HOWARD MOON

Cited source text

H.R. 6624

Biological Intellectual Property Protection Act of 2025

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Original LDA source filings (85)

Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.

2026 · third_quarter · Q3

Firm income: —Client expense: $3,150,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Issues related to drug pricing Issues related to cardiovascular disease awareness and treatment Issues related to FDA Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Issues related to biosimilars reimbursement Issues related to Supply Chain Issues related to 340B Issues related to pharmacy benefit managers Issues related to biosimilars regulatory standards Issues related to bone disease awareness and treatment Issues related to Public law 117-1769 Inflation Reduction Act HR 1492 Ensuring Pathways to Innovative Cures Act HR 1672 Maintaining Investments in New Innovation Act HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14) S 1954 Biosimilar Red Tape Elimination Act H.R.5526 Biosimilar Red Tape Elimination Act S.3345 PBM Price Transparency and Accountability Act H.R. 6166 Lowering Drug Costs for American Families Act S.3019 No Big Blockbuster Bailouts Act HR 4317 PBM Reform Act S 3510 Biosimilar Inspection Modernization Act PL 119-75 Consolidated Appropriations Act of 2026 HR 4299 Protecting Patient Access to Cancer and Complex Therapies Act H.R.7837 Most Favored Patient Act of 2026 S 3788 Clear Labels Act HR 5256 340B Access Act HR 7391 Community Health Center Drug Pricing Protection Act HR 8143/S 4323 Ensuring Access to Lower-Cost Medicines for Seniors Act S.2, Secure America Act (Reconciliation 2.0) S 3014 Ensuring Timely Access to Generics Act of 2025 S 2355 Patients Deserve Price Tags Act HR 8646 Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 HR 8800 National Defense Authorization Act for Fiscal year 2027 HR 9102 BINSA Bill COINS Act, enacted within P.L. 119-60 National Defense Authorization Act for Fiscal Year 2026 S 1414 Expedited Access to Biosimilars Act HR 10628/ S 5571 Biosimilars Access and Affordability Act S 5244 Sustain 340B Act HR 9599 Secure 340B Act HR 5509/ S 2903 Safe Step Act

Source: Senate LDA

Show 96 more cited filings

S. 3452

Biological Intellectual Property Protection Act of 2025

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3452

Biological Intellectual Property Protection Act of 2025

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Abolish the Last Great Plantation in America Resolution

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Abolish the Last Great Plantation in America Resolution

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Abolish the Last Great Plantation in America Resolution

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Abolish the Last Great Plantation in America Resolution

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

For the People Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

For the People Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

For the People Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

For the People Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Methane Waste Prevention Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Methane Waste Prevention Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Methane Waste Prevention Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Methane Waste Prevention Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Connect America Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Connect America Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Connect America Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Connect America Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Connect America Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Connect America Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Foster Care Stabilization Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Foster Care Stabilization Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Foster Care Stabilization Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Foster Care Stabilization Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Foster Care Stabilization Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Foster Care Stabilization Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Separation of Powers Restoration Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Separation of Powers Restoration Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Separation of Powers Restoration Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Separation of Powers Restoration Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Separation of Powers Restoration Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Separation of Powers Restoration Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5256

Flood History Information Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5256

Flood History Information Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5256

Flood History Information Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5509

Student Veteran COVID-19 Protection Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5526

Improving Mental Health and Wellness in Schools Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5526

Improving Mental Health and Wellness in Schools Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 5526

Improving Mental Health and Wellness in Schools Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

District of Columbia Transportation Funding Equality Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

District of Columbia Transportation Funding Equality Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

District of Columbia Transportation Funding Equality Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

District of Columbia Transportation Funding Equality Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

District of Columbia Transportation Funding Equality Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

District of Columbia Transportation Funding Equality Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 7391

ACES Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 7391

ACES Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 7391

ACES Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

National Guard Promotion Improvement Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

National Guard Promotion Improvement Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

National Guard Promotion Improvement Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

National Guard Promotion Improvement Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

National Guard Promotion Improvement Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

National Guard Promotion Improvement Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Lone Star Reimbursement Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Lone Star Reimbursement Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Lone Star Reimbursement Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Lone Star Reimbursement Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 8646

INSPECT Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 8646

INSPECT Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 8800

Supporting Medicare Providers Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 8800

Supporting Medicare Providers Act of 2022

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 9102

Rebuilding the United States-Flag International Fleet Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 9102

Rebuilding the United States-Flag International Fleet Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 9599

Heidi’s Law

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

H.R. 9599

Heidi’s Law

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 1414

Consortia-Led Energy and Advanced Manufacturing Networks Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 1414

Consortia-Led Energy and Advanced Manufacturing Networks Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 1954

John H. Chafee Blackstone River Valley National Heritage Corridor Reauthorization Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 1954

John H. Chafee Blackstone River Valley National Heritage Corridor Reauthorization Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 1954

John H. Chafee Blackstone River Valley National Heritage Corridor Reauthorization Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

AACCENT Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

AACCENT Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

AACCENT Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

AACCENT Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 2355

A bill to require the Administrator of the Small Business Administration make a technical correction to the Restaurant Revitalization program to allow distilleries that are prohibited by State law from meeting the onsite sales requirements under the program to participate in the program.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 2355

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 2903

Emerging Technologies Professional Military Education Act of 2021

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3014

Next Generation Telecommunications Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3014

Next Generation Telecommunications Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

A bill to require the United States Postal Service to designate a single, unique ZIP code for particular communities.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

A bill to require the United States Postal Service to designate a single, unique ZIP code for particular communities.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

A bill to require the United States Postal Service to designate a single, unique ZIP code for particular communities.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

A bill to require the United States Postal Service to designate a single, unique ZIP code for particular communities.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

A bill to require the United States Postal Service to designate a single, unique ZIP code for particular communities.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

A bill to require the United States Postal Service to designate a single, unique ZIP code for particular communities.

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Protecting Ballot Measures from Foreign Influence Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Protecting Ballot Measures from Foreign Influence Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Protecting Ballot Measures from Foreign Influence Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Protecting Ballot Measures from Foreign Influence Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Protecting Ballot Measures from Foreign Influence Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

Protecting Ballot Measures from Foreign Influence Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3349

Streamlining EIDL Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3349

Streamlining EIDL Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3349

Streamlining EIDL Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

S. 3510

Disaster Resiliency Planning Act

Client: AMGEN INC · Firm: AMGEN, INC.

