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Improving Access To Affordable Prescription Drugs Act
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
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vs 3,805 other S bills in the 115th — cohort avg 41d
This bill amends provisions of various laws relating to prescription-drug pricing and affordability. Specifically, the bill: expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures; requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under the Medicare program; requires the GAO to report to Congress on such negotiations conducted by the CMS; requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models for negotiating drug prices; establishes reporting requirements, and corresponding civil penalties for noncompliance, for pharmaceutical companies with respect to spikes in prescription-drug prices; establishes an excise tax on prescription drugs subject to price spikes; lessens prescription-drug cost-sharing requirements under qualified health plans, group health plans, and the Medicare program; modifies provisions related to the importation of prescription drugs; requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program; establishes a prize fund for new and more effective treatments of bacterial infections; establishes a Center for Clinical Research within the National Institutes of Health; modifies provisions related to drug exclusivity; allows the Federal Trade Commission to initiate enforcement proceedings against parties to an agreement resolving or settling a patent-infringement claim in connection with the sale of a drug product; requires the Food and Drug Administration to establish a database of generic drugs; and modifies other provisions related to generic drugs, prescription-drug advertising, and product hopping.
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Filing registrants (52)
Read twice and referred to the Committee on Finance.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2019 · fourth_quarter · Health Issues
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives
Client expense: $3,120,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2019 · third_quarter · Medicare/Medicaid
S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2113: "The Prescription Drug STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs. S.2199: The Insulin Price Reduction Act, require private health insurance plans and Medicare Part D plans to eliminate rebates for insulin and limit out of pocket costs ($250 for individuals, and $500 for families) if manufacturers reduce insulin list prices to prices during plan year 2006 and do not raise insulin prices above inflation. S.2543: The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, -Legislation to amend Medicare and Medicaid to lower prescription drug prices and strengthen safeguards related to prescription drugs. Provisions related to inflation protection provisions and PBM transparency. S.2247: Phair Relief Act, Provisions related to pharmacy DIR. H.R. 3: Lower Drug Costs Now Act of 2019, Provisions to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollment. CMS Proposed rule: "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses," (CMS-4180-P)-provisions related to pharmacy Direct and Indirect Negotiation.
2019 · third_quarter · Medicare/Medicaid
S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2087: "The STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs. S.2199: The Insulin Price Reduction Act, require private health insurance plans and Medicare Part D plans to eliminate rebates for insulin and limit out of pocket costs ($250 for individuals, and $500 for families) if manufacturers reduce insulin list prices to prices during plan year 2006 and do not raise insulin prices above inflation. S.2543: The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, -Legislation to amend Medicare and Medicaid to lower prescription drug prices and strengthen safeguards related to prescription drugs. Provisions related to inflation protection provisions and PBM transparency. S.2247: Phair Relief Act, Provisions related to pharmacy DIR. H.R. 3: Lower Drug Costs Now Act of 2019, Provisions to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollment. CMS Proposed rule: "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses," (CMS-4180-P)-provisions related to pharmacy Direct and Indirect Negotiation.
2019 · second_quarter · Medicare/Medicaid
S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Proposed HHS-OIG rule currently under OMB review entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection, RIN-936-AAO8. (See https://www.reginfo.gov/public/do/eoReviewSearch for questions). Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." S 476: The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act. S 657: Drug Price Transparency Act, eliminates rebates in ERISA plans. Proposed Rule: Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HHSIG-2019-0001-0001. Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 1497: Health Care Price Check Act of 2019, requires Medicare and insurance companies to make available an online tool and a toll-free # for beneficiaries to inquire about the cost, for that specific consumer, of any services, procedure or product including prescription drugs. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2087: "The STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs.
