Legislative Progress
Introduced
February 17, 2022
Latest Action
February 17, 2022
Primary Sponsor
Raphael G. WarnockDemocratic(GA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,357 other S bills in the 117th — cohort avg 38d
Affordable Insulin Now Act This bill limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit. Specifically, the bill caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023. The bill caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at (1) $35 between October 1, 2022, and January 1, 2024; and (2) $35 or 25% of a plan's negotiated price, whichever is less, beginning in 2024. The bill provides funds for FY2022 for the Centers for Medicare & Medicaid Services (CMS) to implement the bill. Currently, the CMS is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.
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Read twice and referred to the Committee on Finance.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2024 · second_quarter · Copyright/Patent/Trademark
H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation related to proposed reforms of the National Institutes of Health Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research Proposed Rule, Federal Trade Commission; Petition for Rulemaking of PIRG and iFixit (89 Fed. Reg. 286, January 3, 2024) Request for Comment, United States Patent and Trademark Office, Department of Commerce; Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace (89 Fed. Reg. 18,907-18,911 March 15, 2024) Notice of Proposed Rulemaking, United States Patent and Trademark Office, Department of Commerce; Setting and Adjusting Patent Fees During Fiscal Year 2025 (89 Fed. Reg. 23,226-23,291, April 3, 2024) Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; March-In rights under the Bayh-Dole Act (P.L. 96-517); establishment of IP attache position for U.S. Embassy in the Republic of Korea; inventorship guidance for AI-Assisted Inventions
Client expense: $13,930,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2024 · first_quarter · Copyright/Patent/Trademark
H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 6943, No AI FRAUD Act S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Draft legislation titled Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act of 2023 Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Proposed Rule, Federal Trade Commission; Petition for Rulemaking of PIRG and iFixit (89 Fed. Reg. 286, January 3, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to pharmaceuticals and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Trade Organization; the World Health Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; right-to-repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; USPTO's IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains;
2023 · fourth_quarter · Copyright/Patent/Trademark
H.R. 2670/S. 2226, National Defense Authorization Act H.R. 5475, Prohibiting Adversarial Patents Act of 2023 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Request for Information, National Institute of Standards and Technology, Department of Commerce; Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 Fed. Reg. 85,593-85,605, December 8, 2023) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Trade Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; right to repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; confirmation of NIH Director; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417)
2023 · third_quarter · Copyright/Patent/Trademark
H.R. 2670/S. 2226, National Defense Authorization Act S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act (117th Congress) Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act (117th Congress) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act (117th Congress) Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Trade Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517); right to repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; confirmation of NIH director; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417)
2023 · second_quarter · Health Issues
Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.3700/HR.6833), The INSULIN Act
Client expense: $1,585,000 · Firm income: Not reported
| Democratic |
| NM |
| Catherine Cortez Masto | Democratic | NV |
| Charles E. Schumer | Democratic | NY |
| Chris Van Hollen | Democratic | MD |
| Christopher Murphy | Democratic | CT |
| Cory A. Booker | Democratic | NJ |
| Debbie Stabenow | Democratic | MI |
| Dianne Feinstein | Democratic | CA |
| Gary C. Peters | Democratic | MI |
| Jack Reed | Democratic | RI |
| Jacky Rosen | Democratic | NV |
| Jeanne Shaheen | Democratic | NH |
| Jeff Merkley | Democratic | OR |
| Joe Manchin, III | Independent | WV |
| John W. Hickenlooper | Democratic | CO |
| Kyrsten Sinema | Independent | AZ |
| Margaret Wood Hassan | Democratic | NH |
| Mark Kelly | Democratic | AZ |
| Martin Heinrich | Democratic | NM |
| Mazie K. Hirono | Democratic | HI |
| Michael F. Bennet | Democratic | CO |
| Richard Blumenthal | Democratic | CT |
| Richard J. Durbin | Democratic | IL |
| Robert Menendez | Democratic | NJ |
| Robert P. Casey, Jr. | Democratic | PA |
| Ron Wyden | Democratic | OR |
| Sheldon Whitehouse | Democratic | RI |
| Sherrod Brown | Democratic | OH |
| Tammy Baldwin | Democratic | WI |
| Tammy Duckworth | Democratic | IL |
| Thomas R. Carper | Democratic | DE |
| Tim Kaine | Democratic | VA |
| Tina Smith | Democratic | MN |
Client expense: $23,370,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
Client expense: $19,080,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
Client expense: $13,590,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Copyright/Patent/Trademark
S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 7776, James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation revising the Family Entertainment and Copyright Act of 2005 Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Advance Notice of Proposed Rulemaking, United States Patent and Trademark Office, Department of Commerce; Changes Under Consideration to Discretionary Institution Practices, Petition Word-Count Limits, and Settlement Practices for America Invents Act Trial Proceedings Before the Patent Trial and Appeal Board (88 Fed. Reg. 24,503-24,518, April 21, 2023) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the United Nations; IP issues related to prescription drug pricing and labeling; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; FY2023 Financial Services and General Government Appropriations bill (including funding for the Office of the Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement)