Cited source text

2026 · second_quarter · Q2

Firm income: —Client expense: $2,440,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

TAR

Tariff (miscellaneous tariff bills)

Issues related to tariffs Issues related to trade agreements S. 3452/HR 6624 Biological Intellectual Property Protection Act of 2025

HCR

Health Issues

MMM

Medicare/Medicaid

Issues related to drug pricing Issues related to cardiovascular disease awareness and treatment Issues related to reimbursement for biologics/biosimilars Issues related to PBM reform Issues related to bone disease awareness and treatment S.3345, PBM Price Transparency and Accountability Act HR 6166, Lowering Drug Costs for American Families Act S 3019 - No Big Blockbuster Bailouts Act S 3349 PBM Disclosure Act HR 4317 PBM Reform Act Issues related to Public law 117-1769 Inflation Reduction Act HR 1672 Maintaining Investments in New Innovation Act (MINI) HR 4299 Protecting Patient Access to Cancer and Complex Therapies Act H.R.7837 Most Favored Patient Act of 2026 PL 119-75 Consolidated Appropriations Act of 2026 HR 8143/S 4323 Ensuring Access to Lower-Cost Medicines for Seniors Act S.2, Secure America Act

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

2026 · first_quarter · Q1

Firm income: —Client expense: $2,580,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

TAR

Tariff (miscellaneous tariff bills)

Issues related to tariffs Issues related to trade agreements S. 3452/HR 6624 Biological Intellectual Property Protection Act of 2025

MMM

Medicare/Medicaid

Issues related to drug pricing Issues related to cardiovascular disease awareness and treatment Issues related to reimbursement for biologics/biosimilars Issues related to PBM reform Issues related to bone disease awareness and treatment HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14) S.3345, PBM Price Transparency and Accountability Act HR 6166, Lowering Drug Costs for American Families Act S 3019 - No Big Blockbuster Bailouts Act S 3349 PBM Disclosure Act HR 4317 PBM Reform Act Issues related to Public law 117-1769 Inflation Reduction Act HR 1492 Ensuring Pathways to Innovative Cures Act (EPIC) HR 1672 Maintaining Investments in New Innovation Act (MINI) HR 4299 Protecting Patient Access to Cancer and Complex Therapies Act H.R.7837 Most Favored Patient Act of 2026 PL 119-75 Consolidated Appropriations Act of 2026

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

2025 · fourth_quarter · Q4

Firm income: —Client expense: $3,550,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Issues related to drug pricing Issues related to Public law 117-1769 Inflation Reduction Act Issues related to cardiovascular disease awareness and treatment Issues related to reimbursement for biologics/biosimilars Issues related to PBM reform Issues related to bone disease awareness and treatment HR 946 Optimizing Research Progress Hope and New Cures Act HR 1492 Ensuring Pathways to Innovative Cures Act HR 1672 Maintaining Investments in New Innovation Act HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14) H.R.1968 - Full-Year Continuing Appropriations and Extensions Act, 2025 S.3345, PBM Price Transparency and Accountability Act H.R. 6166, Lowering Drug Costs for American Families Act S.3019 - No Big Blockbuster Bailouts Act H.Res. 928 - Affirming support for most-favored-Nation drug pricing for United States patients S 3349 PBM Disclosure Act HR 4317 PBM Reform Act

HCR

Health Issues

Issues related to drug pricing Issues related to cardiovascular disease awareness and treatment Issues related to FDA Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Issues related to biosimilars reimbursement Issues related to Supply Chain Issues related to 340B Issues related to pharmacy benefit managers Issues related to biosimilars regulatory standards Issues related to bone disease awareness and treatment Issues related to Public law 117-1769 Inflation Reduction Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 946 Optimizing Research Progress Hope and New Cures Act HR 1492 Ensuring Pathways to Innovative Cures Act HR 1672 Maintaining Investments in New Innovation Act HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14) S 1954 Biosimilar Red Tape Elimination Act HR 5526 Biosimilar Red Tape Elimination Act HR 2214 DRUG Act H.R.1968 - Full-Year Continuing Appropriations and Extensions Act, 2025 HR 5509 Safe Step act HR 5256 340B Access Act HR 4581 340B Patients Act S2296 NDAA FY2026 National Defense Authorization Act, issued related to Biosecure Act H.R. 6703 Lower Health Care Premiums for All Americans Act S.3345 PBM Price Transparency and Accountability Act H.R. 6166 Lowering Drug Costs for American Families Act S.3019 No Big Blockbuster Bailouts Act H.Res. 928 Affirming support for most-favored-Nation drug pricing for United States patients S 3349 PBM Disclosure Act HR 4317 PBM Reform Act S 3510 Biosimilar Inspection Modernization Act

TAR

Tariff (miscellaneous tariff bills)

Issues related to tariffs.

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

Show 81 more original filings

2025 · second_quarter · 2A

Firm income: —Client expense: $2,580,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Issues related to drug pricing Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act Issues related to cardiovascular disease awareness and treatment Issues related to FDA Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Issues related to biosimilars reimbursement Issues related to Supply Chain Issues related to 340B Issues related to pharmacy benefit managers Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues related to biosimilars regulatory standards Issues related to bone disease awareness and treatment Issues related to pediatric priority review voucher reauthorization HR 946 Optimizing Research Progress Hope and New Cures Act HR 1492 Ensuring Pathways to Innovative Cures Act HR 1672 Maintaining Investments in New Innovation Act HR 2214 DRUG Act H.R.1968 - Full-Year Continuing Appropriations and Extensions Act, 2025 HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14) S 1954 Biosimilar Red Tape Elimination Act

MMM

Medicare/Medicaid

TAR

Tariff (miscellaneous tariff bills)

Issues related to tariffs.

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

2025 · third_quarter · Q3

Firm income: —Client expense: $3,550,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

MMM

2025 · second_quarter · Q2

Firm income: —Client expense: $2,580,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

MMM

2025 · first_quarter · Q1

Firm income: —Client expense: $3,610,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

Issues related to drug pricing reform -Changes to Public law 117-1769 Inflation Reduction Act -Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act Issues related to cardiovascular disease awareness and treatment Issues related to FDA Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Issues related to biosimilars reimbursement Issues related to Supply Chain Issues related to 340B Issues related to pharmacy benefit managers Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Issues related to prohibiting the export of biotechnology to certain foreign entities (BIOCOMPETE) Issues related to direct-to-consumer advertising Issues related to obesity disease awareness and treatment Issues related to biosimilars regulatory standards Issues related to bone disease awareness and treatment Issues related to pediatric priority review voucher reauthorization HR 946 Optimizing Research Progress Hope and New Cures Act HR 1492 Insuring Pathways to Innovative Cures Act HR 1672 Maintaining Investments in New Innovation Act HR 2214 DRUG Act H.R.1968 - Full-Year Continuing Appropriations and Extensions Act, 2025 S.Con.Res.7 - An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034. H.Con.Res.14 - Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.