2019 · first_quarter · Pharmacy
Issues related to the FDA Reauthorization Act (Pub.L. 115-52) Drug importation, generally Issues related to the 340B Drug Pricing Program, generally H.R. 1520 Purple Book Continuity Act of 2019; H.R. 1503 Orange Book Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S.771)
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| NJ |
| Elizabeth Warren | Democratic | MA |
| Jack Reed | Democratic | RI |
| Jeff Merkley | Democratic | OR |
| Kirsten E. Gillibrand | Democratic | NY |
| Margaret Wood Hassan | Democratic | NH |
| Richard Blumenthal | Democratic | CT |
| Richard J. Durbin | Democratic | IL |
| Sheldon Whitehouse | Democratic | RI |
| Sherrod Brown | Democratic | OH |
| Tammy Baldwin | Democratic | WI |
| Tom Udall | Democratic | NM |
| S 252 |
115th |
| Related bill |
| S 2478 | 115th | Related bill |
| S 2476 | 115th | Related bill |
| S 1688 | 115th | Related bill |
| HR 6340 | 115th | Related bill |
| HR 1776 | 115th | Identical bill |
| HR 1245 | 115th | Related bill |
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $83,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · first_quarter · Medicare/Medicaid
Provisions affecting market competition for prescription drugs and the drug supply chain; provisions related to rebates at the point of sale; provisions related to pharmacist direct and indirect remuneration; HHS Blueprint to lower drug prices and reduce out-of-pocket costs; Improving Access to Affordable Prescription Drugs Act (S 771/HR 1776); The Prescription Drug Price Transparency Act (HR 1316); The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 340/HR 965); The Phair Pricing Act (S. 640/HR 1034); Preserve Access to Affordable Generics and Biosimilars Act (S. 64); The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act (S. 476); Drug Price Transparency Act (S. 657); The Payment Commission Data Act (S. 801/HR 1264, HR 1781); Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (HR 803);The Prescription Drug Price Transparency Act (HR 1035); Proposed Rule: Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HHSIG-2019-0001-0001.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · first_quarter · Medicare/Medicaid
S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act--issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information --Provisions on Part D. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P), provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Proposed HHS-OIG rule currently under OMB review entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection, RIN-936-AAO8. (See https://www.reginfo.gov/public/do/eoReviewSearch for questions). Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act Pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act. S 64: Preserve Access to Affordable Generics and Biosimilars Act - Prohibits brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. S 476: The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act. S 657: Drug Price Transparency Act - eliminates rebates in ERISA plans. Proposed Rule: Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HHSIG-2019-0001-0001. Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act H.R. 1264 and H.R. 1781 and S. 801 - Provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information.
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act HR 4666 - Relief Act of 2017. Costello (R-PA) S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) HR 3922 - Community Health And Medical Professionals Improve Our Nation Act of 2017: To extend funding for certain public health programs, and for other purposes. Walden (R-OR) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act
Client expense: $210,000 · Firm income: Not reported
Government targets: Defense, Dept of (DOD), Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act
Client expense: $1,190,000 · Firm income: Not reported
Government targets: Defense, Dept of (DOD), Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · 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. Issues included in the Part D Rule and accompanying RFI. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Issues related to pharmacy gag clauses. HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R.3528, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018
Client expense: $611,446 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Medicare/Medicaid
Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits. Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018
Client expense: $611,446 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Health Issues
Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.
Client expense: $611,446 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Pharmacy
Legislation and policies related to: Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 6 - Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R. 749 - Lower Drug Costs through Competition Act H.R. 3692/S. 2317 - Addiction Treatment Access Improvement Act S. 204/H.R. 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 297 - Increasing Competition in Pharmaceuticals Act S. 771/H.R. 1776 - Improving Access to Affordable Prescription Drugs Act S. 892 - Opioid Addiction Prevention Act of 2017 S. 974 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2018 S. 2456 - CARA 2.0 Act of 2018 S. 2680 - Opioid Crisis Response Act of 2018 S. 3680 - Low Drug Prices Act S. 3754 - Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 3775 - Affordable Drug Manufacturing Act of 2018
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Client expense: $920,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Medicare/Medicaid
H.R. 1316-The Prescription Drug Price Transparency Act (MAC); H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); S. 771 and H.R. 1776, Improving Access to Affordable Prescription Drug Act,; HHS/OIG Rule RIN - 936-AA08 entitled, Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Copyright/Patent/Trademark
Issues related to barriers to generic drug and biosimilar market entry including pay-for-delay and REMS. S. 124, The Preserve Access to Affordable Generics Act of 2017 S.771/H.R. 1776, The Improving Access to Affordable Prescription Drugs Act of 2017 H.R. 2051, The Fair Access for Safe and Timely Generics Act of 2017 S. 974/H.R. 2212, The Creating and Restoring Equal Access to Equivalent Samples Act of 2017
Client expense: $1,993,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · fourth_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; SUPPORT for Patients and Communities Act (H.R. 6); Biosimilars Competition Act of 2018 (H.R. 6478); Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143); Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505); Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519); citizen petitions; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.