Client expense: $16,390,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2023 · second_quarter · Health Issues
Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.3700/HR.6833), The INSULIN Act
Client expense: $1,585,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
Potential improvements and modifications to the Affordable Care Act (ACA) Prescription drug rebates in federal health programs Reform to the Centers for Medicare and Medicaid Innovation (CMMI) Proposals to expand Medicare, Medicaid, and ACA premium tax credits in the Inflation Reduction Act Repealing or delaying the Trump administration's rebate rule Inflation Reduction Act's changes to prescription drug pricing in Medicare H.R. 3353Contact Lens Prescription Verification Modernization Act (117th Congress) S. 3700 / H.R. 6833Affordable Insulin Now Act (117th Congress) S. 1001 / H.R. 1843Telehealth Expansion Act Health Savings Account (HSA) expansion H.R. 9160Healthcare Freedom Act (117th Congress) Pharmacy benefit manager (PBM) reform H.R. 3682Improving Transparency to Lower Drug Costs Act (117th Congress) Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act Enhanced PBM spread pricing transparency in Medicaid Enhanced specialty pharmacy reporting in Medicare Part D Reducing Medicare conflicts of interest in pharmacy and therapeutics (P&T) committees Biden administration proposal to expand Medicare price negotiation in FY 2024 budget S. 1644 / H.R. 3761Promising Pathway Act (117th Congress) Reforms to FDA review and approval Updates to Medicare reimbursement procedures for new drugs S. 1038 / H.R. 1613Drug Pricing Transparency in Medicaid Act RIN: 3084-AB37Eyeglass Rule
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Copyright/Patent/Trademark
S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 7430, Protecting American Innovation Act (117th Congress) Potential legislation similar to H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act (117th Congress) Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act (117th Congress) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act (117th Congress) Potential legislation revising the Family Entertainment and Copyright Act of 2005 Potential legislation making omnibus year-end appropriations Potential Legislation regarding the establishment of a SEP royalty court Potential Legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act Notice of Public Listening Session; Request for Comments, United States Patent and Trademark Office; Joint USPTO-FDA Collaboration Initiatives (87 Fed. Reg. 67,019-67,022, November 7, 2022) Request for Comments, United States Patent and Trademark Office; USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights (87 Fed. Reg. 66,282, November 3, 2022) FY2023 Department of Defense Authorization; FY2023 Financial Services and General Government Appropriations bill (including funding for the Office of the Intellectual Property Enforcement Coordinator and other federal agencies) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, and Mexico; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; the United Nations; IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program;
Client expense: $18,660,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2023 · first_quarter · Copyright/Patent/Trademark
S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 7430, Protecting American Innovation Act (117th Congress) Potential legislation similar to H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act (117th Congress) Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act (117th Congress) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act (117th Congress) Potential legislation revising the Family Entertainment and Copyright Act of 2005 Potential legislation making omnibus year-end appropriations Potential Legislation regarding the establishment of a SEP royalty court Potential Legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act Notice of Public Listening Session; Request for Comments, United States Patent and Trademark Office; Joint USPTO-FDA Collaboration Initiatives (87 Fed. Reg. 67,019-67,022, November 7, 2022) Request for Comments, United States Patent and Trademark Office; USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights (87 Fed. Reg. 66,282, November 3, 2022) FY2023 Department of Defense Authorization; FY2023 Financial Services and General Government Appropriations bill (including funding for the Office of the Intellectual Property Enforcement Coordinator and other federal agencies) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, and Mexico; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; the United Nations; IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program;
Client expense: $18,660,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2023 · first_quarter · Health Issues
Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.3700/HR.6833), The INSULIN Act
Client expense: $1,470,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
Implementation of the ACA (PL 111-148) and stabilization issues; Issues related to the federal COVID response and COVID Testing; Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act (PL 116-123); Implementation of Families First Coronavirus Response Act (PL 116-127); Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136); Health; H.R. 925 - the HEROES Act; Implementation of FY2021 Omnibus and COVID Relief and Response Act (PL 116-260); The American Rescue Plan Act of 2021 (PL 117-2); H.R. 6833/S. 3700 - Affordable Insulin Now Act; Issues related to Medicare Advantage payment policies; Issues related to mental health; Issues related to contraceptive coverage; Issues related to hospital billing; Consolidated Appropriations Act, 2023 (PL 117-328).
