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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 | 2021 |
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 | 11/3/2021 10:06:35 AM |
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;
Review of proposed rule regarding testing of Medicare part B prescription drug models;
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;
Medicare payment proposals;
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS)
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 the use of plasma therapies in COVID-19 patients;
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;
Discussions related to amending P.L. 97-414, Orphan Drug Act;
Issues related to global pharmaceutical supply chain operations and manufacturing locations;
Bayh-Dole march-in rights policy issues;
42 USC 1320a-7b, Anti-Kickback Statute;
42 USC 1395nn, Stark Statute;
Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;
Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order;
H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services;
H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation;
H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening;
S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced);
H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA;
S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates;
S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions;
H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors;
E.O. 13937, Access to Affordable Life-Saving Medications;
E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients;
E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen;
E.O. 13947, 13948, Lowering Drug Prices by Putting America First;
E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), 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 BUD
16. Specific lobbying issues
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding;
P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding.
FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
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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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
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
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Tax incentive issues as they relate to proposed global supply chain bills;
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits;
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
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:
| Name | Address |
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) |