2024 · fourth_quarter · Q4

Firm income: —Client expense: $2,780,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652/ HR2630 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act S 3430 Mental Health, Lower Cost Drugs and Extenders Package. BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities HR 8412 Clinical Trial Modernization Act S 5573 Skinny Labels, Big Savings Act HR 10515 American Relief Act

2024 · third_quarter · Q3

Firm income: —Client expense: $2,770,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act HR 2534 PROTECT 340B act of 2023 HR 3561 the PATIENT act Issues related to cardiovascular disease awareness and treatment Issues related to ESRD Issues related to asthma and self-administered drug list Issues related to reimbursement for biologics/biosimilars Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S2407 Treat and Reduce Obesity Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 1542/HR 6283 DRUG Act S652 SAFE Step Act HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 S 2474/HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act HR 5547 Maintaining Investments in New Innovation Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act. S 3430 Mental Health, Lower Cost Drugs and Extenders Package HR 5539 Orphan Cures Act

2024 · second_quarter · Q2

Firm income: —Client expense: $2,740,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Issues related to drug pricing reform -Changes to Public law 117-1769 Inflation Reduction Act -Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542/ hr 6283 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act . H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act . HR 5376 Share the Savings With Seniors Act . S 3430 Mental Health, Lower Cost Drugs and Extenders Package . BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities

2024 · first_quarter · Q1

Firm income: —Client expense: $3,330,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

2023 · third_quarter · 3A

Firm income: —Client expense: $2,980,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

2023 · fourth_quarter · Q4

Firm income: —Client expense: $3,550,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

2023 · third_quarter · Q3

Firm income: —Client expense: $2,240,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill S.2140 Patent Eligibility Restoration Act of 2023 S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. H.R. 3535 Advancing Americas Interests Act H.R. 5475 Prohibiting Adversarial Patents Act of 2023 Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to False Claims Act Issues related to FDA/PTO coordination Issues related to patent thickets/product hopping Issues related to obviousness/ double patenting

HCR

2023 · second_quarter · 2A

Firm income: —Client expense: $1,950,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

HCR

Health Issues

CPT

2023 · second_quarter · Q2

Firm income: —Client expense: $1,950,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

MMM

Medicare/Medicaid

HCR

Health Issues

2023 · first_quarter · Q1

Firm income: —Client expense: $2,800,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

MMM

Medicare/Medicaid

CPT

S. 79 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill Issues related to the Patent Act, no specific bill Issues related to march-in/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to false claims act Issues related to FDA/PTO coordination Issues related to patent thickets/product hopping

2022 · fourth_quarter · 4A

Firm income: —Client expense: $2,140,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

TAX

Taxation/Internal Revenue Code

Issues related to corporate and international tax, including regarding Public Law 115-97, Tax Cuts and Jobs Act Issues related to Puerto Rico Issues related to OECD negotiations on the taxation of global income

HCR

Health Issues

Issues related to drug pricing reform Public law 117-1769 Inflation Reduction Act HR 2617 Consolidated Appropriations Act of 2023, --issues related to cardiovascular disease, --Issues related to FTC, --FDA issues (Food and Drug Omnibus Reforms Act) --Issues related to Pharmacy Benefit Manger transparency --Issues related to clinical trial diversity S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act Issues related to 340B H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters HR 8588 Fair Care Act, 340B hospital reporting HR 4390 Protect 340B Act

2022 · fourth_quarter · Q4

Firm income: —Client expense: $2,140,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

MMM

Medicare/Medicaid

Public law 117-1769 Inflation Reduction Act HR 2617 Consolidated Appropriations Act of 2023 Issues related to drug pricing reform and Medicare Part D redesign S. 1943 and H.R. 3517, Issues related to DXA scans, osteoporosis issues related to cardiovascular disease awareness Issues related to ESRD Issues related to asthma and self-administered drug list Reimbursement for biologics/biosimilars Issues related to discarded drugs

CPT

S.1435 Affordable Prescriptions for Patients Act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S 2891 Restore the America Invents Act S. 2774 - Pride in Patent Ownership Act S. 4704 - Patent Examination and Quality Improvement Act of 2022 S. 4417 - Patent Trial and Appeal Board Reform Act of 2022 S. 4430 - Interagency Patent Coordination and Improvement Act of 2022 FTC related issues Issues related to the Patent Act Issues related to march-in/Bayh Dole, WTO/TRIPS waiver, no specific bill

2022 · third_quarter · Q3

Firm income: —Client expense: $3,150,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Issues related to drug pricing reform and Medicare Part D redesign H.R. 5376 Build Back Better Act S. 1943 and H.R. 3517, Issues related to DXA scans, osteoporosis issues related to cardiovascular disease awareness Issues related to ESRD bundle Issues related to asthma and self-administered drug list S. 2428 False Claims Amendments Act of 2021 Reimbursement for biologics/biosimilars Issues related to discarded drugs

CPT

S.1435 Affordable Prescriptions for Patients Act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S 2891 Restore the America Invents Act S. 2774- Pride in Patent Ownership Act S. 4704- Patent Examination and Quality Improvement Act of 2022 S. 4417- Patent Trial and Appeal Board Reform Act of 2022 S. 4430- Interagency Patent Coordination and Improvement Act of 2022 FTC related issues, no specific bill Issues related to the Patent Act Issues related to march-in/Bayh Dole, WTO/TRIPS waiver, no specific bill Mergers and acquisitions, no specific bill

2022 · second_quarter · Q2

Firm income: —Client expense: $2,070,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

MMM

Medicare/Medicaid

Issues related to drug pricing reform and Medicare Part D redesign H.R. 5376 Build Back Better Act S. 1943 and H.R. 3517, Issues related to DXA scans, osteoporosis Issues related to the 340B program issues related to cardiovascular disease awareness Issues related to ESRD bundle Issues related to asthma and self-administered drug list S. 2428 False Claims Amendments Act of 2021 Reimbursement for biologics/biosimilars Issues related to discarded drugs

2022 · first_quarter · Q1

Firm income: —Client expense: $2,780,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