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
Medicare Advantage (MLR, risk adjustment, star ratings, supplemental benefits), Medicare Prior Authorization (H.R. 3173), Prescription Drug Rebates, Medicare Part D and Part D restructuring (H.R. 3, H.R. 19, S. 2164), Insulin Affordability (S. 3700, H.R. 6833), Telehealth, Build Back Better Act (H. Res. 601 & S. Con. Res. 14), Federal Coronavirus Response (American Rescue Plan, H.R. 1319), Parity for Audio-Only Risk Adjustment (H.R. 2166, S. 150), Inflation Reduction Act (P.L. 117-169), Third Party Marketing Organization Requirements, Behavioral Health (House Ways and Means Committee prints 117-1 & 117-2)
Client expense: $550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Issues related to COVID-19 vaccination programs; issues related to pharmacy, pharmacist provider status, and Medicare reimbursement; issues related to insulin, including the Affordable Insulin Now Act (S. 3700 and HR 6833).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to drug pricing; issues related to influenza vaccines; issues related to RSV Access; issues related to routine immunization rates; general issues related to vaccines; issues related to 340B; issues related to RX to OTC switch; issues related to Pandemic Preparedness in PREVENT Pandemics ACT; issues related to Reconciliation; issues related to Cosmetic Reform; issues related to S.3700 "Affordable Insulin Now Act"; issues related to S.2199 "Insulin Price Reduction Act"; issues related to Clinical Trial Diversity; issues related to Accelerated Approval; issues related to HR 6854 "Depict Act"; issues related to Out-of-Pocket Cap; general issues related to Insulin pricing; issues related to HR7667 "Food and Drug Amendments of 2022"; issues related to S.4348 "Food and Drug Administration and Landmark Advancements (FDASLA) Act; issues related to S.4293 "Pharmacy Benefit Managers Transparency Act of 2022"; issues related to HR 5376 "Inflation Reduction Act"; issues related to drug pricing in Inflation Reduction Act; issues related to cosmetics reform in the Modernization of Cosmetics Regulations Act; issues related to Copay Accumulators; issues related to Vaccine in Children Program; issues related to Q1/Q2 budget spend; issues related to ACNU "additional condition for prescription use; and issues related to HR 3656 "Vaccine Access Improvement Act".
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 6833/S. 3700, the Affordable Insulin Now Act and related issues. Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023, including Pharmacy Benefit Mangers (PBM) transparency, telehealth, mental health, and health care affordability. Issues related to H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022. Issues related to H.R. 7780, the Mental Health Matters Act. Issues related to mental health parity in H.R. 5376 Build Back Better Act. Issues related to P.L. 116-123, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; P.L. 116-127, Families First Coronavirus Response Act; P.L. 116-136, Coronavirus Aid, Response, and Economic Security Act (CARES Act); Issues related to P.L. No: 116-260, the Consolidated Appropriations Act, 2021. Issues related to P.L. 116-260, the Consolidated Appropriations Act of 2021. Issues related to S. 1388, the Prescription Pricing for the People Act of 2021. P.L. 117-103, the Consolidated Appropriations Act, 2022. P.L.117-169, the Inflation Reduction Act of 2022, including Enhanced advance premium tax credits (APTCs) and Medicare Part D redesign. Issues related to expanding availability of Association Health Plans (AHPs). Issues related to removing barriers to biosimilar medicine access.