Client expense: Not reported · Firm income: $320,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Client expense: $6,030,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Trade (domestic/foreign)
Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S. 771: Improving Access to Affordable Prescription Drugs ---General Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Like-minded Countries Initiatives Intellectual Property International Enforcement ---Compulsory Licensing ---Chile ---Malaysia ---India The United States-Mexico-Canada Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Ag-Biotech Provisions ---Regulatory Harmonization Trade and Foreign Drug Price Controls Committee on Foreign Investment in the United States (CFIUS) ---Foreign Investment Risk Review Modernization Act (FIRRMA) Implementation ---Export Control Reform Act (ECRA) Implementation US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Ag-Biotech Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Ag-Biotech Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Ag-Biotech Provisions ---Regulatory Harmonization
Client expense: $2,500,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Consumer Issues/Safety/Products
Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S. 771: Improving Access to Affordable Prescription Drugs ---General Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Client expense: $2,500,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Health Issues
340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.771: Improving Access to Affordable Prescription Drugs ---General Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act ---Incentives for Generic Drug Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---Pricing and Reimbursement Provisions ---IP Provisions ---Regulatory Harmonization US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Diagnostic and Personalized Medicine Regulation and Oversight Precision Medicine Initiative
Client expense: $2,500,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Medicare/Medicaid
Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018
Client expense: $2,500,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Budget/Appropriations
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act Drug importation, generally; Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469) Virtual Medicare Diabetes Prevention Program Issues related to the 340B Drug Pricing Program, generally; 340B Protecting Access for the Underserved and Safety-Net Entities (340 PAUSE) Act (H.R. 4710) Issues related to the FDA Reauthorization Act (Pub.L. 115-52) Improving Access To Affordable Prescription Drugs Act (H.R. 1776/S.771)
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
National Diabetes Prevention Program and other CDC diabetes prevention activities in Pub.L. 115-96 (CR of FY18 Labor, Health and Human Services, and Education Appropriations). Issues related to the 340B Drug Pricing Program, generally; 340B Protecting Access for the Underserved and Safety-Net Entities (340 PAUSE) Act (H.R. 4710) Issues related to the FDA Reauthorization Act (Pub.L. 115-52) Improving Access To Affordable Prescription Drugs Act (H.R. 1776/S.771)
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Issued relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); and the Ensuring the Value of the 340B Program Act (S. 2453). Biodefense research, development and procurement issues; Pandemic All Hazards Preparedness Act (PAHPA) reauthorization; pandemic flu; MCM priority review voucher program Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally, including the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
S. 483 (114th Congress) legislation to prevent and reduce prescription drug abuse. H.R. 592 & S. 109, provide for coverage under Medicare program of pharmacist services. Medication Therapy Management. H.R. 1038 and S. 413, legislation to prohibit prescription drug plan sponsors and MAPD organizations under Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. Pharmaceutical compounding and the implementation of Drug Quality Security Act; FDA implementation of Section 503B of the Food, Drug, and Cosmetic Act; House & Senate Agriculture, FDA & Related Agency Appropriations bills; H.R. 2871, Preserving Patient Access to Compounded Medications Act of 2017. Prescription Drug Importation including S. 771 and H.R. 1776, the Improving Access to Affordable Prescription Drugs Act and S.469, the Affordable and Safe Prescription Drug Importation Act. E-Prescribing bills including H.R. 3528 and S. 2460, the Every Prescription Conveyed Securely (EPCS) Act. H.R. 5958, Phair Pricing Act of 2018. HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. S. 3282 and H.R. 6600, the DEA Order Clearinghouse Act of 2018. H.R. 6, SUPPORT for Patients and Communities Act.
Client expense: $450,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2018 · fourth_quarter · Health Issues
Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771) Issues involving the Federal, Food, Drug and Cosmetic Act (FFDCA)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Taxation/Internal Revenue Code
-HR 1393 - Mobile Workforce State Income Tax Simplification Act of 2017 - all provisions related to cable. -HR 1776 - Improving Access to Affordable Prescription Drugs Act - all provisions related to cable. -HR 2193 - Remote Transactions Parity Act of 2017 - all provisions related to cable. -HR 2450 - Facilitating Investments in Local Markets Act of 2017 - all provisions related to cable. -HR 2887 - No Regulation Without Representation Act of 2017 - all provisions related to cable. -HR 5217 - Transforming Hiring in Rural Industries and Vital Economies Act of 2017 - all provisions related to cable. -HR 7058 - Digital Goods and Services Tax Fairness Act of 2018 - all provisions related to cable. -S 540 - Mobile Workforce State Income Tax Simplification Act of 2017 - all provisions related to cable. -S 771 - Improving Access to Affordable Prescription Drugs Act - all provisions related to cable. -S 976 - Marketplace Fairness Act of 2017 - all provisions related to cable. -S 1144 - Investment in New Ventures and Economic Success Today (INVEST) Act of 2017 - all provisions related to cable. -S 1210 - A bill to amend the Internal Revenue Code of 1986 to reduce tax rates across the board - all provisions related to cable. -S 1229 - Move America Act of 2017 - all provisions related to cable. -S 1469 - A bill to amend the Internal Revenue Code of 1986 to extend tax incentives to permanently extend the special expensing rules for certain film, television, and live theatrical productions - all provisions related to cable. -S 3180 - Stop Taxing Our Potential Act - all provisions related to cable. -S 3581 - Digital Goods and Services Tax Fairness Act of 2018 - all provisions related to cable. -SRes 433 - Expressing the sense of the Senate that the Marketplace Fairness Act of 2017 would harm the economy of the U.S. and place an undue burden on small businesses and multiple States across the U.S. - all provisions related to cable.