MMM

Medicare/Medicaid

S. 99 The Medicare Drug Price Negotiation Act, issues related to international reference pricing and Part D redesign H.R. 3 Lower Drug Costs Now Act, issues related to international reference pricing and Part D redesign H.R. 5376 Build Back Better Act, issues related to international reference pricing and Part D redesign S. 1943 and H.R. 3517, Issues related to DXA, osteoporosis HR 2471 Consolidated Appropriations Act 2022, Issues related to the 340B program HR 2471, Consolidated appropriations Act of 2022, ESRD bundle, calcimimetic access H.R. 19 Lower Costs, More Cures Act of 2021, issues related to international reference pricing and Part D redesign H.R. 5260 Reduced Costs and Continued Cures Act, issues related to international reference pricing and Part D redesign Issues related to prescription drug pricing and Part D redesign S. 2428 False Claims Amendments Act of 2021 Reimbursement for biologics/biosimilars

2021 · fourth_quarter · 4A

Firm income: —Client expense: $2,410,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Biosimilars reimbursement issues, no specific bill H.R. 3, Prescription drug pricing issues FDA issues, no specific bill Supply Chain Issues, no specific bill Patent thickets/product hopping, no specific bill Mergers/acquisitions, no specific bill H.R. 19 Lower Costs, More Cures Act of 2021 H.R. 5260 Reduced Costs and Continued Cures Act H.R.5376, "Build Back Better Act Issues related to clinical trial diversity

MMM

Medicare/Medicaid

S. 99 The Medicare Drug Price Negotiation Act, issues related to international reference pricing and Part D redesign H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act, issues related to international reference pricing and Part D redesign S. 1943 and H.R. 3517, Issues related to DXA, osteoporosis Issues related to international reference pricing Issues related to the 340B program, no specific bill Reimbursement for biologics/biosimilars Issues related to Medicare Part D redesign Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters ESRD bundle, calcimimetic access, no specific bill H.R. 19 Lower Costs, More Cures Act of 2021, issues related to international reference pricing and Part D redesign H.R. 5260 Reduced Costs and Continued Cures Act, issues related to international reference pricing and Part D redesign S. 2428 False Claims Amendments Act of 2021 H.R. 5376 Build Back Better Act, issues related to international reference pricing and Part D redesign H.R. 5801 HELP Copays Act

2021 · fourth_quarter · Q4

Firm income: —Client expense: $2,410,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

S.1435 Affordable Prescriptions for Patients Act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2428 False Claims Amendments Act of 2021 Mergers and acquisitions, no specific bill

HCR

Health Issues

MMM

2021 · third_quarter · Q3

Firm income: —Client expense: $2,620,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

S.1435 Affordable Prescriptions for Patients Act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2428 False Claims Amendments Act of 2021 H.R. 3684 Infrastructure Investment and Jobs Act S.Con.Res.14 - A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022

HCR

Health Issues

Biosimilars reimbursement issues, no specific bill H.R. 3, Prescription drug pricing issues FDA issues, no specific bill Supply Chain Issues, no specific bill Patent thickets/product hopping, no specific bill Mergers/acquisitions, no specific bill H.R. 3684 Infrastructure and Jobs Act H.R.5376, "Build Back Better Act H.R. 19 Lower Costs, More Cures Act of 2021 H.R. 5260 Reduced Costs and Continued Cures Act

MMM

2021 · second_quarter · Q2

Firm income: —Client expense: $1,910,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

Issues related to drug patents and exclusivities, no specific bill Patent eligibility reform, no specific bill FTC related issues, no specific bill Issues related to World Trade Organization IP waiver, no specific bill

HCR

Health Issues

MMM

Medicare/Medicaid

S. 99 The Medicare Drug Price Negotiation Act H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act Issues related to Drug Pricing Issues related to clinical trial diversity S. 1943 and H.R. 3517, Issues related to DXA, osteoporosis Issues related to international reference pricing Issues related to the 340B program, no specific bill Reimbursement for biologics/biosimilars Issues related to Medicare Part D redesign Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Patent thickets/product hopping, no specific bill Mergers/acquisitions, no specific bill Labor-HHS Appropriations

2021 · first_quarter · Q1

Firm income: —Client expense: $2,810,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

S. 99 The Medicare Drug Price Negotiation Act Vial size issues, no specific bill H.R.1319- the American Rescue Plan Act of 2021 Changes to Six Protected Classes & Part D Payment Modernization model for CY22 Issues related to Drug Pricing Issues related to clinical trial diversity Issues related to osteoporosis, no specific bill Issues related to international reference pricing and Most Favored Nation (MFN) model Interim Final Rule Issues related to the 340B program, no specific bill Reimbursement for biologics/biosimilars Issues related to Part D redesign Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Patent thickets/product hopping, no specific bill Mergers/acquisitions, no specific bill

HCR

Health Issues

Biosimilars reimbursement issues, no specific bill H.R. 3, Prescription drug pricing issues FDA issues, no specific bill Vial size issues Supply Chain Issues, no specific bill

2020 · fourth_quarter · Q4

Firm income: —Client expense: $2,560,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 8406 - The HEROES 2.0 (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Executive Order on Lowering Drug Prices by Putting America First and Most Favored Nation (MFN) model Interim Final Rule H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures Act S. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Home administration for Part B medicines due to COVID-19 Reimbursement for biologics/biosimilars Issues related to Part D redesign Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Medicaid Value-Based Purchasing (VBP) Proposed Rule (Line Extensions & Manufacturer Co-pay Assistance) S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act of 2019

2020 · third_quarter · Q3

Firm income: —Client expense: $2,920,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

H.R. 6800 - HEROES (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 8406 - The HEROES 2.0 (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 2021 Notice of Benefit and Payment Parameters (NBPP) rule and cost-sharing assistance H.R. 7647 - Preserving Patient Savings on Drug Costs Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 Issues related to Most Favored Nation (MFN)/International Pricing Index (IPI) Executive Order, no specific bill H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures Act S. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Medicare Part B coverage and reimbursement issues Home administration for Part B medicines due to COVID-19 Issues related to International Pricing Index (IPI), no specific bill Coding and reimbursement for biologics/biosimilars Issues related to Part D redesign Issues related to Part D rebate reform Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to Direct to Consumer Advertisement Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters Medicare End Stage Renal Disease Prospective Payment System (ESRD PPS) Proposed Rule (bundled payment for calcimimetics) Medicaid Value-Based Purchasing (VBP) Proposed Rule (Line Extensions & Manufacturer Co-pay Assistance)

2020 · second_quarter · Q2

Firm income: —Client expense: $2,970,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