Client expense: $1,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021- Rep. Rush, Bobby - patent infringement settlements H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana - GAO study of PBMs H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter - Medicare drug prices H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd - Drug Prices H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin copay caps S. 250 - Fairness in Orphan Drug Exclusivity Act - Sen. Cassidy, Bill - orphan drugs S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha - PBMs and pharmaceutical supply chain S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy -Medicare drug prices S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard - Medicare Drug prices S. 3700 - Affordable Insulin Now Act- Sen. Warnock, Raphael - insulin pricing and cost sharing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to coverage of EUA drugs under Medicare Part D; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,470,000 · 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), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 Medication affordability and access, general diabetes prevention, obesity S.3700/H.R. 6833 Affordable Insulin Now Act and issues related to affordability; No bill, issues related to medication affordability and access, general diabetes prevention, obesity; no bill, issues related to 340B
Client expense: $1,650,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 6007, Expansion of Coverage of Vaccines under Part B of the Medicare Program. Monitored implementation of H.R. 5376 (P.L. 117-169), the Inflation Reduction Act, as it relates to drug pricing issues. Monitored S. 3700 / H.R. 6833, Affordable Insulin Now Act. Monitored issues related to H.R. 3173, the Improving Seniors' Timely Access to Care Act. H.R. 2617 (P.L. 117-328), the Consolidated Appropriations Act of 2023, as it relates to Medicare physician payment and mental health.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to third party servicing of medical devices Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of COVID-19 diagnostic tests Issues related to the Valid Act of 2021 - H.R. 4128/S. 2209 Issues related to Health Equity Issues related to the PASTEUR Act of 2021 - S. 2076/HR 3932 Issues related to COVID-19 Clinical Testing & Testing Supplies Issues related to Public Health Emergency Preparedness Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to COVID-19 Clinical Testing and Testing Supplies Issues related to consumer and health data privacy Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Issues related to S. 4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Issues related to S. 3799, PREVENT Pandemics Act Issues related to S. 3700 Prevent Pandemics Act Issues related to H.R. 2617 Consolidated Appropriations Act Issues related to H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act Issues related to S. 4349 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Issues related to H.R. 7676 Emerging Signals Modernization Act of 2022 Issues related to cyber security including H.R. 7084/S. 3983, PATCH Act and S. 4336 Strengthening Cybersecurity for Medical Devices Act
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Issues related to Medicare Part B, CMS coverage and reimbursement, 340b drug pricing program; S. 773, A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; S. 3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S.4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; Issues related to accelerated approval; Issues related to patient assistance programs and copay accumulators; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Medicare Advantage flexibilities; Monitoring of Medicare Advantage, particularly as it relates to changes in coding intensity, benchmarks, and health risk assessments; Inflation Reduction Act of 2022 (PL 117-169) - extending enhanced premium assistance for ACA marketplace plans through 2025; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments and extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; and possible changes to Medicare provider directory policies; extending Acute Hospital Care at Home waivers and flexibilities through December 31, 2024, increasing transparency for home health payments under Medicare, and extending adjustment to calculation of hospice cap amount under Medicare; policies related to the unwinding of the PHE with respect to the Medicaid Maintenance of Effort; Issues related to implementation of the No Surprises Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity; Bipartisan Safer Communities Act, PL 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)); Issues related to the Public Health Emergency; Continued monitoring of Rebate Rule repeal; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 2617, Consolidated Appropriations Act, 2023 - extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity; Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to the Public Health Emergency; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 2617, Consolidated Appropriations Act, 2023 - extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to the Public Health Emergency; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 2617, Consolidated Appropriations Act, 2023 - permanently extending a policy from the American Rescue Plan allowing states to provide 12 months of postpartum coverage to pregnant individuals in Medicaid and CHIP, and extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; Education and awareness of mental health