Rep. Tonko, Paul [D-NY-20] - biosimilar drugs H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act - Rep. Nadler, Jerrold [D-NY-10] - biosimilar drugs H.R. 3831 - Seniors Securing Access to Vital and Essential Prescription Drugs Act - Rep. Lee, Susie [D-NV-3] - Part D H.R. 4121 - PRO Seniors Act - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates H.R. 4417 - Capping Drug Costs for Seniors Act of 2021 - Rep. Horsford, Steven [D-NV-4] - reduces out of pocket spending H.R. 4418 - SPIKE Act - Rep. Horsford, Steven [D-NV-4] - Medicare drug price threshold H.R. 5623 - The Insulin Cost Reduction Act - Rep. Grothman, Glenn [R-WI-6] - insulin prices under part D H.R. 6000 - Cures 2.0 Act - Rep. DeGette, Diana [D-CO-1] - drug development H.R. 6228 - To limit cost sharing for prescription drugs - Rep. Manning, Kathy E. [D-NC-6] - cost sharing S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy [D-MN] - Part D price negotiation S. 898 - Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Sen. Baldwin, Tammy [D-WI] - reporting price increases S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard [I-VT] - Part D price negotiation S. 1123 - PING Act - Sen. Blackburn, Marsha [R-TN] - Part D non-interference S. 1323 - End Price Gouging for Medications Act - Sen. Merkley, Jeff [D-OR] - reference prices S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy [D-MN] - biosimilar drugs S. 2257 - Expanding Access to Affordable Prescription Drugs and Medical Devices Act - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - DTC Act of 2021- Sen. Durbin, Richard J. [D-IL] - drug pricing S. 2327 - Seniors Prescription Drug Relief Act - Sen. Cassidy, Bill [R-LA] - Medicare part D modernization redesign and reduces out of pocket spending S. 2815 - Seniors Saving on Insulin Act - Sen. Kennedy, John [R-LA] - Part D Senior Savings model S. 3339 - A bill to limit cost sharing for prescription drugs - Sen. Warnock, Raphael G. [D-GA] - cost sharing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
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
2021 · fourth_quarter · Health Issues
H.R. 1319 - American Rescue Plan Act of 2021 - support passage H.R. 5376, Build Back Better Act, support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage S.464/H.R. 2163- Safe Step Act, support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage Wyden Releases Principles For Lowering Drug Prices for Americans, support passage H.R. 2503, Social Determinants Accelerator Act of 2021, support passage S.1524/H.R.3029- Health Care Price Transparency Act, support passage H.R. 2884- Affordable Prescriptions for Patients Through Improvement t o Patent Litigation Act, support passage H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, support passage H.R. 5365, Primary Health Services Enhancement Act, support passage H.R. 2575, Social Security Disability Insurance Return to Work Act, monitor for position determination S.2565- Expanding Access to Palliative Care Act, monitor for impact on people affected by MS H.R. 4714- Disabled Access Credit Expansion Act of 2021- support passage S. 1435, Affordable Prescriptions for Patients Act of 2021, monitor for position determination H.R. 3971, Double Dip Elimination Act, monitor for position determination H.R. 3765, Disability Employment Incentive Act, support passage H.R. 5801, Help Copays Act, support passage
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
2021 · fourth_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures 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
Client expense: $1,918,904 · Firm income: Not reported
2021 · fourth_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act 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.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care 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 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.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, 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
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021
2021 · fourth_quarter · Medicare/Medicaid
S. 1427/HR 2869--Increasing Access to Biosimilars Act HR 2815--Bolstering Innovative Options to Save Immediately on Medicines Act HR 2855--Star Rating for Biosimilars Act HR 5376--Build Back Better Act--Drug pricing/biosimilars S Con Res 14--FY22 Budget Resolution--Drug pricing/biosimilars Issues related to Medicare reimbursement for biosimilars
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Health Issues
Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022 H.R. 2815, BIOSIM Act H.R. 2855, Star Rating for Biosimilars Act. H.R. 2869, Increasing Access to Biosimilars Act of 2021. S. 1427, Increasing Access to Biosimilars Act of 2021. Build Back Better: S. Con. Res. 14, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Medicare/Medicaid
Drug pricing legislation. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022. H.R. 2815, BIOSIM Act H.R. 2855, Star Rating for Biosimilars Act. H.R. 2869, Increasing Access to Biosimilars Act of 2021. S. 1427, Increasing Access to Biosimilars Act of 2021. Build Back Better: S. Con. Res. 14, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · third_quarter · Health Issues
S.164 - Advancing Education on Biosimilars Act of 2021 Pass-Through Status Extension Medicare payments for Biosimilars Appropriations and reach out pertaining to FDA inspections HHS Supply Chain Readiness HHS Biosimilar Uptake 340B Drug Pricing Program American-Made, Security of the American Pharmaceutical and Medical Supply Chain H.R. 2815 - The BIOSIM Act H.R. 2869 / S. 1427 - Increasing Access to Biosimilars Act of 2021 H.R. 2855 - Star Rating for Biosimilars S. 2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S. 1176 - Onshoring Essential Antibiotics Act S. 1693 - Medical Supplies for Pandemics Act 340B Drug Pricing Program HR 3683 Securing America's Pharmaceutical Supply Chain S 2640 Disease X Act S. 2662 Industrial Finance Corporation Act
Client expense: $130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, White House Office
2021 · third_quarter · Pharmacy
Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification 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.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures 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
Client expense: $1,918,904 · Firm income: Not reported
Client expense: $45,264 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
Client expense: $11,123 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
Client expense: $11,123 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
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
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
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
Client expense: $42,877 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Administration, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office
Client expense: $42,877 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
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
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
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
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
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
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $58,183 · 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
Client expense: $2,630,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
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)
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)
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
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
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
Client expense: $1,460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
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