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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 750 9th Street, NW |
Address2 | Suite 575 |
| City | Washington |
State | DC |
Zip Code | 20001-4584 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 57954-12
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6. House ID# 352640002
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| TYPE OF REPORT | 8. Year | 2022 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
| 10. Check if this is a Termination Report | Termination Date |
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11. No Lobbying Issue Activity |
| INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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| 12. Lobbying | 13. Organizations | ||||||||
| INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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| Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
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Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
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| Signature | Digitally Signed By: Andrew Kaplan |
Date | 1/19/2023 6:16:30 PM |
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code MMM
16. Specific lobbying issues
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues;
Policies to enhance patient access to medicines in Medicare;
Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor;
Proposals related to amending the protected classes in Medicare;
H. Res. 1390, Expressing Support for the Six Medicare Protected Class;
Medicare payment proposals;
Medicare telehealth proposals;
IVIG Medicare demonstration project;
CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F);
P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties;
Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy;
H.R. 4941, PACE Part D Choice Action of 2021 - provisions related to Medicare PDP;
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS), White House Office
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Shelley |
Stewart |
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Andrew |
Kaplan |
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Steven |
Tilton |
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Health Policy Coordinator - Energy and Commerce Committee; Senior Policy Advisor - Congressman Bilirakis |
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Natalie |
Morris |
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Erin |
Mendelsohn |
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Legislative Director - Rep Anna Eshoo; Congressional Liaison - Food and Drug Administration |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code HCR
16. Specific lobbying issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit;
Issues related to patient access of plasma therapies;
Discussions to clarify or reform the 340B program;
Discussions on value-based drug contracting;
Issues related to prescription drug vial sizes;
Proposals related to drug pricing, including House and Senate draft bills;
Discussions related to co-pay accumulators; maximizers, alternate funding models;
H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry;
Discussions related to amending P.L. 97-414, Orphan Drug Act;
Proposed FDA guidance on gastroparesis clinical trials;
Bayh-Dole march-in rights policy issues;
Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;
H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening;
Discussions related to Most Favored Nation/International Reference Pricing;
H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices;
S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation;
H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act);
H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy;
H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors;
H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices;
Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision;
S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision;
H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes;
H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity;
H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects;
H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval;
S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness;
Discussions on Customs Border Protection changes impacting southern border plasma collections;
Discussions to establish a Congressional Plasma Caucus;
Discussions related to Cancer Moonshot Initiatives;
S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection;
Issues related to Dengue vaccines;
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Shelley |
Stewart |
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Andrew |
Kaplan |
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Steven |
Tilton |
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Health Policy Coordinator - Energy and Commerce Committee; Senior Policy Advisor - Congressman Bilirakis |
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Natalie |
Morris |
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Erin |
Mendelsohn |
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Legislative Director - Rep Anna Eshoo; Congressional Liaison - Food and Drug Administration |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code TAX
16. Specific lobbying issues
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits;
H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues;
S.749, American Innovation and Jobs Act - provisions related to R&D tax issues;
P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to tax issues;
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Andrew |
Kaplan |
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Shelley |
Stewart |
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Steven |
Tilton |
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Health Policy Coordinator - Energy and Commerce Committee; Senior Policy Advisor - Congressman Bilirakis |
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Erin |
Mendelsohn |
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Legislative Director - Rep Anna Eshoo; Congressional Liaison - Food and Drug Administration |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code TRD
16. Specific lobbying issues
Issues related to trade-related pharmaceutical intellectual property (TRIPS);
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Erin |
Mendelsohn |
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Shelley |
Stewart |
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Steven |
Tilton |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code BUD
16. Specific lobbying issues
FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding;
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023;
H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA);
P.L. 117-328 (H.R. 2617), Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Steven |
Tilton |
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Health Policy Coordinator - Energy and Commerce Committee; Senior Policy Advisor - Congressman Bilirakis |
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Shelley |
Stewart |
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Erin |
Mendelsohn |
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Health Policy Coordinator - Energy and Commerce Committee; Senior Policy Advisor - Congressman Bilirakis |
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Andrew |
Kaplan |
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Natalie |
Morris |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Information Update Page - Complete ONLY where registration information has changed.
20. Client new address
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21. Client new principal place of business (if different than line 20)
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22. New General description of client’s business or activities
LOBBYIST UPDATE
23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
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Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
| 1 | 2 | 3 |
FOREIGN ENTITIES
27. Add the following foreign entities:
| Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
| 1 | 3 | 5 |
| 2 | 4 | 6 |
CONVICTIONS DISCLOSURE
29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery,
extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
| Lobbyist Name | Description of Offense(s) |