issues, particularly postpartum depression; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: Mental Health Workforce; Senate Finance Committee bipartisan Discussion Draft: The Mental Health Parity; Committee Print 117-1 - Improvements to Medicare Inpatient and Outpatient Mental Health Services (H.R. 8879, Inpatient Psychiatric Facility Improvement Act; H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program); Committee Print 117-2 - Improvements to the Medicare Program Related to Physician Services and Education (H.R. 432, Mental Health Access Improvement Act of 2021; H.R. 8910, Behavioral Health Integration Awareness Act of 2022; H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program; H.R. 8890, Physician Wellness Program Act of 2022; H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act); Committee Print 117-3 - Requiring Coverage of Forensic Medical Exams with No Cost Sharing (H.R. 8891, No Surprises for Survivors Act of 2022); Committee Print 117-4 - Improved Information in Provider Directories, Plan Definitions and Crisis Services for Private Insurance Plans (H.R. 8885, Better Health Care Directories Act; H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act; H.R. 8892, To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes); Committee Print 117-5 - Improved Information for Network Coverage and Plan Documents in Private Insurance Plans (H.R. 8881, To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; H.R. 8889, Readable Insurance Coverage Explanations Act (RICE Act)); Bipartisan Safer Communities Act, PL 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency, including flexibilities to prescribe controlled substances via telehealth; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) implementation - creating Medicare negotiation of drugs, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year, and preventing commercial spillover of maximum fair price into markets beyond Medicare; Consolidated Appropriations Act, 2023 (PL 117-328)- allowing new vaccines to be added to the Vaccine Injury Compensation Fund (VICF), preserving coverage and access to Part D products under EUA; Antibiotics/stewardship; Value of prescription drugs; S. 2076/H.R. 3932, PASTEUR Act of 2021; ACIP recommendations related to pneumococcal vaccines; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; S. 2706/H.R. 5030, DIVERSE Trials Act; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Education around tumor infiltrating lymphocytes (TIL) cancer therapies; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; Issues related to accelerated approval; CMS Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Rates Proposed Rule for FY 2023; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) - creating Medicare negotiation of drugs, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year. , and preventing commercial spillover of maximum fair price into markets beyond Medicare; Value of prescription drugs; Issues related to patient assistance programs and copay accumulators; Issues related to 340b Drug Pricing Program; Issues related to Medicare Part D; Issues related to Medicare Part B; Education around innovative therapies in dermatology; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) - - creating Medicare negotiation of drugs, extending enhanced premium assistance for ACA marketplace plans through 2025, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year, and preventing commercial spillover of maximum fair price into markets beyond Medicare; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments, extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024, and extending Acute Hospital Care at Home waivers and flexibilities through December 31, 2024; Healthcare workforce shortage issues; Committee Print 117-1 - Improvements to Medicare Inpatient and Outpatient Mental Health Services (H.R. 8879, Inpatient Psychiatric Facility Improvement Act; H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program); Committee Print 117-2 - Improvements to the Medicare Program Related to Physician Services and Education (H.R. 432, Mental Health Access Improvement Act of 2021; H.R. 8910, Behavioral Health Integration Awareness Act of 2022; H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program; H.R. 8890, Physician Wellness Program Act of 2022; H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act); Committee Print 117-3 - Requiring Coverage of Forensic Medical Exams with No Cost Sharing (H.R. 8891, No Surprises for Survivors Act of 2022); Committee Print 117-4 - Improved Information in Provider Directories, Plan Definitions and Crisis Services for Private Insurance Plans (H.R. 8885, Better Health Care Directories Act; H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act; H.R. 8892, To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes); Committee Print 117-5 - Improved Information for Network Coverage and Plan Documents in Private Insurance Plans (H.R. 8881, To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; H.R. 8889, Readable Insurance Coverage Explanations Act (RICE Act)); Cybersecurity in the healthcare sector; H.R. 8152, American Data Privacy and Protection Act; Issues related to privacy in the healthcare space; Issues related to national health information technology standards; Consolidated Appropriations Act, 2022 (PL 117-103); S. 3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: Mental Health Workforce; Bipartisan Safer Communities Act, PL 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; S. 3819, Advanced Research Project Authority for Health (ARPA-H) Act; Issues related to the White House Cancer Moonshot initiative; Issues related to the FY 2023 President's Budget; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