H.R. 6800 - HEROES (Health and Economic Recovery Omnibus Emergency Solutions) Act and temporary access to Part B medicines at home H.R. 266 - Paycheck Protection Program and Health Care Enhancement Act and temporary access to Part B medicines at home H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 2021 Notice of Benefit and Payment Parameters (NBPP) rule and cost-sharing assistance. H.R. 6179 - Increasing Access to Biosimilars Act of 2020 H.R. 4597/S. 3466 - the ACCESS for Biosimilars Act of 2020 H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 19/S. 3129 Lower Costs, More Cures ActS. 2543 Prescription Drug Pricing Reduction Act Issues related to the 340B program, no specific bill Medicare Part B coverage and reimbursement issues Home administration for Part B medicines due to COVID-19 Issues related to International Pricing Index (IPI), no specific bill Coding and reimbursement for biologics/biosimilars Issues related to Part D redesign Issues related to Part D rebate reform Medicare Part D access issues for plan year 2020 and 2021, no specific bill Issues related to Direct to Consumer Advertisement patient affordability issues, including copay cards

HCR

2020 · first_quarter · Q1

Firm income: —Client expense: $2,700,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act

MMM

Medicare/Medicaid

Medicare Part B coverage and reimbursement issues Issues related to International Pricing Index (IPI), no specific bill Coding and reimbursement for biologics/biosimilars Issues related to Part D redesign, no specific bill Issues related to Part D rebate reform, no specific bill Medicare Part D access issues for plan year 2020, no specific bill S. 1676 Chronic Kidney Disease Improvement in Research and Treatment Act; Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues H.R. 2296/S 1391 FAIR Drug Pricing Act S. 1416 Affordable Prescriptions for Patients Act Issues related to Direct to Consumer Advertisement Issues related to Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 1664, Prescription Drug Price Reporting Act H.R. 3 - Lower Prescription Drug Costs Now Act H.R. 2693/S. 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019 Issues related to the Center for Medicare & Medicaid Innovation S. 2543 Prescription Drug Pricing Reduction Act Section 210- Applying Medicaid Drug Rebate Requirement to Drugs Provided as Part of Outpatient Hospital Services H.R. 19/S. 3129 Lower Costs, More Cures Act 2021 Notice of Benefit and Payment Parameters (NBPP) proposed rule and cost-sharing assistance. HR 748 Coronavirus Aid, Relief, and Economic Security (CARES) Act and access to Part B medicines at home Issues related to the 340B program, no specific bill

2019 · second_quarter · 2A

Firm income: —Client expense: $2,200,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

TRD

Trade (domestic/foreign)

United States-Mexico-Canada Trade Agreement, no specific bill.

CPT

S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing

MMM

Medicare/Medicaid

Medicare Part B coverage and reimbursement issues Coding and reimbursement for biologics/biosimilars HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill) Issues related to Part D coverage gap, no specific bill S. 1676 Chronic Kidney Disease Improvement in Research and Treatment Act; Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues H.R. 6142 Reducing Drug Waste Act of 2018 Issues related to the 340b program, no specific bill Drug Price Transparency Bills: oHR 2296/S 1391 FAIR Drug Pricing Act oHR 2113 Prescription Drug STAR Act oHR 2069 SPIKE Act S 1416 Affordable Prescriptions for Patients Act Issues related to Direct to Consumer Advertisement S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act H.R. 2087, Drug Price Transparency Act

2019 · fourth_quarter · Q4

Firm income: —Client expense: $2,400,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

CPT

TRD

Trade (domestic/foreign)

United States-Mexico-Canada Trade Agreement, no specific bill.

2019 · third_quarter · Q3

Firm income: —Client expense: $3,090,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

MMM

Medicare/Medicaid

Medicare Part B coverage and reimbursement issues Coding and reimbursement for biologics/biosimilars Issues related to Part D coverage gap, no specific bill S. 1676 Chronic Kidney Disease Improvement in Research and Treatment Act; Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues Issues related to the 340b program, no specific bill Drug Price Transparency Bills: oHR 2296/S 1391 FAIR Drug Pricing Act oHR 2113 Prescription Drug STAR Act oHR 2069 SPIKE Act S 1416 Affordable Prescriptions for Patients Act Issues related to Direct to Consumer Advertisement S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 637, Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 1664, Prescription Drug Price Reporting Act H.R. 1046, Medicare Negotiation and Competitive Licensing Act H.R. 3 - Lower Prescription Drug Costs Now Act HR 2693/S 283 - Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. (This is the DXA bill) Issues related to the Center for Medicare & Medicaid Innovation

HCR

2019 · second_quarter · Q2

Firm income: —Client expense: $2,200,000Open original LDA filing ↗

Assigned issues and filing targets (4 issues)

TRD

Trade (domestic/foreign)

United States-Mexico-Canada Trade Agreement, no specific bill.

HCR

Health Issues

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289) Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act (S. 1895), a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (S. 1391) H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 637, Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act

2019 · first_quarter · Q1

Firm income: —Client expense: $3,250,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill) Issues related to Part D coverage gap, no specific bill Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues, no specific bill

HCR

Health Issues

2018 · fourth_quarter · Q4

Firm income: —Client expense: $2,700,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 6 -- Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act

HCR

Health Issues

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). S. 2042 Reducing Drug Waste Act of 2017 H.R. 6142 Reducing Drug Wastage Act of 2018 FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289) Issues related to International Pricing Index (IPI), no specific bill

2018 · third_quarter · Q3

Firm income: —Client expense: $2,660,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Medicare Part B coversage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars 340B Protecting Access for the Underserved and Safety-Net Entities S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" H.R. 5598 "340B Optimization Act" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act H.R. 4710 to the name Protecting Access for the Underserved and Safety-Net Entities H.R. 6 -- Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill)

HCR

Health Issues

2018 · second_quarter · Q2

Firm income: —Client expense: $2,290,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). S. 2042 Reducing Drug Waste Act of 2017 H.R. 6142 Reducing Drug Wastage Act of 2018 FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289)

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) Medicare Part D issues Coding and reimbursement for oncology drugs/biologics/biosimilars 340B Protecting Access for the Underserved and Safety-Net Entities S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" H.R. 5598 "340B Optimization Act" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act

2018 · first_quarter · Q1

Firm income: —Client expense: $3,310,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) Medicare Part D rebates Coding and reimbursement for oncology drugs/biologics/biosimilars H.R. 1982 Bipartisan Budget Act of 2018 (issues related to Medicare Part D coverage gap) H.R. 849 Protecting Seniors' Access to Medicare Act of 2017 (issues related to IPAB) 340B Protecting Access for the Underserved and Safety-Net Entities H.R. 1625 Consolidated Appropriations Act, 2018 (biosimilars) (Medicare Part D coverage gap) H.R. 1892 Further Extension of Continuing Appropriations Act (biosimilars)

HCR

Health Issues

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). S. 2042 Reducing Drug Waste Act of 2017 FDA issues, no specific bill H.R. 695 Department of Defense Appropriations Act

2017 · first_quarter · 1A

Firm income: —Client expense: $3,020,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule) Medicare Part D (rebates)

HCR

Health Issues

Biosimilars, no specific bill PDUFA, no specific bill Orphan Drugs, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) H.R. 1628 American Health Care Act; repeal/replace ACA

Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE

2017 · fourth_quarter · Q4

Firm income: —Client expense: $2,000,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) Medicare Part D rebates Coding and reimbursement for oncology drugs/biologics/biosimilars S. 1827 KIDS Act of 2017 H.R. 849 Protecting Seniors' Access to Medicare Act of 2017

HCR

Health Issues

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) H.R. 1628 American Health Care Act; repeal/replace ACA 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). S. 2042 Reducing Drug Waste Act of 2017 FDA issues, no specific bill

TAX

2017 · third_quarter · Q3

Firm income: —Client expense: $2,000,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule) Medicare Part D rebates Coding and reimbursement for oncology drugs/biologics End Stage Renal Disease and issues related to dialysis S. 1827 KIDS Act of 2017 H.R. 849 Protecting Seniors' Access to Medicare Act of 2017

HCR

Health Issues

Biosimilars, no specific bill PDUFA, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) H.R. 1628 American Health Care Act; repeal/replace ACA Health Resources and Services Administration (HRSA) policy regarding discounts on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill

2017 · second_quarter · Q2

Firm income: —Client expense: $3,600,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

HCR

Health Issues

Biosimilars, no specific bill PDUFA, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) H.R. 1628 American Health Care Act; repeal/replace ACA Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill

Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

2017 · first_quarter · Q1

Firm income: —Client expense: $3,020,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule) Medicare Part D (rebates)

Filing targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE

2016 · fourth_quarter · Q4

Firm income: —Client expense: $2,280,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

CPT

Trans-Pacific Partnership (12 years data exclusivity) Patent Settlements, S. 2019, the Preserve Access to Affordable Generics Act

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule)

Filing targets: HOUSE OF REPRESENTATIVES, SENATE

2016 · third_quarter · Q3

Firm income: —Client expense: $2,920,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

Trans-Pacific Partnership (12 years data exclusivity) Patent Settlements, S. 2019, the Preserve Access to Affordable Generics Act

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule) Coding and reimbursement for oncology drugs/biologics

HCR

Health Issues

Biosimilars, no specific bill H.R. 6, 21st Century Cures Act FDA Reform; Senate Innovation for Healthier Americans Initiative (no bill number) H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill Drug vial size issue, S. 3040, FY2017 Labor Health and Human Services and Education Appropriations bill, and S. 2956, FY2017 Agriculture Appropriations bill

2016 · second_quarter · Q2

Firm income: —Client expense: $2,910,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule) Medicare Part D drug reimbursement issues Coding and reimbursement for oncology drugs/biologics

HCR

Health Issues

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill S. 1767, Combination Products Innovation Act of 2015 FDA Reform; Senate Innovation for Healthier Americans Initiative (no bill number) H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

CPT

2016 · first_quarter · Q1

Firm income: —Client expense: $1,750,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

H.R. 9-Innovation Act S.632-Support Technology and Research for our Nations Growth (STRONG) Patents Act Trans-Pacific Partnership (12 years data exclusivity) S. 1137, the PATENT Act Patent Settlements, S. 2019, the Preserve Access to Affordable Generics Act

MMM

Medicare/Medicaid

Medicare Part B (Average Sales Price) (Medicare Program Part B Drug Payment Model proposed rule) Medicare Part D drug reimbursement issues Coding and reimbursement for oncology drugs/biologics

HCR

Health Issues

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill S. 1767, Combination Products Innovation Act of 2015 FDA Reform, H.R. 6, 21st Century Cures H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

2015 · fourth_quarter · Q4

Firm income: —Client expense: $2,670,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill FDA Reform, H.R. 6, 21st Century Cures H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

CPT

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B (Average Sales Price) and Medicare Part D drug reimbursement issues Coding and reimbursement for oncology drugs/biologics

2015 · third_quarter · Q3

Firm income: —Client expense: $2,910,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B (Average Sales Price) and Medicare Part D drug reimbursement issues Coding and reimbursement for oncology drugs/biologics

HCR

Health Issues

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B, Orphan Drugs), no specific bill FDA Reform, H.R. 6, 21st Century Cures Innovation for Healthier Americans Act, no specific bill S. 1906 Orphan Drug Fairness Act H.R. 3618 Orphan Drug Fairness Act

CPT

H.R. 9-Innovation Act S.632-Support Technology and Research for our Nations Growth (STRONG) Patents Act Trans-Pacific Partnership (12 years data exclusivity) S. 1137, the PATENT Act

2015 · second_quarter · Q2

Firm income: —Client expense: $1,970,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

H.R. 9-Innovation Act S.632-Support Technology and Research for our Nations Growth (STRONG) Patents Act Trans-Pacific Partnership (12 years data exclusivity) S. 1137, the PATENT Act

HCR

Health Issues

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B (Average Sales Price) and Medicare Part D drug reimbursement issues Coding and reimbursement for oncology drugs/biologics

2015 · first_quarter · Q1

Firm income: —Client expense: $2,975,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

CPT

H.R. 9-Innovation Act S.632-Support Technology and Research for our Nations Growth (STRONG) Patents Act Trans-Pacific Partnership (12 years data exclusivity)

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B (Average Sales Price) and Medicare Part D drug reimbursement issues

Filing targets: HOUSE OF REPRESENTATIVES, SENATE

2014 · fourth_quarter · Q4

Firm income: —Client expense: $1,970,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

CPT

H.R. 3309 The Innovation Act of 2013 (heightened pleading standards, discovery stay) S. 1720, The Patent Transparency and Improvements Act (demand letters, customer stay) S. 1013, The Patent Abuse Reduction Act (heightened pleading standards, discovery stay) S. 1612, The Patent Litigation Integrity Act (bonding) Trans-Pacific Partnership (12 years data exclusivity) S. 866, The Patient Quality Improvement Act (covered business method patents) Patent Reform, no specific bill

