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Preserving Innovation for the Next Generation Act or the PING Act This bill expresses the sense of the Senate that the current restrictions prohibiting the Centers for Medicare & Medicaid Services from negotiating the prices or establishing a formulary for drugs under the Medicare prescription drug benefit should not be repealed. The bill also prohibits the Center for Medicare and Medicaid Innovation from testing any model that would repeal or require a waiver of such restrictions.
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Filing registrants (3)
2021 · fourth_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5416: Give Kids a Chance Act - To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 4864/H.R. 8725: HAPI Act; Medicaid financial barriers Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Inflation penalty policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Medicare Benefit for Oral Health Provisions related to Medicare's noninterference clause Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
Read twice and referred to the Committee on Finance.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2021 · fourth_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5416: Give Kids a Chance Act - To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 4864/H.R. 8725: HAPI Act; Medicaid financial barriers Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Inflation penalty policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Medicare Benefit for Oral Health Provisions related to Medicare's noninterference clause Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
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.
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
2021 · fourth_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5416: Give Kids a Chance Act - To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Inflation penalty policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
Client expense: $7,160,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2021 · third_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 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 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.
Client expense: $2,250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2021 · third_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 550: Immunization Infrastructure Modernization Act H.R.3684 - Infrastructure Investment and Jobs Act - provisions related to vial size wastage policy H.R.5260 - Reduced Costs and Continued Cures Act H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 H.R. 4100/S. 1712: DISARM Act of 2019 a Provisions related to antimicrobial drug development H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to prescription drug pricing and access H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5463: Drug Pricing Transparency and Accountability Act - To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act a Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) S. 4864/H.R. 8725: HAP Act; Medicaid financial barriers S. 1123: PING Act - Provisions related to Part D and non-interference S. 1287: REFUND Act of 2021 - Provisions related to Part B and vial sizes S. 1773: Prescription Drug Pricing Dashboard Act - Provisions related to Medicare, Medicaid and prescription drug pricing transparency S. 1898: Affordable Medications Act - Provisions related to prescription drug pricing, Part D, non-interference, Part B, and intellectual property S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues ___ Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
2021 · third_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5463: Drug Pricing Transparency and Accountability Act - To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1287: REFUND Act of 2021 - Provisions related to Part B and vial sizes S. 1773: Prescription Drug Pricing Dashboard Act - Provisions related to Medicare, Medicaid and prescription drug pricing transparency S. 1898: Affordable Medications Act - Provisions related to prescription drug pricing, Part D, non-interference, Part B, and intellectual property S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
2021 · second_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 - To require the Government Accountability Office to study the role pharmaceutical benefit managers play in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - To educate health care providers and the public on biosimilar biological products, and for other purposes - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - 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 - To require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs - 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 - 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 - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - A bill to amend XVIII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program - 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. 1132 - A bill to establish a cap on out-of-pocket costs for insulin - Sen. Kennedy, John [R-LA] - out-of-pocket costs S. 1323 - A bill to require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs - 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 - A bill to provide Federal support for nonprofit generic and essential medicine and device manufacturers to increase the availability of drugs and devices in order to reduce drug or device shortages and drug and device costs - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - A bill to amend title XI of the Social Security Act to require that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information - Sen. Durbin, Richard J. [D-IL] - drug pricing 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 · second_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2868: Protecting Access to Affordable Medicines Act of 2021 - Provisions related to Medicaid and prescription drug pricing and rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1323: End Price Gouging for Medications Act - Provisions related to Medicare, Medicaid and prescription drug pricing S. 2164: A bill to provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, and for other purposes Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Issues related to American Families Plan; Issues related to 340B program
2021 · second_quarter · Medicare/Medicaid
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2868: Protecting Access to Affordable Medicines Act of 2021 - Provisions related to Medicaid and prescription drug pricing and rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1323: End Price Gouging for Medications Act - Provisions related to Medicare, Medicaid and prescription drug pricing S. 2164: A bill to provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, and for other purposes Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $7,440,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $2,510,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office
Client expense: $1,300,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $6,430,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)