Inflation Reduction Act of 2022 (PL 117-169) - extending enhanced premium assistance for ACA marketplace plans through 2025; H.R. 2617, Consolidated Appropriations Act, 2023 - extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024 and possible changes to Medicare provider directory policies; Committee Print 117-1 - Improvements to Medicare Inpatient and Outpatient Mental Health Services (H.R. 8879, Inpatient Psychiatric Facility Improvement Act; H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program); Committee Print 117-2 - Improvements to the Medicare Program Related to Physician Services and Education (H.R. 432, Mental Health Access Improvement Act of 2021; H.R. 8910, Behavioral Health Integration Awareness Act of 2022; H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program; H.R. 8890, Physician Wellness Program Act of 2022; H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act); Committee Print 117-3 - Requiring Coverage of Forensic Medical Exams with No Cost Sharing (H.R. 8891, No Surprises for Survivors Act of 2022); Committee Print 117-4 - Improved Information in Provider Directories, Plan Definitions and Crisis Services for Private Insurance Plans (H.R. 8885, Better Health Care Directories Act; H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act; H.R. 8892, To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes); Committee Print 117-5 - Improved Information for Network Coverage and Plan Documents in Private Insurance Plans (H.R. 8881, To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; H.R. 8889, Readable Insurance Coverage Explanations Act (RICE Act)); Telehealth issues related to COVID-19; S. 150/H.R. 2166, Ensuring Parity in MA for Audio-Only Telehealth Act of 2021; HELP Committee bipartisan efforts to improve public health and medical preparedness/response programs; Over the Counter Covid Testing Guidance; Test to Treat Initiative; Issues related to the implementation of the No Surprises Act; S. 3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committee bipartisan Discussion Draft: Mental Health Workforce; Bipartisan Safer Communities Act, P.L. 117-159, specifically policy related to access to mental health services for youth and families through Medicaid and CHIP and telehealth; H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Issues related to FDA user fee reauthorization bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022), including accelerated approval, reimportation, and orphan drugs; Issues related to the Public Health Emergency; H.R. 7007, COVID Supplemental Appropriations Act, 2022; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to Medical Economic Index (MEI) in the 2023 Physician Fee Schedule Rule; H.R. 8800, The Supporting Medicare Providers Act of 2022; Issues related to physician payment cuts, including APM bonuses; Telehealth issues related to COVID-19; Health disparities; H.R. 2617, Consolidated Appropriations Act, 2023 - increasing Medicare Physician Fee Schedule payments and extending all Medicare telehealth flexibilities extended in the Consolidated Appropriations Act of 2022 through December 31, 2024; Issues related to the implementation of the No Surprises Act; S. 3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to the Senate Finance report on mental health and mental health legislation; Senate Finance Committee bipartisan Discussion Draft: Ensuring Access to Telemental Health Services; Senate Finance Committee bipartisan Discussion Draft: Improving Access to Physical and Mental Health Care for Children and Youth under Medicaid and CHIP; Senate Finance Committe bipartisan Discussion Draft: Mental Health Workforce H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022; Committee Print 117-1 - Improvements to Medicare Inpatient and Outpatient Mental Health Services (H.R. 8879, Inpatient Psychiatric Facility Improvement Act; H.R. 8878, To amend title XVIII of the Social Security Act to ensure adequate coverage of outpatient mental health services under the Medicare program); Committee Print 117-2 - Improvements to the Medicare Program Related to Physician Services and Education (H.R. 432, Mental Health Access Improvement Act of 2021; H.R. 8910, Behavioral Health Integration Awareness Act of 2022; H.R. 8884, To direct the Secretary of Health and Human Services to provide outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs under the Medicare program; H.R. 8890, Physician Wellness Program Act of 2022; H.R. 8908, Fighting Stimulant and other Substance Use Disorders Act); Committee Print 117-3 - Requiring Coverage of Forensic Medical Exams with No Cost Sharing (H.R. 8891, No Surprises for Survivors Act of 2022); Committee Print 117-4 - Improved Information in Provider Directories, Plan Definitions and Crisis Services for Private Insurance Plans (H.R. 8885, Better Health Care Directories Act; H.R. 8886, Promoting Clarity in Mental Health and Substance Use Disorder Treatment Act; H.R. 8892, To direct the Secretary of Health and Human Services to conduct a public outreach campaign to inform individuals covered under a group health plan or group or individual health insurance coverage of Federal requirements relating to mental health and substance use disorder crisis services, and for other purposes); Committee Print 117-5 - Improved Information for Network Coverage and Plan Documents in Private Insurance Plans (H.R. 8881, To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; H.R. 8889, Readable Insurance Coverage Explanations Act (RICE Act)); Issues related to reauthorization of FDA user fee bills (H.R. 7667, Food and Drug Amendments of 2022; S. 4348 Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)); Issues related to the Public Health Emergency; S. 368/H.R. 1332, Telehealth Modernization Act; H.R. 7007, COVID Supplemental Appropriations Act, 2022; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R.6087, Improving Access to Workers Compensation for Injured Federal Workers Act; Issues related to medical student federal loan forgiveness; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Monitored the implementation of H.R. 5376 (P.L. 117-169), the Inflation Reduction Act, as it relates to drug pricing. Monitored S. 3700 / H.R. 6833, Affordable Insulin Now Act. H.R. 7389, the MVP Act, issues related to the prescription drug value-based contracts.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Potential improvements and modifications to the Affordable Care Act (ACA) Prescription drug rebates in federal health programs Reform to the Centers for Medicare and Medicaid Innovation (CMMI) Proposals to expand Medicare, Medicaid, and ACA premium tax credits in the Inflation Reduction Act Repealing or delaying the Trump administration's rebate rule H.R. 5376Inflation Reduction Act's changes to prescription drug pricing in Medicare H.R. 3353Contact Lens Prescription Verification Modernization Act Mandatory Medicare negotiation of prescription drug prices Inflation rebates for prescription drugs in Medicare Parts B and D Medicare Part D redesign S. 3700 / H.R. 6833Affordable Insulin Now Act H.R. 5981 / S. 1704Telehealth Expansion Act Health Savings Account (HSA) expansion FDA user fee reauthorization 87 FR 20354Affordability of Employer Coverage for Family Members of Employees Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act HR 9160Healthcare Freedom Act
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
2022 · fourth_quarter · Medicare/Medicaid
Medicare Part D access and drug pricing negotiation. Compulsory licensing policy issues. Insulin policy issues; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act (draft legislation); S.3700, Affordable Insulin Now Act; implementation of H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
HR 5376 Inflation Reduction Act of 2022. Provisions related to health care coverage, Medicare, Medicaid, COVID funding and mental/behavioral health S. 3700 Affordable Insulin Act Now HR 7667 FDA Amendments of 2022 S 4348 The FDA Safety and Landmark Advancements Act HR 6963 Accelerated Approval Integrity Act of 2022 HR 6996 Accelerating Access for Patients Act of 2022 HR 5585 Advanced Research Project Agency Health (ARPA-H) Act HR 6000 Cures 2.0 Act
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Affordable Insulin Now Act (H.R.6833/S.3700); Affordable Insulin for All Act (no bill number)
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Inform policymakers on issues related to H.R. 6833/S. 3700, the Affordable Insulin Now Act and related issues; Issues related to P.L. 117-328, the Consolidated Appropriations Act 2023, including Pharmacy Benefit Managers (PBM) transparency, telehealth, mental health, and health care affordability; Issues related to H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022; Issues Related to H.R. 7780, the Mental Health Matters Act; Issues related to mental health parity in H.R. 5376 Build Back Better Act; and issues related to P.L. 116-260, the Consolidated Appropriations Act of 2021.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
Medicare Advantage (MLR, risk adjustment, star ratings, supplemental benefits), Medicare Prior Authorization (H.R. 3173), Prescription Drug Rebates, Medicare Part D and Part D restructuring (H.R. 3, H.R. 19, S. 2164), Insulin Affordability (S. 3700, H.R. 6833), Telehealth, Build Back Better Act (H. Res. 601 & S. Con. Res. 14), Federal Coronavirus Response (American Rescue Plan, H.R. 1319), Parity for Audio-Only Risk Adjustment (H.R. 2166, S. 150), Inflation Reduction Act (P.L. 117-169), Third Party Marketing Organization Requirements, Behavioral Health (House Ways and Means Committee prints 117-1 & 117-2), Consolidated Appropriations Act, 2023 (P.L. 117-403).
Client expense: $570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; "Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act 2021" (S 2076 & HR.3932); "Inflation Reduction Act" (HR.5376); Affordable Prescriptions for Patients Act of 2021 (S.1435); Prescription Drug User Fee reauthorization; prescription drug approval; Affordable Insulin Now Act (S.3700/HR.6833), The INSULIN Act
Client expense: $2,021,850 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Implementation of the ACA (PL 111-148) and stabilization issues; Issues related to the federal COVID response and COVID Testing; Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act (PL 116-123); Implementation of Families First Coronavirus Response Act (PL 116-127); Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136); Health; H.R. 925 - the HEROES Act; Implementation of FY2021 Omnibus and COVID Relief and Response Act (PL 116-260); H.R. 2166 - The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act; The American Rescue Plan Act of 2021 (PL 117-2); H.R. 6833/S. 3700 - Affordable Insulin Now Act; Issues related to Medicare Advantage payment policies; Issues related to mental health; Issues related to contraceptive coverage. H.R. 8133 The Transparency of Hospital Billing Act. Consolidated Appropriations Act, 2023 (PL 117-328).