MMM

2014 · third_quarter · Q3

Firm income: $2,080,000Client expense: —Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B drug reimbursement issues (Average Sales Price) H.R. 4814 Chronic Kidney Disease Improvement in Research and Treatment Act (End Stage Renal Disease) 2015 Labor/HHS Senate Appropriations draft committee report (340B drug pricing program)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

2014 · second_quarter · Q2

Firm income: —Client expense: $1,950,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

MMM

Medicare/Medicaid

Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

2014 · first_quarter · Q1

Firm income: —Client expense: $2,560,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B drug reimbursement issues (Average Sales Price) H.R. 2810, Medicare Patient Access and Quality Improvement Act of 2013 (Medicare Physician Payments) Medicare Part D drug reimbursement issues (six protected classes)H.R. 4302, Protecting Access to Medicare Act of 2014 (Medicare Physician Payments, end stage renal disease prospective payment system bundling issues)

Filing targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

2013 · third_quarter · Q3

Firm income: —Client expense: $2,520,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B drug reimbursement issues (Average Sales Price)

Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

2013 · second_quarter · Q2

Firm income: —Client expense: $1,980,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

End Stage Renal Disease and issues related to dialysis Medicare Part B drug reimbursement issues (Average Sales Price)

Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

2013 · first_quarter · Q1

Firm income: —Client expense: $2,290,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

P.L. 112-240, American Taxpayer Relief Act of 2012 (end stage renal disease prospective payment system bundling issue) Medicare Part B drug reimbursement issues

Filing targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

2012 · fourth_quarter · Q4

Firm income: —Client expense: $2,250,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

H.R. 8, American Taxpayer Relief Act of 2012 (end stage renal disease prospective payment system bundling issues) Medicare Part B Drug reimbursement issues

Filing targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Medicare Payment Advisory Commission (MedPAC), SENATE

2012 · third_quarter · Q3

Firm income: —Client expense: $2,510,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products Medicare Part B reimbursement issues Medicare Part D Issues

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

2012 · second_quarter · 2A

Firm income: —Client expense: $1,980,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

Implementation of Health Care Reform, P.L 111-148, The Patient Protection and Affordable Care Act Biosimilars HR 5651, the Food and Drug Administration Reform Act (Prescription Drug User Fee Act Reauthorization) S 1387, the Food and Drug Administration Safety and Innovation Act (Prescription Drug User Fee Act Reauthorization)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products Medicare Part B Reimbursement Issues Medicare Part D Issues S. 1096, Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

2012 · second_quarter · Q2

Firm income: —Client expense: $1,980,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

HCR

Health Issues

Filing targets: HOUSE OF REPRESENTATIVES, SENATE

2012 · first_quarter · Q1

Firm income: —Client expense: $2,570,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products H.R. 2630, Middle Class Tax Relief and Job Creation Act of 2012 (sustainable growth rate and impact on Medicare programs; Medicare Part D co-pay assistance, Medicaid, DXA Testing, Medicare Part B Reimbursement)

HCR

Health Issues

Implementation of Health Care Reform, P.L 111-148 The Patient Protection and Affordable Care Act (Biosimilars, IPAB) Reauthorization of the Prescription Drug User Fee Act (no bill)

Filing targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

2011 · fourth_quarter · Q4

Firm income: —Client expense: $2,690,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products S. 365 Budget Control Act of 2011, S. 627 Budget Control Act of 201 - Impact of debt limit and deficit reduction issues and actions of the Joint Committee on Deficit Reduction on Medicare Part B, Medicare Part D, and Medicaid HR 3630 Temporary Payroll Tax Cut Continuation Act of 2011; HR 3765 Temporary Payroll Tax Cat Continuation Act of 2011 (Sustainable growth rate and impact on Medicare programs, Medicare Part D co-pay assistance, Medicaid, DXA Testing, Medicare Part B reimbursement)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

2011 · third_quarter · Q3

Firm income: —Client expense: $2,820,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products, Impact of debt limit and deficit reduction issues and actions of the Joint Committee on Deficit Reduction on Medicare Part B, Medicare Part D, and Medicaid (S. 365 Budget Control Act of 2011, S. 627 Budget Control Act of 2011)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

2011 · second_quarter · Q2

Firm income: —Client expense: $2,290,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products, Medicare Part D issues, Part B reimbursement issues

Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2011 · first_quarter · Q1

Firm income: —Client expense: $2,200,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Part B reimbursement and coverage of dialysis products, Medicare Part D Implementation of P.L. 111-148, "Patient Protection and Affordable Care Act"

Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2010 · second_quarter · 2A

Firm income: —Client expense: $1,920,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of P.L. 111-148 "Patient Protection and Affordable Care Act" (DXA testing; End Stage Renal Disease; Independent Payment and Advisory Board; Medicaid Drug Rebate Program) Implementation of P.L. 111-152, "Health Care and Education Reconciliation Act" (End Stage Renal Disease; Independent Payment and Advisory Board, Medicaid Drug Rebate Program) H.R. 4851 and S. 3153, "Continuing Extension Act of 2010" (Medicare Part D) H.R. 4213, "American Jobs and Closing Tax Loopholes Act of 2010" (Medicaid Drug Rebate Program) H.R. 4899, "Supplemental Appropriations Acot of 2010" (Medicaid Drug Rebate Program)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2010 · fourth_quarter · Q4

Firm income: —Client expense: $2,330,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues (End Stage Renal Disease, PHSA 340(b) Drug Discount Program, Medicare Part D) H.R. 5712, Physician Payment and Therapy Relief Act of 2010 (Medicare Part D) H.R. 4994, Medicare and Medicaid Extenders Act of 2010 (Medicare Part D) H.R. 3082, Continuing Appropriations and Surface Transportation Extensions Act, 2011 (Medicare Part D)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

2010 · third_quarter · Q3

Firm income: —Client expense: $2,940,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues (Medicare Part D) Implementation of P.L. 111-148, Patient Protection and Affordable Care Act (DXA testing; End Stage Renal Disease) Implementation of P.L. 111-152, Health Care and Education Reconciliation Act (End Stage Renal Disease) H.R. 1586, FAA Air Transportation Modernization and Safety Improvement Act (Medicaid Drug Rebate Program and changes to PHSA 340(b) Drug Discount Program) H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010 (Medicaid Drug Rebate Program and changes to PHSA 340(b) Drug Discount Program) H.R. 4899, Supplemental Appropriations Act of 2010 (Medicaid Drug Rebate Program and changes to PHSA 340(b) Drug Discount Program)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2010 · second_quarter · Q2