Client expense: $3,840,000 · Firm income: Not reported
Government targets: Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), Office of Science & Technology Policy (OSTP), SENATE
2018 · fourth_quarter · Pharmacy
Legislation to prevent and reduce prescription drug abuse; Ensuring Patient Access and Effective Drug Enforcement Act (Pub.L. 114-145) Legislation to prohibit prescription drug plan sponsors and MA-PD organizations under Medicare from retroactively reducing payment on clean claims submitted by pharmacies Issues related to pharmaceutical compounding and implementation of the Drug Quality Security Act (Pub.L. 113-54). FDA implementation of Section 503B of the FFDCA HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Issues related to drug pricing, including the Improving Access to Affordable Prescription Drug Act (H.R. 1776/S. 771) Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771)
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Taxation/Internal Revenue Code
Discussions with members of the Senate and House of Representatives on reform of the tax code, including draft proposals that would change the tax deductibility of advertising expenses Proposals to end the tax deduction for expenses for direct-to-consumer prescription drug advertising, including an amendment to H.R. 1 that would eliminate the deduction for prescription drug advertising expenses S.771 & H.R. 1776: Improving Access to Affordable Prescription Drugs Act, section 405 which would eliminate the tax deduction for expenses related to direct-to-consumer prescription drug advertising S. 2478: End Taxpayer Subsidies for Drug Ads Act, to disallow the tax deduction for expenses relating to direct-to-consumer advertising of prescription drugs
Client expense: $480,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $1,570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Medicare/Medicaid
H.R.413/H.R.1038: Improving Transparency and Accuracy in Medicare Part D Spending Act--provisions restricting payer quality payment programs in Medicare Part D. S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act--issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information --Provisions on Part D. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P), provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Proposed HHS-OIG rule currently under OMB review entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection, RIN-936-AAO8. (See https://www.reginfo.gov/public/do/eoReviewSearch for questions). Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
S. 469, Affordable and Safe Prescription Drug Importation Act; H.R. 1245, Affordable and Safe Prescription Drug Importation Act; H.R. 1776, Improving Access to Affordable Prescription Drugs Act; S. 771, Improving Access to Affordable Prescription Drugs Act; H.R. 242, Medicare Prescription Drug Price Negotiation Act of 2017; S. 41, Medicare Prescription Drug Price Negotiation Act of 2017; Drug Pricing Transparency
Client expense: $240,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · fourth_quarter · Health Issues
- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions - H.R. 1318, "Preventing Maternal Deaths Act of 2018", regarding all provisions
Client expense: $2,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · fourth_quarter · Health Issues
Medicaid Rebate provision of the Bipartisan Budget Act of 2015; the Creating & Restoring Equal Access to Equivalent Samples Act ("CREATES Act"); HR 2051-FAST Generics Act; S.771-Improving Access to Affordable Drugs Act; HR 749-Lower Drugs Through Competition Act; and Administration review of drug pricing policies.
Client expense: $700,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Medicare/Medicaid
H.R. 1038 & S.413-Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (DIR); S.771 & H.R. 1776-Improving Access to Affordable Prescription Drugs Act; H.R.1316-The Prescription Drug Price Transparency Act; HHS-OIG rule RIN -936-AAO8 entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
H.R. 1776/S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 749 - Lower Drug Costs Through Competition Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 878/S. 204 - Right to Try Act S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bill, non-interference, 340b, FDASIA implementation, emergency preparedness, counter measures
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act no specific bills - innovation, non-interference, biosimilars, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
prescription drug abuse and deterrence, non-interference PL 114-255 - 21st Century Cures, implementation Multi-modal analgesics S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act S. 3282 - DEA Clearinghouse Act of 2018
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
Importation of prescription drugs (S. 469, S. 771, H.R. 1776, H.R. 1245, H.R. 934, H.R. 1480, S. 92, S. 64) Opioid Abuse - General issues related to opioid drug abuse (H.R. 6, H.R. 6779, H.R. 6600, S. 2838, S. 2837, S. 3120, S. 2680, S.3282) Ensuring Patient Access and Effective Enforcement Act (PL 114-145) Implementation of Public Law 113-54 (DSCSA)
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bills; user fee reauthorization, non-interference, dormant therapies, drug shortages, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE