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Reported covered position: Legislative Assistant, Rep. Karen McCarthy;Senior Health Policy Advisor, Rep. Diana DeGette
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
BAXALTA US INC. via BAXALTA US INC.
2016 · second_quarter · 2T
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.
Source: Senate LDA
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims.
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement
Medicare Home Infusion Site of Care Act of 2015
Client: BAXALTA US INC. · Firm: BAXALTA US INC.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration
Article 29 Working Party on the Protection of Individuals (WP29) statement regarding the landmark CJEU ruling invalidating Safe Harbor as a mechanism of establishing adequacy supporting EU-US data transfers.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BAXALTA US INC. via BAXALTA US INC.
2016 · first_quarter · Q1
FDA rules regarding information requirements for importation of FDA-regulated products
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing
International tax reform
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
Article 29 Working Party on the Protection of Individuals (WP29) statement regarding the landmark CJEU ruling invalidating Safe Harbor as a mechanism of establishing adequacy supporting EU-US data transfers.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BAXALTA US INC. via BAXALTA US INC.
2015 · fourth_quarter · Q4
International tax reform
FDA rules regarding information requirements for importation of FDA-regulated products
Article 29 Working Party on the Protection of Individuals (WP29) statement regarding the landmark CJEU ruling invalidating Safe Harbor as a mechanism of establishing adequacy supporting EU-US data transfers.
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars Gene Therapy Drug Pricing
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BAXALTA US INC. via BAXALTA US INC.
2015 · third_quarter · Q3
H.R. 9, the Innovation Act: To amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes. S. 1137, the Protecting American Talent and Entrepreneurship Act of 2015. A bill to amend title 35, United States Code, and the Leahy-Smith America Invents Act to make improvements and technical corrections, and for other purposes.
H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Biosimilars
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims.
International tax reform
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BAXALTA US INC. via BAXALTA US INC.
2015 · third_quarter · RR
340B Drug Discount Program; Medicare Part B Drug Reimbursement; International Tax Reform; Patent Litigation Reform; Biosimilars; Appropriations
340B Drug Discount Program; Medicare Part B Drug Reimbursement; International Tax Reform; Patent Litigation Reform; Biosimilars; Appropriations
340B Drug Discount Program; Medicare Part B Drug Reimbursement; International Tax Reform; Patent Litigation Reform; Biosimilars; Appropriations
340B Drug Discount Program; Medicare Part B Drug Reimbursement; International Tax Reform; Patent Litigation Reform; Biosimilars; Appropriations
340B Drug Discount Program; Medicare Part B Drug Reimbursement; International Tax Reform; Patent Litigation Reform; Biosimilars; Appropriations
340B Drug Discount Program; Medicare Part B Drug Reimbursement; International Tax Reform; Patent Litigation Reform; Biosimilars; Appropriations