Firm income: —Client expense: $1,920,000Open original LDA filing ↗

Assigned issues and filing targets (1 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of P.L 111-148, "Patient Protection and Affordable Care Act" (DXA testing; End Stage Renal Disease; Independent Payment and Advisory Board; Medicaid Drug Rebate Program) Implementation of P.L. 111-152, "Health Care and Education Reconciliation Act" (End Stage Renal Disease; Independent Payment and Advisory Board, Medicaid Drug Rebate Program) H.R. 4851 and S. 3153, "Continuing Extension Act of 2010" (Medicare Part D) H.R. 4213, "American Jobs and Closing Tax Loopholes Act of 2010" (Medicaid Drug Rebate Program) H.R. 4899, "Supplemental Appropriations Act of 2010" (Medicaid Drug Rebate Program)

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2010 · first_quarter · Q1

Firm income: —Client expense: $3,070,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues HR 1894 and S 769, Medicare Fracture and Osteoporosis Testing Act of 2009 (DXA testing) HR 3590, Patient Protection and Affordable Care Act (End Stage Renal Disease; Medicaid Drug Rebate Program; Medicare Part D Co-pay Assistance, Independent Payment and Advisory Board) HR 4872, Health Care and Education Reconciliation Act (End Stage Renal Disease, Medicaid Drug Rebate Program, Independent Payment and Advisory Board)

HCR

Health Issues

HR 1427 and S 726, Promoting Innovation and Access to Life-Saving Medicine Act (Biosimilars) HR 1548, Pathway for Biosimilars Act (Biosimilars) S 1695, Biologics Price Competition and Innovation Act of 2007 (Biosimilars) HR 3590, Patient Protection and Affordable Care Act (Biosimilars) HR 4872, Health Care and Education Reconciliation Act (Biosimilars)

Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2009 · fourth_quarter · Q4

Firm income: —Client expense: $3,290,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues H.R. 1894 and S. 769 - Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 H.R. 3200, America's Affordable Health Choices Act of 2009(End Stage Renal Disease;Comparative Effectiveness) S. 1796, America's Healthy Future Act of 2009 (Medicaid Drug Rebate Program; Medicare Part D Co-pay Assistance) H.R. 3590, Patient Protection and Affordable Care Act (End Stage Renal Disease; Medicaid Drug Rebate Program; Medicare Part D Co-pay Assistance) H.R. 3962, Affordable Healthcare for America Act (End Stage Renal Disease)

HCR

Health Issues

Biosimilars H.R. 1427 and S. 726, Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548, Pathway for Biosimilars Act S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 3200, America's Affordable Health Choices Act of 2009 S. 1679, The Affordable Health Choices Act S. 1796, America's Healthy Future Act of 2009 H.R. 3590, Patient Protection and Affordable Care Act H.R. 3962, Affordable Healthcare for America Act

2009 · third_quarter · Q3

Firm income: —Client expense: $3,000,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

HCR

Health Issues

Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

2009 · second_quarter · Q2

Firm income: —Client expense: $3,400,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of the Medicaid Drug Rebate Program Issues related to End Stage Renal Disease Issues related to Medicare Part D Co-pay Assistance Comparative Effectiveness H.R. 1894 and S. 769 - Medicare Fracture Prevention and Osteoporosis Testing Act of 2009

Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2009 · first_quarter · Q1

Firm income: —Client expense: $2,750,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of the Medicaid Drug Rebate Program H.R. 1 - The American Recovery and Reinvestment Act of 2009

HCR

Health Issues

Biosimilars H.R. 1427 and S. 726, Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548, Pathway for Biosimilars Act S. 1695 - Biologics Price Competition and Innovation Act of 2007

Filing targets: HOUSE OF REPRESENTATIVES, SENATE

2008 · fourth_quarter · Q4

Firm income: —Client expense: $2,410,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

Biosimilars H.R. 1038, Access to Life-saving Medicines Act H.R. 1956, Patient Protection and Innovative Biologics Medicines Act of 2007 HR. 5629, Pathway for Biosimilars Act

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of the Medicaid Drug Rebate Program

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2008 · third_quarter · Q3

Firm income: —Client expense: $2,370,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

FDA Drug Safety Issues Biosimilars H.R. 1038, Access to Life-saving Medicines Act H.R. 1956, Patient Protection and Innovative Biologics Medicines Act of 2007 HR. 5629, Pathway for Biosimilars Act

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of the Medicaid Drug Rebate Program S. 3101 and HR 6331, Medicare Improvements for Patients and Providers Act of 2008

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2008 · second_quarter · Q2

Firm income: —Client expense: $2,850,000Open original LDA filing ↗

Assigned issues and filing targets (2 issues)

HCR

Health Issues

FDA Drug Safety Issues Biosimilars H.R. 1038, Access to Life-saving Medicines Act H.R. 1956, Patient Protection and Innovative Biologics Medicines Act of 2007 HR. 5629, Pathway for Biosimilars Act

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of the Medicaid Drug Rebate Program S. 3101 and HR 6331, Medicare Improvements for Patients and Providers Act of 2008 S. 3118, Preserving Access to Medicare Act of 2008

Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2008 · first_quarter · Q1

Firm income: —Client expense: $2,520,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

HCR

Health Issues

FDA Drug Safety Oversight Follow-On-Biologics H.R. 1038, Access to Life-saving Medicines Act H.R. 1956, Patient Protection and Innovative Biologics Medicines Act of 2007 HR. 5629, Pathway for Biosimilars Act

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of the Medicaid Drug Rebate Program

CPT

Intellectual property and process patent issues S. 1145 and H.R.. 1908 Patent Reform Act of 2007

Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

2007 · year_end · YY

Firm income: —Client expense: $7,180,000Open original LDA filing ↗

Assigned issues and filing targets (3 issues)

CPT

Intellectual property and process patent issues S. 1145 and H.R.. 1908 Patent Reform Act of 2007

HCR

Health Issues

FDA Drug Safety Oversight H.R. 2900, Prescription Drug User Fee Amendments of 2007 H.R. 3580, Food and Drug Administration Amendments Act of 2007 Follow-On-Biologics

MMM

Medicare/Medicaid

Medicare Coverage and Reimbursement Issues Implementation of H.R. 1 Medicare Prescription Drug & Modernization Act of 2003 Implementation of the Medicaid Drug Rebate Program H.R. 3162, Children's Health and Medicare Protection Act of 2007