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to Mental Health Coverage in Medicare and Medicaid; Issues related to the commercialization of COVID-19 testing, vaccines and treatments. Issues related to the continuation of Telehealth Services. S. 3700 - Affordable Insulin Now Act; Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (PL 117-180); S. 2199 - Insulin Price Reduction Act.
Client expense: Not reported · Firm income: $30,000
Government targets: SENATE
2022 · fourth_quarter · Health Issues
Issues relating to drug pricing; H.R. 6833/S. 3700 - Affordable Insulin Now Act; Improving Needed Safeguards for Users of Lifesaving Insulin Now Act; Consolidated Appropriations Act, 2023 (PL 117-328)-PREVENT Pandemics Act S. 3799.
Client expense: Not reported · Firm income: $80,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022; Draft legislation on pharmacy DIR fee reform
Client expense: $320,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office
2022 · fourth_quarter · Health Issues
HR 2617 - Consolidated Appropriations Act for Fiscal Year 2023 - Issues related to ensuring high quality/ high value pharmacy benefits in the Medicare program. PL 117-169 - The Inflation Reduction Act - Support for policies delaying the Trump-era Rebate Rule. S. 1388 - The Prescription Drug Pricing for the People Act - Support for additional transparency across the prescription drug supply chain. S. 4293 - The Pharmacy Benefit Manager Act of 2022 - Issues related to how PBMs work. S. 3700 - The INSULIN Act - Issues related to making insulin affordable for all Americans. Regulations focused on quality measures used in contracting relationships between pharmacy benefit managers and pharmacies (known as DIR). PL 117-2 - The American Rescue Plan Act - Implementation of policies related to increasing access to health care coverage, including access to prescription drugs, for Americans with both public and private insurance.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medicare/Medicaid
HR 2617 - Consolidated Appropriations Act for Fiscal Year 2023 - Issues related to ensuring high quality/ high value pharmacy benefits in the Medicare program. PL 117-169 - The Inflation Reduction Act - Support for policies delaying the Trump-era Rebate Rule. S. 3700 - The INSULIN Act - Issues related to making insulin affordable for all Americans. Regulations focused on quality measures used in contracting relationships between pharmacy benefit managers and pharmacies (known as DIR). PL 117-2 - The American Rescue Plan Act - Implementation of policies related to increasing access to health care coverage, including access to prescription drugs, for Americans with both public and private insurance.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
HR 2617 - Consolidated Appropriations Act for Fiscal Year 2023 - Issues related to ensuring high quality/ high value pharmacy benefits in the Medicare program. PL 117-169 - The Inflation Reduction Act - Support for policies delaying the Trump-era Rebate Rule. S. 1388 - The Prescription Drug Pricing for the People Act - Support for additional transparency across the prescription drug supply chain. S. 4293 - The Pharmacy Benefit Manager Act of 2022 - Issues related to how PBMs work. S. 2938 - The Bipartisan Safer Communities Act of 2022 - Support for legislation and the inclusion of a one year delay of the Trump era Medicare rebate rule. S. 3700 - The INSULIN Act - Issues related to making insulin affordable for all Americans. Issues and legislative vehicles related to capping the price of Insulin. Regulations focused on quality measures used in contracting relationships between pharmacy benefit managers and pharmacies (known as DIR). H.R. 5376 - The Build Back Better Act - Support of full repeal of the Trump Administration's Rebate Rule. PL 117-2 - The American Rescue Plan Act - Implementation of policies related to increasing access to health care coverage, including access to prescription drugs, for Americans with both public and private insurance.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medicare/Medicaid
Physician Fee Schedule conversion factor/ E/M PPS policy changes HR 4587 Value in Health Care Act H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes. Telehealth issues related to COVID-19; S. 368/H.R. 1332, Telehealth Modernization Act S.3799, PREVENT Pandemics Act; S. 3700/H.R. 6833, Affordable Insulin Now Act; Mental health legislative workstream. Issues related to reauthorization of the FDA user fee bills; HR 5376 Inflation Reduction Act
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE